PANTOPRAZOLE 40 mg GASTRO-RESISTANT TABLETS

Pantoprazole (as pantoprazole sodium sesquihydrate)

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, askyour 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1.    What Pantoprazole Tablets are and what they are used for

2.    Before you take Pantoprazole Tablets

3.    How to take Pantoprazole Tablets

4.    Possible side effects

5.    How to store Pantoprazole Tablets

6.    Further information

OWHAT PANTOPRAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR

Pantoprazole Tablets are a selective "proton pump inhibitor',' a medicine which reduces the amount of acid produced by your stomach. It is used for treating acid-related diseases of the stomach and intestine.

Pantoprazole Tablets are used for treating:

Adults and adolescents 12 years of age and

♦ Reflux oesophagitis. An inflammation of your oesophagus (thetube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid.

Adults:

♦ An infection with a bacterium called Helicobacter pylorim patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy). The aim is to get rid of the bacteria and so reduce the likelihood of these ulcers returning.

♦ Stomachandduodenalulcers ♦ Zollinger-Ellison Syndrome and other conditions producing too much acid in the stomach.

BEFORE YOU TAKE PANTOPRAZOLE TABLETS

♦    repeatedvomiting

♦    difficultyinswallowing

♦    vomiting blood

♦    you look pale and feel weak (anaemia)

♦    you notice blood in your stools

♦    severe and/or persistent diarrhoea, as Pantoprazole Tablets have been associated with a small increase in infectious diarrhoea.

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 Tablets 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. Taking other medicines

Pantoprazole Tablets may influencethe effectiveness of other medicines, so tell your doctor ifyou are taking:

♦    Medicines such as ketoconazole, itraconazole and posaconazole (used to treatfungal infections) or erlotinib (used for certain types of cancer) because Pantoprazole Tablets may stop these and other medicines from working properly

♦    Warfarin and phenprocoumon, which affect the thickening, or thinning of the blood.You may need further checks.

♦    Atazanavir (used to treat HIV-infection).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding

There are no adequate data from the use of pantoprazole in pregnantwomen. Excretion into human milk has been reported. If you are pregnant, or thinkyou may be pregnant, or ifyou are breast-feeding, you should use this medicine only if your doctor considers the benefitfor you are greater than the potential riskfor your unborn child or baby. Askyour doctor or pharmacistfor advice before taking any medicine.

Driving and using machines

If you experience side effects like dizziness or

disturbed vision, you should not drive or operate

Important information about some of the ingredients of Pantoprazole Tablets

Pantoprazole Tablets contains 5.85 mg of sodium per tablet. You should take this into account if you are on a controlled sodium diet.

Do not take Pantoprazole Tablets

•    Ifyou are allergic (hypersensitive) to pantoprazole or to any of the other ingredients of Pantoprazole Tablets (section 6)

•    If you are allergic to medicines containing other proton pump inhibitors.

Take special care with Pantoprazole Tablets

•    Ifyou have severe liver problems. Please tell your doctor if you ever had problems with your liver in the past: He will check your liver enzymes more frequently, especially when you are taking PantoprazoleTablets as a long-term treatment. In the case of a rise of liver enzymes the treatment should be stopped.

•    Ifyou have reduced body stores or risk factors for reduced vitamin B12 and receive pantoprazole long-term treatment. As with all acid reducing agents, pantoprazole may lead to a reduced absorption ofvitamin B12.

•    If you are taking a medicine containing atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, askyour doctor for specific

Taking a proton pump inhibitor like Pantoprazole Tablets, especially over a period of more than one year, may slightly increase your risk offracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Tell your doctor immediately if you notice any of the following symptoms:

•    anunintentionallossofweight

HOW TO TAKE PANTOPRAZOLE TABLETS

Always take PantoprazoleTablets exactly as your doctor has told you.You should checkwith your doctor or pharmacist if you are not sure.

When and how should you take Pantoprazole Tablets?

Take the tablets 1 hour before a meal without chewing or breaking them and swallow them whole with some water.

Unless told otherwise by your doctor, the usual Adults and adolescents 12 years of age and To treat reflux oesophagitis:

The usual dose is one tablet a day.Your doctor may tell you to increase to 2 tablets daily. The treatment periodfor reflux oesophagitis is usually between 4 and 8 weeks.Your doctor will tell you how long to take your medicine.

Adults

For the treatment of an infection with a bacterium called Helicobacter pylori in patients with duodenal ulcers and stomach ulcers in combination with two antibiotics (Eradication therapy).

One tablet, two times a day plus two antibiotic tablets of either amoxicillin, clarithromycin and metronidazole (or tinidazole), each to be taken two times a day with your pantoprazole tablet.Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before your evening meal. Follow your doctor's instructions

and make sure you read the package leaflets for these antibiotics. The usual treatment period is one to two weeks.

For the treatment of stomach and duodenal ulcers:

The usual dose is one tablet a day. After consultation with your doctor, the dose may be doubled.

Your doctor will tell you how long to take your medicine. The treatment period for stomach ulcers is usually between 4 and 8 weeks.The treatment period for duodenal ulcers is usually between 2 and 4weeks. For the long-term treatment of Zollinger-Ellison-Syndrome and of other conditions in which too much stomach acid is produced.

The recommended starting dose is usually two tablets a day.

Take the two tablets 1 hour before a meal.Your doctor may later adjust the dose, depending on the amountofstomach acidyou produce. Ifprescribed more than two tablets a day, the tablets should be taken twice daily.

If your doctor prescribes a daily dose of more than four tablets a day, you will be told exactly when to stop taking the medicine.

Special patient groups:

♦    Ifyou have kidney problems, moderate or severe liver problems,you should nottake Pantoprazole Tabletsfor eradication of Helicobacter pylori

♦    If you suffer from severe liver problems, you should not take more than one tablet 20 mg pantoprazole a day (for this purpose tablets containing 20 mg pantoprazole are available)

♦    Children below 12 years. These tablets are not recommended for use in children below 12 years.

If you take more Pantoprazole Tablets than you should Consult your doctor or pharmacist. There are no known symptoms of overdose.

If you forget to take Pantoprazole Tablets Do not take a double dose to make up for the forgotten dose. Take your next, normal dose at the

If you stop taking Pantoprazole Tablets

Do not stop taking these tablets withoutfirst talking to your doctor or pharmacist.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

Q POSSIBLE SIDE EFFECTS

Like all medicines, Pantoprazole tablets can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).

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:

♦    Serious allergic reactions (frequency rare):

swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling (Quincke's oedema/angioedema), severe dizziness with very fast heartbeat and heavy sweating.

♦    Serious skin conditions (frequency not known): blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema multiforme) and sensitivity to light.

♦    Other serious conditions (frequency not known): yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, and enlarged kidneys sometimes with painful urination and lower back pain (serious inflammation of the kidneys).

Other side effects are:

♦    Uncommon (affects 1 to 10 users in 1,000) 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 of the hip, wrist or spine.

♦    Rare (affects 1 to 10 users in 10,000) disturbances in vision such as blurredvision; hives; pain in the joints; muscle pains; weight changes; raised body temperature; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males.

♦    Very Rare (affects less than 1 user in 10,000) disorientation.

♦    Not known (frequency cannot be estimated from the available data)

Hallucination, confusion (especially in patients with a history of these symptoms); decreased sodium level in blood.

Ifyou are on PantoprazoleTabletsfor more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen asfatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood.Your doctor may decide to perform regular blood tests to monitor your levels of magnesium. Side effects identified through blood tests:

♦    Uncommon (affects 1 to 10 users in 1,000) an increase in liver enzymes

♦    Rare (affects 1 to 10 users in 10,000)

an increase in bilirubin; increased fats in the blood

♦    Very Rare (affects less than 1 user in 10,000)

a reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; a reduction in the number ofwhite blood cells, which may lead to more frequent infections. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

^5 HOW TO STORE PANTOPRAZOLE TABLETS

Keep out of the reach and sight of children.

Store below 30°C.

Do not use PantoprazoleTablets after the expiry date which is stated on the pack after EXP.The expiry date refers to the last day of that month. Medicines should not be disposed ofvia 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. Each gastro-resistant tablet contains, 40 mg Pantoprazole (as pantoprazole sodium sesquihydrate 45.1 mg)

♦    Theotheringredientsare:

Core: Disodium Phosphate Anhydrous, Mannitol (E421), Cellulose Microcrystalline, Croscarmellose Sodium, Magnesium Stearate (vegetable) Coating: Hypromellose,Triethyl Citrate, Sodium Starch Glycolate (Type A), Methacrylic acid-Ethyl acrylate copolymer,Yellow Iron Oxide (E172). What Pantoprazole Tablets look like and contents of the pack

Pantoprazole 40 mg gastro-resistant tablets are oval, yellow tablets

Packs: bottles (HDPE containers with child resistant closure) and blister (aluminium/aluminium blister). PantoprazoleTablets are available in the following

Aluminium/aluminium blister packwith 7, 14, 15,

28, 30, 56, 60, 98 and 100 gastro-resistant tablets. HDPE containers with child resistant closure with 14, 15, 28, 30, 56, 60 & 100 (2x50) gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

TEVA UK Limited, Brampton Road, Hampden Park, East Sussex, BN22 9AG, United Kingdom. Manufacturer

Teva Pharma S.L.U., Poligono Industrial Malpica, calle C, Numero 4, 50016, Zaragoza, Spain.

This leaflet was last approved in October 2013

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