Prospect: information for the user

Clopidogrel Qualigen 75 mg film-coated tablets

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

2. What you need to know before starting to take Clopidogrel Qualigen.

3. How to take Clopidogrel Qualigen.

4. Possible adverse effects.

5. Storage of Clopidogrel Qualigen.

6. Contents of the package and additional information.

Clopidogrel Qualigen contains clopidogrel and belongs to a group of medications known as 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 likelihood of blood clots (a process known as thrombosis) forming.

Clopidogrel is administered to adults to prevent the formation of blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, and which may 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 a severe type of chest pain, known as “unstable angina” or “myocardial infarction”. 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 found in many medications used to relieve pain and reduce fever, as well as to prevent the formation of blood clots).
• you have experienced symptoms of a stroke 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 during the first 24 hours.
• you have an irregular heartbeat, 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 prevent the growth of existing clots. You have been told that “oral anticoagulants” are more effective than acetylsalicylic acid or the combined use of clopidogrel and acetylsalicylic acid for this disease. Your doctor has prescribed clopidogrel if you cannot take “oral anticoagulants” and do not have a high risk of severe bleeding.

Do not take Clopidogrel Qualigen:

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

• If you have an active bleeding, such as a stomach ulcer or brain hemorrhage.
• If you have a severe liver disease.

If you think this may affect you, or if you have any doubts, consult your doctor before starting to take Clopidogrel Qualigen.

Warnings and precautions

Before starting treatment with clopidogrel, inform your doctor if you are in any of the following situations:

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

• You have a disease that involves a 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 diseases.
• If you have had an allergy or reaction to any medication used to treat your disease.
• If you have a history of non-traumatic cerebral hemorrhage.

During treatment with clopidogrel:

• 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, accompanied or not by extreme fatigue, confusion, yellow discoloration of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• If you cut or get a wound, bleeding may take longer than usual to stop. This is related to the way the medication works, as it prevents the blood from forming clots. For minor cuts or wounds, such as cutting during shaving, this is not a problem. 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

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

Taking Clopidogrel Qualigen with other medications

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 or vice versa.

You must inform your doctor specifically 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 generally to treat pain and/or inflammation of muscles or joints,

heparin, or any other injectable medication, used to reduce blood coagulation.

ticlopidineor other antiplatelet agents.

• an SSRI (such as fluoxetine or fluvoxamine and other medications of the same type), medications used normally 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),

- carbamazepine, a medication to treat some forms of epilepsy),

- moclobemide, medication for depression,

- repaglinide, medication for diabetes treatment,

- paclitaxel, medication for cancer treatment,

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

- rosuvastatin (used to reduce cholesterol levels)

If you have had severe chest pain (unstable angina or myocardial infarction), transient ischemic attack, or mild ischemic stroke, you may have been prescribed this medication in combination with acetylsalicylic acid, a substance present in many medications used to relieve pain and reduce fever. A dose of acetylsalicylic acid administered sporadically (not exceeding 1,000 mg in 24 hours) generally should not cause any problems, but prolonged use in other circumstances should be consulted with your doctor.

Taking Clopidogrel Qualigen with food and drinks

This medication can be taken with and without food.

Pregnancy and breastfeeding

It is preferable not to take this medication during pregnancy.

If you are pregnant or think you may be, inform your doctor or pharmacist before taking this medication.

If you become pregnant while taking this medication, consult your doctor immediately since clopidogrel is not recommended 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

Clopidogrel is unlikely to affect your ability to drive or operate machinery.

Clopidogrel Qualigen contains isomalt and sucrose

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

This medication contains sucrose. If your doctor has indicated 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 tablet per day, administered 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 stroke that disappear in a short period of time (also known as transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe 300 mg of clopidogrel (1 300 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.

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

If you take more Clopidogrel Qualigen 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 5620420 (indicating the medication and the amount ingested).

If you forgot to take Clopidogrel Qualigen

If you forget to take a dose of this medication, 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.

In the 28 and 84 tablet format, you can check the last day you took a Clopidogrel Qualigen tablet by looking at the printed calendar on the blister pack.

If you interrupt treatment with Clopidogrel Qualigen

Do not stop 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 extreme 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 clopidogrelis bleeding. Bleeding can occur in the stomach or intestines, 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

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 medication, 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 "Warnings and precautions").

Other side effects include:

Frequent 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, and numbness.

Rare side effects (may affect up to 1 in 1,000 people):

Dizziness, breast enlargement in men.

Very rare side 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 coughing; 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); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste of food.

Side effects of 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 side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Pharmacovigilance of Medicines for Human Use:www.notificarm.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.

This medication does not require special storage conditions. Store in the original packaging.

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.Dispose of the packaging and medications you no longer need at the SIGRE collection pointat your pharmacy. Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Clopidogrel Qualigen Composition

• The active ingredient is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).
• The other components are isomalta (E 953), hydroxypropylcellulose (E 463), hydroxypropylcellulose with low substitution (E 463a), and stearate of sucrose in the tablet core and hypromellose (E 464), macrogol 400, titanium dioxide (E 171), iron oxide red (E 172) in the tablet coating.

Appearance of the product and contents of the packaging

Clopidogrel Qualigen 75 mg tablets are round, with biconvex faces and a pink color.

They are presented in cardboard boxes of 28, 50, and 84 tablets in aluminum/aluminum blisters.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Spain

Responsible manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Spain

Last review date of this leaflet: November 2023