Protium 40 mg i.v.

Protiumi.v.

Powder for Solution for Injection

Pantoprazole

What you should know about Protiumi.v.

Read the whole of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again


• If you have any further questions, ask your doctor or pharmacist


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours


• If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Protiumi.v. powder for solution for injection. In the rest of this leaflet your medicine is called Protiumi.v.

Protiumi.v. is one of a group of medicines called proton pump inhibitors, which work by reducing the amount of acid your stomach produces.

What is in your medicine?

What Protiumi.v. contains

The active substance in Protiumi.v. is pantoprazole. Each injection contains 40 mg of pantoprazole as pantoprazole sodium.

The other ingredients are edetate disodium dihydrate and sodium chloride.

What Protiumi.v. looks like

Protiumi.v. is a powder in a glass container with a rubber cap.

Contents of the pack

It comes in packs of 1, 5 and 20 containers.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Nycomed GmbH

Konstanz

Germany

Manufacturer:

Nycomed GmbH

Singen

Germany

Marketing Company:

Nycomed UK Ltd

Marlow

Buckinghamshire

UK

What is your injection for?

Protiumi.v. is used to treat ulcers in your stomach or intestine. It is used to treat and prevent acid rising from your stomach into your food pipe (oesophagus), which causes symptoms similar to severe heartburn. Protiumi.v. is used to treat conditions in which your stomach produces too much acid.

Before you are given your injection

Do not take Protiumi.v. if:

• You are allergic to pantoprazole or any of the other ingredients in Protiumi.v.


• If you are taking a medicine containing atazanavir (for the treatment of HIV-infection) at the same time.

Take special care with Protiumi.v. if:

• You think you have signs of stomach cancer. These include persistent weight loss, dark
  stools, loss of appetite, feeling full or a lump in your stomach”.

If the above statement applies to you, ask your doctor or pharmacist for advice before you take Protiumi.v.

Taking other medicines

Ask your doctor or pharmacist for advice before taking Protiumi.v. if you are taking any of the following medicines:

• Tablets containing ketoconazole, used to treat fungal infections of the skin and nails. Protiumi.v. may increase or decrease the effect of ketoconazole by altering the
  amount that gets into your body


• Medicines to thin your blood, such as warfarin, phenprocoumon or acenocoumarol.
  Protiumi.v. may alter the effect of these medicines. So your doctor may monitor how well your blood clots.


• Atazanavir, which is commonly used for the treatment of HIV infection. This is because
  Protium i.v. may decrease the amount of atazanavir that gets into your body.

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other
medicine – even those not prescribed.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking Protiumi.v.:

• If you are pregnant or planning to become pregnant


• If you are breast-feeding.

How is Protiumi.v. used?

Protiumi.v. is only used when you cannot take Protium tablets. Protiumi.v. is only for intravenous use (i.e. injection or infusion directly into a vein).

Protiumi.v. is supplied as a powder to which your doctor or nurse will add 10 ml of salt solution to make it into a liquid that can be injected. They may add more liquid, either a salt or sugar solution. This makes the medicine ready for you to have as an infusion (a slow injection lasting 2-15 minutes). Your doctor or nurse will give you Protiumi.v.

The usual dose is one 40 mg injection or infusion per day for up to one week. Your doctor will
switch from Protiumi.v. to Protium tablets as soon as possible.

If your stomach is producing too much acid, the usual starting dose is 80 mg per day. Your doctor will adjust the dose to match the amount of acid your stomach produces.

If you have liver problems, you should not take more than 20 mg of pantoprazole per day.

Protiumi.v. is not recommended for use in children under 18 years.

When your course of injections is finished, your doctor may prescribe further treatment with tablets.

What to do if you forget a dose, or take too many tablets

If you take more Protiumi.v. than you should, contact a doctor or nurse immediately.

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your
next dose. If it is, do not take the missed dose at all. Do not take two doses to make up for the one you have missed.

Do not stop taking Protiumi.v. just because you feel better. If you stop taking your injections too soon, your symptoms may return.

Will Protiumi.v. cause any problems?

Like all medicines, Protiumi.v. can cause side effects, although not everybody gets them.

Common side effects (affect less than 1 in 10 people) are:

• Headache


• Stomach pain


• Constipation


• Wind


• Diarrhoea.

Uncommon side effects (affect less than 1 in 100 people) are:

• Skin rash


• Itchiness


• Feeling sick


• Being sick


• Dizziness


• Blurred vision.

Rare side effects (affect less than 1 in 1000 people) are:

• Dry mouth


• Joint pain


• Depression


• Hallucination


• Disorientation


• Confusion.

Very rare side effects (affect less than 1 in 10,000 people) are:

• A reduction in white cells in your blood (often seen by increased infections)


• A reduction in platelets in your blood (often seen as a tendency to bruise or bleed)


• Swollen ankles, legs or arms


• Severe anaphylactic reactions (sometimes seen as swollen tongue or throat, feeling faint, increased sweating or increased pulse rate)


• Fever


• Muscle pain


• Swelling of your kidneys (sometimes seen as lower back discomfort, changes (either more
  or less) in the amount of urine you pass or traces of blood in your urine)


• Sensitivity to sunlight


• Blistering of the skin


• Increases in some of the chemicals in your liver


• Increased fats in your blood


• Liver problems (often seen as yellowing of the skins or the whites of your eyes).

If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, tell your doctor or pharmacist.

Storing your medicine

Keep your medicine out of the reach and sight of children.

Do not take your medicine after the expiry date given on the carton. The expiry date is the last day of the month shown on the pack.

Do not store above 25°C. Keep the container in the outer carton.

Once Protiumi.v. has been prepared as a solution ready for injection, it is usually used immediately and should not be kept for more than 12 hours, at no more than 25°C.

Do not use Protiumi.v. if you notice the prepared solution is cloudy or contains particles.

The contents of a container should only be used once and any leftover medicine disposed
of. Give any leftover medicine to your doctor or nurse. If you do this, it will help protect the
environment. Do not put your medicine down the drain or in the dustbin.

Protiumi.v. is a registered trademark of Nycomed GmbH Germany.

This leaflet was last approved in January 2008.

GRBR F.1/0108/3.5594.92

Tandem Capsules

Generic Name: ferrous fumarate and ferrous asparto glycinate

Dosage Form: capsule
see all prescribing information for Tandem DESCRIPTION: Each capsule contains: Ferrous Fumarate (anhydrous) .191.1 mg Polysaccharide Iron Complex..135.9 mg (Equivalent to about 125 mg of elemental iron) Vitamin C (from ProAscorb C‡).40 mg Vitamin B3 (from ProAscorb C‡) ..3 mg  Inactive Ingredients: Hypromellose, Magnesium Stearate, Titanium Dioxide,

CLINICAL PHARMACOLOGY: IntegraTM is unique in that it utilizes two (2) different forms of iron, i.e., Ferrous Fumarate and Polysaccharide Iron Complex (as cell-contracted akaganèite), making available a total of 125 mg of elemental iron per capsule as follows:

Ferrous Fumarate (anhydrous)    191.1 mg Polysaccharide iron complex (PIC)    135.9 mg

Ferrous Fumarate: Provides about 62.5 mg of elemental iron per dose. Ferrous Fumarate is an anhydrous salt of a combination of ferrous iron and fumaric acid, containing 33% of iron per weight. The acute toxicity in experimental animals is low and Ferrous Fumarate is well tolerated clinically. As a ferrous salt, it is more efficiently absorbed in the duodenum. Iron absorption is maximal in the duodenum unlike Ferrous Sulfate, which must be protected against oxidation through coating. The IntegraTM Capsule is superior to enteric coated or sustained release preparations that are apt to pass beyond the duodenum and would therefore be poorly absorbed. Ferrous Fumarate contrasts very favorably with the availability of the 20% of elemental iron of ferrous sulfate, and the 13% of elemental iron of ferrous gluconate. Calculation of Dose should be in terms of elemental iron and three doses ranging from 50-100 mg of elemental iron is usually adequate.

Polysaccharide Iron Complex: Provides about 62.5 mg elemental iron, as a cell-contracted akaganèite. It is a product of ferric iron complexed to a low molecular weight polysaccharide. This polysaccharide is produced by the extensive hydrolysis of starch and is a dark brown powder, that dissolves in water to form a very dark brown solution, which is virtually odorless and tasteless.

All IntegraTM products include a unique patented source of iron, e.g. Ferrous Fumarate and Polysaccharide Iron Complex (U.S. Patent No: 11/243,043 Pending). "An increase in tolerability is observed with the (patented formulation) and is believed to occur as the result of distributing the total iron content in the composition among compounds that provide iron to the patient's blood stream via two different mechanisms. The ferrous salts are readily absorbed in the upper gut, by direct dissolution and absorption of the ferrous iron by the bloodstream. However, the iron available from PIC is absorbed in the lower gut, via an active protein transport mechanism".

Clinical Studies: Because Ferrous Fumarate is an organic complex, it contains no free ions, either ferric or ferrous. Polysaccharide Iron Complex is clinically non-toxic. Prior studies in rats demonstrated that Polysaccharide Iron Complex (PIC), when administered as a single oral dose to Sprague Dawley rats, did not produce evidence of toxicity at a dosage level of 5000 mg Iron/kg: (An Acute Oral Toxicity Study in Rats with Polysaccharide-Iron Complex. T.N.Merriman, M. Aikman and R.E. Rush, Springborn Laboratories. Inc. Spencerville, Ohio Study No. 3340.1 March - April 1994). Other clinical studies had demonstrated that Poly-saccharide Iron gives a good hematopoietic response with an almost complete absence of the side effects usually associated with oral iron therapy. Picinni and Ricciotti suggested in 1982, that "the therapeutic effectiveness of Polysaccharide Iron Complex when compared with iron fumarate in the treatment of iron deficiency anemia, appears to be as active as the iron fumarate and as well tolerated, however, it exerted a greater influence on the level of hemoglobin and on the number of red cells..." and that, "it has been exceptionally well tolerated by all patients" (Picinni, L.-Ricciotti, M. 1982. Therapeutic effectiveness of an iron-polysaccharide complex in comparison with iron fumarate in the treatment of iron deficiency anemias): PANMINERVA MEDICA-EUROPA MEDICA, Vol. 24, No. 3, pp. 213-220 (July-September 1982). The patented source of iron used in IntegraTM (Ferrous Fumarate and Polysaccharide Iron Complex) provides a high level of elemental iron with a low incidence of gastric distress.

CONCLUSION: Based on the results of this study, the oral combination of Ferrous Fumarate and Polysaccharide Iron Complex was better tolerated and safer than the oral administration of Ferrous Fumarate alone. The conclusion of this research stated, that the addition of PIC to Ferrous Fumarate surprisingly allows the same concentration of Ferrous Fumarate to be better tolerated than the Ferrous Fumarate alone.

INDICATIONS: The treatment of iron deficiency anemia, which may occur due to an increased need for iron, a deficient intake of iron, or an excessive loss of iron.

CONTRAINDICATIONS: All iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis and hemolytic anemias.

WARNING: Accidental overdose is the leading cause of fatal poisoning in children under six. Keep this and all drugs out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

PRECAUTIONS: Existing gastrointestinal diseases, i.e. peptic ulcers, regional enteritis, ulcerative colitis may be aggravated by causing the iron not to be absorbed and therefore, be ineffective in patients with steatorrhea or those with a partial gastrectomy. It is important to determine and treat the underlying cause of the anemia, in addition to the administration of IntegraTM. Indefinite administration of iron should be avoided.

DOSAGE AND ADMINISTRATION: Adults (persons over 12 years of age), One (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage. Do not administer to children under the age of 12.

TIME AND DURATION: The hematologic response to orally administered iron is indicated by reticulocytosis of 2% to 10% depending on the severity of the anemia, beginning five to ten days after initiation of therapy. A rise in hemoglobin value is observable at the end of the second week. When therapy is adequate, hemoglobin value increases 0.1 to 0.2 gm per 100 ml of blood a day and usually becomes normal in two months. However, to improve body iron stores, treatment may be continued from 3 to 12 months, after the hemoglobin has returned to normal. If no satisfactory response is noted after three weeks of therapy, consideration should be given to (1) whether dosage recommendations have been followed, (2) blood loss is occurring simultaneously, (3) whether there are complicating causes, such as infection, defects in absorption or utilization, (4) whether diagnosis or iron-deficiency was correct.

WARNING: Do not administer to pediatric patients. Do not exceed recommended dosage. Keep this and all drugs out of reach of pediatric patients. If you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

TANDEM   ferrous fumarate and polysacchride iron complex   capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52747-900 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS FUMARATE (IRON) FERROUS FUMARATE 162 mg FERROUS ASPARTO GLYCINATE (IRON) FERROUS ASPARTO GLYCINATE 115.2 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color brown (Light creamy brown) Score score with uneven pieces Shape CAPSULE (Tandem) Size 18mm Flavor Imprint Code Tandem;US Contains

Packaging # NDC Package Description Multilevel Packaging 1 52747-900-90 90 CAPSULE In 1 BLISTER PACK None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/17/2006

TANDEM - F   ferrous fumarate and polysacchride iron complex and folic acid  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52747-901 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS ASPARTO GLYCINATE (IRON) FERROUS ASPARTO GLYCINATE 115.2 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg FERROUS FUMARATE (IRON) FERROUS FUMARATE 162 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color red (red) , brown (brown) Score score with uneven pieces Shape CAPSULE Size 18mm Flavor Imprint Code Tandem;F;US Contains

Packaging # NDC Package Description Multilevel Packaging 1 52747-901-60 90 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/17/2006

TANDEM PLUS   ferrous fumarate and polysacchride iron vitamin mineral complex supplement  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52747-902 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS FUMARATE (IRON) FERROUS FUMARATE 162 mg FERROUS ASPARTO GLYCINATE (IRON) FERROUS ASPARTO GLYCINATE 115.2 mg SODIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 200 mg THIAMINE MONONITRATE (THIAMINE) THIAMINE 10 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 6 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 5 mg CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 15 ug NIACINAMIDE (NIACIN) NIACIN 30 mg CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 10 mg ZINC SULFATE (ZINC CATION) ZINC CATION 18.2 mg MAGNESIUM SULFATE (MAGNESIUM) MAGNESIUM 1.3 mg CUPRIC SULFATE (COPPER) COPPER 0.8 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color pink (Pink) Score score with uneven pieces Shape CAPSULE Size 22mm Flavor Imprint Code Tandem;Plus;US Contains

Packaging # NDC Package Description Multilevel Packaging 1 52747-902-60 90 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/17/2006

Labeler - US Pharmaceutical Corporation (048318224)

Registrant - US Pharmaceutical Corporation (048318224)

Revised: 12/2009US Pharmaceutical Corporation

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• Tandem Capsules Use in Pregnancy & Breastfeeding
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• Iron Deficiency Anemia

Truvada

Pronunciation: EM-trye-SYE-ta-been/ten-OF-oh-vir
Generic Name: Emtricitabine/Tenofovir
Brand Name: Truvada

Severe and sometimes fatal lactic acidosis (a buildup of lactic acid in the blood) and liver problems have occurred with this type of medicine. The risk may be greater in women, patients who are very overweight, or patients who have been taking nucleoside medicines (eg, emtricitabine, tenofovir) for a long time.

Tell your doctor right away if you develop symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or light-headedness; fast or irregular heartbeat). Tell your doctor right away if you develop symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, persistent loss of appetite, nausea, stomach pain).

Truvada has not been approved to treat hepatitis B virus (HBV) infection. The safety and effectiveness of Truvada in patients who have both HBV and HIV infection have not been confirmed. Some patients with both HBV and HIV infection who took Truvada experienced severe worsening of HBV infection after they stopped taking it. Patients who have both HBV and HIV infection need close medical follow-up to check for worsening liver problems for at least several months after they stop Truvada. Keep all doctor and lab appointments. Do not stop taking Truvada without checking with your doctor.

Truvada is used for:

Treating HIV infection in combination with other medicines. Truvada is not a cure for HIV or AIDS. It may also be used for other conditions as determined by your doctor.

Truvada is an antiviral combination of 2 reverse transcriptase inhibitors. It works by reducing the amount of HIV in the body by blocking its ability to multiply.

Do NOT use Truvada if:

• you are allergic to any ingredient in Truvada


• you have severe kidney problems or if you require dialysis treatments


• you are taking adefovir, medicines that contain lamivudine, or another medicine that contains emtricitabine or tenofovir


• you take a medicine that may harm your kidneys (eg, an aminoglycoside antibiotic [eg, gentamicin], amphotericin B, cyclosporine, a nonsteroidal anti-inflammatory drug [NSAID] [eg, ibuprofen], tacrolimus, vancomycin). Ask you doctor if you are not sure if any of your medicines might harm your kidneys

Contact your doctor or health care provider right away if any of these apply to you.

Before using Truvada:

Some medical conditions may interact with Truvada. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have kidney problems, lactic acidosis, abnormal liver function tests or liver problems, including HBV infection


• if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition), or if you have a history of bone problems (eg, fracture)

Some MEDICINES MAY INTERACT with Truvada. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, or medicines that may harm your kidneys (eg, an aminoglycoside antibiotic [eg, gentamicin], amphotericin B, cyclosporine, an NSAID eg, [ibuprofen], tacrolimus, vancomycin) because they may increase the risk of Truvada's side effects. Ask your doctor or pharmacist if you are not sure if any of your medicines may affect your kidneys


• Adefovir, other medicines that contain emtricitabine or tenofovir, lamivudine, or certain protease inhibitors (eg, atazanavir, lopinavir/ritonavir, tipranavir) because they may increase the risk of Truvada's side effects


• Didanosine because the risk of its side effects may be increased by Truvada

This may not be a complete list of all interactions that may occur. Ask your health care provider if Truvada may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Truvada:

Use Truvada as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Truvada. Talk to your pharmacist if you have questions about this information.


• Take Truvada by mouth with or without food.


• Continue to take Truvada even if you feel well. Do not miss any doses.


• Do not suddenly stop taking Truvada without checking with your doctor. This may cause the virus to become less sensitive to this or other medicines. Some conditions (eg, hepatitis B) could become worse if you suddenly stop taking Truvada.


• Taking Truvada at the same time each day will help you remember to take it.


• If you miss a dose of Truvada, take it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than 1 dose in the same day.

Ask your health care provider any questions you may have about how to use Truvada.

Important safety information:

• Truvada may cause dizziness or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Truvada with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• You should be tested for HBV infection before you start to take Truvada.


• Keep a list of all the medicines that you take. Make a new list each time medicines are added or stopped. Find out about medicines that should not be taken while you are using Truvada. Be sure that each of your health care providers knows all the medicines that you are taking.


• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Truvada, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.


• Truvada is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.


• Truvada does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.


• Truvada is not for the treatment of HBV. If you have HBV and HIV, you will need close medical follow-up for several months after stopping treatment with Truvada. Follow-up includes medical exams and blood tests to check for HBV infection that could be getting worse.


• The risk of severe side effects (eg, lactic acidosis, severe liver problems) may be greater in women, patients who are very overweight (obese), and patients who have taken nucleoside medicines (eg, emtricitabine, tenofovir) for a long time. Talk with your doctor if you have questions about your risk for severe side effects from Truvada.


• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Truvada. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.


• Truvada may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Truvada.


• Ask your doctor if you should take a calcium and vitamin D supplement while you are taking Truvada.


• Lab tests, including liver function, kidney function, and bone mineral density, may be performed while you use Truvada. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Truvada should be used with extreme caution in CHILDREN younger than 12 years old, in children weighing less than 77 lb (35 kg), and in ELDERLY patients older than 65 years old; safety and effectiveness in these patients have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Truvada while you are pregnant. It is not known if Truvada is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Truvada to the baby. Do not breast-feed while taking Truvada.

Possible side effects of Truvada:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal skin sensations; back pain; cough; darkened skin color on the palms of hands or soles of feet; diarrhea; dizziness; gas; headache; indigestion; joint pain; loss of appetite; nausea; sinus drainage; skin discoloration (small spots or freckles); strange dreams; sweating; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bone pain; chest pain; fever; mental or mood changes (eg, depression); muscle pain or weakness; numbness, burning, pain, or tingling in the hands or feet; severe or persistent dizziness; severe or persistent nausea or vomiting; shortness of breath; stomach pain; symptoms of kidney problems (eg, increased or decreased urination, increased thirst); symptoms of lactic acidosis (eg, unusual weakness or tiredness; unusual muscle pain; fast or difficult breathing; stomach pain with nausea and vomiting; feeling cold, especially in the arms and legs; dizziness or light-headedness; fast or irregular heartbeat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; persistent loss of appetite).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Truvada side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Truvada:

Store Truvada at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Do not use Truvada if the seal over the bottle opening is broken or missing. Keep Truvada in its original container and keep the container tightly closed. Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away, make sure that children or pets cannot find them. Keep Truvada out of the reach of children and away from pets.

General information:

• If you have any questions about Truvada, please talk with your doctor, pharmacist, or other health care provider.


• Truvada is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Truvada. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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• Truvada Side Effects (in more detail)
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Twynsta

Pronunciation: TEL-mi-SAR-tan/am-LOE-di-peen
Generic Name: Telmisartan/Amlodipine
Brand Name: Twynsta

Do not use Twynsta if you are pregnant. It may cause birth defects or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away.

Twynsta is used for:

Treating high blood pressure. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Twynsta is a calcium channel blocker and angiotensin II receptor blocker combination. It works by relaxing the blood vessels.

Do NOT use Twynsta if:

• you are allergic to any ingredient in Twynsta


• you are pregnant


• you are taking ramipril

Contact your doctor or health care provider right away if any of these apply to you.

Before using Twynsta:

Some medical conditions may interact with Twynsta. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are a woman of childbearing age


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you are vomiting or have diarrhea


• if you are dehydrated, have low blood volume or low blood sodium levels, or are on a low-salt (sodium) diet


• if you have gallbladder, liver, or kidney problems; high blood potassium levels; low blood pressure; blood vessel problems; or heart problems (eg, heart failure, angina, narrowing of heart blood vessels)


• if you have a history of a stroke or a heart attack


• if you have diabetes and you are also taking aliskiren


• if you are on dialysis or will be having surgery


• if you are taking another medicine for blood pressure or heart problems

Some MEDICINES MAY INTERACT with Twynsta. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood pressure may be increased


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, celecoxib, ibuprofen) because the risk of kidney problems may be increased and they may decrease Twynsta's effectiveness


• Aliskiren, potassium-sparing diuretics (eg, triamterene), or potassium supplements because the risk of high blood potassium levels may be increased


• ACE inhibitors (eg, lisinopril, ramipril) because the risk of serious kidney problems and high blood potassium levels may be increase


• Potassium-sparing diuretics (eg, triamterene) or potassium supplements because high blood potassium levels may occur


• Certain azole antifungals (eg, itraconazole, ketoconazole), conivaptan, or HIV protease inhibitors (eg, ritonavir) because they may increase the risk of Twynsta's side effects


• Digoxin, lithium, or simvastatin because the risk of their side effects may be increased by Twynsta

This may not be a complete list of all interactions that may occur. Ask your health care provider if Twynsta may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Twynsta:

Use Twynsta as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Twynsta. Talk to your pharmacist if you have questions about this information.


• Take Twynsta by mouth with or without food.


• Do not take a tablet out of the blister until you are ready to take Twynsta.


• To remove a tablet from the blister, peel the paper layer away from the foil, then push the tablet through the foil.


• Be sure to drink enough liquids while you are taking Twynsta. If you do not, you may become dehydrated, which may increase your risk of low blood pressure. Discuss any questions or concerns with your doctor.


• Take Twynsta on a regular schedule to get the most benefit from it. Taking Twynsta at the same time each day will help you remember to take it.


• Continue to take Twynsta even if you feel well. Do not miss any doses.


• If you miss a dose of Twynsta, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Twynsta.

Important safety information:

• Twynsta may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Twynsta with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Twynsta may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• It may take up to 4 weeks to get the full benefit from Twynsta. Do not stop using Twynsta without checking with your doctor.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Check with your doctor before you use a salt substitute or a product that has potassium in it.


• If vomiting, diarrhea, or excessive sweating occur, you will need to take care not to become dehydrated. This could increase your risk for low blood pressure. Contact your doctor for instructions.


• Tell your doctor or dentist that you take Twynsta before you receive any medical or dental care, emergency care, or surgery.


• Talk with your doctor or pharmacist about all of your blood pressure medicines and how to use them. Do not start, stop, or change the dose of any blood pressure medicine unless your doctor tells you to.


• Lab tests, including blood pressure, liver and kidney function, and blood electrolyte levels, may be performed while you use Twynsta. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Twynsta with caution in the ELDERLY; they may be more sensitive to its effects.


• Twynsta should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Twynsta may cause birth defects, or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Twynsta is found in breast milk. Do not breast-feed while taking Twynsta.

Possible side effects of Twynsta:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; flushing of the face and neck; mild back pain; nausea; stomach pain; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); change in the amount of urine produced; chest, jaw, or left arm pain; fainting; fast, slow, or irregular heartbeat; mental or mood changes (eg, depression); muscle pain, aches, or weakness; numbness of an arm or leg; severe or persistent diarrhea, nausea, or stomach pain; severe or persistent dizziness or light-headedness; shortness of breath; sudden, severe headache or vomiting; sudden, unexplained weight gain; sudden vision changes; swelling of the feet, ankles, or hands; worsening of angina pain (eg, longer, more often, more severe); yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Twynsta side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; fast or slow heartbeat; severe dizziness or light-headedness.

Proper storage of Twynsta:

Store Twynsta between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Twynsta out of the reach of children and away from pets.

General information:

• If you have any questions about Twynsta, please talk with your doctor, pharmacist, or other health care provider.


• Twynsta is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Twynsta. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Twynsta resources

• Twynsta Side Effects (in more detail)
• Twynsta Use in Pregnancy & Breastfeeding
• Twynsta Drug Interactions
• Twynsta Support Group
• 2 Reviews for Twynsta - Add your own review/rating

• Twynsta Prescribing Information (FDA)


• Twynsta Advanced Consumer (Micromedex) - Includes Dosage Information


• Twynsta Consumer Overview

Compare Twynsta with other medications

• High Blood Pressure

Tinactin Jock Itch Topical

Generic Name: tolnaftate (Topical route)

tol-NAF-tate

Commonly used brand name(s)

In the U.S.

• Absorbine Jr. Antifungal


• Aftate


• Blis-To-Sol


• Dermasept Antifungal


• Fungi-Guard


• Podactin


• Q-Naftate


• Tinactin


• Tinaderm


• Ting

In Canada

• Athlete's Foot Gel


• Dr. Scholl's Athlete's Foot


• Pitrex


• Scholl's Athlete's Foot Spray


• Scholl Tritin Antifungal Powder


• Scholl Tritin Antifungal Spray Powder


• Tinactin Aerosol Liquid


• Tinactin Aerosol Powder


• Tinactin Jock Itch


• Tinactin Plus


• Tinactin Plus Aerosol Powder

Available Dosage Forms:

• Ointment


• Spray


• Cream


• Lotion


• Gel/Jelly


• Powder


• Solution

Therapeutic Class: Antifungal

Uses For Tinactin Jock Itch

Tolnaftate belongs to the group of medicines called antifungals. It is used to treat some types of fungus infections. It may also be used together with medicines taken by mouth for fungus infections.

Tolnaftate is available without a prescription.

Before Using Tinactin Jock Itch

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Tolnaftate should not be used on children up to 2 years of age, unless otherwise directed by your doctor. Although there is no specific information comparing use of tolnaftate in children 2 years of age and older with use in other age groups, this medicine is not expected to cause different side effects or problems in children 2 years of age and older than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of tolnaftate in the elderly with use in other age groups.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of tolnaftate

This section provides information on the proper use of a number of products that contain tolnaftate. It may not be specific to Tinactin Jock Itch. Please read with care.

Before applying tolnaftate, wash the affected area and dry thoroughly. Then apply enough medicine to cover the affected area.

Keep this medicine away from the eyes.

For patients using the powder form of this medicine:

• If the powder is used on the feet, sprinkle it between toes, on feet, and in socks and shoes.

For patients using the aerosol powder form of this medicine:

• Shake well before using.


• From a distance of 6 to 10 inches, spray the powder on the affected areas. If it is used on the feet, spray it between toes, on feet, and in socks and shoes.


• Do not inhale the powder.


• Do not use near heat, near open flame, or while smoking.

For patients using the solution form of this medicine:

• If tolnaftate solution becomes a solid, it may be dissolved by warming the closed container of medicine in warm water.

For patients using the aerosol solution form of this medicine:

• Shake well before using.


• From a distance of 6 inches, spray the solution on the affected areas. If it is used on the feet, spray between toes and on feet.


• Do not inhale the vapors from the spray.


• Do not use near heat, near open flame, or while smoking.

To help clear up your infection completely, keep using this medicine for 2 weeks after burning, itching, or other symptoms have disappeared , unless otherwise directed by your doctor. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage forms (aerosol powder, aerosol solution, cream, gel, powder, or topical solution):
  
  • For fungus infections:
    
    • Adults and children 2 years of age and over—Apply to the affected area(s) of the skin two times a day.
    
    
    • Children up to 2 years of age—Use is not recommended except under the advice and supervision of your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Tinactin Jock Itch

If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your health care professional.

To help prevent reinfection after the period of treatment with this medicine, the powder or spray powder form of this medicine may be used each day after bathing and carefully drying the affected area.

Tinactin Jock Itch Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Skin irritation not present before use of this medicine

When you apply the aerosol solution form of this medicine, a mild temporary stinging may be expected.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Tinactin Jock Itch Topical side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Tinactin Jock Itch Topical resources

• Tinactin Jock Itch Topical Side Effects (in more detail)
• Tinactin Jock Itch Topical Use in Pregnancy & Breastfeeding
• Tinactin Jock Itch Topical Support Group
• 0 Reviews for Tinactin Jock Itch Topical - Add your own review/rating

Compare Tinactin Jock Itch Topical with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Guiatussin with Codeine

Generic Name: codeine and guaifenesin (KOE deen and gwye FEN a sin)

Brand Names: Allfen CD, Allfen CDX, Brontex, Cheracol with Codeine, Cheratussin AC, Dex-Tuss, Diabetic Tussin C, Duraganidin NR, ExeClear-C, Guaiatussin AC, Guaifen-C, Guiatuss AC, Guiatussin with Codeine, Iophen-C NR, M-Clear WC, Mar-cof CG, Mytussin AC, Robafen AC, Robitussin-AC, Tussi-Organidin NR, Tussi-Organidin-S NR, Tussiden C, Tusso-C

What is Guiatussin with Codeine (codeine and guaifenesin)?

Codeine is in a group of drugs called narcotics. It is a cough suppressant that affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen mucus congestion in your chest and throat, making it easier to cough out through your mouth.

The combination of codeine and guaifenesin is used to treat cough and to reduce chest congestion caused by upper respiratory infections or the common cold.

Codeine and guaifenesin will not treat a cough that is caused by smoking, asthma, or emphysema.

Codeine and guaifenesin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Guiatussin with Codeine (codeine and guaifenesin)?

Ask a doctor or pharmacist before using any other cough or cold medicine. Guaifenesin is contained in many combination medicines. Taking certain products together can cause you to get too much guaifenesin. Check the label to see if a medicine contains an guaifenesin, or an expectorant. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Codeine may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

What should I discuss with my healthcare provider before taking Guiatussin with Codeine (codeine and guaifenesin)?

You should not take this medication if you are allergic to codeine or guaifenesin.

To make sure you can safely take codeine and guaifenesin, tell your doctor if you have any of these other conditions:

• 
  

  heart disease, heart rhythm disorder;

  
  


• 
  

  asthma, COPD, emphysema, or other breathing disorders;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  a stomach or intestinal disorder;

  
  


• 
  

  Addison's disease or other adrenal gland disorders;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  a thyroid disorder;

  
  


• liver or kidney disease;


• 
  

  enlarged prostate; or

  
  


• 
  

  a history of depression, mental illness, or drug addiction;

  
  

FDA pregnancy category C. It is not known whether codeine and guaifenesin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Codeine may be habit forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

Liquid forms of this medication may contain sugar or artificial sweetener (phenylalanine). Talk to your doctor before using this form of codeine and guaifenesin if you have diabetes or phenylketonuria (PKU).

How should I take Guiatussin with Codeine (codeine and guaifenesin)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take codeine and guaifenesin with food if it upsets your stomach. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you also have a fever, headache, or skin rash.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using codeine and guaifenesin.

Do not stop using this medication suddenly after long-term use or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medication. Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since cough medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of codeine can be fatal.

Overdose symptoms may include extreme dizziness or drowsiness, nausea, vomiting, sweating, confusion, hallucinations, cold and clammy skin, blue-colored lips or fingernails, weak or limp muscles, pinpoint pupils, weak pulse, slow breathing, fainting, or seizures (convulsions).

What should I avoid while taking Guiatussin with Codeine (codeine and guaifenesin)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Ask a doctor or pharmacist before using any other cough or cold medicine. Guaifenesin is contained in many combination medicines. Taking certain products together can cause you to get too much guaifenesin. Check the label to see if a medicine contains an guaifenesin, or an expectorant. Drinking alcohol can increase certain side effects of codeine and guaifenesin.

Guiatussin with Codeine (codeine and guaifenesin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  severe dizziness or drowsiness;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  urinating less than usual or not at all; or

  
  


• 
  

  slow heart rate, weak pulse, fainting, weak or shallow breathing.

  
  

Less serious side effects include:

• 
  

  dizziness, drowsiness, headache;

  
  


• 
  

  warmth, redness, or tingling under your skin;

  
  


• 
  

  nausea, vomiting, upset stomach;

  
  


• 
  

  constipation; or

  
  


• 
  

  skin rash or itching.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Guiatussin with Codeine (codeine and guaifenesin)?

Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by codeine and guaifenesin.

Also tell your doctor if you are using any of the following drugs:

• 
  

  cimetidine (Tagamet);

  
  


• 
  

  quinidine (Quin-G);

  
  


• 
  

  naloxone (Narcan); or

  
  


• 
  

  naltrexone (Vivitrol).

  
  

This list is not complete and other drugs may interact with codeine and guaifenesin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Guiatussin with Codeine resources

• Guiatussin with Codeine Side Effects (in more detail)
• Guiatussin with Codeine Use in Pregnancy & Breastfeeding
• Guiatussin with Codeine Drug Interactions
• Guiatussin with Codeine Support Group
• 0 Reviews for Guiatussin with Codeine - Add your own review/rating

• Brontex MedFacts Consumer Leaflet (Wolters Kluwer)


• ExeClear-C Prescribing Information (FDA)


• Guiatuss AC Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Guiatussin with Codeine with other medications

• Cough

Where can I get more information?

• Your pharmacist can provide more information about codeine and guaifenesin.

See also: Guiatussin with Codeine side effects (in more detail)

Triaminicol Multi Symptom Cough and Cold

Generic Name: chlorpheniramine/dextromethorphan/phenylpropanolamine (klor fen IR a meen/dex troe meth OR fan/fen ill proe pa NOLE a meen)

Brand Names: Cheracol Plus, Kophane, Therahist, Threamine DM, Triaminicol Multi Symptom Cough and Cold, Tricodene Forte, Tricodene NN, Triphenicol

What is Triaminicol Multi Symptom Cough and Cold (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Dextromethorphan is a cough suppressant. It suppresses an area in the brain that causes coughing.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow and allows nasal and respiratory (breathing) passages to open up.

Chlorpheniramine/dextromethorphan/phenylpropanolamine is used to treat nasal congestion, sinusitis (inflammation of the sinuses), and coughs associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Chlorpheniramine/dextromethorphan/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Triaminicol Multi Symptom Cough and Cold (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine/dextromethorphan/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine/dextromethorphan/phenylpropanolamine.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.

Who should not take Triaminicol Multi Symptom Cough and Cold (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Do not take chlorpheniramine/dextromethorphan/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• kidney disease,


• liver disease,


• 
  

  diabetes,

  
  


• 
  

  glaucoma,

  
  


• 
  

  any type of heart disease or high blood pressure,

  
  


• 
  

  thyroid disease,

  
  


• 
  

  emphysema or chronic bronchitis, or

  
  


• 
  

  difficulty urinating or have an enlarged prostate.

  
  

You may not be able to take chlorpheniramine/dextromethorphan/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether chlorpheniramine/dextromethorphan/phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from chlorpheniramine/dextromethorphan/phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Triaminicol Multi Symptom Cough and Cold (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Take chlorpheniramine/dextromethorphan/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

To ensure that you get a correct dose, measure the liquid form of chlorpheniramine/dextromethorphan/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.

Do not take chlorpheniramine/dextromethorphan/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.

Store chlorpheniramine/dextromethorphan/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a chlorpheniramine/dextromethorphan/phenylpropanolamine overdose include dry mouth, large pupils, flushing, nausea, vomiting, hyperactivity, or hallucinations.

What should I avoid while taking Triaminicol Multi Symptom Cough and Cold (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine/dextromethorphan/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking chlorpheniramine/dextromethorphan/phenylpropanolamine.

Triaminicol Multi Symptom Cough and Cold (chlorpheniramine/dextromethorphan/phenylpropanolamine) side effects

Serious side effects are unlikely to occur. Stop taking chlorpheniramine/dextromethorphan/phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take chlorpheniramine/dextromethorphan/phenylpropanolamine and talk to your doctor or try another similar medication if you experience

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  dryness of the eyes, nose, and mouth;

  
  


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  drowsiness or dizziness;

  
  


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  blurred vision;

  
  


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  difficulty urinating; or

  
  


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  excitation in children.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Triaminicol Multi Symptom Cough and Cold (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Do not take chlorpheniramine/dextromethorphan/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking chlorpheniramine/dextromethorphan/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain chlorpheniramine, dextromethorphan, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Chlorpheniramine/dextromethorphan/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine/dextromethorphan/phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with chlorpheniramine/dextromethorphan/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Triaminicol Multi Symptom Cough and Cold resources

• Triaminicol Multi Symptom Cough and Cold Drug Interactions
• Triaminicol Multi Symptom Cough and Cold Support Group
• 0 Reviews for Triaminicol Multi Symptom Cough and Cold - Add your own review/rating

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Where can I get more information?

• Your pharmacist has additional information about chlorpheniramine/dextromethorphan/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Many formulations of chlorpheniramine/dextromethorphan/phenylpropanolamine are available over-the-counter. Ask your pharmacist any questions you have about this medication, especially if it is new to you.