Auroclasa

Package leaflet: Information for the user

Auroclasa, 75 mg + 75 mg, coated tablets
Auroclasa, 75 mg + 100 mg, 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, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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. See section 4.

Leaflet contents

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

1. What Auroclasa is and what it is used for

Auroclasa 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 atherosclerosis).
Auroclasa is used in adults to prevent blood clots in narrowed arteries, which may 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), Auroclasa has been prescribed instead of two separate medicines—clopidogrel and ASA—to help prevent blood clots. To treat this condition, your doctor may have placed a stent in a blocked or narrowed artery to restore adequate blood flow.

2. Important information before taking Auroclasa

When not to take Auroclasa

• 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) inflammatory conditions of muscles or joints.
• if the patient has a medical condition involving asthma, nasal discharge (rhinitis), and nasal polyps (a type of nasal growth).
• if the patient currently has a bleeding condition, 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 three months of pregnancy, doses exceeding 100 mg of acetylsalicylic acid per day must not be used (see section "Pregnancy, breastfeeding and fertility").

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

• 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 into tissues, organs, or joints).
• recent serious injury.
• recent surgical procedure (including dental surgery).
• planned surgery within the next seven days (including dental procedures).
• 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 asthma.
• 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 Auroclasa:

• Inform the doctor
• if the patient is scheduled for surgery (including dental procedures).
• 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 symptoms of a condition called thrombotic thrombocytopenic purpura (TTP) occur, characterized by fever and small subcutaneous bleeding spots (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 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 those occurring during shaving. However, if bleeding occurs, contact the 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 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
Auroclasa 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.

Auroclasa and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Some other medicines may affect the action of Auroclasa 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,
• ASA or other non-steroidal anti-inflammatory drugs (NSAIDs) 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) 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-zoster virus vaccine, a medicine used to prevent chickenpox or shingles, within 6 weeks before starting or during treatment with Auroclasa, 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 any opioid (medicines used to treat severe pain) is prescribed,
• rosuvastatin (a medicine used to lower cholesterol levels).

Other medicines containing clopidogrel must be discontinued during treatment with Auroclasa.
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 the doctor.

Pregnancy and breastfeeding
Auroclasa must not be taken 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 Auroclasa. If the patient becomes pregnant while taking Auroclasa, she should consult a doctor immediately, as use of Auroclasa during pregnancy is not recommended.
If the patient continues or starts treatment with Auroclasa during pregnancy as advised by the doctor, Auroclasa should be taken strictly according to the doctor's instructions and the recommended dose must not be exceeded.

Pregnancy - third trimester
Do not take a dose of acetylsalicylic acid higher than 100 mg per day if the patient is in the last three months of pregnancy, as this may harm the unborn child or cause complications during delivery. Kidney and heart function disorders may occur in the unborn child. The medicine may increase the tendency to bleeding in both the mother and the child and may delay or prolong labour.
If the patient takes acetylsalicylic acid in low doses (up to 100 mg per day inclusive), the obstetric condition should be closely monitored according to the doctor's recommendations.

Pregnancy - first and second trimesters
During the first six months of pregnancy, Auroclasa should not be taken unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time.
Taking Auroclasa from week 20 of pregnancy for longer than a few days may result in kidney function disorders in the unborn child, which may lead to reduced amniotic fluid volume surrounding the child (oligohydramnios), or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding should not be performed during treatment with this medicine.
If the patient is breastfeeding or planning to breastfeed, she should consult a doctor before taking this medicine.

Before taking any medicine, consult a doctor or pharmacist.

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

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

3. How to take Auroclasa

This medicine should always be taken as directed by the doctor or pharmacist. In case of
doubt, consult the doctor or pharmacist.
The recommended dose of Auroclasa is one tablet daily, 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 Auroclasa.
If the patient has had a heart attack, the medicine should be used for at least 4 weeks.
In all cases, the medicine should be used for as long as the doctor has instructed.
Taking more Auroclasa than recommended
Contact a doctor or the nearest hospital emergency department due to increased risk of bleeding.
Missing a dose of Auroclasa
If the patient forgets to take a dose of Auroclasa 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 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.
Stopping Auroclasa
Do not stop treatment without consulting the doctor. Before stopping or restarting treatment, 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 everybody will experience them.
You should contact a doctor immediately if the patient experiences:

• fever, signs of infection, or feeling extremely tired. This may be due to a rare reduction in the number of certain blood cells.
• symptoms of liver problems, 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 reactions, 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 Auroclasa is
bleeding.
Bleeding may occur as gastrointestinal bleeding, bruising, haematoma (unusual bleeding or bruising under the skin), nosebleeds, or 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 Auroclasa
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 while shaving. However, if bleeding occurs, 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, rash, itching, central dizziness, tingling or numbness.
Rare adverse reactions (may affect up to 1 in 1,000 people):
Vestibular dizziness, breast enlargement in men.
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; taste disturbances 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 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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
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 Auroclasa

Keep this medicine out of 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Auroclasa contains
The active substances are clopidogrel + acetylsalicylic acid.

• Each tablet contains 75 mg of clopidogrel (as clopidogrel hydrogen sulfate) and 75 mg of acetylsalicylic acid. Each tablet contains 75 mg of clopidogrel (as clopidogrel hydrogen sulfate) and 100 mg of acetylsalicylic acid.

The other ingredients are:

• Tablet core: Microcrystalline cellulose, mannitol, low-substituted hydroxypropylcellulose, crospovidone, polyethylene glycol, hydrogenated castor oil, pregelatinized starch (corn starch), colloidal anhydrous silica, stearic acid and talc.
• Tablet coating: Polyvinyl alcohol, glyceryl monostearate, polysorbate 80, triacetin, stearic acid, talc, titanium dioxide (E 171), yellow iron oxide (E 172) (for the 75 mg + 75 mg strength) and red iron oxide (E 172) (for the 75 mg + 100 mg strength).

What Auroclasa looks like and contents of the pack
Auroclasa, 75 mg + 75 mg, coated tablets
Yellow, oval, biconvex coated tablets, smooth on both sides.
Auroclasa, 75 mg + 100 mg, coated tablets
Pink, oval, biconvex coated tablets, smooth on both sides.
Auroclasa is available in blisters containing 28 and 30 coated tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus 19, Venda Nova
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Auroclasa
Portugal: Auroclasa