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:
Manufacturer:
Marketing Company:
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
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