PACKAGE LEAFLET: INFORMATION FOR THE USER

PANTOPRAZOLE 20MG GASTRO-RESISTANT TABLETS

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Pantoprazole 20 mg is and what it is used for

2.    What you need to know before you take Pantoprazole 20mg

3.    How to take Pantoprazole 20mg

4.    Possible side effects

5.    How to store Pantoprazole 20mg

6.    Contents of the pack and other information

1. WHAT PANTOPRAZOLE 20 MG IS AND WHAT IT IS USED FOR

Pantoprazole 20 mg 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:

Adult and adolescents 12 years of age and above

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

•    for the long-term management and prevention of reflux oesophagitis (inflammation of the oesophagus accompanied by the regurgitation of stomach acid)

Adults

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANTOPRAZOLE 20 MG

Do not take Pantoprazole 20mg:

•    if you are allergic to pantoprazole, soya lecithin or any of the other ingredients of this medicine (listed in section 6).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Pantoprazole 20mg:

•    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 20 mg as a long-term treatment. If the liver enzyme levels increase, then treatment should be stopped.

•    If you need to take medicines called NSAIDs continuously and are prescribed pantoprazole 20 mg 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 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 diarrhoea, as pantoprazole 20 mg has been associated with a small increase in infectious diarrhoea.

If you take a proton pump inhibitor like pantoprazole 20mg 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 circumstances whenever you see your doctor.

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 are on pantoprazole 20mg 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 levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.

Taking a proton pump inhibitor like pantoprazole 20mg 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).

Other medicines and pantoprazole 20mg

Pantoprazole 20 mg may influence the effectiveness of other medicines, so tell your doctor if your are taking:

•    Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because pantoprazole 20 mg 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).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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 breastfeeding, think you may be pregnant or 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 to be greater than the potential risk for your unborn child.

Driving and using machines

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

Pantoprazole 20mg contains soya lecithin and maltitol

If you are allergic to peanut or soya, do not use this medicine.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before ] -taking this medicinal product.

3. HOW TO TAKE PANTOPRAZOLE 20 MG

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

When and how should you take Pantoprazole 20 mg?

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 - 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.

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.

If you take more Pantoprazole 20 mg than you should

Tell your doctor or pharmacist. There are no known symptoms of overdose.

If you forget to take Pantoprazole 20 mg

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 20 mg

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.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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 (rare): swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, 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 health, blistering (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 (if this medicine is used in high doses and over long durations, see section 2 - Warnings and precautions).

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.

-    If you are on this medicine 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 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 of white blood cells, which may lead to more frequent infections.

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

-    low magnesium levels in blood (hypomagnesaemia) (see section 2 - Warnings and precautions).

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this

leaflet.

5. HOW TO STORE PANTOPRAZOLE 20 MG

Keep this medicine out of the sight and reach of children.

Do not use Pantoprazole 20 mg after the expiry date which is stated on the blister and outer carton after (EXP:). The expiry date refers to the last day of that month.

For tablets packed in plastic bottles: Pantoprazole 20 mg can be used for three months after first opening of the container.

This medicinal product 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 protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Pantoprazole 20 mg contains:

The active substance is: pantoprazole.

Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate).

The other ingredients are:

Tablet core

Maltitol (E 965), crospovidone type B, carmellose sodium, sodium carbonate, anhydrous (E 500), calcium stearate

Tablet coating

Poly (vinyl alcohol), talc (E 553b), titanium dioxide (E 171), macrogol 3350, soya lecithin, iron oxide yellow (E 172), sodium carbonate anhydrous (E 500), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E 1505)

What Pantoprazole 20 mg looks like and contents of the pack:

Pantoprazole 20 mg are oval, yellow, gastro-resistant tablets. Pantoprazole 20 mg are available in packs of 2 (starter pack), 7, 10, 14, 15, 20, 28, 30, 30x1,50, 56, 60, 90, 98, 100, 120, 140, 280, 500, 700 tablets.

Not all pack sizes may be marketed.

The Marketing authorisation holder is: Winthrop Pharmaceuticals UK Limited, PO Box 611, Guildford, Surrey, GU1 4YS, UK or Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK.

The Manufacturer is: Przedsifbiorstwo Farmaceutyczne Jelfa S.A., 21 Wincentego Pola Str., 58-500 Jelenia Gora, Poland or Sanofi-Aventis Sp. z o.o., Drug Production and Distribution Plant, ul. Lubelska 52, 35-233 Rzeszow, Poland or Sofarimex - Industria Quimicae Farmaceutica, S.A., Av. das Industrias, Alto de Colaride, Agualva, 2735-213 Cacem, Portugal or Artesan GmbH & Co KG, Wendlandstrasse 1,29439 Luchow, Germany or Rottendorf Pharma GmbH Ostenfelder Str. 51-61,59320 Ennigerloh, Germany

This leaflet was last updated in April 2012.