75 mg film-coated tablets
clopidogrel
What Clopidogrel Mylan is and what it is used for
Clopidogrel Mylan contains clopidogrel and belongs to a group of medicines called platelet inhibitors. Platelets are very small cells in the blood, which form clots during clotting of the blood (blood clotting). By preventing this clot formation, platelet inhibitors reduce the risk of blood clots forming (a process known as thrombosis or blood clot formation).
Clopidogrel Mylan used by adults to prevent blood clots ( thrombosis s) in hardened blood vessels ( artery s), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke ( stroke ), heart attack, or death).
You have been given Clopidogrel Mylan 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 suffer from something called a peripheral arterial disease or
- You have had severe angina ( unstable angina ) or 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 should also get acetylsalicylic acid (a substance found in many medicines used to relieve pain and lower fever and also to prevent the formation of blood clots) from your doctor.
- You have an irregular heartbeat, something called atrial fibrillation, and you cannot take blood-thinning drugs orally ( vitamin K antagonists ) that prevent new blood clots from forming and prevent existing blood clots from growing. You should have learned that orally, blood thinners are more effective than acetylsalicylic acid or the combination of Clopidogrel Mylan and acetylsalicylic acid for this disease. Your doctor should have given you Clopidogrel Mylan and acetylsalicylic acid if you are unable to take blood-thinning medicines orally and you are not at risk of heavy bleeding.
What you need to know before you take Clopidogrel Mylan
Do not take Clopidogrel Mylan
- If you are allergic 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 stomach ulcers or bleeding in the brain.
- If you suffer from severe liver disease.
If you think any of these are suitable for you, or if you have any doubts, talk to your doctor before starting Clopidogrel Mylan.
Warnings and cautions
Talk to your doctor before taking Clopidogrel Mylan if any of the following conditions apply to you:
- if you are at risk of bleeding, for example:
- a disease that puts you at risk of 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
While taking Clopidogrel Mylan:
- 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 the 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 does not help.
Other medicines and Clopidogrel Mylan
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 Clopidogrel Mylan or vice versa. It is especially important that you tell your doctor if you are taking
- medicines that may increase your bleeding risk such as:
- blood-thinning drugs taken orally, drugs used to reduce the formation of blood clots
- non-steroidal anti-inflammatory drugs ( NSAIDs ), which are commonly used to treat painful and/or inflammatory conditions in muscles and joints,
- heparin or any other medicine 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 or 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 treatment with opioids (used to treat severe pain).
If you have had severe chest pain ( unstable angina or heart attack), you can be prescribed Clopidogrel Mylan in combination with acetylsalicylic acid, a substance found in many medicines used to 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.
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 Clopidogrel Mylan. If you become pregnant while taking Clopidogrel Mylan, contact your doctor immediately as it is not recommended to take clopidogrel during pregnancy.
You should not breast-feed while taking this medicine.
If you are breast-feeding or planning to breast-feed, talk to your doctor before taking this medicine.
Consult a doctor or pharmacist before taking any medicine.
Driving and using machines
Clopidogrel Mylan is unlikely to affect your ability to drive or use machines.
Clopidogrel Mylan contains hydrogenated castor oil
This can cause stomach upset and diarrhea.
How to take Clopidogrel Mylan
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 one 75 mg tablet of Clopidogrel Mylan per day to be swallowed with or without food at the same time each day.
For the treatment of severe chest pain after a heart attack or unstable angina (see section 1.), your doctor may give you Clopidogrel Mylan 300 mg (4 tablets of 75 mg) to start treatment. After this, the recommended dose is one of 75 mg Clopidogrel Mylan per day.
You should take Clopidogrel Mylan for as long as your doctor prescribes it
If you take more Clopidogrel Mylan then you should
Contact your doctor or the nearest hospital emergency department due to the increased risk of bleeding.
If you forget to take Clopidogrel Mylan
If you forget to take a dose of Clopidogrel Mylan 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, 56, and 84 tablets (calendar blisters), you can check which day you last took a Clopidogrel Mylan tablet by looking at the calendar printed on the blister (the pressure pack)
If you stop taking Clopidogrel Mylan
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.
4. 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 bleeding under the skin (visible as red dots), and/or confusion (see section 2 “Warnings and precautions”).
- Swelling in 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 Clopidogrel Mylan is bleeding.
Bleeding can occur as bleeding in the stomach or intestines, bruising, hematoma (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. In a few cases, bleeding in the eye, internal bleeding in the head, lungs, or joints have also been reported.
If you experience prolonged bleeding while taking Clopidogrel Mylan
If you cut or injure yourself, it may take a little 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 usually has no significance for minor cuts and injuries, eg 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, feeling of 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 people):
Jaundice, severe abdominal pain with or without back pain, fever, difficulty breathing sometimes with cough, generalized (scattered) allergic reactions (eg a feeling of heat with sudden discomfort until fainting), swelling in the mouth, blisters on the skin, skin allergy, sore mouth ( stomatitis ), decrease in blood pressure, confusion, hallucinations, joint pain, muscle aches, taste changes, loss of taste.
Adverse reactions that have been reported (affects 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Clopidogrel Mylan
Keep out of 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 expiration date is the last day of the specified month.
Store in the original package.
Sensitive to light. Moisture sensitive.
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. Contents of the packaging and other information
Content declaration
The active substance is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
Other ingredients are:
- Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000, and hydrogenated castor oil (see section 2 “Clopidogrel Mylan contains hydrogenated castor oil”).
- Tablet coating: polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc, and macrogol 3000.
What the medicine looks like and the contents of the pack
The film-coated tablets are pink, round, and biconvex.
Cartons of 7, 14, 28, 30, 50, 56, 84, 90 and 100 film-coated tablets in blisters are available.
Cartons of 7, 14, 28, 56, 84 film-coated tablets in calendar blisters are available.
Cartons of 30×1 and 50×1 film-coated tablets in perforated unit dose blisters are available.
Not all packaging may be marketed.
Marketing Authorisation Holder
Mylan SAS, 117 Allée des Parcs, 69 800 Saint Priest, France
Manufacturer:
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder: