PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole 20mg Gastro-resistant Tablets

Pantoprazole

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

In this leaflet:

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

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

Pantoprazole Tablets are selective “proton pump inhibitors”, which are medicines that reduce the amount of acid produced in your stomach. They are used for treating acid-related diseases of the stomach and intestine.

Pantoprazole Tablets are used for:

Adults and adolescents 12 years of age and above:

•    Treating symptoms (e.g. heartburn, acid regurgitation, pain on swallowing) associated to gastro-oesophageal reflux disease caused by reflux of acid from the stomach.

•    Long-term management of reflux oesophagitis (inflammation of the oesophagus accompanied by regurgitation of stomach acid) and preventing its return.

Adults:

•    Preventing duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example ibuprofen) in patients at risk who need to take NSAIDs continuously.

Pantoprazole Tablets have been associated with a small increase in infectious diarrhea.

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 a proton pump inhibitor like Pantoprazole Tablets, especially over a period of more than one year, may slightly increase your risk of fracture 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).

Taking other medicines

Pantoprazole Tablets may influence the effectiveness of other medicines, so tell your doctor if you are taking

•    Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because pantoprazole 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 pregnant women. Excretion into human milk has been reported. If you are pregnant, or think you may be pregnant, or if you are breast-feeding, 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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machinery

If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines.

3. How to take Pantoprazole Tablets

2. Before you take Pantoprazole Tablets

Do not take Pantoprazole Tablets

•    If you are allergic (hypersensitive) to pantoprazole or to any of the other ingredients in Pantoprazole Tablets (see section 6).

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

Take special care with Pantoprazole

Tablets

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

•    If you need to take medicines called NSAIDs continuously and receive Pantoprazole Tablets because you have an increased risk of developing stomach and intestinal complications. Any increased risk will be assessed according to your own personal risk factors such as your age (65 years old or more), a history of stomach or duodenal ulcers or of stomach or intestinal bleeding.

•    If you have reduced body stores or risk factors for reduced vitamin B12 and receive Pantoprazole Tablets as a long-term treatment. As with all acid reducing agents, pantoprazole may lead to a reduced absorption of vitamin B12.

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

Tell your doctor immediately if you

notice any of the following symptoms:

•    an unintentional loss of weight

•    repeated vomiting

•    difficulty in swallowing

•    vomiting blood

•    you look pale and feel weak (anaemia)

•    you notice blood in your stools

•    severe and/or persistent diarrhea, as

Always take Pantoprazole Tablets exactly as your doctor has told you. You should check with 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 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 to 4 weeks - at most after another four weeks. Your doctor will tell you how long to continue taking the medicine. After this any reoccurring 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 40mg Tablets instead, one a day. After healing, you can reduce the dose back again to one tablet 20mg 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.

Special patient groups

•    If you suffer from severe liver problems, you should not take more than one 20 mg tablet a day.

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

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If you take more Pantoprazole Tablets than you should

Tell 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 usual time.

If you stop taking Pantoprazole Tablets

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 product, ask your doctor or pharmacist.

levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

If any of the side effects get 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

4. Possible side effects

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

Keep out the reach and sight of children.

Do not use Pantoprazole Tablets after the expiry date, which is stated on the label and blister. The expiry date refers to the last day of that month.

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)

This medicinal product does not require any special temperature storage conditions. Store in the original container to protect from moisture.

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 protect the environment.

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; diarrhea; 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; fractures of the hip, wrist or spine.

•    Rare (affects 1 to 10 users in 10,000) disturbances in vision such as blurred vision; 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.

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 of white blood cells, which may lead to more frequent infections.

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

If you are on Pantoprazole Tablets for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, 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

6. Further information

What Pantoprazole Tablets contain

•    The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20mg of pantoprazole (as sodium sesquihydrate).

•    The other ingredients are:

Core: mannitol (E421), partially pre-gelatinised maize starch, colloidial anhydrous silica, sodium carbonate (E500) (i), calcium stearate, talc (E553b), sodium starch glycolate (type A).

Coating: methacrylic acid - ethyl acrylate copolymer, sodium hydroxide (E524), triethyl citrate (E1505), talc (E553b), hypromellose (E464), titanium dioxide (E171), macrogol 4000, iron oxide yellow (E172), and blue indigo carmine aluminium lake (E132).

What Pantoprazole Tablets look like and the contents of the pack

A yellow, oval, biconvex gastro-resistant tablet; plain on both sides.

Packs: blister pack and outer cardboard carton.

Pantoprazole Tablets are available in a pack size of 28 tablets.

Marketing Authorisation Holder:

Wockhardt UK Ltd,

Ash Road North,

Wrexham, LL13, 9UF, UK.

Manufacturer:

CP Pharmaceuticals Ltd,

Ash Road North,

Wrexham, LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

This is a service provided by the Royal National Institute of Blind People.

For the Republic of Ireland please call + 353 52 36253.

This medicinal product is authorised in the following Member States in the EEA, under the following names:

Cyprus - Pantoprazole Wockhardt 20 mg

Gastro-resistant Tablets

Malta - Pantoprazole 20mg

Gastro-resistant Tablets

Poland - Pantoprazole Wockhardt

Republic of Ireland - Pantoprazole 20mg

Gastro-resistant Tablets

United Kingdom - Pantoprazole 20mg

Gastro-resistant Tablets

Leaflet Prepared: May 2012.

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MH/DRUGS/AD/068

WOCKHARDT