ACETIC ACID SALICYLIC ARISTO 100 mg GASTRO-RESISTANT TABLETS

2. What you need to know before taking Aristo Acetylsalicylic Acid

Do not take Aristo Acetylsalicylic Acid:

• if you are allergic to acetylsalicylic acid, other salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs; NSAIDs are usually used for arthritis or rheumatism and pain) or to any of the other components of this medication (listed in section 6)
• if you have had an asthma attack or swelling of some parts of the body, e.g. face, lips, throat, or tongue (angioedema) after taking salicylates or NSAIDs
• if you currently have or have had a stomach or small intestine ulcer
• if you have a history of gastrointestinal bleeding or perforation (gastric or intestinal) caused by previous therapy
• if you have a history of recurrent gastric or duodenal ulcers with episodes of ulcers or bleeding or other types 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 can cause difficulty breathing and swelling of the ankles
• if you are in the last 3 months of pregnancy; you should not take more than 100 mg per day (see section "Pregnancy and breastfeeding")
• if you are taking a medication called methotrexate (e.g. to treat cancer or rheumatoid arthritis) in doses greater than 15 mg per week.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Acetylsalicylic Acid.

• if you have kidney, liver, or heart problems
• if you have or have had ulcers or bleeding (e.g. in your stomach or small intestine)
• if you have 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 periods
• if you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD).

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

Inform your doctor if you have a planned surgical intervention (even a minor one, such as a tooth extraction) as acetylsalicylic acid is an anticoagulant, and there may be an increased risk of bleeding.

You should be careful not to become dehydrated (you may feel thirsty and have a dry mouth) as the use of acetylsalicylic acid at the same time may cause kidney function to deteriorate.

This medication 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 very rare disease that affects the brain and liver and can be life-threatening. For this reason, Aristo Acetylsalicylic Acid should not be administered to children under 16 years of age, unless prescribed by a doctor.

Taking Aristo Acetylsalicylic Acid with other medications

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

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

• prevent blood clot formation (e.g. warfarin, heparin, clopidogrel, alteplase)
• prevent organ transplant rejection (cyclosporine, tacrolimus)
• treat high blood pressure (e.g. diuretics and ACE inhibitors)
• regulate heart rhythm (digoxin)
• treat manic-depressive disorder (lithium)
• relieve pain and inflammation (e.g. NSAIDs (such as ibuprofen) or steroids)
• metamizole (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells stick together and form a blood clot). Therefore, this combination should be used with caution in patients taking low doses of acetylsalicylic acid as a cardioprotector
• gout (e.g. probenecid)
• epilepsy (valproate, phenytoin)
• glaucoma (acetazolamide)
• cancer or rheumatoid arthritis (methotrexate; in 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 or pituitary glands have been destroyed or removed, or medications to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids).

Taking Aristo Acetylsalicylic Acid 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 medication.

Pregnant women should not take acetylsalicylic acid during pregnancy unless their doctor advises them to do so. You should not take Aristo Acetylsalicylic Acid if you are in the last 3 months of pregnancy, unless your doctor advises you to do so, and in that case, the daily dose should not exceed 100 mg (see section "Do not take Aristo Acetylsalicylic Acid"). Normal or high doses of this medication during the last phase of pregnancy may cause serious complications in the mother or baby.

Breastfeeding women should not take acetylsalicylic acid unless their doctor advises them to do so.

Acetylsalicylic acid may affect female fertility by affecting ovulation. This effect is reversible after treatment is discontinued.

Driving and using machines

Aristo Acetylsalicylic Acid should not affect your ability to drive or use machines.

Aristo Acetylsalicylic Acid contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Aristo Acetylsalicylic Acid

Follow the administration instructions of this medication exactly 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 75-300 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 heart surgery:

? The recommended dose is 75-160 mg once a day.

This medication should not be used at higher doses (not exceeding 300 mg per day) unless advised by a doctor.

Elderly patients

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

Children and adolescents

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

Method of administration

Oral route.

The tablets should be swallowed whole with a sufficient amount of liquid (half a glass of water). The tablets have a gastro-resistant coating that prevents irritating effects on the intestine, and therefore should not be crushed, broken, or chewed.

If you take more Aristo Acetylsalicylic Acid than you should

If you (or someone else) accidentally take too many tablets, you should inform your doctor immediately, contact the nearest emergency service, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medication and the amount taken. Show your doctor the medication or the empty package.

The 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 faster than normal breathing (hyperventilation), fever, excessive sweating, restlessness, convulsions, hallucinations, low blood sugar levels, pulmonary edema, coma, and shock.

If you forget to take Aristo Acetylsalicylic Acid

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

If you stop taking Aristo Acetylsalicylic Acid

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects, stop taking Aristo Acetylsalicylic Acid and contact your doctor immediately:

? Sudden difficulty breathing, swelling of your lips, face, or body, rash, 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:

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

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

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

• Hives.
• Runny nose.
• Difficulty breathing.

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

• Severe bleeding in the stomach or intestines, cerebral hemorrhage; altered blood cell count.
• Cramps in the lower respiratory tract, asthma attack.
• Inflammation of blood vessels.
• Bruises with purple spots (cutaneous bleeding).
• Severe skin reactions, such as a rash known as erythema multiforme, and can be life-threatening, Stevens-Johnson syndrome, and Lyell syndrome.
• Hypersensitivity reactions, such as swelling of, e.g. 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 periods.

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

• Ringing in your ears (tinnitus) or reduced hearing ability.
• Headache.
• Dizziness.
• Ulcers in the stomach or small intestine and perforation.
• Prolonged bleeding time.
• Disorder of kidney function.
• Disorder of liver function, increased liver enzymes.
• High levels of uric acid in the blood.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Aristo Acetylsalicylic Acid

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

Store below 30°C.

Keep in the original packaging to protect from moisture.

Do not use this medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Aristo Acetylsalicylic Acid

The active ingredient is acetylsalicylic acid. Each gastro-resistant tablet contains 100 mg of acetylsalicylic acid.

The other ingredients are:

Lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, potato starch, talc, triacetin, ethyl acrylate-methacrylic acid copolymer.

Appearance of the product and package contents

Aristo Acetylsalicylic Acid 100 mg tablets are white, round, biconvex, and approximately 8.1 mm in diameter.

They are available in PVC-Al blisters.

They are available in packages containing 10, 20, 28, 30, 50, 56, 60, 90, or 100 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer:

G.L. Pharma GmbH

Schloßplatz 1, A-8502 Lannach

Austria

This medication is authorized in the EEA Member States under the following names:

Czech Republic: Manoass 100 mg enterosolventní tablet

Germany: Acetylsalicylsäure G.L. Pharma 100 mg magensaftresistente Tabletten

Poland: Alepton

Slovakia: Gerasa 100 mg gastrorezistentné tablety

Sweden: Thromboass 100 mg enterotabletter

Spain: Ácido Acetilsalicílico Aristo 100 mg comprimidos gastrorresistentes

Date of last revision of this leaflet: October 2020

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