Package Insert: Information for the Patient

Aristo Acetylsalicylic Acid 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 read 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.

1. What is Acetylsalicylic Acid Aristo and what is it used for

2. What you need to know before starting to take Acetylsalicylic Acid Aristo

3. How to take Acetylsalicylic Acid Aristo

4. Possible adverse effects

5. Storage of Acetylsalicylic Acid Aristo

6. Contents of the package and additional information

This medication 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 infarct.

Aristo Acetylsalicylic Acid is taken to reduce the risk of blood clots forming and consequently prevent:

?heart attacks

?cerebral infarcts

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

Aristo Acetylsalicylic Acid is also used to prevent blood clots from forming 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 Aristo Acetylsalicylic Acid:

• if you are allergic to acetylsalicylic acid, other salicylates, or nonsteroidal anti-inflammatory drugs (NSAIDs; NSAIDs are often used for arthritis or rheumatism and pain) or any of the other ingredients in thismedication (listed in section 6)
• 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 ever had an ulcer in your stomach or small intestine
• 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 and duodenal ulcers or bleeding, or other types of bleeding, such as a cerebral hemorrhage
• 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 (seesection “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 ever had ulcers or bleeding (for example, 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 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, abnormal 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 procedure (including a minor procedure, such as a tooth extraction) as acetylsalicylic acid is an anticoagulant, there may be an increased risk of bleeding.

You must 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 deterioration of renal function.

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

If you are in any of the above cases, 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 your life at risk. For this reason, Acetylsalicylic Acid Aristo should not be administered to children under 16 years of age, unless a doctor indicates otherwise.

Acetylsalicylic Acid Aristo with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, 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 the formation of blood clots (e.g., warfarin, heparin, clopidogrel, alteplase)
• prevent the rejection of a transplanted organ (ciclosporin, tacrolimus)
• treating high blood pressure (e.g., diuretics and ACE inhibitors)
• regulate heart rhythm (digoxin)
• manic-depressive disorder (lithium)
• pain and inflammation (e.g., NSAIDs (such as ibuprofen), or steroids)
• metamizol (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)
• used as hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed or removed, or medications to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids).

Acetylsalicylic Acid Aristo 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 indicates otherwise. Do not take Acetylsalicylic Acid Aristo 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 Acetylsalicylic Acid Aristo”). Normal or high doses of this medication 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.

Acetylsalicylic acid may affect female fertility through an effect on ovulation. This effect is reversible after stopping treatment.

Driving and operating machinery

Acetylsalicylic Acid Aristo should not affect your ability to drive and operate machinery.

Acetylsalicylic Acid Aristo contains lactose

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

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 75-300 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 cardiac surgery:

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

This medicationshould not be usedat higher doses (not to exceed 300 mg per day) unless advisedby a doctor.

Senior patients

The same doses as adults. In general, aspirin 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

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 administration.

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

If you take more Aspirin Aristo than you should

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

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, convulsions, hallucinations, low blood sugar levels, pulmonary edema, coma, and shock.

If you forget to take Aspirin Aristo

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

If you interrupt treatment withAspirin Aristo

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

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

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

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

?Severe 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:

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

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

Poorly frequent(may affect up to 1 in 100 patients):

• Urticaria.
• Nasal discharge.
• Difficulty breathing.

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

• Intense bleeding in the stomach or intestines, cerebral hemorrhage; altered blood cell count.
• Cramps in the lower respiratory tract, asthma attack.
• Inflammation of blood vessels.
• Brusing with purple spots (cutaneous bleeding).
• Severe skin reactions such as hives known as erythema multiforme, and may be life-threatening, Stevens-Johnson syndrome, and Lyell syndrome.
• Severe hypersensitivity reactions, such as swelling of, for example, lips, face, or body, or shock.
• The Reye syndrome(a veryinfrequent diseasein childrenthat affectsthe brainand liver(see section2"Children andadolescents").
• Abnormally heavy or prolonged menstrual bleeding.

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

• Tinnitus or reduced hearing.
• Headache.
• Dizziness.
• Ulcers in the stomach or small intestine and perforation.
• Prolonged bleeding time.
• Renal function disorder.
• 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 prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use, Website:www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Store below 30°C.

Store in the original packaging to maintain humidity.

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 unusedmedicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Acetilsalicylic Acid Aristo

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

The other components are:

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

Appearance of the product and content of the packaging

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

They are presented in PVC-Al blisters.

They are presented in containers holding 10, 20, 28, 30, 50, 56, 60, 90, or 100 gastro-resistant tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aristo Pharma Iberia, S.L

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for manufacturing

G.L. Pharma GmbH

Schloßplatz 1, A-8502 Lannach

Austria

That medicine is authorized in the EEA Member States with 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: Acetilsalicylic Acid Aristo 100 mg gastro-resistant tablets

Last review date of this leaflet: October 2020

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