Adiro 100 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ADIRO 100 mg

enteric-coated tablets EFG

acetylsalicylic acid

Read all of this 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 be harmful to 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 Adiro 100 mg is and what it is used for
2. What you need to know before taking Adiro 100 mg
3. How to take Adiro 100 mg
4. Possible side effects
5. How to store Adiro 100 mg

Pack contents and additional information

1. What Adiro 100 mg 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 blood components smaller than red and white blood cells that clump together when blood clots. By preventing this clumping, antiplatelet agents reduce the likelihood of blood clots (thrombi) forming.

Your doctor has prescribed Adiro 100 mg to prevent the formation of blood clots and to reduce the risk of blockage of your arteries, because:

• You have previously had 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 Adiro 100 mg

Do not take Adiro 100 mg

• 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 reactions of an asthmatic type (difficulty breathing, suffocation, bronchospasm, and in some cases coughing or wheezing) when taking anti-inflammatory drugs, acetylsalicylic acid, other analgesics, or the dye tartrazine.
• 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 Adiro 100 mg or other non-steroidal anti-inflammatory drugs (NSAIDs).
• if you have hemophilia 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 severe heart disease.
• 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 the last three months of pregnancy, you should not use doses exceeding 100 mg per day (see section “Pregnancy, breastfeeding and fertility”).

Warnings and precautions

Tell your doctor before taking Adiro 100 mg 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, such as ibuprofen or naproxen, or other types of medication, as certain medicines may interact with Adiro 100 mg and cause unwanted effects (see “Use of Adiro 100 mg 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.

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 medicines

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

Certain medicines may interact with Adiro 100 mg 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, 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, as they increase the risk of bleeding.

• Medicines for blood coagulation (oral anticoagulants), as they increase the risk of bleeding.

• Some medicines for controlling hypertension.

• Medicines used to lower blood sugar levels.

• Cyclosporine, used in transplant patients.

• Vancomycin, an antibiotic used for certain infections.

• Interferon alfa.

• Lithium, used in certain psychiatric disorders.

• Methotrexate, used in the treatment of cancer and rheumatoid arthritis: increases methotrexate hepatotoxicity.

• 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.

• If administered concomitantly, metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clumping to form a clot). Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid as a cardioprotective agent.

Taking Adiro 100 mg with food, drinks, and alcohol

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 Adiro 100 mg may cause stomach bleeding.

Pregnancy, breastfeeding, and fertility

Pregnancy

Consult your doctor or pharmacist before using any medicine.

If you continue or start treatment with Adiro 100 mg during pregnancy as directed by your doctor, use Adiro 100 mg exactly as prescribed and do not exceed the recommended dose.

Pregnancy – third trimester

Do not take Adiro at doses exceeding 100 mg per day if you are in the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and that of your baby to bleed and may delay or prolong labor beyond the expected duration.

If you take Adiro at low doses (100 mg per day or lower), strict obstetric monitoring is required as directed by your doctor.

Pregnancy – first and second trimesters

You should not take Adiro 100 mg during the first 6 months of pregnancy unless absolutely necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, the lowest effective dose should be taken 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 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 is needed for longer than a few days, your doctor may recommend additional monitoring.

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.

Fertility

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

Driving and use of machines

No effects have been reported in this regard.

Interference with diagnostic tests:

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

Adiro 100 mg contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Adiro 100 mg

Follow exactly the instructions given by your doctor for taking this medicine. 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.

If you have any doubts, consult your doctor or pharmacist. The usual dose is one Adiro 100 mg tablet once daily.

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

Your doctor will determine how long your treatment with Adiro 100 mg should last. Do not stop treatment prematurely.

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

Due to its modified-release formulation, Adiro 100 mg is not indicated at the time of acute myocardial infarction. However, in an emergency situation where its use is required, 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

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 Adiro 100 mg

Do not take a double dose to make up for missed doses. Take the missed dose as soon as possible and then continue taking the medicine as prescribed.

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 can 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 effect 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 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 adverse effects

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

• At high doses: hypoprothrombinemia (reduced level 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)

• 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 in swallowing or breathing)
• bleeding in the brain and within the skull
• bruising
• 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 children under 16 years of age with fever, influenza or varicella (see “What you need to know before taking Adiro 100 mg”)

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 heart rhythm)
• procedural bleeding
• respiratory disease exacerbated by acetylsalicylic acid (respiratory syndrome characterized by nasal polyps (soft growths developing inside the nose), asthma, and sensitivity to acetylsalicylic acid)
• intestinal diaphragm disease (narrowing of the intestinal tract)

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

Treatment must be stopped immediately if the patient experiences any episode of deafness, 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 type of adverse effect, consult your doctor, pharmacist, or nurse, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Adiro 100 mg

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 is the last day of the month indicated.

Store in the original packaging below 25°C.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of Adiro 100 mg

The active substance is acetylsalicylic acid.

The other components are: powdered cellulose, corn starch, methacrylic acid copolymer type C, sodium dodecyl sulfate, polysorbate 80, talc and triethyl citrate.

Appearance of the product and contents of the pack

Adiro 100 mg tablets are round and white. They are coated with a gastro-resistant coating that prevents the immediate release of acetylsalicylic acid in the stomach, allowing delayed release in the duodenum. The tablets are available in packs of 30 tablets in PP/Aluminum or PVC/Aluminum blisters, and in packs of 60 or 100 tablets in PP/Aluminum blisters.

Only certain pack sizes may be marketed.

Other presentations

Adiro 300 mg. Packs containing 30 tablets.

Adiro 300 mg. Packs containing 60 tablets.

Marketing Authorization Holder:

Bayer Hispania, S.L.

Av. Baix Llobregat 3-5

08970 – Sant Joan Despí – Barcelona

Spain

Manufacturer:

Bayer Bitterfeld GmbH

OT Greppin

Salegaster Chaussee, 1

06803 - Bitterfeld-Wolfen

Germany

o

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

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Bayer AG Kaiser-Wilhelm-Allee 51368 Leverkusen Germany

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

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)