Name
Aspirin Pain and Inflammation
500 mg 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 aches.
Aspirin Pain and Inflammation is specifically reserved for adults and children aged 16 years and over.
Talk to your doctor or pharmacist about other forms of acetylsalicylic acid for patients weighing less than 40 kg.

Contact your doctor if you notice no improvement or if you notice 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 gastric or intestinal ulcers (including duodenal ulcers);
• if you have 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 "thinning" the blood and prevent clots from forming);
• if it is after the 5th month of pregnancy (more than 24 weeks of absence of menstruation);
• Children and young people under 16 years of age.

If you have any doubts, talk to your doctor or pharmacist before taking this medicine.


Warnings and precautions
Talk to 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 may lead to reduced kidney function;
• if you have a G6PD (Glucose-6-phosphate dehydrogenase) deficiency, an inherited disease affecting red blood cells, because high doses of acetylsalicylic acid could lead to haemolysis (destruction of red blood cells);
• if you have a previous 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 stool, dark colored stool): stop treatment and call your doctor or emergency room immediately;
• if you are also taking medicines that thin the blood and prevent clotting (anticoagulants);
• if you suffer from mild or moderate impairment of kidney function;
• 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 taking it. Tell your doctor, surgeon, anesthetist or dentist if you are planning to have surgery, even a minor one;
• acetylsalicylic acid changes the amount of uric acid in the blood. This should be taken into account if you are taking a medicine 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 were given acetylsalicylic acid. As a result:
• in case of viral illness such as influenza or chickenpox, administration of acetylsalicylic acid to a child should not take place without first consulting a doctor;
• if signs of dizziness or fainting, behavioral changes or vomiting occur in a child taking acetylsalicylic acid, tell your doctor immediately.


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 need urgent medical attention or hospitalization. Tell your doctor immediately or go to the nearest hospital if you notice any of the following symptoms:
• bleeding (nosebleeds or gum bleeding, red spots under the skin);
• allergic reactions such as skin rash, asthma attack or swelling of the face accompanied by difficulty breathing;
• headache, dizziness, feeling of hearing loss, tinnitus (ringing in the ears) which are usually signs of overdose;
• cerebral hemorrhage;
• stomach ache;
• gastrointestinal bleeding. See section "Warnings and precautions". These occur more frequently when high doses are taken;
• Increased liver enzymes generally reversible upon discontinuation of treatment, alteration of 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 and taking acetylsalicylic acid (see Section 2: What you need to know before taking Aspirin Pain and Inflammation);
• renal impairment and acute kidney injury;
• intestinal diaphragm disease (a narrowing of the intestine), especially in long-term treatment.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.