Wednesday, September 14, 2016

Pantoprazole 40mg Gastro-resistant Tablets





Pantoprazole 40mg 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 40mg 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 heartburn) and ulcers in the stomach (gastric ulcer) or in the upper part of the intestine (duodenal ulcer). Pantoprazole tablets are also used for the long-term treatment of people who secrete too much acid in conditions such as Zollinger-Ellison syndrome.





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:



  • The usual dose for the treatment of acid reflux, a gastric and duodenal ulcer is one tablet taken in the morning, with or without food.


  • The usual starting dose for the treatment of Zollinger-Ellison syndrome is one tablet taken twice a day. You should take the first tablet in the morning and the second tablet just before your evening meal. Your doctor may then adjust the dosage, depending on how much medicine is required for your treatment.

Ask your doctor or pharmacist if you are unsure about anything.





Elderly



No dose adjustment is necessary. However, the daily dose of 40mg pantoprazole should not be exceeded. An exception is combination therapy for eradication of H. pylori, where elderly patients should receive the usual pantoprazole dose (2 x 40mg/day) during 1 week treatment.






Children



Pantoprazole tablets are not recommended for use in children below 12 years.





Patients with impaired kidney function



No dose adjustment is necessary. However, the daily dose of 40mg pantoprazole should not be exceeded. For this reason, H. pylori triple therapy is not appropriate in these patients.





Patients with liver cirrhosis



The dose should be reduced to one tablet every other day. For this reason, H. pylori triple therapy is not appropriate in these patients.





General instructions



Pantoprazole tablets should not be chewed or crushed, and should be swallowed whole with liquid.





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



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 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 40mg pantoprazole


  • The other ingredients are: Mannitol, Sodium carbonate anhydrous, Sodium starch glycolate, Methacrylic acid copolymer, Calcium stearate, Opadry white OY-D-7233 (hypromellose, 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 40mg Gastro-resistant Tablets are elliptical, biconvex, dark yellow gastro-resistant tablets.



Pack size 28





Marketing Authorisation Holder




Actavis Group PTC ehf

Reykjavikurvegur 76-78

220 Hafnarfjordur

Iceland





Manufacturer




Actavis Ltd

BLB016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta





This leaflet was last revised in June 2010





If you would like a leaflet with larger text, please contact 01271 311257.






Actavis

Barnstaple

EX32 8NS

UK



L19180ACT-30






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