Acetylsalicylic acid Aristo 100 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acetylsalicylic Acid Aristo 100 mg gastro-resistant tablets

Read the entire leaflet carefully before you start taking this medicine, as 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 other people, 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Acetylsalicylic Acid Aristo is and what it is used for
2. What you need to know before taking Acetylsalicylic Acid Aristo
3. How to take Acetylsalicylic Acid Aristo
4. Possible adverse effects
5. How to store Acetylsalicylic Acid Aristo
6. Contents of the pack and other information

1. What Ácido Acetilsalicílico Aristo is and what it is used for

This medicine contains acetylsalicylic acid, which at low doses belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells that cause blood to clot 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 can cause a heart attack or angina; in the brain, it can cause a stroke.

Ácido Acetilsalicílico Aristo is taken to reduce the risk of thrombus formation and thereby prevent:

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

Ácido Acetilsalicílico Aristo is also used to prevent thrombus 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 Acetylsalicylic Acid Aristo

Do not take Acetylsalicilic Acid Aristo:

• if you are allergic to acetylsalicylic acid, other salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs; NSAIDs are commonly used for arthritis, rheumatism, or pain), or to any of the other ingredients of this medicine (listed in section 6)
• if you have previously experienced an asthma attack or swelling of certain body parts, 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
• 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 ulcer/bleeding, with episodes of ulcers or bleeding, or other types of bleeding, such as a stroke
• if you have ever had problems with blood not clotting properly
• if you have severe liver or kidney problems
• if you have serious heart problems that may cause difficulty breathing and swelling of the ankles
• if you are in the last three months of pregnancy, you must not use doses higher than 100 mg per day (see section “Pregnancy, breastfeeding, and fertility”)
• if you are taking a medicine called methotrexate (e.g. for treating cancer or rheumatoid arthritis) at doses exceeding 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 (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 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, severe skin reactions, or any other signs of a serious allergic reaction (see section “Possible side effects”).

Inform your doctor if you have planned surgery (including minor procedures such as dental extraction), as acetylsalicylic acid is an anticoagulant and may increase the risk of bleeding.

Be careful 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 administered to children. Reye's syndrome is a very rare condition that affects the brain and liver and can be life-threatening. For this reason, Acetylsalicylic Acid Aristo must not be given to children under 16 years of age unless directed by a doctor.

Taking Acetylsalicylic Acid Aristo with other medicines

Inform 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 influenced if acetylsalicylic acid is taken at the same time as other medicines used for:

• preventing blood clots (e.g. warfarin, heparin, clopidogrel, alteplase)
• preventing rejection of a transplanted organ (cyclosporine, tacrolimus)
• treating 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)
• metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clumping together to form a blood clot). Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid for cardioprotection
• 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)
• used as hormone replacement therapy when adrenal or pituitary glands have been destroyed or removed, or medicines used to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids).

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

If you continue or start treatment with acetylsalicylic acid during pregnancy on medical advice, use acetylsalicylic acid as directed by your doctor and do not exceed the recommended dose.

Pregnancy – third trimester

Do not take doses exceeding 100 mg of acetylsalicylic acid per day if you are in the last three months of pregnancy, as it could harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your tendency to bleed and that of your baby, and may cause labor to be delayed or prolonged.

If you take low-dose acetylsalicylic acid (up to 100 mg per day), you will require strict obstetric monitoring as directed by your doctor.

Pregnancy – first and second trimesters

You should not take acetylsalicylic acid during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest possible dose should be used for the shortest possible time. If taken for more than a few days after 20 weeks of pregnancy, acetylsalicylic acid may cause kidney problems in the fetus, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for more than a few days is needed, your doctor may recommend additional monitoring.

Women who are breastfeeding should not take acetylsalicylic acid unless advised by their doctor.

Fertility

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

Driving and using machines

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

Acetylsalicylic Acid Aristo contains lactose

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

3. How to take Acetylsalicylic Acid Aristo

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

Recommended dose:

Adults

Prevention of heart attacks:

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

Prevention of strokes:

? The recommended dose is 75–300 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 heart surgery:

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

This medicine should not be used at higher doses (should not exceed 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 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 a sufficient amount of liquid (half a glass of water). 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 Acetylsalicylic Acid Aristo than you should

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

Symptoms of overdose may include ringing in the ears, hearing disturbances, 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, pulmonary edema, coma, and shock.

If you forget to take Acetylsalicylic Acid Aristo

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 Acetylsalicylic Acid Aristo

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

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 Acetylsalicylic Acid Aristo and contact your doctor immediately:

? Sudden difficulty breathing, swelling of your lips, face or body, rash, fainting or difficulty swallowing (serious allergic reaction).

? Skin redness with blistering or peeling, which 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 adverse effects:

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

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

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

• Urticaria.
• Runny nose.
• Difficulty breathing.

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

• 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 life-threatening forms including 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 condition in children affecting the brain and liver) (see section 2 "Children and adolescents").
• Abnormally heavy or prolonged menstrual periods.

Frequency unknown (frequency cannot be estimated from available data):

• Ringing in the ears (tinnitus) or reduced hearing ability.
• Headache.
• Dizziness.
• Ulcers in the stomach or small intestine and perforation.
• Prolonged bleeding time.
• Renal function disorder.
• Hepatic 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, Website: www.notificaRAM.es

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

5. Storage of Acetylsalicylic Acid Aristo

Keep this medicine 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 medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Acetylsalicylic Acid Aristo

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

The other components are:

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

Appearance of the medicinal product and contents of the container

Acetylsalicylic Acid Aristo 100 mg tablets are white, round, biconvex, with an approximate diameter of 8.1 mm.

They are presented in PVC-Al blisters.

Packaged in containers containing 10, 20, 28, 30, 50, 56, 60, 90 or 100 gastro-resistant tablets.

Only certain 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 medicinal product is authorized in 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 the most recent review of this leaflet: July 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/