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Captopril 25mg Tablets

Document: leaflet MAH GENERIC_PL 15773-0053 change

Package leaflet: Information for the user Captopril 25 mg/50 mg tablets Active substance: 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, 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 Captopril is and what it is used for

2.    What you need to know before you take Captopril

3.    How to take Captopril

4.    Possible side effects

5.    How to store Captopril

6.    Contents of the pack and other information

1.    WHAT CAPTOPRIL IS AND WHAT IT IS USED FOR

Captopril belongs to the group of medicines known as ACE inhibitors (i.e. inhibitors of the enzyme that converts angiotensin), which are used in the treatment of diseases of the heart and blood vessels.

Captopril reduces blood pressure by widening the blood vessels and increases the elimination of fluid and salt from the body. The widening of the blood vessels also causes a reduced workload on the heart in heart failure.

Your doctor has prescribed Captopril for one of the following reasons:

•    You have high blood pressure (hypertension)

•    You have a heart condition known as heart failure (cardiac insufficiency). This is where your heart is not working as well as it used to, in order to pump blood around your body, leading to tiredness after mild exercise, breathlessness and swelling of the ankles and legs

•    You have had a heart attack (myocardial infarction). Captopril can improve survival after a heart attack and reduce further heart problems

•    You have insulin-dependent Type I diabetes kidney disease

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE BEFORE YOU TAKE CAPTOPRIL Do not take Captopril

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

-    if you have previously been treated with a product that belongs to the group of ACE-inhibitors and have suffered a hypersensitivity reaction in the form of angio-oedema involving, for example, swelling of the face or extremities, lips, tongue, mouth or mucous membranes, which may be associated with breathlessness or difficulties in swallowing.

-    if you have suffered angio-oedema for any other reason

if your blood relative has had angio-oedema (the trait can run in family).

if you are more than 3 months pregnant (It is also better to avoid Captopril 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 or pharmacist before taking Captopril :

Please tell your doctor:

•    if you suffer from kidney or liver disease

•    if you suffer from narrowing or thickening of the heart valves, restricting blood flow away from the heart (e.g. aortic stenosis or mitral valve stenosis)

•    if you suffer from diabetes mellitus and have previously been treated with oral antidiabetic drugs or insulin.

•    if you suffer from narrowing of the blood vessels supplying the kidney (bilateral renal artery stenosis or unilateral renal artery stenosis in a single functioning kidney)

•    if you suffer from hypertension and your body’s fluid levels are subject to fluctuation (electrolyte imbalance) due to diuretic therapy, diarrhoea, vomiting or dietary salt restriction

•    if you suffer from heart failure.

•    if you suffer from proteinuria (too much protein present in your urine).

•    if you are about to have desensitisation therapy (treatment to reduce the effect of insect stings)

•    if you are about to have a treatment called low density lipoprotein (LDL) apheresis, which is the removal of cholesterol from your blood by a machine

•    if you undergo haemodialysis.

•    if your body’s immune system is suppressed (e.g. if you are using medicines such as cyclosporin,

tracrolimus or azathioprine).

•    if you suffer from any auto-immune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus or

scleroderma ).

•    if you are of Afro-Carribean decent please consult your doctor before taking Captopril

•    if you are using potassium sparing diuretics (i.e. water tablets), potassium supplements, potassium containing salt substitutes or drugs associated with increased serum potassium (e.g.heparin)

•    if you are about to undergo major surgery or anaesthesia

•    if you are lactose intolerant or suffer from glucose and galactose malabsorption 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”

Contact your doctor if you develop a dry, persistent, irritating cough during treatment, as this can be a side effect of captopril.

You must tell your doctor if you think you are (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).

Other medicines and Captopril

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell particularly to your doctor if you are taking any of following medicines:

•    potassium tablets, potassium solution or other potassium supplements (such as products that replace table salt), since they can lead to an excessive increase in the potassium content in the blood during treatment with captopril

•    diuretics, since during treatment with captopril it may be necessary to reduce the dose to prevent fluid loss and an excessive fall in blood pressure

•    potassium-sparing diuretics, such amiloride, spironolactone or triamterene, as they too can cause an excessive increase in the potassium content in the blood

•    other blood pressure medicines e.g.angiotensin II receptor blocker (ARB) or aliskiren (antihypertensive agents): 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 Captopril” and “Warnings and precautions”)

•    nitroglycerine or other drugs used for the treatment or prevention of angina pectoris (episodic chest pains)

•    lithium, as its concentration in the body can increase to harmful levels during treatment with captopril

•    phenothiazines, which are used in the treatment of psychosis, barbiturates or so-called tricyclic antidepressants, which are used for depression, as the blood pressure-lowering effect of Captopril can be increased

•    allopurinol (medicine for gout) or procainamide (medicine for rhythm disorders)

•    cytostatics or drugs that reduce the body’s immune defences (such as cyclosporin, tacrolimus and azathioprine)

•    anti-inflammatory drugs, such as ibuprofen, ketoprofen or acetylsalicylic acid

•    insulin or oral diabetes medicines, as Captopril can increase their blood sugar-lowering effect

•    sympathomimetic drugs (used for the treatment of hypertension, shock, cardiac failure, asthma or allergies) such as ephedrine, noradrenaline or adrenaline

Captopril with food and drink

Captopril can be taken together with fluid, for example a glass of water, either on an empty stomach or with food. Taking food at the same time does not affect the absorption of Captopril.

Pregnancy ,breast-feeding and fertility

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

Pregnancy

Do not take Captopril during pregnancy as its use causes side effects to the foetus. Contact and consult 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 or if you become pregnant during treatment with Captopril.

Breast-feeding

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 breast-feeding, compared with other treatments.

Driving and using machines

Some patients can experience side effects such as dizziness, tiredness, headache or other symptoms that affect the ability to drive and other activities that require attention. If you develop these symptoms, avoid driving and activities that require attention. The symptoms usually occur at the beginning of treatment or when the dose is adjusted and are unlikely if the treatment is well adjusted.

Captopril contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

3. HOW TO TAKE CAPTOPRIL

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

The recommended dose is

High blood pressure (hypertension)

Treatment is usually initiated with 25-50 mg in two divided doses daily. Your doctor may increase the dose gradually to 100-150 mg per day in two divided doses (one dose in the morning and one dose in the evening) as required. If you are also taking other antihypertensive drugs (e.g. thiazide diuretics) your doctor may decide on a once daily dose.

Heart failure

Captopril therapy should be started under close medical supervision. Treatment is usually initiated with 6.25-12.5 mg twice or three times per day. This dose may be increased gradually to the maximum 150 mg per day in divided doses.

Heart attack (myocardial infarction)

After a heart attack treatment is usually initiated in hospital with 6.25 mg which can gradually be increased by your doctor to a maximum of 150 mg daily in two or three divided doses.

Patients who suffer with kidney problems related to diabetes

If you suffer from kidney disease due to diabetes (diabetic nephropathy), the usual dose is 75-100 mg daily in divided doses.

The dose in special situations

Elderly patients

Therapy should be initiated at the lowest possible dose of 6.25 mg twice a day to achieve the desired effect.

Children and adolescents

Treatment should be initiated at approximately 0.3 mg/kg body weight. For children with kidney problems, premature infants, new-borns and infants the starting dose should be 0.15 mg/kg body weight. The dose regimen will be decided by your doctor.

Kidney problems

Your doctor may reduce the dose according to your real kidney function.

If you take more Captopril than you should

If you have accidentally taken more Captopril than you should, contact your nearest hospital or tell your doctor/pharmacist immediately. Take this leaflet and any left-over tablets with you to show them.

If you forget to take Captopril

Take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet/dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects requiring immediate contact to doctor or first aid

If you suddenly develop swelling of the face or extremities, lips, tongue, mouth or mucous membranes, which may be associated with breathlessness or difficulties in swallowing (angio-oedema), contact your doctor or the first aid service immediately.

Other possible side effects

Common (may affect up to 1 in 10people)

•    dry, persistent, irritating cough - contact your doctor if you develop this symptom during treatment

•    sleep disorders

•    taste disorders or dry mouth

•    dizziness

•    nausea, vomiting, irritation of the stomach, diarrhoea or constipation

•    skin rash with itching, itching skin without rash, or hair loss Uncommon (may affect up to 1 in 100people)

•    rapid heart rate or other rhythm disorders, palpitations or chest pain

•    abnormally low blood pressure, worsening of Raynaud’s syndrome (white fingers), redness or pallor

•    tiredness or a feeling of unwellness

Rare ( may affect up to 1 in 1,000 people)

•    loss of appetite (anorexia)

•    drowsiness, headache, tingling or prickling sensations

•    mouth infection or mouth ulcers

•    functional disorders of the kidneys, small or large amount of urine, increased/frequent need to urinate

•    allergic reaction in the small intestine (intestinal angioedema)

Very rare (may affect up to 1 in 10,000 people)

•    unexplained fever, sore throat or flu-like symptoms (caused by reduced number or lack of white blood cells)

-contact your doctor if you develop these symptoms during treatment

•    anaemia, enlarged lymph nodes or an auto-immune disease develops

•    reduced number of blood platelets (can cause a tendency to bruising or nose bleeds)

•    confusion or depression

•    disorders of the circulation of the brain due to low blood pressure (faintness, paralysis)

•    blurred vision

•    cardiac arrest, cardiogenic shock

• narrowing of the airways and breathlessness, runny nose, allergic inflammation of the air sacs in the lungs or inflammation of the lungs

•    inflammation of the tongue, stomach ulcer, inflammation or the pancreas.

•    impaired liver function, cholestasis (yellow colour of the skin and whites of the eyes and itching of the skin), inflammation of the liver or liver necrosis

•    nettle rash, drug eczema, troublesome scaling skin and mucous membrane reactions or light sensitivity

•    muscle or joint pain

•    impotence or swelling of the breasts in men

•    protein in the urine

•    changes in laboratory values: increase in serum potassium or decrease in serum sodium, increase in creatinine, bilirubin or liver enzyme values

•    fever

•    hyperkalaemia

•    hypoglycaemia

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE CAPTOPRIL

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after {abbreviation used for expiry date}. The expiry date refers to the last day of that month.

Do not store above 25 °C.

Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater 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 contains

The active substance is captopril.

•    25 mg tablets - Each tablet contains 25 mg captopril.

•    50 mg tablets - Each tablet contains 50 mg captopril.

The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, hydrated castor oil, colloidal anhydrous silicon dioxide and magnesium stearate.

What Captopril looks like and contents of the pack

25 mg tablets

white, round, biconvex tablet with a break cross score on one side, diameter 8 mm.

Pack sizes: 20, 30, 45, 50, 56, 60, 84, 90, 100 tablets. The tablet can be divided into equal halves or quarters.

50 mg tablets

white, round, biconvex tablet with a break cross score on one side, diameter 10 mm.

Pack sizes: 24, 30, 45, 50, 56, 60, 84, 90, 100 tablets. The tablet can be divided into equal halves or quarters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

MA Holder: ratiopharm GmbH, Graf-Arco-Str.3, D-89079 Ulm, Germany.

Manufacturer: Merckle GmbH, Ludwig-Merckle Str.3, 89143 Blaubeuren, Germany.

This medicinal product is authorised in the Member States of the EEA under the following names:

Finland (FI) - Captopril-ratiopharm 12.5/25/50 mg tabletti Italy (IT) - Captopril-ratiopharm 25/50 mg compresse United kingdom (UK) - Captopril 12.5/25/50 mg tablets

This leaflet was last approved in March 2015. PL 15773/0053

PL 15773/0055