ACESAN

Package leaflet: Information for the user

ACESAN, 75 mg, tablets
Acidum acetylsalicylicum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If symptoms do not improve or worsen, consult your doctor.

Contents of the leaflet

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

1. What Acesan is and what it is used for

The active substance in Acesan is acetylsalicylic acid, which inhibits the ability of blood platelets to aggregate (clump together) and form clots. Acetylsalicylic acid belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Its mechanism of action involves inhibition of the enzyme cyclooxygenase (COX), which is essential for the synthesis of thromboxane A2 (TXA2), the main factor causing platelet aggregation.

Therapeutic indications:

• Prevention of myocardial infarction in patients with multiple risk factors
• Prevention of thromboembolic complications following vascular interventions (coronary artery bypass grafting – CABG)
• Prevention of stroke
• Management of angina pectoris
• Prevention of thromboembolic complications after acute myocardial infarction

2. Important information before using medicine A

When not to use medicine A:

• if the patient is allergic to the active substance – acetylsalicylic acid, other salicylates, or any of the other components of this medicine (listed in section 6),
• in patients with haemorrhagic diathesis,
• in patients with active peptic ulcer disease of the stomach and/or duodenum,
• in patients with severe hepatic insufficiency,
• in patients with severe renal insufficiency,
• in patients with severe heart failure,
• in patients who have previously experienced asthma attacks induced by salicylates or substances with similar effects, particularly non-steroidal anti-inflammatory drugs,
• concomitantly with methotrexate at doses of 15 mg per week or higher,
• if the patient is in the last three months of pregnancy, doses higher than 100 mg per day must not be used (see "Pregnancy and breastfeeding"),
• in children under 12 years of age during viral infections, particularly influenza or varicella, due to the risk of Reye's syndrome – a rare but serious condition causing liver and brain damage.

Warnings and precautions
Before starting treatment with medicine A, discuss it with your doctor or pharmacist.
Acetylsalicylic acid should be used with caution:

• during the first and second trimesters of pregnancy,
• during breastfeeding,
• in cases of hypersensitivity to non-steroidal anti-inflammatory and anti-rheumatic drugs or other allergenic substances,
• when used concomitantly with anticoagulant medicines,
• in patients with impaired renal function,
• in patients with impaired hepatic function,
• in patients with a history of peptic ulcer disease of the stomach and/or duodenum or gastrointestinal bleeding,
• in patients with glucose-6-phosphate dehydrogenase deficiency,
• before planned surgical procedures, due to the risk of bleeding.

Medicine A should not be used as an analgesic or antipyretic.
Acetylsalicylic acid may cause bronchospasm and trigger asthma attacks or other hypersensitivity
reactions. Patients particularly at risk include those with bronchial asthma, chronic respiratory
diseases, hay fever with nasal polyps, and those who experience allergic reactions (e.g. skin reactions, itching, urticaria) to other substances.
Patients undergoing surgical procedures (including minor procedures, e.g. tooth extraction) should
inform their doctor about taking medicine A. Usually, discontinuation of the medicine 5–7 days
before the planned surgical procedure is recommended.
Acetylsalicylic acid, even in low doses, reduces the excretion of uric acid from the body.
In patients predisposed to reduced uric acid excretion, the medicine may trigger attacks of gout.

Medicine A and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Acetylsalicylic acid increases:

• the toxic effect of methotrexate on bone marrow. Acetylsalicylic acid should not be used concomitantly with methotrexate administered at doses of 15 mg per week or higher; concomitant use of methotrexate at doses lower than 15 mg per week requires special caution;

• the effect of anticoagulant medicines (e.g. coumarin derivatives, heparin), thrombolytic medicines (fibrinolytics, e.g. streptokinase, urokinase), and platelet aggregation inhibitors (e.g. ticlopidine), which may increase the risk of prolonged bleeding time and haemorrhage;

• the risk of peptic ulcer disease of the stomach and/or duodenum and gastrointestinal bleeding when used concomitantly with corticosteroids, other non-steroidal anti-inflammatory drugs, including other salicylates in high doses, or when alcohol is consumed during treatment;

• the risk of gastrointestinal bleeding when used concomitantly with antidepressants belonging to the selective serotonin reuptake inhibitors group (e.g. sertraline, paroxetine);

• the effect of digoxin by increasing its plasma concentration;

• the effect of antidiabetic medicines, e.g. insulin, sulfonylurea derivatives;

• the toxic effect of valproic acid, which in turn enhances the antiplatelet effect of acetylsalicylic acid.

Acetylsalicylic acid reduces the effect of:

• uricosuric medicines used in the treatment of gout that increase uric acid excretion from the body (e.g. benzbromarone, probenecid), which may exacerbate symptoms of gout;
• diuretic medicines;
• certain antihypertensive medicines (angiotensin-converting enzyme inhibitors, e.g. captopril, enalapril).

Concomitant use of ibuprofen diminishes the cardioprotective effect of acetylsalicylic acid.
Concomitant use of metamizole with acetylsalicylic acid may reduce the inhibitory effect of acetylsalicylic acid on platelet aggregation. Therefore, metamizole should be used with caution in patients taking low-dose acetylsalicylic acid for cardiovascular protection.
Medicine A may be used concomitantly with the above-mentioned medicines only after consultation
with a doctor (except for methotrexate administered at doses of 15 mg per week or higher, when use of medicine A is contraindicated).

Medicine A with food and drink
The medicine should be taken during a meal, with a large amount of liquid.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
If you continue or start treatment with medicine A during pregnancy as advised by your doctor, you should use medicine A according to your doctor's instructions and should not take a higher dose than recommended.

Pregnancy – third trimester
Do not take medicine A in doses exceeding 100 mg per day during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery.
Use of medicine A may cause disturbances in kidney and heart function in the unborn child.
It may also affect the tendency of both mother and child to bleed and may cause delay or prolongation of labour.
If you take medicine A in low doses (up to 100 mg per day inclusive), strict obstetric monitoring according to your doctor's recommendations is required.

Pregnancy – first and second trimester
Medicine A should not be used during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration. If medicine A is taken for longer than a few days beyond week 20 of pregnancy, it may cause disturbances in kidney function in the unborn child, leading to reduced amniotic fluid volume (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If prolonged treatment is necessary, your doctor may recommend additional monitoring.

Breastfeeding
Acetylsalicylic acid passes into breast milk in small amounts. Consult your doctor before using this medicine.

Driving and operating machinery
This medicine has no influence on the ability to drive motor vehicles or operate machinery.

Medicine A contains carmine
Due to the presence of carmine, this medicine may cause allergic reactions.

Medicine A contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use medicine A

This medicine should always be taken exactly as described in this patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Symbols indicating the days of the week are printed on the immediate packaging. These will help the patient
to check whether the tablet for a given day has already been taken.
The dosage of medicine A is determined by the doctor based on medical history. Usually, one tablet is taken once daily.
The tablets should be taken orally, preferably during a meal, with a large amount of fluid.

Taking a higher than recommended dose of medicine A
If a higher than recommended dose of medicine A has been taken, seek immediate advice from a doctor or
pharmacist. In cases of severe poisoning, the patient should be immediately transported to hospital.
The first symptoms of poisoning include: dizziness, tinnitus, deafness, excessive sweating, nausea and
vomiting, headache, confusion (disorders of consciousness with disorientation, disturbances in thinking and speech,
hallucinations, delusions, anxiety, and psychomotor agitation), rapid breathing, abnormally deep
breathing, visual disturbances (spots before the eyes), and fainting.
In cases of severe poisoning, the following may occur: high fever, disturbances in heart and blood vessel function (ranging from irregular heartbeat and low blood pressure to cardiac arrest), fluid and electrolyte loss (due to dehydration, oliguria – reduction in daily urine output below 400–500 mL in adults – up to kidney failure), increased or decreased blood glucose concentration (especially in children), ketosis (increased blood ketone levels), gastrointestinal bleeding, blood coagulation disorders, and neurological disturbances manifesting as lethargy, confusion, progressing to coma and convulsions.

Missing a dose of medicine A
If a dose of medicine A is missed, take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.
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 can cause adverse reactions, although not everyone experiences them.
Treatment must be discontinued and immediate medical advice sought if the patient develops first signs of hypersensitivity (e.g. swelling of the face, lips, tongue, or throat causing difficulty in breathing or swallowing) or if bleeding occurs, e.g. gastrointestinal bleeding (symptoms: black stools), or haemorrhage. The physician will then assess the severity of symptoms and decide on further management.

Following the use of acetylsalicylic acid, the following have been reported:

Common (in 1 to 10 out of 100 patients):

• Dyspeptic symptoms (heartburn, nausea, vomiting) and abdominal pain.

Uncommon (in 1 to 10 out of 10,000 patients):

• Inflammation of the stomach and intestines, gastric and (or) duodenal ulceration, very rarely leading to haemorrhage and perforation;
• Transient disturbances in liver function (increased aminotransferase activity).

Uncommon or very rare:

• Serious bleeding such as gastrointestinal haemorrhage (symptoms: black stools), cerebral haemorrhage (particularly in patients with uncontrolled arterial hypertension and (or) when used concomitantly with anticoagulant drugs). Haemorrhage may lead to acute or chronic anaemia due to blood loss and (or) iron-deficiency anaemia (symptoms: weakness, pallor).

Very rare (less than 1 in 10,000 patients):

• Severe allergic reactions, including anaphylactic shock (symptoms: swelling of the face, eyelids, tongue, and larynx, marked drop in blood pressure, and disturbances in heart rhythm and breathing);
• Impaired kidney function;
• Decreased blood glucose concentration.

Additionally reported:

• Dizziness and tinnitus (symptoms of overdose);
• Hypersensitivity reactions: rash, urticaria, angioedema, pruritus, cardiac and respiratory disorders (including asthma);
• Increased risk of bleeding, prolonged bleeding time and prothrombin time, decreased platelet count;
• Perioperative haemorrhage, bruising, bleeding (from nose, genitourinary tract, gums).

When using medicines belonging to the group of non-steroidal anti-inflammatory drugs, oedema, hypertension, and heart failure have been reported as adverse reactions.

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
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 allows additional information on the safety of the medicine to be collected.

5. How to store medicine A

Keep this medicine out of sight and reach of children.
Store below 25°C.
Keep in the original packaging to protect from moisture.
Do not use medicine A after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
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 package and other information

What A medicine contains

• The active substance is acetylsalicylic acid. Each tablet contains 75 mg of acetylsalicylic acid.
• The other components are: microcrystalline cellulose, sodium carboxymethyl starch (type A), stearic acid, carmine red, lac (E 124).

What A medicine looks like and contents of the pack
Medicine A is a pink-coloured, round, biconvex tablet with a uniform surface.
Packaging: PVC/PCTFE/Aluminium blisters in a cardboard box
Pack size: 63 tablets or 200 tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
tel. +48 22 350 66 69

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany