ASPIRIN PAIN INF*20TB500MG

Aspirin Pain and Inflammation
500 mg film-coated tablets
Acetylsalicylic acid

What it is and what it is used for
Aspirin Pain and Inflammation contains acetylsalicylic acid. Acetylsalicylic acid is an analgesic (reduces pain) and antipyretic (reduces fever).
Aspirin Pain and Inflammation is used for the symptomatic treatment of fever and/or mild to moderate pain, such as headache, flu-like symptoms, toothache, muscle pain.
Aspirin Pain and Inflammation is specifically reserved for adults and adolescents aged 16 years and over.
Consult your doctor or pharmacist for other forms of acetylsalicylic acid for patients weighing less than 40 kg.

Consult your doctor if you do not notice improvements or if you notice a worsening of symptoms after 3 days (for fever) or 3-4 days (for pain).

What you need to know before taking the medicine
Do not take Aspirin Pain and Inflammation:
• if you are allergic to acetylsalicylic acid or other salicylates or any of the other ingredients of this medicine (listed in section 6);
• if you have suffered from asthma or allergic reactions (e.g. urticaria, angioedema, severe rhinitis, shock) induced by the administration of acetylsalicylic acid or related medicines (in particular non-steroidal anti-inflammatory drugs);
• if you suffer from a stomach or intestinal ulcer (including duodenal ulcer);
• if you suffer from a bleeding condition or are at risk of bleeding;
• if you suffer from severe hepatic, renal, or cardiac insufficiency;
• if you are taking methotrexate in doses exceeding 15 mg/week;
• if you are taking oral anticoagulants (medicines to thin the blood and prevent clot formation);
• if you are after the 5th month of pregnancy (more than 24 weeks without menstruation);
• Children and adolescents under 16 years of age.

If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Consult your doctor or pharmacist before taking Aspirin Pain and Inflammation:

• if you are taking other products containing acetylsalicylic acid, to avoid the risk of overdose;
• if you experience headache while taking high doses of acetylsalicylic acid for a prolonged period of time, do not increase the dosage but rather ask your doctor or pharmacist for advice;
• if you use painkillers regularly, especially different painkillers in combination, this can lead to reduced kidney function;
• if you have a G6PD deficiency (Glucose-6-phosphate dehydrogenase), a hereditary disease affecting red blood cells, because high doses of acetylsalicylic acid could lead to hemolysis (destruction of red blood cells);
• if you have a history of stomach or intestinal ulcers, or stomach or intestinal bleeding or gastritis;
• if you suffer from hepatic or renal insufficiency;
• if you suffer from asthma: the occurrence of an asthma attack, in some patients, may be related to an allergic reaction to non-steroidal anti-inflammatory drugs or acetylsalicylic acid. In this case, the use of this medicine is not recommended;
• in case of heavy menstruation;
• if gastrointestinal bleeding occurs during treatment (blood loss from the mouth, blood in the stools, dark stool color): stop treatment and immediately call your doctor or emergency room;
• if you are also taking medicines that thin the blood and prevent clotting (anticoagulants);
• if you suffer from mild or moderate renal impairment;
• if you suffer from an alteration of cardiovascular circulation;
• acetylsalicylic acid increases the risk of bleeding even at low doses and even several days after intake. Inform your doctor, surgeon, or anesthetist or dentist if surgery is planned, even minor surgery;
• acetylsalicylic acid alters the amount of uric acid in the blood. This must be taken into consideration if you are taking a medication for gout;
• It is recommended not to take this medicine during breastfeeding;

Children
Reye's syndrome (a rare but very serious disease mainly associated with neurological and liver damage) has been observed in children with viral diseases and undergoing acetylsalicylic acid administration. Therefore:
• in case of a viral disease such as flu or chickenpox, acetylsalicylic acid should not be administered to a child without first consulting a doctor;
• if signs of dizziness or fainting, behavioral changes, or vomiting occur in a child taking acetylsalicylic acid, immediately inform the doctor.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequencies: not known: frequency cannot be estimated from the available data.

Possible side effects due to acetylsalicylic acid are:
These side effects are all very serious and you may urgently need medical attention or hospitalization. Immediately inform your doctor or go to the nearest hospital if you notice any of the following symptoms:
• bleeding (blood loss from the nose or gums, red spots under the skin);
• allergic reactions such as skin rash, asthma attack, or facial swelling accompanied by difficulty breathing;
• headache, dizziness, feeling of hearing loss, tinnitus (ringing in the ears) which are usually signs of overdose;
• cerebral hemorrhage;
• stomachache;
• gastrointestinal bleeding. See Warnings and precautions section. These occur more frequently when high doses are taken;
• Increase in liver enzymes generally reversible with discontinuation of treatment, alteration of liver function (particularly liver cells);
• urticaria, skin reactions;
• Reye's syndrome (altered state of consciousness or abnormal behavior, or vomiting) in children with viral diseases and taking acetylsalicylic acid (see Section 2: What you need to know before taking Aspirin Pain and Inflammation);
• renal impairment and acute kidney damage;
• intestinal diaphragm disease (a narrowing of the intestine), especially with long-term treatment.

Reporting of side effects
If you get any side effects, 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: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.