CLOPIDOGREL OPKO 75 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopidogrel OPKO 75mg 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Clopidogrel OPKO and what is it 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. Contents of the pack and other information

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

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

Clopidogrel is given to adults to prevent blood clots (thrombi) in the blood vessels (arteries) that become hardened, a process known as atherothrombosis, which can cause atherothrombotic events (such as stroke, heart attack, or death).

You have been prescribed clopidogrel to 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 disease, your doctor may need to place an endovascular prosthesis (stent) in the blocked or narrowed artery to restore effective blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medications used to relieve pain and reduce fever, and also to prevent blood clots).
• You have experienced symptoms of a stroke that disappear within a short period (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also administer acetylsalicylic acid during the first 24 hours.
• You have an irregular heartbeat, a disease known as 'atrial fibrillation', and you cannot take medications 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 disease than acetylsalicylic acid or the combined use of clopidogrel and acetylsalicylic acid. Your doctor should administer clopidogrel with acetylsalicylic acid if you cannot take 'oral anticoagulants' and do not present a risk of severe bleeding.

2. What you need to know before taking Clopidogrel OPKO

Do not take Clopidogrel OPKO

? if you are allergic (hypersensitive) to clopidogrel or any of the other ingredients of this medicine (listed in section 6).

? if you have a disease that is currently causing bleeding, such as a stomach ulcer or cerebral hemorrhage.

? if you have severe liver disease.

If you think any of these apply to you, or if you are unsure, consult your doctor before taking Clopidogrel OPKO.

Warnings and precautions

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

? if you have a risk of bleeding, such as

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

? If you had a blood clot in an artery of the brain (ischemic stroke) in 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 disease.
• If you have had a history of non-traumatic cerebral hemorrhage.

While taking Clopidogrel OPKO

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

? You should also inform your doctor immediately if you have a disease (known as thrombotic thrombocytopenic purpura or TTP) that manifests with fever and bruising (bruises) under the skin that can be seen as small red dots, accompanied or not by excessive unexplained fatigue, confusion, yellowing of the skin and eyes (jaundice) (see section 4 'Possible side effects').

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

? Your doctor may prescribe blood tests.

Children and adolescents

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

Other medicines and Clopidogrel OPKO

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

You should inform your doctor, specifically, if you are taking

• medicines that may increase the risk of bleeding, such as:
• oral anticoagulants, which are medications that reduce blood clotting,

• a non-steroidal anti-inflammatory drug, which is usually indicated for painful or inflammatory conditions of muscles or joints,

• heparin or any other injectable medication used to reduce blood clotting,

• ticlopidine, or other antiplatelet agents,

• a serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other medications of the same type), medications used to treat depression,
• rifampicin (used for severe infections)

• medicines to treat stomach upset, such as omeprazole or esomeprazole,
• medicines to treat fungal infections, such as fluconazole or voriconazole,
• efavirenz, or other antiretroviral medications (used to treat HIV infections),

• medicines to treat some forms of epilepsy, such as carbamazepine,
• moclobemide, a medication for depression,
• repaglinide, a medication for diabetes,
• paclitaxel, a medication for cancer.
• opioids: if you are being treated with clopidogrel, you should inform your doctor before they prescribe you any opioid (used to treat severe pain),

rosuvastatin (used to reduce cholesterol levels).

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

Taking Clopidogrel OPKO with food and drinks

Clopidogrel can be taken with or without food.

Pregnancy and breastfeeding

It is recommended not to take this medicine during pregnancy.

If you are or think you may be pregnant, you should consult your doctor or pharmacist before taking clopidogrel. If you become pregnant during treatment with Clopidogrel OPKO, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

Do not breastfeed while taking this medicine.

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

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

It is unlikely that Clopidogrel OPKO will affect your ability to drive or use machines.

Clopidogrel OPKO contains lactose

If your doctor has told you that you have an intolerance to some sugars (e.g., lactose), consult them before taking this medicine.

Clopidogrel OPKO contains hydrogenated castor oil

This may cause stomach upset and diarrhea.

3. How to take Clopidogrel OPKO

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

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

If you have suffered severe chest pain (unstable angina or heart attack), your doctor may prescribe you 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 start of treatment. Afterward, the recommended dose is one 75 mg clopidogrel tablet per day as described above.

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

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

If you take more Clopidogrel OPKO than you should

Call your doctor or the emergency room of the nearest hospital because you have a higher risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 0420.

If you forget to take Clopidogrel OPKO

If you forget to take a dose of clopidogrel, but remember before 12 hours have passed since the time you should have taken the dose, take your tablet immediately and then take your next dose at the usual time.

If more than 12 hours have passed since the dose, simply take the next dose at the usual 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, ask your doctor or pharmacist.

4. Possible side effects

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

Consult your doctor immediately if you experience:

• fever, signs of infection, or excessive fatigue. This may be due to a decrease in some blood cells that occurs rarely.
• signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), associated or not with bleeding that appears under the skin as small red dots 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 can be signs of an allergic reaction.

Bleeding is the most common side effect reported with Clopidogrel OPKO.Bleeding can manifest as stomach or intestinal bleeding, bruising (bruises or unusual bleeding under the skin), nosebleeds, or blood in the urine. In a small number of cases, bleeding has also been reported in the eye, inside the head, lungs, or joints.

If you experience prolonged bleeding while taking Clopidogrel OPKO.

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

Other side effects reported for Clopidogrel OPKO are:

Common side effects (may affect up to 1 in 10 people):

Diarrhea, abdominal pain, indigestion, or heartburn.

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

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

Rare side effects

Dizziness, breast enlargement in men.

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

Jaundice; severe abdominal pain that may be accompanied by back pain; fever, breathing difficulties sometimes associated with cough; generalized allergic reactions (e.g., feeling of heat with sudden general discomfort leading to fainting); swelling of the mouth; blisters on the skin; skin allergy; inflammation of the mouth mucosa (stomatitis); low blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste of food.

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 identify changes in the results of blood or urine tests.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System:

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

5. Storage of Clopidogrel OPKO

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

Do not use this medicine after the expiration date that appears on the box and on the blister after the word Exp. The expiration date is the last day of the month indicated.

This medicine does not require 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. 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 ingredients are (see section 2 "Clopidogrel OPKO contains lactose" and "Clopidogrel OPKO contains hydrogenated castor oil"):

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

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

Appearance of Clopidogrel OPKO

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

Contents of the pack of Clopidogrel OPKO

The tablets are presented in blister packs of 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

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB,

United Kingdom

Or

Synoptis Industrial Sp. z o.o

ul. Rabowicka 15, Swarzedz,

62-020,

Poland

Or

STM Group SRL

Strada Provinziale Pianura 2

80078 Pozzuoli

Italy

Or

Laboratori Fundació Dau

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

08040, Barcelona,

Spain

Date of last revision of this leaflet: August 2023

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/