PLAVIX 300 mg. 10 tablets
Plavix contains clopidogrel 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, antiplatelet medicinal products reduce the risk of blood clots forming (a process called thrombosis).
Plavix is taken from adult patients to prevent blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Plavix is prescribed 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);
You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease;
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 should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to 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 Plavix plus acetylsalicylic acid for this condition. Your doctor should prescribe Plavix plus acetylsalicylic acid if you can not take 'oral anticoagulants' and you no risk of major bleeding.
2. What you need to know before taking Plavix
Do not take Plavix:
If you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6);
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 think any of these apply to you, or you have any doubts, consult your doctor before taking Plavix.
Warnings and Precautions
If any of the following conditions apply to you, you should tell your doctor before taking Plavix:
if you are at risk of bleeding such as:
disease puts you at risk of internal bleeding (such as a stomach ulcer);
a blood disorder that predisposes to internal bleeding (bleeding in the tissues, organs or joints of your body);
recent serious injury;
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 (ischemic stroke) occurred within the last seven days;
if you have kidney or liver disease;
if you have an allergy or reaction to any of the drugs used to treat your disease.
While taking Plavix:
You should tell your doctor if a surgery (including dental);
You should also immediately inform your doctor if you develop a medical condition (also 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 "Possible side effects");
If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is related to the mode of action of the drug to prevent 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 immediately (see section 4 "Possible side effects");
Your doctor may order blood tests.
Children and adolescents
Do not give this medicine to children because there is no effect.
Other medications and Plavix
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Some medicines may influence the use of Plavix or vice versa.
You should tell your doctor if you take:
oral anticoagulants, medicines used to reduce blood clotting;
nonsteroidal anti-inflammatory drugs commonly used for the treatment of painful and / or inflammatory conditions of the muscles or joints;
heparin or other injectable medicines used to reduce blood clotting;
omeprazole, esomeprazole or cimetidine, medicines used to treat stomach upset;
fluconazole, voriconazole, ciprofloxacin, or chloramphenicol, medicines for the treatment of bacterial and fungal infections;
fluoxetine, fluvoxamine, or moclobemide, medicines for the treatment of depression;
carbamazepine or oxcarbazepine, medicines to treat some forms of epilepsy;
ticlopidine, other antiplatelet agent.
If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed Plavix 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.
Plavix with food and drink
Plavix may be taken with or without food.
Pregnancy and lactation
It is preferable not to take this medicine during pregnancy.
If you are pregnant or think you may be pregnant, you should tell your doctor or pharmacist before taking Plavix. If you become pregnant while taking Plavix, immediately consult your doctor, because it is not recommended for use clopidogrel during pregnancy.
You should not breast-feed while taking this medicine.
If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medicine.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Plavix is unlikely to affect your ability to drive or operate machinery.
Plavix contains lactose
If your doctor has told you that you have an intolerance to some sugars (eg. Lactose), contact him before taking this medicine.
Plavix contains hydrogenated castor oil
This can cause stomach upset or diarrhea.
3. How to take Plavix
Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
If you have experienced severe chest pain (unstable stenokardiya or heart attack), your doctor may give you 300 mg Plavix (1 tablet of 300 mg or 4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one tablet of 75 mg Plavix per day to be taken orally with or without food, and at the same time each day.
You should take Plavix, as long as your doctor prescribes it for you.
If you take more dose Plavix
Contact your doctor or go to the emergency department at the nearest hospital because of the increased risk of bleeding.
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.
Tell your doctor immediately if you experience:
fever, signs of infection or excessive fatigue. This may be due to a decrease of some blood cells, which is rare;
signs of liver problems such as yellowing of the skin and / or eyes (jaundice), whether or not associated with bleeding which appears as small red dots and / or confusion (see section 2 "Warnings and Precautions");
swelling of the mouth or skin disorders such as rashes and itching, blisters of the skin. These may be symptoms of an allergic reaction.
The most frequently reported adverse reaction with Plavix is bleeding. 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, lung or joints.
If you experience prolonged bleeding when taking Plavix
If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is related to the mode of action of the drug to prevent 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 immediately (see section 2 "Warnings and precautions").
Other side effects include:
Common side effects (may affect up to 1 in 10 people):
Diarrhea, 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 the stomach or intestines, rashes, itching, dizziness, numbness and tingling.
Rare side effects (may affect up to 1 in 1000 people):
Very rare side effects (may affect up to 1 in 10,000 people):
jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalized allergic reactions (eg, a general feeling of warmth with a sudden malaise fainting); swelling of the mouth; blisters of the skin; Allergic skin reactions; inflammation of the mouth (stomatitis); lowering blood pressure; confusion; hallucinations; joint pain; muscle pain; change in the taste of food.
In addition, your doctor may identify changes in your blood or urine.
Adverse event reporting
If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet. You can also report adverse events directly through the national reporting system. As reported adverse reactions, you can do your bit to get more information on the safety of this medicine.
5. How to store Plavix
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not use this medicine if you notice any visible sign of deterioration.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Plavix contains
The active substance is clopidogrel. Each tablet contains 300 mg of clopidogrel (as hydrogen sulphate).
The other ingredients are (see section 2 "Plavix contains lactose" and "Plavix contains hydrogenated castor oil"):
Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose;
Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172) and titanium dioxide (E 171);
Polishing agent: carnauba wax.
What Plavix looks like and contents of the pack
Plavix 300 mg film-coated tablets are oblong, pink, engraved with the number "300" on one side and the number "1332" on the other side. Plavix is available in cartons containing 4 x 1, 10 x 1, 30 x 1 and 100 x 1 tablets in aluminum perforated unit dose blisters.
Not all pack sizes may be marketed.