Anacard protect
Poland
Table of Contents
Package leaflet: information for the patient
ANACARD protect
150 mg, enteric-coated tablets
Acidum acetylsalicylicum
Please read this leaflet carefully before using 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 the
physician or pharmacist.
- Keep this leaflet for future reference.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement or if you feel worse, consult your doctor.
Table of contents:
- What ANACARD protect is and what it is used for
- Important information before taking ANACARD protect
- How to take ANACARD protect
- Possible side effects
- How to store ANACARD protect
- Contents of the pack and other information
1. What ANACARD protect is and what it is used for
The active substance in this medicine is acetylsalicylic acid, which inhibits platelet aggregation (clumping).
ANACARD protect is intended for long-term use in diseases associated with risk of thrombus and embolus formation in blood vessels.
The enteric-coated tablet of ANACARD protect has a coating and does not disintegrate in the stomach, thereby reducing the irritating effect of acetylsalicylic acid on the gastric mucosa.
Indications for use
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,
- 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 TIA,
- in patients with peripheral arterial disease due to 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 thoroughly chewed to ensure rapid absorption.
The decision on initiating treatment and the dosage used is made by the physician.
2. Important information before using ANACARD protect
When not to use ANACARD protect:
if the patient is allergic to the active substance, other salicylates, or any of the other
ingredients of this medicine (listed in section 6),
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 third trimester of pregnancy,
in children and adolescents under 16 years of age with viral infections (e.g. influenza or varicella), due to the risk of liver and brain damage (Reye's syndrome).
Warnings and precautions
Before starting treatment with ANACARD protect, discuss this with your doctor or pharmacist.
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 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 gastrointestinal ulcer disease or gastrointestinal bleeding,
if the patient has a genetic disorder involving glucose-6-phosphate dehydrogenase deficiency.
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 mucosal polyps, and those who experience allergic reactions to other substances (e.g. skin reactions, itching, urticaria).
Patients scheduled for surgical procedures (including minor procedures, e.g. tooth extraction) should inform their doctor about taking ANACARD protect. The medicine should not be used within 5 days before a planned surgical procedure (including minor procedures, e.g. tooth extraction).
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 provoke an attack of gout.
In elderly patients, there is an increased risk of adverse effects, including gastrointestinal bleeding and gastrointestinal ulcer perforation.
Children and adolescents
ANACARD protect should not be used in children and adolescents under 16 years of age.
ANACARD protect and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan 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 bone marrow.
Concurrent use of methotrexate at doses lower than 15 mg per week requires special caution.
ANACARD protect:
- when used with anticoagulants (e.g. coumarin derivatives, heparin), thrombolytics dissolving clots (e.g. streptokinase, urokinase), and platelet aggregation inhibitors (e.g. ticlopidine), may prolong bleeding time and increase risk of hemorrhage,
- when used with glucocorticosteroids, 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 plasma 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,
- when used with lithium, may increase its plasma concentration,
- enhances the toxic effect of cyclosporine and tacrolimus,
- when used with serotonin reuptake inhibitors (SSRIs) (e.g. sertraline or paroxetine), increases the risk of gastrointestinal bleeding,
- reduces the effect of drugs used in the treatment of gout (e.g. probenecid, benzbromarone),
- reduces the effect of diuretics,
- reduces the effect of certain antihypertensive drugs (e.g. captopril, enalapril).
Concurrent use of ANACARD protect with ibuprofen or metamizole may reduce the effect of low-dose acetylsalicylic acid on platelet aggregation.
ANACARD protect may be used concurrently with the above-mentioned medicines only after consultation with a doctor.
ANACARD protect with food, drink, and alcohol
Alcohol may increase the risk of gastrointestinal adverse effects caused by acetylsalicylic acid, such as bleeding or ulceration.
The tablet should be swallowed whole.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
ANACARD protect is contraindicated in the third trimester of pregnancy, as it may cause complications in the perinatal period for both mother and newborn.
During the first and second trimesters, consult a doctor before using this medicine.
Breastfeeding women should contact their doctor before using this medicine.
Driving and operating machinery
ANACARD protect has no influence on the ability to drive or operate machinery.
This medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per enteric-coated tablet, meaning it is considered "sodium-free".
This medicine contains azo dyes
ANACARD protect contains azo dyes. This medicine may cause allergic reactions.
3. How to use ANACARD protect
This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Consult a doctor before starting treatment with ANACARD protect.
The doctor will recommend the appropriate dose for the individual patient and determine the duration of treatment.
This medicine is taken orally.
Unless otherwise advised by a doctor: 1 tablet (150 mg) once daily. The tablets should be swallowed whole, not chewed (except in cases of heart attack!).
Acute myocardial infarction or suspected acute myocardial infarction:
Single dose of 2 tablets (300 mg).
The tablets should be thoroughly chewed to ensure rapid absorption.
Note: in acute myocardial infarction or suspected acute myocardial infarction, enteric-coated tablets may be used when uncoated acetylsalicylic acid tablets are not available.
The decision on initiating long-term treatment with acetylsalicylic acid and the dose to be used should be made by a doctor.
Taking more ANACARD protect than recommended
If more than the recommended dose has been taken, consult a doctor or pharmacist. In case of severe poisoning, the patient should be immediately transported to hospital.
Early signs of poisoning include: dizziness, tinnitus, hearing loss, excessive sweating, nausea and vomiting, headache, confusion (disturbances in consciousness with disorientation, impaired thinking and speech, hallucinations, delusions, anxiety, and psychomotor agitation), rapid breathing, abnormally deep breathing, visual disturbances (spots before the eyes), and fainting.
In severe poisoning, additional symptoms may include: high fever, respiratory disturbances (up to respiratory arrest and suffocation), disturbances in heart and circulatory function (from irregular heartbeat and low blood pressure to cardiac arrest), fluid and electrolyte loss (from dehydration and oliguria (reduced daily urine output below 400–500 ml in adults) up to renal failure), increased or decreased blood glucose levels (especially in children), ketosis (increased blood ketone levels), gastrointestinal bleeding, coagulation disorders, and neurological disturbances ranging from lethargy and confusion to coma and convulsions.
Missed dose of ANACARD protect
If a dose is missed, take the next dose as scheduled. 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 they do not occur in everyone.
Common (in 1 to 10 out of 100 patients):
abdominal pain, heartburn, nausea, vomiting, indigestion.
Rare (in 1 to 10 out of 10,000 patients):
inflammation of the gastrointestinal tract, potentially life-threatening gastrointestinal bleeding: overt (coffee-ground vomiting, tarry stools) or occult (bleeding occurs more frequently with higher doses); gastric and/or duodenal ulcer disease, perforation, transient disturbances in liver function (increased aminotransferase activity), intracerebral haemorrhage (particularly in patients with uncontrolled 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 (less than 1 in 10,000 patients):
severe allergic reactions, including anaphylactic shock.
Additionally reported:
dizziness and tinnitus, 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 haemorrhagic anaemia, manifesting as asthenia (exhaustion, weakness), 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 reactions with symptoms including rash, urticaria, oedema (including angioedema), respiratory disturbances, and cardiac disturbances, bronchial asthma.
If coffee-ground vomiting or black, tarry stools occur, the medicine should be discontinued and medical advice sought immediately.
Symptoms of severe hypersensitivity may include: facial and eyelid swelling, swelling of the tongue and larynx with airway narrowing, breathing difficulties, shortness of breath up to asthma attacks, rapid heartbeat, sudden drop in blood pressure up to life-threatening shock. If any of these symptoms occur, immediate professional medical care must be provided. These reactions may occur even after the first dose of the medicine.
Long-term use of medicines containing acetylsalicylic acid may cause headaches that worsen with each subsequent dose.
Prolonged use of analgesics, especially those containing multiple active substances, may lead to severe kidney dysfunction and renal failure.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store ANACARD protect
Store in the original packaging, at a temperature below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.
6. Contents of the packaging and other information
What ANACARD protect contains
- The active substance is acetylsalicylic acid. One tablet contains 150 mg of acetylsalicylic acid.
- The other ingredients are: microcrystalline cellulose, pregelatinized corn starch, sodium carboxymethyl starch (type A), hypromellose, titanium dioxide (E 171), triacetin, methacrylic acid and ethyl acrylate copolymer, iron oxide red (E 172), sodium bicarbonate, sodium lauryl sulfate, sunset yellow (E 110), indigo carmine, indigotine (E 132), macrogol 6000, simethicone.
What ANACARD protect looks like and contents of the pack
ANACARD protect is pink, round, biconvex coated tablets 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
Information on the medicinal product
tel.: (22) 742 00 22
e-mail: [email protected]