Clopidogrel Opko 75 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopidogrel OPKO 75 mg film-coated tablets EFG

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, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Clopidogrel OPKO tablets are and what they are used for
2. What you need to know before taking Clopidogrel OPKO
3. How to take Clopidogrel OPKO
4. Possible side effects
5. How to store Clopidogrel OPKO
6. Package contents and other information

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

Clopidogrel OPKO contains clopidogrel and belongs to a group of medicines called platelet aggregation inhibitors. Platelets are very small components in the blood that clump together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the chances of blood clots forming (a process known as thrombosis).

Clopidogrel is given to adults to help prevent blood clots (thrombi) from forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack 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 that hardens the arteries (also known as atherosclerosis), and
• You have a history of heart attack, stroke, or a disease known as peripheral arterial disease, or
• You have experienced severe chest pain known as 'unstable angina' or 'myocardial infarction' (heart attack). To treat this condition, your doctor may have inserted a stent into the blocked or narrowed artery to restore effective blood flow. Your doctor may also have prescribed you acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, and also to prevent blood clots).
• You have experienced stroke symptoms that disappeared within a short period of time (also known as transient ischaemic attack) or a mild ischaemic stroke. Your doctor may also give you acetylsalicylic acid during the first 24 hours.
  • You have an irregular heartbeat, a condition known as 'atrial fibrillation', and you cannot take medicines known as 'oral anticoagulants' (vitamin K antagonists) that prevent the formation of new clots and the growth of existing ones. You should have been informed that 'oral anticoagulants' are more effective in treating this condition than acetylsalicylic acid or the combination of clopidogrel and acetylsalicylic acid. Your doctor should prescribe clopidogrel with 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 Clopidogrel OPKO

Do not take Clopidogrel OPKO

? If you are allergic (hypersensitive) to clopidogrel or to any of the components of this
medication (listed in section 6).

? If you have a condition that is currently causing you to bleed, such as a stomach ulcer or cerebral hemorrhage.

? If you have severe liver disease.

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

Warnings and precautions

If you are in any of the situations listed below, you must inform your doctor before taking clopidogrel:

? if you are at risk of bleeding, such as

• a condition that makes you prone to internal bleeding (such as a stomach ulcer);
• a blood disorder that predisposes you to internal hemorrhages (bleeding inside tissues, organs, or joints of the body);
• a recent severe injury;
• a recent surgical procedure (including dental surgery);
• a planned surgical procedure (including dental surgery) within the next seven days.

? If you have had a blood clot in a brain artery (ischemic stroke) within the last seven 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 cerebral hemorrhage.

While taking Clopidogrel OPKO

? You must inform your doctor if you have a surgical procedure (including dental surgery) scheduled.

? You should also inform your doctor immediately if you develop a condition (known as thrombotic thrombocytopenic purpura or TTP) that presents with fever and bruising (bruises) under the skin, which may appear as tiny red spots, with or without unexplained excessive fatigue, confusion, or yellowing of the skin and eyes (jaundice) (see section 4 'Possible side effects').

? If you get a cut or injury, it may take longer than usual to stop bleeding. This is due to the mechanism of action of your medication, which inhibits the blood's ability to form clots. Minor cuts or injuries, such as shaving or minor cuts, are usually not a cause for concern. However, if you are concerned about your bleeding, you should call your doctor immediately (see section 4 'Possible side effects').

? Your doctor may request blood tests.

Children and adolescents

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

Other medicines and Clopidogrel OPKO

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 other medicines may affect the use of Clopidogrel OPKO or may be affected by this medication.

You must specifically inform your doctor if you are taking

• medicines that may increase the risk of bleeding, such as:

  • oral anticoagulants, which are medicines that reduce blood clotting,

• a non-steroidal anti-inflammatory drug, usually prescribed to treat painful or inflammatory conditions 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)

• medicines for stomach discomfort, such as omeprazole or esomeprazole,

• medicines for fungal infections, such as fluconazole or voriconazole,

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

• a medicine to treat certain forms of epilepsy such as carbamazepine,

• moclobemide, a medicine for depression,

• repaglinide, a medicine for the treatment of diabetes,

• paclitaxel, a medicine for the treatment of cancer.

• opioids: if you are being treated with 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 experienced severe chest pain (unstable angina or heart attack), transient ischemic attack, or mild to moderate ischemic stroke, you may be prescribed Clopidogrel OPKO in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. Occasional use of acetylsalicylic acid (up to 1000 mg in any 24-hour period) should not cause problems, but it is important that you consult your doctor about prolonged use on other occasions.

Taking Clopidogrel OPKO with food and drink

Clopidogrel may be taken with or without food.

Pregnancy and breastfeeding

It is recommended not to take this medication during pregnancy.

If you are or suspect you are pregnant, you should consult your doctor or pharmacist before taking clopidogrel. If you become pregnant while being treated with Clopidogrel OPKO, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

Do not breastfeed while taking this medication.

If you are breastfeeding or planning to breastfeed, talk to your doctor before taking this medication.

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

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

Clopidogrel OPKO 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 medication.

Clopidogrel OPKO contains hydrogenated castor oil

This may cause stomach discomfort and diarrhea.

3. How to take Clopidogrel OPKO

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

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 (1 or 2 tablets of 300 mg or 4 or 8 tablets of 75 mg) to be taken once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg clopidogrel tablet daily, as described above.

If you have experienced stroke symptoms that disappear 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 (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 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.

Take clopidogrel for as long as your doctor continues to prescribe it.

If you take more Clopidogrel OPKO than you should

Call your doctor or go to the nearest hospital emergency department, as you will have 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 91 562 0420.

If you forget to take Clopidogrel OPKO

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

If more than 12 hours have passed since the missed dose, simply take the next dose at your regular time. Do not take a double dose to make up for the missed dose.

If you stop taking Clopidogrel OPKO

Do not stop taking your medicine unless your doctor tells you to. Consult your doctor or pharmacist before stopping this medicine.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not in everyone.

Consult your doctor immediately if you experience:

• fever, signs of infection, or excessive tiredness. This may be due to a decrease in certain blood cells, which occurs rarely.
• signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing under the skin as tiny 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.

Bleeding is the most frequently reported adverse reaction with Clopidogrel OPKO. Bleeding may present as bleeding in the stomach or intestines, bruising (bruises or unusual bleeding under the skin), nosebleeds, or blood in the urine. In a small number of cases, bleeding in the eye, inside the head, lungs, or joints has also been reported.

If you experience prolonged bleeding while taking Clopidogrel OPKO.

If you get a cut or wound, it may take longer than usual for the bleeding to stop. This is due to the mechanism of action of your medicine, as it inhibits the blood's ability to form clots. Minor cuts or injuries, such as those from shaving, are usually not a cause for concern. However, if you are worried about your bleeding, you should call your doctor immediately (see section 2 "Warnings and precautions").

Other adverse reactions reported for Clopidogrel OPKO are:

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

Diarrhea, abdominal pain, indigestion, or heartburn.

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

Headache, gastric ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestines, rashes, itching, dizziness, tingling or numbness sensations.

Rare adverse effects (may affect up to 1 in 1000 people):

Vertigo, breast enlargement in males.

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

Jaundice; severe abdominal pain, which may or may not be accompanied by lower back pain; fever, breathing difficulties sometimes associated with cough; generalized allergic reactions (for example, a sensation of warmth with sudden general discomfort up to fainting); swelling of the mouth; skin blisters; skin allergy; inflammation of the mouth mucosa (stomatitis); drop in 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.

Additionally, your doctor may identify changes in blood or urine test results.

Reporting of adverse effects:

If you experience any type of 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 via the Spanish Pharmacovigilance System for Human Medicinal Products:

https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clopidogrel OPKO

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack, following the word "Exp". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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 will help protect the environment.

6. Contents of the pack and other information

Composition of Clopidogrel OPKO

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

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

Core: lactose monohydrate, low-substituted hydroxypropylcellulose, colloidal anhydrous silica, hydrogenated castor oil, dimethicone

Coating: hypromellose (E464), macrogol 400, titanium dioxide (E171), iron oxide red (E172)

Appearance of Clopidogrel OPKO

Clopidogrel OPKO tablets are round, pink-colored, biconvex, film-coated tablets, marked with "LII" on one side and smooth on the other.

Packaging contents of Clopidogrel OPKO

The tablets are supplied in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

OPKO HEALTH SPAIN, S.L.U.

Pl. Europa 13-15, 08908

L’Hospitalet de Llobregat (Barcelona)

Spain

Manufacturer

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, Swarzedz,

62-020,

Poland

Or

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind. Zona Franca,

08040, Barcelona,

Spain

Date of latest revision of this leaflet: January 2026

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/