Package Insert: Information for the Patient

Acid Acetylsalicylic Krka 100 mg Enteric-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Acido acetilsalicilico Krka contains acetylsalicylic acid, which at low doses belongs to a group of medications called antiplatelet agents. Platelets are small blood cells that produce blood clotting and are involved in thrombosis. When a blood clot forms in an artery, it stops blood flow and cuts off oxygen supply. When this occurs in the heart, it can cause a heart attack or angina; in the brain, it can cause a cerebral infarction.

Acido acetilsalicilico Krka is taken to reduce the risk of blood clot formation and therefore prevent further:

• heart attacks
• cerebral infarctions
• cardiovascular problems in patients who have stable or unstable angina (a type of chest pain).

Acido acetilsalicilico Krka is also used to prevent blood clot formation after certain types of cardiac surgery to widen or unblock blood vessels.

This medication is not recommended for emergency cases. It can only be used as a preventive treatment.

Do not take Acido acetilsalicilico Krka

• if you are allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other salicylates or nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used for arthritis or rheumatism and for pain.
• if you have had an asthma attack or swelling of some parts of your body, for example, face, lips, throat or tongue (angioedema) after taking salicylates or NSAIDs.
• if you currently have, or have had at any time, an ulcer in your stomach or small intestine or any other type of bleeding such as a stroke.
• if you have ever had a problem with your blood not clotting properly.
• if you have severe liver or kidney problems.
• if you have severe heart problems that may cause difficulty breathing and swelling of the ankles.
• if you are in the last 3 months of pregnancy; do not use doses greater than 100 mg per day (see section "Pregnancy and breastfeeding").
• if you are taking a medicine called methotrexate (for example, to treat cancer or rheumatoid arthritis) in doses greater than 15 mg per week.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Acido acetilsalicilico Krka

• if you have problems with your kidneys, liver or heart.
• if you have or have had at any time problems with your stomach or small intestine.
• if you have uncontrolled high blood pressure.
• if you are asthmatic, have hay fever, nasal polyps or other chronic respiratory diseases; acetylsalicylic acid may induce an asthma attack.
• if you have ever had gout.
• if you have heavy menstrual bleeding.
• if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD).

You must consult a doctor immediately if your symptoms worsen or if you experience severe or unexpected side effects, for example, unusual bleeding symptoms, severe skin reactions or any other sign of severe allergy (see section "Possible side effects").

Inform your doctor if you are planning a surgical intervention (including minor surgery, such as a tooth extraction) as acetylsalicylic acid may dilute the blood and increase the risk of bleeding.

You must be careful not to become dehydrated (you may feel thirsty and your mouth may be dry) as the use of acetylsalicylic acid at the same time may cause deterioration of renal function.

This medicine is not suitable for relieving pain or reducing fever.

If you are in any of the above situations, or if you are unsure, consult your doctor or pharmacist.

Children and adolescents

Acetylsalicylic acid may cause Reye's syndrome when administered to children. Reye's syndrome is a rare disease that affects the brain and liver and may put life at risk. For this reason, Acido acetilsalicilico Krka should not be administered to children under 16 years of age, unless a doctor indicates otherwise.

Other medicines and Acido acetilsalicilico Krka

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medicine.

The effect of treatment may be influenced if acetylsalicylic acid is taken at the same time as other medicines that are used to:

• dilute the blood/prevent the formation of blood clots in the blood or dissolve them (for example, warfarin, heparin, clopidogrel, alteplase);
• prevent organ transplant rejection (ciclosporin, tacrolimus);
• high blood pressure (for example, diuretics and ACE inhibitors);
• regulate heart rhythm (digoxin);
• manic-depressive disorder (lithium);
• pain and inflammation (for example, NSAIDs such as ibuprofen, or steroids);
• reduce pain and fever (metamizol), the effect of acetylsalicylic acid on platelet aggregation may be reduced when administered together with metamizol;
• gout (for example, probenecid);
• epilepsy (valproate, phenytoin);
• glaucoma (acetazolamide);
• cancer or rheumatoid arthritis (methotrexate; in doses less than 15 mg per week);
• diabetes (for example, glibenclamide, insulin);
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine);
• hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed or removed, or medicines to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids).

Acido acetilsalicilico Krka with food, drinks and alcohol

Drinking alcohol may possibly increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnant women should not take acetylsalicylic acid during pregnancy unless their doctor indicates otherwise. Do not take Acido acetilsalicilico Krka if you are in the last 3 months of pregnancy, unless your doctor indicates otherwise and in that case the daily dose should not exceed 100 mg (see section "Do not take Acido acetilsalicilico Krka"). Normal or high doses of this medicine during the last phase of pregnancy may cause serious complications in the mother or baby.

Women who are breastfeeding should not take acetylsalicylic acid unless their doctor indicates otherwise.

Driving and operating machines

Acido acetilsalicilico Krka should not affect your ability to drive and operate machines.

Acido acetilsalicilico Krka contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults

Prevention of heart attacks:

• The recommended dose is 75–160 mg once a day.

Prevention of strokes:

• The recommended dose is 75–325 mg once a day.

Prevention of cardiovascular problems in patients with stable or unstable angina (a type of chest pain):

• The recommended dose is 75–160 mg once a day.

Prevention of thrombus formation after certain types of cardiac surgery:

• The recommended dose is 75–160 mg once a day.

This medicationshould not be usedat higher doses thanunless advisedby a doctor, in which case the dose should not exceed 325 mg per day.

Older patients

The same doses as adults. In general, aspirin should be used with caution in older patients who are more prone to adverse events. Treatment should be reviewed at regular intervals.

Use in children and adolescents

Aspirin should not be administered to children and adolescents under 16 years of age, unless prescribed by a doctor (see section «Warnings and precautions»).

Administration form

Oral route.

Tablets should be swallowed whole with a sufficient amount of liquid (half a glass of water) and at least 30 minutes before meals. Tablets have a gastric-resistant coating that prevents irritating effects on the intestine, and therefore should not be crushed, broken, or chewed.

If you take more Acido acetilsalicilico Krka than you should

If you (or another person) accidentally take too many tablets, you should inform your doctor immediately or contact the nearest emergency service, bringing the remaining medication or the empty packaging with you. Show your doctor the medication or the empty packaging. You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of overdose may include ringing in the ears, hearing problems, headaches, dizziness, confusion, nausea, vomiting, and abdominal pain. A large overdose can lead to rapid breathing (hyperventilation), fever, excessive sweating, restlessness, seizures, hallucinations, low blood sugar, coma, and shock.

If you forgot to take Acido acetilsalicilico Krka

If you forget to take a dose, wait until the time to take the next dose and continue treatment as usual.

Do not take a double dose to make up for the missed doses.

If you interrupt the treatment with Acido acetilsalicilico Krka

Do not stop treatment with Acido acetilsalicilico Krka without consulting your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects, stop taking Acido acetilsalicilico Krka and contact a doctor immediately:

• Sudden difficulty breathing, swelling of your lips, face, or body, hives, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling and may be associated with high fever and joint pain. This could be erythema multiforme, Stevens-Johnson syndrome, or Lyell syndrome.
• Unusual bleeding, such as coughing up blood, blood in your vomit or urine, or black stools.

Other side effects are:

Frequent (may affect up to 1 in 10 people):

• Nausea, vomiting, diarrhea.
• Indigestion.
• Increased tendency to bleed.

Less frequent (may affect up to 1 in 100 people):

• Urticaria.
• Nasal discharge.
• Difficulty breathing.

Rare (may affect up to 1 in 1,000 people):

• Intense bleeding in the stomach or intestines, cerebral hemorrhage; altered number of blood cells.
• Chest pain in the lower respiratory tract, asthma attack.
• Inflammation of blood vessels.
• Purple spots (cutaneous bleeding).
• Severe skin reactions such as hives known as erythema multiforme, and life-threatening forms, Stevens-Johnson syndrome, and Lyell syndrome.
• Hypersensitivity reactions, such as swelling of, for example, lips, face, or body, or shock.
• Reye's syndrome (a very rare disease in children that affects the brain and liver (see section 2 "Children and adolescents").
• Abnormally heavy or prolonged menstrual bleeding.

Unknown frequency (frequency cannot be estimated from available data):

• Ring in your ears (tinnitus) or reduced hearing ability.
• Headache.
• Dizziness.
• Ulcers in the stomach or small intestine and perforation.
• Prolonged bleeding time.
• Renal function disorder, acute renal insufficiency.
• Liver function disorder, increased liver enzymes.
• High levels of uric acid in the blood.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Acetylsalicylic Acid Krka

The active ingredient is acetylsalicylic acid.

Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.

The other components are:

• Core of the tablet: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, and potato starch.
• Covering: talc, triacetin, copolymer of methacrylic acid-ethyl acrylate (1:1) dispersion 30%, sodium dodecyl sulfate*, and polysorbate 80*.

* May contain sodium dodecyl sulfate and polysorbate 80

Appearance of the product and contents of the package

White film-coated tablets, round, biconvex, with an approximate diameter of 8.1 mm.

Package sizes:

Blister packs: 20, 28, 30, 50, 56, 60, 84, 90, and 100 gastro-resistant tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura, 10, 28108 Alcobendas, Madrid, Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this prospectus: May 2023

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es).