Package leaflet: Information for the patient

AREPLEX
75 mg, coated tablets
Clopidogrelum
Please read carefully the entire leaflet 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 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 another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents

What is the medicine and what is it used for
Important information before taking the medicine
How to take the medicine
Possible adverse effects
How to store the medicine
Contents of the packaging and other information

1. What it is and what it is used for
AREPLEX 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 called thrombosis).
AREPLEX is used in adult patients to prevent the formation of blood clots (thrombi) in atherosclerotic blood vessels (arteries), which can lead to atherosclerosis-related events (such as: stroke, heart attack, or death).
AREPLEX is prescribed to prevent blood clots and reduce the risk of these serious events because:

the patient has atherosclerotic arterial disease (also known as atherosclerosis), and
the patient has previously had a heart attack, stroke, or has peripheral arterial disease, or
the patient has experienced 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 effective blood flow. The treating doctor should also prescribe acetylsalicylic acid (a substance present in many medicines used both to relieve pain and reduce fever, as well as to prevent blood clotting).
the patient has experienced transient ischemic attack (TIA) or mild ischemic stroke. The treating doctor may also prescribe acetylsalicylic acid within the first 24 hours.
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 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 AREPLEX. When oral anticoagulants cannot be used and there is no risk of severe bleeding, the doctor should prescribe AREPLEX with acetylsalicylic acid.

2. Important information before taking the medicine

When not to take AREPLEX

if the patient has a known allergy (hypersensitivity) to clopidogrel or any of the other ingredients of this medicine (listed in section 6);
if the patient currently has a medical condition causing bleeding, such as a stomach ulcer or intracranial hemorrhage;
if the patient has severe liver disease.

If the patient believes any of these conditions apply, or has any other doubts, they should consult their doctor before taking AREPLEX.

Warnings and precautions

If any of the situations listed below apply to the patient, they should inform their doctor before taking AREPLEX:

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 within tissues, organs, or joints)
- recent severe trauma
- 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 (ischemic 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 medicine used to treat this condition
if the patient has previously experienced non-traumatic intracranial hemorrhage.

While taking AREPLEX:

Inform your doctor if you are scheduled for surgery (including dental procedures).
Also inform your doctor immediately if you develop a condition called thrombotic thrombocytopenic purpura (TTP), which may present with fever and small red or purple spots under the skin, appearing with or without unexplained extreme fatigue, confusion, or yellowing of the skin or eyes (jaundice) (see section 4 “Possible adverse 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 those occurring during shaving. However, if bleeding occurs, contact your doctor immediately (see section 4 “Possible adverse effects”).
Your doctor may order blood tests.

Children and adolescents
AREPLEX should not be used in children, as it has not been shown to be effective in this patient group.

AREPLEX and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those obtained without a prescription, as well as any medicines you plan to take.
Some medicines may affect the action of AREPLEX, and vice versa.
In particular, inform 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 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 and other antiplatelet medicines,
- selective serotonin reuptake inhibitors (SSRIs), including but not limited to fluoxetine or fluvoxamine, usually used to treat depression,
- rifampicin (used to treat severe 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 prescribing any opioid (medicines used to treat severe pain),
rosuvastatin, a medicine used to lower cholesterol levels.

Patients who have experienced severe chest pain (unstable angina or heart attack) may be prescribed AREPLEX 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 the treating doctor.

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

Pregnancy and breastfeeding
Use of this medicine during pregnancy is not recommended.
If the patient is pregnant or suspects she may be pregnant, she should consult her doctor or pharmacist before taking this medicine. If the patient becomes pregnant while taking AREPLEX, she should consult her 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 her doctor before taking this medicine.

Before taking any medicine, consult your doctor or pharmacist.

Driving and operating machinery
No specific warnings.

AREPLEX 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.

AREPLEX contains hydrogenated castor oil
This may cause digestive discomfort or diarrhea.

3. How to use

This medicine should always be taken as directed by the physician or pharmacist. In case of doubt,
consult a doctor or pharmacist.
The recommended dose of AREPLEX is 75 mg once daily, taken orally at the same time each day,
with or without food. This dosage also applies to patients with a condition known as "atrial fibrillation"
(irregular heartbeat).
If a patient has experienced severe chest pain (unstable angina or heart attack), the treating physician
may initially prescribe a loading dose of 300 mg or 600 mg of the medicine (4 or 8 tablets of 75 mg).
Afterwards, the recommended dose is one tablet of 75 mg daily (as described above).
If a patient has experienced stroke-like symptoms 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 the medicine (4 tablets of 75 mg).
Subsequently, the recommended dose is one tablet of 75 mg daily, as described above, together with
acetylsalicylic acid for 3 weeks. After this period, the doctor may prescribe the medicine or
acetylsalicylic acid separately.
The medicine should be taken for as long as directed by the treating physician.
Taking more medicine than recommended
Contact the treating physician or the nearest hospital emergency department due to increased
risk of bleeding.
Missed dose
If a patient forgets to take a dose and remembers within 12 hours of the usual dosing 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 simply take the next single dose at the
regular time. Do not take a double dose to make up for a missed dose.
Stopping the medicine
Do not stop treatment unless advised by the doctor. Before discontinuing the medicine, consult
the treating physician or pharmacist.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should contact the doctor in charge 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 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 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 this medicine 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 rare reports of bleeding in the eye, brain, lungs, or joints.
If prolonged bleeding occurs during treatment with this medicine
After minor 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. Nevertheless, if bleeding occurs, you should contact the doctor in charge immediately (see section 2 "Warnings and precautions").
Other adverse reactions reported during treatment with this medicine include:
Common adverse reactions (may affect 1 in 10 patients):
Diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon adverse reactions (may affect 1 in 100 patients):
Headache, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rash, itching, dizziness, tingling or numbness.
Rare adverse reactions (may affect 1 in 1,000 patients):
Vertigo, breast enlargement in males.
Very rare adverse reactions (may affect 1 in 10,000 patients):
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; inflammation of the oral mucosa (stomatitis); 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, the doctor in charge 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 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store

Keep the medicine out of the sight and reach of children.
Store below 25ºC.
Do not use this medicine after the expiry date stated on the carton and blister after:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
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 the medicine contains

The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as clopidogrel hydrogen sulfate).
The other ingredients are: mannitol, pregelatinized starch, microcrystalline cellulose with colloidal anhydrous silica, hydrogenated castor oil, low-substituted hydroxypropyl cellulose, hypromellose, lactose monohydrate, triacetin, titanium dioxide, iron oxide red, iron oxide yellow, iron oxide black.

What the medicine looks like and contents of the pack
The coated tablets are pink, round, and biconvex.
The medicine is packed in cardboard boxes containing 28 or 84 tablets in blisters made of PA/Aluminium/PVC/Aluminium.
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel. +48 22 732 77 00
Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów