ADIRO 100 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

ADIRO 100 mg

gastro-resistant EFG tablets

acetylsalicylic acid

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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. Storage of Adiro 100 mg

Contents of the pack and additional information

1. What Adiro 100 mg is and what it is used for

Acetylsalicylic acid, at the dose present in this medication, belongs to the group of medications called antiplatelet agents. Platelets are components of the blood, smaller than red and white blood cells, that aggregate when the blood clots. By preventing this aggregation, antiplatelet agents reduce the possibility of blood clots (thrombi) forming.

Your doctor has prescribed Adiro 100 mg to prevent the formation of thrombi and reduce the risk of obstruction of your arteries, as:

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

2. What you need to know before taking Adiro 100 mg

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 presented allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases cough or wheezing when breathing) when taking anti-inflammatory drugs, acetylsalicylic acid, other analgesics, as well as the dye tartrazine.
• if you have or have had acute gastroduodenal ulcer or recurring gastric discomfort.
• if you have a history of hemorrhage or gastric perforation after treatment with Adiro 100 mg or other non-steroidal anti-inflammatory drugs.
• if you have hemophilia or other blood coagulation problems 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 blood coagulation medications (oral anticoagulants).
• if you have severe heart disease.
• if you are being treated with methotrexate.
• if you are under 16 years old, unless explicitly indicated by your doctor, 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, you should not use doses higher than 100 mg per day (see "Pregnancy, breastfeeding, and fertility").

Warnings and precautions

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

• you have recently undergone surgical intervention, including dental surgery.
• you are going to undergo surgical intervention, including dental surgery, in the next seven days.
• you are taking non-steroidal anti-inflammatory drugs, such as ibuprofen or naproxen, or other types of medications, as certain medications can interact with Adiro 100 mg and produce unwanted effects (see "Use of Adiro 100 mg with other medications").
• you are being treated with corticosteroids.
• you are being treated with antidepressants.
• you are being treated with antiplatelet agents.
• you have hypertension or severe kidney, heart, or liver problems, have blood coagulation disorders, or are being treated with anticoagulants.
• you are allergic to other anti-inflammatory or anti-rheumatic medications.
• you have a deficiency of glucose-6-phosphate dehydrogenase.
• you have rhinitis and/or urticaria.
• you have suffered or suffer from gout attacks.

Adiro 100 mg may cause bronchospasm, asthma attacks, or other hypersensitivity reactions. Risk factors are: pre-existing asthma, hay fever, nasal polyps, or chronic respiratory insufficiency, and also in 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 recently used, or may need to use any other medication.

Certain medications can interact with Adiro 100 mg, so they 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 muscle 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.
• Certain antidepressants, such as selective serotonin reuptake inhibitors, as they increase the risk of bleeding.

• Blood coagulation medications (oral anticoagulants), as they increase the risk of bleeding.
• Certain medications for controlling hypertension.

• Medications to lower blood sugar levels.

• Cyclosporine, used in transplants.
• Vancomycin, an antibiotic used in some infections.
• Interferon alpha.
• Lithium, used in some psychiatric diseases.

• Methotrexate, used to treat cancer and rheumatoid arthritis: increases the hepatic toxicity of methotrexate.
• Medications used to treat gout.
• Antacids.
• Digoxin, used in heart problems.
• Barbiturates, medications used as sedatives for sleep problems and to treat convulsions.
• Zidovudine, used in the treatment of HIV infections.
• Phenytoin 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 habitually consume alcohol (three or more alcoholic beverages - beer, wine, liquor, etc. per day), taking Adiro 100 mg may cause stomach bleeding.

Pregnancy, breastfeeding, 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 indicated 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 and your baby's predisposition to bleeding 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

Do not take Adiro 100 mg during the first 6 months of pregnancy unless it is 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 the 20th week 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 more than a few days, your doctor may recommend additional checks.

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

Driving and using machines

No effects have been described in this regard.

Interference with diagnostic tests:

If you are going to undergo any diagnostic tests (including blood tests, urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Adiro 100 mg contains sodium

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

3. How to take Adiro 100 mg

Follow your doctor's instructions for taking this medication exactly. Take this medication 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.

Try 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 before then.

If you think 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 event of acute myocardial infarction. However, if its use is necessary in an emergency, 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 Adiro 100 mg than you should

Consult your doctor or pharmacist immediately.

Given the nature of the preparation, the possibility of accidental intoxication 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 Toxicology Information Service. Phone: 91 562 04 20.

If you forget to take Adiro 100 mg

Do not take a double dose to make up for forgotten doses. Take it as soon as possible and continue taking it according to your usual schedule.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package 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 corresponding clinical symptoms, such as fatigue and paleness.

In patients with severe glucose-6-phosphate dehydrogenase deficiency, cases of hemolysis and hemolytic anemia have been reported.

General list of possible side effects

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

• With high doses: hypoprothrombinemia (decreased value of a blood protein necessary for coagulation)
• dizziness
• tinnitus (ringing in the ears)
• epistaxis (nasal bleeding), rhinitis
• gastrointestinal disorders such as indigestion, gastrointestinal and abdominal pain, inflammation

gastrointestinal bleeding

• skin rash, itching
• bleeding from the urinary and genital tracts

Uncommon 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 can cause difficulty swallowing or breathing) bleeding in the brain and inside the skull
• hematoma
• nasal congestion
• gum bleeding, gastrointestinal erosion, and ulcer
• liver failure 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 febrile processes, flu, or chickenpox (see "What you need to know before taking 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, bleeding in the muscles
• perforation of gastrointestinal ulcer
• increase in liver enzyme levels (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 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 (narrowing of the intestinal tract)

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

Treatment should be stopped immediately if the patient notices any episode of deafness, ringing in the ears, or dizziness.

In patients who have presented an allergic reaction to acetylsalicylic acid and other non-steroidal 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 medications.

Reporting 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 listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Adiro 100 mg

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging at a temperature below 25°C.

Do not store at a temperature above 30°C.

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Adiro100 mg

The active ingredient is acetylsalicylic acid.

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

Appearance of the Product and Packaging Content

Adiro 100 mg tablets are round and white in color. They are coated with a gastro-resistant coating that makes the acetylsalicylic acid not released immediately in the stomach, but in a delayed manner in the duodenum. They are available in packages of 30 tablets, in PP/Aluminum or PVC/Aluminum blisters, and 60 or 100 tablets in PP/Aluminum blisters.

Only some package sizes may be marketed.

Other Presentations

Adiro 300 mg. Packages with 30 tablets.

Adiro 300 mg. Packages with 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

or

Bayer HealthCare Manufacturing S.r.l.Via delle Groane, 12620024 Garbagnate Milanese

Italy

or

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

Date of the Last Revision of this Prospectus: August 2024

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