Clopidogrel + Acetilsalicilic acid Msn

Leaflet attached to the packaging: information for the user

Clopidogrel + Acetylsalicylic acid MSN, 75 mg + 75 mg, coated tablets

Clopidogrel + Acetylsalicylic acid

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Clopidogrel + Acetylsalicylic acid MSN and what is it used for
• 2. Important information before taking Clopidogrel + Acetylsalicylic acid MSN
• 3. How to take Clopidogrel + Acetylsalicylic acid MSN
• 4. Possible side effects
• 5. How to store Clopidogrel + Acetylsalicylic acid MSN
• 6. Contents of the packaging and other information

1. What is Clopidogrel + Acetylsalicylic acid MSN and what is it used for

Clopidogrel + Acetylsalicylic acid MSN contains clopidogrel and acetylsalicylic acid (also known as Acetylsalicylic Acid, ASA) and belongs to a group of medicines called antiplatelet agents. Platelets are very small blood cells that clump together during blood clotting. By preventing platelets from clumping together in certain types of blood vessels (called arteries), antiplatelet agents reduce the risk of blood clots (a process known as atherothrombotic events).
Clopidogrel + Acetylsalicylic acid MSN is used in adults to prevent the formation of blood clots in atherosclerotic arteries, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Due to a history of a certain type of severe chest pain called "unstable angina" or heart attack (myocardial infarction), the patient has been prescribed Clopidogrel + Acetylsalicylic acid MSN instead of two separate medicines, namely clopidogrel and ASA, which help prevent blood clots. To treat this condition, the doctor may insert a stent into a blocked or narrowed artery to restore effective blood flow.

2. Important information before taking Clopidogrel + Acetylsalicylic acid MSN

When not to take Clopidogrel + Acetylsalicylic acid MSN:

• if the patient is allergic (hypersensitive) to clopidogrel, acetylsalicylic acid (ASA), or any of the other ingredients of this medicine (listed in section 6).
• if the patient is allergic to other non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and/or inflammatory conditions of the muscles or joints.
• if the patient has a condition that combines asthma, nasal discharge (rhinitis), and polyps (a type of growth that occurs in the nose).
• if the patient has a condition that is currently causing bleeding, such as a stomach ulcer or bleeding in the brain.
• if the patient has severe liver disease.
• if the patient has severe kidney disease.
• if the patient is in the third trimester of pregnancy.

Warnings and precautions

If any of the following situations apply to the patient, they should discuss this with their doctor before starting Clopidogrel + Acetylsalicylic acid MSN:

• if there is a risk of bleeding, such as:
• a condition that increases the risk of internal bleeding (such as a 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 surgery).
• a planned surgical procedure (including dental surgery) 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 asthma or allergic reactions, including allergy to any medications used to treat this condition.
• if the patient has gout.
• if the patient consumes alcohol, due to the increased risk of bleeding or gastrointestinal damage.
• if the patient has a condition known as glucose-6-phosphate dehydrogenase deficiency, due to the risk of a specific type of anemia (low red blood cell count).

While taking Clopidogrel + Acetylsalicylic acid MSN:

• The patient should inform their doctor:
• if they are scheduled to have surgery (including dental surgery).
• if they experience stomach or abdominal pain, or bleeding from the stomach or intestines (red or black stools).
• The patient should also immediately inform their doctor if they experience:
• a condition known as thrombotic thrombocytopenic purpura (TTP), characterized by fever and purple spots on the skin, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4).
• If the patient is injured or cut, the time it takes for the bleeding to stop may be slightly longer than usual. This is due 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 4 "Possible side effects").
• The doctor may order blood tests.
• The patient should immediately inform their doctor if they experience symptoms of a drug reaction with eosinophilia and systemic symptoms (DRESS), which may include flu-like symptoms and rash with fever, swollen lymph nodes, and increased levels of certain white blood cells (eosinophilia). Other abnormal blood test results may include (but are not limited to) increased liver enzyme activity (see section 4 "Possible side effects").

Children and adolescents

Clopidogrel + Acetylsalicylic acid MSN is not intended for use in children and adolescents under 18 years of age. In children and adolescents, there is a possible link between acetylsalicylic acid (ASA) and Reye's syndrome, a rare but serious condition that can cause death, if ASA-containing medications are taken due to a viral infection.

Clopidogrel + Acetylsalicylic acid MSN and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some other medicines may affect the action of Clopidogrel + Acetylsalicylic acid MSN, and vice versa.
In particular, the patient should inform their doctor if they are taking:

• medicines that may increase the risk of bleeding, such as:
• oral anticoagulants, medicines used to prevent blood clotting,
• ASA or other non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and/or inflammatory conditions of the muscles or joints,
• heparin or other injectable medicines used to reduce blood clotting,
• ticlopidine or other antiplatelet agents,
• selective serotonin reuptake inhibitors (including, but not limited to, fluoxetine and fluvoxamine), medicines used to treat depression,
• rifampicin (used to treat severe infections),
• omeprazole or esomeprazole, medicines used to treat stomach disorders,
• methotrexate, a medicine used to treat severe arthritis (rheumatoid arthritis) or skin conditions (psoriasis),
• acetazolamide, a medicine used to treat glaucoma (increased pressure in the eye) or epilepsy, or to increase urine flow,
• probenecid, benzbromarone, or sulfinpyrazone, medicines used to treat gout,
• fluconazole or voriconazole, medicines used to treat fungal infections,
• efavirenz or tenofovir, or other antiretroviral medicines (used to treat HIV infection),
• valproic acid, valproate, or carbamazepine, medicines used to treat certain types of epilepsy,
• varicella vaccine, a medicine used to prevent chickenpox or shingles, within 6 weeks before starting Clopidogrel + Acetylsalicylic acid MSN, or during treatment, or if the patient currently has chickenpox or shingles (see section 2 "Children and adolescents"),
• moclobemide, a medicine used to treat depression,
• repaglinide, a medicine used to treat diabetes,
• paclitaxel, a medicine used to treat cancer,
• nicorandil, a medicine used to treat chest pain caused by heart disease,
• opioids: during clopidogrel treatment, the patient should inform their doctor before prescribing any opioid (medicines used to treat severe pain),
• rosuvastatin (a medicine used to lower cholesterol levels).

The patient should stop taking other clopidogrel-containing medicines while taking Clopidogrel + Acetylsalicylic acid MSN.
Occasional use of ASA (no more than 1000 mg in 24 hours) should not usually cause a problem, but long-term use of ASA in other circumstances should be discussed with the doctor.

Pregnancy and breastfeeding

Clopidogrel + Acetylsalicylic acid MSN should not be taken during the third trimester of pregnancy.
It is not recommended to take this medicine during the first and second trimesters of pregnancy.
If the patient is pregnant or thinks she may be pregnant, she should consult her doctor or pharmacist before taking Clopidogrel + Acetylsalicylic acid MSN. If the patient becomes pregnant while taking Clopidogrel + Acetylsalicylic acid MSN, she should immediately consult her doctor, as taking Clopidogrel + Acetylsalicylic acid MSN during pregnancy is not recommended.
This medicine should not be taken during breastfeeding.
If the patient is breastfeeding or plans to breastfeed, she should consult her doctor before taking this medicine.
Before taking any medicine, the patient should consult her doctor or pharmacist.

Driving and using machines

Clopidogrel + Acetylsalicylic acid MSN should not affect the patient's ability to drive or use machines.

Clopidogrel + Acetylsalicylic acid MSN contains lactose

If the patient has previously been diagnosed with intolerance to some sugars (e.g., lactose), they should contact their doctor before taking this medicine.

Clopidogrel + Acetylsalicylic acid MSN contains hydrogenated castor oil

This medicine may cause gastrointestinal upset or diarrhea.

3. How to take Clopidogrel + Acetylsalicylic acid MSN

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose of Clopidogrel + Acetylsalicylic acid MSN is one tablet per day, taken orally, with a glass of water, with or without food.
The medicine should be taken at the same time every day.
Depending on the patient's condition, the doctor will determine the necessary duration of treatment with Clopidogrel + Acetylsalicylic acid MSN. If the patient has had a heart attack, the medicine should be taken for at least 4 weeks. In any case, the medicine should be taken for as long as prescribed by the doctor.

Taking a higher dose of Clopidogrel + Acetylsalicylic acid MSN than recommended

The patient should contact their doctor or the nearest hospital emergency department due to the increased risk of bleeding.

Missing a dose of Clopidogrel + Acetylsalicylic acid MSN

If the patient forgets to take a dose of Clopidogrel + Acetylsalicylic acid MSN but remembers within 12 hours of the scheduled time, they should take the tablet immediately and then take the next tablet at the scheduled time.
If the patient forgets for more than 12 hours, they should take the next single dose at the scheduled time. The patient should not take a double dose to make up for the missed tablet.
In the case of packs of 14, 28, and 84 tablets, the patient can check the day they last took a tablet of Clopidogrel + Acetylsalicylic acid MSN using the calendar printed on the blister pack.

Stopping Clopidogrel + Acetylsalicylic acid MSN

The patient should not stop taking the medicine without their doctor's advice.Before stopping or restarting treatment, the patient should contact their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Clopidogrel + Acetylsalicylic acid MSN can cause side effects, although not everybody gets them.

The patient should immediately contact their doctor if they 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 dysfunction, such as yellowing of the skin and/or eyes (jaundice), with or without bleeding, which appears under the skin as red spots and/or confusion (see section 2 "Warnings and precautions").
• swelling of the mouth or skin disorders, such as rash and itching, blisters.
• severe skin reactions, including DRESS (see section 2 "Warnings and precautions").

The most common side effect reported with Clopidogrel + Acetylsalicylic acid MSN 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 rare cases of bleeding in the eye, into the head (especially in elderly people), lungs, or joints.

If prolonged bleeding occurs while taking Clopidogrel + Acetylsalicylic acid MSN

In the event of injury or cutting, the time it takes for the bleeding to stop may be slightly longer than usual. This is due 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 (may affect up to 1 in 10 people):
Diarrhea, stomach pain, indigestion, or heartburn.
Uncommon side effects (may affect up to 1 in 100 people):
Headache, stomach ulcer, vomiting, nausea, constipation, gas in the stomach or intestines, rash, itching, dizziness, tingling or numbness.
Rare side effects (may affect up to 1 in 1,000 people):
Vertigo, gynecomastia (breast enlargement in men).
Very rare side effects (may affect up to 1 in 10,000 people):
Jaundice (yellowing of the skin and/or eyes); burning sensation in the stomach and/or esophagus; 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 malaise leading to fainting); swelling of the mouth; blisters; skin allergy; oral mucosa ulceration (stomatitis); low blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances or loss of taste, vasculitis (inflammation of small blood vessels).
Side effects with unknown frequency (frequency cannot be estimated from available data):
Ulcer perforation, ringing in the ears, hearing loss, sudden, life-threatening allergic reactions or hypersensitivity reactions, with chest or stomach pain, kidney disease, low blood sugar, gout (a condition associated with painful joint swelling, caused by uric acid crystals), and exacerbation of food allergies, certain types of anemia (low red blood cell count) (see section 2 "Warnings and precautions"), swelling.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Clopidogrel + Acetylsalicylic acid MSN

The medicine should be stored out of 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 month stated.
Store in a temperature below 25°C.
Do not use this medicine if signs of deterioration are visible.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Clopidogrel + Acetylsalicylic acid MSN contains

The active substances of the medicine are clopidogrel and acetylsalicylic acid (ASA). Each tablet contains 75 mg of clopidogrel (as hydrogensulfate) and 75 mg of acetylsalicylic acid.
The other ingredients are:

• Core: mannitol, microcrystalline cellulose, macrogol, hydrated silica, low-substituted hydroxypropylcellulose, cornstarch, hydrogenated castor oil (see section 2 "Clopidogrel + Acetylsalicylic acid MSN contains hydrogenated castor oil"), yellow iron oxide (E 172), stearic acid.
• Coating: hypromellose 2910 (E 464), lactose monohydrate (see section 2 "Clopidogrel + Acetylsalicylic acid MSN contains lactose"), titanium dioxide (E 171), triacetin, yellow iron oxide (E 172).

What Clopidogrel + Acetylsalicylic acid MSN looks like and contents of the pack

Clopidogrel + Acetylsalicylic acid MSN, 75 mg + 75 mg, coated tablets are yellow, oval, coated tablets with the inscription "I" on one side and smooth on the other. Clopidogrel + Acetylsalicylic acid MSN is available in cartons containing:

• 14, 28, 30, and 84 tablets in blisters of OPA/Aluminum/moisture-absorbing agent/PE/Aluminum/PE foil.
• 30 x 1, 50 x 1, 90 x 1, and 100 x 1 tablets in single-dose blisters of OPA/Aluminum/moisture-absorbing agent/PE/Aluminum/PE foil.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Pharmaceutical Works POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer/Importer:

Pharmadox Healthcare Limited
KW20A, Kordin Industrial Park
Paola, PLA 3000
Malta
MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta

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

Germany:
Clopidogrel/Acetylsalicylsäure Vivanta 75 mg/75 mg Filmtabletten
Bulgaria:
Клопидогрел/Ацетилсалицилова киселина MSN 75 mg/75 mg филмирани таблетки
Czech Republic:
Clopidogrel/Acetylsalicylic acid MSN
Hungary:
Clopidogrel/Acetylsalicylic acid MSN 75 mg/75mg filmtabletta
Poland:
Clopidogrel + Acetylsalicylic acid MSN
Romania:
Clopidogrel/Acid Acetilsalicilic MSN 75 mg/75 mg comprimate filmate
Slovakia:
Clopidogrel/Acetylsalicylic acid MSN

Date of last revision of the leaflet: