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 you will find information about: 
1. What Cloriocard is and what it is used for 
2. What you need to know before taking Cloriocard 
3. How to take Cloriocard 
4. Possible side effects 
5. How to store Cloriocard 
6. Contents of the packaging and other information 

1. What Cloriocard is and what it is used for

Cloriocard contains clopidogrel and belongs to a group of medicines called antiplatelet agents. 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).

Cloriocard used by adults to prevent blood clots ( thrombosis s) in hardened blood vessels ( artery s), a process is known as atherothrombosis, which can lead to atherothrombotic events (such as stroke ( stroke ), heart attack, or death).

You have been given Cloriocard 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 blood-thinning drugs taken orally are more effective than acetylsalicylic acid or the combination of Cloriocard and acetylsalicylic acid for this disease. Your doctor should have prescribed Cloriocard 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 Cloriocard may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Cloriocard

Do not take Cloriocard

  • 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. gastric ulcer or bleeding in the brain.
  • if you suffer from severe liver disease.

If you have any of these symptoms or if you have any further questions, ask your doctor before taking Cloriocard.

Warnings and cautions

Talk to your doctor before taking Cloriocard if any of the following situations apply to you:

  • if you are at risk of bleeding such as
    • a disease that puts you at risk for 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 Cloriocard

  • 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 does not help.

Other medicines and Cloriocard

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 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
  • omeprazole or esomeprazole, medicines used to treat stomach problems
  • fluconazole or voriconazole, medicines used to treat fungal infections
  • antiretroviral drugs (drugs for the treatment of HIV 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.

If you have had severe chest pain ( unstable angina or heart attack), your doctor may prescribe Cloriocard 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 1,000 mg for 24 hours) is not generally considered a problem, but long-term use under other conditions should be discussed with your doctor.

Cloriocard with food and drink

Cloriocard can be taken with or without food.

Pregnancy and breastfeeding

This medicine should preferably not be taken during pregnancy.

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. If you become pregnant while using Cloriocard, 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

Cloriocard 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.

3. How to take Cloriocard

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 a 75 mg tablet of Cloriocard 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 300 mg of clopidogrel (4 tablets of Cloriocard 75 mg) once at the beginning of treatment.

Following this, the recommended dose is one Cloriocard 75 mg tablet daily as described above.

You should take Cloriocard for as long as your doctor prescribes it.

If you forget to take Cloriocard

If you forget to take a dose of Cloriocard 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 Cloriocard

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 the rare, narrowing of 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 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 Cloriocard

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 are:

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, dizziness, tingling, and numbness
  • gastric ulcer, inflammation of the gastric mucosa (gastritis; possible signs include stomach pain), vomiting, nausea, constipation, increased flatulence in the stomach or intestines
  • rash and itching

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 (pancreatitis or intestinal inflammation)
  • fever
  • difficulty breathing sometimes associated with coughing
  • generalized allergic reactions (eg a general feeling of warmth with a sudden general feeling of discomfort until you faint), swelling of the mouth, blisters on the skin, allergic skin reactions
  • sore mouth ( stomatitis )
  • decreased blood pressure
  • inflammation of the blood vessels, often with a rash
  • confusion, hallucinations
  • joint pain, muscle aches
  • taste changes, taste loss

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

Your doctor may also notice changes in the answers to 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 Cloriocard

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. or “EXP”. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Store in the original package. Sensitive to light. Moisture sensitive.

Do not use this medicine if you notice any visible signs of deterioration of the product.

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. One film-coated tablet contains 75 mg of clopidogrel (as clopidogrel hydrochloride).
  • The other ingredients in the tablet core are microcrystalline cellulose, low-substituted hydroxypropyl cellulose, hydrogenated castor oil, and in the film coating hypromellose (E464) titanium dioxide (E171), macrogol 400, and red iron oxide (E172).

What the medicine looks like and the contents of the pack

Pink, film-coated, round tablets that are smooth on both sides.

The film-coated tablets are packaged in OPA / Alu / PVC / Alu blister and placed in a carton.

Pack sizes: 14, 28, 30, 50, 84, 90, 100 or 120 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

or

Lek Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia

or

SC Sandoz, SRL, Str. Livezey no. 7A, RO-540472 Targu-Mures, Romania

or

LEK SA, ul. Podlipie 16, 95-010 Stryków, Poland

or

LEK SA, ul. Domaniewska 50 C, 02-672 Warsaw, Poland

or

Lek Pharmaceuticals dd, Trimline 2D, 9220 Lendava, Slovenia

Muhammad Nadeem

Leave a Reply