Clopidogrel aurovitas

Package leaflet: Information for the patient

Clopidogrel Aurovitas, 75 mg, coated tablets
Clopidogrelum
Read the entire leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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

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

Clopidogrel Aurovitas contains the active substance clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets are tiny components in the blood that clump together during blood clotting. By preventing platelet aggregation, antiplatelet medicines reduce the risk of blood clots (a process known as thrombosis).

Clopidogrel Aurovitas is used in adult patients to prevent the formation of blood clots (thrombi) in hardened and narrowed blood vessels (arteries), which could lead to serious cardiovascular events (such as stroke, heart attack, or death).

Clopidogrel Aurovitas is prescribed to prevent blood clots and reduce the risk of such serious events because:

• You have atherosclerosis (also known as atherosclerotic vascular disease), and
• You previously had a heart attack, stroke, or have peripheral arterial disease, or
• You experienced severe chest pain known as "unstable angina" or "myocardial infarction" (heart attack). To treat this condition, your doctor may have placed a stent in a blocked or narrowed artery to restore adequate blood flow. Your doctor may also prescribe acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting).
• You experienced transient ischemic attack (TIA) or mild ischemic stroke. Your doctor may also prescribe acetylsalicylic acid within the first 24 hours.
• You have an irregular heartbeat known as "atrial fibrillation" and you cannot take medicines called "oral anticoagulants" (vitamin K antagonists), which prevent the formation of new clots and the growth of existing ones. Your doctor should inform you that oral anticoagulants are more effective in such cases than acetylsalicylic acid alone or the combination of acetylsalicylic acid with Clopidogrel Aurovitas. If oral anticoagulants cannot be used and there is no high risk of severe bleeding, your doctor should prescribe Clopidogrel Aurovitas together with acetylsalicylic acid.

2. Important information before using Clopidogrel Aurovitas

When not to use Clopidogrel Aurovitas:

• if the patient is allergic (hypersensitive) to clopidogrel or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has a medical condition causing bleeding, such as a stomach ulcer or bleeding in the brain.
• if the patient has severe liver disease.

If the patient thinks any of these conditions apply, or has any other
doubts, he/she should consult a doctor before taking Clopidogrel Aurovitas.
Warnings and precautions
If any of the situations listed below apply to the patient, discuss them with a doctor, pharmacist or nurse before starting
treatment with Clopidogrel Aurovitas:

• if there is a risk of bleeding, such as:
  • a medical condition that increases the risk of internal bleeding (e.g. stomach ulcer).
  • a blood disorder predisposing to internal bleeding (bleeding inside tissues, organs or joints).
  • recent severe injury.
  • recent surgery (including dental procedures).
  • planned surgery (including dental procedures) within the next seven days.
• if the patient has been diagnosed with cerebral artery thrombosis (ischaemic stroke) that occurred within the last seven days.
• if the patient has kidney or liver disease.
• if the patient has previously had an allergic reaction or hypersensitivity to any of the medicines used to treat this condition.
• if the patient has previously experienced non-traumatic intracranial haemorrhage.

While using Clopidogrel Aurovitas:

• Inform the doctor if the patient is scheduled for surgery (including dental procedures).
• Also inform the doctor immediately if the patient develops a condition called thrombotic thrombocytopenic purpura (TTP), characterised by fever and small red or purple spots under the skin, which may appear with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 "Possible side effects").
• In case of cuts or injuries, the time it takes for bleeding to stop may be slightly longer than usual. This is related to the way the medicine works, as it prevents blood clots from forming. This usually does not cause problems with minor cuts or injuries, such as small cuts during shaving. However, if bleeding occurs, contact a doctor immediately (see section 4 "Possible side effects").
• The doctor may order blood tests.

Children and adolescents
This medicine should not be used in children, as it has not been shown to be effective in this patient group.
Clopidogrel Aurovitas and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Some other medicines may affect the action of Clopidogrel Aurovitas and vice versa.
In particular, inform the doctor if the patient is taking:

• medicines that may increase the risk of bleeding, such as:
  • oral anticoagulants, medicines used to inhibit blood clotting,
  • non-steroidal anti-inflammatory drugs (NSAIDs), usually used to treat pain and/or inflammation of muscles or joints,
  • heparin or other injectable medicines used to reduce blood clotting,
  • ticlopidine or other antiplatelet medicines,
  • selective serotonin reuptake inhibitors (SSRIs) (including but not limited to fluoxetine and fluvoxamine), medicines usually used to treat depression,
  • rifampicin (used to treat serious infections),
• omeprazole or esomeprazole, medicines used to treat stomach problems,
• 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 types of epilepsy,
• moclobemide, a medicine used to treat depression,
• repaglinide, a medicine used to treat diabetes,
• paclitaxel, a medicine used to treat cancer,
• opioids: during treatment with clopidogrel, the patient should inform the doctor before being prescribed any opioid (medicines used to treat severe pain),
• rosuvastatin (used to lower cholesterol levels).

Patients who have experienced severe chest pain (unstable angina or heart attack) may be prescribed Clopidogrel Aurovitas in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. Occasional use of acetylsalicylic acid (not more than 1000 mg within 24 hours) should not usually cause a problem, but long-term use in other circumstances should be discussed with a doctor.
Clopidogrel Aurovitas with food and drink
Clopidogrel Aurovitas can be taken with or without food.
Pregnancy and breastfeeding
This medicine is not recommended during pregnancy.
If the patient is pregnant or suspects she may be pregnant, she should consult a doctor or pharmacist before using this medicine. If the patient becomes pregnant while taking Clopidogrel Aurovitas, she should consult a doctor immediately, as use of clopidogrel during pregnancy is not recommended.
This medicine should not be used during breastfeeding.
If the patient is breastfeeding or planning to breastfeed, she should consult a doctor before using this medicine.
Before taking any medicine, consult a doctor or pharmacist.
Driving and using machines
Clopidogrel Aurovitas is unlikely to affect the ability to drive or operate machinery.
Clopidogrel Aurovitas contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, he/she should contact the doctor before taking this medicine.
Clopidogrel Aurovitas contains hydrogenated castor oil
This may cause digestive discomfort or diarrhoea.

3. How to take Clopidogrel Aurovitas

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
The recommended dose of Clopidogrel Aurovitas is 75 mg once daily, taken orally at the same time each day,
with or without food. This dose also applies to patients with a condition known as "atrial fibrillation" (irregular heartbeat).
If the patient has experienced severe chest pain (unstable angina or heart attack), the doctor may prescribe an initial
loading dose of 300 mg or 600 mg of Clopidogrel Aurovitas (4 or 8 tablets of 75 mg). After this, the recommended
dose of Clopidogrel Aurovitas is one 75 mg tablet daily (as described above).
If the patient has experienced symptoms of stroke that resolve quickly (also known as transient ischaemic attack) or
a mild ischaemic stroke, the doctor may prescribe an initial single dose of 300 mg of Clopidogrel Aurovitas
(4 tablets of 75 mg). Afterwards, the recommended dose is one tablet of Clopidogrel Aurovitas, 75 mg daily (as
described above), together with acetylsalicylic acid for 3 weeks. After this period, the doctor may prescribe either
clopidogrel or acetylsalicylic acid alone.
Clopidogrel Aurovitas should be taken for as long as your doctor recommends.
Taking more Clopidogrel Aurovitas than recommended
You should contact your doctor or the nearest hospital emergency department due to an increased risk of bleeding.
Missing a dose of Clopidogrel Aurovitas
If the patient forgets to take a dose of Clopidogrel Aurovitas but remembers within 12 hours of the scheduled time,
they should take the tablet immediately, then take the next tablet at the usual time.
If more than 12 hours have passed, the patient should take the next single dose at the usual time. Do not take a
double dose to make up for the missed tablet.
Stopping treatment with Clopidogrel Aurovitas
Do not stop treatment unless advised by your doctor. Before stopping the medicine, you should consult your doctor
or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should contact a doctor immediately if the patient experiences:

• fever, signs of infection, or a feeling of extreme fatigue. This may be due to a rare reduction in the number of certain blood cells.
• symptoms of liver problems, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding, appearing under the skin as red pinpoint spots and/or confusion (see section 2 "Warnings and precautions").
• swelling of the lips or skin reactions such as rash and itching, skin blisters. These may be symptoms of an allergic reaction.

The most common adverse reaction reported during treatment with clopidogrel is
bleeding. Bleeding may occur as gastrointestinal bleeding (in the stomach or intestines), bruising, haematoma (unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine. There have also been rare reports of bleeding in the eye, brain, lungs, or joints.
If prolonged bleeding occurs while taking Clopidogrel Aurovitas
In case of cuts or injuries, the time it takes for bleeding to stop may be slightly longer than usual. This is related to the way the medicine works, as it prevents blood clots from forming. This usually does not cause problems with minor cuts or injuries, such as small cuts during shaving. However, if bleeding occurs, you should contact a doctor immediately (see section 2 "Warnings and precautions").
Other adverse reactions include:
Common adverse reactions (occurring in up to 1 in 10 people):
Diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon adverse reactions (occurring in up to 1 in 100 people):
Headache, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rash, itching, dizziness, tingling or numbness.
Rare adverse reactions (occurring in up to 1 in 1,000 people):
Vertigo, gynaecomastia (enlargement of the breasts in males).
Very rare adverse reactions (occurring in up to 1 in 10,000 people):
Jaundice, severe abdominal pain with or without back pain; fever, breathing difficulties, sometimes associated with cough; generalized allergic reactions (e.g. general feeling of warmth with sudden general malaise up to fainting); swelling of the lips; skin blisters; skin allergy; stomatitis (inflammation of the mucous membrane of the mouth); hypotension (low blood pressure); confusion; hallucinations; joint pain; muscle pain; taste disturbances or loss of taste.
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
Hypersensitivity reactions with chest pain or abdominal pain, persistent symptoms of low blood sugar.
Additionally, your doctor may observe changes in blood or urine laboratory test results.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Clopidogrel Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after: EXP.
The expiry date refers to the last day of the stated month.
Store below 30 °C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Clopidogrel Aurovitas contains

• The active substance is clopidogrel. Each coated tablet contains 97.875 mg of clopidogrel hydrogen sulfate (equivalent to 75 mg of clopidogrel).
• Other ingredients are: Tablet core: microcrystalline cellulose (grade 113), mannitol, low-substituted hydroxypropylcellulose (grade 21 and grade 11), crospovidone (type A), macrogol 6000, hydrogenated castor oil. Tablet coating: lactose monohydrate, hypromellose 2910/15 cp, titanium dioxide (E 171), triacetin, iron oxide red (E 172).

What Clopidogrel Aurovitas looks like and contents of the pack
Coated tablet.
Pink, round, biconvex coated tablets with bevelled edges, embossed with "E" on one side and "34" on the other.
Clopidogrel Aurovitas 75 mg, coated tablets are available in blisters and HDPE bottles, packed in a cardboard box.
Pack sizes:
Blisters: 28, 30, 56, 60, 84, 90, 98, 100, 112, 120 and 180 coated tablets.
HDPE bottles: 30, 56, 60, 90, 98, 100 and 250 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium: Clopidogrel AB 75 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten
Poland: Clopidogrel Aurovitas
Portugal: Clopidogrel Generis