Clopidogrel 75 mg. 30 tablets ACCORD

WHAT CLOPIDOGREL ACCORD AND WHAT IT IS USED
Clopidogrel Accord belongs to the group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood, smaller than red or white blood cells, which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the risk of blood clots forming (a process called thrombosis).
Clopidogrel Accord is taken to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).

You have been prescribed Clopidogrel Accord to prevent blood clots and reduce the risk of these severe events because:
You have a condition of hardening of arteries (also known as atherosclerosis), or;
You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or;
You have experienced severe chest pain known as 'unstable angina' or 'myocardial infarction' (heart attack). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. You may be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, and prevent blood clotting) by your doctor;
You irregular heartbeat, a condition called "atrial fibrillation" and you can not take medicines known as 'oral anticoagulants' (vitamin K antagonists) which prevent the formation and growth of blood clots. You should know that oral anticoagulants are more effective than acetylsalicylic acid or the combined use of clopidogrel plus aspirin Accord in this condition. Your doctor should prescribe Accord Clopidogrel plus aspirin if you can not take 'oral anticoagulants' and you no risk of major bleeding.

2. BEFORE YOU TAKE CLOPIDOGREL ACCORD
Do not take Clopidogrel Accord:
If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of Clopidogrel Accord;
If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding in the brain;
If you suffer from severe liver disease.
If you think any of these conditions apply to you, or have any doubts, consult your doctor before taking Clopidogrel Accord.

Take special care with Clopidogrel Accord
If any of the following situations apply to you, you should tell your doctor before taking Clopidogrel Accord:
if you have a risk of bleeding such as:
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);
recent serious injury;
recent surgery (including dental);
planned surgery (including dental) in the next seven days;
if you have had a clot in the cerebral artery (ischemic stroke) which occurred within the last seven days;
if you have kidney or liver disease.
During clopidogrel Accord
You should tell your doctor if a surgery (including dental).
Must also immediately inform your doctor if you develop a medical condition (also known as thrombotic thrombocytopenic purpura (TTP)), which 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 "Possible side effects").
If you cut or injure yourself, it may take a little longer than usual to stop bleeding. This is related to the mode of action of the drug prevents the formation of blood clots. For minor cuts and injuries eg, cutting yourself, shaving, this is irrelevant. However, if the bleeding you are worried, you should contact your doctor straightaway (see "Possible side effects").
Your doctor may order blood tests.
Clopidogrel Accord is not intended for use by children and adolescents.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently other medicines, including medicines obtained without a prescription.

Some other medicines may influence the use of Clopidogrel Accord or vice versa.
Especially you should tell your doctor if you take:
oral anticoagulants (medicines used to reduce blood clotting);
nonsteroidal anti-inflammatory drug commonly used to treat painful and / or inflammatory conditions of muscles or joints;
heparin or any other medicine used to reduce blood clotting;
omeprazole, esomeprazole or cimetidine (a medicine to treat stomach problems);
fluconazole varikonazol, ciprofloxacin, or chloramphenicol (medicines for treating bacterial and fungal infections);
fluoxetine, fluvoxamine, or moclobemide (medicine for depression);
carbamazepine or oxcarbazepine (medicines for some forms of epilepsy);
ticlopidine (another antiplatelet agent).
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Clopidogrel Accord in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever. An occasional use of acetylsalicylic acid (no more than 1000 mg per 24 hours) would not be a problem, but prolonged use in other circumstances should be discussed with your doctor.

Taking Clopidogrel Accord with food and drink
Accord Clopidogrel can be taken with or without food.

Pregnancy and lactation
It is preferable not to take this medicine during pregnancy.
If you are pregnant or suspect that you are pregnant, you should tell your doctor or pharmacist before taking Clopidogrel Accord. If you become pregnant while taking Clopidogrel Accord immediately consult your doctor as clopidogrel during pregnancy is not recommended.
You should not breast-feed while taking this medicine.
If you are breastfeeding or plan to breastfeed, talk to your doctor before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Clopidogrel Accord is unlikely to affect your ability to drive or use machines.

Important information about some of the ingredients of Clopidogrel Accord
Clopidogrel Accord contains lactose. If you have been told by your doctor that you have intolerance to some sugars (eg. Lactose), contact before taking this medicine.

Clopidogrel Accord also contains hydrogenated castor oil which may cause stomach upset or diarrhea.

3. HOW TO ACCORD taking clopidogrel
Always take Clopidogrel Accord just as you have been told your doctor. If you are not sure, ask your doctor or pharmacist.
If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg Clopidogrel Accord (4 tablets of 75 mg) once at the beginning of treatment. Then, the usual dose is one tablet of 75 mg clopidogrel per day to be taken orally with or without food, and at the same time each day.
You should take medicine as your doctor prescribes it.

If you take more Clopidogrel Accord
Contact your doctor immediately or go to the nearest hospital because of the increased risk of bleeding.

If you forget to take Clopidogrel Accord
If you forget to take a dose of Clopidogrel Accord, but remember within 12 hours of your usual time, take your tablet on and then take the next one at the usual time.
If you forget to take a dose of more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for forgotten individual doses.

If you stop taking Clopidogrel Accord
Do not stop treatment unless your doctor tells you. Contact your doctor or pharmacist before you do.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, Clopidogrel Accord can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention:
very common (affects more than 1 user in 10);
Common (affects 1 to 10 users in 100);
Uncommon (affects 1 to 10 users in 1,000);
rare (affects 1 to 10 users in 10,000);
very rare (affects less than 1 user in 10,000);
not known (frequency assessment can not be made from the available data).
Tell your doctor immediately if you have:
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 eyes (zhaltenitsa), whether or not associated with bleeding which appear as red pinpoint dots and / or confusion (see "Take special care with Clopidogrel Accord" );
swelling of the mouth or skin disorders such as rashes and itching, blisters on the skin. These may be symptoms of an allergic reaction.
The most commonly reported side effect with clopidogrel is bleeding Accord.
Bleeding may occur as bleeding in the stomach or bowels, bruising, hematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine. In a small number of cases have also been reported bleeding in the eye, head, lungs or joints.

If you experience prolonged bleeding when taking Clopidogrel Accord
If you cut or injure yourself, it may take a little longer than usual to stop bleeding. This is related to the mode of action of the drug prevents the formation of blood clots. For minor cuts and injuries eg, cutting yourself, shaving, this is irrelevant. However, if the bleeding you are worried, you should contact your doctor straightaway (see 'Take special care with Clopidogrel Accord ").

Other side effects reported with Clopidogrel Accord
Common side effects: Diarrhoea, abdominal pain, indigestion or heartburn.

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

Rare side effects: Dizziness.

Very rare side effects: jaundice, abdominal pain with or without back pain, fever, breathing difficulties sometimes associated with cough, generalized allergic reactions, swelling of the mouth, skin blisters, allergic skin reactions, inflammation of the mouth (stomatitis) , lowering blood pressure, confusion, hallucinations, joint pain, muscle pain, taste disturbance.

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

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE CLOPIDOGREL ACCORD
Keep out of reach of children.
Do not use Clopidogrel Accord after the expiry date stated on the carton and blister.
This medicinal product does not require any special storage conditions.
Do not use Clopidogrel Accord if you notice any visible sign of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Clopidogrel Accord
The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulphate).

Other ingredients are:
Tablet core: Lactose anhydrous, low substituted hidroksilpropil cellulose, hydroxypropyl cellulose, microcrystalline cellulose (PH 112) (E460), hydrogenated castor oil, colloidal silicon dioxide (E551).

Film-coating: triacetin (E1518), red iron oxide (E172), hypromellose (E464), titanium dioxide (E171), lactose monohydrate.