ACETAMOL*BB 10SUPP 250MG

ACETAMOL ADULTI 1 g suppositories
ACETAMOL 500 mg suppositories
ACETAMOL BAMBINI 250 mg suppositories
ACETAMOL PRIMA INFANZIA 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 or moderate pain in children (see paragraph "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/administer ACETAMOL to children
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in paragraph 6)
- if you are allergic to other substances similar to paracetamol; in particular to other medicines for pain treatment (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 paragraph "Other medicines and ACETAMOL")

Warnings and precautions
Consult your doctor or pharmacist before using/administering ACETAMOL to children.
Consult your doctor if you/your child:
• have pain or fever of uncertain cause
• suffer from kidney disease (kidney failure)
• suffer from severe liver disease (severe liver failure, acute hepatitis, mild to moderate hepatocellular insufficiency - including Gilbert's syndrome)
• are taking medicines that affect how the liver works
• 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 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 paragraph "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 paragraph "Other medicines and ACETAMOL")
• have suffered from respiratory distress due to narrowing of the airways (bronchospasm) after taking acetylsalicylic acid or anti-inflammatory drugs (aspirin, NSAIDs)
• are taking other medicines (see paragraph "Other medicines and ACETAMOL")

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

If allergic reactions occur, stop treatment and consult your doctor immediately.

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

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.

If you/your child experience allergic reactions during treatment, 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.

The following side effects have been observed during treatment with paracetamol 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 carries 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)
• 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 bull's eye 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 death of the skin (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.