PATIENT INFORMATION LEAFLET

Captopril 12.5mg, 25mg and 50mg Tablets

What this medicine is and what it is used for

Captopril belongs to a group of medicines called

Angiotensin Converting Enzyme (ACE) Inhibitors.

These work by helping to widen your blood vessels,

which then make it easier for your heart to pump

blood through them.

Captopril is used to treat the following:

■    Mild to moderately high blood pressure (hypertension)

■    Severely high blood pressure (hypertension) where standard treatment is ineffective or unsuitable

■    Treatment or prevention of heart failure

■    Short-term (4 weeks) treatment within the first 24 hours of a heart attack

[2 What you need to know before ^ you take Captopril

Do not take Captopril if:

■    You are allergic (hypersensitive) to Captopril, ACE Inhibitors or any of the other ingredients of this medicine or other ACE inhibitors (see Section 6 "Contents of the pack and other information”)

■    You are more than 3 months pregnant (it is also better to avoid Captopril in early pregnancy - see "Pregnancy and breast-feeding” section)

■    You have a history of suffering from swelling of the deeper layers of the skin caused by a build-up of fluid relating to previous treatment with an ACE Inhibitor (angioneurotic oedema)

■    You suffer from an inherited swelling of the deeper layers of the skin caused by a build-up of fluid or without an identifiable cause (hereditary or idiopathic angioedema)

■    If you are breast-feeding (see "Pregnancy and breast-feeding” section)

■    If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warnings and precautions

If you are taking any of the following medicines used

to treat high blood pressure:

■    An angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems

■    Aliskiren

Your doctor may check your kidney function, blood

pressure, and the amount of electrolytes (e.g.

potassium) in your blood at regular intervals.

See also information under the heading "Do not take

Captopril".

Talk to your doctor before taking Captopril:

■    If you are due to have surgery, you should make sure that the anaesthetist is aware you are taking Captopril as treatment with Captopril should be discontinued one day prior to the surgery

■    If you suffer from narrowing of the heart valves, restricting the blood flow (aortic stenosis or mitral stenosis) or thickening of the heart muscle (hypertrophic cardiomyopathy)

■    If you suffer from low blood pressure (hypotension)

■    If you suffer from kidney disorders

■    If you have a history of suffering from swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema). If you are black, you are at higher risk of developing angioedema than in non-black patients

■    If you are currently suffering from a cough

■    If you suffer from liver failure

■    If you are taking lithium, a medicine used to treat mood disorders [antipsychotic] (see "Other medicines and Captopril”)

■    If you suffer from collagen vascular disease (inflammation or weakness of the connective tissue)

■    If you are taking immunosuppressants, medicines used to reduce the body's immunity when receiving organ transplant (see "Other medicines and Captopril” section)

■    If you are taking allopurinol, a medicine used to treat gout (see "Other medicines and Captopril” section)

■    If you are taking procainamide, a medicine used to treat irregular heartbeats [digitalis/cardiac glycosides] (see "Other medicines and Captopril” section)

■    If you suffer from blood disorders. You must tell your doctor if you develop any signs of an infection, such as a sore throat or fever

■    If you are taking potassium-sparing diuretics (e.g. triamterene, amiloride and spironolactone), potassium-containing supplements or salt substitutes or medicines which can increase the level of potassium in the blood e.g. heparin (see "Other medicines and Captopril”)

■    If you are receiving treatment to reduce the effects of an allergy (desensitisation) to a wasp or bee sting

■    If you are diabetic and being treated with oral medicines or insulin

■    If you are at risk of abnormally low levels of potassium in blood (hypokalaemia)

■    If you are having dialysis with high flux membranes e.g. AN69

■    If you are having a non-surgical treatment for the removal of cholesterol (LDL) from your blood by a procedure called LDL apheresis with dextran sulphate

■    If you are pregnant, think that you may be pregnant or are planning to have a baby (see "Pregnancy and breast-feeding” section)

■    If you are black, Captopril may be less effective in

lowering blood pressure than in non-black patients Other medicines and Captopril

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings "Do not take Captopril” and "Warnings and precautions”).

Medicines which may interact with or be affected by

Captopril:

■    Clonidine used to treat high blood pressure

■    Lithium, a medicine used to treat mood disorders (antipsychotic)

■    Tricyclic antidepressants, medicines used to treat depression

■    Diuretics (medicines used to increase frequency of urination), in particular, triamterene, amiloride and spironolactone (potassium-sparing diuretics)

■    Potassium-containing supplements or salt substitutes

■    Indomethacin and other Non-Steroidal AntiInflammatory Drugs (NSAIDs) such as ibuprofen

■    Minoxidil and other medicines used to widen the blood vessels (vasodilators)

■    Allopurinol and probenicid, medicines used to treat gout

■    Procainamide, a medicine used to treat irregular heartbeats

■    Immunosuppressants, medicines used to reduce the body's immunity when receiving organ transplant such as azathioprine and cyclophosphamide

■    Other medicines used to treat high blood pressure (hypertension) such as beta-blockers, calcium channel blockers, alpha blockers

■    Nitroglycerine and other nitrates used to treat angina and heart failure

■    Medicines that may be used to treat a heart attack such as aspirin, thrombolytics, beta-blockers and/or nitrates

■    Insulin and oral diabetic medicines such as sulphonylurea

■    Medicines used to treat cancer (cytostatic agents)

■    Captopril may cause a false-positive urine test for acetone

Taking Captopril with food and drink and alcohol

■    During treatment with Captopril, it is recommended not to drink alcohol

■    These tablets may be taken before, during and after meals

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Captopril is not recommended during the first 3 months of pregnancy and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby.

Breast-feeding

■    If you are breast-feeding, Captopril should not be taken as Captopril is passed into breast milk

■    If you are breast-feeding, Captopril is not recommended for premature babies and for the first few weeks after birth because of the possible risk of effects on the heart and/or kidneys

■    If the infant is older, it may be possible to use Captopril during breast-feeding if treatment is necessary for you and your child is monitored for any adverse effects

Driving and using machines

Captopril may affect your ability to drive and operate machinery. This is more likely to occur at the start of treatment, when the dose is changed or if you drink alcohol. If any symptoms are experienced, it may be necessary to avoid driving or operating machinery or pursuing any activity in which full attention is required.

Captopril contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

How to take Captopril

Always take Captopril exactly as your doctor has

told you. You should check with your doctor or

pharmacist if you are not sure.

■    These tablets are to be taken orally with a glass of water

■    The score line on the tablet is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses

■    The recommended maximum daily dose is 150mg

■    These tablets may be taken before, during and after meals

Adults

High blood pressure (hypertension):

■    The recommended starting dose is 12.5mg twice daily

■    The usual maintenance dose is 25mg twice daily

■    This dose may be increased by increments at 2-4 week intervals

■    The maximum dose is 50mg twice daily, but for severely high blood pressure a maximum dose of 50mg three times daily may be given

Heart failure:

■    The recommended starting dose is 6.25mg or 12.5mg twice daily or three times daily

■    The usual maintenance dose is 75-150mg per day

Continued....

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