5 mg film-coated tablets
clopidogrel
What Clopidogrel Actavis is and what it is used for
Clopidogrel Actavis contains clopidogrel and belongs to a group of medicines called platelet inhibitors. Platelets are very small cells in the blood, which form clots ( clots ) when the blood coagulates (blood clots). By preventing this clot formation, platelet inhibitors reduce the risk of blood clots forming (a process known as thrombosis or blood clot formation).
Clopidogrel Actavis 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 Actavis 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 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 Actavis and acetylsalicylic acid for this disease. Your doctor should have given you Clopidogrel Actavis and acetylsalicylic acid if you are unable to take blood-thinning medicines orally and you are not at risk of heavy bleeding
Clopidogrel contained in Clopidogrel Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you use Clopidogrel Actavis
Do not take Clopidogrel Actavis
- if you are allergic to clopidogrel, soybean oil, peanut oil, or any of the other ingredients of this medicine (see 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 have severe liver disease
If you think any of these apply to you or if you are not sure, talk to your doctor before taking Clopidogrel Actavis.
Warnings and cautions
Talk to your doctor or pharmacist before taking Clopidogrel Actavis:
- if you are at risk of bleeding, eg:
- 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 clot in an artery in your brain (ischemic stroke ) in the last 7 days
- 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 Actavis
- You should inform your doctor if surgery (including dental surgery) is planned.
- You should also tell your doctor immediately if you develop a condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pin-sized dots, with or without unexplained extreme fatigue, confusion, yellowing of the skin. or yellow eyes (jaundice) (see section 4).
- If you cut yourself or injure yourself, it may take longer than usual for the bleeding to stop. This is because of the way your medicine works because it prevents blood clots from forming. For minor cuts and injuries, such as if you cut yourself when shaving, this is usually not a problem. However, if you are concerned about your bleeding, contact your doctor immediately (see section 4).
- Your doctor may order blood samples.
Children and young people
Do not give this medicine to children as it does not help.
Other medicines and Clopidogrel Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some other medicines may affect the use of Clopidogrel Actavis 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 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,
- omeprazole or esomeprazole, medicines used to treat stomach upset,
- fluconazole or voriconazole, medicines used to treat fungal infections,
- efavirenz or other antiretroviral medicines (used to treat HIV infections ),
- carbamazepine, a drug used to treat various forms of epilepsy,
- moclobemide, medicines used to treat depression,
- repaglinide, medicines used to treat diabetes,
- paclitaxel, medicines 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 Actavis 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 under other conditions should be discussed with your doctor.
Clopidogrel Actavis with food and drink
Clopidogrel Actavis can be taken with or without food.
Pregnancy and breastfeeding
This medicine should preferably not be used during pregnancy.
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant while taking Clopidogrel Actavis, you should contact your doctor immediately as it is not recommended to take clopidogrel during pregnancy.
This medicine should not be used during breast-feeding.
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 Actavis is unlikely to affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Clopidogrel Actavis contains lactose and soybean oil
Clopidogrel Actavis contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Clopidogrel Actavis contains soybean oil. Do not take this medicine if you are allergic to peanuts or soy
How to use Clopidogrel Actavis
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 Actavis 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 Clopidogrel Actavis 300 mg (4 tablets of 75 mg) to start treatment. After this, the recommended dose is one of 75 mg Clopidogrel Actavis per day as described above.
You should take Clopidogrel Actavis for as long as your doctor prescribes it.
If you forget to use Clopidogrel Actavis
If you forget to take a dose of Clopidogrel Actavis 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 14, 28 56, 84, and 98 tablets, you can check which day you last took a Clopidogrel Actavis tablet by looking at the calendar printed on the blister.
If you stop using Clopidogrel Actavis
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 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 Clopidogrel Actavis 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 Actavis
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 (may affect up to 1 in 10 people):
Diarrhea, abdominal pain, indigestion, or heartburn.
Uncommon (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, or numbness.
Rare (may affect up to 1 in 1,000 people):
Dizziness, enlarged breasts in men.
Very rare (may affect up to 1 in 10,000 people): Jaundice, severe abdominal pain with or without back pain, fever, difficulty breathing sometimes while coughing, generalized (widespread) allergic reactions (for example, a feeling of heat with sudden discomfort until fainting), swelling of the mouth, blisters on the skin, skin allergy, pain in the mouth ( stomatitis ), decreased blood pressure, confusion, hallucinations, joint pain, muscle aches, taste changes, loss of taste.
Has been reported (occurs 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 find 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 Actavis
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 after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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 a clopidogrel result. Each tablet contains 75 mg of clopidogrel.
- The other ingredients are Tablet core: lactose, microcrystalline cellulose, crospovidone type A, glycerol behenate, talc. Tablet coating: polyvinyl alcohol, talc, macrogol 3350, lecithin (soybean oil) (E 322), titanium dioxide (E 171), red iron oxide (E 172).
What the medicine looks like and the contents of the pack
Film-coated tablet.
Pink, 9 mm, round, biconvex, film-coated tablet, embossed with “II” on one side.
Pack sizes:
Blisters: 10, 20, 28, 30, 50 x 1 (single dose), 56, 60, 84, 98 and 100 tablets.
Tablet jar: 100 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
IS-220 Hafnarfjörður
Iceland
Manufacturer
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Balkanpharma – Dupnitsa AD
3, Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria
Actavis Group PTC ehf.
Reykjavikurvegur 78
IS-220 Hafnarfjordur
Iceland