Pantium 40mg Gastro-resistant Tablets

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1 Package leaflet: Information for the user Pantium 40mg 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 Pantium is and what it is used for 2. What you need to know before you take Pantium 3. How to take Pantium 4. Possible side effects 5. How to store Pantium 6. Contents of the pack and other information 1. What Pantium is and what it is used for Pantium is a medicine that reduces the production of stomach acid (selective proton pump inhibitor). Pantium is used in combination with antibiotics for the treatment of duodenal ulcers and gastric ulcers. This treatment involves eradicating Helicobacter pylori, a disease-causing microorganism (pathogen) responsible for causing ulcers of the stomach and intestines. for the treatment of duodenal ulcers for the treatment of gastric ulcers for the treatment of moderate and severe forms of reflux oesophagitis (inflammation of the gullet) for the long-term treatment of conditions whereby too much stomach acid is produced (e.g. Zollinger-Ellison syndrome) 2. What you need to know before you take Pantium DO NOT take Pantium If you are allergic to pantoprazole, other proton pump inhibitors or any of the other ingredients of this medicine (listed in section 6.). If you suffer from severe liver dysfunction. This applies only if you are being treated with pantoprazole and antibiotics for the eradication of Helicobacter pylori. Warnings and precautions Talk to your doctor or pharmacist before taking Pantium. Especially: If you suffer from a severe liver disorder. Please talk to your doctor who will decide whether the dose has to be adjusted. Also the doctor may decide to do regular controls of your liver enzymes. If you take Pantium on a long-term basis (e.g. longer than 1 year) your doctor may want to see you regularly. Please talk to your doctor about any new symptoms or any other exceptional circumstances. If you take Pantium for the eradication of Helicobacter pylori (together with antibiotics) please also read the package leaflets of the antibiotics carefully. If you ever had a deficiency of vitamin B12, please tell your doctor who might then check for your vitamin B12 levels. If you have recently lost weight or suffer from recurrent vomiting, pain on swallowing or vomiting of blood, or if you have experienced blood in your stool or very dark stools you should talk to your doctor. Your doctor might possibly perform additionally diagnostics (e.g. gastroscopy = visual Page 1 of 6

2 inspection of the gullet, stomach and upper intestine). Please also tell your doctor if your symptoms persist despite adequate treatment with this medicine. Taking a proton pump inhibitor like Pantium, 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). Children below 12 years of age: Please do not give Pantium to children below 12 years of age as there is no experience with pantoprazole in children below 12 years of age. Other medicines and Pantium Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially one of the following: Medicines to treat fungal infections (e.g. ketoconazole or itraconazole) or erlotinib (used for certain types of cancer) and other medicines for which it is known that their blood levels depend on the acid secretion in the stomach. Medicines to thin your blood (so called coumarin-derivatives, like phenprocoumon or warfarin) in which case your doctor would have to control the clotting properties of your blood. Atazanavir for the treatment of HIV infection. Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your Pantium treatment. Pregnancy and breast-feeding 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. There are no adequate data from the use of pantoprazole in pregnant women. Excretion into human milk has been reported. Therefore, during the entire pregnancy and breast-feeding period, you may only use Pantium if your doctor is convinced that the benefits of the treatment for you outweigh the risks for your unborn child/baby. Studies in animals have shown reproductive toxicity. Driving and using machines If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines. Pantium contains maltitol 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 Pantium Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Directions for use: Swallow Pantium tablets whole (not chewed or crushed) with a glass of water. If you are also taking antibiotics to eradicate Helicobacter pylori bacteria, take your second Pantium tablet before your evening meal. Unless otherwise prescribed by your doctor, the recommended dose is: Adults and adolescents 12 years of age and above Treatment of reflux oesophagitis 1 Pantium tablet a day (equivalent to 40 mg of pantoprazole). If you have so far failed to respond to other medication, the dose can - in individual cases - be increased to 2 Pantium tablets a day (equivalent to 80 mg of pantoprazole). Page 2 of 6

3 Adults Treatment of duodenal and gastric ulcers to eradicate the Helicobacter pylori germ, if you are also receiving treatment with antibiotics The following combinations are recommended: Morning Evening 1 Pantium 40 mg tablet 1 Pantium 40 mg tablet 1000 mg amoxicillin 1000 mg amoxicillin 500 mg clarithromycin 500 mg clarithromycin or Morning Evening 1 Pantium 40 mg tablet 1 Pantium 40 mg tablet mg metronidazole mg metronidazole mg clarithromycin mg clarithromycin or Morning Evening 1 Pantium 40 mg tablet 1 Pantium 40 mg tablet 1000 mg amoxicillin 1000 mg amoxicillin mg metronidazole mg metronidazole Treatment of duodenal ulcers, gastric ulcers 1 Pantium tablet a day (equivalent to 40 mg of pantoprazole). If you have so far failed to respond to other medication, the dose can - in individual cases - be increased to 2 Pantium tablets a day (equivalent to 80 mg of pantoprazole). Long-term treatment of patients with conditions whereby too much stomach acid is produced (e.g. Zollinger-Ellison syndrome) The recommended starting dose is 2 Pantium tablets a day (equivalent to 80 mg of pantoprazole). Thereafter, your doctor should individually adjust your dose to suit your clinical needs. If you need to take more than 2 Pantium tablets a day, you should divide your daily dosage into two single doses. For a limited period, the daily dose can - in individual cases - be increased to over 4 Pantium tablets (equivalent to 160 mg of pantoprazole). Patients with severe liver impairment If you belong to this patient group, talk to your doctor who will decide whether a reduction in dose will be necessary. As a rule, these patients should be treated with 1 Pantium tablet (equivalent to 40 mg of pantoprazole) every other day. Patients with impaired kidney function If you belong to this patient group, talk to your doctor. However, a dosage adjustment or change in dose is usually not required. Elderly patients If you belong to this patient group, please also talk to your doctor who will decide whether a reduction of dose will be necessary. As a rule, a daily dose of 1 Pantium tablet (equivalent to 40 mg of pantoprazole) should not be exceeded. One exception is treatment for eradicating Helicobacter pylori bacteria. In this case, even elderly patients receive 2 Pantium tablets a day (equivalent to 80 mg of pantoprazole). Children below 12 years of age: There is no experience on the treatment of children below 12 years of age. Page 3 of 6

4 How long you should take Pantium If you are also receiving antibiotic treatment, you should take 2 Pantium tablets a day for 7 days up to a maximum of two weeks (equivalent to 80 mg of pantoprazole). Thereafter, you should take 1 Pantium tablet a day (equivalent to 40 mg of pantoprazole) until your ulcer has completely healed. Duodenal ulcers generally heal within two weeks. If a two-week course of treatment is not sufficient, healing will be achieved in almost all cases within two weeks of further treatment. For gastric ulcers and reflux oesophagitis, a four-week course of treatment is required in most cases. If this is not sufficient, healing will be achieved in most cases within four weeks of further treatment. In patients with conditions where too much stomach acid is produced (e.g. Zollinger-Ellison syndrome), there are no limits on the length of treatment and should be continued for as long as it is required. If you do not respond to treatment after 4 weeks you should talk to your doctor who will decide whether a prolongation of treatment will be necessary. If you take more Pantium than you should There is no information available on the effects of overdose in humans. However, if you do notice signs of intoxication, please inform a doctor. Depending on the dose taken and/or which symptoms occur, the doctor will decide on the next course of action to take. If you forget to take Pantium Do not take a double dose to make up for a forgotten dose. Simply continue with your normal dosage at the next scheduled time. If you stop taking Pantium Always talk to your doctor, before stopping treatment with Pantium on your own initiative or ending treatment before you should. 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. Significant side effects Please stop taking Pantium immediately and see your doctor if you experience one of the following symptoms: Swelling of the face, tongue, and throat Difficulty with swallowing Skin reactions with blistering or ulceration, and hives. Difficulty in breathing Severe dizziness with increased pulse rate and sweating Other possible side effects Common side effects (may affect up to 1 in 10 people) Headache, upper abdominal complaints, diarrhoea, constipation and flatulence. Uncommon side effects (may affect up to 1 in 100 people) Dizziness and visual disturbances such as blurred vision, nausea and vomiting, allergic reactions, e.g. itching and skin rash, exanthema, eruption, sleep disorders, dry mouth, abdominal pain and discomfort, increased liver values, fracture of the hip, wrist or spine, feeling weak, exhausted or generally unwell. Rare side effects (may affect up to 1 in 1,000 people) Joint and muscle pain, depression, hallucination, disorientation and confusion, especially in patients having a tendency to these symptoms as well as the worsening of these symptoms in case of preexistence, sharp drop in circulating granular white blood cells, associated with high fever Page 4 of 6

5 (agranulocytosis), severe allergic reaction manifested as acute general symptoms such as rapid pulse, excessive sweating and substantial drop in blood pressure, increased serum lipids, weight changes, taste disorders, an increase in bilirubin, hives, swelling of the skin or mucous membranes (angiooedema), breast enlargement in males (gynaecomastia), increased body temperature, swelling of the lower arms and legs (peripheral oedema). Very rare side effects (may affect up to 1 in 10,000 people) Loss of white blood cells (which increases the risk of infections), loss of blood platelets (which increases the risk of bruises and bleedings), coexisting abnormal reduction in the number of red and white blood cells, as well as platelets (pancytopenia), inflamed kidneys (interstitial nephritis with possible progression to kidney failure), severe reactions of the skin and mucous membranes accompanied by blistering (Stevens-Johnson syndrome, erythema multiforme), Lyell s syndrome ( scalded skin syndrome ), increased sensitivity to light (photosensitivity), hypernatraemia in the elderly, severe liver damage, resulting in jaundice with or without liver failure. Not known (frequency cannot be estimated from the available data) Decreased sodium blood levels, decreased potassium blood levels, tingling sensations (paraesthesia), muscle spasm as a consequence of electrolyte disturbances. If you are on Pantium 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. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: ; Fax: Website: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine. 5. How to store Pantium 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 blister and outer carton after (EXP:). The expiry date refers to the last day of that month. For tablets packed in plastic bottles: Pantium 40 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 Pantium 40 mg contains: The active substance is: pantoprazole Each gastro-resistant tablet contains 40 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(vinylalcohol), talc (E553b), titanium dioxide (E171), macrogol 3350, soya lecithin, iron oxide yellow (E172), sodium carbonate anhydrous (E500), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate (E1505). Page 5 of 6

6 What Pantium 40 mg looks like and contents of the pack: Pantium 40 mg are oval, yellow, gastro-resistant tablets. Pantium 40 mg are available in blister packs of 7, 14, 15, 28, 30, 56, 60, 100 tablets and in bottles of 100 tablets. Not all pack sizes may be marketed. Marketing authorisation holder Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary Manufacturer STADA Arzneimittel AG, Stadastrasse 2-18, Bad Vilbel, Germany. This medicinal product is authorised in the Member States of the EEA under the following names: DE (RMS): Tifipan 40 mg magensaftresistente Tabletten FR: PANTOPRAZOLE EG 40 mg, comprimé gastro-résistant IE: Pantium 40 mg gastro-resistant tablet This leaflet was last revised in June Page 6 of 6

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