Terry White Chemists Ranitidine Active ingredient, (ra-nit-ti-deen) hydrochloride Consumer Medicine Information What is in this leaflet Read this leaflet carefully before taking your. Ask your doctor or pharmacist if you do not understand anything or are worried about taking your. This leaflet answers some common questions about Terry White Chemists Ranitidine. It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist. The information in this leaflet was last updated on the date listed on the last page. Some more recent information on the may be available. Speak to your pharmacist or doctor to obtain the most up to date information on the. All s have risks and benefits. Your doctor has weighed the risks of you taking against the benefits they expect it will have for you. Keep this leaflet with the. You may need to read it again. What is used for The name of your is Terry White Chemists Ranitidine. It contains the active ingredient, (as hydrochloride). Ranitidine belongs to a group of s called H2 antagonists or H2 blockers. Ranitidine works by decreasing the amount of acid made by the stomach. This helps reduce pain and also allows an ulcer and/or reflux disease to heal in most people. Ulcers Ulcers may be caused in part by too much acid being made in the stomach. Depending on the position of the ulcer, an ulcer is called a gastric or duodenal ulcer. A gastric ulcer occurs in the stomach. A duodenal ulcer occurs in the duodenum which is the tube leading out of the stomach. Ranitidine is used to help heal ulcers as well as prevent relapse in already healed ulcers. Reflux Oesophagitis Ranitidine is also used to treat reflux oesophagitis or reflux disease as well as prevent relapse in already treated reflux oesophagitis. This can be caused by "washing back" (reflux) of food from the stomach into the food pipe, also known as the oesophagus. Reflux can cause a burning sensation in the chest rising up to the throat, also known as heartburn. Zollinger-Ellison syndrome Ranitidine is also used to treat a rare condition called Zollinger-Ellison syndrome, where the stomach produces very large amounts of acid, much more than in ulcers and reflux disease. Ask your doctor if you have any questions about why this has been prescribed for you. Your doctor may have prescribed for another reason. This is available only with a doctor's prescription. There is no evidence that this is addictive. This is not expected to affect your ability to drive a car or operate machinery, but make sure you know how if affects you before driving. Before you take When you must not take it Do not take this if you have had an allergic reaction to or to any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, muscle pain or tenderness or joint pain or rash, itching or hives on the skin. Do not take this medication if the packaging is torn or shows signs of tampering. Do not take this medication after TERRY WHITE CHEMISTS RANITIDINE 1
the expiry date (EXP) printed on the pack. If you take this after the expiry date has passed, it may not work as well. If you are not sure whether you should start taking, talk to your doctor. Before you start to take it Tell your doctor if: 1. You have allergies to: * any other s * any other substances, such as foods, preservatives or dyes. 2. You have or have had any medical conditions, especially * kidney disease * liver disease * porphyria (rare disease of blood pigments) * lung complaint, cough or chest infection * diabetes * lowered immunity. 3. You plan to become pregnant or breast-feed. If you have not told your doctor about any of the above, tell them before you start taking. Taking other s Tell your doctor or pharmacist if you are taking any other s, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some s and may interfere with each other. These include:- * sucralfate, another used to treat peptic ulcer * ketoconazole, a used to treat fungal infection * heart medication e.g. procainamide * anticoagulant, e.g. warfarin * benzodiazepines e.g. triazolam, midazolam * antiretrovirals e.g. atazanavir, delavirdine * antidiabetic e.g. glipizide * anticancer e.g. gefitinib These s may be affected by or may affect how well it works. You may need different amounts of your, or you may need to take different s. Your doctor or pharmacist will advise you. They will tell you if you are taking any of these s. They may also have more information on s to be careful with or avoid while taking. How to take this Follow all directions from your doctor or pharmacist carefully. They may differ from the information in this leaflet. If you do not understand any written instructions, ask your doctor or pharmacist for help. How much to take Your doctor or pharmacist will tell you how many tablets you will need to take. This depends on your condition and whether or not you are taking any other s. How to take it Swallow each tablet whole with a drink of water. When to take it Take it about the same time each day. Taking your at the same time each day will have the best effect. It will also help you remember when to take it. It does not matter if you take it before or after food. If is prescribed twice a day, the best time to take it is in the morning and at bedtime. If is prescribed once daily, the best time to take it is at bedtime. If you do not understand the instructions on the box, ask your doctor or pharmacist for help. How long to take it Continue taking your for as long as your doctor tells you. Make sure you have enough to last over weekends and holidays. If you forget to take it If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking it as you would normally. Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect. If you are not sure whether to skip the dose, talk to your doctor or pharmacist. If you have trouble remembering to take your tablets, ask your pharmacist for some hints. If you take too much (overdose) Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to the Accident and Emergency Department at your nearest hospital, if you think that you or anyone else may have taken too much. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. If you take too many tablets you will probably experience adverse effects similar to those described in the section titled 'Side Effects' below. In TERRY WHITE CHEMISTS RANITIDINE 2
addition you may feel dizzy or light headed, faint, tired, or you may notice abnormal balance or walking. While you are taking Things you must do Tell any other doctors, dentists and pharmacists who are treating you that you are taking. Tell your doctor immediately if you become pregnant. If you are about to have any blood tests, tell your doctor that you are taking this. Go to your doctor regularly for a check-up. Your doctor may occasionally do tests to make sure the is working and to prevent side effects. Things you must not do Do not give this to anyone else, even if their symptoms seem similar to yours. Do not take your to treat any other complaints unless your doctor or pharmacists tells you to. Do not stop taking your, or change the dosage, without checking with your doctor. Things to be careful of Be careful driving or operating machinery until you know how affects you. Ranitidine generally does not cause any problems with your ability to drive a car or operate machinery. However, as with many other s, may cause dizziness or light-headedness in some people. Things that may help your condition Some self help measures suggested below may help your condition. Talk to your doctor or pharmacist about these measures and for more information: * Alcohol - limit your alcohol intake. * Aspirin and many other s used to treat arthritis/period pain/ headaches - these s may irritate the stomach and may make your condition worse. Your doctor or pharmacist may suggest other s you can take. * Caffeine - limit the number of drinks which contain caffeine, such as coffee, tea, cocoa and cola drinks, because they contain ingredients that may irritate your stomach. * Eating habits - eat smaller, more frequent meals. Eat slowly and chew your food carefully. Try not to rush at meal times. * Smoking - stop smoking or at least cut down. * Weight - your doctor may suggest losing some weight to help your condition. Side effects of All s may have some unwanted side effects. Sometimes they are serious, most of the time they are not. Your doctor has weighed the risks of using this against the benefits it will have for you. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking. Ask your doctor or pharmacist to answer any questions you may have. Following is a list of possible side effects. Do not be alarmed by this list. You may not experience any of them. If you notice any of the following side effects after taking, tell your doctor, but there is no immediate reason to stop taking the tablets unless you are concerned: * headache * dizziness or light-headedness, * uncontrolled movements. This effect is reversible and should get better once you stop taking this * if you are a man, breast tenderness and/or breast enlargement; loss in sexual desire or performance. The interference with sexual function is normally reversible and should get better once you stop taking this * inflammation of blood vessels (vasculitis) * abdominal discomfort or pain * constipation or diarrhoea (especially if antibiotics are also being taken) * sore joints and/or muscles * feeling of agitation or depression * hallucinations * loss of hair. Inform your doctor immediately if you get any signs of liver problems which may cause one or more of * generally feeling unwell * changes in the way the heart beats; either faster or slower * severe nausea (feeling sick) * loss of appetite * development of yellowish tinge to skin and/or eyes (jaundice) TERRY WHITE CHEMISTS RANITIDINE 3
* fever * rash and/or itching * dark coloured urine * confusion * muscle tremor * vomiting (being sick) * slow or irregular heart beat * unusual tiredness, shortness of breath or tendency to infections or bruising, which can be caused by upsets to "blood counts" * severe stomach pain rarely caused by inflamed pancreas * blurred vision. A few people can be allergic to some s; if any of the following happen, stop using and tell your doctor immediately or go to casualty at your nearest hospital: * sudden wheeziness or tightness in the chest * swelling of the eyelids, lips, face, tongue or throat (which may cause difficulty in swallowing or breathing) with or without a lumpy skin rash ("hives") anywhere on the body * unexplained fever * feeling faint, especially on standing up. Other problems are more likely to arise from the ulcer itself rather than the treatment. For this reason, contact your doctor immediately if you notice any of * pain or indigestion occurring during treatment with * you begin to vomit blood or food * your pass black (blood-stained) motions. Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell. After taking this Storage Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well. Keep it in a cool dry place where the temperature stays below 25 degrees C. Do not store it or any other in the bathroom or near a sink. Do not leave it on window sill or in the car on hot days. Heat and dampness can destroy some s. Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store s. Disposal If your doctor or pharmacist tells you to stop taking this or it has passed its expiry date, ask your pharmacist what to do with any tablets that are left over. Where to go for further information Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition. Product description What Terry White Chemists Ranitidine looks like tablets are available in two different strengths: 150 mg tablets: white to off-white, round, biconvex tablets. Scored on one side and engraved "RAN" over "150" on the other side. Available in blister packs of 60. 300 mg tablets: white to off-white, capsule-shaped, biconvex tablets. Scored on one side and engraved "RAN 300" on the other side Available in blister packs of 30. Ingredients tablets contain (as hydrochloride) as the active ingredient. 150 mg tablets contains hydrochloride equivalent to 150 mg. 300 mg tablets contains hydrochloride equivalent to 300 mg. tablets also contain the following inactive ingredients: * cellulose - microcrystalline * magnesium stearate * silica - colloidal anhydrous * hypromellose * polydextrose * titanium dioxide * vanillin * carnauba wax. does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes. TERRY WHITE CHEMISTS RANITIDINE 4
Australian Registration Numbers 150 mg tablets blister pack: AUST R 121975. 300 mg tablets blister pack: AUST R 121978. Sponsor Apotex Pty Ltd ABN 52 096 916 418 66 Waterloo Road North Ryde, NSW 2113 Australia Distributor Symbion Pharmacy Services Pty Ltd ABN 25 000 875 034 48-58 Overseas Drive Noble Park North VIC 3174 Australia Terry White Chemists is a registered trade mark of Symbion Pharmacy Services Pty Ltd. This leaflet was last updated in July 2008. TERRY WHITE CHEMISTS RANITIDINE 5