Package leaflet: Information for the user Pantoprazol Orifarm 40 mg gastro-resistant tablets. pantoprazole

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1 Package leaflet: Information for the user Pantoprazol Orifarm 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. What is in this leaflet: 1. What Pantoprazol Orifarm is and what it is used for 2. What you need to know before you take Pantoprazol Orifarm 3. How to take Pantoprazol Orifarm 4. Possible side effects 5. How to store Pantoprazol Orifarm 6. Contents of the pack and other information 1. What Pantoprazol Orifarm is and what it is used for Pantoprazol Orifarm belongs to a group of medicines called proton pump inhibitors. Proton pump inhibitors reduce the amount of acid that your stomach makes. You have been given Pantoprazol Orifarm tablets because you have a condition caused by stomach acid. Pantoprazol Orifarm 40 mg gastro-resistant tablets are used in the short-term treatment and to relieve the symptoms of: - duodenal ulcer - gastric ulcer - esophagitis (inflammation of esophagus) caused by acid secretion. Additionally, the preparation is used: - in combination with antibiotics in patients whose ulceration is related to Helicobacter pylori bacteria - in the long-term treatment of conditions where gastric acid is constantly being secreted too much (e.g. Zollinger-Ellison syndrome). 2. What you need to know before you take Pantoprazol Orifarm Do not take Pantoprazol Orifarm - if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6). - if you are taking atazanavir (which is used for the treatment of HIV infection) - if you have any relevant impairment of liver or kidney function and the product has been prescribed for you for the eradication of Helicobacter pylori. 1

2 Warnings and precautionstalk to your doctor or pharmacist before taking Pantoprazol Orifarm - if you have severe liver impairment. In case of severe hepatic disorder your doctor should monitor your liver function while you use Pantoprazol Orifarm - if you have been diagnosed with vitamin B12 malabsorption - if your doctor has given you Pantoprazol Orifarm in addition to other medicines intended for the treatment of Helicobacter pylori infection (antibiotics): please also read the package leaflets of these medicines carefully. Taking a proton pump inhibitor like Pantoprazol Orifarm, 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). Please tell your doctor if you suffer or have recently suffered from any of the following symptoms: unintentional weight loss, recurrent vomiting or vomiting of blood, or dark stool. Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease. Other medicines and Pantoprazol OrifarmOther concomitant medication may affect the efficacy and safety of this medicine. Pantoprazol Orifarm may also affect the efficacy and safety of other medications. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.. Remember to tell your doctor about your treatment with Pantoprazol Orifarm if you are prescribed another medicine while the treatment is still ongoing. It is especially important to tell your doctor: - if you are using atazanavir which is used for the treatment of HIV infection - if you are using ketoconazole or itraconazole which are used for the treatment of fungal infections, since pantoprazole may affect their concentrations in your body - if you are using anticoagulant medicines, e.g. warfarin, since it may be necessary to monitor your blood coagulation tests more often. Pantoprazol Orifarm with food and drink The gastro-resistant tablets should be taken 1 hour before food with water. 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.experience with use of Pantoprazol Orifarm in pregnant women is limited. There is no information on the excretion of pantoprazole into human breast milk. If you are pregnant or if you are breast-feeding, you should use this medicine only if your treating physician considers the benefit for you greater than the potential risk for your unborn child or baby. Driving and using machines There are no known effects on the ability to drive and use machines. Adverse drug reactions such as dizziness and visual disturbances may occur and which may decrease the ability to react. Pantoprazol Orifarm contains phenylalanine This medicinal product contains phenylalanine. May be harmful for the people with phenylketonurie. 3. How to take Pantoprazol Orifarm 2

3 Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Method of administration The tablets should be swallowed whole, with sufficient fluid (e.g. one glass of water) and should not be chewed or crushed. Dosage Always take Pantoprazol Orifarm exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure about the dosage. Adults and adolescents 12 years of age and above: Esophagitis (inflammation of esophagus) caused by acid secretion: The recommended dose is 1 tablet (40 mg) daily. Adults: Duodenal ulcer: The recommended dose is 1 tablet (40 mg) daily. Gastric ulcer: The recommended dose is 1 tablet (40 mg) daily. In combination with antibiotics in patients whose ulceration is related to Helicobacter pylori bacteria: The recommended dose is 1 tablet (40 mg) two times daily in combination with antibiotics. The second pantoprazole tablet should be taken before the evening meal. The recommended antibiotics to be taken concomitantly with Pantoprazol Orifarm are the following: Amoxicillin (1000 mg) and clarithromycin (500 mg) both taken twice daily or Metronidazole (400mg or 500 mg) and clarithromycin (250 mg or 500 mg) both taken twice daily or Amoxicillin (1000 mg) and metronidazole (400 mg or 500 mg) both taken twice daily. Please ask your doctor if you are not sure. Long-term treatment of conditions where gastric acid is constantly being secreted too much (e.g. Zollinger-Ellison syndrome): Initial dose is 2 tablets (2 x 40 mg) daily. With doses above 80 mg daily, the dose should be divided and given twice daily. Elderly and patients with renal impairment: Daily dose of 40 mg should not be exceeded, except in elderly whose ulceration is related to Helicobacter pylori bacteria. Patients with hepatic impairment: Dose of 1 tablet (40 mg) should be given every second day. Children: Pantoprazol Orifarm 40 mg is not recommended for use in children below 12 years. If you take more Pantoprazol Orifarm than you should If you or someone you know accidentally takes a lot more than the stated dose (an overdose) you should contact a doctor immediately. If you forget to take Pantoprazol Orifarm 3

4 If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten tablet. If you stop taking Pantoprazol Orifarm Do not change the dosage or stop the medication without discussing it with your doctor first, especially if you are taking Pantoprazol Orifarm together with antibioitics in order to eradicate Helicobacter pylori, as this may increase the resistance of the germ to certain antibiotics. 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. Tell your doctor immediately or contact the casualty department at your nearest hospital, if you get any of the following serious side effects. Stop taking this medicine straight away, but take this leaflet and/or the tablets with you. - Serious allergic reactions (rare): Hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema. Typical symptoms are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, hives (nettle rash), severe dizziness with very fast heartbeat and heavy sweating. - Serious skin reactions (frequency not known): rash with swelling, blistering or peeling of the skin, losing skin and bleeding around eyes, nose, mouth or genitals and rapid deterioration of your general health, or rash when exposed to the sun. - Other serious reactions (frequency not known): yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as painful urination and lower back pain with fever. Side effects may occur with certain frequencies, which are defined as follows: 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. - Uncommon side effects: headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; bellyache and discomfort; skin rash or hives; itching; feeling weak, exhausted or generally unwell; sleep disorders; increase in liver enzymes in a blood test. - Rare side effects: disturbances in vision such as blurred vision; pain in the joints; muscle pains; weight changes; raised body temperature; swelling of the extremities; allergic reactions; depression; increased bilirubin and fat levels in blood (seen in blood tests). - Very rare side effects: disorientation; reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; reduction in the number of white blood cells, which may lead to more frequent infections. - Frequency not known: 4

5 hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium in blood. If you are on Pantoprazol Orifarm 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. 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 Pantoprazol Orifarm 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. The expiry date refers to the last day of that month. Do not store above 30 C. 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 Pantoprazol Orifarm contains The active substance is pantoprazol. Each gastro-resistant tablet contains 40 mg pantoprazole (as pantoprazole sodium sesquihydrate). The other ingredients are Mannitol (E 421), Sodium carbonate, anhydrous (E 500), Crospovidone, Hydroxypropylcellulose, Talc (E 553b), Calcium stearate, Zein F4000 (containing phenylalanine), Methacrylic acid-ethyl acrylate copolymer (1:1), Triethyl citrate (E 1505), Titanium dioxide (E 171), Talc (E 553b), Hypromellose, Macrogol 400, Iron oxid, yellow (E 172), Shellac (E 904), Iron oxide, black (E 172), N-butyl alcohol, Water, purified, Propylene glycol (E 1520), Methylated Spirit, Isopropyl alcohol. What Pantoprazol Orifarm looks like and contents of the pack Yellow, round, biconvex coated tablets printed with P40 on one side with black ink and plain on the other side. Blister pack (plain or unit dose): Cold formable foil as the base material and hard tempered aluminium foil as lidding foil material: 7, 10, 14, 15, 28, 30, 50, 56, 60, 98, 99, 100 gastro-resistant tablets Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer To be completed nationally 5

6 This medicinal product is authorised in the Member States of the EEA under the following names: DK: Pantoprazol Orifarm, 40 mg enterotablet FI: Pantoprazol Orifarm, 40 mg enterotabletti SE: Pantoprazol Orifarm, 40 mg enterotablett] This leaflet was last revised in [To be completed nationally] 6