QYDAXER

Package leaflet: Information for the user

Qydaxer, 75 mg, coated tablets
Clopidogrel
Please read the entire 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Qydaxer is and what it is used for
2. What you need to know 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 the active substance clopidogrel and belongs to a group of medicines called antiplatelet medicines.
Platelets are very small components in the blood that stick together during blood clotting. By preventing this clumping, antiplatelet medicines reduce the risk of blood clots (a process known as thrombosis).
Qydaxer is used in adult patients to prevent blood clots (thrombi) in arteries hardened by atherosclerosis, which could lead to atherothrombotic events (such as stroke, heart attack or death).
Qydaxer 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 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 have placed a stent in the blocked or narrowed artery to restore adequate 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 experienced transient ischaemic attack (TIA) or mild ischaemic stroke. The 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 growth of existing ones. The doctor should inform the patient that oral anticoagulants are more effective in such cases than acetylsalicylic acid or the combination of acetylsalicylic acid with Qydaxer. If oral anticoagulants cannot be used and there is no high risk of severe bleeding, the doctor should prescribe Qydaxer together with acetylsalicylic acid.

2. Important information before using Qydaxer

When not to use Qydaxer:

• 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 bleeding in the brain.
• If the patient has severe liver disease.

If the patient thinks any of these conditions apply, or has any doubts, they should consult their doctor before using Qydaxer.

Warnings and precautions

If any of the situations listed below apply to the patient, they should discuss them with their doctor before starting treatment with Qydaxer:

• 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 serious injury.
  • Recent surgery (including dental procedures).
  • Planned surgery (including dental procedures) within the next seven days.
• If the patient has had a cerebral artery thrombosis (ischaemic 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 of the medicines used to treat this condition.
• If the patient has previously experienced a non-traumatic intracranial haemorrhage.

While taking Qydaxer:

• Inform the doctor if the patient is scheduled for surgery (including dental procedures).
• Also inform the doctor immediately if the patient develops a condition called thrombotic thrombocytopenic purpura (TTP), which may present with fever and small red or purple spots under the skin resembling bruises, 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 due 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 shaving cuts. However, if bleeding occurs, contact the doctor immediately (see section 4 "Possible side effects").
• The doctor may order blood tests.

Children and adolescents

This medicine should not be used in children, as it has not been shown to be effective in this patient group.

Qydaxer with other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take, including those available without a prescription.

Some other medicines may affect the action of Qydaxer, and vice versa.

In particular, inform the doctor if the patient is 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), commonly used to treat pain and/or inflammation of muscles or joints,
  • Heparin or other injectable medicines used to reduce blood clotting,
  • Ticlopidine or other antiplatelet medicines,
  • Selective serotonin reuptake inhibitors (including, but not limited to, fluoxetine and fluvoxamine), medicines commonly used to treat depression,
  • Rifampicin (used to treat serious 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: while being treated with clopidogrel, the patient should inform the doctor before being prescribed any opioid (medicines used to treat severe pain),
• Rosuvastatin (used to lower cholesterol levels).

Patients who have experienced severe chest pain (unstable angina or heart attack), transient ischaemic attack, or mild ischaemic stroke may be prescribed Qydaxer 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) is unlikely to cause problems, but long-term use in other circumstances should be discussed with the doctor.

Qydaxer with food and drink

Qydaxer 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 might be pregnant, she should consult her doctor or pharmacist before using this medicine. If the patient becomes pregnant while taking Qydaxer, she should contact 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 using this medicine.

Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

Qydaxer is unlikely to affect the ability to drive or operate machinery.

Qydaxer contains hydrogenated castor oil

This may cause gastrointestinal discomfort or diarrhoea.

Qydaxer contains lactose

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to take Qydaxer

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.

The recommended dose of Qydaxer 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 the patient has experienced severe chest pain (unstable angina or heart attack), the doctor may prescribe an initial loading dose of 300 mg or 600 mg of Qydaxer (4 or 8 tablets of 75 mg). After this, the recommended dose of Qydaxer is one 75 mg tablet daily (as described above).

If the patient has experienced symptoms of stroke that resolve quickly (also known as transient ischaemic attack) or mild ischaemic stroke, the doctor may prescribe a single loading dose of 300 mg Qydaxer (4 tablets of 75 mg) at the start of treatment. Subsequently, the recommended dose is one tablet of Qydaxer 75 mg daily, as described above, taken together with acetylsalicylic acid for 3 weeks. After this period, the doctor may prescribe clopidogrel or acetylsalicylic acid separately.

Qydaxer should be taken for as long as your doctor recommends.

Taking more Qydaxer than prescribed
If you take more Qydaxer than you should, contact your doctor or go to the nearest hospital emergency department immediately due to an increased risk of bleeding.

If you forget to take Qydaxer
If you forget to take a dose of Qydaxer but remember within 12 hours of the usual time, take the tablet immediately, then take the next tablet at your usual time.
If you remember more than 12 hours after the usual time, take the next single dose at your usual time. Do not take a double dose to make up for the missed tablet.

For packs containing 7, 14, 28, 56, 84 or 112 tablets, you can check the day on which you last took a Qydaxer tablet by referring to the calendar printed on the blister.

Stopping Qydaxer
Do not stop taking this medicine unless your doctor tells you to. Before stopping treatment, please consult your doctor or pharmacist.

If you have any further questions about the use of this 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 a doctor immediately if the patient experiences:

• fever, signs of infection, or a feeling of extreme fatigue. This may be caused by 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 disorders, such as: skin rash and itching, skin blisters. These may be symptoms of an allergic reaction.

The most common adverse reaction reported during treatment with Qydaxer is
bleeding. Bleeding may occur as gastrointestinal bleeding, bruising, haematoma (unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine. A small number of cases of bleeding into the eye, brain, lungs or joints have also been reported.
If prolonged bleeding occurs during treatment with Qydaxer
Following a cut or injury, the time taken 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 a doctor immediately (see section 2 "Warnings and precautions").
Other adverse reactions include:
Common adverse reactions (in up to 1 in 10 people):
Diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon adverse reactions (in up to 1 in 100 people):
Headache, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines, rash, itching, dizziness, tingling or numbness sensations.
Rare adverse reactions (in up to 1 in 1,000 people):
Vertigo, gynaecomastia (breast enlargement in males).
Very rare adverse reactions (in up to 1 in 10,000 people):
Jaundice, severe abdominal pain with or without back pain; fever, difficulty breathing, 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, your doctor may observe changes in blood or urine laboratory 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Qydaxer

Keep this medicine 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 stated month.
No special storage instructions apply for this medicine.
Do not use Qydaxer if signs of deterioration are observed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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).
The other ingredients are:

• Tablet core: mannitol, microcrystalline cellulose (PH 112), macrogol, colloidal hydrated silica, low-substituted hydroxypropylcellulose, hydrogenated castor oil.
• Tablet coating: lactose monohydrate, hypromellose 2910, titanium dioxide, triacetin, iron oxide red, iron oxide black.

See section 2 "Qydaxer contains hydrogenated castor oil" and "Qydaxer contains lactose".
What Qydaxer looks like and contents of the pack
Qydaxer 75 mg film-coated tablets are pink, round, film-coated tablets, embossed with "MC 5" on one side and smooth on the other.
Qydaxer 75 mg film-coated tablets are available in cardboard boxes containing:

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

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 authorised in 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