PACKAGE LEAFLET: INFORMATION FOR THE USER

Transcription

1 a Novartis Company PACKAGE LEAFLET: INFORMATION FOR THE USER Pantoprazole Read all of this leaflet carefully before you start using this medicine. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What is and what it is used for 2. Before you use 3. How to use 4. Possible side effects 5. How to store 6. Further information 1. WHAT PANTOPRAZOLE 40 MG POWDER FOR SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR This is one of a group of medicines called proton pump inhibitors which work by reducing the amount of acid your stomach produces. This medicine is used to treat: inflammation of the gullet (oesophagus) caused by acid from the stomach escaping into the gullet(usually with heartburn) ulcers in the stomach (gastric ulcer) ulcers in the upper part of the intestines (duodenal ulcer) severely increased acid secretion in the stomach (Zollinger-Ellison syndrome). 2. BEFORE YOU USE PANTOPRAZOLE 40 MG POWDER FOR SOLUTION FOR INJECTION Do not use : if you are allergic (hypersensitive) to pantoprazole

2 Sandoz GmbH Confidential Page 2 Take special care with This medicine should not be used for mild gastrointestinal complaints such as nervous indigestion. Tell your doctor if you suffer from kidney or liver disease because this is important for your doctor in order to give you the right dose. Before you start using this medicine your doctor should have established that you do not suffer from a malignant disorder of the stomach or gullet. Tell your doctor if you have recently: suffered any unintentional weight loss been vomiting frequently experienced pain or difficulty when swallowing vomited blood or dark particles that look like coffee-grounds passed black tarry stools. Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important to mention to your doctor if you are also taking: ketoconazole (used to treat fungal infections of the skin or nails) or other medicines whose uptake in the blood depends on the degree of acidity in the stomach anticoagulants (blood thinning tablets like warfarin or phenprocoumon): your doctor may check your blood clotting to adapt the dose Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Experience in pregnant women is very limited. If you are pregnant you should not be given this medicine unless your doctor considers it absolutely necessary. There is no information on the excretion of pantoprazole, the active substance in this medicine, into human breast milk. If you are breast-feeding and treatment with this medicine is necessary, your doctor should decide whether to continue or discontinue breast-feeding. Driving and using machines No effect on the ability to drive and use machines is to be expected. Important information about some of the ingredients of Pantoprazole 40 mg powder for solution for This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially sodium-free.

3 Sandoz GmbH Confidential Page 3 3. HOW TO USE PANTOPRAZOLE 40 MG POWDER FOR SOLUTION FOR INJECTION This medicine is used when it is not suitable for you to take tablets. It is only for intravenous use (i.e. or infusion directly into a vein) and it is supplied as a powder that is diluted before use by your doctor or nurse. Your nurse or doctor will administer each. Please tell them if you think you have missed a dose or have been given too much medicine. When your course of s is finished, your doctor may prescribe further treatment with tablets. Dosage: Treatment of the inflammation of the gullet and ulcers in the stomach or intestine: The usual dose is one /infusion of 40 mg each day, given over a 2 to 15 minute period of time, for up to a week. Treatment of Zollinger-Ellison syndrome: The usual starting dose is a daily treatment of 80 mg. Thereafter, the dosage can be adjusted as necessary, based on measurements of gastric acid secretion. With doses above 80 mg daily, the dose should be divided and given twice daily. A temporary increase of the dosage above 160 mg pantoprazole is possible but should not be applied longer than necessary. Patients with liver problems: If you have severe liver disease your doctor may reduce your dose to 20 mg. Your doctor may take blood tests to watch how well your liver is working. Patients with kidney problems and elderly patients: The daily dose should not exceed 40 mg. Children: This medicine is not recommended for children. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, can cause side effects, although not everybody gets them. Serious side effects

4 Sandoz GmbH Confidential Page 4 Tell your doctor or nurse straight away if you have any of the following symptoms of a severe allergic reaction: sudden difficulty in breathing, speaking and swallowing swelling of the lips, face and neck extreme dizziness or collapse severe or itchy skin rash, especially if this shows blistering and there is soreness of the eyes, mouth or genital organs Contact your doctor as soon as possible if you experience any of the following side effects: yellowing of the skin or whites of the eyes caused by liver problems increased or reduced urine output, or traces of blood in your urine, sometimes with swollen limbs and/or flank pain caused by kidney problems skin rash caused by sensitivity to sunlight unusual bruising or bleeding caused by reduction of blood platelets These are all serious side effects. You may need urgent medical attention. Serious side effects are very rare (affecting less than 1 in 10,000 people). Other possible side effects Common (affecting less than 1 in 10 people): stomach pain diarrhoea, constipation, wind headache Uncommon (affecting less than 1 in 100 people): nausea, vomiting dizziness blurred vision itchiness, skin rash Rare (affecting less than 1 in 1,000 people): dry mouth joint pain Very rare (affecting less than 1 in 10,000 people): redness and/or swelling at the site swollen ankles fever muscle pain feeling sad or depressed reduction in the number of white blood cells, which makes infections more likely

5 Sandoz GmbH Confidential Page 5 increased levels of blood lipids (triglycerides) blood tests which show changes of the way the liver is working. If you use this medicine for long term treatment tell your doctor if you experience any of the following signs of a lack of vitamin B12: tiredness, sore mouth, tingling and numbness of hands and feet, pale skin. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE PANTOPRAZOLE 40 MG POWDER FOR SOLUTION FOR INJECTION Keep out of the reach and sight of children. Do not use after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month. Do not store above 25 C. Keep container in outer carton. After preparation of the solution by your doctor or nurse, it must be stored below 25 C and used within 12 hours. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. should not be used if you notice cloudiness or precipitation. These are visible signs of deterioration. The contents of the vial is meant for single use; any product that has remained in the vial has to be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What contains Active substance: one vial contains mg pantoprazole sodium sesquihydrate, equivalent to 40 mg pantoprazole. Other ingredients: the medicinal product contains no other ingredients than the active substance.

6 Sandoz GmbH Confidential Page 6 What looks like and contents of the pack is a glass vial closed with a red rubber stopper and sealed by an aluminium cap, containing a white to yellowish powder, i.e. the powder for solution for. The vials are packed in carton boxes. Each box contains 1, 5, 10 or 20 glass vials. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: [To be completed nationally] Manufacturer: Lek Pharmaceuticals d.d. Verovškova Ljubljana Slovenia This medicinal product is authorised in the Member States of the EEA under the following names: Austria: 40 mg - Trockenstechampulle Belgium: 40 mg poeder voor oplossing voor injectie Denmark: Finland: Italy: PANTOPRAZOLO SANDOZ GmbH 40 mg polvere per soluzione iniettabile the Netherlands: injectie 40 mg, poeder voor oplossing voor injectie Norway: Poland: Portugal: Pantoprazol SANDOZ 40 mg Pó para Solução Injectável Slovak Republic: 40 mg prášok na injekčný roztok Slovenija: ACIPAN 40 mg prašek za raztopino za injiciranje Spain: 40 mg polvo para solución inyectable EFG United Kingdom: This leaflet was last approved in MM/YYYY [To be completed nationally] The following information is intended for medical or healthcare professionals only:

7 Sandoz GmbH Confidential Page 7 A ready-to-use solution is prepared by injecting 10 ml of physiological sodium chloride solution into the vial containing the dry substance. The reconstituted solution should be colourless to faintly yellow. This solution may be administered directly or may be administered after mixing with 100 ml physiological sodium chloride solution, or 5% Glucose. After preparation the solution must be used within 12 hours. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at not more than 25 C. should not be manufactured or mixed with solvents other than those stated. The medicinal product should be administered intravenously over 2-15 minutes. Any product that has remained in the container or the visual appearance of which has changed (e.g. if cloudiness or precipitation is observed) has to be discarded. The contents of the vial is for single use only.