Package leaflet: Information for the user. Ranitidine 150 mg film-coated tablets Ranitidine 300 mg film-coated tablets. Ranitidine

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1 Package leaflet: Information for the user Ranitidine 150 mg film-coated tablets Ranitidine 300 mg film-coated 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. What is in this leaflet 1. What Ranitidine is and what it is used for 2. What you need to know before you take Ranitidine 3. How to take Ranitidine 4. Possible side effects 5. How to store Ranitidine 6. Contents of the pack and other information 1. What Ranitidine is and what it is used for Ranitidine film-coated tablets are a gastrointestinal medicine (a medicine to treat gastrointestinal diseases) containing ranitidine. It belongs to the group known as histamine H2 antagonists, which inhibit the production of stomach acid. Ranitidine film-coated tablets are used to treat diseases of the stomach and duodenum in which a reduction in the production of gastric acid is required: - Duodenal ulcer. - Benign gastric ulcer. - Long term treatment of duodenal ulcers (150 mg only). - Reflux oesophagitis (inflammation of the oesophagus as a result of regurgitation of stomach contents). - Zollinger-Ellison Syndrome (a disease in which the stomach produces too much acid). Ranitidine film-coated tablets are used in Children from 3 to 18 years Short-term treatment of peptic ulcer Treatment of gastroesophageal reflux, including reflux oesophagitis, and relief of the symptoms of gastroesophageal reflux disease. 2. What you need to know before you take Ranitidine Do not take Ranitidine tablets - If you are allergic (hypersensitive) to ranitidine or any of the other ingredients of this medicine (listed in section 6).

2 Warnings and precautions - If you suffer from impaired kidney function; a lower dose may be necessary (see section 3, How to take Ranitidine tablets ). - If you have severely impaired liver function. - Stomach or duodenal ulcers can be caused by a certain bacterium called Helicobacter pylori. Your doctor may therefore prescribe other medicines that can kill these bacteria (antibiotics). - If you have ever had attacks of a disease that interferes with the production of red blood cells (porphyria, a serious disease with symptoms including the following: hypersensitivity to light, paralysis and severe abdominal pain), since ranitidine can very rarely trigger an attack of porphyria. - If you have unintended weight loss as a result of dyspepsia. - If you are middle-aged or elderly and are having dyspeptic symptoms for the first time or if the symptoms have recently changed, consult your doctor or pharmacist. - If you have a lung disease, diabetes or heart failure or if you have immunodeficiency (a disturbance of your immune system). One study showed an increased risk of pneumonia in users of H2 receptor antagonists. Consult your doctor if any of the above warnings applies to you, or has done so in the past. Other medicines and Ranitidine Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Do not take these tablets at the same time as the following medicines: - If use of erlotinib is considered during treatment with ranitidine, administration must be staggered, i.e. erlotinib must be taken at least 2 hours before or 10 hours after taking ranitidine. It is possible after long-term administration of ranitidine that the absorption of cyanocobalamine may be inhibited, resulting in a vitamin B12 deficiency. - If you are using this medicine at the same time as theophylline (an anti-asthma drug); the theophylline dose may require adjustment. - Caution must be exercised in the event of simultaneous administration with atazanavir or delaviridine, for treating HIV infection or gefitnib for lung cancer. - Lidocaine, a local anaesthetic - Propranolol, procainamide or n-acetylprocainamide, for heart problems - Diazepam, for worry or anxiety problems - Phenytoin, for epilepsy - Warfarin, for thinning your blood - Antacids and sucralfate (another drug used to treat disorders such as stomach and intestinal ulcers); simultaneous use can reduce ranitidine absorption into the bloodstream (as a result of which it becomes less effective). For this reason these drugs must therefore be taken about 2 hours after taking ranitidine. - If you are taking non-steroidal anti-inflammatory painkillers (NSAIDs, such as aspirin). - Medicines whose absorption is dependent on the amount of acid in the stomach may be affected; since ranitidine affects stomach acidity, there may be changes in the absorption of this type of substance into the blood, with consequent changes in its effect. The result may be either increased absorption, e.g. triazolam, midazolam (used to help you sleep and/or relieve anxiety) or glipizide (a drug used to reduce blood sugar levels), or decreased absorption, e.g. ketoconazole, itraconazole and posaconazole (medicines used to treat fungal infections). Taking Ranitidine with food, drink and alcohol The effect of small amounts of alcohol may be intensified if you are taking ranitidine at the same time. The tablets can be taken with or without food. Pregnancy, breast-feeding and fertility

3 Pregnancy If you are pregnant or intending to become pregnant or are breastfeeding, consult your doctor or pharmacist. No side effects have been observed to date with ranitidine use during pregnancy. Ask your doctor or pharmacist for advice before taking any medicine. Ranitidine should only be used during pregnancy if it is considered necessary. Breast-feeding Ranitidine passes into breast milk. It is not known whether this has any effect on the infant and therefore breastfeeding is not recommended if you are using this medicine. Ask your doctor or pharmacist for advice. Driving and using machines Ranitidine has no or negligible influence on the ability to drive and use machines. Ranitidine contains castor oil It may cause stomach upset and diarrhoea 3. How to take Ranitidine Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Dosage and method of administration You can swallow the tablets with a little water. It is not necessary to take the tablets with meals. If you have to take a dose of Ranitidine once daily, it is best that you do so in the evening before bedtime. With a dosage taken twice daily, you must take Ranitidine in the morning and in the evening. The recommended dose is: Adults: (including the elderly)/adolescents (12 years and older) Intestinal or benign gastric ulcer: Two Ranitidine 150 mg tablets (= 300 mg ranitidine) a day (=24 hours), in a single dose after the evening meal or in the evening before bedtime, or in two doses, i.e. 150 mg at breakfast and 150 mg in the evening before bedtime. Treatment lasts for 4 weeks, but can be extended to 8 weeks. Long-term treatment of duodenal ulcers, patients with recurrent ulcers: One Ranitidine 150 mg tablet per day (= 24 hours), in the evening before bedtime. Treatment lasts for 12 months or less, as decided by your doctor. Inflammation of the oesophagus due to regurgitation of stomach contents (reflux oesophagitis): Two Ranitidine 150 mg tablets (= 300 mg ranitidine) a day (=24 hours), in a single dose after an evening meal or in the evening before bedtime. The tablets may if necessary be taken in two doses, 150 mg at breakfast time and 150 mg in the evening before bedtime. Treatment lasts for 8 weeks. Zollinger-Ellison Syndrome (a disease in which the stomach produces too much acid): Starting dose: One Ranitidine 150 mg tablet three times a day (=24 hours). If necessary, the dosage can be increased to mg (4-6 tablets) a day (=24 hours). Duration of treatment: as directed by your doctor. Patients with impaired kidney function:

4 The dosage will be reduced by your doctor, depending on the extent to which your kidney function is impaired. Children from 3 to 11 years and over 30 kg of weight Your doctor will work out the right dose for you based on your child s weight. Treatment of stomach or duodenal (small intestine) ulcers: The usual dose is 2mg for each kg of body weight, twice a day for four weeks. This dose may be increased to 4 mg for each kg, twice a day. Take each dose about 12 hours apart. The duration of treatment may be increased to 8 weeks. Treatment of heartburn due to too much acid: The usual dose is 2.5 mg for each kg of body weight, twice a day for two weeks. This dose may be increased to 5 mg for each kg, twice a day. Take each dose about 12 hours apart. Safety and efficacy in new-born patients has not been established. If you notice that the effect of Ranitidine tablets is too strong or not quite strong enough, consult your doctor or pharmacist. If you take more Ranitidine than you should If you have taken more than the prescribed dose, do not wait before asking your doctor what to do or contacting the emergency department at the nearest hospital. If you forget to take Ranitidine If you have missed a dose, take this dose as soon as possible. However, if it is nearly time for your next dose, skip the forgotten dose and carry on with your normal dosage schedule. Never take a double doses. You should check with your doctor or pharmacist if you are not sure. If you stop taking Ranitidine If you suddenly stop using this medicine, the symptoms that were present before starting treatment may return. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Ranitidine can cause side effects, although not everybody gets them. The following frequency convention has been used in the evaluation of side effects: Very common may affect more than 1 in 10 people Common may affect up to 1 in 10 people Uncommon may affect up to 1 in 100 people Rare may affect up to 1 in 1,000 people Very rare may affect up to 1 in 10,000 people Blood and lymphatic system disorders Rare: Reduction in all white blood cells (leukopenia) or platelets (thrombocytopenia). These changes are normally reversible. Very rare: Changes in blood count (low levels of a certain type of white blood cells [agranulocytosis], low levels of all blood cells [pancytopenia] or changes in bone marrow [bone marrow hypoplasia/aplasia]).

5 Agranulocytosis, low levels of white blood cells, which can cause increased susceptibility to infection with fever, sore throat/pharynx/mouth or urinary problems. If you notice any of the above mentioned side effects, please contact your doctor immediately Immune system disorders Rare: Hypersensitivity (allergic) reactions (e.g. a rise in the number of eosinophilic blood cells, hives, fever, drop in blood pressure, sudden accumulation of body fluid in the skin and mucous membranes, spasm of the larynx (voice box), bronchial spasms, chest pain, circulatory shock and angioedema, swollen face, tongue or pharynx (back of the throat), swallowing difficulties and breathing problems. Very Rare: Anaphylactic shock. These reactions are uncommon after a single dose. Psychiatric disorders Very Rare: Reversible mental confusion, depression, irritability and hallucinations. This has been reported in seriously ill and/or elderly patients. Nervous system disorders Uncommon: Malaise, fatigue Very rare: dizziness, sever headache, reversible (temporary) involuntary movement disorders. Central nervous system disturbances have occurred, primarily in the elderly or in seriously ill patients. These symptoms disappeared when the treatment with ranitidine was discontinued. Eye disorders Very rare: Blurred vision. This disappeared when ranitidine treatment was discontinued. Cardiac disorders Very rare: Faster heart rate, slower heart rate and disturbances in the electrical signal that causes the heart to beat [AV block]. Vascular disorders Very rare: Vasculitis, inflammation of one or more blood vessels. Gastrointestinal disorders Uncommon: Diarrhoea, constipation or nausea and loss of appetite, abdominal pain. In most cases, these symptoms improve during continuing treatment. Very rare: Acute inflammation of the pancreas (accompanied by severe pain in the upper abdomen, radiating to the back). Hepatobiliary disorders Rare: Transient (temporary) changes in liver function tests, which normalised with continuing treatment or after discontinuation of treatment. Very rare: Hepatitis (inflammation of the liver) with or without jaundice (yellow discoloration of the skin or the whites of the eyes). In most cases, these changes were reversible after discontinuing treatment. Skin and subcutaneous tissue disorders Rare: rash, itching. Very rare: Erythema multiforme (a particular type of skin rash), Hair loss. Musculoskeletal and connective tissue disorders Very rare: Joint disorders, muscle pain. Renal and urinary disorders Rare: Increase in plasma creatinine levels. Such increases were mostly minor and generally normalised on continuing treatment with ranitidine.

6 Very rare: Acute interstitial nephritis (inflammation of the kidneys). Reproductive system and breast disorders Very rare: Breast formation in men, loss of sex drive [libido] and reversible impotence. It has not yet been established whether there is an actual causal link between use of ranitidine and the occurrence of these disorders. 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 Ranitidine 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 carton and blister. The expiry date refers to the last day of that month. This medicinal product does not require any special storage condition. Do not throw away any medicine 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 pack an other information What Ranitidine contains: The active substance is ranitidine. For 150mg: Each tablet contains ranitidine hydrochloride equivalent to 150mg ranitidine. For 300mg: Each tablet contains ranitidine hydrochloride equivalent to 300mg ranitidine. The other ingredients are: Tablet core: microcrystalline cellulose (E460), croscarmellose sodium (E468), anhydrous colloidal silica (E551), purified talc (E553b), magnesium stearate (E572). Tablet coating: hypromellose(e464), castor oil, titanium dioxide (E171), yellow iron oxide (E172), purified talc (E553b). What Ranitidine tablets look like and content of the pack: Ranitidine 150 mg tablets are Creamish yellow, round, biconvex, film-coated tablets having approximately 10 mm diameter with the inscription "IL" on one side and plain on the other side. Ranitidine 300 mg tablets are Creamish yellow, round, biconvex, film-coated tablets having approximately 12.5 mm diameter with the inscription "II" on one side and plain on the other side. Ranitidine 150 mg and 300 mg tablets are packaged in aluminium blister strips with 10 tablets. Ranitidine 150 mg film-coated tablets are supplied in packs containing 30,60 and 100 tablets. Ranitidine 300 mg film-coated tablets are supplied in packs containing 10,30,60 and 100 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer:

7 Accord Healthcare Limited, Sage House, 319 Pinner Road, Harrow, Middlesex, HA1 4HF United Kingdom The leaflet was last revised in 04/2014.