Package leaflet: Information for the user

Codaxor, 75 mg + 75 mg, film-coated tablets
Clopidogrel + Acetylsalicylic Acid
Please read all of this leaflet carefully before taking this medicine, because 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 you personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Codaxor is and what it is used for
What you need to know before you take Codaxor
How to take Codaxor
Possible side effects
How to store Codaxor
Contents of the pack and other information

1. What Codaxor is and what it is used for

Codaxor 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 together in certain blood vessels (called arteries), antiplatelet medicines reduce the risk of blood clots (a process known as atherothrombotic complications).
Codaxor is used in adults to prevent the formation of blood clots in atherosclerotic arteries, which may lead to atherothrombotic events (such as stroke, heart attack, or death).
Because you have experienced a serious chest pain known as "unstable angina" or a heart attack (myocardial infarction), your doctor has prescribed Codaxor instead of two separate medicines – clopidogrel and ASA – both of which help prevent blood clots. To treat this condition, your doctor may have inserted a stent into a blocked or narrowed artery to restore adequate blood flow.

2. Important information before using Codaxor

When not to use Codaxor

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 medicines known as non-steroidal anti-inflammatory drugs, usually used to treat pain and/or inflammatory conditions 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 third trimester of pregnancy.

Warnings and precautions
If any of the following situations apply to the patient, discuss them with a doctor before starting treatment with Codaxor:

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 that predisposes to internal bleeding (bleeding inside tissues, organs, or joints).
- recent severe trauma.
- 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 had 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 developing a specific type of anaemia (low red blood cell count).

While taking Codaxor:

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 stools).
Also inform the doctor immediately if the patient develops a condition called thrombotic thrombocytopenic purpura (TTP), characterised by fever and small bleeding spots under the skin (petechiae), appearing as red pinpoint spots, with or without unexplained extreme fatigue, confusion, or 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 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 a doctor immediately (see section 4 "Possible side effects").
The doctor may order blood tests.
Inform the treating doctor immediately 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
Codaxor 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.

Codaxor with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Some medicines may affect the action of Codaxor, and Codaxor may affect the action of other medicines.
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,
- ASA or another non-steroidal anti-inflammatory drug usually used to treat pain and/or inflammatory conditions 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 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-zoster virus vaccine, a medicine used to prevent chickenpox or shingles, within 6 weeks before starting Codaxor 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 taking any other medicines containing clopidogrel while taking Codaxor.
Occasional use of ASA (not more than 1000 mg within 24 hours) should not usually cause problems, but long-term use of ASA in other circumstances should be discussed with a doctor.

Pregnancy and breastfeeding
Do not use Codaxor 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 Codaxor. If the patient becomes pregnant while taking Codaxor, she should consult a doctor immediately, as use of Codaxor during pregnancy is not recommended.
Do not use this medicine during breastfeeding.
If the patient is breastfeeding or planning to breastfeed, she should consult a doctor before using this medicine.
Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines
Codaxor is unlikely to affect the ability to drive or operate machinery.

Codaxor contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars (e.g. lactose), the patient should consult a doctor before taking this medicine.

Codaxor contains hydrogenated castor oil
This medicine may cause gastrointestinal discomfort or diarrhoea.

3. How to take Codaxor

This medicine should always be taken as prescribed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose of Codaxor is one tablet daily, taken orally with a glass of water,
with or without food.
The medicine should be taken at the same time each day.
Depending on the patient's condition, the doctor will determine the required duration of treatment with Codaxor.
If the patient has had a heart attack, the medicine should be used for at least 4 weeks. In any case, the medicine
should be taken for as long as the doctor has recommended.
Taking a higher than recommended dose of Codaxor
Contact a doctor or the nearest hospital emergency department due to increased risk of bleeding.
Missing a dose of Codaxor
If the patient forgets to take a dose of Codaxor but remembers within 12 hours of the scheduled time,
they should take the tablet immediately, then take the next tablet at the usual time.
If the patient remembers more than 12 hours later, they 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 pack sizes of 14, 28, and 84 tablets, the patient may check the day on which they last took a Codaxor tablet
using the calendar printed on the blister.
Stopping Codaxor treatment
Do not stop treatment without medical advice. Before stopping or restarting the medicine,
consult a doctor.
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 may 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").
swelling of the lips or skin disorders, such as: rash 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 Codaxor is
bleeding. Bleeding may occur in the stomach or intestines, bruising, haematoma
(unusual bleeding or bruising under the skin), nosebleeds, blood in the urine. There have also
been reports of a small number of cases of bleeding in the eye, inside the head (especially in elderly
people), lungs, or joints.
If prolonged bleeding occurs while taking Codaxor
After 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 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:
Frequent 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,
rash, 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, breathing difficulties, sometimes associated
with cough; generalised 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
(oral inflammation); low blood pressure; confusion; hallucinations; joint pain; muscle pain; taste
disturbances or loss of taste, inflammation of small blood vessels.
Adverse reactions with unknown frequency (frequency cannot be determined from available data):
Ulcer perforation, sensation of ringing in the ears, hearing loss, sudden life-threatening allergic or
hypersensitivity reactions with chest or abdominal pain, kidney disorders, decreased blood sugar
levels, gout (a disease 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.
In addition, your doctor may detect changes in blood or urine test results.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your
doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of
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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Codaxor

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack after: EXP. The expiry date refers to the last day of the specified month.
Store below 25°C.
Do not use this medicine 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 package and other information

What Codaxor contains

The active substances in Codaxor are clopidogrel and acetylsalicylic acid (ASA). Each tablet contains 75 mg of clopidogrel (as hydrogen sulfate) and 75 mg of acetylsalicylic acid.
Other components are:
Tablet core: mannitol, microcrystalline cellulose, polyethylene glycol, colloidal hydrated silica, low-substituted hydroxypropylcellulose, corn starch, hydrogenated castor oil (see section 2 "Codaxor contains hydrogenated castor oil"), yellow iron oxide (E 172), stearic acid.
Tablet coating: hypromellose 2910 (E 464), monohydrate lactose (see section 2 "Codaxor contains lactose"), titanium dioxide (E 171), triacetin, yellow iron oxide (E 172).

What Codaxor looks like and contents of the pack
Codaxor 75 mg + 75 mg film-coated tablets are yellow, oval, film-coated tablets, embossed with the mark "I" on one side and smooth on the other. Codaxor is supplied in cardboard boxes containing:

14, 28, 30 and 84 tablets in blisters made of OPA/Aluminium/Moisture Absorbing Layer/PE/Aluminium/PE.
30 x 1, 50 x 1, 90 x 1 and 100 x 1 tablet in unit-dose blisters made of OPA/Aluminium/Moisture Absorbing Layer/PE/Aluminium/PE.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 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 medicinal product is authorised for marketing in the European Economic Area under the following names:
Germany: Clopidogrel/Acetylsalicylsäure Vivanta 75 mg/75 mg Filmtabletten
Bulgaria: Кайдаксер Дуо 75 mg/75 mg филмирани таблетки
Czech Republic: Qydaxer Duo
Hungary: Qydaxer Duo 75 mg/75mg filmtabletta
Poland: Codaxor
Romania: Qydaxer Duo 75 mg/75 mg comprimate filmate
Slovakia: Qydaxer Duo 75 mg/75 mg