TARKA 2/180, TARKA 4/240

Transcription

1 TARKA 2/180, TARKA 4/240 trandolapril and verapamil hydrochloride (sustained release) Consumer Medicine Information What is in this leaflet This leaflet answers some common questions about Tarka. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Tarka against the benefits they expect it will have for you. If you have any concerns about taking this medicine, talk to your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. What Tarka is used for Tarka lowers high blood pressure, which doctors call hypertension. Tarka modified-release tablets belong to the group of blood-pressure lowering medicines (also called antihypertensives). Tarka contains two different types of medicines: a calcium channel blocker (verapamil) an Angiotensin Converting Enzyme (ACE) inhibitor (trandolapril) Everyone has blood pressure. This pressure helps get your blood all around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed. There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. You may feel fine and have no symptoms, but if high blood pressure is not treated, it can lead to serious health problems. Tarka helps to lower your blood pressure. Your doctor may have prescribed Tarka for another reason. Ask your doctor if you have any questions about why Tarka has been prescribed for you. Tarka is not recommended for use in children under the age of 18, as there have been no studies of its effects in children. This medicine is available only with a doctor's prescription. There is no evidence that Tarka is addictive. Before you take Tarka Copyright, Abbott Page 1 of 8

2 When you must not take it Do not take Tarka if you have had an allergic reaction to medicines containing verapamil hydrochloride or trandolapril or any other ACE inhibitors. Some of the symptoms of an allergic reaction may include severe blisters, skin rash, itching or flaking skin. Do not take Tarka if you have had an allergic reaction to any of the ingredients listed at the end of this leaflet. Do not take Tarka if you are pregnant or plan to become pregnant. Tarka is not recommended for use during pregnancy. Do not take Tarka if you are breastfeeding or plan to breastfeed. Tarka is not recommended while you are breastfeeding. Do not take Tarka if you have ever experienced excessive swelling of the face, lips or the throat, which has made it difficult to breathe. Taking Tarka could cause this problem to happen again. Do not take Tarka if you have: Certain other heart conditions (such as heart failure, a very slow heart rate, some arrhythmias or disease of the heart muscle). Low blood pressure also called hypotension. Severe liver problems associated with fluid swelling of the abdomen. Problems with your adrenal glands (i.e. Conn's Syndrome) Do not take Tarka after the expiry date (EXP) printed on the pack. Do not take Tarka if the packaging is torn or shows signs of tampering. If you are not sure whether you should start taking Tarka contact your doctor. Before you start to take it: Tell your doctor if you have allergies to: any other medicines any other substances, such as foods, dyes or preservatives. Tell your doctor if you have or have had any medical conditions especially the following: any other heart problem blood vessel (circulatory) disease or a stroke liver or kidney problems muscle conditions such as Duchenne's muscular dystrophy, myasthenia gravis or Lambert-Eaton syndrome regular dialysis, blood filtration or similar procedures high levels of potassium in your blood dizzy spells diabetes collagen disease are about to have surgery or a general anaesthetic If you have not told your doctor about any of the above, tell them before you start taking Tarka. Taking other medicines Copyright, Abbott Page 2 of 8

3 Several medicines can cause unwanted reactions if used with Tarka. Ask your doctor or pharmacist for advice before taking this medicine. In particular tell your doctor if you are taking any of the following medicines: Medicines to treat heart problems or high blood pressure: Diuretics (also called fluid tablets) or potassium supplements. Any medicines used to control your heart beat (such as beta blockers, or other medicines used to control irregular heart beats) or your blood pressure. They may cause your blood pressure to become too low or may slow your heart beat too much. Medicines to treat or prevent organ transplant rejection: Such as cyclosporine, everolimus, sirolimus and tacrolimus Medicines to treat epilepsy or seizures: Such as phenytoin, carbamazepine and phenobarbital. Medicines used to treat infections or tuberculosis: Such as erythromycin, clarithromycin, telithromycin or rifampicin Medicines used to treat asthma: Such as theophylline Medicines used to treat diabetes: Such as insulin and some oral diabetes medicines Medicines used to treat pain or reduce swelling such as: Steroids e.g. cortisone or prednisone Certain anti-inflammatory medicines or pain-killers e.g. naproxen, ibuprofen or aspirin Medicines to treat indigestion or stomach ulcers: Such as antacids and cimetidine Medicines used to lower cholesterol: Such as atorvastatin or simvastatin Medicines used in surgical procedures such as: General anaesthetics used for inducing sleep Muscle relaxants e.g. dantrolene Medicines used to treat or prevent gout: Such as allopurinol or colchicine Medicines used to treat psychological problems: Any medicines to treat depression, or psychosis. Such as imipramine, midazolam or lithium Medicines to treat cancer: Such as doxorubicin. Copyright, Abbott Page 3 of 8

4 Avoid alcohol while using Tarka. You may experience greater blood pressure lowering effects than usual. Avoid grapefruit juice, as this may increase the blood levels of verapamil. These medicines may be affected by Tarka, or may affect how well it works. You may need different amounts of your medicines or you may need to take different medicines. Your doctor will advise you. This is not a complete list of medicines which may interfere with Tarka. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines or herbal remedies, including those obtained without a prescription from a pharmacy, supermarket or health food shop. Your doctor and pharmacist may have more information on medicines to be careful with or to avoid while taking Tarka. How to take Tarka How much to take The usual dose of Tarka is one tablet a day, with or after food. Follow all directions given to you by your doctor carefully. These directions may differ from the information contained in this leaflet. If you do not understand the instructions on the pharmacist's label fixed on the box, ask your doctor or pharmacist for help. How to take it Swallow the Tarka tablet whole with a glass of water. Avoid grapefruit and its juice while you are using Tarka. Grapefruit juice may increase the amount of verapamil which your body absorbs. This may increase your risk of side effects from Tarka. When to take it Take Tarka at about the same time each day. It should be taken with or after food, not including grapefruit. Taking your tablet at the same time each day will have the best effect. It will also help you to remember when to take the tablet. How long to take it Tarka is usually taken long term. Keep taking Tarka for as long as your doctor recommends. 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, if it is the same day, take it as soon as you remember, and then go back to taking you medicine at the same time 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 what to do, ask your doctor or pharmacist. Copyright, Abbott Page 4 of 8

5 If you take too much (overdose) Immediately telephone your doctor or the Poisons Information Centre (telephone ) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much Tarka. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. If you take too much Tarka, you may have severe dizziness, lightheadedness, weakness, irregular heartbeat, chest pain, feel very faint or collapse. While you are taking Tarka Things you must do If you become pregnant while taking Tarka, tell your doctor immediately. If you are about to be started on any new medicine, tell your doctor or pharmacist that you are taking Tarka. Tell all doctors, dentists and pharmacists who are treating you that you are taking Tarka. If you are going to have surgery including dental surgery, tell your doctor or dentist that you are taking Tarka. Consult your doctor if you have severe vomiting or diarrhoea while taking Tarka. This may lead to dehydration, which interferes with the way Tarka works. If you have conditions affecting your kidneys or blood vessels and you have been taking Tarka for many months or more, ask your doctor about having periodic blood tests. If you are taking medicines other than Tarka, which can affect your kidneys or immune system, ask your doctor about having periodic blood tests. Things you must not do Do not take Tarka with grapefruit or its juice. Do not give Tarka to anyone else, even if they have the same condition as you. Do not take Tarka to treat any other complaints unless you doctor tells you to. Do not stop taking Tarka, or lower the dosage without checking with your doctor. Things to be careful of Be careful getting up from a sitting position. Dizziness, lightheadedness or fainting may occur, especially when you get up quickly. Getting up slowly may help. Be careful driving or operating machinery until you know how Tarka affects you. As with other medicines, Tarka may cause dizziness, lightheadedness or tiredness in some people. If this occurs do not drive, operate machinery or do anything else that could be dangerous if you are tired, dizzy or lightheaded. If you drink alcohol while taking Tarka, dizziness or light-headedness may be worse. Copyright, Abbott Page 5 of 8

6 Side effects Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Tarka. Like all other medicines, Tarka may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. As with most medicines, if you are over 65 years of age you may have an increased change of getting side effects. Report any side effects to your doctor promptly. Ask your doctor or pharmacist any questions you may have. Tell your doctor if you notice any of the following more common side effects and they worry you: constipation dizziness, spinning sensation headache feeling sick, also known as nausea abdominal pain unusual tiredness or weakness dry cough hot flushes These side effects are usually mild. Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following: slow, fast, or irregular heart beat shortness of breath (sometimes with tiredness, weakness and reduced ability to exercise palpitations yellowing of the skin or eyes, a fever or tenderness around the middle These may be serious side effects. You may need urgent medical attention. Serious side effects are rare. If any of the following happen, stop taking Tarka and either tell you doctor immediately or go to Accident and Emergency at your nearest hospital: swelling of the face, lips mouth, tongue or throat which may cause difficulty in swallowing or breathing chest pain, fainting, collapse symptoms of allergy such as severe blisters, skin rash, itching or flaking skin - sometimes with fever. These are very serious side effects. You may need urgent medical attention or hospitalisation. Other side effects not listed above may also occur in some patients. Ask your doctor or pharmacist for more information about side effects, as they have a more complete list of side effects. Inform your doctor promptly about these or any other symptoms. If the condition persists or worsens, seek medical attention. Do not be alarmed by this list of possible side effects. You may not experience any of them or only some of them. Tell your doctor if you notice anything that is making you feel unwell. After using Tarka Storage Keep your tablets in the pack until it is time to take them. Keep Tarka in a cool dry place where the temperature stays below 25 C. Copyright, Abbott Page 6 of 8

7 Do not keep Tarka or any other medicine in the bathroom or near a sink. Do not leave it in the car on hot days or on window sills. Heat and dampness can destroy some medicines. Keep you tablets where children cannot reach them. Disposal Medicines should not be disposed of via wastewater or household waste. If your doctor tells you to stop taking Tarka, or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets left over. Product description What it looks like Tarka tablets come in two strengths: Tarka 2/180: pink film coated tablets Tarka 4/240: red-brown film coated tablets Tarka tablets are presented in a blister pack of 28 tablets. Ingredients The active substances are verapamil hydrochloride and trandolapril. Tarka 2/180 tablets contain trandolapril 2mg and verapamil hydrochloride (sustained release) 180mg. Tarka 4/240 tablets contain trandolapril 4mg and verapamil hydrochloride (sustained release) 240mg. Tarka tablets also contain: starch-maize povidone sodium stearylfumarate lactose cellulose - microcrystalline sodium alginate magnesium stearate hypromellose hydroxypropylcellulose Macrogol 400 Macrogol 6000 Docusate sodium Talc - purified Silica-colloidal anhydrous Titanium dioxide Iron oxide yellow CI Iron oxide red CI77491 Iron oxide black CI Tarka tablets are gluten free. Supplier Tarka tablets are supplied by: Abbott Australasia Pty Ltd ABN Lord Street Copyright, Abbott Page 7 of 8

8 Botany NSW 2019 Australian registration numbers: Tarka 2/180 - AUST R Tarka 4/240 - AUST R This leaflet was updated on: 07 June 2010 Version 04 Published by MIMS/myDr October 2010 Copyright, Abbott Page 8 of 8