Active ingredient
- pantoprazole sodium sesquihydrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL16189/0036.
Protium 40 mg i.v. Powder for Solution for Injection
Package leaflet: Information for the user
Protium i.v. 40 mg powder for solution for injection
Pantoprazole
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Protium is and what it is used for
2. What you need to know before you use Protium
3. How to use Protium
4. Possible side effects
5. How to store Protium
6. Contents of the pack and other information
1. What Protium is and what it is used for
Protium contains the active substance pantoprazole.Protium is a selective “proton pump inhibitor”, a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine.
This preparation is injected into a vein and will only be given to you if your doctor thinks pantoprazole injections are more suitable for you at the moment than pantoprazole tablets. Tablets will replace your injections as soon as your doctor sees fit.
Protium is used for treating:
2. What you need to know before you take Protium
Do not use Protium
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Protium
Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease:
Your doctor may decide that you need some tests to rule out malignant disease because pantoprazole also alleviates the symptoms of cancer and could cause delay in diagnosing it. If your symptoms continue in spite of your treatment, further investigations will be considered.
Children and adolescents
Protium is not recommended for use in children as it has not been proven to work in children below 18 years of age.
Other medicines and Protium
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
This is because Protium may influence the effectiveness of other medicines, so tell your doctor if you are taking:
Pregnancy and breast-feeding
There are no adequate data from the use of pantoprazole in pregnant women. Excretion into human milk has been reported.
If you are pregnant or breast feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should use this medicine, only if your doctor considers the benefit for you greater than the potential risk for your unborn child or baby.
Driving and using machines
Protium has no or negligible influence on the ability to drive and use machines.
If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines.
Important information about some of the ingredients of Protium
This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. is essentially ‘sodium- free’.
3. How to take Protium
Your nurse or your doctor will administer the daily dose to you as an injection into a vein over a period of 2 - 15 minutes.
The recommended dose is:
Adults
-For gastric ulcers, duodenal ulcers and reflux oesophagitis.
One vial (40 mg pantoprazole) a day.
-For the long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much stomach acid is produced.
Two vials (80 mg pantoprazole) a day.
Your doctor may later adjust the dose, depending on the amount of stomach acid you produce. If you are prescribed more than two vials (80 mg) a day, the injections will be given in two equal doses. Your doctor may prescribe a temporary dose of more than four vials (160 mg) a day. If your stomach acid level needs to be controlled rapidly, a starting dose of 160 mg (four vials) should be enough to lower the amount of stomach acid sufficiently.
Patients with liver problems
If you suffer from severe liver problems, the daily injection should be only 20 mg (half a vial).
Use in children and adolescents
These injections are not recommended for use in children and adolescents under 18 years.
If you use more Protium than you should
These doses are carefully checked by your nurse or your doctor so an overdose is extremely unlikely. There are no known symptoms of overdose.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following side effects, tell your doctor immediately, or contact the casualty department at your nearest hospital:
Other side effects are:
Side effects identified through blood tests:
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Protium
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton and the vial after EXP. The expiry date refers to the last day of that month.
Do not store above 25 °C.
Keep the vial in the outer carton in order to protect it from light.
Use the reconstituted solution within 12 hours.
Use the reconstituted and diluted solution within 12 hours.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at not more than 25 °C.
Do not use Protium if you notice that the visual appearance has changed (e.g. if cloudiness or precipitation is observed).
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Protium contains
What Protium looks like and contents of the pack
Protium is a white to off-white powder for solution for injection. It comes in a 10 ml clear glass vial closed with an aluminium cap and grey rubber stopper containing 40 mg powder for solution for injection.
Protium is available in the following pack sizes:
Pack with 1 vial.
Pack with 5 (5x1) vials.
Hospital pack with 1 vial.
Hospital pack with 5 (5x1) vials.
Hospital pack with 10 (10x1) vials.
Hospital pack with 20 (20x1) vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This medicine is authorised in the Member States of the EEA under the following names:
Name of Member State Name of the medicinal product
Austria Pantoloc 40 mg-Trockenstechampulle
Cyprus, Czech Republic, Greece, Hungary, Romania, Slovakia, Controloc i.v.
Denmark, Sweden Pantoloc
Finland SOMAC 40 mg powder for solution for injection
France Eupantol 40 mg poudre pour solution injectable IV
Germany, Netherlands Pantozol i.v.
Ireland, UK Protium i.v.
Italy Pantorc
Norway Somac
Poland Controloc 40 mg
Portugal Pantoc IV
Slovenia Controloc 40 mg prašek za raztopino za injiciranje
Spain Anagastra 40 mg polvo para solución inyectable I.V.
This leaflet was last revised in 07/2019.
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