CLOPIDOGREL SANDOZ 75 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Clopidogrel Sandoz75 mg film-coated tablets EFG

clopidogrel

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Package Leaflet Contents

1. What is Clopidogrel Sandoz and what is it used for
2. What you need to know before taking Clopidogrel Sandoz
3. How to take Clopidogrel Sandoz
4. Possible side effects
5. Storage of Clopidogrel Sandoz
6. Package Contents and Additional Information

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

Clopidogrel Sandoz contains clopidogrel and belongs to a group of medications called antiplatelet agents. Platelets are very small elements in the blood that clump together when the blood coagulates. Antiplatelet agents, by preventing this clumping, reduce the likelihood of blood clots (a process called thrombosis) forming.

Clopidogrel is used in adults to prevent the formation of blood clots (thrombi) in blood vessels (arteries) that have become hardened, a process known as atherothrombosis, which can cause atherothrombotic events (such as stroke, myocardial infarction, or death).

You have been prescribed clopidogrel to help prevent the formation of blood clots and reduce the risk of these serious events, as:

• you suffer from a process that causes hardening of the arteries (also called atherothrombosis), and
• you have previously suffered a myocardial infarction, a stroke, or suffer from a disease called peripheral arterial disease,
• you have suffered a type of severe chest pain, known as "unstable angina" or "myocardial infarction" (heart attack). For the treatment of this disease, your doctor may need to place a stent in the obstructed or narrowed artery to restore adequate blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance present in many medications used to relieve pain and reduce fever, as well as to prevent blood clots),
• you have experienced symptoms of a stroke that disappear in a short period (also known as a transient ischemic attack) or a mild ischemic stroke. Your doctor may also administer acetylsalicylic acid to you during the first 24 hours.
• you have an irregular heartbeat, a disease called "atrial fibrillation", and you 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 will 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 will have prescribed clopidogrel plus acetylsalicylic acid if you cannot take "oral anticoagulants" and do not have a risk of severe bleeding.

2. What you need to know before taking Clopidogrel Sandoz

Do not take Clopidogrel Sandoz

• if you are allergic to clopidogrel or any of the other components of this medication (listed in section 6),
• if you have a medical condition that is currently causing active bleeding, such as a stomach ulcer or bleeding in the brain,
• if you have severe liver disease.

If you think any of these may apply to you, or if you are unsure, consult your doctor before taking Clopidogrel Sandoz.

Warnings and Precautions

Consult your doctor before starting to take Clopidogrel Sandoz 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 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) within the next seven days,

• if you have had a blood clot in an artery of the brain (ischemic stroke) in the last 7 days,
• if you have liver or kidney disease,
• if you have had an allergy or reaction to any medication used to treat your disease,
• if you have had a history of non-traumatic cerebral hemorrhage.

During treatment with Clopidogrel Sandoz:

• You must inform your doctor if you are scheduled to undergo 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 bruising under the skin that can appear as red spots, accompanied or not by unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• If you cut or injure yourself, 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 cuts while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Warnings and Precautions").
• Your doctor may ask you to have blood tests.

Children and Adolescents

This medication should not be given to children as it is not effective.

Other Medications and Clopidogrel Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Some medications may affect the use of Clopidogrel Sandoz or vice versa.

You must explicitly inform your doctor if you are taking

• medications that may increase the risk of bleeding, such as:

• oral anticoagulants, medications used to decrease blood coagulation,
• non-steroidal anti-inflammatory drugs, medications used to treat pain and/or inflammation of muscles or joints,
• heparin, or any other injectable medication used to decrease blood coagulation,
• ticlopidine, another antiplatelet agent,
• a serotonin reuptake inhibitor (including fluoxetine or fluvoxamine), medications used to treat depression,
• rifampicin (used for severe 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 some forms of epilepsy, moclobemide, a medication for depression,

• repaglinide, a medication for the treatment of diabetes,
• paclitaxel, a medication for the treatment of cancer,
• opioids: while you are being treated with clopidogrel, you must inform your doctor before they prescribe you any opioid (used to treat severe pain),
• rosuvastatin (used to reduce cholesterol levels).

If you have suffered severe chest pain (unstable angina or myocardial infarction), a transient ischemic attack, or a mild ischemic stroke, you may have been prescribed clopidogrel in combination with acetylsalicylic acid, a substance present in many medications used to relieve pain and reduce fever. A dose of acetylsalicylic acid administered occasionally (not exceeding 1,000 mg in 24 hours) is generally not a problem, but prolonged use in other circumstances should be discussed with your doctor.

Taking Clopidogrel Sandoz with Food and Drinks

Clopidogrel Sandoz 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 breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. If you become pregnant while taking Clopidogrel Sandoz, 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 breastfeed, consult your doctor before using this medication.

Driving and Using Machines

It is unlikely that Clopidogrel Sandoz will affect your ability to drive or use machines.

Clopidogrel Sandoz contains hydrogenated castor oil

It may cause stomach upset and diarrhea.

3. How to take Clopidogrel Sandoz

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose, even for patients with a disease called "atrial fibrillation" (an irregular heartbeat), is one 75 mg clopidogrel tablet per day, administered orally with or without food and at the same time each day.

If you have suffered severe chest pain (unstable angina or myocardial infarction), your doctor may prescribe you 300 mg or 600 mg of clopidogrel (4 tablets or 8 tablets of 75 mg of Clopidogrel Sandoz) to be taken once at the start of treatment. Afterward, the recommended dose is one 75 mg clopidogrel tablet per dayas described above.

If you have experienced symptoms of a stroke that disappear in a short period (also known as a transient ischemic attack) or a mild ischemic stroke, your doctor may prescribe you 300 mg of clopidogrel (4 tablets of 75 mg) once at the start of treatment. Afterward, the recommended dose is one 75 mg clopidogrel tablet per day as described above, with acetylsalicylic acid for 3 weeks. Afterward, your doctor will prescribe you either clopidogrel alone or acetylsalicylic acid alone.

You should take clopidogrel for as long as your doctor continues to prescribe it.

If you take more Clopidogrel Sandoz than you should

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

If you forget to take a dose of clopidogrel, 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 missed dose.

If you stop taking Clopidogrel Sandoz

Do not stop your treatment unless your doctor tells you to.Consult 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.

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone gets 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 "Warnings and Precautions"),
• 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 common side effect reported with clopidogrel is bleeding.

Bleeding can occur in the stomach or intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases of bleeding in the blood vessels of the eyes, intracranial bleeding, pulmonary bleeding, or joint bleeding have also been reported.

If you experience prolonged bleeding while taking Clopidogrel Sandoz

If you cut or injure yourself, 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 cuts while shaving, this is usually not a problem. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 "Warnings and Precautions").

Other side effects are:

Common, may affect up to 1 in 10 patients:

• diarrhea, abdominal pain, indigestion, or heartburn.

Uncommon, may affect up to 1 in 100 patients:

• headache, dizziness, sensation of tingling or numbness,
• stomach ulcer, inflammation of the stomach lining (gastritis, including signs of stomach pain), vomiting, nausea, constipation, excess gas in the stomach or intestine,
• rash and itching.

Rare, may affect up to 1 in 1,000 patients:

• dizziness,
• breast enlargement in men.

Very rare, may affect up to 1 in 10,000 patients:

• jaundice,
• severe abdominal pain with or without back pain (pancreatitis, intestinal inflammation),
• fever,
• breathing difficulties sometimes associated with cough,
• generalized allergic reactions (e.g., general feeling of heat with sudden general discomfort leading to fainting), swelling in the mouth, blisters on the skin, or skin allergies,
• mouth pain (stomatitis),
• decreased blood pressure,
• inflammation of blood vessels, sometimes with skin rash,
• confusion, hallucinations,
• joint pain, muscle pain,
• changes in taste or loss of taste for food.

Frequency not known(cannot be estimated from available data)

• hypersensitivity reactions with abdominal or chest pain,
• persistent symptoms of low blood sugar levels.

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Clopidogrel Sandoz

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

Do not use this medication after the expiration date stated on the carton and blister after CAD/EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect from light and moisture.

Do not use this medication if you notice any visible signs of deterioration.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofClopidogrel Sandoz:

• The active ingredient is clopidogrel.

Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).

• The other ingredients of the core are microcrystalline cellulose, low-substituted hydroxypropylcellulose, hydrogenated castor oil, and those of the coating are hypromellose (E 464), titanium dioxide (E 171), macrogol 400, and red iron oxide (E 172).

Appearance of the Product and Package Contents

Film-coated tablets are pink, round, and smooth on both sides.

The film-coated tablets are packaged in OPA/Alu/PCV/Alu blisters within cardboard boxes.

Package sizes:

14, 28, 50, 84, and 100 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Pharmaceutical, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

S.C. Sandoz, S.R.L

Str. Livezeni nr. 7A

RO-540472-Targu Mures

Romania

or

Lek Pharmaceuticals d.d

Verovskova, 57

SLO-1526 Ljubljana

Slovenia

or

Lek S.A.

UL Domaniewska 50 C

Warszawa, PL 02-672

Poland

or

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany:Clopicaro 75 mg Filmtabletten

Date of the last revision of this leaflet:August 2023.

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