Pantoprazole 20mg Gastro-resistant Tablets
Read all 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 of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- The full name of this medicine is Pantoprazole 20mg Gastro-resistant Tablets but within the leaflet it will be referred to as Pantoprazole tablets.
In this leaflet:
1 What Pantoprazole tablets are and what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
What Pantoprazole tablets are and what they are used for
Pantoprazole tablets are used to treat acid reflux (a type of heart-burn) and help prevent it from returning.
Pantoprazole tablets may also be given to patients who need to take non-selective non-steroidal anti-inflammatory drugs (NSAIDs) for a continuous period. These patients are at a greater risk of developing an ulcer and associated symptoms. Pantoprazole tablets help reduce the risk by preventing an ulcer from developing.
Before you take
Do not take Pantoprazole tablets if you
- are allergic (hypersensitive) to pantoprazole or any of the other ingredients of Pantoprazole tablets.
Take special care with Pantoprazole tablets if you
- have a liver disease
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
This applies particularly for:
- ketoconazole (to treat fungal infections of the skin and nails)
Inform your doctor if you are taking medicines to thin your blood, such as warfarin, phenprocoumon or acenocoumarol.
Taking vitamin supplements
Please tell your doctor or pharmacist if you are taking Vitamin B supplements as Pantoprazole tablets may affect how well Vitamin B is absorbed.
Taking Pantoprazole tablets with food and drink
Pantoprazole tablets should be taken before a meal with water. Do not crush, break or chew the tablet.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pantoprazole tablets must only be used during pregnancy and lactation if clearly advised by your doctor.
Driving and using machines
Pantoprazole tablets do not affect the ability to drive and use machines.
How to take
Always take Pantoprazole tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is:
Mild reflux disease and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing)
- The recommended oral dosage is 20mg per day. Symptom relief is generally accomplished within 2-4 weeks, and a 4-week treatment period is usually required for healing of associated oesophagitis. If this is not sufficient, healing will normally be achieved within a further 4 weeks. When symptom relief has been achieved, reoccurring symptoms can be controlled using an on-demand regimen of 20mg once daily, when required. A switch to continuous therapy may be considered in case satisfactory symptom control cannot be maintained with on-demand treatment.
Long-term management and prevention of relapse in reflux oesophagitis
- For long-term management, a maintenance dose of 20mg per day is recommended, increasing to 40mg per day if a relapse occurs. Pantoprazole 40mg tablets are available for this case. After healing of the relapse the dosage can be reduced again to 20mg pantoprazole.
Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment
- The recommended oral dosage is 20mg per day.
Elderly
No dose adjustment is necessary. Follow your doctor’s instructions.
Children
Pantoprazole tablets are not recommended for children.
Reduced kidney function
No dose adjustment is necessary. Follow your doctor’s instructions
Reduced liver function
A daily dose of 20mg pantoprazole should not be exceeded in patients with severe liver impairment.
General instructions
Pantoprazole tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
If you take more Pantoprazole tablets than you should
Contact your doctor, emergency room or pharmacist if you have taken more Pantoprazole tablets than stated in this leaflet or more than your doctor has prescribed.
If you forget to take Pantoprazole tablets
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Pantoprazole tablets
Keep taking the tablets until you have finished the course of treatment or until your doctor tells you to stop. Do not stop just because you feel better. If you stop taking your tablets too soon, your symptoms may return.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Pantoprazole tablets can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Common (they occur in between one and ten per 100 patients who receive treatment)
Stomach pain, diarrhoea, constipation, wind, headache.
Uncommon (they occur in between one and ten per 1000 patients who receive treatment)
Nausea, vomiting, dizziness, blurred vision, allergic reactions.
Rare (they occur in between one and ten per 10,000 patients who receive treatment)
Dry mouth, joint pain
Very rare (they occur in less than one per 10,000 patients who receive treatment)
Reduction in some cells in your blood, swollen ankles, liver damage leading to jaundice with or without liver failure, anaphylactic reactions, fever, muscle pain, mental depression, inflammation of the kidneys, nettle rash, severe skin reactions with blistering of the skin.
How to store
Keep out of the reach and sight of children.
This medicinal product requires no special storage conditions.
Do not take Pantoprazole tablets after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
What Pantoprazole tablets contain
- The active substance is pantoprazole (as pantoprazole sodium sesquihydrate). Each tablet contains 20mg pantoprazole
- The other ingredients are: Mannitol, Sodium carbonate anhydrous, Sodium starch glycolate, Methacrylic acid copolymer, Calcium stearate, Opadry white OY-D-7233 (hypromellose 3cP, titanium dioxide, talc, macrogol, sodium lauryl sulphate), Kollicoat MAE 30 DP yellow (methacrylic acid-ethyl acrylate copolymer dispersion 30%, propylene glycol, yellow iron oxide, titanium dioxide, talc)
What Pantoprazole tablets look like and contents of the pack
Pantoprazole 20mg Gastro-resistant Tablets are elliptical, biconvex, light yellow gastro-resistant tablets.
Pack sizes 28
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in June 2010.
If you would like a leaflet with larger text, please contact 01271 311257.
L19180ACT-30
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