CLOPIDOGREL TECNIGEN 75 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the

Clopidogrel TecniGen 75 mg film-coated tablets EFG

Clopidogrel

Read the entire leaflet carefully before starting to use the medication:

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

1. What is Clopidogrel TecniGen 75 mg and what is it used for
2. Before taking Clopidogrel TecniGen 75 mg
3. How to take Clopidogrel TecniGen 75 mg
4. Possible adverse effects
5. Storage of Clopidogrel TecniGen 75 mg

Additional information

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

Clopidogrel TecniGen 75 mg belongs to a group of medications called antiplatelet agents. Platelets are small elements in the blood that are smaller than red or white blood cells, and they aggregate when blood clots. Antiplatelet agents, by preventing this aggregation, reduce the possibility of blood clots (a process called thrombosis) forming.

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

You have been prescribed Clopidogrel TecniGen 75 mg to help prevent the formation of blood clots and reduce the risk of these serious events because:

• You suffer from a process that causes hardening of the arteries (also called atherosclerosis), and
• You have previously suffered a myocardial infarction, a stroke, or suffer from 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 any of the other components of Clopidogrel TecniGen 75 mg;
• If you have an active bleeding, such as a stomach ulcer or bleeding in the brain;
• If you have a severe liver disease;

If you think any of these may affect you, or if you have any doubts, consult your doctor before taking Clopidogrel TecniGen 75 mg.

Be careful 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 (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 had 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 brain artery (ischemic stroke) in the last seven days.
• If you are using other medications (see "Using other medications").

• If you have liver or kidney disease.

During treatment with Clopidogrel TecniGen:

• Inform your doctor if you are scheduled to undergo surgery (including dental surgery).

• Inform your doctor immediately if you develop a disorder that includes fever and bruising (bruises) under the skin that can appear as red spots, accompanied or not by unexplained extreme fatigue, confusion, yellow color in the skin or eyes (jaundice) (see section 4 "POSSIBLE ADVERSE EFFECTS")

• If you cut or injure yourself, the bleeding may take longer than usual to stop. This is related to the way the medication works, as it prevents the blood's ability to form clots. For minor cuts or injuries, such as cutting yourself while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Be careful with Clopidogrel TecniGen 75 mg")

• Your doctor may ask you to have blood tests.

• Inform your doctor or pharmacist if you notice any adverse effect not mentioned in section 4 of "POSSIBLE ADVERSE EFFECTS" or if you notice that any adverse effect worsens

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

Taking clopidogrel with other medications:

Some medications may influence the use of Clopidogrel TecniGen 75 mg or vice versa.

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

Concomitant administration of Clopidogrel TecniGen 75 mg with oral anticoagulants (medications used to decrease blood clotting) is not recommended.

You must explicitly inform your doctor if you are taking non-steroidal anti-inflammatory drugs, medications commonly used to treat pain and/or muscle or joint inflammation, or if you are taking heparin, or any other medication used to decrease blood clotting, or if you are taking a proton pump inhibitor (e.g., omeprazol) for stomach discomfort, or if you are taking ticlopidine, another antiplatelet agent, or if you are taking antiretrovirals (medications for treating HIV infection).

A dose of acetylsalicylic acid administered occasionally (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 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 medication during pregnancy and breastfeeding.

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

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

Driving and using machines:

It is unlikely that Clopidogrel TecniGen will alter 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 told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Clopidogrel TecniGen 75 mg

Follow the administration instructions of Clopidogrel TecniGen 75 mg exactly as indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

The normal dose is one 75 mg tablet of Clopidogrel TecniGen per day, administered orally, with or without food, and at the same time every day.

You should take Clopidogrel TecniGen 75 mg for as long as your doctor continues to prescribe it.

If you take more Clopidogrel TecniGen 75 mg than you should:

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 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 make up for the forgotten dose.

If you interrupt treatment with Clopidogrel TecniGen 75 mg:

Do not interrupt your treatment. Contact your doctor or pharmacist before stopping this medication.

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

4. Possible adverse effects

Like all medications, Clopidogrel TecniGen 75 mg can have 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 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 "Be careful with Clopidogrel TecniGen 75 mg").

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

The most frequently reported adverse effect with Clopidogrel TecniGen 75 mg(affecting between 1 and 10 patients out of 100) is bleeding. Bleeding can occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nasal bleeding, blood in urine. A reduced number of cases of bleeding in the blood vessels of the eyes, intracranial bleeding, pulmonary or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Clopidogrel TecniGen 75 mg

If you cut or injure yourself, the 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 injuries, such as cutting yourself while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Be careful with Clopidogrel TecniGen 75 mg")

Other adverse effects reported with Clopidogrel TecniGen 75 mg are:

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

Uncommon adverse effects (affecting between 1 and 10 patients out of 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestine, rash, itching, dizziness, tingling, and numbness.

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

Very rare adverse effects (affecting less than 1 patient out of 10,000): 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); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste; eosinophilic pneumonia; acquired hemophilia A.

Adverse effects of unknown frequency (cannot be estimated from the available data): Hypersensitivity reactions.

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

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not mentioned in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 expiration date that appears on the carton and blister.

This medication does not require special storage conditions.

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

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need in the of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Additional information

Composition of Clopidogrel TecniGen 75 mg:

The active ingredient 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 oil. Coating (Opadry II Pink 33G34629): hypromellose, titanium dioxide (E-171), lactose monohydrate, macrogol, triacetin, red iron oxide (E-172).

Appearance of the product and package contents:

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

They are presented in cardboard boxes of 28, 50, and 84 tablets in PCTFE+PE+PVC/Alu blisters.

Marketing authorization holder and manufacturer:

Marketing authorization 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 updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/