Package leaflet: Information for the user. Ranitidine Sandoz effervescent 150, 150 mg effervescent tablets Ranitidine

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1 Sandoz Business use only Page 1 of 9 PACKAGE LEAFLET Package leaflet: Information for the user Ranitidine Sandoz effervescent 150, 150 mg effervescent tablets Ranitidine 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 Ranitidine Sandoz effervescent 150 is and what it is used for 2. What you need to know before you take Ranitidine Sandoz effervescent How to take Ranitidine Sandoz effervescent Possible side effects 5. How to store Ranitidine Sandoz effervescent Contents of the pack and other information 1 What Ranitidine Sandoz effervescent 150 is and what it is used for Ranitidine belongs to the group of so-called histamine (H 2 ) antagonists. These are medicines that inhibit gastric acid production and have a beneficial effect on stomach or duodenal ulcers and oesophageal irritation. Ranitidine Sandoz effervescent 150 in adults is used: to heal ulcers in the stomach or duodenum to prevent the recurrence of ulcers in the duodenum to treat inflammation of the gullet (oesophagus) caused by reflux of gastric acid (reflux oesophagitis) to treat a disease in which the stomach produces too much acid (Zollinger - Ellison syndrome).

2 Sandoz Business use only Page 2 of 9 This medicine is not meant for the treatment of mild stomach ache or intestinal complaints, e.g. an irritated stomach due to tension.

3 Sandoz Business use only Page 3 of 9 Ranitidine Sandoz effervescent 150 in children is used: to heal ulcers in the stomach or duodenum to treat inflammation of the gullet (oesophagus) caused by reflux of gastric acid (reflux oesophagitis) 2 What you need to know before you take Ranitidine Sandoz effervescent 150 Do not take Ranitidine Sandoz effervescent 150: if you are allergic to ranitidine or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Ranitidine Sandoz effervescent 150 if: you suffer from reduced renal or hepatic function or if you are elderly; a lower dose may be required. you have stomach ulcer caused by a certain bacteria (Helicobacter pylori). If your doctor finds out that this applies for you he/she can prescribe other medicines that are able to kill these bacteria (antibiotics). Before starting treatment with ranitidine, your doctor must have already ascertained that the stomach or duodenal ulcer is not malignant. you have stomach cancer you have a rare condition called acute porphyria. you have lung disease. you are diabetic. you have any problems with your immune system. you have had stomach ulcers before and you are taking Non-Steroidal Anti- Inflammatory (NSAIDs) medicines. Other medicines and Ranitidine Sandoz effervescent 150 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important to mention the following before taking this medicine: Non-Steroidal Anti-Inflammatory (NSAID) medicines, for pain and inflammation lidocaine, a local anaesthetic propranolol, procainamide or n-acetylprocainamide, for heart problems diazepam, for worry or anxiety problems phenytoin, for epilepsy (fits) theophylline, for breathing problems (asthma) warfarin, for thinning your blood. glipizide, for lowering blood glucose

4 Sandoz Business use only Page 4 of 9 atazanavir or delaviridine, for treating HIV infection triazolam, for sleep problems gefitnib, for lung cancer ketoconazole, an anti fungal medicine. gastric acid-binding medicinal products (antacids) and sucralphate (another product used for e.g. stomach or duodenal ulcers): the uptake of ranitidine in the blood (and thus its effect) may be reduced. These medicines must therefore be taken about 2 hours after ranitidine; Midazolam is a medicine that may be given to you just before you have an operation. Tell the doctor you are taking Ranitidine tablets before your operation in case he or she wants to give you midazolam. Caution, medicines mentioned above may be known to you under another name, often the trade name. In this section only the active substance or therapeutic group of the medicine is named and not the trade name. That is why you should always carefully examine the packaging and read the patient information leaflet thoroughly of the medicines that you are already using to see what the active substance or therapeutic group of that product is. Ranitidine Sandoz effervescent 150 with food, drink and alcohol You are advised not to drink alcohol with this medicine. The effects of small amounts of alcohol with this medicine may give you a headache, dizziness and confusion. There is a possibility of hallucinations occurring. Pregnancy, breast-feeding and fertility 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. The effects on human fertility are not known. Driving and using machines Ranitidine Sandoz effervescent 150 has no or negligible effect on the ability to drive or use machines. Ranitidine Sandoz effervescent 150 contains 120 mg sodium per tablet. If you are on a lowsalt or salt-free diet, you must take this into consideration. Ranitidine Sandoz effervescent 150 contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 3 How to take Ranitidine Sandoz effervescent 150

5 Sandoz Business use only Page 5 of 9 Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Usual dosage in adults: For duodenal or stomach ulcer: 150 mg in the morning and 150 mg in the evening or a single dose of 300 mg in the evening. Duration of the treatment: 4 weeks, but can be extended to 8 weeks. To prevent the recurrence of duodenal ulcers: 150 mg in the evening. Duration of the treatment: 12 months or less according to the doctor's instructions. For inflammation of the oesophagus through reflux of gastric acid: 150 mg in the morning and 150 mg in the evening or a single dose of 300 mg in the evening. If necessary, the daily dose can be raised to 600 mg. Duration of treatment: 8 weeks, but can be extended to 12 weeks. Patients with extreme gastric hyperacidity, as in Zollinger-Ellison syndrome: Initial dosage: 150 mg in the morning, 150 mg in the afternoon, and 150 mg in the evening. If necessary, the daily dose can be raised to 600 to 900 mg. Duration of treatment: according to the doctor s instructions. Dosage in patients with reduced renal function: The dose will be reduced by your doctor, depending on the extent to which your renal function is impaired. Usual dosage in children (3 to 11 years and over 30 kg of weight): For duodenal or stomach ulcer: The recommended dosage is 4 to 8 mg per kg body weight per day, with a maximum of 300 mg per day, split into 2 separate doses. Children should only take this medicine up to 4 weeks. If healing is incomplete at that time, give Ranitidine another 4 weeks. For inflammation of the oesophagus through reflux of gastric acid: The recommended dosage is 5 to 10 mg per kg body weight per day, with a maximum of 600 mg per day, split into 2 separate doses. Method of administration: The effervescent tablets should be dissolved in a large quantity of water without breaking them (= 1 full glass), waiting until the effervescent tablets are completely dissolved and then drinking the solution. This does not necessarily have to be done during or before a meal. In the evening the tablets may be taken after the evening meal or at night before going to bed.

6 Sandoz Business use only Page 6 of 9 If you notice that the effect of this medicine is too strong or inadequate, consult your doctor or pharmacist. If you take more Ranitidine Sandoz effervescent 150 than you should Do not take more than your doctor tells you to. If you have accidentally taken more than the prescribed dose, go to the nearest hospital casualty department or tell your doctor/pharmacist immediately. Take the container and any remaining effervescent tablets or this leaflet with you so the medical staff knows exactly what you have taken. If you forget to take Ranitidine Sandoz effervescent 150 If you forget to take a dose, take another as soon as you remember. Then carry on as before. Do not take a double dose to make up for a forgotten dose. If you stop taking Ranitidine Sandoz effervescent 150 After a few days you should feel much better but don t stop taking the tablets until your doctor tells you to or the pain and discomfort may return. 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. Serious side effects Tell your doctor straight away if you have any of the following symptoms of a severe allergic reaction (isolated cases): sudden difficulty in breathing, speaking and swallowing swelling of the lips, face and neck, skin rash, itching fever chest pain abdominal pain extreme dizziness or collapse Contact your doctor as soon as possible if you experience any of the following side effects (may affect up to 1 in 10,000 people): 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 flank pain, fever, drowsiness caused by kidney problems

7 Sandoz Business use only Page 7 of 9 severe pain in the abdomen and back caused by inflammation of the pancreas These are all serious side effects. You may need urgent medical attention. Other possible side effects Uncommon (may affect up to 1 in 100 people): abdominal pain, constipation, feeling sick Rare (may affect up to 1 in 1,000 people): skin rash blood tests which show changes in the way the kidney or the liver is working Very rare (may affect up to 1 in 10,000 people): fast, slow, or irregular heart beat blurred vision uncontrolled movements, this effect is usually reversible severe headache dizziness confusion, hallucinations, or depression in predominantly severely ill, elderly and patients with kidney problems hair loss skin rash with pink-red blotches muscle pain, joint pain enlarged breasts in males and inability to achieve an erection allergic inflammation of blood vessels, often as skin rash (allergic vasculitis) diarrhoea changes in blood count, reduction in white blood cell which makes infections more likely, reduction in blood platelets which makes bruising or bleeding more likely, reduction in red blood cells which can make the skin pale and cause weakness Not known (frequency cannot be estimated from the available data): difficulty in breathing 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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

8 Sandoz Business use only Page 8 of 9 5 How to store Ranitidine Sandoz effervescent 150 Keep this medicine out of the sight and reach of children. Do not use Ranitidine Sandoz effervescent 150 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 30 C. Keep the container tightly closed. 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 Ranitidine Sandoz effervescent 150 contains The active substance is: ranitidine hydrochloride. Each tabletcontains 150 mg ranitidine (as hydrochloride). The other ingredients are: tartaric acid, sodium hydrogen carbonate, lactose monohydrate, povidone, riboflavin sodium phosphate (E101), simethicone emulsion (contains simethicone, methylcellulose, sorbic acid and purified water), sodium cyclamate, sodium saccharine, lemon flavour (contains citral, citronella oil, coriander oil, lime and gum arabic), macrogol 6000 and sodium hydroxide. What Ranitidine Sandoz effervescent 150 looks like and contents of the pack Yellow-white to light-yellow cylindrical effervescent tablets with bevelled edges Polypropylene container with LDPE cap. A quantity of desiccant (silicagel) is incorporated into the cap. Pack sizes: 10, 15, 20, 28, 30, 50, 60, 90 or 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer [To be completed nationally] This medicinal product is authorised in the Member States of the EEA under the following names: [To be completed nationally]

9 Sandoz Business use only Page 9 of 9 This leaflet was last revised in {MM/YYYY} [To be completed nationally]