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.
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:
Do not take Clopidogrel Sandoz
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:
During treatment with Clopidogrel Sandoz:
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
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:
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:
Less frequent,may affectup to 1 in 100 patients:
Rare,may affect up to 1 in 1,000 patients:
Very rare,may affectup to 1 in 10,000 patients:
Unknown frequency(cannot be estimated from the known data)
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:
Each film-coated tablet contains 75 mg of clopidogrel (as hydrochloride).
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/
O preço médio do Clopidogrel sandoz 75 mg comprimidos recubiertos con pelicula efg em julho de 2025 é de cerca de 16.81 EUR. Os valores podem variar consoante a região, a farmácia e a necessidade de receita. Confirme sempre com uma farmácia local ou fonte online para obter informações atualizadas.
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