Iscover 75 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Iscover 75 mg film-coated tablets

clopidogrel

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Iscover is and what it is used for
2. What you need to know before taking Iscover
3. How to take Iscover
4. Possible side effects
5. How to store Iscover
6. Contents of the pack and other information

1. What Iscover is and what it is used for

Iscover contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small blood cells that clump together when blood clots. Antiplatelet medicines prevent this clumping, thereby reducing the likelihood of blood clots forming (a process known as thrombosis).

Iscover is administered in adults to prevent the formation of blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, myocardial infarction, or death).

You have been prescribed Iscover to help prevent the formation of blood clots and to reduce the risk of these serious events because:

• you have a condition causing hardening of the arteries (also known as atherosclerosis), and
• you have previously had a myocardial infarction, stroke, or suffer from a condition called peripheral arterial disease, or
• you have experienced a severe type of chest pain known as "unstable angina" or "myocardial infarction." For the treatment of this condition, your doctor may have placed a stent in the blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed you acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clot formation).
• you have experienced symptoms of a stroke that disappeared within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may also administer acetylsalicylic acid within the first 24 hours.
• you have an irregular heartbeat, a condition called "atrial fibrillation", and cannot take medicines known as "oral anticoagulants" (vitamin K antagonists) that prevent the formation of new clots and stop existing clots from growing. You will have been informed that "oral anticoagulants" are more effective than acetylsalicylic acid or the combination of Iscover and acetylsalicylic acid for this condition. Your doctor will have prescribed Iscover plus acetylsalicylic acid if you cannot take "oral anticoagulants" and do not have a high risk of serious bleeding.

2. What you need to know before taking Iscover

Do not take Iscover

• If you are allergic (hypersensitive) to clopidogrel or to any of the other components of this medicine (listed in section 6).
• If you have active bleeding, such as a stomach ulcer or bleeding in the brain.
• If you suffer from severe liver disease.

If you think any of these apply to you, or if you have any doubts, consult your doctor before taking Iscover.

Warnings and precautions

Before starting treatment with Iscover, inform your doctor if you are in any of the following situations:

• If you are at risk of bleeding because:

  • you have a condition that increases your risk of bleeding (such as a stomach ulcer).
  • you have a blood disorder that predisposes you to internal bleeding (bleeding into tissues, organs, or joints).
  • you have recently suffered a serious injury.
  • you have recently undergone surgery (including dental surgery).
  • you are scheduled to undergo surgery (including dental surgery) within the next seven days.

• If you have had a blood clot in a brain artery (ischemic stroke) within the last 7 days.

• If you have liver or kidney disease.

• If you have had an allergic reaction or adverse reaction to any medication used to treat your condition.

• If you have a history of non-traumatic intracranial bleeding.

During treatment with Iscover:

• Inform your doctor if you are scheduled for surgery (including dental surgery).
• Inform your doctor immediately if you develop a disorder (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising (bruises) under the skin which may appear as localized red spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).
• If you get a cut or injury, bleeding may take longer than usual to stop. This is related to how the medicine works, as it prevents blood from forming clots. For minor cuts or injuries, such as during shaving, this is usually not a concern. However, if you are concerned about blood loss, consult your doctor immediately (see section 4 “Possible side effects”).
• Your doctor may ask you to have blood tests.

Children and adolescents

This medicine should not be given to children because it is not effective.

Taking Iscover with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines may affect the use of Iscover or vice versa.

You must specifically inform your doctor if you are taking:

• Medicines that may increase the risk of bleeding such as:

  • Oral anticoagulants, medicines used to reduce blood clotting,
  • Non-steroidal anti-inflammatory drugs (NSAIDs), medicines generally used to treat pain and/or inflammation of muscles or joints,
  • Heparin, or any other injectable medicine used to reduce blood clotting,
  • Ticlopidine, or other antiplatelet agents,
  • A serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other drugs of the same type), medicines generally used to treat depression,
  • Rifampicin (used for serious infections)

• Omeprazole or esomeprazole, medicines used to treat stomach discomfort,

• Fluconazole or voriconazole, medicines used to treat fungal infections,

• Efavirenz, or other antiretroviral medicines (used to treat HIV infections),

• Carbamazepine, a medicine used to treat certain forms of epilepsy,

• Moclobemide, a medicine for depression,

• Repaglinide, a medicine used to treat diabetes,

• Paclitaxel, a medicine used to treat cancer,

• Opioids: if you are being treated with clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain),

• Rosuvastatin (used to reduce cholesterol levels).

If you have experienced severe chest pain (unstable angina or myocardial infarction), transient ischemic attack, or mild ischemic stroke, you may have been prescribed Iscover in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. An occasional dose of acetylsalicylic acid (not exceeding 1,000 mg in 24 hours) generally should not cause any problems, but prolonged use under other circumstances should be discussed with your doctor.

Taking Iscover with food and drink

Iscover may be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant or think you may be pregnant, you must inform your doctor or pharmacist before taking Iscover. If you become pregnant while taking Iscover, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

You must not breastfeed while taking this medicine.

If you are breastfeeding or plan to breastfeed, inform your doctor before taking this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It is unlikely that Iscover will affect your ability to drive or operate machinery.

Iscover contains lactose

If your doctor has informed you that you have an intolerance to certain sugars (e.g. lactose), consult him before taking this medicine.

Iscover contains hydrogenated castor oil

This may cause stomach discomfort and diarrhea.

3. How to take Iscover

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose, including for patients with a condition called "atrial fibrillation" (an irregular heartbeat), is one 75 mg Iscover tablet per day, taken orally with or without food, at the same time each day.

If you have experienced severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe you 300 mg or 600 mg of Iscover (1 or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg) to take as a single dose at the beginning of treatment. Afterwards, the recommended dose is one 75 mg Iscover tablet per day, as described above.

If you have experienced symptoms of a stroke that disappear within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe you 300 mg of Plavix (1 tablet of 300 mg or 4 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg Plavix tablet per day as described above, together with acetylsalicylic acid for 3 weeks. After this, your doctor will prescribe either Plavix alone or acetylsalicylic acid alone.

You should take Iscover for as long as your doctor continues to prescribe it.

If you take more Iscover than you should

Contact your doctor or go to the nearest hospital emergency department, as there is an increased risk of bleeding.

If you forget to take Iscover

If you forget to take a dose of Iscover but remember within 12 hours of the time you were supposed to take it, take the tablet immediately and take the next dose at the usual time.

If more than 12 hours have passed, simply take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

With the 7-, 14-, 28-, and 84-tablet packs, you can check the last day you took an Iscover tablet by looking at the calendar printed on the blister.

If you stop taking Iscover

Do not stop your treatment unless instructed by your doctor. Contact your doctor or pharmacist before stopping this medicine.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Iscover can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience:

• Fever, signs of infection, or extreme tiredness. These symptoms may be due to a rare reduction in certain blood cells.
• Signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing under the skin as red spots and/or confusion (see section 2 “Warnings and precautions”).
• Swelling of the mouth or skin disorders such as rashes and itching, blisters on the skin. These may be signs of an allergic reaction.

The most frequently reported adverse effect with Iscover is bleeding. Bleeding may occur in the stomach or intestines, bruising, haematomas (abnormal bleeding or bruising under the skin), nosebleeds, or blood in the urine. A small number of cases have also been reported of: bleeding from blood vessels in the eyes, intracranial, pulmonary, or joint bleeding.

If you experience prolonged bleeding while taking Iscover

If you cut yourself or sustain an injury, bleeding may take longer than usual to stop. This is related to the mechanism of action of the medicine, as it prevents blood from forming clots. For minor cuts or injuries, such as shaving cuts, this is usually not a concern. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 “Warnings and precautions”).

Other adverse effects reported with Iscover include:

Frequent adverse effects (may affect up to 1 in 10 people):

Diarrhoea, abdominal pain, indigestion or heartburn.

Uncommon adverse effects (may affect up to 1 in 100 people):

Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rashes, itching, dizziness, tingling and numbness.

Rare adverse effects (may affect up to 1 in 1,000 people):

Dizziness, breast enlargement in males.

Very rare adverse effects (may affect up to 1 in 10,000 people):

Jaundice; severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with cough; generalized allergic reactions (e.g., feeling of warmth with sudden general discomfort up to fainting); swelling of the mouth; blisters on the skin; skin allergy; inflammation of the mucous membrane of the mouth (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste.

Adverse effects with unknown frequency (cannot be estimated from available data): Hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

In addition, your doctor may observe changes in your blood or urine test results.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Iscover

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister, after EXP. The expiry date is the last day of the month indicated.

See storage conditions on the packaging.

Store below 30 °C when Iscover is presented in PVC/PVDC/aluminum blisters.

When Iscover is presented in any aluminum blister, no special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Iscover

The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).

The other components are (see section 2 "Iscover contains lactose" and "Iscover contains hydrogenated castor oil"):

• Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000, and low-substituted hydroxypropylcellulose.
• Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), iron oxide red (E172), and titanium dioxide (E171).
• Polish: carnauba wax.

Product appearance and pack contents

Iscover 75 mg coated tablets are round, biconvex, pink-colored tablets, marked with the number "75" on one side and "1171" on the other. Iscover is available in cardboard packs containing:

• 7, 14, 28, 30, 84, 90 and 100 tablets in PVC/PVDC/Aluminum blisters or Aluminum/Aluminum blisters,
• 50x1 tablets in PVC/PVDC/Aluminum blisters or in single-dose aluminum blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturers:

Sanofi Winthrop Industrie

1, Rue de la Vierge, Ambarès & Lagrave,

F-33565 Carbon Blanc cedex, France.

or

Delpharm Dijon

6, Boulevard de l’Europe, F - 21800 Quétigny, France

or

Sanofi S.r.l.

Strada Statale 17, Km 22

67019 Scoppito (AQ) – Italy

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet: December 2022

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/