Package leaflet: Information for the patient

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Pantoprazole 40 mg Gastro-resistant Tablets

Pantoprazole

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 (see section 4).

What is in this leaflet:

1.    What Pantoprazole 40 mg is and what it is used for

2.    What you need to know before you take Pantoprazole 40 mg

3.    How to take Pantoprazole 40 mg

4.    Possible side effects

5.    How to store Pantoprazole 40 mg

6.    Contents of the pack and other information

1. What Pantoprazole 40 mg is and what it is used for

Pantoprazole 40 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 40 mg is used for treating:

Adults and adolescents 12 years of age and above:

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

Adults:

•    An infection with a bacterium called Helicobacter pylori in 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.

•    Stomach and duodenal ulcers

•    Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach

2. What you need to know before you take Pantoprazole 40 mg

Do not take Pantoprazole 40 mg

•    If you are allergic (hypersensitive) to pantoprazole or to any of the other ingredients of this medicine (see 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 40 mg:

•    If you 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 Pantoprazole 40 mg as a long-term treatment. In the case of a rise of liver enzymes the treatment should be stopped.

•    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.

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 40 mg has 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 40 mg 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.

Other medicines and Pantoprazole 40 mg

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Pantoprazole 40 mg may influence the effectiveness of other medicines, so tell you 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 40 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).

•    Methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate your doctor may temporarily stop your Pantoprazole 40 mg treatment.

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.

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.

Driving and using machines

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

Pantoprazole 40 mg contains the colouring agent Ponceau 4R aluminium lake (E 124):

It may cause allergic reactions.

3. How to take Pantoprazole 40 mg

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 40 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 reflux oesophagitis

The usual dose is one tablet a day. Your doctor may tell you to increase to 2 tablets daily. The treatment period for 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 4 weeks.

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 amount of stomach acid you produce. If prescribed 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:

•    If you have kidney problems, moderate or severe liver problems, you should not take Pantoprazole 40 mg for 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.

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If you take more Pantoprazole 40 mg than you should

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

If you forget to take Pantoprazole 40 mg

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 40 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 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:

•    Serious allergic reactions (may affect up to 1 in 1,000 people): 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 possible 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.

Taking a proton pump inhibitor like (Pantoprazole 40 mg), 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).

•    Rare (may affect up to 1 in 1,000 people): distortion 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); allergic reactions; depression; breast enlargement in males.

•    Very Rare (may affect up to 1 in 10,000 people):

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 Pantoprazole 40 mg 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 (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; sharp drop in circulating granular white blood cells, associated with high fever.

•    Very Rare (may affect up to 1 in 10,000 people):

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; coexisting abnormal reduction in the number of white and red blood cells, as well as platelets.

Reporting of side effects

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

You can also report side effects directly via Yellow Card Scheme: 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 40 mg

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

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and the blister or bottle after “EXP”. The expiry date refers to the last day of that month.

Do not use Pantoprazole after 6 months have elapsed from opening of the HDPE-bottle.

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 to protect the environment.

6. Contents of the pack and other information

What Pantoprazole 40 mg contains

The active substance is pantoprazole. Each gastro-resistant tablet contains 40 mg pantoprazole (as pantoprazole sodium sesquihydrate).

The other ingredients are Tablet core: calcium stearate; cellulose microcrystalline; crospovidone;

hydroxypropylcellulose (type EXF); sodium carbonate, anhydrous; silica, colloidal anhydrous.

Coating: hypromellose, iron oxide yellow (E172), macrogol 400,

methacrylic acid - ethyl acrylate copolymer (1:1), polysorbate 80,

ponceau 4R aluminium lake (E124), quinoline yellow aluminium lake (E104), sodium lauryl sulphate, titanium dioxide (E171), triethyl citrate.

What Pantoprazole 40 mg looks like and contents of the pack

Pantoprazole 40 mg gastro-resistant tablets are yellow, oval tablets (coated with a special layer) and available in blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 56x1,60, 84, 90, 98, 100, 100x1, 140, 168 tablets

containers of 14, 28, 56, 98, 100, 250, 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Ltd,

Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR,

UK.

Manufacturer

Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1,

D-39179 Barleben,

Germany

or

Lek Spolka Akcyjna, ul. Domaniewska 50 C,

02-672 Warsaw,

Poland

or

Lek Pharmaceuticals d.d.,

Verovskova 57,

1000 Ljubljana,

Slovenia

or

Lek Pharmaceuticals d.d., Trimlini 2 D,

9220 Lendava,

Slovenia

or

Sandoz S.R.L.,

Str. Livezeni nr. 7A, 540472 Targu-Mures, Romania.

This leaflet was last revised in 12/2013.

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