Package Insert: Information for the

Clopidogrel TecniGen 75 mg Film-Coated Tablets

Clopidogrel

Read this package insert carefully before starting to use the medication:

• Keep this package insert, as you may need to refer to 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 any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

Additional Information

Clopidogrel TecniGen 75 mg belongs to a group of medicines called antiplatelet agents. Platelets are the smallest elements of blood, smaller than red or white blood cells, and they aggregate when blood coagulates. Antiplatelet agents, by preventing this aggregation, reduce the likelihood of blood clots (a process known as thrombosis) forming.

Clopidogrel TecniGen 75 mg is administered to prevent blood clots (thrombi) from forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can cause atherothrombotic effects (such as cerebral infarction, myocardial infarction, or death).

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

• You suffer from a process that produces the hardening of 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

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 an active bleeding, such as a stomach ulcer or bleeding in the brain;
• If you have a severe liver disease;

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

Be especially 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 have a risk of bleeding (bleeding) because:

• Patient has a disease that involves a risk of internal bleeding (such as a stomach ulcer).
• Patient has a blood disorder that predisposes them to internal bleeding (bleeding in tissues, organs, or joints of the body).
• Recently suffered a serious injury.
• Recently underwent surgery (including dental surgery).
• Must undergo surgery (including dental surgery) in the next seven days.

• If you have had a clot in an artery of the brain (ischemic cerebral infarction) in the last seven days.
• If you are using another type of medication (see “Use of other medications”).

• If you have liver or kidney diseases.

During treatment with Clopidogrel TecniGen:

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

• Inform your doctor immediately if you develop a disorder that includes fever and hematomas (bruises) under the skin that may appear as localized red spots, accompanied or not by extreme fatigue, confusion, yellow color in the skin or eyes (jaundice) (see section 4 “Possible Adverse Effects”)

• If you cut or get a wound, bleeding may take longer 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 Adverse Effects”).

• Your doctor may ask you to have blood tests.

• Inform your doctor or pharmacist if you observe any adverse effect not mentioned in section 4 “Possible Adverse Effects” or if you observe that some adverse effect worsens

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

Use of 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, even those acquired without a prescription.

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

You must inform your doctor explicitly if you are taking nonsteroidal anti-inflammatory drugs, medications used to treat pain and/or inflammation of muscles or joints, or if you are taking heparin, or any other medication used to reduce blood coagulation,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 (medications to treat HIV infection).

A 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.

Use of clopidogrel with food and beverages:

Clopidogrel TecniGen 75 mg can be taken with and 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, inform your doctor or pharmacist before taking Clopidogrel TecniGen. If you become pregnant while taking Clopidogrel TecniGen, consult your doctor immediately since it is not recommended to take clopidogrel during pregnancy.

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

Driving and operating machinery:

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 indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

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

The usual dose is one 75 mg Clopidogrel TecniGen tablet per day, taken 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 nearest hospital emergency department, 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 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 when 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 missed 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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Clopidogrel TecniGen 75 mg may cause side effects, although not everyone will experience them.

Contact your doctor immediately if you experience:

Fever, signs of infection, or severe fatigue. These symptomsmay be due to a rare decrease in some blood cells.

??Symptoms 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 especially careful with Clopidogrel TecniGen 75 mg”).

??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 Clopidogrel TecniGen 75 mg(affecting between 1 and 10 patients in every 100) is bleeding. Bleeding can appear in the stomach or intestine, bruises, hematomas (abnormal bleeding or bruises under the skin), nasal bleeding, blood in urine. Also, a reduced number of cases have been reported: bleeding of the blood vessels of the eyes, intracranial, pulmonary, or joint bleeding.

If you experience prolonged bleeding while taking Clopidogrel TecniGen 75 mg

If you cut or get a wound, it is possible that bleeding will 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 “Be especially careful withClopidogrel TecniGen 75 mg”)

Other side effects reported with Clopidogrel TecniGen 75 mg are:

Frequent side effects (affecting between 1 and 10 patients in every 100): Diarrhea, abdominal pain, indigestion, or heartburn.

Rare side effects (affecting between 1 and 10 patients in every 1,000): Headache, stomach ulcer, vomiting, nausea, constipation, excessive gas in the stomach or intestine, rashes, itching, dizziness, numbness, and tingling.

Rare side effects (affecting between 1 and 10 patients in every 10,000): Dizziness.

Very rare side effects (affecting fewer than 1 patient in every 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 mucous membrane of the mouth (stomatitis); decreased blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in the taste of things;pulmonary eosinophilia; acquired hemophilia A.

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

Your doctor may also observe changes in your blood or urine test results

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 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 medication.

Keep out of reach and sight of children.

Do not use Clopidogrel TecniGen 75 mg after the expiration date that appears on the carton and in the blister.

This medication does not require special storage conditions.

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

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

Clopidogrel TecniGen 75 mg Composition:

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

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

Product Appearance and Packaging Content:

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

They are presented in carton packaging of 28, 50, and 84 tablets in blister packs of PCTFE+PE+PVC/Alu.

Marketing Authorization Holder and Responsible 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

Responsible Manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande nº 2, Abrunheira. 2710 – 089 Sintra (Portugal).

This leaflet was approved in June 2019

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