Acetylsalicylic acid Krka 100 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acidum acetylsalicylicum Krka 100 mg gastro-resistant tablets

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Acido acetilsalicilico Krka is and what it is used for

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

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

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

This medicine is also used to prevent blood clot formation after certain types of cardiac surgery intended to widen or unblock blood vessels.

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

2. What you need to know before taking Acido acetilsalicilico Krka

Do not take Acido acetilsalicilico Krka

• if you are allergic to acetylsalicylic acid or to any of the other components of this medicine (listed in section 6).
• if you are allergic to other salicylates or to non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are commonly used for arthritis or rheumatism and for pain relief.
• if you have ever had an asthma attack or swelling of any parts of the body, e.g., face, lips, throat or tongue (angioedema), after taking salicylates or NSAIDs.
• if you currently have, or have ever had, a stomach or small intestine ulcer or any other type of bleeding, such as a stroke.
• if you have ever had problems with blood clotting.
• 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; you should not use doses higher than 100 mg per day (see section "Pregnancy and lactation").
• if you are taking a medicine called methotrexate (e.g., to treat cancer or rheumatoid arthritis) at doses higher than 15 mg per week.

Warnings and precautions

Talk to your doctor or pharmacist before taking Acido acetilsalicilico Krka

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

You should consult a doctor immediately if your symptoms worsen or if you experience serious or unexpected adverse effects, e.g., unusual bleeding symptoms, serious skin reactions, or any other signs of a severe allergic reaction (see section "Possible adverse effects").

Inform your doctor if you have planned any surgical procedure (including minor procedures such as dental extraction), as acetylsalicylic acid thins the blood and may increase the risk of bleeding.

You should take care not to become dehydrated (you may feel thirsty and have a dry mouth), as using acetylsalicylic acid at the same time may lead to impaired kidney 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 given to children. Reye's syndrome is a very rare condition affecting the brain and liver and may be life-threatening. For this reason, Acido acetilsalicilico Krka must not be given to children under 16 years of age, unless directed by a doctor.

Other medicines and Acido acetilsalicilico Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The effect of treatment may be affected if acetylsalicylic acid is taken at the same time as other medicines used for:

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

Taking 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnant women should not take acetylsalicylic acid during pregnancy unless advised by their doctor. You must not take Acido acetilsalicilico Krka during the last 3 months of pregnancy unless directed by your doctor, and in such case the daily dose must not exceed 100 mg (see section "Do not take Acido acetilsalicilico Krka"). Normal or high doses of this medicine during the final stage of pregnancy may cause serious complications in the mother or baby.

Breastfeeding women should not take acetylsalicylic acid unless advised by their doctor.

Driving and using machines

Acido acetilsalicilico Krka is not expected to affect your ability to drive or use machines.

Acido acetilsalicilico Krka contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Acido acetilsalicilico Krka

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults

Prevention of heart attacks:

• The recommended dose is 75–160 mg once daily.

Prevention of strokes:

• The recommended dose is 75–325 mg once daily.

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

• The recommended dose is 75–160 mg once daily.

Prevention of blood clot formation after certain types of cardiac surgery:

• The recommended dose is 75–160 mg once daily.

This medicine should not be used at higher doses unless advised by a doctor, in which case the dose should not exceed 325 mg per day.

Elderly patients

Doses are the same as for adults. In general, acetylsalicylic acid should be used with caution in elderly patients, who may be more prone to adverse events. Treatment should be reviewed at regular intervals.

Use in children and adolescents

Acetylsalicylic acid must not be given to children and adolescents under 16 years of age unless prescribed by a doctor (see section "Warnings and precautions").

Method of administration

Oral use.

The tablets should be swallowed whole with sufficient liquid (half a glass of water) and at least 30 minutes before meals. The tablets have an enteric coating that prevents irritating effects in the intestine; therefore, they must not be crushed, broken, or chewed.

If you take more Acido acetilsalicilico Krka than you should

If you (or someone else) accidentally take too many tablets, you must contact your doctor immediately or go to the nearest emergency department, taking with you the remaining amount of medicine or the empty packaging. Show the medicine or empty container to your doctor. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested.

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

If you forget to take Acido acetilsalicilico Krka

If you forget to take a dose, wait until it is time for your next dose and then continue treatment as usual.

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

If you stop taking Acido acetilsalicilico Krka

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

Other adverse effects include:

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

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

Uncommon (may affect up to 1 in 100 people):

• Urticaria.
• Runny nose.
• Difficulty breathing.

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

• Severe bleeding in the stomach or intestines, brain haemorrhage; altered blood cell count.
• Cramps in the lower respiratory tract, asthma attack.
• Inflammation of blood vessels.
• Bruising with purple spots (cutaneous bleeding).
• Severe skin reactions such as rash known as erythema multiforme, and its life-threatening forms, Stevens-Johnson syndrome and Lyell’s syndrome.
• Hypersensitivity reactions, such as swelling of, e.g., lips, face or body, or shock.
• Reye's syndrome (a very rare condition in children affecting the brain and liver (see section 2 "Children and adolescents")).
• Abnormally heavy or prolonged menstrual periods.

Frequency not known (frequency cannot be estimated from available data):

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylsalicylic Acid Krka

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE point located in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acido acetilsalicilico Krka

The active substance is acetylsalicylic acid.

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

The other components are:

• Tablet core: monohydrate lactose, microcrystalline cellulose, anhydrous colloidal silica and potato starch.

• Coating: talc, triacetin, methacrylic acid-ethyl acrylate copolymer (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 container

Film-coated white, round, biconvex tablets with an approximate diameter of 8.1 mm.

Pack sizes:

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

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

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: May 2023

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