Pegorel

Pegorel 75 mg coated tablets
Clopidogrelum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist.
See section 4.

Contents of the leaflet:

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

1. What Pegorel is and what it is used for

Pegorel contains clopidogrel and belongs to a group of medicines called antiplatelet agents. Platelets
are very small blood cells that clump together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the risk of blood clots (a process known as thrombosis).

Pegorel is given to adults to prevent the formation of blood clots (thrombi) in hardened and narrowed blood vessels (arteries) caused by atherosclerosis, which could lead to serious atherosclerosis-related events (such as stroke, heart attack, or death).

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

• the patient has atherosclerotic disease (also known as atherosclerosis), and
• the patient has previously experienced a heart attack, stroke, or has a condition known as peripheral arterial disease, or
• the patient has had severe chest pain known as “unstable angina” or “myocardial infarction” (heart attack). To treat this condition, the doctor may have inserted a stent into a blocked or narrowed artery to restore effective blood flow. The treating doctor should also prescribe acetylsalicylic acid (a substance found in many medicines, used both for pain relief and fever reduction, as well as for preventing blood clotting)
• the patient has an irregular heartbeat known as “atrial fibrillation” and cannot take medicines called “oral anticoagulants” (vitamin K antagonists), which prevent the formation of new blood clots and the enlargement of existing ones. The treating doctor should inform the patient that oral anticoagulants are more effective in such cases than acetylsalicylic acid alone, or the combination of acetylsalicylic acid with Pegorel. If oral anticoagulants cannot be used and there is no high risk of severe bleeding, the doctor should prescribe Pegorel together with acetylsalicylic acid.

2. Information before using Pegorel

When not to use Pegorel

• if the patient has a known allergy (hypersensitivity) to clopidogrel or any of the other ingredients of the medicine (listed in section 6);
• if the patient currently has a medical condition causing 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 apply, or has any other
doubts, they should consult their doctor before taking Pegorel.
Warnings and precautions
If any of the situations listed below apply to the patient, they should inform their doctor before taking
Pegorel:

• if there is any 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 within tissues, organs or joints)
• recent severe injury
• recent surgery (including dental surgery)
• planned surgery (including dental surgery) within the next seven days
• if the patient has had a blood clot in the brain (ischaemic stroke) 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 in treating this condition.

While taking Pegorel:

• The patient should inform their doctor if they are scheduled for surgery (including dental procedures).
• The patient should also immediately inform their doctor if they develop a condition called thrombotic thrombocytopenic purpura (TTP), characterised by fever and small red or purple spots under the skin caused by bleeding, 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 how 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, the patient should contact their doctor immediately (see section 4 Possible side effects).
• The doctor may order blood tests.

Children and adolescents
Do not use this medicine in children, as it has not been shown to be effective in this patient group.
Pegorel and other medicines
Tell the doctor 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 medicines may affect the action of Pegorel and vice versa.
In particular, inform the doctor if the patient is taking:

• medicines that may increase the risk of bleeding, such as:
  o oral anticoagulants, medicines used to inhibit blood clotting,
  o non-steroidal anti-inflammatory drugs (NSAIDs), usually used to treat pain and/or inflammatory conditions of muscles or joints,
  o heparin or other injectable medicines used to reduce blood clotting,
  o ticlopidine and other antiplatelet medicines,
  o selective serotonin reuptake inhibitors (including, but not limited to fluoxetine or fluvoxamine), medicines usually used to treat depression,
  o moclobemide, a medicine used to treat depression,

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

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

• efavirenz, a medicine used to treat HIV infection (human immunodeficiency virus),

• moclobemide, a medicine used to treat depression,

• carbamazepine, a medicine used to treat certain types of epilepsy,

• repaglinide, a medicine used to treat diabetes,

• paclitaxel, a medicine used to treat cancer.

Patients who have experienced severe chest pain (unstable angina or heart attack) may be prescribed Pegorel in combination with acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever. Occasional use of acetylsalicylic acid (no more than 1000 mg within 24 hours) is unlikely to cause problems, but long-term use in other circumstances should be discussed with the doctor.
Taking Pegorel with food and drink
Pegorel can be taken with or without food.
Pregnancy and breastfeeding
Use of this medicine during pregnancy is not recommended.
If the patient is pregnant, breastfeeding, or suspects she may be pregnant, she should speak to her doctor before taking this medicine. If the patient becomes pregnant while taking Pegorel, she should consult her doctor immediately, as use of clopidogrel during pregnancy is not recommended.
Do not use this medicine during breastfeeding.
If the patient is breastfeeding or planning to breastfeed, she should talk to her doctor before taking this medicine.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
Pegorel is unlikely to affect the ability to drive or operate machinery.
Pegorel contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars (e.g. lactose), the patient should contact their doctor before taking this medicine.

3. How to use Pegorel

You should always take this medicine exactly as your doctor or pharmacist has told you. If you are
unsure, you should contact your doctor or pharmacist again.
The recommended dose of Pegorel, including for patients with a condition called "atrial fibrillation"
(irregular heartbeat), is 75 mg once daily, taken orally at the same time each day, with or without food.
If a patient has experienced severe chest pain (unstable angina or heart attack), the treating doctor
may initially prescribe an immediate loading dose of 300 mg of Pegorel (4 tablets of 75 mg). After this,
the recommended dose of Pegorel is one 75 mg tablet daily (as above).
Pegorel should be taken for as long as your doctor recommends.
Taking more than the recommended dose of Pegorel
You should contact your doctor or the nearest emergency department due to the increased risk of
bleeding.
Missing a dose of Pegorel
If a patient forgets to take a dose of Pegorel but remembers within 12 hours of the usual 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 simply take the next single dose at the usual
time. Do not take a double dose to make up for a missed tablet.
Stopping the use of Pegorel
Do not stop treatment unless advised by your doctor.
Before stopping treatment, you should contact your doctor or pharmacist.
If you have any doubts about how to use the medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should contact your doctor immediately if you experience:

• fever, signs of infection, or a feeling of extreme fatigue. This may be due to a rare decrease in the number of certain blood cells.
• symptoms of liver dysfunction, 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 disorders such as rash and itching, skin blisters. These may be signs of allergic reactions.

The most common adverse reaction reported during treatment with Pegorel is bleeding.
Bleeding may occur as gastrointestinal bleeding, bruising, haematoma (unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine. There have also been reports of a small number of cases of bleeding into the eye, brain, lungs, or joints.
If prolonged bleeding occurs while taking Pegorel
After a cut or injury, 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 your doctor immediately (see section 2 "Warnings and precautions").

Other adverse reactions include:
Common adverse reactions (occur in 1 to 10 people): diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon adverse reactions (occur in 1 to 100 people): headache, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rash, itching, dizziness, tingling or numbness.
Rare adverse reactions (occur in 1 to 1000 people): vertigo, gynaecomastia in males.
Very rare adverse reactions (occur in 1 to 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 discomfort up to fainting); swelling of the lips; skin blisters; skin allergy; ulceration of the oral mucosa (stomatitis); low blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances.
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
Hypersensitivity reactions with chest pain or abdominal pain.

In addition, 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, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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,
e-mail: [email protected].
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE PEGOREL

Keep out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the cardboard box and
on the blister pack after EXP. The expiry date refers to the last day of the stated month.
Check the storage conditions on the cardboard box.
If the product is packed in PVC/PE/PVDC/Aluminium blisters, store below 25°C.
If the product is packed in PA/Aluminium/PVC/Aluminium blisters, there are no special storage
requirements.
Do not use this medicinal product if signs of damage are visible.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Pegorel contains
The active substance is clopidogrel. Each coated tablet contains 75 mg of clopidogrel.
Other ingredients are:

• tablet core: microcrystalline cellulose, mannitol, hydroxypropylcellulose, crospovidone (type A), citric acid monohydrate, macrogol 6000, stearic acid, talc
• coating: hypromellose, lactose monohydrate, iron oxide red (E 172), triacetin, titanium dioxide (E 171)

What Pegorel looks like and contents of the pack
Pegorel 75 mg coated tablets are pink, round, and biconvex.
The medicine is available in PVC/PE/PVDC/Aluminium or PA/Aluminium/PVC/Aluminium (Aluminium-Aluminium) blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 500 and 50 x 1 coated tablets, packed in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków
Poland

Manufacturer
Pharmathen S.A.
6 Dervenakion
15351 Pallini, Attiki
Greece

This medicinal product is authorised in the European Economic Area member states under the following names:
Denmark Pegorel
Estonia Pegorel
Lithuania Pegorel
Latvia Pegorel
Poland Pegorel