P0349T

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

CAPTOPRIL lZ5mg, 25mg and 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 further questions, please askyour 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.

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

1. What Captopril tablets are and what they are used for

The name of your medicine is Captopril 12.5mg, 25mg and 50mg Tablets, but will be referred to as Captopril Tablets' throughout the remainder of the Leaflet.

Captopril Tablets belong to a group of medicines known as ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).

ACE inhibitors works by making your blood vessels wider, which then make easier for your heart to pump blood through them. Captopril Tablets is used to treat high blood pressure and certain heart conditions. If high blood pressure is left uncontrolled it can increase the risk of heart disease or stroke. Captopril works by lowering your blood pressure which reduces this risk.

Captopril Tablets can also help peopje whose heart no longer

^ blood as well as it once did.This condition is known as ailure.

Captopril Tablets may also be used to treat patients who recently suffered a heart attack. A heart attack happens once one of the major blood vessels supplying blood to the heart muscle becomes blocked. This means that the heart does not receive the oxygen it needs and the heart muscle becomes damaged.

In addition, Captopril Tablets 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 Captopril Tablets if you:

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

• are more than 3 months pregnant. It is also better to avoid Captopril Tablets in early pregnancy - see pregnancy section. • 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 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 Tablets. 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 Tablets if you'.

You must tell your doctor if you:

• think you are (or might become) pregnant. Captopril 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).

• suffer from kidney disease • suffer from liver disease • are undergoing dialysis

• suffer from heart disease, in particular problems with the valves of the heart • have diabetes

•    have recently suffered from excessive vomiting or diarrhoea

•    are receiving immune-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 Tablets to obtain an adequate reduction in blood pressure.

Children and adolescents

Safety and effectiveness in children have not been established. Other medicines and Captopril Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is especially important to tell your doctor if you are taking any of the following:

•    water tablets (diuretics)

•    medicines to treat mental health problems including depression (such as lithium or amitryptiline)

•    medicines that cause dilation of the blood vessels (e.g. minoxidil, clonidine)

•    non-steroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, ibuprofen or diclofenac (for pain or inflammation)

•    potassium supplements or salt substitutes containing potassium or any other medicines which can increase potassium in your body, (e.g amiloride, spironolactone)

•    immunosuppressants (e.g. ciclosporin, azathioprine and cyclophosphamide)

•    medicines for gout (e.g. allopurinol)

•    any other medicines to treat high blood pressure (e.g. beta-blockers such as propranolol, atenolol, or calcium channel blockers such as amlodipine, nifedipine)

•    medicines for diabetes (as the amount you need to use may have to be changed while taking Captopril Tablets)

•    any medicine that may be used during and after a heart attack

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 Tablets if you' and 'Warnings and precautions'. Captopril Tablets with food and drink You can take Captopril Tablets with or without food.

Moderate amounts of alcohol will not affect Captopril Tablets, however, you should check with your doctor first to see if drinking is advisable for you.

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 or pharmacist for advice before taking this medicine.

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 Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Captopril Tablets. Captopril 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. Breastfeeding

Tell your doctor if you are breast-feeding or about to start breastfeeding. Breast-feeding newborn babies (first few weeks after birth), and especially premature babies, is NOT recommended whilst taking Captopril Tablets.

GRASSHOPPER

Code

AW.CRC.86.02.V02

Grasshopper Sistemas de Informagao

geral@gsiportugal.com

www.gsiportugal.com

SISTEMAS DE INFORMACAO

Date

2016-09-23

In the case of an older baby your doctor should advise you on the benefits and risks of taking Captopril Tablets whilst breastfeeding, compared with other treatments.

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 Tablets as there may be a sudden fall in your blood pressure.

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 Captopril tablets, you should not drive or use machinery.

Captopril tablets contains lactose Captopril 12.5mg, 25mg and 50 mg tablets contains 32.5 mg, 65.0 mg and 130 mg lactose, respectively, which is a type of sugar, 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 Tablets

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

The recommended doses are:

For the treatment of high blood pressure (hypertension)

The usual starting dose is one 12.5mg - 25mg tablet twice a day. Your doctor may gradually increase this dose to 100mg -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 6.25mg-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 T50mg a day.

For the treatment of diabetic patients with kidney disease The usual dose is 75mg - 10Omg a day.

Use in children and adolescents

The starting dose in children is 0.3mg per kg bodyweight and your doctor may adjust the dose depending on the response.

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. The tablets can be broken in half for a 12.5mg dose or quarters for 6.25mg dose.

Sometimes patients may feel dizzy after taking the first one or two doses of Captopril Tablets. If this happens to you, lie down until these symptoms disappear.

You should try to take Captopril Tablets 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 Tablets until your doctor tells you otherwise.

If you take more Captopril Tablets than you should

If you or anyone else takes too many tablets you should tell your doctor or go to the nearest hospital casualty department straight away. Remember to take the carton and any remaining tablets you nave with you.

If you forget to take Captopril Tablets

If you miss a dose do not worry. Just carry on taking your normal dose when the next one is due.

DO NOT take a double dose to make up for a forgotten tablet.

4.    Possible side effects

Like all medicines, this medicine can cause 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 (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, vomiting, 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,

•    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, mouth, eyes and genitals),

•    Changes in levels of chemicals in the blood or lymphatic systems (e.g. potassium, sugars).

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. 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 Tablets

KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.

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

DO NOT store above 25°C.

DO NOT use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

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 Tablet contains

The active substance is captopril. Each tablet contains 12.5mg, 25mg, or 50mg of captopril.

The other ingredients are lactose, maize starch, microcrystalline cellulose ana stearic acid.

What Captopril Tablet look like and contents of the pack

Captopril 12.5mg tablets are white, round, flat tablets scored on one side and marked “G12.5” on the other, 6mm in diameter. Captopril 25mg tablets are white, round, flat tablets scored on one side and marked “G25” on the other, 8mm in diameter Captopril 50mg tablets are white, round, flat tablets scored on one side and marked “G50” on the other, 10mm in diameter.

The tablets can be divided into equal doses.

They are supplied in calendar blister packs of 56 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 September 2016.

Customer    Description

Crescent

CAPTOPRIL 12.5mg, 25mg and 50mg TABLETS

(Package leaflet EN)

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PHARMA L