Plavocorin

Patient Information Leaflet

Plavocorin, 75 mg, film-coated tablets
Clopidogrelum
Please read this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents:

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

1. What Plavocorin is and what it is used for

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

Plavocorin is used in adults to prevent blood clots (thrombi) in hardened and narrowed blood vessels (arteries), which may lead to atherosclerotic events (such as stroke, heart attack, or death).

Your doctor has prescribed Plavocorin to prevent blood clots and reduce the risk of these serious events because:

• you have atherosclerosis (also known as hardening of the arteries), and
• you have previously had a heart attack, stroke, or have been diagnosed with peripheral arterial disease, or
• you have experienced severe chest pain known as unstable angina or a heart attack (myocardial infarction). To treat this condition, your doctor may have inserted a stent into a blocked or narrowed artery to restore proper blood flow. You may also be taking acetylsalicylic acid (a substance found in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting), as advised by your doctor.
• you have had symptoms of stroke that resolved quickly (known as transient ischaemic attack, or TIA) or a mild ischaemic stroke. Your doctor may prescribe acetylsalicylic acid within the first 24 hours as recommended.
• your heart beats irregularly (known as "atrial fibrillation") and you cannot take medicines called "oral anticoagulants" (vitamin K antagonists), which prevent the formation and growth of existing blood clots. Your doctor should inform you that oral anticoagulants are more effective than acetylsalicylic acid or Plavocorin taken together with acetylsalicylic acid. For patients who cannot take oral anticoagulants and are not at high risk of bleeding, your doctor should prescribe

Plavocorin with acetylsalicylic acid.

2. Important information before using Plavocorin

When not to use Plavocorin
if the patient is allergic (hypersensitive) to clopidogrel or to any of the other
components of this medicine (listed in section 6);
if the patient has a medical condition causing active bleeding, such as a stomach ulcer or
bleeding within the brain;
if the patient has severe liver disease.
If the patient thinks any of these conditions apply, or has any doubts, they should consult a doctor before
using Plavocorin.

Warnings and precautions
Before starting Plavocorin, discuss with the doctor if any of the following situations apply to the patient:

• risk of bleeding, such as:
• a medical condition that increases the risk of internal bleeding (e.g. stomach ulcer)
• a blood disorder that predisposes to internal bleeding (bleeding within tissues, organs or joints)
• recent severe trauma
• recent surgical procedure (including dental procedures)
• planned surgical procedure within the next seven days (including dental procedures)
• if the patient has had a cerebral artery thrombosis (ischaemic stroke) in the past seven days
• if the patient has kidney or liver disease
• if the patient has experienced an allergic reaction or hypersensitivity to any medicine used to treat an existing condition
• if the patient has previously experienced a non-traumatic brain haemorrhage.

While taking Plavocorin:
Inform the doctor about any planned surgical procedure (including dental procedures).
Also inform the doctor immediately if the patient develops a condition (known as thrombotic thrombocytopenic purpura or TTP) involving fever and skin petechiae, which may appear as small red spots, possibly accompanied by unexplained, severe fatigue, confusion, or yellowing of the skin and eyes (jaundice); see section 4 "Possible side effects".
In case of cuts or injuries, stopping the bleeding may take longer than usual.
This is due to the medicine's effect of preventing blood clotting. Minor cuts and injuries, such as those occurring during shaving, usually do not pose a problem. However, if the patient is concerned about bleeding, they should contact their doctor immediately (see section 4 "Possible side effects").
The doctor may recommend blood tests.

Children and adolescents
This medicine should not be given to children, as it has no therapeutic effect in this patient group.

Plavocorin 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 they plan to use, including those available without a prescription.
Some medicines may interact with Plavocorin, affecting its action.
Especially inform the doctor if the patient is taking:

• medicines that may increase the risk of bleeding, such as:
• oral anticoagulants (medicines used to reduce blood clotting),
• non-steroidal anti-inflammatory drugs usually used to treat pain and/or inflammation of muscles or joints,
• heparin or other injectable medicines used to reduce blood clotting,
• ticlopidine, other antiplatelet medicines,
• selective serotonin reuptake inhibitors, including (but not limited to) fluoxetine or fluvoxamine (medicines usually used to treat depression),
• rifampicin (a medicine 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 in HIV infection),
• carbamazepine (a medicine used to treat certain types of epilepsy),
• moclobemide (a medicine used to treat depression),
• repaglinide (an antidiabetic medicine),
• paclitaxel (an anticancer medicine),
• opioids: if the patient is being treated with clopidogrel, they should inform their doctor before being prescribed any opioid medicine (medicines used to treat severe pain),
• rosuvastatin (a medicine used to lower cholesterol levels).

Patients who have experienced severe chest pain (unstable angina or myocardial infarction), transient ischaemic attack, or mild ischaemic stroke may be prescribed Plavocorin together 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) is usually not a problem, but long-term use in other circumstances should be discussed with the doctor.

Plavocorin with food and drink
Plavocorin can be taken with or without food.

Pregnancy and breastfeeding
Use of this medicine during pregnancy is not recommended. If the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine. If the patient becomes pregnant while taking Plavocorin, she should consult her doctor immediately, as use of clopidogrel during pregnancy is not recommended.
Breastfeeding should not be undertaken while taking this medicine.
If the patient is breastfeeding or planning to breastfeed, she should consult her doctor before using this medicine.

Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines
It is unlikely that Plavocorin will affect the ability to drive or operate machinery.

3. How to take Plavocorin

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
The recommended dose, including for patients with a condition called "atrial fibrillation"
(irregular heartbeat), is one 75 mg Plavocorin tablet daily, taken orally with or without food, at the same time each day.
If the patient has experienced severe chest pain (unstable angina or myocardial infarction), the doctor may recommend
an initial treatment dose of 300 mg or 600 mg of clopidogrel (4 or 8 tablets of 75 mg Plavocorin). Thereafter, the recommended dose is
one 75 mg Plavocorin tablet daily, as described above.
If the patient has experienced symptoms of stroke that resolved quickly (also known as transient ischaemic attack) or mild ischaemic stroke,
the doctor may prescribe an initial dose of 300 mg of Plavocorin (4 tablets of 75 mg). Thereafter, the recommended dose is one 75 mg Plavocorin tablet daily,
as described above, together with acetylsalicylic acid for 3 weeks. Afterwards, the doctor may prescribe Plavocorin as monotherapy or acetylsalicylic acid as monotherapy.
Plavocorin should be taken for as long as prescribed by the doctor.

Taking more Plavocorin than recommended
Due to the increased risk of bleeding, you should contact your doctor or nearest emergency department immediately.

Missing a dose of Plavocorin
If the patient forgets to take a dose of Plavocorin but remembers within 12 hours of the usual time, they should take the tablet immediately,
and 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 Plavocorin treatment
Do not stop treatment unless advised by your doctor.
Before stopping treatment, you should consult your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should contact your doctor immediately if any of the following occur:

• fever, signs of infection, or feeling extremely tired. 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), regardless of whether it is associated with bleeding appearing under the skin as red spots and (or) confusion (see section 2 "Warnings and precautions").
• swelling of the lips or skin disorders such as rash, itching, and formation of blisters on the skin. These may be symptoms of an allergic reaction.

The most frequently occurring adverse reaction associated with clopidogrel use is bleeding.
Bleeding may occur as gastrointestinal bleeding, petechiae,
haematomas (unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine.
Rarely, bleeding inside the eye, brain, lungs, or joints has also been reported.
Prolonged bleeding during treatment with Plavocorin
If you cut or injure yourself, stopping the bleeding may take longer than usual. This is
due to the action of the medicine, which prevents blood clots from forming. Minor cuts
and injuries, for example while shaving, usually do not pose a problem. However, if the patient is concerned
about bleeding, they should contact their doctor immediately (see section 2 "Warnings
and precautions").
Other adverse reactions
Common (may occur in less than 1 in 10 people):
diarrhoea, stomach pain, indigestion or heartburn
Uncommon (may occur in less than 1 in 100 people):
headache, dizziness, tingling or numbness
stomach ulcer, inflammation of the stomach lining (gastritis; possible symptoms include stomach pain),
vomiting, nausea, constipation, excess gas in the stomach or intestines
skin rash and itching
Rare (may occur in less than 1 in 1,000 people):
peripheral vertigo
gynaecomastia (enlargement of the breasts in men)
Very rare (may occur in less than 1 in 10,000 people):
jaundice
severe abdominal pain with or without back pain (pancreatitis, intestinal inflammation)
fever
difficulty breathing, sometimes with cough
generalised allergic reactions (e.g. feeling of warmth with sudden discomfort ending in fainting),
oral mucosal swelling, skin blisters, skin allergies
inflammation of the mouth
decrease in blood pressure
inflammation of blood vessels, often with skin rash
disorientation, hallucinations
joint pain, muscle pain
changes or loss of taste sensation
Frequency not known (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 detect changes in blood or urine test results.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of 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 Plavocorin

This medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Plavocorin contains

• The active substance is clopidogrel. Each coated tablet contains 75 mg of clopidogrel (as clopidogrel hydrogen sulfate).
• The other ingredients are: mannitol, microcrystalline cellulose (Avicel PH 112), low-substituted hydroxypropylcellulose, hydrogenated vegetable oil. Coating: Opadry Pink 03B54942: hypromellose 6cP, titanium dioxide (E171), macrogol 400, iron oxide red (E172). Ink S-1-17823 Black: shellac, iron oxide black (E172), n-butyl alcohol, propylene glycol, isopropyl alcohol and ammonium hydroxide.

What Plavocorin looks like and contents of the pack
Pink, round coated tablets, printed on one side and smooth on the other,
with a diameter of approximately 9 mm.
The coated tablets are packed in blisters made of OPA/Aluminium/PVC/Aluminium or
PVC/Aclar/Aluminium, placed in a cardboard box.
Pack sizes contain 28, 84 or 100 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
39179 Barleben, Germany
S.C. Sandoz, S.R.L.
Livezeni Street no 7A
540472 Targu Mures, Romania
For further information about the medicine and its names in other Member States of the
European Economic Area and in the United Kingdom (Northern Ireland), please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. +48 22 209 70 00