Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover) - patient leaflet, side effects, dosage

1. What Clopidogrel/Acetylsalicylic acid Zentiva is and what it is used for

Clopidogrel/A­cetylsalicylic acid Zentiva contains clopidogrel and acetylsalicylic acid (ASA) and belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood which clump together during blood clotting. By preventing this clumping in some types of blood vessels (called arteries), antiplatelet medicinal products reduce the chances of blood clots forming (a process called atherothrombosis).

Clopidogrel/A­cetylsalicylic acid Zentiva is taken by adults to prevent blood clots forming in hardened arteries which can lead to atherothrombotic events (such as stroke, heart attack, or death).

You have been prescribed Clopidogrel/A­cetylsalicylic acid Zentiva in place of the two separate medicines, clopidogrel and ASA, to help prevent blood clots because you have experienced a severe type of chest pain known as ‘unstable angina’ or heart attack (myocardial infarction). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow.

2. What you need to know before you take Clopidogrel/Acetylsalicylic acid Zentiva

Do not take Clopidogrel/A­cetylsalicylic acid Zentiva

• if you are allergic to clopidogrel, acetylsalicylic acid (ASA) or any of the other ingredients of

this medicine (listed in section 6).

• if you are allergic to other products called non-steroidal anti-inflammatory products usually used

to treat painful and/or inflammatory conditions of muscles or joints.

• if you have a medical condition that includes the combination of asthma, nasal discharge (runny

nose) and polyps (a type of growth in the nose).

• if you have a medical condition that is currently causing bleeding such as a stomach ulcer or

bleeding within the brain.

• if you suffer from severe liver disease.
• if you suffer from severe kidney disease.
• if you are in your last trimester of pregnancy.

Warnings and precautions

If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel/A­cetylsalicylic acid Zentiva:

• if you have a risk of bleeding such as:

• – a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).

• – a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).

• – a recent serious injury.

• – a recent surgery (including dental).

• – a planned surgery (including dental) in the next seven days.

• if you have had a clot in an artery of your brain (ischaemic stroke) which occurred in the last seven days.
• if you have kidney or liver disease.
• if you have a history of asthma or allergic reactions including allergy to any medicine used to treat your disease.
• if you have gout.
• if you drink alcohol, because of the increased risk of bleeding or gastrointestinal injury.
• if you have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency because of the risk of a particular form of anaemia (low number of red blood cells).

While you are taking Clopidogrel/A­cetylsalicylic acid Zentiva:

• You should tell your doctor

• – if a surgery (including dental) is planned.

• – if you have any stomach or abdominal pain or bleeding in the stomach or bowels (red stools or black stools).

• You should also tell your doctor immediately if you develop a medical condition known as Thrombotic Thrombocytopenic Purpura or TTP that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4).
• If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to

the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects’).

• Your doctor may order blood tests.

Children and adolescents

Clopidogrel/A­cetylsalicylic acid Zentiva is not intended for use in children or adolescents less than 18 years of age. There is a possible association between acetylsalicylic acid (ASA) and Reye’s Syndrome when products containing ASA are given to children or adolescents with a viral infection. Reye’s Syndrome is a very rare disease which can be fatal.

Other medicines and Clopidogrel/A­cetylsalicylic acid Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some other medicines may influence the use of Clopidogrel/A­cetylsalicylic acid Zentiva or vice versa.

You should specifically tell your doctor if you take

• medicines that may increase your risk of bleeding such as:

• – oral anticoagulants, medicines used to reduce blood clotting,

• – ASA or another non-steroidal anti-inflammatory medicine usually used to treat painful and/or inflammatory conditions of muscle or joints,

• – heparin or any other injectable medicine used to reduce blood clotting,

• – ticlopidine, other antiplatelet agent,

• – a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,

• omeprazole or esomeprazole, medicines to treat upset stomach,
• methotrexate, a medicine used to treat severe joint disease (rheumatoid arthritis) or skin disease (psoriasis),
• acetazolamide, a medicine used to treat glaucoma (increased ocular pressure) or epilepsy or to increase urine flow,
• probenecid, benzbromarone, or sulfinpyrazone, medicines used to treat gout,
• fluconazole or voriconazole, medicines to treat fungal infections,
• efavirenz or tenofovir, medicines to treat HIV (human immunodeficiency virus) infections,
• valproic acid, valproate or carbamazepine, medicines to treat some forms of epilepsy,
• the varicella vaccine, a medicine used to prevent chickenpox or shingles, within 6 weeks of

taking Clopidogrel/A­cetylsalicylic acid Zentiva, or if you have active chickenpox or shingles infection (see section 2 ‘Children and adolescents’),

• moclobemide, medicine to treat depression,
• repaglinide, medicine to treat diabetes,
• paclitaxel, medicine to treat cancer,
• nicorandil, medicine to treat cardiac chest pain,
• opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioids treatment.

You should stop other clopidogrel treatment while you are taking Clopidogrel/A­cetylsalicylic acid Zentiva.

An occasional use of ASA (no more than 1,000 mg in any 24-hour period) should generally not cause a problem, but prolonged use of ASA in other circumstances should be discussed with your doctor or pharmacist.

Pregnancy and breast-feeding

Do not take Clopidogrel/A­cetylsalicylic acid Zentiva during third trimester of pregnancy.

It is preferable not to take this medicine during first and second trimesters of pregnancy.

If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel/A­cetylsalicylic acid Zentiva. If you become pregnant while taking Clopidogrel/A­cetylsalicylic acid Zentiva, consult your doctor immediately as it is recommended not to take Clopidogrel/A­cetylsalicylic acid Zentiva while you are pregnant.

You should not breast-feed while using this medicine.

If you are breast-feeding or planning to breast-feed, talk to your doctor before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Clopidogrel/A­cetylsalicylic acid Zentiva should not affect your ability to drive or to use machines.

Clopidogrel/A­cetylsalicylic acid Zentiva contains lactose

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.

Clopidogrel/A­cetylsalicylic acid Zentiva contains hydrogenated castor oil

This may cause stomach upset or diarrhoea.

3. How to take Clopidogrel/Acetylsalicylic acid Zentiva

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

The recommended dose is one tablet of Clopidogrel/A­cetylsalicylic acid Zentiva per day to be taken orally with a glass of water, with or without food.

You should take your medicine at the same time each day.

Depending on your condition, your doctor will determine the length of time for which you need to take Clopidogrel/A­cetylsalicylic acid Zentiva. If you have had a heart attack, it should be prescribed for at least four weeks. In any case, you should take it for as long as your doctor continues to prescribe it.

If you take more Clopidogrel/A­cetylsalicylic acid Zentiva than you should

Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.

If you forget to take Clopidogrel/A­cetylsalicylic acid Zentiva

If you forget to take a dose of Clopidogrel/A­cetylsalicylic acid Zentiva, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.

If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

For the 14, 28 and 84 tablets pack sizes you can check the day on which you last took a tablet of Clopidogrel/A­cetylsalicylic acid Zentiva by referring to the calendar printed on the blister.

If you stop taking Clopidogrel/A­cetylsalicylic acid Zentiva

Do not stop the treatment unless your doctor tells you so. Contact your doctor before stopping or restarting your treatment.

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.

Contact your doctor immediately if you experience:

• fever, signs of infection or extreme tiredness. These may be due to rare decrease of some blood cells.
• signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots, and/or confusion (see section 2 ‘Warnings and precautions’).
• swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin. These may be the signs of an allergic reaction.

The most common side effect which has been seen with Clopidogrel/A­cetylsalicylic acid Zentiva is bleeding. Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine. In a small number of cases, bleeding in the eye, inside the head (especially in elderly), the lung or the joints has also been reported.

If you experience prolonged bleeding when taking Clopidogrel/A­cetylsalicylic acid Zentiva

If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions’).

Other side effects include:

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

Diarrhoea, abdominal pain, indigestion or heartburn.

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

Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.

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

Vertigo, enlarged breasts in males.

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

Jaundice (yellowing of skin and/or eyes); burning in stomach and/or esophagus (gullet); severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste or loss of taste of foods, inflammation of small vessels.

Side effects with frequency not known (frequency cannot be estimated from the available data) : Ulcer perforation, ringing in the ears, hearing loss, sudden life-threatening allergic or hypersensitivity reactions with chest or abdominal pain, kidney disease, low blood sugar, gout (a condition of painful, swollen joints caused by uric acid crystals) and worsening of food allergies, a particular form of anaemia (low number of red blood cells) (see section 2 ‘Warnings and precautions’), swelling.

In addition, your doctor may identify changes in your blood or urine tests.

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 Clopidogrel/Acetylsalicylic acid Zentiva

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 on the blister, after EXP. The expiry date refers to the last day of that month.

Store below 25°C.

Do not use this medicine if you notice any visible sign of deterioration.

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 to protect the environment.

6. Contents of the pack and other information

What Clopidogrel/A­cetylsalicylic acid Zentiva contains

Clopidogrel/A­cetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets

The active substances are clopidogrel and acetylsalicylic acid (ASA). Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 75 mg of acetylsalicylic a­cid.

The other ingredients are:

• – Tablet core: mannitol (E421), macrogol 6000, microcrystalline cellulose, low substituted

hydroxypropyl­cellulose, maize starch, hydrogenated castor oil (see section 2

‘Clopidogrel/A­cetylsalicylic acid Zentiva contains hydrogenated castor oil’), stearic acid and colloidal anhydrous silica

• – Tablet coating: lactose monohydrate (see section 2 ‘Clopidogrel/A­cetylsalicylic acid Zentiva

contains lactose’), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), yellow iron oxide (E172)

• – Polishing agent: carnauba wax

Clopidogrel/A­cetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets

The active substances are clopidogrel and acetylsalicylic acid (ASA). Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate) and 100 mg of acetylsalicylic a­cid.

The other ingredients are:

• – Tablet core: mannitol (E421), macrogol 6000, microcrystalline cellulose, low substituted hydroxypropyl­cellulose, maize starch, hydrogenated castor oil (see section 2

‘Clopidogrel/A­cetylsalicylic acid Zentiva contains hydrogenated castor oil’), stearic acid and colloidal anhydrous silica

• – Tablet coating: lactose monohydrate (see section 2 ‘Clopidogrel/A­cetylsalicylic acid Zentiva contains lactose’), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172)

• – Polishing agent: carnauba wax

What Clopidogrel/Acetylsalicylic acid Zentiva looks like and contents of the pack

Clopidogrel/A­cetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets

Clopidogrel/A­cetylsalicylic acid Zentiva 75 mg/75 mg film-coated tablets (tablets) are oval, slightly biconvex, yellow, engraved on one side with ‘C75’ and ‘A75’on the other side.

Clopidogrel/A­cetylsalicylic acid Zentiva is supplied in cardboard cartons containing:

• – 14, 28, 30 and 84 tablets in all-aluminium blisters

• – 30×1, 50×1, 90×1 and 100×1 tablet in all-aluminium perforated unit-dose blisters.

Clopidogrel/A­cetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets

Clopidogrel/A­cetylsalicylic acid Zentiva 75 mg/100 mg film-coated tablets (tablets) are oval, slightly biconvex, light pink, engraved on one side with ‘C75’ and ‘A100’on the other side.

Clopidogrel/A­cetylsalicylic acid Zentiva is supplied in cardboard cartons containing:

• – 14, 28 and 84 tablets in all-aluminium blisters

• – 30×1, 50×1, 90×1 and 100×1 tablet in all-aluminium perforated unit-dose blisters.