Clopidogrel Pensa 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clopidogrel pensa 75 mg film-coated tablets EFG

clopidogrel

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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 give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Clopidogrel pensa is and what it is used for
2. What you need to know before taking Clopidogrel pensa
3. How to take Clopidogrel pensa
4. Possible side effects
5. How to store Clopidogrel pensa
6. Contents of the pack and other information

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

Clopidogrel pensa belongs to a group of medicines called antiplatelet agents. Platelets are very small blood cells that clump together when blood clots. Antiplatelet medicines prevent this clumping, thereby reducing the likelihood of blood clots (a process known as thrombosis).

Clopidogrel pensa is used to help prevent blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).

You have been prescribed this medicine to help prevent blood clots and reduce the risk of these serious events because:

• you have a condition that causes hardening of the arteries (also known as atherosclerosis), and
• you have previously had a heart attack, stroke, or you have a condition called peripheral arterial disease, or
• you have experienced a type of severe chest pain known as “unstable angina” or “heart attack.” For the treatment of this condition, your doctor may have placed a stent (a small tube) in the blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed you acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clots).
• you have an irregular heartbeat, a condition called “atrial fibrillation,” and you cannot take medicines known as “oral anticoagulants” (vitamin K antagonists), which prevent the formation of new clots and stop existing clots from growing. You will have been informed that “oral anticoagulants” are more effective than acetylsalicylic acid or the combination of clopidogrel and acetylsalicylic acid for this condition. Your doctor will have prescribed clopidogrel plus acetylsalicylic acid if you cannot take “oral anticoagulants” and you have no risk of serious bleeding.

2. What you need to know before taking Clopidogrel pensa

Do not take Clopidogrel pensa

• If you are allergic (hypersensitive) to clopidogrel or to any of the other components of this medicine (listed in section 6);
• If you have active bleeding, such as a stomach ulcer or bleeding in the brain;
• If you suffer from severe liver disease.

If you think any of these conditions may apply to 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 (haemorrhage) because:

• You have a disease that involves a risk of internal bleeding (such as a stomach ulcer).

• You have a blood disorder that makes you prone to internal bleeding (bleeding into tissues, organs, or joints).

• You have recently suffered a serious injury.

• You have recently undergone surgery (including dental surgery).

• You are scheduled to undergo surgery (including dental surgery) within the next seven days.

  • If you have had a blood clot in a brain artery (ischaemic stroke) within the last 7 days.
  • If you have liver or kidney disease.
  • If you have had an allergy or reaction to any medicine used to treat your condition.

During treatment with Clopidogrel pensa:

• Inform your doctor if you have surgery scheduled (including dental surgery).
• Inform your doctor immediately if you develop a disorder (also known as thrombotic thrombocytopenic purpura or TTP) that includes fever and bruising (bruises) under the skin which may appear as localized red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).
• If you cut yourself or sustain a wound, bleeding may take longer than normal to stop. This is related to how the medicine works, as it prevents blood from forming clots. For minor cuts or wounds, such as during shaving, this is not significant. However, if you are concerned about blood loss, consult your doctor immediately (see section 4 “Possible side effects”).
• Your doctor may ask you to have blood tests.

Children and adolescents

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

Taking Clopidogrel pensa with other medicines

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

Some medicines may affect the use of Clopidogrel pensa or vice versa.

You should specifically inform your doctor if you are taking:

• Medicines that may increase the risk of bleeding such as:

  • Oral anticoagulants, medicines used to reduce blood clotting,
  • Non-steroidal anti-inflammatory drugs (NSAIDs), medicines generally used to treat pain and/or inflammation of muscles or joints,
  • Heparin, or any other injectable medicine used to reduce blood clotting,

• Ticlopidine, another antiplatelet agent,

• A serotonin reuptake inhibitor (such as fluoxetine or fluvoxamine and other drugs of the same type), medicines generally used for the treatment of depression,

• Rifampicin (used for serious infections),

• Omeprazole or esomeprazole, medicines used to treat stomach discomfort,

• Fluconazole or voriconazole, medicines used to treat fungal infections,

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

• Carbamazepine, a medicine used to treat certain forms of epilepsy,

• Moclobemide, a medicine for depression,

• Repaglinide, a medicine used to treat diabetes,

• Paclitaxel, a medicine used to treat cancer,

• Opioids: if you are being treated with clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain).

If you have experienced 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 medicines used to relieve pain and reduce fever. A single dose of acetylsalicylic acid (not exceeding 1,000 mg in 24 hours) should not cause any problems, but prolonged use under other circumstances should be discussed 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 medicine during pregnancy.

If you are pregnant or think you may be pregnant, you must inform your doctor or pharmacist before taking Clopidogrel pensa. If you become pregnant while taking Clopidogrel pensa, consult your doctor immediately, as clopidogrel is not recommended during pregnancy.

You must not breastfeed while taking this medicine.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It is unlikely that Clopidogrel pensa will impair your ability to drive or operate machinery.

Clopidogrel Pensa contains lactose

Clopidogrel Pensa contains lactose. Patients with hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

3. How to take Clopidogrel pensa

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose, including for patients with a condition called “atrial fibrillation” (an irregular heartbeat), is one 75 mg Clopidogrel pensa tablet daily, taken orally with or without food, at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe 300 mg of Clopidogrel pensa (4 tablets of 75 mg) to be taken once at the beginning of treatment. After this, the recommended dose is one 75 mg Clopidogrel pensa tablet daily, as described above.

You should continue taking Clopidogrel pensa for as long as your doctor prescribes it.

If you take more Clopidogrel pensa than you should

Contact your doctor or go to the nearest hospital emergency department, as there is an increased risk of bleeding.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Clopidogrel pensa

If you forget to take a dose of Clopidogrel pensa but remember within 12 hours of the time you were supposed to take it, take the tablet immediately and then take the next dose at the usual time.

If more than 12 hours have passed, 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 pensa

Do not stop your treatment unless your doctor tells you to do so. Contact 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience:

• fever, signs of infection, or extreme tiredness. These symptoms may be due to a rare decrease in certain blood cells.

• signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding appearing under the skin as red spots 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 may be signs of an allergic reaction.

The most common adverse effect reported with clopidogrel is bleeding. Bleeding may occur in the stomach or intestines, bruising, haematomas (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases have also been reported of: bleeding from blood vessels in the eyes, intracranial bleeding, pulmonary bleeding, or bleeding into joints.

If you experience prolonged bleeding while taking Clopidogrel pensa

If you cut yourself or sustain a wound, it may take longer than usual for the bleeding to stop. This is related to the mechanism of action of the medicine, as it prevents blood from forming clots. For minor cuts or wounds, such as those occurring during shaving, this is usually not a concern. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 “Warnings and precautions”).

Other adverse effects include:

Frequent adverse effects (may affect up to 1 in 10 people): Diarrhoea, abdominal pain, indigestion or heartburn.

Uncommon adverse effects (may affect up to 1 in 100 people): headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, skin rashes, itching, dizziness, tingling and numbness.

Rare adverse effects (may affect up to 1 in 1,000 people): dizziness, breast enlargement in men.

Very rare adverse 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, a sensation of warmth with sudden general discomfort up to fainting); swelling of the mouth; blisters on the skin, skin allergy; inflammation of the mucous membrane of the mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste or loss of taste.

Adverse 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 observe changes in the results of your blood or urine tests.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clopidogrel Pensa

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

Do not store above 30°C.

Store in the original packaging to protect it from moisture.

Do not use Clopidogrel Pensa after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Clopidogrel pensa

The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as clopidogrel besylate).

The other components are:

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

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

Appearance of the product and contents of the container

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

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

Only some pack sizes may be commercially available.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer responsible for manufacturing:

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

Via Grignano, 43

24041 Brembate, Italy

Date of the most recent revision of this leaflet: March 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/