ACETAMOL*AD 20COATEDTABLETS 500MG

ACETAMOL 300 mg effervescent granules
ACETAMOL ADULTI 500 mg tablets
Paracetamol

What it is and what it is used for
ACETAMOL is a medicine containing paracetamol.
ACETAMOL is used to treat the symptoms of fever and mild to moderate pain in children from 8 years of age (effervescent granules only), adolescents, and adults.

Consult your doctor if you do not feel better or if you feel worse after 3 days.

What you need to know before taking the medicine
This medicine contains paracetamol. Do not take in combination with other medicines containing paracetamol. If paracetamol is taken in high doses, serious side effects can occur, including severe liver disease and kidney and blood disorders.

Do not take/give ACETAMOL to the child
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to other substances similar to paracetamol; in particular, to other medicines for the treatment of pain (analgesics) and for lowering fever (antipyretics)
- together with other medicines that contain the same active ingredient because, if paracetamol is taken in high doses, serious side effects can occur (see "Other medicines and ACETAMOL" section)

Warnings and precautions
Talk to your doctor or pharmacist before taking/giving ACETAMOL to the child.
Consult your doctor if you/the child:
• have pain or fever of uncertain cause
• suffer from kidney disease (kidney failure)
• suffer from liver diseases, even severe (severe liver failure, acute hepatitis, mild to moderate hepatocellular insufficiency - including Gilbert's syndrome)
• are taking medicines that alter liver function
• suffer from a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (a hereditary disease that leads to a decrease in red blood cell count)
• suffer from a disease due to the destruction of certain blood cells, red blood cells (hemolytic anemia)
• suffer from chronic inflammatory disease with difficulty breathing (asthma)
• suffer from chronic alcoholism or consume large quantities of alcohol
• are taking other medicines to treat pain (analgesics) and to lower fever (antipyretics) or to treat inflammation (non-steroidal anti-inflammatory drugs) (see "Other medicines and ACETAMOL" section).
• are taking other medicines (see "Other medicines and ACETAMOL" section)
• have suffered from breathing difficulties due to reduced airway width (bronchospasm) following the intake of acetylsalicylic acid or anti-inflammatory medicines (aspirin, NSAIDs)
• are dehydrated (your body's water content is insufficient), malnourished, or underweight.

Prolonged use or excessive doses of this medicine can cause liver disease, kidney problems, or blood problems, even severe ones.
In case of incorrect or prolonged use of painkillers in high doses, headaches may occur, which should not be treated with higher doses of the medicine; if this occurs, your doctor will discontinue the medicine.
The sudden interruption of analgesic intake after a prolonged period of incorrect use at high doses can cause headache, fatigue, muscle pain, nervousness, and withdrawal symptoms that resolve within a few days. Until then, avoid taking other painkillers and do not start taking them again without consulting your doctor.

In case of allergic reactions, stop treatment and consult your doctor immediately.

Children and adolescents
Consult your doctor before administering the medicine to the child.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

If during treatment you/the child experience allergic reactions, even severe ones such as:
• swelling of the face, lips, eyelids, tongue and/or throat, hands, feet, ankles (angioedema)
• swelling of the larynx
• anaphylactic shock
• bronchospasm

STOP treatment and contact your doctor immediately.

During treatment with paracetamol, the following side effects have been reported with unknown frequency (frequency cannot be estimated from the available data):
• decrease in the number of platelets in the blood (thrombocytopenia)
• decrease in hemoglobin, a substance that transports oxygen in the blood (anemia)
• decrease in the number of granulocytes in the blood, a type of white blood cell (agranulocytosis)
• alterations in liver function
• inflammation of the liver (hepatitis)
• kidney disease (acute renal failure)
• inflammation of the kidneys (interstitial nephritis)
• presence of blood in the urine (hematuria)
• absence of urine production (anuria)
• hemorrhage (bleeding)
• abdominal pain
• diarrhea
• nausea
• vomiting
• dizziness

Very rare side effects:
• condition characterized by the appearance of red spots on the skin with a bull's eye appearance associated with itching (erythema multiforme)
• severe skin diseases characterized by erythema, bullous lesions with areas of skin detachment (Stevens-Johnson syndrome)
• severe skin disease characterized by redness, bullous lesions with areas of detachment and skin death (epidermal necrolysis); the lesions are accompanied by fever and the appearance of blisters on the mucous membranes
• reduction in the number of white blood cells in the blood (leukopenia).

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.