Acetylsalicylic acid Farmalider 75 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acetylsalicylic acid Farmalider 75 mg gastro-resistant tablets

Read the entire 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 other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Acetylsalicylic acid, at the dose present in this medicine, belongs to a group of medicines known as antiplatelet agents. Platelets are components of the blood, smaller than red and white blood cells, which clump together when blood clots. By preventing this clumping, antiplatelet agents reduce the possibility of blood clots (thrombi) forming.

Your doctor has prescribed Acetylsalicylic Acid Farmalider to prevent the formation of blood clots and to reduce the risk of blockage in your arteries, because:

• You have previously suffered a myocardial infarction or angina pectoris.
• You have had a non-haemorrhagic stroke, either transient or permanent.
• You have undergone a surgical procedure such as coronary angioplasty or coronary bypass surgery.

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

Do not take Acetylsalicylic Acid Farmalider:

• if you are allergic to acetylsalicylic acid or to any of the other components of this medicine (listed in section 6).
• if you have or have had asthma, with or without nasal polyps, after taking acetylsalicylic acid.
• if you have experienced allergic-type asthma reactions (difficulty breathing, suffocation, bronchospasm, and in some cases coughing or wheezing) when taking anti-inflammatory drugs, acetylsalicylic acid, other analgesics, or the colouring agent tartrazine.
• if you have or have had acute gastroduodenal ulcer or recurrent stomach discomfort.
• if you have a history of gastrointestinal bleeding or perforation following treatment with Acetylsalicylic Acid Farmalider or other non-steroidal anti-inflammatory drugs (NSAIDs).
• if you have haemophilia or other blood coagulation disorders 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 drugs (oral anticoagulants).
• if you have a serious heart condition.
• if you are being treated with methotrexate.
• if you are under 16 years of age, unless specifically instructed by a doctor, as the use of acetylsalicylic acid is associated with the development of Reye's syndrome, a rare but serious illness.
• if you are in your third trimester of pregnancy.

If taken concomitantly, metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (the blood cells clump together to form a blood clot). Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid for cardioprotection.

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 surgery, including dental surgery.
• you are scheduled to undergo surgery, including dental surgery, within the next seven days.
• you are taking non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, or other types of medication, as certain medicines may interact with Acetylsalicylic Acid Farmalider and cause undesirable effects (see “Use of Acetylsalicylic Acid Farmalider with other medicines”).
• you are being treated with corticosteroids.
• you are being treated with antidepressants.
• you are being treated with antiplatelet agents.
• you have hypertension or serious kidney, heart, or liver problems, blood coagulation disorders, or are being treated with anticoagulants.
• you are allergic to other anti-inflammatory or antirheumatic drugs.
• you have glucose-6-phosphate dehydrogenase deficiency.
• you have rhinitis and/or urticaria.
• you have had or currently suffer from gout attacks.

Acetylsalicylic Acid Farmalider 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 in patients with other allergic manifestations, such as skin reactions, itching, or urticaria.

Use of Acetylsalicylic Acid Farmalider with other medicines

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

Certain medicines may interact with Acetylsalicylic Acid Farmalider and therefore should not be used without consulting your doctor. This is especially important in the case of:

• Analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, used to treat pain and/or muscle inflammation.
• Corticosteroids, except hydrocortisone used in Addison's disease, as they may increase the risk of gastrointestinal bleeding.
• Diuretics.
• Some antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), as they increase the risk of bleeding.
• Medicines for blood clotting (oral anticoagulants), as they increase the risk of bleeding.
• Some medicines for controlling high blood pressure.
• Medicines to lower blood sugar levels.
• Cyclosporine, used in transplant patients.
• Vancomycin, an antibiotic used for certain infections.
• Interferon alfa.
• Lithium, used in certain psychiatric conditions.
• Methotrexate, used for the treatment of cancer and rheumatoid arthritis.
• Medicines used to treat gout.
• Antacids.
• Digoxin, used for heart problems.
• Barbiturates, medicines used as sedatives for sleep disorders and to treat seizures.
• Zidovudine, used in the treatment of HIV infections.
• Phenytoin and valproic acid, medicines used for epilepsy.

Taking Acetylsalicylic Acid Farmalider with food, drinks, and alcohol

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

If you regularly consume alcohol (three or more alcoholic drinks – beer, wine, spirits, etc. – per day), taking Acetylsalicylic Acid Farmalider may cause stomach bleeding.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medicine.

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 medicine. Taking this medicine during the first and second trimesters of pregnancy may be harmful to the embryo or fetus and must be monitored by your doctor. You must not take this medicine during the third trimester of pregnancy.

Breastfeeding
Consult your doctor or pharmacist before using any medicine.

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

Driving and use of machines

No effects have been reported in this regard.

Interference with diagnostic tests

If you are scheduled for any diagnostic tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Acetylsalicylic Acid Farmalider 75 mg contains maize starch.

3. How to take Acetylsalicylic Acid Farmalider

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

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

Consult your doctor or pharmacist if you have any doubts. The usual dose is one tablet of Acetylsalicylic Acid Farmalider once daily.

Try to take the medicine regularly, at the same time each day.

Your doctor will determine the duration of treatment with Acetylsalicylic Acid Farmalider. Do not stop your treatment prematurely.

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

Due to its modified-release formulation, Acetylsalicylic Acid Farmalider is not indicated at the time of acute myocardial infarction. However, in an emergency situation where its use becomes necessary, 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

Contact your doctor or pharmacist immediately.

Due to the nature of this preparation, the likelihood of accidental poisoning is very low.

The main symptoms of overdose are: headache, dizziness, tinnitus, blurred vision, drowsiness, sweating, rapid breathing, confusion, nausea, vomiting, and occasionally diarrhea.

In case of overdose or accidental ingestion, contact 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 then continue taking it according to the usual schedule.

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

4. Possible adverse effects

Like all medicines, Ácido acetilsalicílico Farmalider may produce adverse effects, although not everyone will experience them.

Due to its effect on platelet aggregation, acetylsalicylic acid may increase the risk of bleeding, leading to acute or chronic anemia, or iron-deficiency anemia, with 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 adverse 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 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 (reduced levels of a blood protein necessary for coagulation).

Uncommon adverse effects:

• Reye's syndrome (a rare and serious illness characterized by inflammation of the brain and liver) in patients under 16 years of age with fever, influenza, or chickenpox (see “What you need to know before taking Ácido acetilsalicílico Farmalider”).
• Liver disorders, particularly in patients with juvenile arthritis.

With long-term treatment and high doses, the following may occur: dizziness, tinnitus, hearing loss, sweating, headache, confusion, and kidney problems, including reported cases of renal failure and acute renal failure.

Treatment must be discontinued immediately if the patient experiences any episode of hearing loss, tinnitus, or dizziness.

In patients who have previously shown allergic reactions to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), 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 drugs.

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

5. Storage of Acetylsalicylic Acid Farmalider

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

Store below 30°C. Do not refrigerate.

Keep in the original packaging.

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 drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acetylsalicylic Acid Farmalider

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

Tablet core

Pregelatinized corn starch and powdered cellulose.

Coating

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

Appearance of the medicinal product and contents of the container

Acetylsalicylic Acid Farmalider 75 mg gastro-resistant tablets are white, round, biconvex film-coated tablets. They are coated with a gastro-resistant layer that prevents the immediate release of acetylsalicylic acid in the stomach, allowing delayed release in the duodenum.

Presented in packs of 30 tablets in PVC-Al/PVC-PVDC blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Farmalider S.A.
C/ La Granja, 1, 3rd Floor
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 most recent review of this leaflet: February 2024

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/