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Carvedilol AN 3.125, 6.25, 12.5 & 25 mg tablets Carvedilol AN

Consumer Medicine Information

What is in this leaflet : Carvedilol AN helps to lower your Heart failure occurs when the heart blood pressure. can no longer pump blood strongly This leaflet answers some of the Your doctor may have prescribed enough for the body's needs. Often common questions about Carvedilol Carvedilol AN for another reason. AN. It does not contain all the the heart grows in size to try to available information. It does not improve the blood flow but this can Ask your doctor if you have any take the place of talking to your make the heart failure worse. questions about why Carvedilol AN has been prescribed for you. doctor or pharmacist. Symptoms of heart failure include All medicines have risks and shortness of breath and swelling of benefits. Your doctor has weighed the feet or legs due to fluid build-up. the possible risks of Carvedilol AN Carvedilol AN reduces the pressure Before you take against the expected benefits. that the heart has to pump against as Carvedilol AN If you have any concerns about this well as controlling your heart rate. medicine talk to your doctor or Over 6 months or more this will pharmacist. reduce the size of an oversized heart When you must not take and increase its efficiency. Keep this leaflet until you have Cervedilol AN Carvedilol AN reduces the chances finished treatment with the You must not take Carvedilol AN medicine. of you being admitted to hospital if: You may need to read it again. and/ or dying from this condition. 1. you have had an allergic Carvedilol AN is often used with reaction to carvedilol or any of other medicines to treat heart failure. the other ingredients contained : in this medicine. What Carvedilol AN is Symptoms of an allergic reaction used for All people have blood pressure. This pressure helps to push blood all may include: around your body. Your blood - shortness of breath, wheezing or Carvedilol AN contains carvedilol as pressure changes during the day, difficulty breathing, the active ingredient. depending on how busy you are or - swelling of the face, lips, tongue Carvedilol AN belongs to a group of how you are feeling. or other part of the body, medicines called beta-blockers. - rash, itching or hives of the skin. You have hypertension (high blood These medicines work by relaxing pressure) when your blood pressure 2. you have asthma or other tightened blood vessels and slowing stays higher than is needed, even conditions which make you the heart rate. Carvedilol AN has the when you are calm and relaxed. short of breath from time to additional effect of being an time. Regular blood pressure checks are antioxidant. 3. you have a history of allergic the only way of knowing that you Carvedilol AN is used to treat problems, including hayfever. have hypertension. There are usually patients with heart failure and high Symptoms of an allergy may no symptoms of hypertension and blood pressure, which is called include: rash, itching, watery you may feel fine. If hypertension is hypertension. eyes or sneezing. not treated, serious health problems 4. you have a history of a very such as stroke, heart disease and slow heart rate or uneven heart kidney failure may occur. beating.

Carvedilol AN 3.125, 6.25, 12.5 & 25 mg tablets Published by MIMS November 2014 1 5. you have certain other heart • You have any other health • , a medicine used to conditions. problems, especially the treat tuberculosis (e.g. Rimycin®, 6. you have problems following: Rifadin®) including liver failure. - or chest pain/tightness • , a medicine used to 7. you have very low blood which occurs even when you are treat stomach ulcers or reflux (e.g pressure. at rest (also called unstable Tagamet®, Magicul®) angina) 8. the packaging is torn or shows • Digoxin, a medicine used to treat - Low blood pressure signs of tampering. heart failure (e.g. Lanoxin®) - High blood pressure which • Mono-amine oxidase inhibitors 9. the expiry (EXP) printed on the varies widely pack has passed of if the tablets (MAOI's) such as phenelzine - Very poor circulation to your (Nardil®) and tranylcypromine appear damaged in any way. fingers and/or toes (also called (Parnate®), medicines used to If you take this medicine after the peripheral vascular disease) expiry date has passed, it may not treat depression - A history of poor kidney • work as well. function , a medicine used to If you are not sure if you should be - Chronic bronchitis or treat high blood pressure, migraine or menopausal taking Carvedilol AN, talk to your emphysema causing breathing doctor. difficulties symptoms (e.g. Catapres®) • Diltiazem, a medicine used to Do not give Carvedilol AN to - Diabetes treat high blood pressure or people under 18 years of age. - Sudden low blood sugar levels (also called hypoglycaemia) angina (e.g. Carizem®, Coras®, Safety and effectiveness in children - Thyroid disorders Diltahexal®, Dilzem®, has not been established. - Severe allergic reactions Vasocardol®) causing swelling and/or difficulty • Verapamil, a medicine used to Before you are given it breathing treat high blood pressure, angina - A rare cancer of the adrenal or fast heart rate (e.g. Isoptin®, Before you receive Carvedilol AN gland called phaeochromocytoma Cordilox®, Anpec®) tell your doctor if: which is not being treated with • Drugs for when your heart doesn't • You are pregnant or plan to other medicines beat smoothly, includuing become pregnant - Skin disease such as psoriasis disopyramide (Rythmodan®), It is not known whether • You are allergic to any other mexiletine (Mexitil®), Carvedilol AN is harmful to an medicines, foods, dyes or lignocaine, flecainide unborn baby when taken by preservatives (Tambocor®), and pregnant women. Your doctor • (Cordarone®, Aratac®) will discuss the risks and benefits You plan to have surgery Your surgeon and anaesthetist • Drugs for diabetes, including of using Carvedilol AN during should know well ahead of the insulin injections, glibenclamide your . date of your surgery so they can (Daonil®, Glimel®), metformin • You are or plan allow for your condition and (Diabex®, Diaformin®, to breastfeed medications. Glucohexal®, Glucomet®, Carvedilol AN passes into Glucophage®), gliclazide breastmilk. Your doctor will Tell your doctor about any of the (Diamicron®), glipizide discuss the risks and benefits of above before you start taking (Minidiab®, Melzide®) taking Carvedilol AN if you are Carvedilol AN. • Cyclosporine, a medicine used to breastfeeding. Taking other medicines with treat certain problems with the immune system (e.g. Neoral®, Carvedilol AN Cicloral®, Sandimmun®) Tell your doctor if you are taking • Aspirin and other pain relievers any other medicines or have taken or non steroidal anti- other medicines until recently. This inflammatory medicines such as includes those medicines that you ibuprofen (Nurofen®), or buy without a prescription from a naproxen (Naprosyn®) pharmacy, supermarket or health • food shop. Medicines which may relieve asthma or help you breath better Some medicines may interfere with such as (Ventolin®) Carvedilol AN. These include: and (Serevent®/Seretide®)

Carvedilol AN 3.125, 6.25, 12.5 & 25 mg tablets Published by MIMS November 2014 2 • Fluoxetine, a medicine used to Thereafter, the recommended dosage If you forget to take Carvedilol treat depression and other is 25 mg once a day. AN conditions (e.g. Prozac®) If necessary, the dosage may be • Other medicines that may help If it is almost time for your next increased every two weeks up to the dose, skip the dose and take our lower your blood pressure. recommended maximum daily dose next dose when you are meant to. These medicines may be affected by of 50 mg given once a day or in Carvedilol AN, or may affect how divided doses (twice daily). Otherwise, take it as soon as you remember then go back to taking well it works. You may need to use Elderly: your medicine as you would different amounts of your medicine, The recommended dose for initiation normally. or you may need to take different of therapy is 12.5 mg once daily, Do not take a double dose to make medicines. Your doctor will advise which has provided satisfactory up for that dose you missed. you. control in some patients. If the This may increase the chance of you Your doctor or pharmacist has more response is inadequate, the dose may getting an unwanted side effect. information on medicines to be be increased every two weeks up to careful with or avoid while taking the recommended maximum daily If you are not sure what to do, ask Carvedilol AN. dose. your doctor or pharmacist. Ask your doctor or pharmacist if Your doctor will monitor you If you have trouble remembering you are not sure about this list of carefully each time the dose is your dose, ask your pharmacist for medicines. increased. some hints.

How to take Carvedilol AN In case of an overdose

Swallow tablets whole or halved If you think you or anyone else How Carvedilol AN is may have taken too much given with a glass of water. Do not crush or chew the tablets. Carvedilol AN, immediately telephone your doctor or Poisons Follow all directions given to you Information Center (telephone by your doctor or pharmacist When to take Carvedilol AN 13 11 26) or go to Accident and carefully. Emergency at your nearest Take Carvedilol AN during or They may differ from the hospital. Do this even if there are immediately after a meal, at about information contained in this leaflet. no signs of discomfort or the same times each day. poisoning. Taking your medicine at the same How much is given time each day will have the best Keep telephone numbers for these effect. It will also help you to places handy. Take Carvedilol AN exactly as remember when to take it. your doctor has prescribed. If you are not sure what to do, Your doctor will tell you how many If you take Carvedilol AN on an contact your doctor or pharmacist. Carvedilol AN tablets to take each empty stomach it may increase the You may need urgent medical day. This depends on your condition risk of some of the . attention. and whether or not you are taking The following are some symptoms, other medicines. How long to take Carvedilol which may or may not occur: Heart Failure AN • Low blood pressure causing The usual starting dose in heart or fainting Continue taking Carvedilol AN failure is 3.125 mg twice daily. The • until your doctor tells you to stop. A very slow heart rate dose is usually increased every two • Difficulty breathing weeks to 6.25 mg twice daily, 12.5 Make sure you have enough to last • Vomiting mg twice daily and then 25 mg twice over weekends and holidays. • Shock daily. However, this may be done It is very important that Carvedilol • Seizures more slowly if side effects occur. If AN is not ceased suddenly. If you are the tablets slow your heart too much to stop taking Carvedilol AN, your you may go back to a lower dose. doctor will advise you to reduce the High Blood Pressure dose slowly over approximately two Adults: weeks. The recommended dose for initiation of therapy is 12.5 mg a day for the first two days.

Carvedilol AN 3.125, 6.25, 12.5 & 25 mg tablets Published by MIMS November 2014 3 While you are taking Do not give Carvedilol AN to • Headache (this is usually mild Carvedilol AN anyone else even if they have the and happens at the start of your same condition as you. treatment) Do not use Carvedilol AN to treat • Tiredness, drowsiness Things you must do other complaints unless your • Low blood pressure. The signs doctor says to. include feeling dizzy or light- Tell all doctors, dentists and pharmacists who are treating you Do not take any other medicines headed especially after you stand that you are taking Carvedilol AN. whenterh they require a up. You should also tell your surgeon prescription or not without first • Abnormal or blurry vision and anaesthetist if you are having telling your doctor or consulting • Slow heart rate surgery. your pharmacist. • Diarrhoea If you feel light-headed, dizzy or • Nausea or vomiting Things to be careful of faint when getting out of bed or • Bronchitis standing up, get up slowly. Be careful driving or operating • Loss of control of blood sugar in Make sure you drink enough water machinery until you know how diabetics during exercise and hot weather Carvedilol AN affects you. • Weight increase when you are taking Carvedilol Carvedilol AN may affect your • Fluid retention. The signs include AN, especially if you sweat a lot. ability to drive a car or operate overall swelling of parts of your machinery when started or the Tell your doctor if you become body for example your hands, dosage is increased. pregnant while taking Carvedilol feet, ankles and legs. AN. If you wear contact lenses you may • Unusual hair loss or thinning also notice a reduction in tear fluid in Tell your doctor that you are These are the more common side your eyes. taking Carvedilol AN if you are effects of Carvedilol AN. Mostly going to have any laboratory tests. When taken with grapefruit juice the these are mild and will decrease as Tell your doctor if, for any reason, amount of Carvedilol AN absorbed you get used to your medicine. you have not taken your medicine by your body may be increased. Tell your doctor immediately or go exactly as prescribed. to Accident and Emergency at Otherwise your doctor may think that your nearest hospital if you notice it was not effective and change your any of the following: treatment unnecessarily. Side effects • Itching, dark , loss of Tell your doctor if you feel the appetite, yellowing of skin or Tell your doctor, nurse or tablets are not helping with your eyes, or feeling 'flu'like' with no pharmacist as soon as possible if condition. clear cause you do not feel well while you are Be sure to keep all of your taking Carvedilol AN. • Shortness of breath or swelling of appointments with your doctor so Carvedilol AN helps most people the mouth or tongue that your progress can be checked. with heart failure but it may have • Uneven heart beating Your doctor may examine your unwanted side effects in a few • Swelling of the feet or legs due to eyes and test your blood glucose people. All medicines have side fluid build up and kidney function from time to effects. Sometimes they are serious, • Bleeding or bruising more easily time. most of the time they are not. You than normal may need medical treatment if you These may be serious side effects. get some of the side effects. Things you must not do You may need urgent medical Do not stop taking Carvedilol AN Do not be alarmed by the following attention. Serious side effects are or change the dose without first list of side effects. You may not rare. experience any of them. checking with your doctor. This is not a complete list of all Do not let yourself run out of Ask your doctor or pharmacists to possible side effects. Others may medicine over the weekend or on answer any questions you may occur in some people and there may holiday. have. be some side effects not yet known. Carvedilol AN should only be Tell your doctor if you notice any Tell your doctor or pharmacist if stopped by gradually reducing the of the following and they worry you notice anything else that is amount over a two week period. you: making you feel unwell, even if it is not on this list.

Carvedilol AN 3.125, 6.25, 12.5 & 25 mg tablets Published by MIMS November 2014 4 Ask your doctor or pharmacist if • Carvedilol AN 3.125 mg Name and Address of the you don't understand anything in (Blister pack: AUST R 174792 & Sponsor this list. bottle: AUST R 174790) White to off white, oval shaped, Scentia Pharmaceuticals Pty Ltd film coated tablets debossed with 8-12 Ordish Road 'E' on one side and '01' on the Dandenong South, VIC 3175 After taking Carvedilol other side. AN • Carvedilol AN 6.25 mg Date of Preparation (Blister pack: AUST R 174785 & 29 November 2013 bottle: AUST R 174794) Storage White to off white, oval shaped, film coated tablets debossed with Keep your tablets in the blister until it is time to take them. 'F57' on one side and deep break If you take the tablets out of the line on the other side. blister pack they may not keep well. • Carvedilol AN 12.5 mg Carvedilol AN Is known to fade (Blister pack: AUST R 174805 & when exposed to light. bottle: AUST R 174784) White to off white, oval shaped, Keep Carvedilol AN in a cool dry film coated tablets debossed with place where the temperature stays 'F58' on one side and deep break below 25°C. line on the other side. Do not store it, or any other • Carvedilol AN 25 mg medicine, in a bathroom or near a (Blister pack: AUST R 174804 & sink, or any other place where bottle: AUST R 174797) there is high humidity. White to off white, oval shaped, Do not leave it in the car or on film coated tablets debossed with window sills. 'F59' on one side and deep break Heat and dampness can destroy some line on the other side. medicines. Keep Carvedilol AN where young Ingredients children cannot reach it. Active ingredient: A locked cupboard at least one and a Carvedilol half meters above the ground is a good place to store medicines. Each tablet may contain either 3.125, 6.25, 12.5 or 25 mg of carvedilol. Disposal Other ingredients: • Lactose If your doctor tells you to stop taking Carvedilol AN, or the • Colloidal anhydrous silica tablets have passed their expiry • Crospovidone (Type A & Type date, ask your pharmacist what to B) do with any tablets that are left • Povidone over. • Sucrose • Magnesium stearate • Macrogol 400 Product description • Polysorbate 80 • Titanium dooxide & • Hypromellose What it looks like Please read this leaflet carefully Carvedilol AN 3.125 mg, 6.25 mg, before you start taking Carvedilol 12.5 mg, & 25 mg are presented in AN. You may wish to keep it to read pack sizes of 30 & 60 tablets in it again. blister and 30, 60 & 1000 tablets in bottle.

Carvedilol AN 3.125, 6.25, 12.5 & 25 mg tablets Published by MIMS November 2014 5