Clopidogrel Kern Pharma 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopidogrel Kern Pharma 75 mg film-coated tablets EFG

Package leaflet contents:

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

1. What Clopidogrel Kern Pharma is and what it is used for

Clopidogrel Kern Pharma belongs to a group of medicines known as 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 called thrombosis).

Clopidogrel is given to 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 the formation of 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 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 adequate 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 clots).
• you have experienced symptoms of a stroke that disappeared within a short period of time (also known as a 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 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 clopidogrel and acetylsalicylic acid for this condition. Your doctor will have prescribed clopidogrel plus acetylsalicylic acid if you cannot take "oral anticoagulants" and have no risk of serious bleeding.

2. What you need to know before starting to take Clopidogrel Kern Pharma

Do not take Clopidogrel Kern Pharma

• 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 may apply to you, or if you have any doubts, consult your doctor before taking Clopidogrel Kern Pharma.

Warnings and precautions Before starting treatment with Clopidogrel Kern Pharma, inform your doctor if you are in any of the following situations:

• If you are at risk of experiencing bleeding (haemorrhage) because:
  • You have a condition 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 need to undergo surgery (including dental surgery) within the next seven days.
• If you have had a blood clot in a brain artery (ischaemic 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 haemorrhage.

During treatment with Clopidogrel Kern Pharma:

• Inform your doctor if you have scheduled 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, yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).
• If you cut yourself or sustain a wound, bleeding may take longer than normal to stop. This is related to how the medicine works, as it prevents blood from forming clots. For minor cuts and wounds, 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

Clopidogrel Kern Pharma must not be given to children because it is not effective.

Taking Clopidogrel Kern Pharma with other medicines

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 Kern Pharma or vice versa.

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicines, including those obtained without a prescription.

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 usually 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 (medicines for treating HIV infections),

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

• Moclobemide, a medicine for depression,

• Repaglinide, a medicine for treating diabetes,

• Paclitaxel, a medicine for treating 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 ischaemic attack, or mild ischaemic stroke, you may have been prescribed Clopidogrel Kern Pharma 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 Kern Pharma with food and drinks

Clopidogrel Kern Pharma may be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to use this medicine during pregnancy.

If you are pregnant or think you may be pregnant, you must inform your doctor or pharmacist before taking Clopidogrel Kern Pharma. If you become pregnant while taking Clopidogrel Kern Pharma, 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 Clopidogrel Kern Pharma will impair your ability to drive or operate machinery.

Clopidogrel Kern Pharma contains lactose

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

3. How to take Clopidogrel Kern Pharma

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist.

The recommended dose, including for patients with a condition called “atrial fibrillation” (an irregular heartbeat), is one 75 mg clopidogrel tablet taken orally once daily, 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 an initial single dose of 300 mg or 600 mg of clopidogrel (4 or 8 tablets of 75 mg). After this, the recommended dose is one 75 mg clopidogrel tablet per day as described above.

If you have experienced symptoms of a stroke that resolve within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe an initial single dose of 300 mg clopidogrel (4 tablets of 75 mg). After this, 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 continue taking clopidogrel for as long as your doctor prescribes it.

If you take more Clopidogrel Kern Pharma than you should

In case of overdose or accidental ingestion, contact the Toxicology Information Service by telephone at 91 562 04 20 (indicating the medicine and the amount ingested).

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

If you forget to take Clopidogrel Kern Pharma

If you forget to take a dose of clopidogrel but remember within 12 hours of the scheduled time, 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 regular time. Do not take a double dose to make up for a missed tablet.

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

If you stop taking Clopidogrel Kern Pharma

Do not stop your treatment unless your doctor advises you to do so. 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, Clopidogrel Kern Pharma can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience:

• Fever, signs of infection, or extreme fatigue. 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 Kern Pharma 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, pulmonary or joint bleeding.

If you experience prolonged bleeding while taking Clopidogrel Kern Pharma

If you cut yourself or sustain a wound, it may take 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 problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 “Warnings and precautions”).

Other adverse effects 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, skin rashes, itching, dizziness, tingling and numbness.

Rare adverse effects (may affect up to 1 in 1,000 people): vertigo, 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 (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); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (Website: www.notificaRAM.es).

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clopidogrel Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clopidogrel Kern Pharma

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

The other components are:

• Tablet core: anhydrous lactose, microcrystalline cellulose (E-460i), crospovidone, glycerol dibehenate and talc.
• Tablet coating: polyvinyl alcohol, talc, titanium dioxide (E-171), macrogol 3350, soybean lecithin and red iron oxide (E-172).

Appearance of the medicinal product and contents of the pack

Film-coated, round, biconvex tablets, pink in colour.

Packaged in aluminium-aluminium blisters containing 28, 50 or 84 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Kern Pharma, S.L.

Venus, 72 – Polígono Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 – Polígono Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

Actavis Limited

BLB015-016 Bulebel Industrial Estate,

ZTN3000, Zejtun

Malta

Date of latest revision of this leaflet: March 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)