ASPIRIN PAIN INF*8TAB 500MG

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 syndrome, toothache, muscle pain.
Aspirin Pain and Inflammation is specifically reserved for adults and adolescents aged 16 years and over.
Please 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 improvement or if your symptoms worsen 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 gastric or intestinal ulcer (including duodenal);
• if you suffer from a bleeding condition or are at risk of bleeding;
• if you suffer from severe liver, kidney or heart failure;
• if you are taking methotrexate therapy in doses greater than 15 mg/week;
• if you are taking oral anticoagulants (medicines to thin the blood and prevent clot formation);
• if you are beyond the 5th month of pregnancy (more than 24 weeks of amenorrhea);
• 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 a headache while taking high doses of acetylsalicylic acid for a prolonged period of time, do not increase the dosage but rather seek advice from your doctor or pharmacist;
• if you use painkillers regularly, especially different painkillers in combination, this can lead to reduced kidney function;
• if you have 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 gastric or intestinal ulcers, or gastric or intestinal bleeding or gastritis;
• if you suffer from liver or kidney failure;
• if you suffer from asthma: the occurrence of an asthma attack, in some patients, may be linked 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 stools): stop treatment and immediately call your doctor or emergency room;
• if you are also taking medicines that thin the blood and prevent its coagulation (anticoagulants);
• if you suffer from mild or moderate renal impairment;
• if you suffer from impaired cardiovascular circulation;
• acetylsalicylic acid increases the risk of bleeding even at low doses and even several days after taking it. Inform your doctor, surgeon or anaesthetist or dentist if surgery is planned, even minor surgery;
• acetylsalicylic acid changes the amount of uric acid in the blood. This must be taken into account if you are taking 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 who have been given acetylsalicylic acid. Consequently:
• in case of viral disease such as flu or chickenpox, acetylsalicylic acid should not be given to a child without first consulting a doctor;
• if signs of dizziness or fainting, behavioural changes or vomiting appear in a child taking acetylsalicylic acid, immediately notify the doctor.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone 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 need urgent medical attention or hospitalisation. 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, sensation of hearing loss, tinnitus (ringing in the ears) which are usually signs of overdose;
• cerebral haemorrhage;
• stomach ache;
• gastrointestinal haemorrhage. See Warnings and precautions section. These occur more frequently when high doses are taken;
• Increase in liver enzymes, generally reversible upon discontinuation of treatment, altered liver function (particularly liver cells);
• urticaria, skin reactions;
• Reye's syndrome (altered state of consciousness or abnormal behaviour, or vomiting) in children with viral diseases taking acetylsalicylic acid (see Section 2: What you need to know before taking Aspirin Pain and Inflammation);
• kidney impairment and acute kidney damage;
• intestinal diaphragm disease (a narrowing of the intestine), especially in long-term treatment.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.