Package Insert: Information for the User

ADIRO 100 mg

Enteric-coated EFG tablets

Acetylsalicylic acid

Read this package insert carefully before starting to take this medicine, 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 medicine has been prescribed only for you, and you should not give it 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. See section 4.

Contents of the package and additional information

Acetylsalicylic acid, 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 Adiro 100 mg 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 Adiro 100 mg

• 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 gastric discomfort.
• if you have a history of bleeding or perforation of the stomach after treatment with Adiro 100 mg 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 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 the last three months of pregnancy, do not use doses higher than 100 mg per day (see section "Pregnancy, lactation, and fertility").

Warnings and precautions

Inform your doctor before taking Adiro 100 mg if you are in any of the following situations:

• if 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 Adiro 100 mg and produce undesirable effects (see "Use of Adiro 100 mg 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, 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 are experiencing gout attacks.

Adiro 100 mg 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 Adiro 100 mg 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 Adiro 100 mg, 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 muscle 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.

• Medications for coagulation (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.

• Methotrexate, used to treat cancer and rheumatoid arthritis: increases the hepatotoxicity of methotrexate.
• 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.
• Phenobarbital and valproic acid, medications for epilepsy.
• If administered together, metamizole (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.

Taking Adiro 100 mg with food, drinks, and alcohol

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 Adiro 100 mg may cause stomach bleeding.

Pregnancy, lactation, and fertility

Pregnancy

Consult your doctor or pharmacist before using any medication.

If you continue or start treatment with Adiro 100 mg during pregnancy, following your doctor's instructions, use Adiro 100 mg as directed by your doctor and do not use a dose higher than recommended.

Pregnancy – last trimester

Do not take Adiro at doses higher than 100 mg per day 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 predisposition and that of your baby to bleed and delay or prolong delivery more than expected.

If you take Adiro at low doses (100 mg per day or lower doses), you need strict obstetric control as indicated by your doctor.

Pregnancy – first and second trimester

You should not take Adiro 100 mg during the first 6 months of pregnancy unless it is absolutely necessary and as your doctor indicates.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, Adiro 100 mg 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 controls.

Lactation

Consult your doctor or pharmacist before using any medication.

Women in the lactation period 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 demonstrated a consistent effect of acetylsalicylic acid on fertility deterioration, and there is no conclusive evidence in animal studies.

Driving and operating machines

No effects have been described.

Interference with diagnostic tests:

Inform your doctor if you are taking this medication, as it may alter the results of any diagnostic tests (including blood, urine, etc.).

Adiro 100 mg 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.This medication should be taken with a glass of water, preferably on an empty stomach and at least 1 hour before meals. The tablets should not be crushed, broken, or chewed.

Consult your doctor or pharmacist if you have any doubts. The normal dose is one Adiro 100 mg 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 Adiro 100 mg. Do not stop treatment prematurely.

If you estimate that the effect of Adiro 100 mg is too strong or too weak, inform your doctor or pharmacist.

Due to its delayed-release galenic form, Adiro 100 mg 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 Adiro 100 mg 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 Adiro 100 mg

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)

- With high doses: hypotrombinemia (decreased value of a blood protein necessary for coagulation)

- Dizziness

- Tinnitus (sounds in the ears)

- Epistaxis (nosebleed), rhinitis

- Gastrointestinal disorders such as indigestion, gastrointestinal and abdominal pain, inflammation

gastrointestinal, gastrointestinal bleeding

- Skin rash, pruritus

- Urinary and genital bleeding

Less frequent 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

- Bleeding gums, gastrointestinal erosion, and ulcer

- Liver 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 with fever, flu, or varicella (see "What you need to know before starting to take Adiro 100 mg)

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 (acute syndrome caused by severe respiratory insufficiency that also alters heart rhythm)

- Procedural bleeding

- Exacerbated respiratory disease by acetylsalicylic acid (respiratory syndrome characterized by nasal polyps, asthma, and sensitivity to acetylsalicylic acid)

- Diaphragmatic intestinal disease (intestinal tract narrowing)

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

The treatment should be suspended immediately if the patient notes any episode of hearing loss, ear noises, 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 of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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.

Store in the original packaging below 25°C.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Adiro 100 mg

The active ingredient is acetylsalicylic acid.

The other components are: powdered cellulose, cornstarch, copolymer of methacrylic acid type C, sodium dodecyl sulfate, polisorbate 80, talc, and triethyl citrate.

Appearance of the product and content of the packaging

Adiro 100 mg tablets are round and white. 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 packaging of 30 tablets, in PP/Aluminum or PVC/Aluminum blisters, and 60 or 100 tablets in PP/Aluminum blisters.

Only some sizes of packaging may be commercially available.

Other presentations

Adiro 300 mg. Packaging with 30 tablets.

Adiro 300 mg. Packaging with 60 tablets.

Marketing authorization holder:

Bayer Hispania, S.L.

Av. Baix Llobregat 3-5

08970 – Sant Joan Despí – Barcelona

Spain

Responsible for manufacturing:

Bayer Bitterfeld GmbH

OT Greppin

Salegaster Chaussee, 1

06803- Bitterfeld-Wolfen

Germany

or

Bayer HealthCare Manufacturing S.r.l.
Via delle Groane, 126
20024 Garbagnate Milanese

Italy

or

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

Last review date of this leaflet: August 2024

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