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CAPTOPRIL 25MG TABLETS

Transcript

Patient Information Leaflet ECOPACE 12.5mg, 25mg and 50mg TABLETS Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. • The name of your medicine is Ecopace 12.5mg, 25mg and 50mg Tablets, but will be referred to as ‘Ecopace Tablets’ throughout the remainder of the Leaflet. In this leaflet: 1. What Ecopace Tablets are and what they are used for 2. Before you take Ecopace Tablets 3. How to take Ecopace Tablets 4. Possible side effects 5. Storing Ecopace Tablets 6. Further information 1. WHAT ECOPACE TABLETS ARE AND WHAT THEY ARE USED FOR Ecopace Tablets belong to a group of medicines known as ACE inhibitors (Angiotensin Converting Enzyme Inhibitors). Captopril works by making your blood vessels wider. This helps your blood pressure to fall. It also makes it easier for your heart to pump blood around your body. Ecopace Tablets can be used to treat • High blood pressure – also called hypertension • Heart failure - where the heart has difficulty pumping blood around your body. • Heart attack (Myocardial infarction) - where the heart has difficulty pumping blood around your body. 2.

BEFORE YOU TAKE ECOPACE TABLETS

Do not take Ecopace Tablets if: • You are pregnant, planning to become pregnant or are breast-feeding. • You have ever had an allergic (hypersensitivity) reaction to Captopril, any other ACE inhibitor medicine, or any of the ingredients in these tablets (see Section 6: Further Information). Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. If you are not sure about taking Captopril, talk to your doctor. Take special care and check with your doctor before you take Captopril if you: • Have kidney problems as your doctor will want to monitor you and also may reduce your dose. • Are undergoing dialysis, • Have been told or know that you are suffering from a medical illness in which there is an obstruction to the pumping of blood, from the heart (aortic stenosis or outflow tract obstruction) • Suffer from heart disease, in particular problems with the valves of the heart • Have diabetes

Have collagen vascular disease (e. g. rheumatoid arthritis or systemic lupus erythematosus) as your doctor will need to monitor your blood count at regular intervals. Suffer from fever or any infection such as sore throat. If you are to have desensitisation treatment for wasp or bee stings you should tell the doctor who is treating you that you are taking Captopril. If you are about to have treatment for the removal of cholesterol from your blood by a machine, (called LDL apheresis) you should tell your doctor you are taking Captopril.

You must tell your doctor if you think you are (or might become) pregnant. Ecopace Tablets is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section). Please talk to your doctor before taking Captopril if any of the above apply to you, even if they applied only in the past. Taking Captopril with other medicines The effect of Captopril may be changed if you take it at the same time as other medicines. Talk to your doctor before taking Captopril if you are taking any of the following medicines: • Water tablets (diuretics) such as spironolactone, triamterene or amiloride. Captopril may increase the levels of potassium in your blood. • Water tablets (diuretics) such as thiazides, frusemide, or other medicines to lower your blood pressure, medicines for chest pain (angina). Taking Captopril at the same time may cause low blood pressure. • Lithium or amitryptiline (for some types of mental illness) • Vasodilators (medicines that relax the blood vessels) e. g.minoxidil, clonidine. • Non-steroidal anti-inflammatory drugs (NSAIDs), such as indometacin or diclofenac (for pain or inflammation). These medicines may make Captopril work less well. • Potassium Supplements or salt substitutes containing potassium. • Immunosuppressants (e. g. ciclosporin, azathioprine and cyclophosphamide), • Allopurinol (used to treat gout and kidney stones), procainamide (used to treat heart beat problems), • Any other medicines to treat high blood pressure such as diazoxide, moxonidine, propranolol, atenolol, or calcium channel blockers such as amlodipine, nifedipine. • Medicines that may be used for heart conditions like nitroglycerine, digoxin, acetylsalicylic acid and beta-blockers. • Medicines used for the treatment of depression e. g. tricyclic antidepressants. • Probenecid, used for the treatment of gout. • Medicines for diabetes (as the amount you need to use may have to be changed while taking Captopril), • Tizanidine, Baclofen used as for muscle spasticity. • Anxiolytics, hypnotics used to treat anxiety. • Alprostadil, moxisylyte used to treat erectile dysfunction. • Aldesleukin, used for the treatment of kidney cancer. • Levodopa, used for the treatment of Parkinson's disease. Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine - even those not prescribed. If you are going to have an anaesthetic (for an operation), tell your doctor or dentist that you are taking Captopril. Taking Captopril with food and drink • You can take Captopril with or without food. • If you drink alcohol while taking Captopril you may feel dizzy, light-headed or faint. Take care with the amount of alcohol you drink.

Pregnancy and Breast-feeding Pregnancy You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Ecopace Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Ecopace Tablets. Ecopace Tablets is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. • Use contraception to stop you getting pregnant when taking Captopril. If you are pregnant talk to your doctor or pharmacist before taking any medicine. Breastfeeding If you are breast-feeding you should not take Captopril as it may become present in the breast milk. Driving and using machines Captopril can affect your ability to drive, usually when you first start taking your medicine or if your doctor changes your dose. If you do feel light-headed or dizzy when taking Ecopace Tablets, you should not drive or use machinery. Important information about some of the ingredients in Ecopace Tablets Ecopace Tablets contain lactose. If you have been told that you cannot digest or tolerate some sugars, talk to your doctor before taking Captopril. 3.

HOW TO TAKE ECOPACE TABLETS

Always take Captopril exactly as your doctor has told you. The dose of Captopril will depend on the condition being treated and any other medicines you are taking. This leaflet gives the usual dose but you should read the amount prescribed for you on the medicine label. You should check with your doctor or pharmacist if you are not sure. Taking Ecopace Tablets • Swallow the tablets with water. You can take them with or without food. • Take your tablet at about the same time each day. Take the Captopril tablet marked for the correct day on the blister pack. This will help you remember whether you have taken it. • Take your medicine until your doctor tells you to stop. If you feel better, do not stop taking the tablets. If you stop them, your condition may get worse. The first Ecopace Tablets you take might make you feel dizzy or light-headed. This is because the first dose may make your blood pressure fall by more than doses you take after that. It may help to lie down until you feel better. If you are concerned talk to your doctor or pharmacist. Your doctor may ask to see you more frequently when you start taking the medicine or when your dose is changed to monitor how you are responding to taking Captopril. You should not skip these visits even if you feel well. Adults with high blood pressure (hypertension) The usual starting dose is one 12.5mg tablet, twice each day. This may be increased gradually to a maximum daily dose of one 50mg tablets twice daily depending on your needs and the severity of the disease. Your doctor may give you water tablets (diuretics) when you are receiving Ecopace Tablets. Adults with heart failure • The starting dose is usually half or one 12.5mg tablet, two or three times a day. • The dose may be increased to a maximum daily dosage of one 50mg tablet three times a day. • Your doctor may give you water tablets (diuretics) when you are receiving Ecopace Tablets.

AFTER A HEART ATTACK Treatment with Ecopace Tablets is usually started 3 days after a heart attack. The starting dose is half of one 12.5mg tablet and this will be gradually increased to about one 50mg tablet three times a day. In this case the medicine will normally be started in hospital, and the hospital doctor will decide the best dose for you. • Your doctor may prescribe a different dose - if this applies to you, you should discuss it with your doctor if you have not already done so. • You should keep taking your Captopril regularly unless your doctor tells you otherwise. Keep your doctors appointments, even if you feel well. • It is important not to stop taking these tablets without talking to your doctor. Your doctor may give you other medications such as aspirin, betablockers & drugs used to break blood clot (thrombolytics) when you are receiving Ecopace Tablets. People with kidney problems • If you have kidney problems, the doctor will alter the amount of Captopril you take depending on how well your kidneys are working. • If you are on kidney dialysis your dosage will vary day by day. Your doctor will let you know what your dose should be. Older People • Your dose will be decided by your doctor. It will depend on how well your kidneys are working. Children Ecopace Tablets are not recommended in children for the treatment of high blood pressure. However, your doctor may prescribe a lower dose depending on the weight of the child. The starting dose in children is 0.3mg per kg bodyweight and your doctor may adjust the dose depending on the response. If you take more Ecopace Tablets than you should Contact your doctor or go to the nearest hospital casualty department straight away. Remember to take with you any tablets If you forget to take Ecopace Tablets If you miss a dose do not worry. Take your normal dose when it is next due. Do not take a double dose to make up for a forgotten tablet. 4.

POSSIBLE SIDE EFFECTS

Like all medicines, Captopril may cause some unwanted side effects although not everybody gets them. If you experience any of the following reactions stop taking Captopril and contact your doctor immediately: • Swelling of the hands, face, lips or tongue. • Difficulty in breathing, • A sudden, unexpected rash or burning, red or peeling skin, • Sore throat or fever, • Severe dizziness or fainting, • Severe stomach pain, • Unusually fast or irregular heartbeat, • Yellowing of the skin and/or eyes (jaundice). Common side effects (affecting between 1 in 10 and 1 in 100 people) • Dizziness, • Dry mouth, • Itching,

Sleep problems, Rashes, Diarrhoea or constipation, Hair loss, Dry, irritating cough, Changes in the way things taste, Upset stomach, sickness, Shortness of breath abdominal pain.

Uncommon side effects (affecting between 1 in 100 and 1 in 1000 people) • Fast, irregular, louder heartbeat, • Tiredness, • Chest pain, • Generally feeling unwell, • Low blood pressure, • Looking pale, • Reduced blood flow to the hands and feet • Swelling of the eyes and lips (angioedema). (e. g. Raynaud's syndrome) • Flushing, Rare side effects (affecting between 1 in 1000 and 1 in 10,000 people) • Loss of appetite, • Mouth ulcers, • Drowsiness, • Kidney disorders or failure, • Headache, • Changes in frequency of passing urine. • Pins and needles, numbness or tingling, Very rare side effects (affecting less than 1 in 10,000 people) • Impaired liver function and raised liver enzymes, • Liver damage, inflammation of the liver or jaundice, • Confusion, depression, fainting, • Stomach ulcers, • Mini-stroke, • Muscle pain, • Blurred vision, • Joint pain, • Heart problems including heart attack, • Wheezing or difficulty breathing and chest infections, • Inflammation of the pancreas, • Rashes or skin reactions, • Runny nose, • Swelling of breast tissue in men, • Swollen tongue, • Fever, • Impotence, • Sensitivity of the skin to light, • Stevens-Johnson syndrome (a serious illness with blistering of the skin, in the blood or lymphatic systems, mouth, eyes and genitals) • Changes in levels of chemicals (e. g. potassium, sugars). If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately. It will help if you make a note of what you experienced, when it started and how long it lasted.

HOW TO STORE ECOPACE TABLETS Keep your medicine in a safe place out of the reach and sight of children. Store in the original package in order to protect from light. Do not store above 30°C. Do not use this medicine after the expiry date shown on the pack.

6. FURTHER INFORMATION What Ecopace Tablet contains Each tablet contains 12.5mg, 25mg or 50mg of Captopril as the active substance. Other ingredients are lactose, maize starch, microcrystalline cellulose and stearic acid. What Ecopace Tablet looks like and contents of the pack Ecopace 12.5mg Tablets are white, round, flat tablets scored on one side and marked “G12.5” on the other, 6mm in diameter. Ecopace 25mg Tablets are white, round, flat tablets scored on one side and marked “G25” on the other, 8mm in diameter Ecopace 50mg Tablets are white, round, flat tablets scored on one side and marked “G50” on the other, 10mm in diameter. They are supplied in calendar blister packs of tablets. Marketing Authorisation Holder and Manufacturer: Crescent Pharma Limited, Units 3 & 4 Quidhampton Business Units, Polhampton Lane, Overton, Hampshire, RG25 3ED UK

This leaflet was last revised in November 2014.

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.