Mediclarum
Medicine guide

Clopidogrel HCS

·

  • Prescription status not stated
  • Blood, clotting and anaemia
Active substance
Clopidogrel
Made by
HCS bvba

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is for

You have been prescribed Clopidogrel HCS to help prevent blood clots and reduce the risk of these severe events because:

  • Clopidogrel HCS contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small structures in the blood, which clump together during blood clotting. By preventing this clumping, antiplatelet medicinal products reduce the chances of blood clots forming (a process called thrombosis).
  • Clopidogrel HCS is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
  • - You have a condition of hardening of arteries (also known as atherosclerosis), and
  • - You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or
  • - You have experienced a severe type of chest pain known as ‘ unstable angina’ or ‘ myocardial infarction’ (heart attack). For the treatment of this condition your doctor may have placed a stent in the blocked or narrowed artery to restore effective blood flow. You should also be given acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever as well as to prevent blood clotting) by your doctor.
  • - You have an irregular heartbeat, a condition called ‘atrial fibrillation’, and you cannot take medicines known as ‘oral anticoagulants’ (vitamin K antagonists) which prevent new clots from forming and prevent existing clots from growing. You should have been told that ‘oral anticoagulants’ are more effective than acetylsalicylic acid or the combined use of Clopidogrel HCS and acetylsalicylic acid for this condition. Your doctor should have prescribed Clopidogrel HCS plus acetylsalicylic acid if you cannot take ‘oral anticoagulants’ and you do not have a risk of major bleeding.

From the package leaflet in EMA’s product information, p. 29 · 2018-08-01

Do not take it if

  • If you are allergic to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
  • If you have a medical condition that is currently causing bleeding such as a stomach ulcer or bleeding within the brain,
  • If you suffer from severe liver disease.
  • If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel HCS.

From the package leaflet in EMA’s product information, p. 30.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Always take this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
  • The recommended dose, including for patients with a condition called ‘atrial fibrillation’ (an irregular heartbeat), is one 75 mg tablet of Clopidogrel HCS per day to be taken orally with or without food, and at the same time each day.
  • If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel HCS (4 tablets of 75 mg) once at the start of treatment. Then, the recommended dose is one 75 mg tablet of Clopidogrel HCS per day as described above.
  • You should take Clopidogrel HCS for as long as your doctor continues to prescribe it.
  • If you take more Clopidogrel HCS than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
  • If you forget to take Clopidogrel HCS If you forget to take a dose of Clopidogrel HCS, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
  • If you forget for more than 12 hours, simply take the next single dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
  • For the 28x1 tablets pack size, you can check the day on which you last took a tablet of Clopidogrel HCS by referring to the calendar printed on the blister.
  • If you stop taking Clopidogrel HCS Do not stop the treatment unless your doctor tells you so. Contact your doctor or pharmacist before stopping.
  • If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

From the package leaflet in EMA’s product information, p. 31–32.

Warnings and precautions

  • If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel HCS:
  • if you have a risk of bleeding such as
  • a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer).
  • a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body).
  • a recent serious injury.
  • a recent surgery (including dental).
  • a planned surgery (including dental) in the next seven days.
  • if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the last seven days.
  • if you have kidney or liver disease.
  • if you have had an allergy or reaction to any medicine used to treat your disease.
  • While you are taking Clopidogrel HCS:
  • You should tell your doctor if a surgery (including dental) is planned.
  • You should also tell 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 appear as red pinpoint dots, with or without unexplained extreme tiredness, 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 bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 4 ‘Possible side effects’).
  • Your doctor may order blood tests.
  • Children and adolescents Do not give this medicine to children (under 12 years of age) because it does not work.

From the package leaflet in EMA’s product information, p. 30.

Pregnancy and breastfeeding

  • It is preferable not to take this product during pregnancy.
  • If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel HCS. If you become pregnant while taking Clopidogrel HCS, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
  • 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.

From the package leaflet in EMA’s product information, p. 31.

Other medicines

  • Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
  • Some other medicines may influence the use of Clopidogrel HCS or vice versa.
  • You should specifically tell your doctor if you take
  • medicines that may increase your risk of bleeding such as:
  • o oral anticoagulants, medicines used to reduce blood clotting, o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, o heparin, or any other injectable medicine used to reduce blood clotting, o ticlopidine, other antiplatelet agent, o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,
  • omeprazole or esomeprazole, medicines to treat upset stomach,
  • fluconazole or voriconazole medicines to treat fungal infections,
  • efavirenz, a medicine to treat HIV (human immunodeficiency virus) infections,
  • carbamazepine, a medicine to treat some forms of epilepsy,
  • moclobemide, medicine to treat depression,
  • repaglinide, medicine to treat diabetes,
  • paclitaxel, medicine to treat cancer.
  • If you have experienced severe chest pain (unstable angina or heart attack), you may be prescribed clopidogrel in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever. An occasional use of acetylsalicylic acid (no more than 1,000 mg in any 24 hour period) should generally not cause a problem, but prolonged use in other circumstances should be discussed with your doctor.

From the package leaflet in EMA’s product information, p. 30–31.

Driving and using machines

  • Clopidogrel HCS is unlikely to affect your ability to drive or to use machines.
  • Clopidogrel HCS contains hydrogenated castor oil This may cause stomach upset or diarrhoea.

From the package leaflet in EMA’s product information, p. 31.

Side effects

  • Like all medicines, this medicine can cause side effects, although not everybody gets them.
  • Contact your doctor immediately if you experience:
  • fever, signs of infection or extreme tiredness. These may be due to rare decrease of some blood cells.
  • signs of liver problems such as yellowing of the skin and/or the eyes (jaundice), whether or not associated with bleeding which appears under the skin as red pinpoint dots and/or confusion (see section 2 ‘Warnings and precautions’).
  • swelling in the mouth or skin disorders such as rashes and itching, blisters of the skin. These may be the signs of an allergic reaction.
  • The most common side effect reported with Clopidogrel HCS is bleeding.
  • Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine. In a small number of cases, bleeding in the eye, inside the head, the lung or the joints has also been reported.
  • If you experience prolonged bleeding when taking Clopidogrel HCS If you cut or injure yourself, it may take slightly longer than usual for bleeding to stop. This is linked to the way your medicine works as it prevents the ability of blood clots to form. For minor cuts and injuries e.g., cutting yourself, shaving, this is usually of no concern. However, if you are concerned by your bleeding, you should contact your doctor straightaway (see section 2 ‘Warnings and precautions’).
  • Other side effects include:
  • Common side effects (may affect up to 1 in 10 people):
  • Diarrhoea, abdominal pain, indigestion or heartburn.
  • Uncommon side effects (may affect up to 1 in 100 people):
  • Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in stomach or intestines, rashes, itching, dizziness, sensation of tingling and numbness.
  • Rare side effect (may affect up to 1 in 1000 people):
  • Vertigo, enlarged breasts in males.
  • Very rare side effects (may affect up to 1 in 10,000 people):
  • Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain;
  • changes in taste or loss of taste of food.
  • Side effects with frequency not known (frequency cannot be estimated from the available data):
  • Hypersensitivity reactions with chest or abdominal pain.
  • In addition, your doctor may identify changes in your blood or urine test results.
  • Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 32–33.

How to store it

  • 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 on the blister, after EXP. The expiry date refers to the last day of that month.
  • Store in the original package in order to protect from moisture and light.
  • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

From the package leaflet in EMA’s product information, p. 33.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

  • The other ingredients are (see section 2 ‘Clopidogrel HCS contains hydrogenated castor oil’):
  • Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone (type A), macrogol 6000 and hydrogenated castor oil.
  • Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), talc and macrogol 3000.

From the package leaflet in EMA’s product information, p. 33.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

United StatesNo exact match for this strength and form

Every strength and form (17)

BulgariaNo exact match for this strength and form

Every strength and form (13)

SpainNo exact match for this strength and form

Every strength and form (67)

CanadaNo exact match for this strength and form

Every strength and form (30)

NetherlandsNo exact match for this strength and form

Every strength and form (26)

SwitzerlandNo exact match for this strength and form

Every strength and form (11)

Details

Made byHCS bvba
Active substanceClopidogrel
Used inBlood, clotting and anaemia
ClassificationB01AC04 · Blood, clotting and anaemia
GenericYes — a generic medicine, according to the register
Authorised on2010-10-28
Last updated by the regulator2018-08-01
EMA product numberEMEA/H/C/002255

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Clopidogrel Zentiva (previously Clopidogrel Winthrop)EU authorisation Zentiva k.s. · Clopidogrel · B01AC04Clopidogrel Viatris (previously Clopidogrel Taw Pharma)EU authorisation Viatris Limited · Clopidogrel · B01AC04IscoverEU authorisation Sanofi Winthrop Industrie · Clopidogrel · B01AC04PlavixEU authorisation Sanofi Winthrop Industrie · Clopidogrel · B01AC04GrepidEU authorisation Pharmathen S.A. · Clopidogrel · B01AC04Clopidogrel KrkaEU authorisation Krka, d.d., Novo mesto · Clopidogrel · B01AC04

See every product with Clopidogrel