75 mg film-coated tablets 
clopidogrel

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Clopidogrel Aurobindo is and what it is used for 
2. What you need to know before you take Clopidogrel Aurobindo 
3. How to take Clopidogrel Aurobindo 
4. Possible side effects 
5. How to store Clopidogrel Aurobindo 
6. Package contents and other information 

What Clopidogrel Aurobindo is and what it is used for

Clopidogrel Aurobindo contains clopidogrel and belongs to a group of medicines called platelet inhibitors. Platelets are very small cells in the blood, which form clotsduring 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 Aurobindo 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 Aurobindo 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 oral blood thinners are more effective than acetylsalicylic acid or the combination of Clopidogrel Aurobindo and acetylsalicylic acid for this disease. Your doctor should have given you Clopidogrel Aurobindo 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 Aurobindo 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 take Clopidogrel Aurobindo

Do not take Clopidogrel Aurobindo:

  • 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 stomach ulcers or bleeding in the brain.
  • If you suffer from severe liver disease.

If you have any questions about these medicines, or if you have any further questions, ask your doctor before starting Clopidogrel Aurobindo.

Warnings and cautions

If any of the following apply to you, talk to your doctor or pharmacist before taking Clopidogrel Aurobindo.

  • 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 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 Aurobindo:

  • 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 Clopidogrel Aurobindo:

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 Aurobindo 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 ), 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 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 Aurobindo 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 Aurobindo with food and drink

Clopidogrel Aurobindo can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

This medicine should preferably not be taken during pregnancy.

If you are pregnant or suspect you may be pregnant, tell your doctor or pharmacist before taking Clopidogrel Aurobindo. If you become pregnant while taking Clopidogrel Aurobindo, you should 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.

Driving and using machines

Clopidogrel Aurobindo 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 increased 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 Aurobindo contains lactose

Clopidogrel Aurobindo 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 Aurobindo contains hydrogenated castor oil.

This can cause stomach upset or diarrhea.

How to take Clopidogrel Aurobindo

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 Aurobindo 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 Aurobindo 300 mg (one 300 mg tablet or 4 75 mg tablets) to start treatment. Following this, the recommended dose is one of 75 mg Clopidogrel Aurobindo per day as described above.

You should take Clopidogrel Aurobindo for as long as your doctor prescribes it.

If you forget to take Clopidogrel Aurobindo:

If you forget to take a dose of Clopidogrel Aurobindo 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.

If you stop taking Clopidogrel Aurobindo:

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 the use of Clopidogrel Aurobindo 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 Aurobindo 
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 patients):

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 patients):

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 warmth with sudden discomfort until fainting), swelling in the mouth, blisters on the skin, skin allergy, pain in the 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 ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effectsdirectly (see details below). By reporting side effects , you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

Website:

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 Aurobindo

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, jar and blister after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Use within 6 months after first opening the jar.

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 hydrogen sulfate).
  • The other ingredients are microcrystalline cellulose (class 113), mannitol, low-substituted hydroxypropylcellulose, crospovidone (type A), macrogol 6000, hydrogenated castor oil, lactose monohydrate (see section 2 “Clopidogrel Aurobindo contains lactose”), hyp171 (c) titriol (c) , triacetin, red iron oxide (E172).

What the medicine looks like and the contents of the pack

Film-coated tablet.

Pink, round, biconvex, film-coated tablets with bevelled edges and with ‘E’ embossed on one side and ’34’ on the other side.

Clopidogrel Aurobindo 75 mg film-coated tablets are supplied in blister packs containing 14, 28, 30, 50, 56, 84, 100 and 500 film-coated tablets.

Jars contain 30, 100 and 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aurobindo Pharma (Malta) Limited 
Vault 14, Level 2, Valletta Waterfront 
Floriana FRN 1913 
Malta

Manufacturer 
Milpharm Limited 
Ares Block, Odyssey Business Park 
West End Road 
Ruislip HA4 6QD 
United Kingdom

or

APL Swift Services (Malta) Limited 
HF26, Hal Far Industrial Estate, Hal Far 
Birzebbugia, BBG 3000 
Malta

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd, medinfo@orionpharma.com

Muhammad Nadeem

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