75 mg film-coated tablets
clopidogrel
What Plavix is and what it is used for
Plavix contains clopidogrel and belongs to a group of medicines called platelet inhibitors. Platelets are very small cells in the blood, which form clots (clots) during coagulation of the blood (blood clotting). By preventing this clot formation, platelet inhibitors reduce the risk of blood clots forming (a process called thrombosis or blood clot formation).
Plavix is used by adults to prevent the formation of blood clots ( thrombi ) in atherosclerotic blood vessels ( arteries ), a process called atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
You have been given Plavix to prevent the formation of blood clots and to reduce the risk of these serious events due to:
- You suffer from atherosclerosis (also known as atherosclerosis), and
- You have previously had a heart attack, stroke, or are suffering from something called peripheral arterial disease, or
- You have had severe angina ( unstable angina ) or a heart attack (heart attack). To treat this condition, your doctor may have placed a stent in the blocked or narrowed blood vessel to restore effective blood flow. You can also get acetylsalicylic acid (a substance found in many medicines used to relieve pain and lower fever and in addition to prevent the formation of blood clots) by your doctor.
- You have had signs of a stroke that disappears within a shorter period (also called a transient ischemic attack, TIA attack/mini-stroke) or a mild ischemic stroke. You can also get acetylsalicylic acid from your doctor within the first 24 hours.
- You have an irregular heartbeat, something called atrial fibrillation, and you can not take blood-thinning drugs that are taken orally (vitamin K antagonists ) that prevent new blood clots from forming and prevent existing blood clots from growing. You should have learned that blood-thinning drugs taken orally are more effective than acetylsalicylic acid or the combination of Plavix and acetylsalicylic acid for this disease. Your doctor should have given you Plavix and acetylsalicylic acid if you can not take blood-thinning medicines orally and you are not at risk of heavy bleeding.
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 suffer from any disease that causes you to have active bleeding, such as. gastric ulcer or bleeding in the brain
- If you suffer from severe liver disease
If you have any of these symptoms or if you have any further questions, ask your doctor before taking Plavix.
Warnings and cautions
If any of the following apply to you, you should inform your doctor before taking Plavix:
- if you are at risk of bleeding such as:
- a disease that puts you at risk for internal bleeding (such as stomach ulcers )
- a blood disease that puts you at risk of internal bleeding (in the body’s tissues, organs, or joints)
- a recent serious injury
- a recent surgery (including dental surgery)
- a planned operation (including dental operations) within the next week
- if you have had a blockage in an artery in your brain (ischemic stroke ) that occurred within the last week
- if you suffer from kidney or liver disease
- if you have had an allergy or reaction to other medicines to treat your illness
- if you have previously had non-traumatic cerebral hemorrhage (ie not caused by external influences such as severe violence to the head)
While taking Plavix:
- You should inform your doctor if surgery (including dental surgery) is planned.
- You should also inform your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may occur as red pin-sized dots, with or without unexplained severe weakness, 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 the bleeding to stop. This is linked to how your medicine works because it prevents the formation of blood clots. This normally has no significance for minor cuts and injuries such as. if you cut yourself when shaving. However, if you are concerned about your bleeding, contact your doctor immediately (see section 4 “Possible side effects”).
- Your doctor may order blood tests.
Children and young people
Do not give this medicine to children as it will not help.
Other medicines 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 other medicines may affect the use of Plavix or vice versa.
You must tell your doctor if you are taking
- medicines that may increase your risk of bleeding such as:
- blood-thinning drugs taken orally, drugs used to reduce the formation of blood clots
- non-steroidal anti-inflammatory drugs ( NSAIDs ), commonly used to treat painful and/or inflammatory conditions in muscles and joints
- heparin or any other drug that is injected to reduce the formation of blood clots
- ticlopidine, another antiplatelet agent
- selective serotonin reuptake inhibitors (including but not limited to fluoxetine or fluvoxamine), medicines commonly used to treat depression
- rifampicin (used to treat severe infections )
- omeprazole or esomeprazole, medicines used to treat stomach problems
- fluconazole or voriconazole, medicines used to treat fungal infections
- efavirenz or other antiretroviral medicines (used to treat HIV (human immunodeficiency virus) infections )
- carbamazepine, a drug used to treat various forms of epilepsy
- moclobemide, a medicine used to treat depression
- repaglinide, a medicine used to treat diabetes
- paclitaxel, a medicine used to treat cancer
- opioids: when you are being treated with clopidogrel, you should inform your doctor before receiving opioids ( used to treat severe pain)
- rosuvastatin (used to lower your cholesterol).
If you have had severe chest pain ( unstable angina or heart attack), transient ischemic attack ( TIA attack/mini-stroke), or mild ischemic stroke, you can be prescribed Plavix in combination with acetylsalicylic acid, a substance found in many medicines used to treat relieve pain and lower fever. Temporary use of acetylsalicylic acid (not more than 1000 mg for 24 hours) is not generally considered a problem, but long-term use in other conditions should be discussed with your doctor.
Plavix with food and drink
Plavix can be taken with or without food.
Pregnancy and breastfeeding
This medicine should preferably not be taken during pregnancy.
If you are pregnant or think you may be pregnant, tell your doctor or pharmacist before taking Plavix. If you become pregnant while taking Plavix, contact your doctor immediately as it is not recommended to take clopidogrel during pregnancy.
You should not breastfeed 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 for advice before taking any medicine.
Driving and using machines
Plavix is unlikely to affect your ability to drive or use machines.
Plavix contains lactose
If you have been told by your doctor that you have an intolerance to some sugars (eg lactose ), contact your doctor before taking this medicine.
Plavix contains hydrogenated castor oil
This may cause stomach upset or diarrhea.
How to take Plavix
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose, including for patients with a condition called atrial fibrillation (irregular heartbeat), is a 75 mg tablet of Plavix per day taken orally, with or without food, and at the same time each day.
If you have had severe chest pain ( unstable angina or heart attack), your doctor may give you Plavix 300 mg or 600 mg (one or two tablets of 300 mg or 4 or 8 tablets of 75 mg) to start treatment. After this, the recommended dose is 75 mg of Plavix per day as described above.
If you have had a sign of a stroke that disappears within a short period (also called a transient ischemic attack, TIA attack/mini-stroke) or a mild ischemic stroke, your doctor may give you Plavix 300 mg (1 tablet of 300 mg or 4 tablets of 75 mg) as a starting dose. Thereafter, the recommended dose is one tablet of Plavix 75 mg daily together with acetylsalicylic acid for 3 weeks, as described above.
After that, your doctor may prescribe either Plavix alone or acetylsalicylic acid only.
You should take Plavix for as long as your doctor prescribes it.
If you take more Plavix than you should
Contact your doctor or the nearest hospital emergency department due to the increased risk of bleeding.
If you forget to take Plavix
If you forget to take a dose of Plavix and discover it within 12 hours, take the tablet as soon as you notice and take the next tablet at the usual time.
If it takes more than 12 hours before you discover it, simply take the next daily dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
For pack sizes of 7, 14, 28, and 84 tablets, you can check which day you last took a Plavix tablet by looking at the calendar printed on the pack.
If you stop taking Plavix
Do not stop treatment unless your doctor tells you to. Contact a doctor or pharmacist before stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you have:
- fever, signs of infection, or severe weakness. This may be due to a rare decrease in certain blood cells.
- signs of liver problems such as yellowing of the skin and/or eyes (jaundice), with or without concomitant small punctate hemorrhages under the skin (visible as red dots), and/or confusion (see section 2 “Warnings and precautions”).
- swelling of the mouth or skin problems such as rash and itching, blisters on the skin. This may be a sign of an allergic reaction.
The most common side effect reported with Plavix is bleeding. Bleeding can occur as bleeding in the stomach or intestines, bruising, hematoma (unusual bleeding or bruising under the skin), nosebleeds, and blood in the urine. In a few cases, bleeding in the eye, and internal bleeding in the head, lungs, or joints have also been reported.
If you experience prolonged bleeding while taking Plavix
If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is linked to how your medicine works because it prevents the formation of blood clots. This normally has no significance for minor cuts and injuries such as. if you cut yourself when shaving. However, if you are concerned about your bleeding, 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, increased gas in the stomach or intestines, rash, itching, dizziness, tingling, and numbness.
Rare side effects (may affect up to 1 in 1,000 people): Dizziness, enlarged breasts in men.
Very rare side effects (may affect up to 1 in 10,000 patients): Jaundice, severe abdominal pain with or without back pain, fever, difficulty breathing sometimes with cough, generalized (widespread) allergic reactions (eg a feeling of heat with sudden discomfort until fainting), swelling in the mouth, blisters on the skin, skin allergy, mouth pain ( stomatitis ), decrease in blood pressure, confusion, hallucinations, joint pain, muscle aches, taste changes, loss of taste.
Adverse reactions that have been reported (occurring in an unknown number of users):
Hypersensitivity reaction you with chest pain or abdominal pain, signs of persistent low blood sugar.
In addition, your doctor may detect changes in your blood or urine tests.
How to store Plavix
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
The expiration date is the last day of the specified month.
See storage instructions on the box.
Store below 30 ° C if Plavix is sold in PVC / PVDC / aluminum blisters.
No special storage instructions for Plavix are sold in blisters made of aluminum only.
Do not use this medicine if you notice any visible signs 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.
Contents of the pack and other information
Content declaration
The active substance is clopidogrel. Each tablet contains 75 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 (E171)
- Polish: carnauba wax.
What the medicine looks like and the contents of the pack
Plavix 75 mg film-coated tablets are round, biconvex, pink, and marked with the number “75” on one side and the number “1171” on the other side. Plavix is sold in packages (cardboard boxes) that contain:
- 7, 14, 28, 30, 84, 90 and 100 tablets in blisters of PVC / PVDC / aluminum or just aluminum
- 50×1 tablets in single-dose blisters of PVC / PVDC / aluminum or just aluminum.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder :
sanofi-aventis groupe
54, rue La Boétie – F-75008 Paris – France
Manufacturers:
Sanofi Winthrop Industrie
1, Rue de la Vierge, Ambarès & Lagrave, F-33565 Carbon Blanc cedex, France
or
Sanofi-Synthelabo Limited,
Edgefield Avenue, Fawdon
Newcastle Upon Tyne, Tyne & Wear NE3 3TT, UK
or
Delpharm Dijon
6, Boulevard de l’Europe, F-21800 Quétigny, France
or
Sanofi Srl
Strada Statale 17, Km 22
67019 Scoppito (AQ) – Italy
or
Sanofi Winthrop Industry
30-36 avenue Gustave Eiffel
37100 Tours
France
Further information on this medicine can be obtained from the representative of the marketing authorization holder:
Sanofi AB
Tel: +46 (0) 8 634 50 00