CARDIOASPIRIN 100 mg Enteric-Coated Tablet

Зміст інструкції

1. Cardioaspirin 100 mg gastro-resistant tablets
   1. What Cardioaspirin is and what it is used for
   2. What you need to know before taking Cardioaspirin
   3. How to take Cardioaspirin
   4. Possible side effects
   5. How to store Cardioaspirin
   6. Contents of the pack and other information

Cardioaspirin 100 mg gastro-resistant tablets

acetylsalicylic acid

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Cardioaspirin is and what it is used for

Cardioaspirin is an antithrombotic, meaning a medicine that prevents the formation of blood clots
(thrombi) in blood vessels.
Cardioaspirin is used in:

• Prevention of major atherothrombotic events:
• after myocardial infarction (heart attack);
• after stroke (sudden interruption of blood flow to the brain) or transient ischemic attacks (TIA) (temporary interruption or reduction of blood flow to the brain);
• in patients with unstable angina pectoris (attacks that manifest with pain and a feeling of tightness in the chest in the sternal region, at rest);
• in patients with stable chronic angina pectoris (or exertion angina, which manifests with severe chest pain and a feeling of tightness in the region behind the sternum, generally following exertion).
• Prevention of re-occlusion of aortocoronary bypasses (the surgical technique that allows restoring correct blood flow to the heart) and in percutaneous transluminal coronary angioplasty (PTCA) (the non-surgical intervention technique that allows restoring correct blood flow to the heart).
• Prevention of cardiovascular events in patients with established atherosclerotic disease (disease leading to stiffening and deposition of fat inside the arteries), in patients undergoing blood dialysis and in the prevention of thrombosis during extracorporeal circulation.
• Prevention of cardiovascular events in patients at high risk.

2. What you need to know before taking Cardioaspirin

Do not take Cardioaspirin

• if you are allergic to acetylsalicylic acid, salicylates or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from mastocytosis (a type of blood cancer), because the use of acetylsalicylic acid can cause you severe allergic reactions (including circulatory shock with hot flashes, hypotension, tachycardia and vomiting);
• if you have previously suffered from asthma induced by the administration of salicylates or substances with similar activity, in particular non-steroidal anti-inflammatory drugs (NSAIDs);
• if you suffer from gastroduodenal ulcer (ulcer in the stomach or the first part of the intestine);
• if you suffer from a bleeding diathesis (tendency to bleed);
• if you suffer from severe kidney (reduced kidney function) or liver (liver) or heart (heart) failure;
• if you are undergoing concomitant treatment with methotrexateat doses of 15 mg/week or more (see “Other medicines and Cardioaspirin”);
• if you are in the last trimester of pregnancy (see “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Cardioaspirin:

• If you are allergic to analgesic (pain relieving), anti-inflammatory or rheumatic medicines, and/or suffer from other allergies. Stop using Cardioaspirin at the first signs of skin reaction, mucosal lesions and other signs of allergy.
• If you have suffered from gastrointestinal ulcers, or gastrointestinal bleeding;
• If you are undergoing concomitant treatment with anticoagulants, medicines to thin the blood/prevent blood clots (see “Other medicines and Cardioaspirin”);
• If you have kidney or cardiovascular problems, such as renal vasculopathy (alterations in the blood vessels of the kidneys), congestive heart failure, depletion of volume (reduction in blood volume), major surgery, sepsis (severe generalized infection) or major bleeding, as acetylsalicylic acid may further increase the risk of impaired kidney function and acute renal failure (rapid reduction in kidney function);
• If you suffer from severe glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme whose absence, genetically determined, causes a disease characterized by reduced red blood cell survival, called favism). Acetylsalicylic acid may induce hemolysis (destruction of red blood cells) or hemolytic anemia.
• If you have liver problems;
• If you are taking certain non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen (medicines for pain, fever or inflammation). (see “Other medicines and Cardioaspirin”);
• If you suffer from asthma, hay fever, nasal polyps (small growths along the nasal mucosa or inside the sinuses), or chronic respiratory diseases. These conditions increase the likelihood that acetylsalicylic acid may cause bronchospasm (contraction of the airway muscles that obstructs the passage of air) and induce asthma attacks or other allergic reactions. These reactions can also occur in patients who have allergic reactions (e.g., skin reactions, itching, urticaria (small spots on the skin and itching) to other substances.
• If you are over 70 years of age, especially if you are also following other therapies;
• If you are to undergo surgery, even minor, such as a tooth extraction, because, due to its inhibitory effect on platelet aggregation, which persists for several days after administration, acetylsalicylic acid may increase the tendency to bleed during and after surgery;
• If you have ever had gout, because, at low doses, acetylsalicylic acid reduces the excretion of uric acid and this can sometimes cause gout attacks in predisposed patients.

Children and adolescents
Cardioaspirin is not indicated for use in the pediatric population. Medicines containing acetylsalicylic acid should not be used in children and adolescents under 16 years of age with viral infections (such as influenza and chickenpox), regardless of the presence or absence of fever. Salicylic acid can cause Reye's syndrome, a very rare but life-threatening condition that requires immediate medical attention. Persistent vomiting in patients with these diseases may be a sign of Reye's syndrome.

Other medicines and Cardioaspirin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The effect of the treatment may be altered if Cardioaspirin is taken at the same time as other medicines such as:

• anticoagulants (to thin the blood/prevent blood clots, e.g. warfarin);
• anti-rejection medicines (to prevent organ rejection after transplantation, e.g. cyclosporine, tacrolimus);
• antihypertensives (to treat high blood pressure, e.g. diuretics and ACE-inhibitors);
• non-steroidal anti-inflammatory drugs (NSAIDs) (for pain, fever and inflammation) and other rheumatic medicines in general;
• medicines for gout (probenecid);
• medicines for the treatment of cancer and for rheumatoid arthritis (methotrexate).

Do not take Cardioaspirin together with methotrexate at doses greater than or equal to 15 mg/week, because it increases the toxicity of methotrexate in the blood.
Take Cardioaspirin together with the following medicines only under strict medical supervision:

• Methotrexate at doses less than 15 mg/week;
• Some NSAIDs such as ibuprofen and naproxen: treatment with these medicines in patients with increased cardiovascular risk may limit the cardioprotective effects of acetylsalicylic acid.
• Anticoagulants, thrombolytics/other antiplatelet agents: increased risk of bleeding;
• Non-steroidal anti-inflammatory medicines containing salicylates: increased risk of ulcers and gastrointestinal bleeding;
• Metamizole(a substance used to reduce pain and fever) may decrease the effect of acetylsalicylic acid on platelet aggregation (blood cells that attach and form a blood clot) if taken at the same time. Therefore, this combination should be used with caution in patients taking aspirin at low doses for cardioprotection.
• Selective serotonin re-uptake inhibitors(medicines used for depression): increased risk of bleeding in the upper gastrointestinal tract;
• Cyclosporine and other immunosuppressant drugs: increased renal toxicity. Be particularly careful if you are elderly.
• Digoxin(a medicine used for heart failure): increased concentration of digoxin in the blood;
• Antidiabetics, for example insulin, sulfonylureas in association with high doses of acetylsalicylic acid: increased hypoglycemic effect at the highest doses of acetylsalicylic acid;
• Diureticsin association with high doses of acetylsalicylic acid;
• Systemic glucocorticoids (corticosteroids), except hydrocortisone used as replacement therapy in Addison's disease (adrenal insufficiency): risk of overdose (overdose) of Cardioaspirin when treatment with glucocorticoids is stopped. Increased risk of ulcers and bleeding in the stomach and intestines with the concomitant use of Cardioaspirin and systemic glucocorticoids.
• Angiotensin Converting Enzyme (ACE) inhibitorsin association with high doses of acetylsalicylic acid: reduced kidney filtration and reduction of the antihypertensive effect;
• Other antihypertensives (beta-blockers): decreased antihypertensive action
• Valproic acid(a medicine used against epilepsy): increased toxicity of valproic acid
• Phenytoin(a medicine used against epilepsy): increased effect of phenytoin;
• Uricosuric drugs(medicines that increase the elimination of uric acid) such as benzbromarone, probenecid: decreased uricosuric effect.

Cardioaspirin with alcohol
Drinking alcohol with Cardioaspirin causes an increase in damage to the gastrointestinal mucosa and a prolongation of bleeding time.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine.

Pregnancy
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development.
Do not take Cardioaspirin during the third trimester of pregnancy (see “Do not take Cardioaspirin”).
During the first and second trimesters of pregnancy, take this medicine only if absolutely necessary and on the advice of your doctor.
If you are planning a pregnancy, take medicines containing acetylsalicylic acid for the shortest possible period and at the lowest possible dose.

Breastfeeding
Salicylates and some of their derivatives pass into breast milk in small amounts.
As no adverse effects have been observed in the infant following occasional use, discontinuation of breastfeeding is not normally necessary. However, in case of regular use or high doses, the possibility of early weaning should be considered.

Fertility
If you are a woman with fertility problems or are undergoing fertility investigations, keep in mind that the use of acetylsalicylic acid, like any medicine that inhibits the synthesis of prostaglandins and cyclooxygenase, may interfere with fertility.

Driving and using machines
Cardioaspirin does not impair the ability to drive or operate machinery.

Cardioaspirin contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per gastro-resistant tablet, i.e. essentially “sodium-free”.

3. How to take Cardioaspirin

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

The recommended dose is: 1 tablet daily in a single dose.
Take the medicine with a plentiful amount of liquid (½ - 1 glass of water), at least 30
minutes before meals.
The prevention of cardiovascular events in patients at high risk should be carried out with a
dosage of 100 mg (1 tablet).
Do not take Cardioaspirin at higher dosages without express prescription from your doctor.

Use in children and adolescents
Cardioaspirin is not indicated in children and adolescents under the age of 16 years (see
“Children and adolescents”).

If you take more Cardioaspirin than you should
In case of accidental ingestion of an excessive dose of Cardioaspirin, immediately inform your
doctor or go to the nearest hospital.
Salicylate toxicity (a dosage higher than 100 mg/kg/day for 2 consecutive days may
induce toxicity) may be the consequence of chronic (long-term) intake of excessive doses, or acute overdose, potentially life-threatening, which also includes
accidental ingestion in children.
Symptoms of mild/moderate overdose may include:

• accelerated breathing, sweating, nausea, vomiting, headache, dizziness.
• Symptoms of moderate/severe overdosemay include: fever, respiratory failure, asphyxia, pulmonary edema, arrhythmias (irregular heartbeat), hypotension (low blood pressure), cardiorespiratory arrest (cessation of heartbeat), dehydration, oliguria (decreased urine output) up to renal insufficiency (reduced kidney function), altered sugar metabolism, ketosis (“acetone”), tinnitus (ringing or whistling in the ear), hearing loss, gastrointestinal bleeding, gastric ulcer, altered blood coagulation, encephalopathy (brain damage), cerebral edema (swelling of brain tissue) and depression of the central nervous system, with manifestations ranging from lethargy (deep sleepiness) and confusion to coma and convulsions.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects are gastrointestinal disorders which may or may not be associated
with bleeding and may occur with any dose of acetylsalicylic acid and in patients with or without
predictive symptoms and with or without a history of serious gastrointestinal events.

The following are other side effects that have been observed during treatment
with Cardioaspirin, grouped according to their frequency:
Common(may affect up to 1 in 10 people)

• dizziness
• ringing in the ears (tinnitus)
• nosebleeds (epistaxis)
• runny nose
• inflammation of the stomach and intestines
• stomach, intestinal and abdominal pain
• indigestion
• mild, invisible (occult) bleeding of the stomach or intestines
• skin rash
• itchy skin
• urinary and genital bleeding Uncommon(may affect up to 1 in 100 people)
• iron deficiency anemia following bleeding
• allergy, drug allergy (also as sudden swelling of body parts)
• bleeding inside the skull (intracranial hemorrhage)
• bruising or localized blood swelling (hematoma)
• blocked nose (nasal congestion)
• bleeding gums
• erosion and ulcers in the stomach or intestines
• impaired liver function
• hives (may affect up to 1 in 1000 people)
• anemia following hemorrhage
• anaphylactic reaction
• bleeding, bleeding in the muscles
• perforation of stomach or intestinal ulcer
• blood tests may show an increase in certain liver enzymes (transaminases) impaired kidney function or sudden kidney failure (if you already have kidney or cardiovascular problems)

Not known(frequency cannot be estimated from available data)

• breakage of red blood cells, which can cause anemia (if a severe deficiency of glucose-6- phosphate dehydrogenase (G6PD) is present)
• anaphylactic shock (severe acute generalized allergic reaction)
• disorders affecting the heart and lungs (in the context of a severe allergic reaction)
• bleeding during or after surgery
• respiratory disease aggravated by acetylsalicylic acid
• narrowing of the intestinal tract (intestinal diaphragm disease)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Cardioaspirin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the box and blister after
“expiry”. The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly stored.
Store at a temperature below 30 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cardioaspirin contains

• The active ingredient is acetylsalicylic acid. One tablet contains 100 mg of acetylsalicylic acid
• The other ingredients are: cellulose powder, corn starch, methacrylic acid copolymers, sodium lauryl sulfate, polysorbate 80, talc, triethyl citrate.

Description of the appearance of Cardioaspirin and contents of the pack
The pack contains 30, 60 or 90 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa 130 – Milan

Manufacturer
Bayer HealthCare Manufacturing S.r.l. - via delle Groane 126, Garbagnate Milanese (MI)