Clopidogrel Esseti 75 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopidogrel Esseti 75 mg film-coated tablets EFG

Package leaflet contents:

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

1. What Clopidogrel Esseti is and what it is used for

Clopidogrel Esseti 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 (a process known as thrombosis).

Clopidogrel 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 clopidogrel to help prevent blood clots and 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 you have 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 stroke symptoms that disappear within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may also administer acetylsalicylic acid during the first 24 hours,
• you have an irregular heartbeat, a condition called "atrial fibrillation", and you cannot take medicines known as "oral anticoagulants" (vitamin K antagonists) that prevent the formation of new clots and stop existing clots from growing. You have been informed that "oral anticoagulants" are more effective than acetylsalicylic acid or the combination of clopidogrel and acetylsalicylic acid for this condition. Your doctor has prescribed clopidogrel plus acetylsalicylic acid if you cannot take "oral anticoagulants" and you have no risk of serious bleeding.

2. What you need to know before taking Clopidogrel Esseti

Do not take Clopidogrel Esseti:

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

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

Warnings and precautions

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

If you are at risk of bleeding because:

• You have a disease that involves a risk of internal 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 allergy or reaction to any medication used to treat your condition.

• If you have a history of non-traumatic intracerebral hemorrhage.

During treatment with Clopidogrel Esseti:

• 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) including fever and bruising (bruises) under the skin that may appear as localized red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).
• If you cut yourself or sustain an 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 those occurring while shaving, this is not significant. 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.

Other medicines and Clopidogrel Esseti

Inform 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 Clopidogrel Esseti 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 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 commonly 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 Clopidogrel Esseti in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. A single 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 Clopidogrel Esseti with food and drink

Clopidogrel Esseti can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to take this medicine during pregnancy and breastfeeding.

If you are pregnant or think you may be pregnant, you must inform your doctor or pharmacist before taking Clopidogrel Esseti.

If you become pregnant while taking Clopidogrel Esseti, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

You must not breastfeed while taking this medicine.

If you are breastfeeding or planning 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 Clopidogrel Esseti will affect your ability to drive or operate machinery.

Clopidogrel Esseti contains isomalt and sucrose

This medicine contains isomalt. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Clopidogrel Esseti

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, even for patients with a condition called "atrial fibrillation" (an irregular heartbeat), is one 75 mg clopidogrel tablet daily, taken orally with or without food, at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe 300 mg or 600 mg of clopidogrel (one or two 300 mg tablets or four or eight 75 mg tablets) as a single dose at the start of treatment. Afterward, the recommended dose is one 75 mg clopidogrel tablet daily, as described above.

If you have experienced symptoms of a stroke that resolve within a short period of time (also known as transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe 300 mg of clopidogrel (one 300 mg tablet or four 75 mg tablets) as a single dose at the beginning of treatment. Afterward, the recommended dose is one 75 mg clopidogrel tablet daily, as described above, together with acetylsalicylic acid for 3 weeks. After this period, your doctor will prescribe either clopidogrel alone or acetylsalicylic acid alone.

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

If you take more Clopidogrel Esseti than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 5620420 (indicating the medicine and the amount ingested).

If you forget to take Clopidogrel Esseti

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

If you forget for more than 12 hours, simply take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

You can check the last day you took a Clopidogrel Esseti tablet by looking at the calendar printed on the blister pack.

If you stop taking Clopidogrel Esseti

Do not stop your treatment unless your doctor tells you to. 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 side effects

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

Contact your doctor immediately if you experience:

• fever, signs of infection, or extreme tiredness. These symptoms 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 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 Clopidogrel Esseti is bleeding. Bleeding may occur in the stomach or intestines, bruising, haematomas (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases have also been reported of: bleeding from blood vessels in the eyes, intracranial bleeding, pulmonary bleeding, or bleeding in joints.

If you experience prolonged bleeding while taking Clopidogrel Esseti

If you cut yourself or sustain a wound, it may take slightly longer than usual for the bleeding to stop. This is related to the mechanism of action of the medicine, as it prevents blood from forming clots. For minor cuts or wounds, such as those occurring during shaving, 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 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, excess gas in the stomach or intestines, skin rashes, itching, dizziness, tingling and 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 associated with cough; generalized allergic reactions (for example, a sensation of warmth with sudden general discomfort up to fainting); swelling of the mouth; blisters on the skin; skin allergy; inflammation of the mouth mucosa (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste.

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

In addition, your doctor may observe changes in the results of your blood or urine tests.

Reporting of side effects

If you experience any side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting side effects, you help provide more information on the safety of this medicine.

5. Storage of Clopidogrel Esseti

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 blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions. Store in the original packaging.

Do not use Clopidogrel Esseti 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 will help protect the environment.

6. Contents of the pack and other information

Composition of Clopidogrel Esseti

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

The other components are isomalt (E 953), hydroxypropylcellulose (E 463), low-substituted hydroxypropylcellulose (E 463a), sucrose stearate in the tablet core, and hypromellose (E 464), macrogol 400, titanium dioxide (E 171), iron oxide red (E 172) in the tablet coating.

Appearance of the product and contents of the pack

Clopidogrel Esseti 75 mg tablets are round, biconvex-faced, and pink in colour.
They are presented in cardboard boxes containing 28 tablets in aluminum/aluminum blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
ESSETI FARMACEUTICI S.R.L.
Via Raffaele De Cesare, 7
Naples
Postal Code: 80132
Italy

Manufacturer:
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona, Spain

Date of the most recent review of this leaflet: February 2024