Aspirinetta

Package leaflet: Information for the patient

Aspirinetta 100 mg tablets

acetylsalicylic acid
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Aspirinetta is and what it is used for

Aspirinetta is an antipyretic (reduces fever), anti-inflammatory, and analgesic
(pain reliever: reduces pain).
Aspirinetta is used to treat:

• rheumatic disease (acute febrile inflammatory disease affecting joints, heart, skin, and the nervous system);
• Kawasaki syndrome (a disease occurring in children characterized by fever, enlargement of neck lymph nodes, and inflammation of the arteries).

2. What you need to know before taking Aspirinetta

Do not take Aspirinetta

• if you are allergic to acetylsalicylic acid or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other analgesics (painkillers)/antipyretics (fever reducers)/non-steroidal anti-inflammatory drugs (NSAIDs);
• if you suffer from gastroduodenal ulcer (ulcer of the stomach or the first part of the intestine);
• if you suffer from haemorrhagic diathesis (tendency to bleed);
• if you suffer from severe heart, liver, or kidney failure;
• if you have glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme deficiency, genetically determined, leading to a disease characterized by reduced survival of red blood cells, known as favism);
• if you are receiving concomitant treatment with methotrexate (at doses of 15 mg/week or more) or with warfarin (see "Other medicines and Aspirinetta 100 mg tablets");
• if you suffer from asthma or have previously experienced asthma induced by salicylates or substances with similar activity, particularly non-steroidal anti-inflammatory drugs;
• if you suffer from hypophosphatemia (lack of phosphates in the blood);
• if you are in the last three months of pregnancy, you must not use doses exceeding 100 mg per day (see "Pregnancy, breastfeeding and fertility");
• if you are breastfeeding (see "Pregnancy, breastfeeding and fertility");
• if you have viral infections caused by viruses, such as chickenpox or influenza, due to the risk of Reye's syndrome (a disease causing brain and liver damage, affecting children and adolescents).

Warnings and precautions
Talk to your doctor or pharmacist before taking Aspirinetta.
Take the medicine only with food.
Before administering any medicine, take all necessary precautions to prevent unwanted reactions:

• rule out any history of allergic reactions to this or other medicines;
• rule out the presence of other contraindications or conditions that may expose you to potentially serious side effects. If in doubt, consult your doctor or pharmacist.
• do not use acetylsalicylic acid together with another NSAID, or in any case, do not use more than one NSAID at a time.

Allergic reactions
Acetylsalicylic acid and other NSAIDs may cause allergic reactions (including asthma attacks, rhinitis (nasal congestion and runny nose), angioedema (swelling of the skin of the face and mucous membranes), or urticaria (skin rash and itching)).
The risk is higher in individuals who have previously experienced an allergic reaction after using this type of medicine (see "Do not take Aspirinetta 100 mg tablets") and in individuals who have allergic reactions to other substances (e.g. skin reactions, itching, urticaria).
In individuals with asthma and/or rhinitis (with or without nasal polyps) and/or urticaria, reactions may be more frequent and severe.
Elderly (especially over 75 years of age)
If you are elderly, you have a higher risk of serious adverse effects.
Inform your doctor if:

• you are scheduled for surgery (even minor procedures such as tooth extraction), as preoperative use may interfere with intraoperative haemostasis (stopping bleeding during surgery);
• you need to undergo testing for occult blood, since acetylsalicylic acid may cause gastrointestinal bleeding;
• you have blood clotting disorders or are taking anticoagulant medicines;
• you suffer from kidney, heart, or liver disease;
• you suffer from a condition called gout (joint inflammation causing pain and swelling). The use of acetylsalicylic acid and other NSAIDs may mask symptoms of gout, delaying diagnosis.
• you are taking certain non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen (medicines for pain, fever, or inflammation). (see "Other medicines and Aspirinetta 100 mg tablets")

Other medicines and Aspirinetta
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Aspirinetta with these medicines (see "Do not take Aspirinetta"):

• Methotrexate (used in certain cancers and rheumatoid arthritis) (doses greater than or equal to 15 mg/week);
• Warfarin (anticoagulant) may increase the risk of bleeding.

The effect of treatment may also be altered if acetylsalicylic acid is taken concomitantly with immunosuppressants (e.g. cyclosporine or tacrolimus, used to prevent organ transplant rejection).
Take Aspirinetta with these medicines only under strict medical supervision:

• Selective serotonin reuptake inhibitors (SSRIs) (used for depression): may increase the risk of gastrointestinal bleeding;
• ACE inhibitors (used for high blood pressure);
• Acetazolamide (used in certain types of edema (swelling));
• Valproic acid (used in epilepsy);
• Other NSAIDs including ibuprofen and naproxene (excluding those for topical use);
• Antacids (used for digestive disorders);
• Antiplatelet agents (used for prevention and treatment of blood clots in arteries);
• Thrombolytics (used to dissolve blood clots) or anticoagulants (used to slow down or inhibit blood clotting) taken orally or by injection;
• Antidiabetics (e.g. insulin and oral hypoglycemics) (used to stimulate insulin production by the pancreas): may induce hypoglycemia (low blood sugar levels);
• Digoxin (used in heart failure);
• Diuretics (used to increase urine output): may increase the risk of kidney toxicity;
• Phenytoin (used in epilepsy);
• Corticosteroids (excluding those for topical use and those used in replacement therapy for adrenal insufficiency): may increase the risk of gastrointestinal injury;
• Metoclopramide (used for vomiting);
• Methotrexate (doses less than 15 mg/week);
• Uricosuric agents such as probenecid, benzbromarone (used to increase excretion of uric acid);
• Zafirlukast (used for asthma); may increase the risk of kidney toxicity;
• Metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells that clump together to form a clot) when taken simultaneously. Therefore, this combination should be used with caution in patients taking low-dose aspirin for cardioprotection.

Therefore, unless otherwise prescribed by your doctor, do not take Aspirinetta concomitantly with the above-mentioned preparations.
Do not administer other oral medicines within 1 or 2 hours of taking this medicine.
Aspirinetta and alcohol
The combined effects of alcohol and acetylsalicylic acid increase the risk of gastrointestinal bleeding.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
If you need to continue or start treatment with Aspirinetta during pregnancy on medical advice, use Aspirinetta as recommended by your doctor and do not use doses higher than recommended.
Pregnancy – third trimester
Do not take Aspirinetta at doses exceeding 100 mg per day during the last three months of pregnancy, as it could harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labour beyond expected duration.
If you take Aspirinetta at low doses (up to 100 mg per day inclusive), close obstetric monitoring as advised by your doctor is required.
Pregnancy – first and second trimesters
You should not take Aspirinetta during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest effective dose for the shortest possible duration should be used.
From the 20th week of pregnancy, Aspirinetta may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing constriction of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Do not take Aspirinetta while breastfeeding.
Fertility
If you are a woman with fertility problems or undergoing fertility investigations, be aware that the use of acetylsalicylic acid, like any medicine inhibiting prostaglandin synthesis and cyclooxygenase, may interfere with fertility.
Driving and using machines
Due to the possible occurrence of dizziness, Aspirinetta may impair your ability to drive or operate machinery.
Aspirinetta contains sodium, wheat starch and lactose
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".
The wheat starch in this medicine contains only a very small amount of gluten (considered gluten-free); it is very unlikely to cause problems if you have celiac disease.
One tablet contains no more than 0.2 micrograms of gluten.
If you are allergic to wheat (a condition different from celiac disease), do not take this medicine.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Aspirinetta

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Use in children and adolescents
Aspirinetta tablets should preferably be dispersed directly in water, or chewed and then swallowed with plenty of water.
Due to their small size and pleasant fruity taste, the 100 mg Aspirinetta tablets may be allowed to dissolve in the mouth, even in younger patients.
Take the medicine preferably after main meals, or at least with a full stomach.
The recommended dose is:
Children aged 1–3 years: 1 tablet 1–2 times daily.
Children aged 3–5 years: 1 tablet 3 times daily.
Children aged 5–11 years: 2 tablets 3 times daily.
Adolescents aged 11–15 years: 3 tablets 3 times daily.
Do not exceed the recommended doses.

Kawasaki syndrome
Treatment should begin with a dose of 80–100 mg/kg body weight per day, divided into 4 single doses, and continued until the 14th day of illness.
This should be followed by a daily dose of 3–5 mg/kg body weight for 6–8 weeks.
After this period, if coronary lesions (affecting the heart's blood vessels) are evident, continue treatment indefinitely.
Always use the lowest effective dose and increase it only if it is insufficient to relieve symptoms.

If you take more Aspirinetta than you should
In case of accidental ingestion of an excessive dose of Aspirinetta, contact your doctor immediately or go to the nearest hospital.
Salicylate toxicity (a dosage exceeding 100 mg/kg/day for two consecutive days may cause toxicity) can result from chronic intake of excessive doses or from acute overdose, which may be potentially life-threatening and includes accidental ingestion in children.

• Chronic intoxication: Chronic salicylate poisoning may be insidious, as signs and symptoms are non-specific. Mild chronic salicylate intoxication, or salicylism, usually occurs only after repeated use of considerable doses. Symptoms include dizziness, vertigo, tinnitus (ringing or buzzing in the ear), hearing loss, sweating, nausea and vomiting, headache, and confusion. These symptoms can be controlled by reducing the dose. Tinnitus may appear at blood concentrations between 150 and 300 micrograms/ml, while more serious adverse events occur at concentrations above 300 micrograms/ml.
• Acute intoxication: The main feature of acute intoxication is a severe disturbance of acid-base balance, which may vary with age and severity of intoxication. In children, the most common presentation is metabolic acidosis (accumulation of acids in the body). The severity of poisoning cannot be estimated from blood concentration alone; absorption of acetylsalicylic acid may be delayed due to reduced gastric emptying, formation of concretions in the stomach, or ingestion of gastro-resistant formulations. Management of acetylsalicylic acid poisoning depends on its extent, stage, and clinical symptoms, and should be carried out according to conventional poisoning management techniques. The main measures to be taken include accelerating

elimination of the substance and restoring electrolyte (salt) and acid-base balance.
Due to the complex physiopathological effects associated with salicylate poisoning, signs, symptoms, and results of biochemical and instrumental tests may include:

• Signs and symptoms of mild/moderate overdose: tachypnea (rapid breathing), hyperventilation (excessively deep breathing), respiratory alkalosis (acid-base imbalance due to altered breathing), sweating, nausea, vomiting, headache, dizziness.
• Signs and symptoms of moderate/severe overdose: respiratory alkalosis with compensatory metabolic acidosis (acid-base imbalance due to altered breathing and accumulation of acids in the body), fever, hyperventilation, pulmonary edema (fluid in the lungs), respiratory failure, asphyxia, arrhythmias (irregular heartbeat), hypotension (low blood pressure), circulatory arrest (cessation of heartbeat), dehydration, oliguria (reduced urine output) progressing to renal failure (impaired kidney function), ketosis (acetone), hyperglycemia (increased blood sugar levels), severe hypoglycemia (severe drop in blood sugar), tinnitus (ringing or buzzing in the ear), hearing loss, gastrointestinal bleeding, gastric ulcer, coagulopathy (impaired blood clotting), encephalopathy (brain dysfunction), and central nervous system depression, ranging from lethargy (extreme drowsiness) and confusion to coma and seizures, cerebral edema (swelling of brain tissue), liver damage.
• At high doses, iron-deficiency anemia (only after prolonged treatment), taste disturbances, and skin rashes (acneiform, erythematous, scarlatiniform, eczematoid, desquamative, bullous, purpuric) may also occur.
• Other signs and symptoms: conjunctivitis, anorexia (loss of appetite), reduced visual acuity (blurred vision), drowsiness.
• Rarely observed: aplastic anemia (failure to produce red blood cells), agranulocytosis (absence of granulocytes in the blood), disseminated intravascular coagulation (widespread formation of blood clots), pancytopenia (deficiency of all types of blood cells), leukopenia (low white blood cell count), thrombocytopenia (low platelet count), eosinopenia (low eosinophil count), purpura (reddish skin patches), eosinophilia (increased eosinophils) associated with drug-induced hepatotoxicity, renal toxicity (allergic tubulo-interstitial nephritis), hematuria (blood in urine). Acute allergic reactions following acetylsalicylic acid intake may be treated, if necessary, with adrenaline, corticosteroids, and antihistamines. In emergencies and if no contraindications exist (e.g., reduced or absent airway protective reflexes, reduced consciousness, risk of gastrointestinal hemorrhage or perforation, or concurrent ingestion of corrosive substances), attempts may be made to enhance elimination of orally ingested acetylsalicylic acid by administering activated charcoal or performing gastric lavage. Management of fluids and electrolytes may be required, and forced alkaline diuresis may be indicated. Acetylsalicylic acid is dialyzable (can be removed by blood dialysis). If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most frequently observed side effects involve the gastrointestinal system. Their occurrence increases significantly in subjects at risk of gastrointestinal disorders.
These disturbances may be partially alleviated by taking the medicine with food.
Most side effects are dependent on both the dose and the duration of treatment.
Side effects observed with acetylsalicylic acid are generally common to other NSAIDs.

Effects on blood

• Prolongation of bleeding time,
• Anemia due to gastrointestinal hemorrhage,
• Reduced platelet count (thrombocytopenia) in extremely rare cases. Following hemorrhage, hemorrhagic/sideropenic anemia (due to iron deficiency) (e.g., due to occult microbleeding) may occur, with associated laboratory parameter changes and corresponding clinical signs and symptoms such as asthenia (weakness), pallor, and hypoperfusion (reduced tissue perfusion by blood).

Effects on the nervous system

• Headache,
• Dizziness. Rarely, Reye's syndrome (*) may occur—an acute illness affecting the brain and liver, potentially fatal, which affects almost exclusively children.

From rare to very rare occurrences:

• Cerebral hemorrhage, especially in patients with uncontrolled hypertension (high blood pressure) and/or undergoing anticoagulant therapy (medicines used to slow down or inhibit blood coagulation), which in isolated cases may be potentially life-threatening.

Effects on the ear and labyrinth

• Tinnitus (ringing/hissing/whistling in the ear).

Effects on the respiratory system

• Respiratory disease exacerbated by acetylsalicylic acid,
• Asthmatic syndrome,
• Rhinitis (runny nose),
• Nasal congestion (feeling of blocked nose and stuffy nose), (associated with allergic reactions);
• Epistaxis (nosebleed).

Effects on the heart

• Cardio-respiratory distress (severe and sudden respiratory failure) (associated with allergic reactions).

Effects on the eye

• Conjunctivitis (associated with allergic reactions).

Effects on the gastrointestinal system

• Gastrointestinal bleeding (occult),
• Gastric disturbances,
• Pyrosis (heartburn),
• Gastrointestinal pain,
• Gingival bleeding,
• Vomiting,
• Diarrhea,
• Nausea,
• Cramp-like abdominal pain (associated with allergic reactions).

Rarely may occur:

• Gastrointestinal inflammation,
• Gastrointestinal erosion,
• Gastrointestinal ulceration,
• Hematemesis (vomiting blood or material resembling "coffee grounds"),
• Melena (passage of black, tarry stools),
• Esophagitis (inflammation of the esophagus).

Very rarely may occur:

• Hemorrhagic gastrointestinal ulcer and/or gastrointestinal perforation, with corresponding clinical signs and symptoms and changes in laboratory parameters. May occur with unknown frequency (especially during long-term treatment):
• Intestinal diaphragm disease.

Effects on the liver

• Rarely: hepatotoxicity (generally mild and asymptomatic liver cell damage) manifested by increased transaminase levels.

Effects on the skin

• Skin rash,
• Edema (swelling),
• Urticaria,
• Pruritus,
• Erythema (redness),
• Angioedema (associated with allergic reactions).

Effects on the kidneys and urinary tract

• Impaired renal function and acute kidney injury (in conditions of impaired blood circulation in the kidneys),
• Urogenital hemorrhages (of the urinary and genital systems).

Effects on the body as a whole

• Procedural hemorrhages (immediately before, during, and immediately after surgical intervention),
• Hematomas (collections of blood outside blood vessels).

Effects on the immune system

• Rarely: anaphylactic shock (severe allergic reaction, potentially life-threatening), with associated laboratory parameter changes and clinical manifestations.

(*) Reye's syndrome (RS)
RS initially presents with vomiting (persistent or recurrent) and other signs of varying degrees of encephalopathy: from lethargy, drowsiness, or personality changes (irritability or aggression) to disorientation, confusion or delirium, up to seizures or loss of consciousness. The variability of the clinical picture should be considered: vomiting may even be absent or replaced by diarrhea.
If these symptoms arise in the days immediately following an influenza episode (or flu-like illness, chickenpox, or another viral infection) during which acetylsalicylic acid or other medicines containing salicylates were administered, the physician should immediately consider the possibility of RS.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aspirinetta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Aspirinetta contains

• The active substance is acetylsalicylic acid. One tablet contains 100 mg of acetylsalicylic acid.
• The other components are: powdered cellulose, maize starch, sodium saccharin, raspberry flavour (contains wheat starch and lactose).

Description of the appearance of Aspirinetta and pack contents
The pack contains 24 tablets of 100 mg.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa, 130 – 20156 Milan, Italy
Manufacturer
Bayer Bitterfeld GmbH – Greppin, Germany