Package leaflet: Information for the patient

ANACARD medica protect,
75 mg, enteric-coated tablets
Acidum acetylsalicylicum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician, pharmacist, or nurse.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your physician, pharmacist, or nurse.
If your condition does not improve or worsens, contact your physician.

Table of contents

What ANACARD medica protect is and what it is used for
Important information before taking ANACARD medica protect
How to take ANACARD medica protect
Possible side effects
How to store ANACARD medica protect
Contents of the pack and other information

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

The active substance in this medicine is acetylsalicylic acid, which inhibits platelet aggregation (clumping).
ANACARD medica protect is intended for long-term use in diseases that carry a risk of thrombus and embolus formation in blood vessels.
The enteric-coated tablet of ANACARD medica protect has a coating and does not disintegrate in the stomach, thereby reducing the irritating effect of acetylsalicylic acid on the gastric mucosa.
Indications
Ischaemic heart disease (coronary artery disease) and all clinical conditions where inhibition of platelet aggregation is indicated:

prevention of myocardial infarction in high-risk individuals,
acute myocardial infarction or suspected acute myocardial infarction,
history of unstable angina,
secondary prevention in patients after myocardial infarction,
status after coronary artery bypass grafting or coronary angioplasty,
prevention of transient ischaemic attacks (TIA) and ischaemic stroke in patients with TIA,
after ischaemic stroke in patients with prior TIA,
in patients with peripheral arterial atherosclerosis,
prevention of venous thrombosis and pulmonary embolism in patients who are immobilised for prolonged periods, e.g. after major surgical procedures, as an adjunct to other prophylactic measures.

Note: in acute myocardial infarction or suspected acute 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 thoroughly to ensure rapid absorption.

2. Important information before using the medicine medica protect

When not to use medica protect:
if the patient is allergic to the active substance or to any of the other ingredients of this
medicine (listed in section 6),
if the patient is allergic to other salicylates,
if the patient has a bleeding tendency (predisposition to bleeding),
if the patient has active peptic ulcer disease of the stomach and/or duodenum,
if the patient has severe heart failure, severe liver failure, or severe kidney failure,
if the patient has previously experienced asthma attacks triggered by salicylates or
substances with similar effects, particularly non-steroidal anti-inflammatory drugs (NSAIDs),
if the patient is concurrently taking methotrexate (used, among others, in cancer treatment)
at doses of 15 mg per week or higher,
if the patient is in the last three months of pregnancy, doses exceeding
100 mg per day must not be used (see section "Pregnancy and breastfeeding"),
in children under 12 years of age during viral infections due to the risk of liver and brain damage (Reye's syndrome).

Warnings and precautions
Before starting treatment with medica protect, discuss it with your 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 to other allergenic substances,
if the patient is concurrently taking anticoagulant drugs (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 involving glucose-6-phosphate dehydrogenase deficiency.
Alcohol may increase the risk of gastrointestinal adverse effects caused by acetylsalicylic acid.
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, nasal polyps, and patients who experience allergic reactions to other substances (e.g. skin reactions, itching, urticaria).
Patients undergoing surgical procedures (including minor procedures such as tooth extraction)
should inform their doctor about taking medica protect. The medicine should not be used
within 5 days before a planned surgical procedure.
Acetylsalicylic acid, even at low doses, reduces the excretion of uric acid from the body. In patients predisposed to reduced uric acid excretion, the medicine may provoke an attack of gout.

medica protect and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Do not use acetylsalicylic acid concurrently with methotrexate at doses of 15 mg per week or higher, as it enhances the toxic effect of methotrexate on the bone marrow.
Concurrent use of methotrexate at doses lower than 15 mg per week requires special caution.
medica protect:
combined with anticoagulants (e.g. coumarin derivatives, heparin), thrombolytics,
fibrinolytic agents (e.g. streptokinase, urokinase), and antiplatelet agents (e.g. ticlopidine), may prolong bleeding time and increase the risk of hemorrhage,
combined with glucocorticosteroids or NSAIDs increases the risk of peptic ulcer disease and gastrointestinal bleeding (with the exception of hydrocortisone used as replacement therapy in Addison's disease). Concurrent use of glucocorticosteroids with acetylsalicylic acid increases the risk of salicylate overdose after discontinuation of corticosteroid therapy,
increases serum concentration of digoxin,
enhances the effect of antidiabetic drugs (e.g. insulin, sulfonylurea derivatives),
enhances the toxic effect of valproic acid, which in turn enhances the antiplatelet effect of acetylsalicylic acid,
with lithium, may increase its plasma concentration,
enhances the toxic effects of cyclosporine and tacrolimus,
combined with serotonin reuptake inhibitors (SSRIs) (e.g. sertraline or paroxetine) increases the risk of gastrointestinal bleeding,
reduces the effectiveness of drugs used in the treatment of gout (e.g. probenecid, benzbromarone),
reduces the effectiveness of diuretics,
reduces the effectiveness of certain antihypertensive drugs (e.g. captopril, enalapril).
Concurrent use of medica protect with ibuprofen or metamizole may reduce the effect of low-dose acetylsalicylic acid on platelet aggregation.
medica protect may be used concurrently with the above-mentioned medicines only after consultation with a doctor.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
If the patient continues or initiates treatment with medica protect during pregnancy,
she should use medica protect according to the doctor's recommendations and should not take a higher dose than prescribed.

Pregnancy - third trimester
Do not use doses of medica protect exceeding 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. Use of medica protect may cause kidney and heart function disorders in the unborn child. This may affect the tendency to bleeding in both the mother and her child and may cause delay or prolongation of labor.
If the patient uses medica protect at low doses (up to 100 mg per day inclusive), strict obstetric monitoring according to the doctor's recommendations is required.

Pregnancy - first and second trimester
Do not use medica protect 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 effective dose should be used for the shortest possible duration. Use of medica protect for longer than a few days, starting from week 20 of pregnancy, may cause kidney dysfunction in the unborn child, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios), or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment longer than a few days is necessary, the doctor may recommend additional monitoring.
Breastfeeding women should consult their doctor before using the medicine.

Driving and operating machinery
medica protect has no effect on the ability to drive vehicles or operate machinery.

3. How to take medica protect

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
This medicine is for oral use.
Unless otherwise advised by your doctor: 1 tablet (75 mg) once daily. The tablets should be swallowed whole and not chewed (except in cases of acute myocardial infarction!).
Acute myocardial infarction or suspected acute myocardial infarction:
Single dose of 4 tablets (300 mg).
The tablets should be thoroughly chewed to ensure rapid absorption.

Taking more medica protect than recommended
If you take more medica protect than recommended, consult your doctor or pharmacist immediately. In case of severe poisoning, the patient should be taken to hospital immediately.
Early signs of overdose include: dizziness, tinnitus, hearing loss, excessive sweating, nausea and vomiting, headache, confusion (disturbances of consciousness with disorientation, impaired thinking and speech, hallucinations, illusions, anxiety, and psychomotor agitation), rapid breathing, abnormally deep breathing, visual disturbances (spots before the eyes), and fainting.
In severe poisoning, additional symptoms may occur: high fever, respiratory disturbances (up to respiratory arrest and suffocation), disturbances in heart and blood vessel function (from irregular heartbeat and low blood pressure to cardiac arrest), fluid and electrolyte loss (from dehydration, oliguria (reduced daily urine output below 400–500 ml in adults) up to kidney failure), increased or decreased blood glucose levels (especially in children), ketosis (increased blood ketone levels), gastrointestinal bleeding, disturbances in blood coagulation, and neurological disturbances manifesting as lethargy, confusion, progressing to coma and convulsions.

If you forget to take medica protect
If you miss a dose, take the next dose as scheduled.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common (may affect up to 1 in 10 patients):
abdominal pain, heartburn, nausea, vomiting, indigestion.

Uncommon (may affect up to 1 in 1,000 patients):
gastrointestinal inflammation, potentially life-threatening gastrointestinal bleeding: overt (coffee-ground vomiting, tarry stools) or occult (bleeding occurs more frequently with higher doses); gastric and/or duodenal ulceration, perforation, transient liver function abnormalities (increased aminotransferase activity), intracerebral haemorrhage (particularly in patients with uncontrolled arterial hypertension and/or concomitant use of other antithrombotic drugs), potentially life-threatening. With long-term use of high doses of acetylsalicylic acid, renal papillary necrosis and interstitial nephritis have been reported.

Very rare (may affect up to 1 in 10,000 patients):
severe allergic reactions, including anaphylactic shock.

Additionally reported adverse reactions include:
dizziness and tinnitus, which are usually symptoms of overdose;
increased risk of bleeding, haemorrhages (postoperative, epistaxis, gingival, genitourinary), bruising, prolonged bleeding time and prothrombin time, thrombocytopenia (low platelet count). Bleeding may lead to acute or chronic iron-deficiency anaemia or acute post-haemorrhagic anaemia, manifesting as asthenia (weakness, fatigue), pallor, hypoperfusion (reduced blood flow), as well as abnormal laboratory test results.

Hypersensitivity reactions with clinical symptoms and abnormal laboratory findings, such as asthma, mild to moderate skin, respiratory, and cardiovascular system reactions with symptoms including: rash, urticaria, oedema (including angioedema), breathing difficulties, and cardiac disturbances, bronchial asthma.

If coffee-ground vomiting or black, tarry stools occur, the medicine should be discontinued and a doctor consulted immediately.

Symptoms of severe hypersensitivity may include: facial and eyelid swelling, swelling of the tongue and larynx with airway constriction, difficulty breathing, shortness of breath up to asthma attacks, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock. In case of any of these symptoms, immediate professional medical help must be sought. These reactions may occur even after the first dose of the medicine.

Long-term use of medicines containing acetylsalicylic acid may cause headache, which worsens with continued dosing.

Long-term use of analgesics, particularly those containing multiple active substances, may lead to severe kidney dysfunction and renal failure.

Reporting of adverse reactions

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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,
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorisation holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Anacard medica protect

Store below 25°C.
Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine contains medica protect

The active substance is acetylsalicylic acid. One tablet contains 75 mg of acetylsalicylic acid.
The other components (excipients) are: microcrystalline cellulose, pregelatinized corn starch, sodium carboxymethyl starch (type A), hypromellose, titanium dioxide (E 171), triacetin, methacrylic acid-ethyl acrylate copolymer, talc, triethyl citrate, colloidal anhydrous silica, sodium hydrogen carbonate, sodium lauryl sulfate.

What medica protect looks like and contents of the pack
medica protect is a white, round, biconvex coated tablet with a smooth, uniform surface.
One pack contains 30 or 60 tablets.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine Information
tel.: 22 742 00 22
e-mail: [email protected]