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Capozide 50mg/25mg Tablets

Document: leaflet MAH BRAND_PLPI 16369-0582 change

1. What Capozide is and what it is used for


2. What you need to know before you take Capozide



3. How to take Capozide


PACKAGE LEAFLET: INFORMATION FOR THE USER CAPOZIDE® 50MG / 25MG TABLETS

(captopril / hydrochlorothiazide)

Your medicine will be referred to as Capozide throughout the remainder of this leaflet.

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, ask your doctor or pharmacist.

■    This medicine has been prescribed for you only. Do 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. See section 4.

What is in this leaflet

1.    What Capozide is and what it is used for

2.    What you need to know before you take Capozide

3.    How to take Capozide

4.    Possible side effects

5.    How to store Capozide

6.    Contents of the pack and other information

Capozide is a combination of two active substances, captopril and hydrochlorothiazide. Captopril belongs to a group of medicinal products called Angiotensin Converting Enzyme (ACE) Inhibitors. ACE inhibitors cause blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicinal products called thiazide diuretics (also known as water tablets). They increase urine output and hence decrease blood pressure.

The two active substances in Capozide work together to decrease blood pressure further than if either was given alone.

Capozide is used in the treatment of high blood pressure (essential hypertension), if treatment with captopril or hydrochlorothiazide alone has not led to a sufficient decrease in blood pressure.

Please read the following section attentively. It contains important

information which you and your doctor should observe prior to taking

of Capozide.

Do not take Capozide

■    if you are allergic to captopril or to any other ACE inhibitors or to any of the other ingredients of this medicine (listed in section 6).

■    if you are allergic to hydrochlorothiazide or to any other sulphonamide derivatives.

■    if you have previously been treated with a medicine in the same group as Capozide (ACE inhibitors) and have had an allergic reaction which caused swelling of the arms, legs, ankles, lips, tongue and/or throat with difficulty in swallowing or breathing (angioedema) or if a member of your family has had a similar reaction.

■    if you have severe liver or kidney problems (ask your doctor if you have any doubt).

■    if you are more than 3 months pregnant. (It is also better to avoid Capozide in early pregnancy - see pregnancy section).

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

Warnings and precautions

Talk to your doctor before taking Capozide and if any of the following applies to you:

■    if you suffer from excessive vomiting or diarrhoea.

■    if you are on a low-salt diet and you use salt substitutes or supplements containing potassium.

■    if you have any liver or kidney problems (ask your doctor if you have any doubt).

■    if you know that you have reduced blood circulation in the heart muscle or a narrowing of the aorta (aortic stenosis) or the renal artery (renal artery stenosis).

■    if you have had shock following heart failure (cardiogenic shock).

■    if you suffer from diabetes.

Capozide may influence the effect of insulin or other anti-diabetic medicines. Please ask your doctor for advice.

■    if you are using dialysis.

There have been some reports of allergic-type reactions when people using medicinal products such as Capozide undergo dialysis with certain dialysis membranes [so called High-flux-Haemodialysis-Membranes or low-density lipoprotein (LDL)-apheresis with dextran sulphate absorption]. Tell your doctor before your next dialysis treatment.

■    if you are to have desensitisation treatment for wasp or bee stings.

There have been some reports of allergic-type reactions when people using medicinal products such as Capozide have such desensitisation treatment. Tell your doctor before your treatment.

■    if you suffer from lupus or lupus-like disorders.

■    if you have changes in your vision or pain in one or both of your eyes while taking Capozide. This could be a sign that you are developing glaucoma, increased pressure in your eye(s). You should discontinue Capozide treatment and seek medical attention.

■    if you are taking any of the following medicines used to treat high blood pressure:

-    an angiotensin II receptor blocker (ARB) (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 CAPOZIDE”.

You must tell your doctor if you think you are (or might become) pregnant. Capozide 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).

Medicinal products containing lithium should not be taken with Capozide without close monitoring by your doctor.

If you develop one of the following, contact your doctor immediately:

■    swelling of the arms, legs, ankles, face, lips, tongue and/or throat with difficulty swallowing or breathing,

■    any sign of infection (such as sore throat or fever) not readily responding to the usual treatment,

■    severe dizziness or fainting,

■    severe abdominal pain,

■    unusually fast or irregular heart beat,

■    jaundice (yellow skin/eyes),

■    any sudden, unexplained rash or burning, red or peeling skin.

Please inform following persons that you take Capozide:

•    the medical staff, especially the anaesthetist (if you are having an operation) if you are hospitalised.

•    your dentist before you have an anaesthetic for a dental procedure.

If you are taking Capozide for the first time you may feel light-headed or dizzy for a short time and it may help to sit or lie down. This is unlikely to happen when you are taking the tablets regularly. If you are worried, contact your doctor.

The hydrochlorothiazide contained in this medicine could produce a positive result in a doping test.

Children and adolescents

Capozide should not be given to children and adolescents (< 18 years).

Other medicines and Capozide

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

These include medicines for a cold, cough, hay fever or sinus problems as these may increase your blood pressure.

This applies in particular if you are also taking

■    some pain-killers which are also called 'anti-inflammatories' (e.g. indomethacin, ibuprofen),

■    lithium (for the treatment of mental disorders),

■    carbenoxolone (for the treatment of gastrointestinal ulcers),

■    corticosteroids, corticotrophin (ACTH),

■    some laxatives,

■    injections of an antifungal (amphotericin),

■    muscle relaxants (given at the time of surgery),

■    cholestyramine resin, colestipol (for lowering blood cholesterol),

■    allopurinol (for the treatment of gout)

■    procainamide and digoxin or other cardiac glycosides (treatment for irregular pulse),

■    cytostatic or immunosuppressive agents (e.g. azathioprine and cyclophosphamide),

■    calcium salts,

■    potassium supplements or salt substitutes containing potassium, diuretics (water tablets, in particular those so called potassium sparing), other drugs which can increase potassium in your body (such as heparin),

■    drugs that reduce blood pressure by widening of the blood vessels (e.g. minoxidil),

■    carbamazepine (for the treatment of epilepsy)

■    drugs used in diabetes (insulin and oral antidiabetics such as sulphonyl ureas),

■    drugs used to treat psychotic conditions and some antidepressants,

■    or any other treatment for high blood pressure.

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

If you are taking:

■    an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take CAPOZIDE” and “Warnings and precautions”).

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 Capozide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Capozide. Capozide is not recommended during 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.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Capozide is not recommended for mothers who are breast-feeding.

Driving and using machines

Caution is necessary when driving or operating machinery if side effects occur such as light-headedness, dizziness or tiredness. This applies in particular at the start of the treatment, when the dosage is changed or if you have had any alcohol.

Capozide contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor has prescribed Capozide since previous treatment for high blood pressure did not provide appropriate blood pressure reduction. Your doctor will inform you how to switch from the previous treatment to Capozide.

Dosage:

The usual dose is 1 tablet Capozide a day (corresponding to 50 mg captopril and 25 mg hydrochlorothiazide). The maximum daily dose of 1 tablet Capozide should not be exceeded.