PACKAGE LEAFLET Package leaflet: Information for the user Ranitidin Actavis 150 mg and 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. See section 4. What is in this leaflet 1. What Ranitidin Actavis is and what it is used for 2. What you need to know before you take Ranitidin Actavis 3. How to take Ranitidin Actavis 4. Possible side effects 5. How to store Ranitidin Actavis 6. Contents of the pack and further information 1. What Ranitidin Actavis is and what it is used for Effect: The gastric acid in the stomach is an important cause of ulcers of the duodenum and stomach. Ranitidine, the active substance in Ranitidin Actavis, lowers the production of histamine (a substance occurring naturally in the body) that stimulates the acid-producing cells of the stomach mucosa, so that the production of gastric juice is reduced. Use in adults: Ranitidin Actavis is used to treat: - Ulcers of the duodenum - Benign ulcers of the stomach - Symptoms caused by reflux of gastric juice into the oesophagus (gastrooesophageal reflux disease) - Inflammation in the lower oesophagus caused by reflux of gastric juice into the oesophagus (reflux oesophagitis) - Diseases associated with an abnormally large production of gastric juice (Zollinger-Ellison s syndrome). - Chronically recurrent ulcers of the duodenum Ranitidine, which is contained in Ranitidin Actavis, may also be authorised to treat other illnesses, which are not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have further questions and always follow their instructions. Use in children: Ranitidin Actavis can also be used in children from 3 years of age for treating stomach ulcers and symptoms caused by reflux of gastric juice into the oesophagus. 2. What you need to know before you take Ranitidin Actavis Do not take Ranitidin Actavis: 1
- 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 before taking Ranitidin Actavis if: - You are elderly or have lowered function of the kidneys and/or liver. Your doctor may need to lower your ranitidine dose. - You are elderly, have pulmonary disease, diabetes, heart failure or an impaired immune system, as you may have an increased risk of pneumonia. - You are taking medicines called NSAIDs (non-steroidal anti-inflammatory drugs) which work by reducing pain, inflammation and fever. - You suffer from acute porphyria (a genetic disorder, one of the symptoms being reddish discolouration of the urine). Other medicines and Ranitidin Actavis Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are being treated with one of the medicines below, please consult your doctor as your treatment may need to be adjusted: - Warfarin (medicine against blood clots) - Glipizide (medicine against diabetes) - Midazolam, triazolam (sleeping medicine) - Phenytoin (medicine against epilepsy) - Ketoconazole (medicine against fungal infections), atazanavir, delaviridine (medicines against viral infections) and gefitnib for treating cancer. The use of ranitidine may impact on the effect of such medicines, whose absorption in the body depends on the acidity of the stomach. - Procainamide (medicine against heart arrhythmia). High doses of ranitidine may reduce the excretion of procainamide from the body. If you use antacids or high doses (2 g) of sucralfate (medicine against ulcers), you should take ranitidine about 2 hours before taking such medicine, as such medicine reduces the absorption of ranitidine. Ranitidin Actavis with food and drink The effect of ranitidine is not altered by food, the tablets can be taken during or between meals. Tablets can be swallowed whole, divided or crushed. Simultaneous use of ranitidine and alcohol may increase the effect of alcohol. 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. Pregnancy Experience in use of ranitidine in pregnant women is limited. Only take Ranitidin Actavis according to your doctor s instructions. Breast-feeding Ranitidine is excreted in breast milk which may affect the child. Only take Ranitidin Actavis according to your doctor s instructions. Driving and using machines Ranitidin Actavis can sometimes cause side effects like headache, dizziness, tiredness, confusion and hallucinations. If you suffer from these side effects, do not drive any vehicle and/or operate machines that require concentration. 2
You alone are responsible to decide if you are in fit condition to drive a motor vehicle or perform other tasks that demand increased concentration. Because of their effects or undesirable effects, one of the factors that can reduce your ability to do these things safely is your use of medicines. Descriptions of these effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor, nurse or pharmacist if you are unsure about anything. 3. How to take Ranitidin Actavis Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Adults and adolescents 12 years and older: Ulcers of the duodenum, benign stomach ulcers 300 mg per day, either as 300 mg as an evening dose or 150 mg morning and evening. Normal duration of treatment is four weeks, but if the ulcer has not healed up after four weeks treatment, treatment should continue for another four weeks. If necessary, the dose may be increased to 300 mg morning and evening for four weeks. Preventive treatment of chronic recurrent ulcer of the duodenum 150 mg in the evening. Treatment of symptoms of gastric juice reflux into the oesophagus (gastro-oesophageal reflux disease) 150 mg in the morning and evening for 2-4 weeks. Treatment of inflammation in the lower oesophagus caused by reflux of gastric juice into the oesophagus (reflux oesophagitis) 150 mg in the morning and evening or 300 mg as an evening dose for 4-8 weeks. In severe cases, doses may be increased to a total of 600 mg per day, distributed on several doses for up to 12 weeks. For maintenance treatment, the recommended dose is 150 mg morning and evening. Treatment of abnormally large production of stomach juice (Zollinger-Ellison s syndrome) 150 mg 3 times daily, but, if necessary, the dose may be increased according to your doctor s instructions. Reduced function of kidneys and/or liver Adjustment of dose is necessary. Follow your doctor s instructions. Elderly patients Adjustment of dose is necessary. Follow your doctor s instructions. Children 12 years and over For children 12 years and over the adult dosage is given. Children from 3 to 11 years and above 30 kg of weight Acute treatment of stomach ulcer The doctor decides which dose should be given dependant upon the body weight of the child, but never more than 300 mg daily. The treatment normally lasts 4 weeks but in case of incomplete healing of the ulcer another 4 weeks of treatment may be needed. Treatment of symptoms of gastric juice reflux into the oesophagus (gastro-oesophageal reflux disease) The doctor decides which dose should be given dependant upon the body weight of the child, but never more than 600 mg daily. 3
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Tablets can be swallowed whole, divided or crushed. If you take more Ranitidin Actavis than you should Contact your doctor, emergency room or pharmacist if you have taken more Ranitidin Actavis than stated in this leaflet or more than prescribed by your doctor. Symptoms of overdose may be slow pulse, shortness of breath, uncoordinated muscle activity, seizures. If you forget to take Ranitidin Actavis Do not take a double dose to make up for a forgotten dose. Continue treatment as instructed by your doctor. 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. Common side effects (may affect up to 1 in 10 people) - Tiredness - Skin reactions. Uncommon side effects (may affect up to 1 in 100 people) - Stomach pain - Nausea - Diarrhoea - Constipation. Rare side effects (may affect up to 1 in 1,000 people) - Hives - Severe hypersensitivity reaction with swelling of face, tongue and throat or cramps in airways - Hepatitis due to hypersensitivity to ranitidine - Low blood pressure - Reduced content of haemoglobin in the blood (haemolytic anaemia) - Fever - Erectile dysfunction - Transient effect on liver function - Effect on kidney function - Liver failure. Very rare side effects (may affect up to 1 in 10,000 people) - Headache - Dizziness - Involuntary movements - Muscle and joint pains (Myalgia and Arthralgia) - Slow heart rate (Bradycardia) - Effect on heart function (AV block) - Fast or irregular heart rate (Tachycardia) - Unusual secretion of breast milk or breast enlargement in men - Reversible impotence - Acute inflammation of the pancreas and kidneys - Hepatitis with or without jaundice - Patchy red rash (Erythema multiforme) - Hair loss 4
- Blurred vision - Effect on blood composition and bone marrow - Inflammation of the blood vessels (vasculitis) - Severe allergic reactions. Unknown (frequency cannot be estimated from the available data) - Shortness of breath Elderly, seriously ill people and those with kidney problems may in particular experience transient confusion, depression and hallucinations. You should stop taking Ranitidin Actavis and see your doctor immediately if you experience symptoms of - angioedema such as swollen face, tongue or pharynx, difficulty to swallow, hives and difficulties to breath - reduced number of white blood cells (agranulocytosis) which can cause increased infection sensitivity with fever, sore throat/pharynx/mouth or urinary problems. 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. 5. How to store Ranitidin Actavis Keep this medicine out of the sight and reach of children. Do not store above 25 C. Do not use Ranitidin Actavis after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. 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 to protect the environment. 6. Contents of the pack and further information What Ranitidin Actavis contains - The active substance is ranitidine. Each tablet contains 150 mg or 300 mg ranitidine (in the form of ranitidine hydrochloride). - The other ingredients are: Tablet core: Croscarmellose sodium, magnesium stearate, microcrystalline cellulose. Film coating: Polymethacrylic acid (Eudragit E 100), hypromellose, macrogol 6000, talc, titanium dioxide (E171). What Ranitidin Actavis looks like and contents of the pack 150 mg: Round, convex, white to yellowish, film-coated tablets, scored on one side. 300 mg: Oblong, convex, white to yellowish, film-coated tablets, scored on one side. Pack sizes 150 mg: 10, 20, 30, 60 and 90 film-coated tablets. 300 mg: 10, 14, 20, 30, 60 and 90 film-coated tablets. Not all pack sizes may be marketed. 5
Marketing Authorisation Holder and Manufacturer Marketing authorisation holder <[To be completed nationally]> {Name and address} <{tel}> <{fax}> <{e-mail}> Manufacturer Actavis ehf. Reykjavikurvegi 78 220 Hafnarfjordur Iceland Actavis Ltd. BLB 016 Bulebel Industrial Estate Zejtun ZTN 3000 Malta <[To be completed nationally]> This leaflet was last revised in 2018-04-20 6