Diclofenac diethylamine teva

Package leaflet: Information for the user

Qydaxer Duo, 75 mg + 100 mg, film-coated tablets
Clopidogrel + Acetylsalicylic acid
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Contents of the leaflet:

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

1. What Qydaxer Duo is and what it is used for

This medicine contains clopidogrel and 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 in certain blood vessels (called arteries), antiplatelet medicines reduce the risk of blood clots (a process known as atherothrombotic complications).
Qydaxer Duo is used in adults to prevent the formation of blood clots in atherosclerotic arteries, which could lead to atherothrombotic events (such as stroke, heart attack, or death).
Due to a history of severe chest pain known as "unstable angina" or heart attack (myocardial infarction), Qydaxer Duo has been prescribed to help prevent blood clots, instead of two separate medicines—clopidogrel and ASA. To treat this condition, your doctor may have placed a stent into a blocked or narrowed artery to restore adequate blood flow.

2. Important information before using Qydaxer Duo

When not to use Qydaxer Duo

• if the patient is allergic 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 medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), usually used to treat pain and/or inflammation of muscles or joints;
• if the patient has a medical condition involving asthma, nasal discharge (rhinitis), and nasal polyps (a type of abnormal tissue growth in the nose);
• if the patient currently has a disease causing bleeding, such as a stomach ulcer or bleeding within the brain;
• if the patient has severe liver disease;
• if the patient has severe kidney disease;
• if the patient is in the last trimester of pregnancy.

Warnings and precautions
If any of the situations listed below apply to the patient, discuss them with a doctor before starting treatment with Qydaxer Duo:

• 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 inside tissues, organs, or joints);
  • recent severe injury;
  • recent surgical procedure (including dental surgery);
  • planned surgical procedure (including dental surgery) within the next seven days.
• if the patient has had a cerebral artery clot (ischaemic stroke) within the last seven days;
• if the patient has kidney or liver disease;
• if the patient has previously experienced asthma or allergic reactions, including allergy to any of the medicines used to treat this condition;
• if the patient has gout;
• if the patient consumes alcohol, due to 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 anaemia (low number of red blood cells).

While using Qydaxer Duo:

• Inform the doctor:
  • if the patient is scheduled for a surgical procedure (including dental surgery);
  • if the patient experiences stomach or abdominal pain, or bleeding from the stomach or intestines (red or black-coloured stools).
• Also inform the doctor immediately if symptoms of a condition called thrombotic thrombocytopenic purpura (TTP) occur, which may include fever and small bleeding spots under the skin appearing as red pinpoint spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice) (see section 4).
• 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 shaving cuts. However, if bleeding occurs, contact a doctor immediately (see section 4 "Possible side effects").
• The doctor may order blood tests.
• Immediately inform the treating doctor if symptoms of drug reaction with eosinophilia and systemic symptoms (DRESS) occur, which may include flu-like symptoms and rash with fever, swollen lymph nodes, and increased numbers 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
Qydaxer Duo is not intended for use in children and adolescents under 18 years of age.
In children and adolescents, there is a probable association between acetylsalicylic acid (ASA) and Reye's syndrome when ASA-containing medicines are used during viral infections. Reye's syndrome is a very rare disease that may lead to death.

Qydaxer Duo with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Some other medicines may affect the action of Qydaxer Duo and vice versa.
In particular, inform your doctor if the patient is taking:

• medicines that may increase the risk of bleeding, such as:
  • oral anticoagulants, medicines used to reduce blood clotting;
  • ASA or another non-steroidal anti-inflammatory drug (NSAID), usually 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 usually used to treat depression;
  • rifampicin (used to treat serious infections);
• omeprazole or esomeprazole, medicines used to treat stomach problems;
• methotrexate, a medicine used to treat severe joint disease (rheumatoid arthritis) or skin disease (psoriasis);
• acetazolamide, a medicine used to treat glaucoma (increased pressure inside the eye), 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, tenofovir, or other antiretroviral medicines (used to treat HIV infection);
• valproic acid, valproate, or carbamazepine, medicines used to treat certain types of epilepsy;
• varicella-zoster virus vaccine, a medicine used to prevent chickenpox or shingles, within 6 weeks before starting Qydaxer Duo or during its use, 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 treatment with clopidogrel, the patient should inform the doctor before being prescribed any opioid (medicines used to treat severe pain);
• rosuvastatin (a medicine used to lower cholesterol levels).

Stop using other medicines containing clopidogrel while taking Qydaxer Duo.
Occasional use of ASA (not more than 1000 mg within 24 hours) should not usually cause a problem, but long-term use of ASA in other circumstances should be discussed with a doctor or pharmacist.

Pregnancy and breastfeeding
Do not use Qydaxer Duo during the third trimester of pregnancy.
Use of this medicine is not recommended during the first and second trimesters of pregnancy.
If the patient is pregnant or suspects she may be pregnant, she should consult a doctor or pharmacist before using Qydaxer Duo. If the patient becomes pregnant while taking Qydaxer Duo, she should consult a doctor immediately, as use of Qydaxer Duo during pregnancy is not recommended.
Do not use this medicine while breastfeeding.
If the patient is breastfeeding or planning to breastfeed, she should consult a doctor before using this medicine.
Before using any medicine, consult a doctor or pharmacist.

Driving and using machines
Qydaxer Duo is not expected to affect the ability to drive or operate machinery.

Qydaxer Duo contains lactose
If the patient has been diagnosed with intolerance to certain sugars (e.g. lactose), the patient should contact a doctor before taking this medicine.

Qydaxer Duo contains hydrogenated castor oil
This medicine may cause indigestion or diarrhoea.

3. How to take Qydaxer Duo

This medicine should always be taken as instructed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
The recommended dose of Qydaxer Duo is one tablet per day, taken orally with a glass of water,
with or without food.
The medicine should be taken every day at the same time.
Depending on the patient's condition, the doctor will determine the necessary duration of treatment with Qydaxer Duo.
If the patient has suffered a heart attack, the medicine should be used for at least 4 weeks. In
all cases, the medicine should be taken for as long as the doctor has advised.
Taking a higher than recommended dose of Qydaxer Duo
Contact a doctor or the nearest hospital emergency department due to increased risk of bleeding.
Missing a dose of Qydaxer Duo
If the patient forgets to take a dose of Qydaxer Duo but remembers within 12 hours of the scheduled time, they should take the tablet immediately, then continue taking the next tablet at the usual time.
If more than 12 hours have passed, the patient should take the next single dose at the usual time. A double dose should not be taken to make up for the missed tablet.
For packs containing 14, 28, and 84 tablets, the patient can check the day on which they last took a Qydaxer Duo tablet by referring to the calendar printed on the blister pack.
Stopping Qydaxer Duo treatment
Do not stop treatment without medical advice. Before stopping or restarting the medicine, contact the doctor.
If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact a doctor 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").
• mouth swelling or skin disorders such as: rashes and itching, skin blisters. These may be symptoms of an allergic reaction.
• severe reactions affecting the skin, blood, and internal organs (DRESS) (see section 2 "Warnings and precautions").

The most commonly reported adverse reaction during treatment with Qydaxer Duo is
bleeding. Bleeding may occur as gastrointestinal or intestinal bleeding, bruising, haematoma
(unusual bleeding or bruising under the skin), nosebleeds, or blood in the urine. There have also been
a small number of reports of bleeding in the eye, inside the head (especially in elderly individuals),
into the lungs, or into joints.
If prolonged bleeding occurs during treatment with Qydaxer Duo
Following a cut or injury, 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 the formation of blood clots. This usually does
not cause problems with minor cuts or injuries, such as small nicks during shaving. However, if any
bleeding causes concern, you should contact a doctor immediately (see section 2 "Warnings and
precautions").
Other adverse reactions include:
Common adverse reactions (may affect up to 1 in 10 people):
Diarrhoea, abdominal pain, indigestion or heartburn.
Uncommon adverse reactions (may affect up to 1 in 100 people):
Headache, gastric ulcer, vomiting, nausea, constipation, excess gas in the stomach or intestines,
rashes, itching, central dizziness, tingling or numbness.
Rare adverse reactions (may affect up to 1 in 1,000 people):
Vestibular dizziness, breast enlargement in males.
Very rare adverse reactions (may affect up to 1 in 10,000 people):
Jaundice (yellowing of the skin and (or) eyes); burning sensation in the stomach and (or) oesophagus;
severe abdominal pain with or without back pain; fever, difficulty breathing, sometimes accompanied
by 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; oral mucosal ulceration (stomatitis);
low blood pressure; confusion; hallucinations; joint pain; muscle pain; changes in taste sensation or
loss of taste, inflammation of small blood vessels.
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
Ulcer perforation, sensation of ringing in the ears, hearing loss, sudden life-threatening allergic
reactions or hypersensitivity reactions with chest or abdominal pain, kidney disease, low blood sugar
levels, gout (a condition associated with painful joint swelling caused by uric acid crystals), worsening
of food allergies, specific types of anaemia (low number of red blood cells) (see section 2 "Warnings
and precautions"), oedema.
Additionally, your doctor 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
of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +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 Duo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging and
on the blister after: EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must 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 Duo contains
The active substances in this medicine are clopidogrel and acetylsalicylic acid (ASA). Each tablet contains
75 mg of clopidogrel (as hydrogen sulfate) and 100 mg of acetylsalicylic acid.
The other ingredients are:

• Tablet core: mannitol, microcrystalline cellulose, macrogol, colloidal hydrated silica, low-substituted hydroxypropylcellulose, corn starch, hydrogenated castor oil
  (see section 2 "Qydaxer Duo contains hydrogenated castor oil"), yellow iron oxide (E 172), stearic acid.

• Tablet coating: hypromellose (E 464), lactose monohydrate (see section 2 "Qydaxer Duo contains lactose"), titanium dioxide (E 171), triacetin, red iron oxide (E 172).

What Qydaxer Duo looks like and contents of the pack
Qydaxer Duo 75 mg + 100 mg film-coated tablets are light pink to pink, oval, film-coated tablets with the imprint "II" on one side and smooth on the other. Qydaxer Duo is supplied in cardboard boxes containing:

• 14, 28 or 84 tablets in blisters made of OPA/Aluminium/desiccant/PE/Aluminium/PE.
• 30 x 1, 50 x 1, 90 x 1 or 100 x 1 tablets in unit-dose blisters made of OPA/Aluminium/desiccant/PE/Aluminium/PE.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer/Importer
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 Park
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 countries under the following names:
Iceland: Qydaxer Duo 75 mg/100 mg filmuhúðaðar töflur
Czech Republic: Qydaxer Duo
Poland: Qydaxer Duo
Estonia: Clopidogrel/Acetylsalicylic acid MSN
Lithuania: Clopidogrel/Acetylsalicylic acid MSN 75 mg/100 mg plėvele dengtos tabletės
Latvia: Clopidogrel/Acetylsalicylic acid MSN 75 mg/100 mg apvalkotās tabletes