75 mg film-coated tablets
clopidogrel
1. What Clopidogrel Accord is and what it is used for
Clopidogrel Accord contains clopidogrel and is part of a group of medicines called platelet inhibitors. Platelets are very small cells in the blood that 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 known as thrombosis or blood clot formation).
Clopidogrel Accord 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 ), myocardial infarction, or death).
You have been given Clopidogrel Accord 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 myocardial infarction (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, reduce fever and 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 Accord and acetylsalicylic acid for this disease. Your doctor should have given you Clopidogrel Accord 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 the Clopidogrel Accord 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.
2. What you need to know before using Clopidogrel Accord
Do not use Clopidogrel Accord
- if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6)
- if you suffer from a disease that causes you to have active bleeding, such as stomach ulcers or bleeding in the brain
- if you suffer from serious liver disease.
If you think any of the above applies to you, or if you are not sure, consult your doctor or pharmacist before taking this medicine.
Warnings and cautions
If any of the following apply to you, you should consult your doctor or pharmacist before taking Clopidogrel Accord:
- If you are at risk of bleeding such as
- 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 operation (including dental operations)
- 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 has occurred within the last week.
- If you suffer from kidney or liver disease.
- If you have become allergic or have reacted to other medicines used to treat your illness
While taking Clopidogrel Accord
- Tell your doctor if surgery (including dental surgery) is planned.
- Tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) with fever and bruising under the skin that may look like red pin-sized dots, possibly associated with unexplained severe weakness, confusion, yellowing of the skin, or the eyes (jaundice) (see section 4, “Possible side effects”).
- If you cut yourself or injure yourself, it may take longer than usual before you stop bleeding. This is linked to how the medicine works, as it prevents the formation of blood clots. It normally has no significance for minor cuts and injuries, such as. if you cut yourself when you shave. However, if you are concerned about any bleeding, consult 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 has no effect.
Other medicines and Clopidogrel Accord
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 Accord 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:
- oral anticoagulants, i.e. blood-thinning drugs to prevent 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 other medicine injected to prevent 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 for stomach upset
- fluconazole or voriconazole, medicines used to treat fungal infections
- moclobemide, a medicine used to treat depression
- efavirenz, drugs used to treat HIV (human immunodeficiency virus) infection s
- carbamazepine, a drug used to treat various forms of epilepsy
- repaglinide, a medicine used to treat diabetes
- paclitaxel, a medicine used to treat cancer.
- antiretroviral drugs (drugs for the treatment of HIV – infection s).
If you have had severe chest pain ( unstable angina or heart attack), you can be prescribed clopidogrel in combination with acetylsalicylic acid, a substance found in many painkillers and antipyretics. Temporary use of acetylsalicylic acid (not more than 1,000 mg for 24 hours) should not normally cause any problems, but long-term use under other conditions should be discussed with your doctor.
Clopidogrel Accord with food and drink
Clopidogrel Accord 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 this medicine. If you become pregnant while taking Clopidogrel Accord, tell your doctor immediately, as it is not recommended that you 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.
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.
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 Accord contains lactose and hydrogenated castor oil
Lactose: Clopidogrel Accord contains lactose. If you have been told by your doctor that you have an intolerance to some sugars (eg lactose ), talk to your doctor before taking this medicine.
Hydrogenated castor oil: This can cause stomach upset and diarrhea.
3. How to use Clopidogrel Accord
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 Accord 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 a single dose of 300 mg (4 tablets of 75 mg) at the start of treatment. Thereafter, the recommended dose is one tablet of 75 mg Clopidogrel Accord per day as described above.
You should take Clopidogrel Accord for as long as your doctor prescribes it.
If you forget to use Clopidogrel Accord
If you forget to take a dose of Clopidogrel Accord but remember it within 12 hours of taking the tablet, take the tablet immediately. Then take the next tablet at the usual time.
If it takes longer than 12 hours before you remember to take the tablet, wait and take the next daily dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you stop using Clopidogrel Accord
Do not interrupt treatment. Talk to your doctor or pharmacist before stopping your medicine.
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 experience or experience any of the following
- Fever, signs of infection, or severe weakness. They 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 small punctate hemorrhages 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, itching, and blisters on the skin. It may be a sign of a severe allergic reaction.
The most common side effect reported with Clopidogrel Accord 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 Accord
If you cut yourself or injure yourself, it may take longer than usual before you stop bleeding. This is linked to how the medicine works, as it prevents the formation of blood clots. This normally has no significance for minor cuts and injuries, such as if you cut yourself when you shave. However, if you are concerned about bleeding, consult a 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 formation 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 people):
Jaundice, severe abdominal pain (with or without back pain), fever, difficulty breathing sometimes combined with cough, general allergic reactions (eg general feeling of heat with sudden general discomfort until you faint), swelling in the mouth, blisters on the skin, skin allergy, sores in the oral mucosa ( stomatitis ), decreased blood pressure, confusion, hallucinations, joint pain, muscle aches, taste changes or 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 Accord
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 and blister after EXP.
The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if you notice any visible 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. Contents of the packaging and other information
Content declaration
The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
The other ingredients are (see section 2 “Clopidogrel Accord contains lactose” and “Clopidogrel Accord contains hydrogenated castor oil”):
Tablet core:
Anhydrous lactose, hydroxypropyl cellulose, microcrystalline cellulose, hydrogenated castor oil, colloidal anhydrous silica.
Drag:
Triacetin (E1518), red iron oxide (E172), hypromellose (E464), titanium dioxide (E171), lactose monohydrate.
What the medicine looks like and the contents of the pack
Clopidogrel Accord 75 mg film-coated tablets are pink, round, biconvex tablets, unlabeled on both sides.
Clopidogrel Accord 75 mg tablets are packaged in aluminum-aluminum blister packs and outer cartons.
Pack sizes: 7, 10, 14, 28, 30, 50, 84, 90 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht, The Netherlands
Manufacturer:
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF, UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland