ISCOVER 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Iscover 75 mg Film-Coated Tablets

clopidogrel

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

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Iscover and what is it used for

Iscover contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small cells in the blood that help it to clot when you cut yourself. Antiplatelet agents prevent platelets from aggregating (sticking together) and so reduce the risk of a blood clot (thrombus) forming.

Iscover is given to adults to prevent atherosclerotic (blood vessel) events such as heart attack (myocardial infarction), stroke and death from heart disease in patients who have had a heart attack, stroke or have peripheral arterial disease.

You have been prescribed Iscover to help prevent blood clots from forming because you have had:

• a condition that affects blood flow to the heart, brain or legs (peripheral arterial disease), or
• had a heart attack, stroke or mini-stroke (transient ischaemic attack), or
• had severe chest pain (unstable angina or myocardial infarction). Your doctor may also have given you aspirin to take together with Iscover.
• had a mini-stroke (transient ischaemic attack) or a mild stroke.
• have an irregular heartbeat, a condition called atrial fibrillation, and cannot take medicines that prevent the formation of blood clots (oral anticoagulants) that thin the blood to prevent clots from forming.

2. What you need to know before you take Iscover

Do not take Iscover

• if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6).
• if you have a condition where you may be at risk of bleeding (such as stomach ulcer or bleeding in the brain).
• if you have severe liver disease.

If you think any of these apply to you, or if you are in any doubt, tell your doctor before taking Iscover.

Warnings and precautions

Before starting treatment, tell your doctor if you:

• have a risk of bleeding (such as stomach ulcer or bleeding in the brain),
• have had a recent severe injury,
• have recently had surgery (including dental surgery),
• are due to have surgery (including dental surgery) in the next 7 days,
• have had a stroke (ischaemic stroke) in the last 7 days,
• have kidney or liver disease,
• have had an allergic reaction or intolerance to any medicine used to treat your condition.

While taking Iscover:

• tell your doctor if you have any plans for surgery (including dental surgery),
• tell your doctor immediately if you develop a condition where you may bruise or bleed easily, or if you notice any of the following: fever, signs of infection or tiredness. These may be due to a rare decrease in the number of blood cells (agranulocytosis or thrombocytopenia),
• if you cut or injure yourself, it may take longer than usual for bleeding to stop. This is because Iscover affects the ability of your blood to clot. For minor cuts and injuries, e.g. cutting yourself while shaving, this is usually of no concern. However, if you are concerned about your bleeding, you should contact your doctor (see section 2 "Warnings and precautions"),
• your doctor may want you to have blood tests.

Children and adolescents

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

Taking other medicines

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

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

Especially tell your doctor if you are taking:

• medicines that may increase the risk of bleeding, such as:
• oral anticoagulants, medicines used to thin the blood to prevent clots from forming,
• non-steroidal anti-inflammatory medicines (such as ibuprofen), medicines used to treat pain and/or inflammation of muscles or joints,
• heparin, or any other injectable medicine used to thin the blood,
• ticlopidine, or other antiplatelet agents,
• a selective serotonin reuptake inhibitor (such as fluoxetine), medicines used to treat depression,
• rifampicin (used to treat tuberculosis),

• omeprazole or esomeprazole, medicines used to treat stomach ulcers,
• fluconazole or voriconazole, medicines used to treat fungal infections,
• efavirenz, or other anti-retroviral medicines (used to treat HIV infections),
• carbamazepine, a medicine used to treat some 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: if you are taking clopidogrel, you should inform your doctor before being prescribed any opioid (used to treat severe pain),
• rosuvastatin (used to lower cholesterol levels).

If you have had a heart attack, stroke or mini-stroke, your doctor may prescribe Iscover in combination with aspirin, a substance present in many medicines used to relieve pain and lower fever.

Taking Iscover with food and drink

Iscover can be taken with or without food.

Pregnancy and breast-feeding

It is preferable not to take this medicine during pregnancy.

If you are pregnant or think you might be, tell your doctor or pharmacist before taking Iscover. If you become pregnant while taking Iscover, consult your doctor immediately as it is recommended that Iscover is not taken during pregnancy.

Do not breast-feed while taking this medicine.

If you are breast-feeding or plan to breast-feed, tell your doctor or pharmacist before taking Iscover.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Iscover is unlikely to affect your ability to drive or use machines.

Iscover contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Iscover contains hydrogenated castor oil

This may cause stomach upset or diarrhoea.

3. How to take Iscover

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one 75 mg tablet per day, to be taken orally with or without food, and at the same time each day.

If you have had a heart attack, stroke or mini-stroke, your doctor may give you a single dose of 300 mg (four 75 mg tablets or one 300 mg tablet) on the first day. This is followed by the usual dose of one 75 mg tablet per day.

If you have had a mini-stroke (transient ischaemic attack) or a mild stroke, your doctor may give you a single dose of 300 mg (four 75 mg tablets or one 300 mg tablet) on the first day. This is followed by the usual dose of one 75 mg tablet per day, in combination with aspirin, for a month.

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 immediately if you have taken too much Iscover. There is a risk of bleeding because of the effect of the medicine on the blood.

If you forget to take Iscover

If you forget to take a dose of Iscover, but remember before it is time for your next dose, take the missed dose as soon as you remember. Then take the next dose at the usual time.

If you forget to take a dose of Iscover and it is time for your next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Iscover

Do not stop taking Iscover without talking to your doctor first. Contact your doctor or pharmacist before stopping any treatment with Iscover.

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

4. Possible side effects

Like all medicines, Iscover can cause side effects, although not everybody gets them.

Seek medical help immediately if you experience:

• Fever, signs of infection or tiredness. These may be due to rare decreases in some blood cells.
• Signs of liver problems such as yellowing of the skin and/or eyes (jaundice), whether or not associated with bleeding that appears under the skin as red pinpoint dots.
• Swelling of the mouth or skin disorders such as redness, itching and rash.

The most common side effect reported with Iscover is bleeding. Bleeding may occur in the form of bruising, nosebleeds, blood in the urine, black or tarry stools or coughing up blood. Less common side effects are bleeding in the eyes, ears, gums or joints, or bleeding that may make it difficult to stop, heavy menstrual periods in women.

If you experience prolonged bleeding when taking Iscover

If you cut or injure yourself, it may take longer than usual for bleeding to stop. This is because Iscover affects the ability of your blood to clot. For minor cuts and injuries, e.g. cutting yourself while shaving, this is usually of no concern. However, if you are concerned about your bleeding, you should contact your doctor (see section 2 "Warnings and precautions").

Other side effects reported with Iscover 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, excess gas in the stomach or intestines, rash, itching, dizziness, feeling of weakness, or numbness.

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

Dizziness, breast enlargement 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 with cough; generalised allergic reactions (for example, overall sensation of heat with sudden profuse sweating, feeling of faintness or collapse); swelling in the mouth; blisters on the skin; skin allergy; inflammation of the mucous membrane of the mouth (stomatitis); low blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in the way things taste or loss of taste.

Side effects with frequency not known (cannot be estimated from the available data): Hypersensitivity reactions with chest or abdominal pain, persistent low blood sugar levels.

Your doctor may want to monitor your condition by performing blood tests.

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.

5. Storage of Iscover

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 expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

For blister packs: Store below 30°C.

For aluminium blister packs: No special storage conditions.

Do not use this medicine if you notice any visible signs of 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. Package Contents and Additional Information

Iscover Composition

The active ingredient 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"):

• Core of the tablet: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000, and low-substituted hydroxypropylcellulose.
• Coating of the tablet: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172), and titanium dioxide (E171).
• Varnish: carnauba wax.

Product Appearance and Package Contents

Iscover 75 mg film-coated tablets are round, biconvex, pink, and engraved with the number "75" on one side and the number "1171" on the other. Iscover is available in cardboard boxes of:

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

Only some package 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 more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Date of Last Revision of this Leaflet: December 2022

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