Package Leaflet: Information for the Patient

Acid Acetilsalicylic Farmalider 75 mg gastro-resistant tablets

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

1.What is Acid Acetilsalicylic Farmalider and for what it is used

2.What you need to know before starting to take Acid Acetilsalicylic Farmalider

3.How to take Acid Acetilsalicylic Farmalider

4.Possible side effects

5.Storage of Acid Acetilsalicylic Farmalider

6.Contents of the pack and additional information

Acetylsalicylic acid, at the present dose in this medication, belongs to the group of medications called platelet aggregation inhibitors. Platelets are blood components, smaller than red and white blood cells, that aggregate when blood coagulates. By preventing this aggregation, platelet aggregation inhibitors reduce the likelihood of blood clots (thrombi) forming.

Your doctor has prescribed Farmalider Acetylsalicylic Acid to prevent thrombi formation and reduce the risk of artery obstruction, as:

• You have previously suffered a myocardial infarction or angina pectoris.
• You have suffered a non-hemorrhagic transient or permanent transient ischemic attack.
• You have undergone a surgical intervention, such as coronary angioplasty or coronary bypass.

Do not take Farmalider Acetylsalicylic Acid:

• if you are allergic to acetylsalicylic acid or any of the other components of this medication (listed in section 6).
• if you have or have had asthma, with or without nasal polyps, after taking acetylsalicylic acid.
• if you have had allergic reactions of the asthmatic type (difficulty breathing, choking, bronchospasm, and in some cases, coughing or wheezing) when taking anti-inflammatory medications, acetylsalicylic acid, other analgesics, as well as tartrazine dye.
• if you have or have had acute gastric ulcers or recurring gastric discomfort.
• if you have a history of bleeding or perforation of the stomach after treatment with Farmalider Acetylsalicylic Acid or other nonsteroidal anti-inflammatory drugs.
• if you have hemophilia or other bleeding disorders that predispose you to internal bleeding.
• if you have severe kidney or liver disease (severe renal and/or hepatic insufficiency).
• if you are being treated with oral anticoagulants.
• if you have severe heart disease.
• if you are being treated with methotrexate.
• if you are under 16 years old, unless a doctor's explicit indication, as the use of acetylsalicylic acid is related to the appearance of Reye's syndrome, a rare but serious disease.
• if you are in your third trimester of pregnancy.

If administered together, metamizol (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells come 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Farmalider Acetylsalicylic Acid if you are in any of the following situations:

• you have recently undergone surgery, including dental surgery.
• if you are to undergo surgery, including dental surgery in the next seven days.
• if you are taking nonsteroidal anti-inflammatory drugs, such as ibuprofen, or other medications, as certain medications may interact with Farmalider Acetylsalicylic Acid and produce undesirable effects (see "Use of Farmalider Acetylsalicylic Acid with other medications").
• if you are being treated with corticosteroids.
• if you are being treated with antidepressants.
• if you are being treated with antiplatelet agents.
• if you have hypertension or have severe kidney, heart, or liver problems, have coagulation disorders, or are being treated with anticoagulants.
• if you are allergic to other anti-inflammatory or antirheumatic medications.
• if you have glucose-6-phosphate dehydrogenase deficiency.
• if you have rhinitis and/or urticaria.
• if you have had or have gout attacks.

Farmalider Acetylsalicylic Acid may cause bronchospasm, asthma attacks, or other hypersensitivity reactions. Risk factors include pre-existing asthma, hay fever, nasal polyps, or chronic respiratory insufficiency, as well as patients with other allergic manifestations, such as skin reactions, itching, or urticaria.

Use of Farmalider Acetylsalicylic Acid with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription, homeopathic, herbal, or other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Certain medications may interact with Farmalider Acetylsalicylic Acid, so they should not be used without consulting a doctor. This is especially important in the case of:

• Analgesics and nonsteroidal anti-inflammatory drugs, such as ibuprofen, used to treat muscle pain and/or inflammation.
• Corticosteroids, except for hydrocortisone used in Addison's disease, as it may increase the risk of gastrointestinal bleeding.
• Diuretics.
• Some antidepressants, such as selective serotonin reuptake inhibitors, as they increase the risk of bleeding.
• Medications for coagulation (oral anticoagulants) that increase the risk of bleeding.
• Some medications for blood pressure control.
• Medications to lower blood sugar levels.
• Ciclosporin, used in transplants.
• Vancomycin, an antibiotic used in some infections.
• Interferon alfa.
• Lithium, used in some psychiatric diseases.
• Methotrexate, used to treat cancer and rheumatoid arthritis.
• Medications used to treat gout.
• Antacids.
• Digoxin, used in heart problems.
• Barbiturates, used as sedatives for sleep problems and to treat seizures.
• Zidovudine, used to treat HIV infections.
• Fenitoin and valproic acid, used to treat epilepsy.

Administration of Farmalider Acetylsalicylic Acid 75 mgcontains cornstarch.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Take this medication preferably before meals or with some food and sufficient liquid.

Consult your doctor or pharmacist if you have doubts. The normal dose is one Farmalider Acetylsalicylic Acid tablet once a day.

Make sure to take the medication regularly, every day at the same time.

Your doctor will indicate the duration of treatment with Farmalider Acetylsalicylic Acid. Do not stop treatment before.

If you estimate that the action of Farmalider Acetylsalicylic Acid is too strong or weak, inform your doctor or pharmacist.

Due to its delayed-release formulation, Farmalider Acetylsalicylic Acid is not indicated in the acute myocardial infarction. However, if in an emergency it must be used, it is recommended to crush the first tablet or chew it in order to accelerate the absorption of acetylsalicylic acid.

If you take more Farmalider Acetylsalicylic Acid than you should

Consult your doctor or pharmacist immediately.

Given the nature of the preparation, the possibility of accidental poisoning is very low.

The main symptoms of overdose are: headache, dizziness, ringing in the ears, blurred vision, drowsiness, sweating, rapid breathing, mental confusion, nausea, vomiting, and occasionally diarrhea.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 04 20.

If you forgot to take Farmalider Acetylsalicylic Acid

Do not take a double dose to compensate for the missed doses. Take it as soon as possible and continue taking it according to the usual schedule.

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

Like all medications, Farmalider Acetylsalicylic Acidmay cause side effects, although not everyone will experience them.

Due to its effect on platelet aggregation, acetylsalicylic acid may increase the risk of bleeding and cause acute or chronic anemia, or iron deficiency anemia, with the corresponding clinical symptoms, such as fatigue and pallor.

In patients with severe glucose-6-phosphate dehydrogenase deficiency, cases of hemolysis and hemolytic anemia have been reported.

Frequent side effects:

• Gastrointestinal disorders, such as gastric ulcer, duodenal ulcer, gastrointestinal bleeding, abdominal pain, gastric discomfort, nausea, vomiting.
• Respiratory disorders, such as difficulty breathing, bronchospasm (sudden constriction of the bronchial muscles), rhinitis, nasal congestion.
• Urticaria, skin rashes, angioedema (swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing).
• At high doses: hypoprothrombinemia (decreased levels of a blood protein necessary for coagulation).

Rare side effects:

• Reye's syndrome (a rare and serious condition characterized by inflammation of the brain and liver) in children under 16 years old with fever, flu, or chickenpox (see "What you need to know before starting to take Farmalider Acetylsalicylic Acid").
• Liver disorders, especially in patients with juvenile arthritis.

In long-term treatments and at high doses, the following may occur: dizziness, ear ringing, hearing loss, sweating, headache, confusion, and kidney problems, with cases of acute kidney failure and renal failure reported.

Treatment should be immediately suspended if the patient experiences any episode of hearing loss, ear ringing, or dizziness.

In patients who have had an allergic reaction to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs, anaphylactic or anaphylactoid reactions (severe and generalized allergic reactions) may occur. This may also happen in patients who have not previously shown hypersensitivity to these medications.

Reporting side effects

Ifyou experience any type of side effect, consult yourdoctor orpharmacist,evenifit is a possible side effectthatdoes not appearin thisleaflet. You can also report them directly through the Spanish System for 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 medication.

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

Store below 30°C. Do not refrigerate.

Store in the original packaging.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Compositionof Acetylsalicylic AcidFarmalider

• The active ingredient is acetylsalicylic acid.Each gastro-resistant tablet contains 75 mgof acetylsalicylic acid.
• The other components are:

Tablet core

Maize pregelatinized starch and powdered cellulose.

Coating

Polycarboxylate type C, talc, macrogol, anhydrous colloidal silica, sodium bicarbonate, and sodium lauryl sulfate.

Appearance ofthe product andcontent of the packaging

Farmalider 75 mg Acetylsalicylic Acid gastro-resistant tablets are white, round, and biconvex film-coated tablets. They are coated with a gastro-resistant coating that prevents the acetylsalicylic acid from being released immediately in the stomach, but rather in a delayed manner in the duodenum.

They are presented in packs of 30 tablets in PVC-Al/PVC-PVDC blisters.

Holder ofthe marketing authorization andresponsible for manufacturing

Holder of the marketing authorization

Farmalider S.A.

C/ La Granja, 1 3rd Floor

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

Farmalider S.A.

C/ Aragoneses, 2

28108 Alcobendas, Madrid

Spain

Toll Manufacturing Services S.L.

C/Aragoneses, 2

28108 Alcobendas, Madrid

Spain

Last revision date of this leaflet:February 2024

The 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/