Document: leaflet MAH GENERIC_PL 17907-0037 change

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• leaflet MAH GENERIC_PL 39484-0012

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8 mm

Package leaflet: Information for the user

CAPTOPRIL 12.5 MG, 25 MG & 50 MG TABLETS

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 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 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 this medicine is Captopril Tablets. The active ingredient is Captopril.

Captopril belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors.

ACE inhibitors 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 high blood pressure (hypertension), congestive heart failure, kidney problems caused by diabetes, and to improve survival after a heart attack.

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,

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

•    are more than 3 months pregnant or breast-feeding (it is also better to avoid Captopril in early pregnancy - see pregnancy section.)

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

Warnings and precautions

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).

Talk to your doctor, pharmacist or nurse if you:

•    suffer from liver or kidney disease,

•    are undergoing dialysis,

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

•    are taking diuretic (water tablets)

•    get swelling in your face, neck or throat

•    get any changes in the colour of your skin or the whites of your eyes, you must see your doctor immediately

•    are going to have a dental surgery or major surgery involving anesthetic

•    get stomach pains - you need to tell your doctor you are taking Captopril

•    feel ill, become aware of your heartbeat and get muscle weakness - you may have high amounts of potassium in your blood, your doctor will perform a blood test to check this.

•    are on a reduced-salt diet

•    have diabetes

•    have recently suffered from excessive vomiting or diarrhoea,

•    are receiving immuno-suppressant therapy

•    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 these tablets if you”

•    are to have desensitisation treatment, e.g. for an allergic reaction to wasp or bee stings

•    are about to have treatment for the removal of cholesterol from your blood by a machine, (called LDL apheresis)

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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 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 these tablets if you” and "Warnings and Precautions”.

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

•    Diuretics (water tablets)

•    Potassium supplements or salt substitutes containing potassium (e.g. triamterene, amiloride and spironolactone).

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

•    Medicines to treat mental problems including manic depression or depression (e.g. lithium and amitriptyline)

•    Immuno-suppressants (e.g. azathioprine and cyclophosphamide)

•    Medicines to treat gout (e.g. allopurinol and probenecid)

•    Medicines to treat irregular heartbeats (e.g. procainamide)

•    Non-steroidal anti-inflammatory painkiller (NSAIDS) (e.g. indometacin, and ibuprofen)

•    Medicines to treat diabetes (e.g. oral antidiabetics and insulin)

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

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

Captopril with food, drink and alcohol

Captopril 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 advice you to stop taking Captopril before you become pregnant or as soon as you know you are pregnant and will advice 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 breast-feeding, compared with other treatments.

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 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 this medicine exactly as advised by your doctor. You should check with your doctor or pharmacist if you are not sure.

•    The tablets should be swallowed whole with a glass of water.

The recommended doses are as follows:

For the treatment of high blood pressure (hypertension)

•    The recommended 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.

In heart failure

•    The recommended 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 recommended 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 recommended dose is 75 - 100mg a day.

Elderly patients (over 65 years):

Your doctor may start you on lower dose. if you have a kidney disorder your doctor will increase the dose gradually until your blood pressure is adequately controlled. The dosage may then be adjusted by your doctor to suit individual requirements.

For children

If this medicine is prescribed for a child make sure that the tablets are taken as stated on the label. The dosage for children is worked out on the basis of child's weight in kilograms.

The recommended starting dose is 0.3mg/kg body weight daily. If required, your doctor may increase the dose gradually.

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

If you or someone else swallow several of these tablets together, contact your doctor or nearest hospital emergency department immediately. Always take any tablets left over with you, this leaflet and also the box, as this will allow easier identification of the tablets.

If you forget to take Captopril tablets

If you miss a dose, take it as soon as you remember and carry on as before. If it is almost time for your next dose, skip the forgotten dose and continue as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking these tablets

Do not stop taking these tablets without first talking to your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

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, eyes, lips or tongue

•    Wheezing or Difficulty in breathing

•    Ulcers, blistering and skin rashes or burning, red, peeling skin on the lips, tongue and genitals, sometimes spreading to the eyes, face and body, (a very rare illness known as Stevens-Johnson syndrome)

•    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)

•    Dry mouth

•    Itching or a red rash

•    Sleep problems

•    Rashes

•    Diarrhoea or constipation

•    Hair loss

•    Dry, irritating cough

•    Upset stomach, sickness, abdominal pain

•    Shortness of breath

•    Loss of taste (usually reversible on stopping treatment)

Uncommon side effects (may affect up to 1 in 100 people)

•    Tiredness, generally felling unwell

•    Chest pain

•    Low blood pressure

•    Flushed or looking unusually pale

•    Reduced blood flow to the hands and feet (e.g. Raynaud syndrome)

Rare side effects (may affect up to 1 in 1000 people)

•    Loss of appetite and weight loss

•    Mouth ulcers

•    Drowsiness, headache

•    Kidney disorders or failure

•    Changes in frequency of passing urine

•    Pins and needles, numbness or tingling

•    allergic reaction in the gut causing severe abdominal pain (intestinal angioedema),

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

•    Changes to your liver function or liver damage

•    Confusion, depression,

•    Stomach ulcers

•    Mini-stroke

•    Muscle or joint pain

•    Blurred vision

•    Heart problems including heart attack, and chest infections

•    Inflammation of the pancreas

•    Runny nose

•    Swelling of breast tissue in men, impotence

•    Swollen tongue

•    Sensitivity of the skin to light

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

•    Changes in your blood. Your doctor will carry out tests to check this

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 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

•    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. Not all pack sizes may be marketed.

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)l442 873717

E-mail:    info@bristol-labs.co.uk