Clopidogrel Sandoz 75 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Clopidogrel Sandoz 75 mg film-coated tablets EFG

clopidogrel

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Clopidogrel Sandoz is and what it is used for
2. What you need to know before taking Clopidogrel Sandoz
3. How to take Clopidogrel Sandoz
4. Possible side effects
5. How to store Clopidogrel Sandoz
6. Contents of the pack and other information

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

Clopidogrel Sandoz contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are very small components of the blood that clump together when blood clots. Antiplatelet medicines prevent this clumping, thereby reducing the likelihood of blood clots (a process known as thrombosis).

Clopidogrel is used in adults 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).

You have been prescribed clopidogrel 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 atherothrombosis), and
• you have previously had a myocardial infarction, stroke, or have peripheral arterial disease,
• you have experienced a severe type of chest pain known as "unstable angina" or "myocardial infarction" (heart attack). For the treatment of this condition, your doctor may have placed a stent in the blocked or narrowed artery to restore proper blood flow. Your doctor may also have prescribed acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clot formation),
• you have experienced symptoms of a stroke that disappear within a short period of time (also known as transient ischemic attack) or a mild ischemic stroke. Your doctor may also administer acetylsalicylic acid within the first 24 hours.
• you have an irregular heartbeat, a condition called "atrial fibrillation", and you cannot take medicines known as "oral anticoagulants" (vitamin K antagonists) that prevent the formation of new clots and stop existing clots from growing. You will have been informed that "oral anticoagulants" are more effective than acetylsalicylic acid or the combination of clopidogrel and acetylsalicylic acid for this condition. Your doctor will have prescribed clopidogrel plus acetylsalicylic acid if you cannot take "oral anticoagulants" and do not have a risk of serious bleeding.

2. What you need to know before taking Clopidogrel Sandoz

Do not take Clopidogrel Sandoz

• if you are allergic to clopidogrel or to 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 bleeding in the brain,
• if you have 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 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 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 7 days,

• if you have liver or kidney disease,

• if you have had an allergic reaction or adverse reaction to any medication used to treat your condition,

• if you have a history of non-traumatic intracranial bleeding.

During treatment with Clopidogrel Sandoz:

• You must inform your doctor if you have scheduled 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 appearing as localized red spots, with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “Possible side effects”).
• If you cut yourself or sustain an 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 shaving cuts, this is usually not a concern. However, if you are concerned about blood loss, consult your doctor immediately (see section 4 “Possible side effects”).
• Your doctor may request blood tests.

Children and adolescents

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

Other medicines and Clopidogrel Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

You must specifically inform your doctor 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 (NSAIDs), medicines generally 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,

• a serotonin reuptake inhibitor (including, among others, fluoxetine or fluvoxamine), medicines generally used to treat depression,

• rifampicin (used for serious infections),

• omeprazole or esomeprazole, medicines used to treat stomach discomfort,

• fluconazole or voriconazole, medicines used to treat fungal infections,

• efavirenz or other antiretroviral medicines (used to treat HIV infection),

• carbamazepine, a medicine used to treat certain forms of epilepsy, moclobemide, a medicine for depression,

• repaglinide, a medicine used to treat diabetes,

• paclitaxel, a medicine used to treat cancer,

• opioids: while taking clopidogrel, you must inform your doctor before being prescribed any opioid (used to treat severe pain),

• rosuvastatin (used to lower cholesterol levels).

If you have experienced severe chest pain (unstable angina or myocardial infarction), transient ischaemic attack, or mild ischaemic 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. An occasional dose of acetylsalicylic acid (not exceeding 1,000 mg in 24 hours) generally should not cause any problems, but prolonged use under other circumstances should be discussed with your doctor.

Taking Clopidogrel Sandoz with food and drink

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 pregnant or breastfeeding, think you may be pregnant, or are planning 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 clopidogrel is not recommended during pregnancy.

You must not breastfeed while taking this medicine.

If you are breastfeeding or planning to breastfeed, consult your doctor before using this medicine.

Driving and using machines

It is unlikely that Clopidogrel Sandoz will impair your ability to drive or operate machinery.

Clopidogrel Sandoz contains hydrogenated castor oil

It may cause stomach discomfort and diarrhoea.

3. How to take Clopidogrel Sandoz

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose, including for patients with a condition called "atrial fibrillation" (an irregular heartbeat), is one 75 mg clopidogrel tablet daily, taken orally with or without food, at the same time each day.

If you have experienced severe chest pain (unstable angina or heart attack), your doctor may prescribe 300 mg or 600 mg of clopidogrel (4 or 8 tablets of 75 mg Clopidogrel Sandoz) as a single dose at the beginning of treatment. Afterwards, the recommended dose is one 75 mg clopidogrel tablet daily, as described above.

If you have experienced symptoms of a stroke that disappear within a short period of time (also known as a transient ischaemic attack) or a mild ischaemic stroke, your doctor may prescribe 300 mg of clopidogrel (4 tablets of 75 mg) once at the beginning of treatment. Afterwards, the recommended dose is one 75 mg clopidogrel tablet daily as described above, taken together with acetylsalicylic acid for 3 weeks. After this period, your doctor will prescribe 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 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 number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Clopidogrel Sandoz

If you forget to take a dose of clopidogrel 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 Sandoz

Do not stop your treatment unless your doctor tells you to do so. Contact your doctor or pharmacist before stopping 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, this medicine can have adverse effects, although not everyone gets them.

Contact your doctor immediately if you experience:

• fever, signs of infection, or severe tiredness. These symptoms may be due to a rare decrease 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 “Warnings and precautions”),
• swelling of the mouth or skin disorders such as rashes and itching, blisters on the skin. These may be signs of an allergic reaction.

The most common adverse effect reported with clopidogrel is bleeding.

Bleeding may occur in the stomach or intestines, bruising, haematomas (abnormal bleeding or bruising under the skin), nosebleeds, blood in urine. A small number of cases have also been reported of: bleeding from blood vessels in the eyes, intracranial bleeding, pulmonary bleeding, or bleeding into joints.

If you experience prolonged bleeding while taking Clopidogrel Sandoz

If you cut yourself or sustain a wound, bleeding may take slightly longer than usual to stop. This is related to the mechanism of action of the medicine, as it prevents blood from forming clots. For minor cuts or wounds, such as those occurring during shaving, this is usually not a concern. However, if you are concerned about your bleeding, consult your doctor immediately (see section 2 “Warnings and precautions”).

Other adverse effects are:

Common, may affect up to 1 in 10 patients:

• diarrhoea, abdominal pain, indigestion or heartburn.

Uncommon, may affect up to 1 in 100 patients:

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

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

• vertigo,
• breast enlargement in men.

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

• jaundice,
• severe abdominal pain with or without back pain (inflammation of the pancreas, inflammation of the intestine),
• fever,
• breathing difficulties sometimes associated with cough,
• generalized allergic reactions (for example, general feeling of warmth with sudden general discomfort up to fainting), swelling in the mouth, blisters on the skin or skin allergies,
• mouth pain (stomatitis),
• decrease in 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 of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, 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: https://www.notificaram.es.

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

5. Storage of Clopidogrel Sandoz

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

Do not use this medicine after the expiry date which is stated on the carton and on the blister after CAD/EXP. The expiry date refers to 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 medicine if you notice any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Clopidogrel Sandoz:

• The active substance is clopidogrel.

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

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

Appearance of the product and contents of the pack

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

The film-coated tablets are packed in OPA/Alu/PCV/Alu blisters within cardboard packs.

Pack sizes:

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, 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 European Economic Area member states under the following names:

Germany: Clopicaro 75 mg Filmtabletten

Date of the most recent revision of this leaflet: August 2023.

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