Clopidogrel Tecnigen 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the

Clopidogrel TecniGen 75 mg film-coated tablets EFG

Clopidogrel

Read the entire leaflet carefully before you start taking this medicine:

• 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 other people, even if they have the same symptoms as you, because it could harm them.
• If you think any of the side effects you experience is serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Clopidogrel TecniGen 75 mg is and what it is used for
2. Before you take Clopidogrel TecniGen 75 mg
3. How to take Clopidogrel TecniGen 75 mg
4. Possible side effects
5. How to store Clopidogrel TecniGen 75 mg

Additional information

1. What Clopidogrel TecniGen 75 mg is and what it is used for

Clopidogrel TecniGen 75 mg belongs to a group of medicines called antiplatelet agents. Platelets are blood components smaller than red or white blood cells, and they clump together when blood clots. Antiplatelet medicines reduce the chance of blood clots (a process known as thrombosis) by preventing this clumping.

Clopidogrel TecniGen 75 mg is given to prevent the formation of blood clots (thrombi) in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, myocardial infarction, or death).

Your doctor has prescribed Clopidogrel TecniGen 75 mg to help prevent blood clots and reduce the risk of these serious events because:

• You have a condition causing hardening of the arteries (also known as atherosclerosis), and
• You have previously had a heart attack, stroke, or you have a disease called peripheral arterial disease, or

2. Before taking Clopidogrel TecniGen 75 mg

Do not take Clopidogrel TecniGen 75 mg:

• If you are allergic (hypersensitive) to clopidogrel or to any of the other components of Clopidogrel TecniGen 75 mg;
• 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 may apply to you, or if you have any doubts, consult your doctor before taking Clopidogrel TecniGen 75 mg.

Take special care with Clopidogrel TecniGen 75 mg:

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

• If you are at risk of bleeding 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 more 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 seven days.

• If you are taking other types of medicines (see “Use of other medicines”).

• If you have liver or kidney disease.

During treatment with Clopidogrel TecniGen:

• Inform your doctor if you have scheduled surgery (including dental surgery).

• Inform your doctor immediately if you develop a disorder involving fever and bruising (bruises) under the skin, which may appear as localized red spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “POSSIBLE ADVERSE EFFECTS”).

• If you get a cut or injury, bleeding may take longer than usual to stop. This is related to how the medicine works, as it reduces the blood’s ability to form clots. For minor cuts or injuries, such as during shaving, this is not significant. However, if you are concerned about blood loss, consult your doctor immediately (see section 4 “POSSIBLE ADVERSE EFFECTS”).

• Your doctor may ask you to have blood tests.

• Inform your doctor or pharmacist if you notice any adverse effects not listed in section 4 “POSSIBLE ADVERSE EFFECTS”, or if you notice that any adverse effects worsen.

Clopidogrel TecniGen 75 mg should not be given to children or adolescents.

Taking clopidogrel with other medicines:

Some medicines may affect the use of Clopidogrel TecniGen 75 mg or vice versa.

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

The concomitant administration of Clopidogrel TecniGen 75 mg with oral anticoagulants (medicines used to reduce blood clotting) is not recommended.

You must specifically inform your doctor if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), medicines generally used to treat pain and/or inflammation of muscles or joints, or if you are taking heparin, or any other medicine used to reduce blood clotting, or if you are taking a proton pump inhibitor (e.g., omeprazole) for stomach discomfort, or if you are taking ticlopidine, another antiplatelet agent, or if you are taking antiretrovirals (medicines to treat HIV infection).

An occasional 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 with food and drinks:

Clopidogrel TecniGen 75 mg can be taken with or without food.

Pregnancy and breastfeeding:

It is preferable not to use this medicine during pregnancy and breastfeeding.

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

If you are taking Clopidogrel TecniGen, consult your doctor about breastfeeding. Consult your doctor or pharmacist before using any medicine.

Driving and using machines:

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

Important information about some of the components of Clopidogrel TecniGen 75 mg:

Clopidogrel TecniGen 75 mg contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Clopidogrel TecniGen 75 mg

Follow exactly the instructions for use of Clopidogrel TecniGen 75 mg as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

The usual dose is one 75 mg Clopidogrel TecniGen tablet daily, taken orally, with or without food, at the same time each day.

You should take Clopidogrel TecniGen 75 mg for as long as your doctor prescribes it.

If you take more Clopidogrel TecniGen 75 mg 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 at telephone: 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to take Clopidogrel TecniGen 75 mg:

If you forget to take a dose of Clopidogrel TecniGen 75 mg but remember within 12 hours of the scheduled time, take the tablet immediately and then take the next dose 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 make up for the missed dose.

If you stop taking Clopidogrel TecniGen 75 mg:

Do not stop your treatment. Contact your doctor or pharmacist before discontinuing 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, Clopidogrel TecniGen 75 mg can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately if you experience:

??Fever, signs of infection, or severe fatigue. These symptoms may be due to a rare reduction 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 “Take special care with Clopidogrel TecniGen 75 mg”).

??Swelling of the mouth or skin disorders such as rash and itching, blisters on the skin. These may be signs of an allergic reaction.

The most frequently reported adverse effect with Clopidogrel TecniGen 75 mg (affecting between 1 and 10 out of every 100 patients) is bleeding. Bleeding may occur in the stomach or intestines, bruising, haematomas (abnormal bleeding or bruising under the skin), nosebleeds, blood in the urine. A small number of cases have also been reported of: bleeding from blood vessels in the eyes, intracranial bleeding, pulmonary bleeding, or joint bleeding.

If you experience prolonged bleeding while taking Clopidogrel TecniGen 75 mg

If you cut yourself or sustain an injury, bleeding may take slightly longer than normal to stop. This is related to the mechanism of action of the medicine, as it prevents blood from forming clots. For minor cuts or injuries, such as during shaving, this is usually not a concern. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 “Take special care with Clopidogrel TecniGen 75 mg”).

Other adverse effects reported with Clopidogrel TecniGen 75 mg are:

Frequent adverse effects (affecting between 1 and 10 out of every 100 patients): Diarrhoea, abdominal pain, indigestion or heartburn.

Uncommon adverse effects (affecting between 1 and 10 out of every 1,000 patients): headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, skin rashes, itching, dizziness, tingling and numbness.

Rare adverse effects (affecting between 1 and 10 out of every 10,000 patients): dizziness.

Very rare adverse effects (affecting fewer than 1 out of every 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 mouth mucosa (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste; eosinophilic pneumonia; acquired haemophilia A.

Adverse effects with unknown frequency (cannot be estimated from available data): hypersensitivity reactions.

In addition, your doctor may observe changes in the results of your blood or urine tests.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult 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 TecniGen 75 mg

Keep out of the reach and sight of children.

Do not use Clopidogrel TecniGen 75 mg after the expiry date stated on the carton and blister.

This medicine does not require any special storage conditions.

Do not use Clopidogrel TecniGen 75 mg if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and their packaging properly. This will help protect the environment.

6. Information for the user

Composition of Clopidogrel TecniGen 75 mg:

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

The other components are Core: anhydrous lactose, pregelatinized corn starch, polyethylene glycol (PEG 6000), microcrystalline cellulose, hydrogenated cottonseed vegetable oil. Coating (Opadry II Pink 33G34629): hypromellose, titanium dioxide (E-171), lactose monohydrate, macrogol, triacetin, iron oxide red (E-172).

Appearance of the medicinal product and contents of the pack:

Clopidogrel TecniGen 75 mg are film-coated tablets, round and pink in colour.

They are supplied in cardboard packs containing 28, 50 or 84 tablets in blisters made of PCTFE+PE+PVC/Alu.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Tecnimede España Industria Farmacéutica, S.A.
Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,
28108 Alcobendas (Madrid) SPAIN

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA
Rua da Tapada Grande nº 2, Abrunheira. 2710 – 089 Sintra (Portugal).

This leaflet was approved in June 2019

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.es/