Document: Captopril Actavis tablet ENG PL change

• Captopril Actavis tablet PL
• Captopril Actavis tablet ENG PL

---

Package leaflet: Information for the user

Captopril Actavis 25 mg and 50 mg 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 any further questions, ask your doctor, pharmacist or nurse.

- 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.

What is in this leaflet

1. What Captopril Actavis is and what it is used for

2. What you need to know before you take Captopril Actavis

3. How to take Captopril Actavis

4. Possible side effects

6. Contents of the pack and other information

Captopril Actavis belongs to the pharmacotherapeutic group of antihypertensive medications, angiotensin converting enzyme inhibitors (ACEIs).

Captopril reduces the formation of angiotensin II, a compound that raises the blood pressure.

Captopril is used for:

• High blood pressure

• Reduced heart function (chronic heart failure) in combination with diuretic medicine (“water tablets”) and in some cases other heart medication.

• Prevention and treatment of heart attack

• Diabetic patients who also have kidney problems with increased level of proteins in the urine

Do not take Captopril Actavis:

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

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

- if you have a medical history of swelling of the face, lips, throat or tongue (angioneurotic oedema) associated with previous treatment with ACEIs or of hereditary or unknown origin.

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

Warnings and precautions

Captopril Actavis tablets can cause symptoms of low blood pressure (dizziness and fainting), especially if taken together with other medicines which are lowering the blood pressure. Always tell your doctor if such symptoms occur.

Before an operation and anestesia your doctor must be informed that you take Captopril Actavis tablets, because the blood pressure can be lowered during the anestesia.

If you experience severe allergic reactions such as swelling of the tongue, throat and airways and you have difficulties breathing you must see a doctor immediately.

Contact your doctor if you suffer from abdominal pain, stomach cramps and possibly nausea or vomiting.

If you develop jaundice you must see your doctor as soon as possible.

Talk to your doctor or pharmacist before taking Captopril Actavis

- if you have reduced heart function

- if you have kidney problems

- if you are taking diuretic medicines

- if you are a diabetic

- if you due to allergy are undergoing desensitising treatment

- if you are to undergo dialysis or LDL apheresis (which is a removal of cholesterol from the blood by a machine

- 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 Actavis”

Regular checks on levels of sugar in the blood should be done during the first month of treatment if you are diabetic.

Captopril Actavis should be used with extream caution in patients with:

- connective tissue disease

- immunusuppressant therapy

- treatment with allopurinol or procainamide

- reduced kidney function

Some of these patients may develop serious infections which can not be treated with antibiotics.

It is not recommended to use Captopril Actavis and lithium at the same time.

You may experience a persistent, non-productive cough which will disappear when treatment is stopped.

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

Captopril Actavis lowers the blood pressure in black patients less effectively than in non‑black patients.

Other medicines and Captopril Actavis

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 Captopril Actavis” and “Warnings and precautions”).

Captopril may reduce the bodys excreation of potassium. You must therefore consult your doctor before using potassium containing supplements or potassium salts.

The following medications can increase the effect of captopril:

- diuretics

- vasodilators (widens the blood vessels)

- antidepressants / antipsychotics

- other anti-hypertensive agents

The following medications can reduce the effect of captopril:

- non-steroidal anti-inflammatory drugs (pain relievers)

- sympathicomimetics (working on the central nervous system)

Administration of captopril with the following medications can cause the following effects:

- lithium: raised serum levels

- allopurinol, cytostatics (cancer therapy) or immunosuppressants (reduces the immune system used after e.g. organ-transplantations), or procainamide: increased risk of leucopoenia (reduction of the white blood cells) resulting from the use of these drugs

- non-steroidal anti-inflammatory drugs: raised serum potassium and reduced kidney function

- anti-diabetics: increase in the blood-sugar reducing effect of oral anti-diabetics or insulin

Captropril Actavis with food and drink

Captopril Actavis can be taken before, during or 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 or pharmacist for advice before taking this medicine.

Pregnancy

Your doctor will normally advise you to stop taking Captopril Actavis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Captopril Actavis. Captopril Actavis 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

Breast-feeding newborn babies (first few weeks after birth), and especially premature babies, is not recommended whilst taking Captopril Actavis.

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

Driving and using machines

Your ability to drive or use machines may be reduced, mainly at the start of treatment, or while the medication is being adjusted. Combination with alcohol may also reduce your ability to drive or use machines. How you may be affected will depend on your susceptibility and may be different from how someone else reacts.

Captopril Actavis contains lactose

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

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

General recommendations: Your doctor will adjust your dose to one that is ideal for you. The maximum recommended dose is 150mg a day. The usual dosage(s) are:

- High blood pressure: 12.5-25 mg two times a day. If needed the dosage may be increased to 100-150 mg a day divided in 2 doses.

- Heart failure: 6.25-12.5 mg two or three times a day. Your doctor can if needed increase your dose at regular intervals up to 75-150 mg a day divided in two or three doses.

- Heart attack: 6.25 mg, which your doctor may increase up to a maximum of 150 mg a day divided in several doses.

- Kidney disease in diabetics: 75-100 mg divided in several doses.

Elderly and patients with reduced kidney function may start with a lower dose.

Use in children and adolescents

For Children and adolescents the usual starting dose is 0.3 mg per kg of body-weight. For premature and new-borns the starting dose is 0.15 mg per kg of body-weight.

Speak to your doctor if you feel that Captopril Actavis is too strong or too weak for you.

If you take more Captopril Actavis than you should

If you take more tablets than you should, contact your doctor or your nearest hospital casualty department immediately. Symptoms of overdose is low blood pressure (faintness on standing), shock, lack of energy, slow pulse rate, electrolyte disturbance and renal failure.

If you forget to take Captopril Actavis

If you forget to take a tablet take one as soon as you remember, unless it is nearly the time to take the next one. Do not take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time. Always check with 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 Actavis and contact your doctor immediately:

Uncommon (may affect up to 1 in 100 people):

- Swelling of the face, lips, throat or tongue, difficulties swallowing and breathing, (angioedema)

- Racing or irregular heartbeat

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

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

- Difficulty in breathing, narrowing of the airways

- Unexpected rash or burning, blistering, red or peeling skin (erythema multiforme)

- Life-threatening allergic reactions with blistering of the skin, mouth, eyes and genitals (Stevens Johnson syndrome)

- Severe abdominal and back pain with simultaneous strong general feeling of sickness and nausea (pancreatitis)

Other side effects may include:

Common (may affect up to 1 in 10 people):

- Sleep disorders, loss of taste, dizziness

- Dry irritative (unproductive) cough, shortness of breath

- Nausea, vomiting, gastric irritation, stomach pain, diarrhoea, constipation, dry mouth

- Itching skin reaction, rash and hair loss.

Uncommon (may affect up to 1 in 100 people):

- Chest pain, irregular or strong heartbeat (palpitations), low blood pressure, redness, paleness, cold hands and feet, tiredness, discomfort.

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

- Loss of appetite, drowsiness, headache, feelings of numbness or tingling, inflammation of the mouth/mouth ulcers

- Changes in renal function, including kidney failure, increased or decreased frequency and amount of urination.

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

- Anaemia, changes in numbers of blood cells, increased level of potassium in the blood, decreased level of sodium in the blood, low blood sugar, brain haemorrage including stroke and fainting.

- Swollen glands in the neck, armpit or groin (lymphadenopathy), auto-immune diseases

- Confusion and depression

- Blurred vision, cardiac arrest, or severely reduced heart function

- Running nose, allergic lung inflammation, inflammation of the tongue, stomach ulcer.

- Itchy skin, sensitivity to light, and flaking eczema, muscular and joint pain

- Kidney disease with increased level of albumin in the urine

- Impotence, enlarged breasts in men, fever.

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Captopril Actavis

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

Keep the tablets stored below 25°C

Do not use this medicine after the expiry date which is stated on the carton. 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 Actavis contains

• The active substance is Captopril

• The other ingredients are lactose monohydrate, pre-gelatinised starch, microcrystalline cellulose and stearic acid

What Captopril Actavis looks like and contents of the pack

25 mg tablet: The tablets are white, round, flat 8 mm tablets scored on one side.

50 mg tablet: The tablets are white, round, flat 10 mm tablets scored on one side.

25 mg tablet pack sizes: 30, 100 and 200 tablets.

50 mg tablet pack sizes: 30, 100 and 200 tablets.

Please note that not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

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

Denmark: Captopril Actavis

Sweden: Captopril Actavis

Norway: Captopril Actavis

This leaflet was last revised in

2015-04-17