Package Leaflet: Information for the User

Clopidogrel pensa 75 mg Film-Coated Tablets

clopidogrel

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 only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Clopidogrel pensa

3. How to take Clopidogrel pensa

4. Possible side effects

5. Storage of Clopidogrel pensa

6. Contents of the pack and additional information

Clopidogrel pensa belongs to a group of medications known as antiplatelet agents. Platelets arevery 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 forming (a process known as thrombosis).

Clopidogrel pensa is administered 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).

This medication has been prescribed 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 arteriosclerosis), 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”. For the treatment of this disease, your doctor may need to place a stent (a small tube) 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 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 plus acetylsalicylic acid if you cannot take “oral anticoagulants” and do not have a high risk of severe bleeding

Do not take Clopidogrel pensa

• If you are allergic (hypersensitive) to clopidogrel or 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 taking Clopidogrel pensa.

Warnings and precautions

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

• If you are at risk of bleeding (hemorrhage) 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.

During treatment with Clopidogrel pensa:

• 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 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 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 childrenbecause it is not effective.

Taking Clopidogrel pensa 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 pensa or vice versa.

You should 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 clotting,
• nonsteroidal anti-inflammatory drugs (NSAIDs), medications used to treat pain and/or inflammation of muscles or joints,
• heparin, or any other injectable medication used to reduce blood clotting,

• -
• ticlopidine, another antiplatelet agent,
• an SSRI (selective serotonin reuptake inhibitor) (such as fluoxetine or fluvoxamine and other medications of the same type), 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),
• carbamazepine,a medication to treat certain forms of epilepsy,
• moclobemide, a medication for depression,
• repaglinide, a medication to treat diabetes,
• paclitaxel, a medication to treat cancer,
• opioids: if you are taking clopidogrel, inform your doctor before being prescribed any opioid (used to treat severe pain).

If you have had severe chest pain (unstable angina or myocardial infarction), you may have been prescribed Clopidogrel pensa in combination with acetylsalicylic acid, a substance present in many medications used to relieve pain and reduce fever. A single dose of acetylsalicylic acid administered sporadically (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.

Taking Clopidogrel pensa with food and drinks

Clopidogrel pensa can be taken with or without food.

Pregnancy and breastfeeding

It is preferable not to use this medication during pregnancy.

If you are pregnant or think you may be, inform your doctor or pharmacist before taking Clopidogrel pensa. If you become pregnant while taking Clopidogrel pensa, 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

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

Clopidogrel Pensa contains lactose

Clopidogrel Pensa contains lactose. Patients with lactose intolerance, total lactase deficiency, or problems with glucose or galactose absorption should not take 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 disease called "atrial fibrillation" (an irregular heart rhythm), is one 75 mg Clopidogrel pensa 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 of Clopidogrel pensa (4 tablets of 75 mg) for you to take once at the beginning of treatment.After that, the recommended dose is one 75 mg Clopidogrel pensa tablet per day as described above.

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

If you take more Clopidogrel pensa 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 forget to take Clopidogrel pensa

If you forget to take a dose of Clopidogrel pensa, 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 treatment with Clopidogrel pensa

Do not stop your treatmentunless 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 think

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.

Infrequent 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,gynecomastia in males.

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 cough; generalized allergic reactions(for example, generalized feeling of heat with sudden general malaise 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 orloss of taste of food.

Side effects of unknown frequency(cannot be estimated from available data): Hypersensitivity reactionswith 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, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: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 store at a temperature above30°C

Store in the original packaging to protect it from humidity

Do not useClopidogrel Pensaafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use Clopidogrel Pensa if you observe any visible signs of deterioration.

Medicines should not be disposed of through drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Clopidogrel pensa Composition

The active ingredient is clopidogrel. Each tablet contains 75 mg of clopidogrel (in the form of besilate).

The other components are:

Tablet core: pregelatinized cornstarch, microcrystalline cellulose, crospovidone type A, anhydrous colloidal silica, type 50 stearic acid.

Coating: carnauba wax, lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518), iron oxide red (E172).

Product appearance and container content

Clopidogrel pensa film-coated tablets are pink film-coated, round, biconvex tablets with an approximate diameter of 8.3mm.

Clopidogrel pensa is marketed in blisters of: 14, 28, 30, 50, 84, 90, and 100 film-coated tablets.

Only some container sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

FINE FOODS & PHARMACEUTICALS N.T.M.S.P.A.

Via Grignano, 43

24041 Brembate, Italy

Last review date of this leaflet: March 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/