Pegorel

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Pegorel 75 mg film-coated tablets

Clopidogrel

Read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult your doctor or pharmacist.
This medicine has been prescribed to you by a doctor and should not be given to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
See section 4.

Table of contents of the leaflet:

• 1. What is Pegorel and what is it 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 is Pegorel and what is it used for

Pegorel contains clopidogrel and belongs to a group of medicines called antiplatelet medicines. Platelets are very small blood cells that clump together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the chance of blood clots forming (a process called thrombosis).
Pegorel is given to adults to prevent blood clots forming in hardened arteries (blood vessels) which can lead to events related to artery disease (such as stroke, heart attack, or death).
Pegorel is prescribed to prevent blood clots and reduce the risk of these serious events because:

• the patient has artery disease (also known as atherosclerosis) and
• the patient has previously had 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 place a stent in the blocked or narrowed artery to restore blood flow. The 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)
• the patient has an irregular heartbeat, known as "atrial fibrillation" and the patient cannot take medicines called "oral anticoagulants" (vitamin K antagonists) which prevent the formation of new blood clots and the growth of existing ones. The doctor should inform the patient that oral anticoagulants are more effective in these cases than acetylsalicylic acid, or the combined use of acetylsalicylic acid with Pegorel. In the absence of the possibility of using oral anticoagulants and the absence of a risk of severe bleeding, the doctor should prescribe Pegorel with acetylsalicylic acid.

2. Important information before taking Pegorel

When not to take Pegorel

• if the patient has been diagnosed with an allergy (hypersensitivity) to clopidogrel or any of the other ingredients of the medicine (listed in section 6);
• if the patient has a condition that causes bleeding, such as a stomach ulcer or bleeding in the brain;
• if the patient has severe liver disease.

If the patient thinks they may have any of these problems or has any other doubts, they should consult their doctor before taking Pegorel.

Warnings and precautions

If any of the following situations apply to the patient, they should tell their doctor before taking Pegorel:

• if bleeding occurs, such as:
• a condition that increases the risk of internal bleeding (e.g. stomach ulcer)
• a blood disorder that increases the risk of internal bleeding (bleeding into tissues, organs, or joints)
• a recent severe injury
• a recent surgical procedure (including dental)
• a planned surgical procedure (including dental) within the next seven days
• if the patient has had a blood clot in the brain (ischemic stroke) within the last seven days
• if the patient has kidney or liver disease
• if the patient has had an allergy or hypersensitivity to any of the medicines used to treat this condition.

While taking Pegorel:

• The patient should tell their doctor if they are planning to have surgery (including dental).
• The patient should also immediately tell their doctor if they experience a condition (known as thrombotic thrombocytopenic purpura - TTP), characterized by fever and purple spots on the skin, which may appear as red, pinpoint spots with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4 Possible side effects).
• In the event of a cut or injury, the time it takes for the 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 and injuries, such as cuts while shaving. However, if bleeding occurs, the patient should immediately contact their doctor (see section 2 Warnings and precautions).
• The doctor may order blood tests.

Children and adolescents

Do not give this medicine to children, as it is not effective in this group of patients.

Pegorel and other medicines

Tell your doctor about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Some other medicines may affect the action of Pegorel and vice versa.
In particular, tell your doctor if you are taking:

• medicines that may increase the risk of bleeding, such as: oral anticoagulants, medicines used to inhibit blood clotting,

non-steroidal anti-inflammatory medicines, usually used to treat painful conditions and (or) inflammatory conditions of muscles or joints,
heparin or other injectable medicines used to reduce blood clotting,
ticlopidine and other antiplatelet medicines,
selective serotonin reuptake inhibitors (including fluoxetine or fluvoxamine), medicines usually used to treat depression,
moclobemide, a medicine used to treat depression,

• omeprazole or esomeprazole, medicines used to treat stomach disorders,
• 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 had severe chest pain (unstable angina or heart attack) may be prescribed Pegorel in combination with acetylsalicylic acid, a substance found in many medicines, used to relieve pain and reduce fever. Occasional use of acetylsalicylic acid (no more than 1000 mg in 24 hours) should not usually cause a problem, 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

it is recommended to use this medicine during pregnancy.
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before taking this medicine. If you become pregnant while taking Pegorel, consult your doctor immediately, as the use of clopidogrel during pregnancy is not recommended.
Do not take this medicine while breastfeeding.
If you are breastfeeding or plan to breastfeed, consult your doctor before taking this medicine.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Pegorel is unlikely to affect your ability to drive or use machines.

Pegorel contains lactose

If you have been diagnosed with an intolerance to some sugars (e.g. lactose), consult your doctor before taking this medicine.

3. How to take Pegorel

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist again.
The recommended dose of Pegorel is 75 mg once a day, taken orally at the same time every day, with or without food.
If you have had severe chest pain (unstable angina or heart attack), your doctor may prescribe 300 mg of Pegorel (4 tablets of 75 mg) immediately to start treatment. Then, the recommended dose of Pegorel is one 75 mg tablet per day (as above).
Take Pegorel for as long as your doctor recommends.

Taking more Pegorel than recommended

Consult your doctor or the nearest emergency department due to the increased risk of bleeding.

Missing a dose of Pegorel

If you forget to take a dose of Pegorel, but remember within 12 hours of the time you usually take it, take the tablet immediately, and then take the next tablet at the usual time.
If you forget for more than 12 hours, simply 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 Pegorel

Do not stop treatment unless advised by your doctor.
Before stopping treatment, consult your doctor or pharmacist.
If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pegorel can cause side effects, although not everybody gets them.

Immediately consult your doctor if you experience:

• fever, signs of infection, or extreme fatigue. This may be due to a rare decrease 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, which appears 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 rashes and itching, blisters. This may be a sign of an allergic reaction.

The most common side effect reported when taking Pegorel is bleeding.

Bleeding may occur as stomach or intestinal bleeding, bruising, hematoma (unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. There have also been reports of a small number of cases of bleeding in the eye, into the brain, lungs, or joints.

If prolonged bleeding occurs while taking Pegorel

In the event of a cut or injury, the time it takes for the 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 and injuries, such as cuts while shaving. However, if bleeding occurs, the patient should immediately contact their doctor (see section 2 Warnings and precautions).

Other side effects include:

Common side effects (occurring in 1 to 10 people): diarrhea, stomach pain, indigestion or heartburn.
Uncommon side effects (occurring in 1 to 100 people): headache, stomach ulcers, vomiting, nausea, constipation, gas in the stomach or intestines, rashes, itching, dizziness, tingling or numbness.
Rare side effects (occurring in 1 to 1000 people): dizziness of inner ear origin, breast enlargement in men.
Very rare side effects (occurring in 1 to 10,000 people): jaundice; severe stomach pain with or without back pain; fever, difficulty breathing, sometimes accompanied by cough; generalized allergic reactions (e.g. general feeling of heat with sudden general discomfort up to fainting); swelling of the lips; blisters; skin allergy; mouth ulcers (stomatitis); low blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disorders.
Side effects of unknown frequency (frequency cannot be estimated from available data):
Hypersensitivity reactions with chest pain or stomach pain.
Additionally, your doctor may detect changes in your blood or urine test results.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309,
e-mail: ndl@urpl.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE PEGOREL

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Pegorel contains

The active substance is clopidogrel. Each film-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 film-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 film-coated tablets packaged in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

S-LAB Sp. z o.o.
ul. Kiełczowska 2
55-095 Mirków

Manufacturer:

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark
Pegorel
Estonia
Pegorel
Lithuania
Pegorel
Latvia
Pegorel
Poland
Pegorel

Date of last revision of the leaflet: 09/2017