APO-TELMISARTAN/ AMLODIPINE Tablets Telmisartan/Amlodipine Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet vessels tightening. As a result, the · rash, itching or hives on the skin blood vessels relax, and blood Do not take this medicine if you This leaflet answers some common pressure is lowered. have or have had any of the questions about telmisartan/ Ask your doctor if you have any following medical conditions: amlodipine. It does not contain all questions about why this medicine · biliary obstruction the available information. It does not has been prescribed for you. · severe liver problems take the place of talking to your Your doctor may have prescribed this doctor or pharmacist. medicine for another reason. · heart attack All medicines have risks and This medicine is available only with · diabetes or kidney problems and benefits. Your doctor has weighed a doctor©s prescription. you are taking aliskiren (a the risks of you using this medicine medicine used to treat high blood This medicine is not addictive. against the benefits they expect it pressure) will have for you. There is not enough information to Do not take this medicine if you recommend the use of this medicine If you have any concerns about are pregnant, plan to become in children. taking this medicine, ask your pregnant or are breastfeeding. doctor or pharmacist. This medicine may affect your Keep this leaflet with the medicine. developing baby if you take it during You may want to read it again. pregnancy. It may also pass into Before you take this human breast milk. medicine Do not take this medicine after the expiry date printed on the pack or When you must not take it What this medicine is if the packaging is torn or shows used for Do not take this medicine if you signs of tampering. have an allergy to: If it has expired or is damaged, return Telmisartan/amlodipine is used to · telmisartan it to your pharmacist for disposal. lower high blood pressure · amlodipine If you are not sure whether you (hypertension). · dihydropyridine medicines should start taking this medicine, Telmisartan belongs to a group of talk to your doctor. medicines called angiotensin II · any of the ingredients listed at the receptor antagonists. end of this leaflet. Before you start to take it Some of the symptoms of an allergic Amlodipine belongs to a group of Tell your doctor if you have reaction may include: medicines called calcium channel allergies to any other medicines, blockers. · shortness of breath foods, preservatives or dyes. · wheezing, difficulty breathing or Tell your doctor if you have or How it works tightness in chest have had any of the following Telmisartan and amlodipine work · swelling of the face, lips, tongue, medical conditions: together to help stop your blood throat or other parts of the body · liver problems

APO-TELMISARTAN AMLODIPINE TABLETS 1 · kidney problems or kidney · anti-proteases, medicines used to When to take it transplant treat HIV infection such as Take this medicine at about the ritonavir · heart problems same time each day. · simvastatin, a cholesterol- · recent severe diarrhoea or Taking it at the same time each day lowering medication vomiting will have the best effect. It will also · primary aldosteronism or · herbal medicines derived from St help you remember when to take it. John©s wort (Hypericum hyperaldosteronism It does not matter if you take it with perforatum) · diabetes or without food. · grapefruit or grapefruit juice · high levels of potassium in your blood · immunosuppressants such as How long to take it cyclosporin or tacrolimus, · fructose or sorbitol intolerance Continue taking your medicine for as medicines used to prevent organ long as your doctor tells you. Tell your doctor if you are rejection after transplantation. planning to have surgery, dental Make sure you have enough to last These medicines may be affected by over weekends and holidays. treatment or an anaesthetic. this medicine or may affect how well If you have not told your doctor it works. You may need different If you forget to take it about any of the above, tell them amounts of your medicines, or you before you start taking this may need to take different medicines. If it is almost time to take your next dose, skip the dose you missed and medicine. Your doctor and pharmacist have take your next dose at the usual time. more information on medicines to be Taking other medicines careful with or avoid while taking Otherwise, take it as soon as you Tell your doctor or pharmacist if this medicine. remember and then go back to taking your medicine as you would you are taking any other Other medicines not listed above normally. medicines, including any that you may also interact with telmisartan/ get without a prescription from amlodipine. Do not take a double dose to make your pharmacy, supermarket or up for missed doses. health food shop. This may increase the chance of you Some medicines and this one may experiencing side effects. interact with each other. These How to take this If you have trouble remembering to include: medicine take your medicine, ask your · other medicines used to treat high pharmacist for some hints. blood pressure (e.g. ACE Follow all directions given to you inhibitors, diuretics, aliskiren) by your doctor and pharmacist If you take too much especially if you have diabetes- carefully. (overdose) related kidney problems They may differ to the information Immediately telephone your doctor contained in this leaflet. · potassium supplements or or the Poisons Information Centre potassium-containing salt If you do not understand the (telephone 13 11 26) for advice, or substitutes instructions on the box, ask your go to Accident and Emergency at · lithium, used to treat mood doctor or pharmacist for help. your nearest hospital if you think disorders that you or anyone else may have How much to take · non-steroidal anti-inflammatory taken too much of this medicine. drugs (NSAIDs) or COX-2 Your doctor will tell you how much Do this even if there are no signs of inhibitors, used to relieve pain of this medicine you should take, discomfort or poisoning. and inflammation depending on your condition and You may need urgent medical · medicines used to treat epilepsy whether you are taking any other attention. (e.g. carbamazepine, phenytoin, medicines. phenobarbital, primidone) How to take it · some antibiotics (e.g. rifampicin) Swallow the tablet whole with a glass · some antifungals, such as of water. ketoconazole or itraconazole

APO-TELMISARTAN AMLODIPINE TABLETS 2 While you are using pressure. If this problem continues or · low blood pressure this medicine gets worse, talk to your doctor. · flushed or pale skin · cough Things you must do · stomach pain If you are about to be started on Side effects · tender or enlarged gums any new medicine, remind your · itching, rash, redness of skin doctor and pharmacist that you Tell your doctor or pharmacist as are taking this medicine. soon as possible if you do not feel · pain in joints Tell any other doctors, dentists and well while you are taking · muscle cramps pharmacists who are treating you telmisartan/amlodipine. · aching, tender or weak muscles that you take this medicine. This medicine helps most people not caused by exercise with hypertension, but it may have If you become pregnant while · back pain, pain in extremity unwanted side effects in a few taking this medicine, tell your people. All medicines can have side · night-time or frequent urination doctor immediately. effects. Sometimes they are serious, · difficulty in getting or Tell your doctor you are going to most of the time they are not. You maintaining an erection have surgery or an anaesthetic or may need medical attention if you get · generally feeling unwell are going into hospital. some of the side effects. · chest pain Keep all of your doctor's Do not be alarmed by the following · feeling anxious or sad appointments so that your progress lists of side effects. You may not can be checked. experience any of them. The above list includes serious side effects that may require medical Your doctor may occasionally do Ask your doctor or pharmacist to attention. tests to make sure the medicine is answer any questions you may working and to prevent side effects. have. If you experience any of the following, stop taking your Tell your doctor or pharmacist if Things you must not do medicine and contact your doctor you notice any of the following and immediately or go to Accident and Do not give this medicine to anyone they worry you: else, even if they have the same Emergency at your nearest · feeling light-headed, dizzy or condition as you. hospital: faint Do not take your medicine to treat · shortness of breath, wheezing, · headache any other complaint unless your difficulty breathing or tightness in doctor tells you to. · an uncomfortable feeling in the chest; swelling of the face, lips, stomach or belching after eating tongue, throat or other parts of the Do not stop taking your medicine, (indigestion) body; rash, itching or hives on the or change the dosage, without first skin (signs of an allergic reaction) checking with your doctor. · dry mouth · diarrhoea The above list includes very serious Things to be careful of side effects and you may need urgent · feeling sick (nausea) or vomiting medical attention or hospitalisation. Be careful driving or operating The above list includes the more Tell your doctor or pharmacist if machinery until you know how this common side effects of your you notice anything that is making medicine affects you. medicine. you feel unwell. This medicine may cause dizziness in Tell your doctor if you notice any Other side effects not listed above some people. If you have any of of the following: these symptoms, do not drive, may occur in some patients. · swelling of hands, ankles or feet operate machinery or do anything else that could be dangerous. · sleepiness or tiredness, weakness or difficulty sleeping If you feel light-headed, dizzy or Storage and Disposal faint when getting out of bed or · tingling, numbness or pain in the standing up, get up slowly. hands or feet, pins and needles Storage Standing up slowly, especially when · taste disturbances or loss of taste you get up from bed or chairs, will · shaking or tremors Keep your medicine in the pack help your body get used to the until it is time to take it. · slow heart beat change in position and blood If you take your medicine out of its · palpitations pack it may not keep well.

APO-TELMISARTAN AMLODIPINE TABLETS 3 Keep your medicine in a cool dry · povidone place where the temperature stays · meglumine below 30°C. · sodium hydroxide Do not store your medicine, or any · calcium hydrogen phosphate other medicine, in the bathroom or near a sink. Do not leave it on a · microcrystalline cellulose window sill or in the car. · croscarmellose sodium Heat and dampness can destroy some · silicon dioxide medicines. · magnesium stearate Keep this medicine where children · brilliant blue FCF Aluminium cannot reach it. Lake A locked cupboard at least one-and- · iron oxide yellow a-half metres above the ground is a good place to store medicines. · iron oxide black. This medicine does not contain Disposal gluten, lactose, sucrose, tartrazine or If your doctor tells you to stop taking any other azo dyes. this medicine or the expiry date has passed, ask your pharmacist what to Sponsor do with any medicine left over. Apotex Pty Ltd 16 Giffnock Avenue Macquarie Park NSW 2113 Product description APO and APOTEX are registered What it looks like trademarks of Apotex Inc. White and blue coloured, two- layered, modified capsule-shaped, This leaflet was prepared in February biconvex uncoated tablets. White 2019. layer may contain blue specks and blue layer may contain white specks. "APO" engraved on one side. · 40/5 mg: "40/5" on the other side. AUST R 276429. · 40/10 mg: "40/10" on the other side. AUST R 276427. · 80/5 mg: "80/5" on the other side. AUST R 276426. · 80/10 mg: "80/10" on the other side. AUST R 276424. Available in blister pack of 28 tablets. * Not all strengths, pack types and/or pack sizes may be available.

Ingredients Each tablet contains 40 mg or 80mg of telmisartan, and 5 mg or 10 mg of amlodipine as the active ingredient. It also contains the following: · isomalt · mannitol

APO-TELMISARTAN AMLODIPINE TABLETS 4