Patient Information Leaflet

Clopidogrel Sandoz75 mg Film-Coated Tablets

Clopidogrel

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

• 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 only. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isClopidogrel Sandozand what is it used for

2. What you need to know before you start takingClopidogrel Sandoz

3. How to takeClopidogrel Sandoz

4. Possible side effects

5. Storage ofClopidogrel Sandoz

6. Contents of the pack and additional information

Clopidogrel Sandoz contains clopidogrel and belongs to a group of medications known as antiplatelet agents. Platelets are very small elements of the blood and aggregate when blood coagulates. Antiplatelet agents, by preventing this aggregation, reduce the likelihood of blood clots (a process known as thrombosis) forming.

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

You have been prescribed clopidogrel to help prevent blood clots from forming and reduce the risk of these serious events because:

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

Do not take Clopidogrel Sandoz

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

If you think this may affect you, or if you are unsure, consult your doctor before takingClopidogrel 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:

• presents a disease that involves an increased risk of internal bleeding (such as a stomach ulcer),
• has a blood disorder that predisposes you to internal bleeding (bleeding in tissues, organs, or joints of the body),
• has recently suffered a serious injury,
• has recently undergone surgery (including dental surgery),
• is scheduled to undergo surgery (including dental surgery) in the next seven days,

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

During treatment with Clopidogrel Sandoz:

• You must inform your doctor if you are scheduled for 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 hematomas under the skin that may appear as localized red spots, accompanied or not by extreme fatigue, confusion, yellow discoloration of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• If you cut or get a wound, bleeding may take longer to stop than usual. 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 side effects").
• Your doctor may ask you to have blood tests.

Children and adolescents

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

Other medicines and Clopidogrel Sandoz

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

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

You must inform your doctor explicitly 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, medicines 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,
• an SSRI (selective serotonin reuptake inhibitor) (including fluoxetine or fluvoxamine), medicines used to treat depression,
• rifampicin (used to treat serious infections),

• omeprazole or esomeprazole, medicines to treat stomach discomfort,
• fluconazole or voriconazole, medicines to treat fungal infections,
• efavirenz or other antiretroviral medicines (used to treat HIV infections),

• carbamazepine, a medicine to treat some forms of epilepsy, moclobemide, a medicine to treat depression,

• repaglinide, a medicine to treat diabetes,
• paclitaxel, a medicine to treat cancer,
• opioids: while taking clopidogrel, you must inform your doctor before they prescribe any opioid (used to treat intense pain),
• rosuvastatin (used to reduce cholesterol levels).

If you have had severe chest pain (unstable angina or myocardial infarction), transient ischemic attack, or mild ischemic stroke, you may have been prescribed clopidogrel in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. A single dose of acetylsalicylic acid 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 medicine during pregnancy.

If you are pregnantor in the lactation period, believe you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine. 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 medicine.

If you are breastfeeding or plan to do so, consult your doctor before using this medicine.

Driving and operating machinery

Clopidogrel Sandoz is unlikely to affect your ability to drive or operate machinery.

Clopidogrel Sandoz contains hydrogenated castor oil

It may cause stomach discomfort and diarrhea.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

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

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

You should take clopidogrel for the time your doctor continues to prescribe it.

If you take moreClopidogrel Sandozthan you should

Contact your doctor or go to the nearest hospital emergency service, 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 forgot to takeClopidogrel 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 compensate for the missed dose.

If you interrupt the treatment with Clopidogrel Sandoz

Do not stop your treatment unless your doctor tells you to.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, this medicine can have side effects, although not everyone will experience 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 hives and itching, blisters on the skin. These may be signs of an allergic reaction.

The most frequent side effect reported with clopidogrelis bleeding.

Bleeding can occur in the stomach or intestine, bruises, hematomas (abnormal bleeding or bruises under the skin), nasal bleeding, blood in urine. There have also been reported a reduced number of cases of: bleeding of the blood vessels of the eyes, intracranial, pulmonary, or joint bleeding.

If you experience prolonged bleeding while taking Clopidogrel Sandoz

If you cut or get a wound, it is possible that bleeding may take a little longer to stop than normal. 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 "Warnings and precautions").

Other side effects are:

Frequent, may affectup to 1 in 10 patients:

• diarrhea, abdominal pain, indigestion, or heartburn.

Less frequent,may affectup to 1 in 100 patients:

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

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

• dizziness,
• breast enlargement in men.

Very rare,may affectup to 1 in 10,000 patients:

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

Unknown frequency(cannot be estimated from the known data)

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not store above 25°C.

Store in the original packaging to protect it from light and moisture

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

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofClopidogrel Sandoz:

• The active ingredient is clopidogrel.

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

• The other components of the corearemicrocrystalline cellulose,low-substituted hydroxypropyl cellulose, hydrogenated castor oil, and the coating components are hypromellose (E 464), titanium dioxide (E 171), macrogol 400, and iron oxide red (E 172).

Appearance of the product and contents of the package

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

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

Package sizes:

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible 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 Domaniewska50 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 medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Clopicaro 75 mg Filmtabletten

Last review date of this leaflet:August 2023.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/