Acard 300 mg

Leaflet attached to the packaging: patient information

ACARD 300 mg, 300 mg, tablets

Acetylsalicylic acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Acard 300 mg and what is it used for
• 2. Important information before taking Acard 300 mg
• 3. How to take Acard 300 mg
• 4. Possible side effects
• 5. How to store Acard 300 mg
• 6. Package contents and other information

1. What is Acard 300 mg and what is it used for

Acard 300 mg contains acetylsalicylic acid, which inhibits blood platelet aggregation.
Acard 300 mg is used in cases of myocardial infarction or suspected myocardial infarction.

What is myocardial infarction?

Myocardial infarction occurs due to insufficient blood supply to a part of the heart, usually caused by the closure of a coronary vessel (supplying blood to the heart) by mechanical factors (embolism, thrombosis) and platelet aggregation.
The most common symptoms of a heart attack are:

• chest pain (usually lasting over 20 minutes, radiating to the left arm, jaw, or back, unrelated to body position or breathing),
• heart rhythm disturbances (feeling of palpitations),
• shortness of breath,
• sweating, feeling of anxiety, increased heart rate,
• nausea and vomiting.

What to do if a patient suspects myocardial infarction?

In case of a heart attack or suspected heart attack, the patient should immediately call the emergency services and then take Acard 300 mg (see section 3).
Every patient with suspected myocardial infarction must receive specialized care as soon as possible.
Quick restoration of blood flow in the closed coronary vessel and prevention of further platelet aggregation and blood clotting processes can limit the area of myocardial necrosis, thereby improving the patient's prognosis and quality of life in the future.
Myocardial infarction is a disease in which immediate treatment is crucial.
Patients at risk of myocardial infarction should carry a medicine containing acetylsalicylic acid (e.g., Acard 300 mg) with them.
Risk factors for myocardial infarction include:

• cardiovascular diseases
• smoking
• increased fat levels in the body
• diabetes
• family history of hypertension or myocardial infarction
• previous myocardial infarction
• obesity
• chest pain occurring during physical exertion or stress.

2. Important information before taking Acard 300 mg

When not to take Acard 300 mg

• if the patient is allergic to acetylsalicylic acid or any other component of this medicine (listed in section 6);
• if the patient is allergic to other non-steroidal anti-inflammatory drugs, with symptoms such as: bronchospasm, nasal mucosa inflammation, anaphylaxis;
• if the patient has active gastric or duodenal ulcer disease and inflammatory or bleeding conditions of the gastrointestinal tract or other organs (e.g., bleeding in the central nervous system);
• if the patient has severe liver, kidney, or heart failure;
• if the patient has blood clotting disorders (e.g., hemophilia, thrombocytopenia);
• if the patient is taking methotrexate in doses of 15 mg per week or higher, due to its toxic effect on the bone marrow;
• if the patient is in the last three months of pregnancy, doses higher than 100 mg per day should not be taken (see "Pregnancy and breastfeeding");
• in children and adolescents under 16 years of age with viral infections, due to the risk of Reye's syndrome - a rare but severe disease causing liver and brain damage.

Warnings and precautions

Particular caution should be exercised when taking Acard 300 mg:

• if the patient has asthma, chronic respiratory diseases, hay fever, or nasal mucosa swelling, as patients with these diseases may react to non-steroidal anti-inflammatory drugs with asthma attacks, limited skin and mucous membrane swelling (angioedema), or urticaria more frequently than other patients;
• in patients with kidney function disorders and chronic kidney failure;
• in patients with systemic lupus erythematosus and impaired liver function;
• in cases of menstrual bleeding, excessive menstrual bleeding, use of an intrauterine contraceptive device, hypertension, heart failure;
• in patients with glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease);
• in elderly patients;
• in patients with a history of gastric ulcers and taking medications that increase the risk of gastric ulcers and gastrointestinal bleeding (such as oral corticosteroids, selective serotonin reuptake inhibitors, and deferasirox); acetylsalicylic acid, even in small doses, reduces uric acid excretion; in predisposed patients, the medicine may cause gout attacks;
• acetylsalicylic acid used with other medications that disrupt hemostasis (anticoagulants, thrombolytics, anti-aggregants, non-steroidal anti-inflammatory drugs,

selective serotonin reuptake inhibitors) may increase the risk of bleeding.
Hypersensitivity to acetylsalicylic acid occurs in 0.3% of the population, including 20% of patients with asthma or chronic urticaria. Hypersensitivity symptoms (urticaria, even anaphylaxis) may occur within 3 hours of taking acetylsalicylic acid.
There have been rare cases of severe skin reactions, including Stevens-Johnson syndrome, associated with acetylsalicylic acid use. If symptoms of skin rash, mucous membrane changes, or other hypersensitivity symptoms occur, the medicine should not be taken again.
Medicines containing acetylsalicylic acid should not be taken by women in the first and second trimesters of pregnancy, unless absolutely necessary (see below).
Acetylsalicylic acid may cause fertility disorders in women (see below).

Acard 300 mg and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Medicines contraindicated for concurrent use with acetylsalicylic acid:

• methotrexate in doses of 15 mg per week or higher, due to its toxic effect on the bone marrow.

Medicines whose concurrent use with acetylsalicylic acid should be avoided:

• medicines that increase uric acid excretion (e.g., probenecid, sulfinpyrazone). Salicylates weaken the effect of medicines that increase uric acid excretion.

Caution should be exercised when taking Acard 300 mg concurrently with:

• methotrexate in doses less than 15 mg per week (used in cancer or rheumatoid diseases);
• diuretics (e.g., furosemide, spironolactone);
• antihypertensive medicines (e.g., ACE inhibitors, angiotensin II receptor antagonists, calcium channel blockers);
• anticoagulant medicines (e.g., warfarin, heparin) and other medicines that inhibit platelet aggregation (e.g., ticlopidine);
• thrombolytic medicines (e.g., streptokinase and alteplase) (used to dissolve blood clots);
• other non-steroidal anti-inflammatory medicines (including ibuprofen);
• selective serotonin reuptake inhibitors (SSRIs) (used to treat depression);
• digoxin (used to treat heart failure);
• lithium salts (used to treat manic episodes);
• antidiabetic medicines (e.g., insulin, sulfonylurea derivatives);
• systemic glucocorticosteroids (except for hydrocortisone used as replacement therapy in Addison's disease);
• valproic acid (used to treat epilepsy);
• acetazolamide (used to treat glaucoma);
• cyclosporine, tacrolimus (used in transplant patients);
• alcohol.

Metamizole (a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (platelet adhesion and clot formation) if taken concurrently. Therefore, caution should be exercised when taking metamizole in patients receiving acetylsalicylic acid.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
If the patient continues or starts treatment with Acard 300 mg during pregnancy according to the doctor's advice, they should take Acard 300 mg as advised and not exceed the recommended dose.
Pregnancy - last trimester
Acetylsalicylic acid should not be taken in doses higher than 100 mg per day in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Taking Acard 300 mg may cause kidney and heart disorders in the unborn child. This may affect the patient's and child's tendency to bleed and cause delayed or prolonged delivery.
If the patient takes acetylsalicylic acid in small doses (up to 100 mg per day), close obstetric monitoring is necessary according to the doctor's advice.
Pregnancy - first and second trimesters
Acard 300 mg should not be taken during the first six months of pregnancy, unless absolutely necessary and advised by a doctor. If treatment is necessary during this period or when trying to conceive, the smallest effective dose should be used for the shortest possible time. Acard 300 mg taken for more than a few days, starting from the 20th week of pregnancy, may cause kidney disorders in the unborn child, leading to low amniotic fluid levels or narrowing of the arterial duct in the child's heart. If longer treatment is necessary, the doctor may recommend additional monitoring.
Breastfeeding
Considering that acetylsalicylic acid passes into breast milk and may pose a risk of Reye's syndrome in infants, the doctor will decide whether to stop breastfeeding, weighing the benefits of breastfeeding for the child and the benefits of treatment for the mother.
Fertility
This medicine belongs to a group of non-steroidal anti-inflammatory drugs that may adversely affect female fertility. This effect is temporary and disappears after treatment is discontinued.

Driving and using machines

The medicine does not affect psychophysical abilities.

3. How to take Acard 300 mg

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
In case of a heart attack or suspected heart attack, the patient should immediately call the emergency services and then take Acard 300 mg.
Acard 300 mg should be taken immediately after the onset of myocardial infarction symptoms, usually chest pain, heart rhythm disturbances, shortness of breath, sweating, feeling of anxiety, increased heart rate, nausea, and vomiting.
Recommended dose
Adults: from 150 mg to 300 mg(from ½ to 1 tablet) once.
Usually, a dose of 300 mg is given once.
Method of administration
The medicine should be taken orally. The tablet should be chewed (to ensure faster action) and then swallowed with water, or it can be dissolved in ½ glass of water.

Taking a higher dose of Acard 300 mg than recommended

If a higher dose of the medicine is taken than recommended (or if someone else takes it by mistake), consult a doctor or go to the nearest hospital emergency department immediately.
After an overdose of acetylsalicylic acid, the following symptoms may occur:

• nausea, vomiting, rapid breathing, tinnitus.

Other symptoms have also been observed, such as:

• hearing loss, vision disturbances, headaches,
• motor agitation, drowsiness, and coma,
• seizures, hyperthermia (body temperature above normal).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following symptoms occur, inform your doctor immediately:

• hypersensitivity reactions such as rash, urticaria, itching;
• facial, lip, tongue, or throat swelling;
• difficulty breathing or swallowing;
• anaphylactic shock, with symptoms such as dizziness, feeling of severe weakness, palpitations, nausea, and vomiting.

After taking acetylsalicylic acid, the following side effects may occur with unknown frequency:

• thrombocytopenia (reduced platelet count), anemia due to microbleeding from the gastrointestinal tract, hemolytic anemia in patients with glucose-6-phosphate dehydrogenase deficiency;
• leukopenia (reduced white blood cell count), agranulocytosis (absence of granulocytes in the blood), eosinopenia (reduced eosinophil count in the blood);
• increased risk of bleeding, prolonged bleeding time, prolonged prothrombin time, iron deficiency anemia, hemolysis (red blood cell breakdown);
• tinnitus (usually as a symptom of overdose), hearing disturbances, dizziness;
• heart failure, hypertension;
• hematomas, bleeding (including from the urogenital system, cerebral, intracranial, perioperative, or into muscles);
• nasal bleeding, analgesic asthma (induced by taking painkillers), nasal mucosa inflammation, nasal congestion;
• indigestion, heartburn, feeling of fullness in the upper abdomen, nausea, vomiting, loss of appetite, abdominal pain;
• gastrointestinal bleeding or perforation (symptoms may include bloody vomiting or black stools), gastric mucosa damage, exacerbation of ulcer disease, gum bleeding, gastrointestinal inflammation;
• focal liver cell necrosis, liver tenderness and enlargement, especially in patients with systemic lupus erythematosus, rheumatic fever, or a history of liver disease;
• transient increase in liver function test values in the blood (aminotransferases, alkaline phosphatase, and bilirubin levels);
• various skin rashes;
• proteinuria, presence of leukocytes and erythrocytes in the urine, renal papillary necrosis,

interstitial nephritis;

• kidney function disorders, acute kidney failure.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices, and Biocides)
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Acard 300 mg

Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiration date stated on the packaging after: EXP.
The expiration date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Package contents and other information

What Acard 300 mg contains

• The active substance of the medicine is acetylsalicylic acid. Each tablet contains 300 mg of acetylsalicylic acid.
• Other ingredients of the medicine are: cornstarch, cellulose powder, microcrystalline cellulose.

What Acard 300 mg looks like and what the package contains

White or almost white, oblong, biconvex tablets with a dividing line on both sides.
The tablet can be divided into equal doses.
The package contains 1 tablet or 10 tablets.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of last leaflet update: