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: PL16189/0034.
Pantoprazole 20 mg gastro-resistant Tablets
Package leaflet: Information for the user
Pantoprazole 20 mg gastro-resistant tablets
Pantoprazole
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Pantoprazole is and what it is used for
2. What you need to know before you take Pantoprazole
3. How to take Pantoprazole
4. Possible side effects
5. How to store Pantoprazole
6. Contents of the pack and other information
1. What Pantoprazole is and what it is used for
Pantoprazole contains the active substance pantoprazole. Pantoprazole 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.
Pantoprazole is used to treat adults and adolescents 12 years of age and above for
Pantoprazole is used to treat adults for
2. What you need to know before you take Pantoprazole
Do not take Pantoprazole
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Pantoprazole
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.
If you take Pantoprazole on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.
Children and adolescents
Pantoprazole is not recommended for use in children as it has not been proven to work in children below 12 years of age.
Other medicines and Pantoprazole
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 Pantoprazole 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
Pantoprazole 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.
3. How to take Pantoprazole
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Method of administration
Take the tablets 1 hour before a meal without chewing or breaking them and swallow them whole with some water.
The recommended dose is:
Adults and adolescents 12 years of age and above
-To treat symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastro-oesophageal reflux disease
The usual dose is one tablet a day. This dose usually brings relief within 2 - 4 weeks – at most after another 4 weeks. Your doctor will tell you how long to continue taking the medicine. After this, any recurring symptoms can be controlled by taking one tablet daily, when required.
-For long-term management and for preventing the return of reflux oesophagitis
The usual dose is one tablet a day. If the illness returns, your doctor can double the dose, in which case you can use Pantoprazole 40 mg tablets instead, one a day. After healing, you can reduce the dose back again to one tablet 20 mg a day.
Adults
-To prevent duodenal and stomach ulcers in patients who need to take NSAIDs continuously
The usual dose is one tablet a day.
Patients with liver problems
If you suffer from severe liver problems, you should not take more than one 20 mg tablet a day.
Use in children and adolescents
These tablets are not recommended for use in children below 12 years.
If you take more Pantoprazole than you should
Tell your doctor or pharmacist. There are no known symptoms of overdose.
If you forget to take Pantoprazole
Do not take a double dose to make up for a forgotten dose. Take your next normal dose at the usual time.
If you stop taking Pantoprazole
Do not stop taking these tablets without first talking to your doctor or pharmacist.
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, stop taking these tablets and tell your doctor immediately, or contact the casualty department at your nearest hospital:
Other side effects are:
Benign polyps in the stomach.
Headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; itching; feeling weak, exhausted or generally unwell; sleep disorders; fracture in the hip, wrist or spine.
Distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; hives, pain in the joints; muscle pains; weight changes; raised body temperature; high fever; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males.
Disorientation.
Hallucination, confusion (especially in patients with a history of these symptoms); decreased sodium level in blood, decreased magnesium level in blood (see section 2), feeling of tingling, prickling, pins and needles, burning sensation or numbness, rash, possibly with pain in the joints, inflammation in the large bowel, that causes persistent watery diarrhoea.
Side effects identified through blood tests:
an increase in liver enzymes.
an increase in bilirubin; increased fat levels in blood; sharp drop in circulating granular white blood cells, associated with high fever.
a reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; a reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets.
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. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Pantoprazole
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 container after EXP. The expiry date refers to the last day of that month.
For bottles: Do not use tablets beyond 120 days after first opening of the bottle.
This medicine does not require any special storage conditions.
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 Pantoprazole contains
What Pantoprazole looks like and contents of the pack
Yellow, oval, biconvex gastro-resistant tablet (tablet) imprinted with “P 20” on one side.
Packs: bottles (high density polyethylene container with low density polyethylene screw cap closure) and blister (ALU/ALU blister) without cardboard reinforcement or with cardboard reinforcement (blister wallet).
Pantoprazole is available in the following pack sizes:
Packs with 7, 10, 14, 15, 24, 28, 30, 48, 49, 56, 60, 84, 90, 98, 98 (2x49), 100, 112, 168 gastro-resistant tablets.
Hospital packs with 50, 56, 84, 90, 112, 140, 140 (10x14 or 5x28), 150 (10x15), 280 (20x14 or 10x28), 500, 700 (5x140) gastro-resistant tablets.
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 Pantoprazol “Nycomed”
Italy Pantoprazolo Nycomed
United Kingdom Pantoprazole
This leaflet was last revised in 07/2019.
Building 3, Glory Park Avenue, Wooburn Green, High Wycombe, HP10 0DF
+44 (0)1628 537 900
+44 (0)1628 537 900