Qidaxer

Package Leaflet: Information for the User

Qydaxer, 75 mg, Coated Tablets

Clopidogrel

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on 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 package leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

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

1. What Qydaxer is and what it is used for

Qydaxer contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products. Platelets are very small blood cells that help to stop bleeding when a blood vessel is injured. By preventing platelets from aggregating, antiplatelet medicines reduce the risk of blood clots (a process called thrombosis). Qydaxer is used in adult patients to prevent atherosclerotic events (such as stroke, myocardial infarction, or death) in patients with atherosclerosis (hardening of the arteries), which can lead to blood clots forming in the arteries.

• In patients with a history of atherosclerotic disease (such as stroke, myocardial infarction, or peripheral artery disease), and
• In patients with unstable angina (severe chest pain) or who have had a heart attack (myocardial infarction), or
• In patients who have had a transient ischaemic attack (TIA, "mini-stroke") or a mild ischaemic stroke.
• In patients with irregular heartbeats (atrial fibrillation) who cannot take oral anticoagulants (blood thinners), the doctor may prescribe Qydaxer with acetylsalicylic acid.

During treatment with Qydaxer:

• Tell your doctor if you are going to have surgery (including dental surgery).
• Also, immediately inform your doctor if you experience symptoms of thrombotic thrombocytopenic purpura (such as fever, bruising, or extreme fatigue).
• If you cut or injure yourself, it may take longer than usual for bleeding to stop. 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 during shaving. However, if bleeding occurs, you should immediately contact your doctor (see section 4 "Possible side effects").
• Your doctor may order blood tests.

Children and Adolescents

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

Qydaxer and Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

• Medicines that may increase the risk of bleeding, such as oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs), heparin, or other antiplatelet agents.
• Omeprazole or esomeprazole, used to treat stomach disorders.
• Fluconazole or voriconazole, used to treat fungal infections.
• Efavirenz or other antiretroviral medicines (used to treat HIV infection).
• Carbamazepine, used to treat certain types of epilepsy.
• Moclobemide, used to treat depression.
• Repaglinide, used to treat diabetes.
• Paclitaxel, used to treat cancer.
• Opioids: during treatment with clopidogrel, you should inform your doctor before being prescribed any opioid (strong painkillers).
• Rosuvastatin (used to lower cholesterol levels).

Patient with severe chest pain (unstable angina or myocardial infarction), transient ischaemic attack, or ischaemic stroke may be given Qydaxer in combination with acetylsalicylic acid.

Qydaxer with Food and Drink

Qydaxer can be taken with or without food.

Pregnancy and Breast-feeding

Do not take this medicine if you are pregnant or think you might be pregnant.

Driving and Using Machines

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

Qydaxer Contains Hydrogenated Castor Oil

This may cause stomach upset or diarrhea.

Qydaxer Contains Lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to Take Qydaxer

Always take this medicine exactly as your doctor or pharmacist has told you.

The recommended dose is one 75 mg tablet per day, to be taken orally with or without food, at the same time each day.

If You Take More Qydaxer Than You Should

Contact your doctor or the nearest hospital emergency department immediately, as there is an increased risk of bleeding.

If You Forget to Take Qydaxer

If you forget to take a dose, but remember within 12 hours of the missed dose, take the missed dose immediately and then take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

If You Stop Taking Qydaxer

Do not stop treatment unless your doctor tells you to.If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

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

Stop Taking Qydaxer and Contact a Doctor Immediately if You Experience:

• Fever, signs of infection, or extreme fatigue. This may be due to a rare decrease in the number of white blood cells.
• Signs of liver problems, such as yellowing of the skin and/or eyes (jaundice), whether or not associated with bleeding, which appears as red pinpoint dots under the skin and/or confusion (see section 2 "Warnings and precautions").
• Mouth or skin bleeding, or bruising, or petechiae (small red spots on the skin).

The Most Common Side Effect Reported with Qydaxer is

Bleeding. Bleeding may occur as stomach or intestinal bleeding, bruising, or bleeding from the nose or into the urine. There have also been reports of bleeding in the eyes, brain, lungs, or joints.

If You Experience Prolonged Bleeding While Taking Qydaxer

If you cut or injure yourself, it may take longer than usual for bleeding to stop. 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 during shaving. However, if bleeding occurs, you should immediately contact your doctor (see section 2 "Warnings and precautions").

Other Side Effects Include:

Common side effects (may affect up to 1 in 10 people):
Diarrhea, abdominal 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, or tingling.
Rare side effects (may affect up to 1 in 1,000 people):
Vertigo, breast enlargement in men.
Very rare side effects (may affect up to 1 in 10,000 people):
Jaundice, severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes with cough; generalized allergic reactions (such as general feeling of heat with sudden general ill-feeling leading to fainting); swelling of the mouth; blistering skin; skin allergy; oral mucosal inflammation (stomatitis); low blood pressure; confusion; hallucinations; joint pain; muscle pain; taste disturbances or loss of taste.
Side effects of unknown frequency (frequency cannot be estimated from available data):
Hypersensitivity reactions with chest or abdominal pain, prolonged low blood sugar levels.

Reporting of Side Effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported to the Department of Drug Safety, Ministry of Health, or directly to the marketing authorization holder.

5. How to Store Qydaxer

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

The expiry date refers to the last day of that month.

There are no special storage conditions for this medicine.

Do not use this medicine if you notice any signs of deterioration.

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 Qydaxer Contains

The active substance is clopidogrel. Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate).

• Core: mannitol, microcrystalline cellulose (PH 112), macrogol, silica colloidal anhydrous, hypromellose, hydrogenated castor oil.
• Coating: lactose monohydrate, hypromellose 2910, titanium dioxide, triacetin, iron oxide red, iron oxide black.

What Qydaxer Looks Like and Contents of the Pack

Qydaxer 75 mg coated tablets are pink, round, coated tablets with "MC 5" engraved on one side and smooth on the other.

• 7, 14, 28, 30, 56, 60, 84, 90, 100, 112, and 120 coated tablets in blisters (with or without calendar blister);
• 50 x 1 coated tablet in unit-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

MSN Labs Europe Limited
KW20A, Corradino Park
Paola, PLA 3000
Malta
tel.: (+48) 699 711 147

Manufacturer/Importer:

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

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Germany:
Clopidogrel MSN 75 mg Filmtabletten
Bulgaria:
Кюдаксер 75 mg филмирани таблетки
Hungary:
Qydaxer 75 mg filmtabletta
Poland:
Qydaxer
Romania:
Qydaxer 75 mg comprimate filmate

Date of Last Revision of the Package Leaflet: 03/2025