Package Leaflet: Information for the User

Clopidogrel Viso Pharmaceutical 75 mg Film-Coated Tablets

Read this 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 and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

ClopidogrelViso Farmacéuticacontains clopidogrel and belongs to a group of medications called antiplatelet agents. Platelets are very small cells that are found in the blood, and they aggregate when the blood clots. Antiplatelet agents, by preventing this aggregation, reduce the possibility of blood clots (a process known as thrombosis) forming.

Clopidogrel is administered to prevent the formation of blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, and which can cause atherothrombotic effects (such as cerebral infarction, 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 process that produces the hardening of the arteries (also known as atherosclerosis), and
• You have previously experienced a myocardial infarction, a cerebral infarction, or suffer from a disease known as peripheral arterial disease, or
• You have experienced intense chest pain known as "unstable angina" or "myocardial infarction" (heart attack). Your doctor may have to place a stent in the blocked or narrowed artery to restore adequate 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, as well as to prevent blood clots from forming).
• You have experienced symptoms of a transient ischemic attack that disappear in a short period of time (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also administer acetylsalicylic acid from the first 24 hours.
• You have irregular heartbeats, a disease known as "atrial fibrillation", and cannot take medications known as "oral anticoagulants" (vitamin K antagonists) that prevent new clots from forming, from formation to prevention of existing clot growth. You should know that "oral anticoagulants" are more effective than acetylsalicylic acid or the combined use of clopidogrel and acetylsalicylic acid for this condition. Your doctor should have prescribed clopidogrel plus acetylsalicylic acid if you cannot take "oral anticoagulants" and do not have a high risk of severe bleeding.

Do not take Clopidogrel Viso Farmacéutica

• If you are allergic to clopidogrel or any of the other components of this medication (listed in section 6);
• If you have a medical condition that is causing active bleeding, such as a stomach ulcer or bleeding in the brain;
• If you have a severe liver disease.

If you think this may affect you, or if you have any doubts, consult your doctor before taking Clopidogrel Viso Farmacéutica.

Warnings and precautions

Inform your doctor before taking Clopidogrel Viso Farmacéutica if you are in any of the following situations:

• If you have a risk of bleeding (bleeding) because:

• You have a disease that involves an increased risk of internal bleeding (such as a stomach ulcer).
• You have a blood disorder that predisposes you to internal bleeding (bleeding in tissues, organs, or joints of the body).
• You have recently suffered a serious injury.
• You have recently undergone surgery (including dental surgery).
• You are scheduled to undergo surgery (including dental surgery) in the next seven days.

• If you have had a blood clot in a cerebral artery (ischemic stroke) in the last 7 days.
• If you have liver or kidney disease.
• If you have had an allergy or reaction to a medication used to treat your disease
• If you have a history of non-traumatic cerebral hemorrhage.

During treatment with Clopidogrel Viso Farmacéutica:

• 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) that includes fever and hematomas (bruises) under the skin that may appear as localized red spots, with or without extreme fatigue, confusion, yellow discoloration of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• If you cut or injure yourself, bleeding may take longer to stop than usual. This is related to the way the medication works, as it prevents the blood from forming clots. For minor cuts or injuries, such as cutting during shaving, this is not a concern. However, if you are concerned about your bleeding, consult your doctor immediately (see section 4 "Possible side effects").
• Your doctor may ask you to have blood tests.

Children and adolescents

Clopidogrel Viso Farmacéutica should not be administered to children or adolescents.

Other medications and Clopidogrel Viso Farmacéutica

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 medications may affect the use of Clopidogrel Viso Farmacéutica or vice versa.

You must inform your doctor explicitly if you are taking:

• Medications that may increase the risk of bleeding, such as:
• Oral anticoagulants, medications used to reduce blood coagulation,
• Non-steroidal anti-inflammatory drugs, medications used to treat pain and/or inflammation of muscles or joints,
• Heparin, or any other injectable medication used to reduce blood coagulation,
• Ticlopidine, or other antiplatelet agents,
• Selective serotonin reuptake inhibitors (including but not limited to fluoxetine or fluvoxamine), medications used to treat depression,
• Rifampicin (used to treat serious infections)
• Omeprazole or esomeprazole, medications to treat stomach discomfort,
• Fluconazole or voriconazole, medications to treat fungal infections.
• Efavirenz, or other antiretroviral medications (used to treat HIV infections),
• Moclobemide, medication to treat depression,
• Carbamazepine, medication to treat some forms of epilepsy,
• Repaglinide, medication to treat diabetes,
• Paclitaxel, medication to treat cancer.
• Opioids: If you are taking clopidogrel, inform your doctor before being prescribed 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 should have been prescribed Clopidogrel Viso Farmacéutica in combination with acetylsalicylic acid, a substance present in many medications used to relieve pain and reduce fever. An occasional dose of acetylsalicylic acid (not exceeding 1,000 mg in 24 hours) should not cause any problems, but prolonged use in other circumstances should be consulted with your doctor.

Use of Clopidogrel Viso Farmacéutica with food and beverages

Clopidogrel Viso Farmacéutica can be taken with or without food.

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

If you become pregnant while taking Clopidogrel Viso Farmacéutica, consult your doctor immediately, as it is not recommended to take clopidogrel during pregnancy.

You should not breastfeed while taking this medication.

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Clopidogrel Viso Farmacéutica contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose, even for patients with a condition called "atrial fibrillation" (an irregular heart beat), is one 75 mg Clopidogrel Viso Farmacéutica tablet per day, administered orally with or without food and at the same time every day.

If you have experienced intense chest pain (unstable angina or myocardial infarction), your doctor may prescribe 300 mg or 600 mg of clopidogrel (4 or 8 tablets of 75 mg) once at the beginning of treatment. Then, the recommended dose is one 75 mg clopidogrel tablet per day.

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 Viso Farmacéutica (4 tablets of 75 mg) once at the beginning of treatment. After that, the recommended dose is one 75 mg Clopidogrel Viso Farmacéutica tablet per day as described above with acetylsalicylic acid for 3 weeks. After that, your doctor will prescribe either Clopidogrel Viso Farmacéutica alone or acetylsalicylic acid alone.

You should take clopidogrel for the time your doctor continues to prescribe it.

If you take more Clopidogrel Viso Farmacéutica than you should

Contact your doctor or go to the nearest hospital emergency service, as there is a higher risk of bleeding.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 (indicating the medication and the amount ingested).

If you forgot to take Clopidogrel Viso Farmacéutica

If you forget to take a dose of clopidogrel, but remember before 12 hours have passed since the time you should have taken the medication, take the tablet immediately and the next one 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 compensate for the missed dose.

If you interrupt the treatment with Clopidogrel Viso Farmacéutica

Do not interrupt your treatment unless your doctor tells you to.Contact your doctor or pharmacist before stopping this medication.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Contact your doctor immediately if you experience:

• Fever, signs of infection, or severe fatigue. These symptoms may be due to a rare decrease in some blood cells.
• 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 red spots and/or confusion (see section 2 Warnings and precautions).
• Swelling of the mouth or skin disorders such as hives and itching, blisters on the skin. These may be signs of an allergic reaction.

The most frequent side effect reported with Clopidogrel Viso Farmacéuticais bleeding.

Bleeding may appear in the stomach or intestine, bruises, hematomas (abnormal bleeding or bruises under the skin), nasal bleeding, blood in urine. Also, a reduced number of cases of: bleeding of the blood vessels of the eyes, intracranial, pulmonary, or joint bleeding have been reported.

If you experience prolonged bleeding while taking Clopidogrel Viso Farmacéutica

If you cut or get a wound, it is possible that bleeding may take a little longer than usual to stop. This is related to the mechanism of action of the medicine, as it prevents the blood's ability to form clots. For minor cuts or wounds, such as cutting during shaving, this usually does not matter. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 “Be especially careful with ClopidogrelViso Farmacéutica”).

Other side effects include:

Frequent side effects (affect more than 1 in 10 patients):

Diarrhea, abdominal pain, indigestion, or heartburn.

Rare side effects (affect more than 1 in 100 patients):

Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestine, rashes, itching, blisters on the skin.

Side effects that are rare (affect more than 1 in 1,000 patients):

Dizziness, breast enlargement in men.

Very rare side effects (affect less than 1 in 10,000 patients):

Jaundice, severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes associated with cough; generalized allergic reactions; swelling of the mouth; blisters on the skin, skin allergy; inflammation of the mucous membrane of the mouth (stomatitis); decreased 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 available data):

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

Your doctor may also observe changes in your 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 packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

See storage conditions on the packaging.

Store below 25 °C.

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

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Clopidogrel Viso Pharmaceutical Composition

• The active ingredient is clopidogrel. Each film-coated tablet contains 75 mg of clopidogrel (as besilate).

• The other components are:

Tablet core: microcrystalline cellulose (E460), mannitol (E421), hydroxypropyl cellulose (E463), crospovidone (E1202), citric acid monohydrate (E330), macrogol 6000 (E1521), stearic acid (E570), talc (E553b)

Tablet coating: hypromellose (E464), lactose monohydrate, iron oxide red (E172), triacetin (E1518), titanium dioxide (E171).

Product appearance and packaging contents

Clopidogrel Viso Pharmaceutical tablets are pink, round, and biconvex. They are supplied in PVC/PE/PVDC/Aluminum blisters packaged in cardboard containers containing

14, 28, 30, 50, 56, 84, 90, 98, 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31,

82194 Gröbenzell,

Germany

Manufacturer:

Pharmathen S.A

6 Dervenakion

Pallini Attiki

15351 Greece

Alternative manufacturer:

Pharmathen International S.A.

Industrial Park Sapes,

Rodopi Prefecture,

Block No 5, Rodopi

69300, Greece

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7th Floor,

28045 Madrid,

Spain

This medication is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

DenmarkClopidogrel Pharmaten

ItalyCLOPIDOGREL Doc Generici

SpainClopidogrel Viso Pharmaceutical 75 mg film-coated tablets EFG

United KingdomClopidogrel 75 mg film-coated tablets

(Northern Ireland)

Last review date of this leaflet:November 2023

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