CONTENTS OF THE PACKAGE INSERT: INFORMATION FOR THE USER

Clopidogrel OPKO 75mg film-coated tablets EFG

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

-Keep this package insert as you may need to refer to it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribedonlyfor youand should not be given to others, even if they have the same symptomsas you, as it may harm them.

-If you experienceside effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

1.What Clopidogrel OPKO tablets are and what they are used for

2.What you need to knowbefore taking Clopidogrel OPKO

3.How to take Clopidogrel OPKO

4.Possible side effects

5.How to store Clopidogrel OPKO

6.Contents of the package inadditional information

Clopidogrel OPKO contains clopidogrel and belongs to a group of medications known as antiplatelet agents. Platelets are very small structures in the blood that come together during blood coagulation. By preventing this union, antiplatelet medications reduce the likelihood of blood clots forming (a process known as thrombosis).

Clopidogrel is administeredin adultsto prevent blood clots (thrombi) from forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can cause atherothrombotic episodes (such as stroke, heart attack, or death).

You have been prescribed clopidogrel to prevent blood clots from forming and reduce the risk of these severe 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 intense chest pain known as 'unstable angina' or 'myocardial infarction' (heart attack). To treat this disease, your doctor may need to place a stent (a vascular prosthesis) in the blocked or narrowed artery to restore effective blood flow. It is possible that your doctor has also prescribed acetylsalicylic acid (a substance present in many medications used to relieve pain and reduce fever, and also to prevent blood clots from forming).

-You have experienced symptoms of a transient ischemic attack that disappear within a short period of time (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 heart rhythm, a disease known as 'atrial fibrillation', and 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 for 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 have a high risk of severe bleeding.

Do not take Clopidogrel OPKO

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

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

?If you have severe liver disease.

If you think any of these cases 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 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 in the interior of tissues, organs, or joints of the body);

-A recent severe injury;

-A recent surgical intervention (including dental intervention);

-A scheduled surgical intervention (including dental intervention) in the next seven days.

?If you had a clot in a cerebral artery (ischemic stroke) in the last seven days.

?If you have a 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 must inform your doctor if you have a scheduled surgical intervention (including dental intervention).

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

?If you get a cut or a wound, 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, such as cutting yourself, shaving, are usually not a cause for concern. However, if you are concerned about bleeding, you should call your doctor immediately (see section 4 'Possible side effects').

?Your doctor may order blood tests.

Children and adolescents

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

Other medications and Clopidogrel OPKO

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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

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

-Medications that may increase the risk of bleeding, such as:

• Oral anticoagulants, which are medications that reduce blood coagulation,

• Non-steroidal anti-inflammatory drugs, which are usually indicated to treat painful or inflammatory muscle or joint conditions,

• Heparin or any other injectable medication used to reduce blood coagulation,

• Ticlopidine, or other antiplatelet agents,

• Inhibitors of serotonin reuptake (such as fluoxetine or fluvoxamine and other medications of the same type), which are used to treat depression,
• Rifampicin (used to treat severe infections)

-Medications to treat stomach discomfort, such as omeprazole or esomeprazole,

-Medications to treat fungal infections, such as fluconazole or voriconazole,

• Efavirenz, or other antiretroviral medications (used to treat HIV infections),

-Medication to treat some forms of epilepsy, such as carbamazepine,

-Moclobemide, medication for depression,

-Repaglinide, medication for diabetes treatment,

-Paclitaxel, medication for cancer treatment.

-Opioids: If you are taking clopidogrel, you must inform your doctor before they prescribe any opioid (used to treat intense pain),

-Rosuvastatin (used to reduce cholesterol levels).

If you have experienced intense chest pain (unstable angina or myocardial infarction), transient ischemic attack, or mild ischemic stroke, you may be prescribed Clopidogrel OPKO combined with acetylsalicylic acid, a substance present in many medications that are indicated to relieve pain and reduce fever. An occasional use of acetylsalicylic acid (up to 1000 mg in any 24-hour period) should not cause any problems, but it is essential to consult your doctor for prolonged use in other cases.

Taking Clopidogrel OPKO with food and drinks

Clopidogrel can be taken alone or with 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 during treatment with Clopidogrel OPKO, consult your doctor immediately, as it is not recommended to take clopidogrel during pregnancy.

Do not breastfeed while taking this medication.

If you are breastfeeding or plan to do so, talk to your doctor before taking this medication.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

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

Clopidogrel OPKO contains lactose

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

Clopidogrel OPKO contains hydrogenated ricin oil

This may cause stomach discomfort and diarrhea.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacistorpharmacist. 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 per day, taken orally with or without food and at the same time every day.

If you have experienced severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg or 600 mg of clopidogrel (1 or 2 300 mg tablets or 4 or 8 75 mg tablets) to be taken once at the beginning of treatment. After that, the recommended dose is one 75 mg clopidogrel tablet per day as described above.

If you have experienced symptoms of a transient ischemic attack (also known as a transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe 300 mg of clopidogrel (1 300 mg tablet or 4 75 mg tablets) once at the beginning of treatment. After that, the recommended dose is one 75 mg clopidogrel tablet per day as described above with acetylsalicylic acid for 3 weeks. After that, your 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 nearest hospital emergency room 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 were supposed to take the dose, take the 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 medication unless your doctor tells you that you can.Consult your doctor or pharmacist before stopping this medication.

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

Like all medicines, this medicine can cause side effects, although not in all people.

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 in rare cases.

-signs of liver problems, such as yellow discoloration 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. They may be signs of an allergic reaction.

Bleeding is the most frequent side effect reported with Clopidogrel OPKO.Bleeding can manifest as bleeding in the stomach or intestines, bruises (bruises or unusual bleeding under the skin), nasal bleeding, presence of blood in the urine. In a small number of cases, eye bleeding, bleeding inside the head, lungs, or joints have 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 to stop the bleeding. This is due to the mechanism of action of your medicine, which inhibits the ability to form blood clots. Minor cuts, such as cutting yourself while 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:

Side effects frequent (may affect up to 1 in 10 people):

Diarrhea, abdominal pain, indigestion or heartburn.

Side effects infrequent(may affect up to 1 in 100 people):

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

Side effects rare(may affect up to 1 in 1,000 people):

Dizziness, breast enlargement in men.

Side effects very rare(pmay affect up to 1 in 10,000 people):

Jaundice; intense abdominal pain that may be accompanied or not by back pain; fever, respiratory difficulties sometimes associated with cough; generalized allergic reactions (e.g., generalized feeling of heat with sudden general discomfort until fainting); swelling of 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 tasteor loss of tasteof food.

Side effects with unknown frequency (cannot be estimated from available data):

Hypersensitivity reactions with chest or abdominal pain, persistent symptoms of low blood sugar.

Your doctor may also identify changes in blood or urine test results.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:

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

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

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

This medication does not require special conditions for its conservation.

Do not use this medication if you observe any visible sign of deterioration.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Clopidogrel OPKO Composition

The active ingredient 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 ricin oil”:

Core: lactose monohydrate, low-substitution hydroxypropyl cellulose, anhydrous colloidal silica, hydrogenated ricin oil, dimethicone

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

Appearance of Clopidogrel OPKO

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

Content of the Clopidogrel OPKO container

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,

UK

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

Last reviewed date of this leaflet: August 2023

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/