ACETAMOL*10SUPP 500MG

ACETAMOL ADULTS 1 g suppositories
ACETAMOL 500 mg suppositories
ACETAMOL CHILDREN 250 mg suppositories
ACETAMOL INFANTS 125 mg suppositories
Paracetamol

What it is and what it is used for
ACETAMOL is a paracetamol-based medicine
ACETAMOL is used for the treatment of fever symptoms and mild to moderate pain in children (see section “How to use/administer ACETAMOL to children”), 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 use/give ACETAMOL to your 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 section “Other medicines and ACETAMOL”)

Warnings and precautions
Consult your doctor or pharmacist before using/administering ACETAMOL to your child.
Consult your doctor if you/your child:
• have pain or fever whose cause is doubtful
• suffer from kidney diseases (renal failure)
• suffer from even severe liver diseases (severe hepatic failure, acute hepatitis, mild to moderate hepatocellular failure - including Gilbert's syndrome)
• are taking medicines that modify the way the liver works
• suffer from a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (an inherited 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 a chronic inflammatory disease with breathing difficulties (asthma)
• fast, eat little or abuse alcohol. In this case, the proposed dosages must be reduced to avoid toxicity even at normal recommended doses (see section “ACETAMOL with food, drink and alcohol”)
• are taking other medicines to treat pain (analgesics) and to lower fever (antipyretics) or to treat inflammation (non-steroidal anti-inflammatory drugs) (see section “Other medicines and ACETAMOL”)
• have suffered from respiratory difficulties due to reduction of the airway lumen (bronchospasm) after taking acetylsalicylic acid or anti-inflammatory drugs (aspirin, NSAIDs)
• are taking other medicines (see section “Other medicines and ACETAMOL”)

Prolonged use or excessive doses of this medicine can cause liver diseases, kidney or blood problems, even severe.

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

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

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

If during treatment you/your 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 the treatment and contact your doctor immediately.

During treatment with paracetamol, the following side effects have been observed with unknown frequency (frequency cannot be estimated from the available data):

• reduction in the number of platelets in the blood (thrombocytopenia)
• reduction of hemoglobin, a substance that transports oxygen in the blood (anemia)
• reduction in the number of blood granulocytes, a type of white blood cell (agranulocytosis)
• liver function disorders
• liver inflammation (hepatitis)
• kidney disease (acute renal failure)
• kidney inflammation (interstitial nephritis)
• presence of blood in the urine (hematuria)
• lack 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 bullseye appearance associated with itching (erythema multiforme)
• severe skin disease characterized by erythema, blistering lesions with areas of skin detachment (Stevens-Johnson syndrome)
• severe skin disease characterized by redness, blistering 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, 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.