Anacard medica protect

Leaflet attached to the packaging: patient information

ANACARD medica protect,

75 mg, enteric-coated 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 the patient leaflet or as directed by a doctor, pharmacist, or nurse.

• 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 any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is ANACARD medica protect and what is it used for

The active substance of the medicine is acetylsalicylic acid, which inhibits platelet aggregation. ANACARD medica protect is intended for long-term use in diseases that threaten the formation of blood clots and emboli in blood vessels. The enteric-coated tablet of ANACARD medica protect has a coating and does not dissolve in the stomach, which reduces the irritating effect of acetylsalicylic acid on the gastric mucosa.

Indications for use

Ischemic heart disease (coronary artery disease) and all clinical situations where platelet aggregation inhibition is desirable:

• prevention of myocardial infarction in people at high risk,
• recent myocardial infarction or suspected recent myocardial infarction,
• history of unstable angina,
• secondary prevention in patients after myocardial infarction,
• state after coronary artery bypass grafting, coronary angioplasty,
• prevention of transient ischemic attacks (TIA) and ischemic stroke in patients with TIA,
• after ischemic stroke in patients with TIA,
• in patients with atherosclerotic peripheral artery disease,
• prevention of venous thrombosis and pulmonary embolism in patients who are immobilized for a long time, e.g., after major surgical procedures as a supplement to other prophylactic methods.

Note: in recent myocardial infarction or suspected recent myocardial infarction, enteric-coated tablets may be used when acetylsalicylic acid in immediate-release tablets is not available. In such cases, the enteric-coated tablets should be chewed very thoroughly to

achieve rapid absorption.

2. Important information before taking ANACARD medica protect

When not to take ANACARD medica protect:

if the patient is hypersensitive to the active substance or any of the other ingredients of this medicine (listed in section 6),
if the patient is hypersensitive to other salicylates,
if the patient has a bleeding disorder (tendency to bleed),
if the patient has active gastric or duodenal ulcer disease,
if the patient has severe heart failure or severe liver or kidney failure,
if the patient has had asthma attacks caused by the administration of salicylates or substances with similar effects, especially non-steroidal anti-inflammatory drugs (NSAIDs),
if the patient is taking methotrexate (used, among others, in cancer diseases) in doses of 15 mg per week or higher,
if the patient is in the third trimester of pregnancy,
in children under 12 years of age with viral infections due to the risk of liver and brain damage (Reye's syndrome).

Warnings and precautions

Before starting ANACARD medica protect, the patient should discuss it with their doctor, pharmacist, or nurse.
Acetylsalicylic acid should be used with caution:
if the patient is in the first or second trimester of pregnancy,
if the patient is breastfeeding,
if the patient has hypersensitivity to non-steroidal anti-inflammatory and anti-rheumatic drugs or other allergenic substances,
if the patient is taking anticoagulant medications (e.g., coumarin derivatives, heparin),
if the patient has impaired liver or kidney function,
if the patient has a history of peptic ulcer disease or gastrointestinal bleeding,
if the patient has a genetic disorder characterized by a deficiency of glucose-6-phosphate dehydrogenase.
Alcohol may increase the risk of adverse reactions from the gastrointestinal tract caused by acetylsalicylic acid.
Acetylsalicylic acid may cause bronchospasm and trigger asthma attacks or other hypersensitivity reactions. Patients with asthma, chronic respiratory diseases, hay fever, nasal polyps, and those who experience allergic reactions to other substances (e.g., skin reactions, itching, hives) are particularly at risk of such reactions.
Patients undergoing surgical procedures (including minor procedures, e.g., tooth extraction) should inform their doctor about taking ANACARD medica protect. The medicine should not be taken 5 days before the planned surgical procedure.
Acetylsalicylic acid, even in small doses, reduces the excretion of uric acid from the body. In patients with a tendency to reduced uric acid excretion, the medicine may cause a gout attack.

ANACARD medica protect and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Acetylsalicylic acid should not be taken simultaneously with methotrexate in doses of 15 mg per week or higher, as it enhances the toxic effect of methotrexate on the bone marrow.
Simultaneous use of methotrexate in doses less than 15 mg per week requires special caution.
ANACARD medica protect:
with anticoagulant medications (e.g., coumarin derivatives, heparin), thrombolytic agents, and platelet aggregation inhibitors (e.g., ticlopidine) may prolong bleeding time and cause bleeding,
with glucocorticosteroids, NSAIDs increases the risk of peptic ulcer disease and gastrointestinal bleeding (except for hydrocortisone used as replacement therapy in Addison's disease). Simultaneous use of glucocorticosteroids with acetylsalicylic acid increases the risk of salicylate overdose after completed corticosteroid therapy,
with digoxin, increases its serum concentration,
enhances the effect of antidiabetic medications (e.g., insulin, sulfonylurea derivatives),
enhances the toxic effect of valproic acid, which in turn enhances the anti-aggregatory effect of acetylsalicylic acid,
with lithium, may increase its serum concentration,
enhances the toxic effect of cyclosporine and tacrolimus,
with serotonin reuptake inhibitors (SSRIs, e.g., sertraline or paroxetine) increases the risk of gastrointestinal bleeding,
reduces the effect of uricosuric medications (e.g., probenecid, benzbromarone),
reduces the effect of diuretic medications,
reduces the effect of some antihypertensive medications (e.g., captopril, enalapril).
Simultaneous administration of ANACARD medica protect and ibuprofen or metamizole may weaken the effect of low doses of acetylsalicylic acid on platelet aggregation.
ANACARD medica protect can be taken simultaneously with the above-mentioned medicines only after consulting a doctor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
ANACARD medica protect is contraindicated in the third trimester of pregnancy, as it may cause complications during the perinatal period, both in the mother and the newborn.
In the first and second trimesters, the medicine should be taken only after consulting a doctor.
Breastfeeding women should contact their doctor before taking the medicine.

Driving and operating machinery

ANACARD medica protect does not affect the ability to drive and operate machinery.

3. How to take ANACARD medica protect

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
The medicine is taken orally.
Unless the doctor recommends otherwise, 1 tablet (75 mg) once a day. The tablets should be swallowed whole, not chewed (except in the case of myocardial infarction!).
Recent myocardial infarction or suspected recent myocardial infarction:
Single dose of 4 tablets (300 mg).
The tablets should be chewed very thoroughly to achieve rapid absorption.

Taking a higher dose of ANACARD medica protect than recommended

In case of taking a higher dose of the medicine than recommended, the patient should consult their doctor or pharmacist, and in case of severe poisoning, the patient should be taken to the hospital immediately.
The first symptoms of poisoning are: dizziness, tinnitus, hearing loss, excessive sweating, nausea, and vomiting, headache, confusion (disorders of consciousness with disorientation, thinking, and speech disorders, delusions, hallucinations, anxiety, and psychomotor agitation), rapid breathing, deep breathing, and blurred vision, fainting.
In case of severe poisoning, the following may also occur: high fever, respiratory disorders (up to respiratory arrest and suffocation), cardiac disorders and vascular disorders (from irregular heartbeat, low blood pressure to cardiac arrest), fluid and electrolyte loss (from dehydration, oliguria (reduced urine output below 400-500 ml in adults) to renal failure), increased or decreased blood glucose levels (especially in children), ketosis (increased ketone levels in the blood), gastrointestinal bleeding, coagulation disorders, neurological disorders manifesting as lethargy, confusion, and coma, and seizures.

Missing a dose of ANACARD medica protect

In case of missing a dose, the patient should take the next dose of ANACARD medica protect. The patient should not take a double dose to make up for the missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, ANACARD medica protect can cause side effects, although not everybody gets them.
Frequent (in 1 to 10 out of 100 patients):
abdominal pain, heartburn, nausea, vomiting, indigestion.
Rare (in 1 to 10 out of 10,000 patients):
gastrointestinal inflammation, potentially life-threatening gastrointestinal bleeding: overt (hematemesis, melena) or occult (more common with higher doses); gastric and duodenal ulcer disease, perforation, transient liver function disorders (elevated aminotransferase activity), cerebral hemorrhage (especially in patients with uncontrolled hypertension and/or concomitantly taking other anticoagulant medications) potentially life-threatening,
after long-term use of high doses of acetylsalicylic acid, renal papillary necrosis and interstitial nephritis have been reported.
Very rare (less than 1 in 10,000 patients):
severe allergic reactions, including anaphylactic shock.
Additionally, the following have been reported:
dizziness and tinnitus, which are usually symptoms of overdose,
increased risk of bleeding, bleeding (postoperative, nasal, gingival, genitourinary), hematomas, prolonged bleeding time, prothrombin time, thrombocytopenia (thrombocytopenia). The consequence of bleeding may be the occurrence of acute or chronic iron deficiency anemia or acute post-hemorrhagic anemia, manifested by asthenia (exhaustion, weakness), pallor, hypoperfusion (reduced blood flow), as well as abnormal laboratory test results,
hypersensitivity reactions with clinical symptoms and abnormal laboratory test results, such as asthma, mild to moderate reactions involving the skin, respiratory system, and cardiovascular system with symptoms such as: rash, urticaria, edema (including angioedema), respiratory disorders, and cardiac disorders,
bronchial asthma.
If the patient experiences hematemesis or melena, they should stop taking the medicine and consult their doctor.
A symptom of severe hypersensitivity may be: facial and eyelid edema, tongue and laryngeal edema with respiratory tract narrowing, difficulty breathing, dyspnea up to asthma attacks, tachycardia, sudden blood pressure drop up to life-threatening shock. If any of these symptoms occur, the patient should immediately seek medical attention. The above reactions may occur even after the first administration of the medicine.
Prolonged use of medicines containing acetylsalicylic acid may cause headache, which worsens with subsequent doses.
Prolonged use of painkillers, especially those containing multiple active substances, may lead to severe kidney function disorders and kidney failure.
Reporting side effects
If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
phone: 22 49 21 301, fax: 22 49 21 309,
e-mail: [email protected].
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 ANACARD medica protect

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children .
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment

6. Package contents and other information

What ANACARD medica protect contains

• -The active substance of the medicine is acetylsalicylic acid. One tablet contains 75 mg of acetylsalicylic acid.
• -The other ingredients (excipients) are: microcrystalline cellulose, corn starch, sodium carboxymethylcellulose (type A), hypromellose, titanium dioxide (E 171),

triacetin, methacrylic acid, and ethyl acrylate copolymer, talc, triethyl citrate, colloidal silica anhydrous, sodium bicarbonate, sodium lauryl sulfate.

What ANACARD medica protect looks like and what the package contains

ANACARD medica protect is a white, round, biconvex, film-coated tablet with a smooth, uniform surface.
One package of the medicine contains 30 or 60 tablets.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

phone: 22 742 00 22
e-mail: [email protected]
Date of last update of the leaflet:05/2021