CAPTOPRIL 12.5MG TABLETS

PACKAGE LEAFLET : INFORMATION FOR THE USER

CAPTOPRIL 12.5MG, 25MG & 50MG TABLETS
(Captopril)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. What is in this leaflet: 1. What Captopril Tablets are and what they are used for 2. What you need to know before you take Captopril Tablets 3. How to take Captopril Tablets 4. Possible side effects 5. How to Store Captopril Tablets 6. Contents of the pack and other information

the heart pump blood around the body. It is also used to treat people after a heart attack to improve survival and reduce further heart problems. In addition, captopril can be used for the treatment of kidney disease in patients with diabetes.

2. What you need to know before you take Captopril Tablets
Do not take these tablets if you: have ever had a reaction which included swelling of the hands, lips, face or tongue where the cause was unknown, suffer from any auto-immune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus or scleroderma). have ever been told that you are allergic to captopril or to any other medicines including other ACE inhibitors (e.g. lisinopril, enalapril) or any of the other ingredients in the tablet (listed in section 6) are more than 3 months pregnant (it is also better to avoid Captopril in early pregnancy - see pregnancy section.) Warnings and precautions You must tell your doctor if you think you (or might become) pregnant. Captopril 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). Talk to your doctor if you; Suffer from kidney disease, Suffer from liver disease, Are undergoing dialysis, Suffer from heart disease, in particular problems with the valves of the heart,

1. What Captopril Tablets are and what they are used for
The name of this medicine is Captopril Tablets. The active ingredient is Captopril. Captopril is a member of a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. ACE inhibitors reduce constriction of blood vessels, which makes it easier for the blood to flow through them. Captopril is used to lower high blood pressure or to help

Have diabetes, Have recently suffered from excessive vomiting or diarrhoea, Are receiving immuno-suppressant therapy. 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 tablets. 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 tablets. Tell your doctor you are taking Captopril tablets before you have any blood or urine tests as Captopril tablets may interfere with the results of some tests. Some Afro-Caribbean patients may require higher doses of Captopril to obtain an adequate reduction in blood pressure. Other medicines and Captopril Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Non steroidal anti-inflammatory painkillers NSAIDs (e.g. indomethacin, ibuprofen), Immunosuppressants (e.g. azathioprine and cyclophosphamide), Potassium supplements, salt substitutes containing potassium or any other medicines which can increase potassium in your body, e.g. (amiloride, spironolactone), Water tablets (diuretics), Medicines for gout (e.g. allopurinol), Medicines for diabetes (as the amount you need to use may have to be changed while taking Captopril), Medicines that cause dilation of the blood vessels (e.g. minoxidil, clonidine),

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Medicines to treat mental health problems including depression (such as lithium or amitriptyline), Any other medicines to treat high blood pressure (e.g. beta-blockers such as propanolol, atenolol or calcium channel blockers such as amlodipine, nifedipine), Any medicine that may be used during and after a heart attack. If you are due to have surgery Before surgery and anaesthesia (even at the dentist) you should tell your doctor or dentist that you are taking Captopril as there may be a sudden fall in your blood pressure. Captopril Tablets with food, drink and alcohol Captopril tablets can be taken with or without food. Moderate amounts of alcohol will not affect Captopril, however, you should check with your doctor first to see if drinking is advisable for you. Pregnancy, breast-feeding and fertility Pregnancy You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Captopril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Captopril. Captopril 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. Breastfeeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Breast-feeding newborn babies (first few weeks after birth), and especially premature babies, is not recommended whilst taking Captopril. In the case of an older baby your doctor should advise you on the

benefits and risks of taking Captopril whilst breastfeeding, compared with other treatments. Driving and using machines Captopril tablets 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 Captopril tablets, you should not drive or use machinery. Captopril Tablets contain Lactose If you have been previously told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.

3. How to take Captopril Tablets
Always take these tablets exactly as advised by your doctor. You should check with your doctor or pharmacist if you are not sure. The number of tablets you need will depend on your condition. The tablets should be swallowed whole with a small glass of water. The usual doses are as follows: For the treatment of high blood pressure The usual starting dose is 12.5 - 25mg twice a day. Your doctor may gradually increase this dose to 100 - 150mg a day. You may also need to be given other medicines to lower your blood pressure. Older patients and those with kidney problems may be given a lower starting dose. In heart failure The usual starting dose is 6.25 12.5mg two or three times a day. Your doctor may gradually increase this dose to a maximum of 150mg a day.

After a heart attack The usual starting dose is 6.25mg, which will then be increased by your doctor to a maximum of 150mg a day. For the treatment of diabetic patients with kidney disease The usual dose is 75 - 100mg a day. For patients with kidney problems a lower dosage will normally be necessary For children The starting dose is 0.3mg/kg bodyweight, which may be increased gradually by the doctor. For children with kidney problems, premature babies and newborn babies and infants The starting dose should be 0.15mg/kg bodyweight. Doctors sometimes prescribe different doses to the above and if this applies to you, you should discuss it with your doctor. Sometimes patients may feel dizzy after taking the first one or two doses of Captopril. If this happens to you, lie down until these symptoms disappear. You should try to take Captopril at about the same time each morning. It can be taken before, during or after meals. Even if you feel well continue to take Captopril until your doctor tells you otherwise. If you take more Captopril tablets than you should Contact your nearest hospital casualty (A&E) or your doctor immediately. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily. If you forget to take Captopril tablets If you forget to take a dose, wait and take your next dose as usual.

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN DOSE If you stop taking these tablets Do not stop taking these tablets without first talking to your doctor. Treatment should continue for as long as your doctor feels it is needed. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects
Like all medicines, these tablets can cause side effects, although not everybody gets them. STOP TAKING this medicine and tell your doctor immediately if you suffer from any of the following undesirable effects: 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 (may affect up to 1 in 10 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, abdominal pain

Shortness of breath Uncommon side effects (may affect up to 1 in 100 people) Fast, irregular, louder heartbeat Tiredness Chest pain Generally feeling unwell Low blood pressure Looking pale Reduced blood flow to the hands and feet (e.g. Raynaud syndrome) Swelling of the eyes and lips (angioedema). Flushing Rare side effects (may affect up to 1 in 1000 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 (may affect up to 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, and chest infections Wheezing or difficulty breathing



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 in the blood or lymphatic systems (e.g. potassium, sugars) Anaemia, Thrombocytopenia (low levels of platelets with symptoms such as increased tendency to bruise/bleed) Neutropenia, Agranulocytosis (low levels of white blood cells with increased susceptibility to infection). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to Store Captopril Tablets
Keep this medicine out of the sight and reach of children Do not use this medicine after expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month. Do not store above 250C. Store in the original package. Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Captopril Tablets contain The active substance is Captopril

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The other ingredients are: Lactose monohydrate, Maize starch, Microcrystalline cellulose and Stearic acid What the Captopril Tablet looks like and contents of the pack Captopril 12.5mg tablets: - White to almost white, round, biconvex, uncoated tablets with 12.5 embossed on one side. Captopril 25mg and 50mg tablets: - White to almost white, round, flat, bevelled edged, uncoated tablets with score line on one side and 25 or 50 embossed on the other side. Captopril tablets are available in packs of 28 and 56 tablets. Marketing Authorisation Holder and Manufacturer Name and address: Bristol Laboratories Ltd, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922 Fax: 0044 (0)1442 873717 E-mail: info@bristol-labs.co.uk Captopril 12.5mg tablets; PL 17907/0037 Captopril 25mg tablets; PL 17907/0038 Captopril 50mg tablets; PL 17907/0039 This leaflet was last revised in January 2013 To request a copy of this leaflet in a braille, large print or audio format, please contact the licence holder at the address above (or telephone, fax, email).