Acetylsalicylic Acid Farmalider 75 mg Gastro-Resistant Tablets

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

Do not take Acetylsalicylic Acid Farmalider:

• 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 presented allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases cough or wheezing when breathing) when taking anti-inflammatory medications, acetylsalicylic acid, other analgesics, as well as the dye tartrazine.
• if you have or have had acute gastroduodenal ulcer or recurring gastric discomfort.
• if you have a history of bleeding or gastric perforation after treatment with Acetylsalicylic Acid Farmalider or other non-steroidal anti-inflammatory drugs.
• if you have hemophilia or other blood coagulation problems that predispose you to internal bleeding.
• if you have severe kidney and/or liver disease (severe renal and/or hepatic insufficiency).
• if you are being treated with anticoagulant medications (oral anticoagulants).
• if you have severe heart disease.
• if you are being treated with methotrexate.
• if you are under 16 years old, unless explicitly indicated by your doctor, 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, metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells that come together to 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 Acetylsalicylic Acid Farmalider if you are in any of the following situations:

• you have recently undergone surgical intervention, including dental surgery.
• you are to undergo surgical intervention, including dental surgery, in the next seven days.
• you are taking non-steroidal anti-inflammatory medications, such as ibuprofen, or other medications, as certain medications can interact with Acetylsalicylic Acid Farmalider and produce unwanted effects (see "Use of Acetylsalicylic Acid Farmalider with other medications").
• you are being treated with corticosteroids.
• you are being treated with antidepressants.
• you are being treated with antiplatelet agents.
• you have hypertension or have serious kidney, heart, or liver problems, present blood coagulation disorders, or are being treated with anticoagulants.
• you are allergic to other anti-inflammatory or anti-rheumatic medications.
• you have a deficiency of glucose-6-phosphate dehydrogenase.
• you have rhinitis and/or urticaria.
• you have suffered or suffer from gout attacks.

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

Use of Acetylsalicylic Acid Farmalider with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those obtained without a prescription, homeopathic, herbal, and 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 Acetylsalicylic Acid Farmalider, so they should not be used without consulting your doctor. This is especially important in the case of:

• Analgesics and non-steroidal anti-inflammatory medications, such as ibuprofen, used to treat muscle pain and/or inflammation.
• Corticosteroids, except for hydrocortisone used in Addison's disease, as they may increase the risk of gastrointestinal bleeding.
• Diuretics.
• Certain antidepressants, such as selective serotonin reuptake inhibitors, as they increase the risk of bleeding.
• Anticoagulant medications (oral anticoagulants), as they increase the risk of bleeding.
• Certain medications for controlling hypertension.
• Medications to lower blood sugar levels.
• Cyclosporine, used in transplants.
• Vancomycin, an antibiotic used in some infections.
• Interferon alpha.
• Lithium, used in some psychiatric illnesses.
• Methotrexate, used to treat cancer and rheumatoid arthritis.
• Medications used to treat gout.
• Antacids.
• Digoxin, used in heart problems.
• Barbiturates, medications used as sedatives for sleep problems and to treat convulsions.
• Zidovudine, used in the treatment of HIV infections.
• Phenytoin and valproic acid, medications for epilepsy.

Taking Acetylsalicylic Acid Farmalider with food, drinks, and alcohol

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

If you habitually consume alcohol (three or more alcoholic beverages - beer, wine, liquor, etc. per day), taking Acetylsalicylic Acid Farmalider may cause stomach bleeding.

Pregnancy and Breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medication.

IMPORTANT FOR WOMEN:

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. The use of this medication during the first and second trimester of pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor. You should not take this medication during the third trimester of pregnancy.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Women who are breastfeeding should consult their doctor before using this medication, as acetylsalicylic acid passes into breast milk.

Driving and Using Machines

No effects have been described in this regard.

Interference with Diagnostic Tests

If you are to undergo any diagnostic tests (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Acetylsalicylic Acid Farmalider 75 mg contains cornstarch.

3. How to take Acetylsalicylic Acid Farmalider

Follow the administration instructions for this medication exactly 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 with sufficient liquid.

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

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

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

If you think the effect of Acetylsalicylic Acid Farmalider is too strong or too weak, inform your doctor or pharmacist.

Due to its delayed-release galenic form, Acetylsalicylic Acid Farmalider is not indicated in the event of acute myocardial infarction. However, if its use is necessary in an emergency, it is recommended to crush the first tablet or chew it to accelerate the absorption of acetylsalicylic acid.

If you take more Acetylsalicylic Acid Farmalider than you should

Consult your doctor or pharmacist immediately.

Given the nature of the preparation, the possibility of accidental intoxication 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 Toxicology Information Service. Telephone: 91 562 04 20.

If you forget to take Acetylsalicylic Acid Farmalider

Do not take a double dose to make up for forgotten doses. Take it as soon as possible and continue taking it according to your usual schedule.

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

4. Possible Side Effects

Like all medications, Acetylsalicylic Acid Farmalider can cause side effects, although not everyone experiences 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 corresponding clinical symptoms, such as fatigue and paleness.

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 narrowing of the bronchial muscle), rhinitis, nasal congestion.
• Urticaria, skin rashes, angioedema (swelling of the face, lips, mouth, tongue, or throat that can cause difficulty swallowing or breathing).
• With high doses: hypoprothrombinemia (decreased value of a blood protein necessary for coagulation).

Uncommon Side Effects:

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

In long-term treatments and with high doses, the following may appear: dizziness, ringing in the ears, deafness, sweating, headache, confusion, and kidney problems, with reports of renal insufficiency and acute renal failure.

Treatment should be stopped immediately if the patient notices any episode of deafness, ringing in the ears, or dizziness.

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

Reporting 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 package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Acetylsalicylic Acid Farmalider

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

Store below 30°C. Do not refrigerate.

Keep in the original packaging.

Do not use this medication after the expiration date shown on the packaging after CAD. 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 medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Acetylsalicylic Acid Farmalider

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

Core of the tablet

Pregelatinized cornstarch and powdered cellulose.

Coating

Metacrylic acid copolymer type C, talc, macrogol, anhydrous colloidal silica, sodium bicarbonate, and sodium lauryl sulfate.

Appearance of the Product and Package Contents

Acetylsalicylic Acid Farmalider 75 mg gastro-resistant tablets are white, round, and biconvex film-coated tablets. They have a gastro-resistant coating that makes the acetylsalicylic acid not released immediately in the stomach, but rather in a delayed manner in the duodenum.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Farmalider S.A.

C/ La Granja, 1 3ª Planta

28108 Alcobendas, Madrid

Spain

Manufacturer

Farmalider S.A.

C/ Aragoneses, 2

28108 Alcobendas, Madrid

Spain

Toll Manufacturing Services S.L.

C/Aragoneses, 2

28108 Alcobendas, Madrid

Spain

Date of the Last Revision of this Package Leaflet:February 2024

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/