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Package leaflet: Information for the patient

Pantoprazole 20 mg Gastro-resistant Tablets

(pantoprazole)

What is in this leaflet:

1.    What Pantoprazole is and what it is used for

2.    What you need to know before you take Pantoprazole

3.    How to take Pantoprazole

4.    Possible side effects

5.    How to store Pantoprazole

6.    Contents of the pack and other information.

1.    What Pantoprazole is and what it is used for

Pantoprazole 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.

It can be used for:

Adults and adolescents 12 years of age and above:

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

•    Long-term management of reflux oesophagitis (inflammation of the oesophagus accompanied by the 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.

2.    What you need to know before you take Pantoprazole

Do not take Pantoprazole:

•    if you are allergic to pantoprazole 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:

•    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 as a long-term treatment. In the case of a rise of liver enzymes the treatment should be stopped.

•    if you need to take medicines called NSAIDs continuously and receive pantoprazole 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 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.

•    if you have ever had a skin reaction after treatment with a medicine similar to pantoprazole that reduces stomach acid.

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 has been associated with a small increase in infectious diarrhoea.

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with pantoprazole. Remember to also mention any other ill-effects like pain in your joints.

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 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, 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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines as Pantoprazole may influence the effectiveness of other medicines.

•    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 similar 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)(see section 2 'Warnings and precautions').

•    Methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer) because pantoprazole may increase the levels of methotrexate in your blood.

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 breast-feeding, think you may be pregnant or are 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 greater than the potential risk for your unborn child or baby.

Driving and using machines

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

3. How to take Pantoprazole

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

When and how should you take Pantoprazole?

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 recommended dose is:

Adults 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

The recommended 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.

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For long-term management and for preventing the return of reflux oesophagitis

The recommended 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 recommended 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 than you should

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

If you forget to take Pantoprazole

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

Do not stop taking these tablets without first talking to your doctor or pharmacist.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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:

Rare (may affect up to 1 in 1,000 people)

•    Serious allergic reactions: 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.

•    a reduction in the number of white and red blood cells and/or platelets, which may be seen in blood tests. You may notice more frequent infections, or you may bruise or bleed more than normal.

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

•    Serious skin conditions: 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), rash, possibly with pain in the joints and sensitivity to light.

•    Other serious conditions: 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 which could lead to kidney failure).

If you are on pantoprazole 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.

Other side effects are:

•    Uncommon (may affect up to 1 in 100 people)

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 (may affect up to 1 in 1,000 people) Changes to or complete lack of the sense of taste, 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), depression, breast enlargement in males.

•    Not known (frequency cannot be estimated from the available data) Hallucination, confusion (especially in patients with a history of these symptoms), pins and needles.

Side effects identified through blood tests:

•    Uncommon (may affect up to

1 in 100 people) an increase in liver enzymes.

•    Rare (may affect up to 1 in 1,000 people) an increase in bilirubin, increased fats in the blood.

•    Not known (frequency cannot be estimated from the available data) decreased sodium level in blood.

Reporting of side effects

If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Pantoprazole

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

Do not use this medicine after the expiry date which is stated on the packaging after 'EXP¹. The expiry date refers to the last day of that month.

For blister pack: This medicine does not require any special storage conditions.

For HDPE Bottles: Once opened use within 100 days. Keep the container tightly closed in order to protect from moisture.

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 contains

The active substance is pantoprazole sodium sesquihydrate equivalent to 20 mg of pantoprazole.

The other ingredients are sodium carbonate, anhydrous, mannitol, crospovidone, povidone and calcium stearate. The coating contains methacrylic acid-ethyl acrylate copolymer (1:1), sodium laurilsulfate, polysorbate 80, triethyl citrate, hypromellose, titanium dioxide, macrogol 400 and iron oxide yellow. The printing ink contains shellac, iron oxide black and ammonium hydroxide.

What Pantoprazole looks like and contents of the pack

Pantoprazole tablets are dark yellow film coated, oval, approximately 4.3 mm x 8.4 mm, biconvex tablets with 'PS2' printed in black ink on one side of the tablet. They are available in plastic bottles and blisters.

Bottle pack comprising of white HDPE bottle with screw cap containing 14, 28, 30, 50,

56, 60, 90, 98, 100 or 250 tablets. The bottle contains also a small plastic canister with silica gel, or a sachet containing silica gel and activated carbon, which protects the tablets from moisture. The canister or sachet cannot be eaten and shouldn't be removed from the bottle.

Blister pack comprising of Aluminium blisters with or without a desiccant layer packed in cardboard cartons containing 7, 14, 28, 28x1, 30, 56, 96, 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan,

Potters Bar, Hertfordshire, EN6 1TL,

United Kingdom

Manufacturer

Gerard Laboratories

35/36 Baldoyle Industrial Estate,

Grange Road,

Dublin 13 Ireland

Mylan Hungary Kft

H-2900 Komarom Mylan utca 1 Hungary

This leaflet was last revised in January 2016

50060677

791622

v1/May 2015