Package Insert: Information for the Patient

Stada Acetylsalicylic Acid 100 mg Gastric-Resistant Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

- Keep this package insert, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed only for you and should not be given to others, 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 not listed in this package insert.

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

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

3. How to take Stada Acetylsalicylic Acid

4. Possible adverse effects

5. Storage of Stada Acetylsalicylic Acid

6. Contents of the package and additional information

Aspirin, at the present dose in this medication, belongs to a group of medications called antiplatelet agents. Platelets are blood components, smaller than red and white blood cells, that aggregate when blood clots. By preventing this aggregation, antiplatelet agents reduce the likelihood of blood clots (thrombi) forming. Your doctor has prescribed aspirin to prevent thrombi formation and reduce the risk of artery obstruction, as:

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

Do not take Acetilsalicílico Stada

• 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.
• if you have or have had acute gastric ulcers or repeated stomach discomfort.
• if you have a history of bleeding or perforation of the stomach after treatment with 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 taking anticoagulant medications.
• if you have severe heart disease.
• if you are taking methotrexate.
• if you are under 16 years old, unless a doctor's express 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.

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.
• if you are scheduled to undergo surgery, including dental surgery in the next seven days.
• if you are taking nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen, or other medications, as certain medications may interact with acetylsalicylic acid and produce undesirable effects (see "Taking Acetilsalicílico Stada with other medications").
• if you are taking corticosteroids.
• if you are taking antidepressants.
• if you are taking antiplatelet medications.
• if you have hypertension or have severe kidney, heart, or liver problems, have coagulation disorders, or are taking 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.

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 Acetilsalicílico Stada with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications may interact with 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 or naproxen, used to treat pain and/or inflammation.
• glucocorticoids, except for 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, as they may increase the risk of bleeding.
• blood thinners (oral anticoagulants) as they may increase the risk of bleeding.
• some medications for controlling hypertension.
• medications for lowering blood sugar levels.
• ciclosporin, used in transplants.
• vancomycin, an antibiotic used in some infections.
• interferon alfa.
• lithium, used in some psychiatric diseases.
• metotrexate, used to treat cancer and rheumatoid arthritis: it increases the hepatotoxicity of metotrexate.
• medications used to treat gout.
• antacids.
• digoxin, used in heart problems.
• barbiturates, medications used as sedatives for sleep problems and to treat seizures.
• zidovudine, used to treat HIV infections.
• phenytoin and valproic acid, medications for epilepsy.
• if taken together, metamizol (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clumping to form a blood clot). Therefore, this combination should be used with caution in patients taking low doses of acetylsalicylic acid as a cardioprotector.

Taking Acetilsalicílico Stada with food and drinks

Take this medication 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 beverages – beer, wine, liquor, etc. per day), taking Acetilsalicílico Stada may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility

Pregnancy

Consult your doctor or pharmacist before using any medication.

Pregnancy – last 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 and your baby's predisposition to bleeding and delay or prolong delivery more than expected.

Pregnancy – first and second trimester

Do not take acetylsalicylic acid during the first 6 months of pregnancy unless absolutely necessary and as indicated by your doctor.If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, if taken for more than a few days, acetylsalicylic acid may cause kidney problems in your fetus, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

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.

Fertility

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

Driving and operating machinery

No effects have been described.

Acetilsalicílico Stada contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. Take this medication with a glass of water, preferably on an empty stomach and at least 1 hour before meals. Do not crush, break, or chew the tablets.

Consult your doctor or pharmacist if you have any doubts. The normal dose is one tablet of acetylsalicylic acid 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 acetylsalicylic acid. Do not stop treatment before.

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

Due to its delayed-release galenic form, this medication is not indicated in the acute myocardial infarction. However, if in an emergency situation it must be used, it is recommended to crush the first tablet or chew it and swallow it in order to accelerate the absorption of acetylsalicylic acid.

If you take more Stada Acetylsalicylic Acid than you should

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

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.

If you forgot to take Stada 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 medicines, this medicine may cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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.

General list of possible side effects

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

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

Infrequent side effects(may affect up to 1 in 100 patients)

• anemia due to low iron levels in the blood
• hypersensitivity, drug-induced hypersensitivity, allergic edema, and angioedema (swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing) cerebral and intracranial bleeding
• hematoma
• nasal congestion
• gum bleeding, gastrointestinal erosion, and ulcer
• hepatic insufficiency and liver disorders (especially in patients with juvenile arthritis)
• urticaria
• Reye's syndrome (a rare and serious disease 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 Acetylsalicylic Acid Stada")

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

• hemorrhagic anemia
• anaphylactic reaction (severe and generalized allergic reaction)
• bleeding, muscle bleeding
• gastrointestinal ulcer perforation
• increase in liver enzyme levels (transaminases)
• renal insufficiency, acute renal failure

Unknown frequency(frequency cannot be estimated from available data)

• hemolysis (destruction of red blood cells), hemolytic anemia
• anaphylactic shock (severe allergic reaction)
• cardiorespiratory distress syndrome (acute syndrome caused by severe respiratory insufficiency that also alters heart rhythm)
• procedural bleeding
• respiratory disease exacerbated by acetylsalicylic acid (respiratory syndrome characterized by nasal polyps, asthma, and sensitivity to acetylsalicylic acid)
• intestinal diaphragmatic disease (intestinal tract narrowing)

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

Treatment should be suspended immediately if the patient notices any episode of hearing loss, ringing in the ears, or dizziness.

In patients who have presented an allergic reaction to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs, 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 drugs.

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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 the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

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

Composition of Stada Acetilsalicilic Acid

- The active ingredient is acetylsalicylic acid

- The other components are: powdered cellulose, pregelatinized cornstarch, Acryl-EZE Clear (93F19255) (polycarboxylate type C, talc, macrogol, anhydrous colloidal silica, sodium bicarbonate, and sodium lauryl sulfate).

Appearance of the product and content of the packaging

The Stada Acetilsalicilic Acid 100 mg tablets are round, biconvex, and white in color. 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 PVC-Al/PVC-PVDC blisters of 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

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

Last review date of this prospectus: June 2024

The detailed information of this medication is available on the webpage of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/