Acetylsalicylic acid STADA 100 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acetylsalicylic Acid Stada 100 mg gastro-resistant tablets EFG

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 and must not be given 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 adverse effects not listed in this leaflet.

Leaflet contents:

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

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

Acetylsalicylic acid, at the dose present in this medicine, belongs to a group of medicines called 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 likelihood of blood clots (thrombi) forming. Your doctor has prescribed acetylsalicylic acid to prevent the formation of blood clots and to reduce the risk of blockage in your arteries, because:

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

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

Do not take Acetylsalicylic Acid Stada

• 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 asthmatic reactions (difficulty breathing, suffocation, bronchospasm, and in some cases coughing or wheezing) when taking anti-inflammatory drugs, acetylsalicylic acid, other analgesics, or the tartrazine dye.
• if you have or have had acute gastroduodenal ulcer or recurrent gastric discomfort.
• if you have a history of gastrointestinal bleeding or perforation following treatment with acetylsalicylic acid 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 Reye's syndrome, a rare but serious illness.
• if you are in the third trimester of pregnancy.

Warnings and precautions

Inform your doctor before taking acetylsalicylic acid 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 naproxen, or other types of medicines, as certain drugs may interact with acetylsalicylic acid and cause undesirable effects (see "Taking Acetylsalicylic Acid Stada 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 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.

Taking Acetylsalicylic Acid Stada with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicine.

Certain medicines may interact with acetylsalicylic acid 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 or naproxen, used to treat pain and/or muscle inflammation.
• Glucocorticoids, except hydrocortisone used in Addison's disease, as they may increase the risk of gastrointestinal bleeding and ulcers.
• 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 used to control 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: increases the hepatotoxicity of methotrexate.
• Medicines used for the treatment of 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.
• When administered together, 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 as a cardioprotective agent.

Taking Acetylsalicylic Acid Stada with food and drinks

Take this medicine with a glass of water, preferably on an empty stomach and at least 1 hour before meals.

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

Pregnancy, breastfeeding, and fertility

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Pregnancy – third trimester

Do not take acetylsalicylic acid if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your bleeding tendency and that of your baby, and may delay or prolong labor beyond expected.

Pregnancy – first and second trimester

You should not take acetylsalicylic acid during the first 6 months of pregnancy unless absolutely necessary and as directed by your doctor. If treatment is required during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, taking acetylsalicylic acid for more than a few days may cause kidney problems in your fetus, which can 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 longer than a few days is needed, your doctor may recommend additional monitoring.

Breast-feeding

Consult your doctor or pharmacist before using any medication.

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

Fertility

Based on limited available published data, human studies have not shown a consistent effect of acetylsalicylic acid on impaired fertility, and there is no conclusive evidence from animal studies.

Driving and use of machines

No effects of this kind have been reported.

Acetylsalicylic Acid Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; i.e., essentially "sodium-free".

3. How to take Acetylsalicylic Acid Stada

Follow exactly the administration instructions for this medicine as indicated by your doctor. Take this medicine with a glass of water, preferably on an empty stomach and at least 1 hour before meals. The tablets must not be crushed, broken, or chewed.

Consult your doctor or pharmacist if you have any doubts. The usual dose is one acetylsalicylic acid tablet once daily.

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

Your doctor will determine the duration of treatment with acetylsalicylic acid. Do not stop your treatment prematurely.

If you feel that the effect of acetylsalicylic acid is too strong or too weak, inform your doctor or pharmacist.

Due to its modified-release formulation, this medicine is not indicated at the time of acute myocardial infarction. However, in case of emergency where its use is necessary, it is recommended to crush the first tablet or chew it and swallow it to accelerate the absorption of acetylsalicylic acid.

If you take more Acetylsalicylic Acid Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 91 562 04 20.

Due to the nature of the 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.

If you forget to take Acetylsalicylic Acid Stada

Do not take a double dose to make up for missed doses. Take it as soon as possible and 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, this medicine may cause adverse effects, although not everyone will experience them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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

Cases of hemolysis and hemolytic anemia have been reported in patients with severe glucose-6-phosphate dehydrogenase deficiency.

General list of possible adverse effects

Frequent adverse effects (may affect up to 1 in 10 patients)

• At high doses: hypoprothrombinemia (reduced levels of a blood protein necessary for coagulation)
• dizziness
• tinnitus (ringing in the ears)
• epistaxis (nosebleeds), rhinitis
• gastrointestinal disorders such as indigestion, gastrointestinal and abdominal pain, gastrointestinal inflammation, gastrointestinal bleeding
• skin rash, itching
• bleeding from the urinary tract and genital organs

Uncommon adverse effects (may affect up to 1 in 100 patients)

• iron-deficiency anemia
• hypersensitivity, drug-induced hypersensitivity, allergic edema and angioedema (swelling of the face, lips, mouth, tongue or throat that may cause difficulty in swallowing or breathing), bleeding in the brain and within the skull
• bruising (hematoma)
• nasal congestion
• bleeding from the gums, gastrointestinal erosion and ulcer
• liver failure and liver disorders (especially in patients with juvenile arthritis)
• urticaria
• 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 varicella (see “What you need to know before taking Acetylsalicylic Acid Stada”)

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

• hemorrhagic anemia
• anaphylactic reaction (severe, generalized allergic reaction)
• bleeding, bleeding into muscles
• gastrointestinal ulcer perforation
• increased levels of liver enzymes (transaminases)
• renal insufficiency, acute renal failure

Frequency not known (frequency cannot be estimated from available data)

• hemolysis (destruction of red blood cells), hemolytic anemia
• anaphylactic shock (severe allergic reaction)
• cardiorespiratory distress (acute syndrome caused by severe respiratory failure affecting also cardiac rhythm)
• procedural bleeding
• aspirin-exacerbated respiratory disease (respiratory syndrome characterized by nasal polyps (soft growths inside the nose), asthma, and sensitivity to acetylsalicylic acid)
• intestinal diaphragm disease (narrowing of the intestinal tract)

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

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

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 Stada

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly discard containers and medicines you no longer need. This way, you will help protect the environment.

Store below 30°C. Do not refrigerate. Store in the original packaging.

6. Contents of the pack and other information

Composition of Acetylsalicylic Acid Stada

• The active substance is acetylsalicylic acid.
• The other components are: powdered cellulose, pregelatinized corn starch, Acryl-EZE Clear (93F19255) (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 Stada 100 mg tablets are round, biconvex and white. They are coated with a gastro-resistant coating that delays the release of acetylsalicylic acid in the stomach, allowing it to be released later in the duodenum. The product is supplied in packs of 30 tablets in PVC-Al/PVC-PVDC blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Toll Manufacturing Services, S.L.

Aragoneses 2

28108 – Alcobendas – Madrid

Spain

or

FARMALIDER S.A.

Aragoneses 2

28108 – Alcobendas – Madrid

Spain

or

Laboratorios Medicamentos Internacionales, S.A. (MEDINSA)

Solana 26,

28850 - Torrejón de Ardoz (Madrid)

Spain

Date of the most recent revision of this leaflet: June 2024

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