ACETAMOL*PRIMA INF SYR 100ML

ACETAMOL PRIMA INFANZIA 25 mg/mL syrup
ACETAMOL PRIMA INFANZIA 100 mg/mL oral drops, solution
Paracetamol

What it is and what it is used for
ACETAMOL PRIMA INFANZIA is a medicine containing paracetamol.
ACETAMOL PRIMA INFANZIA is used for the treatment of fever symptoms and mild or moderate pain in children, weighing between 3 and 15 kg.

Consult your doctor if the child does not feel better or feels 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 give ACETAMOL PRIMA INFANZIA to your child
- if they are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
- if they are allergic to other substances similar to paracetamol; in particular to other medicines for the treatment of pain (analgesics) and to lower 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 PRIMA INFANZIA" section)

Warnings and precautions
Talk to your doctor or pharmacist before giving ACETAMOL PRIMA INFANZIA to your child.

Consult your doctor if the child:
• has pain or fever of uncertain cause
• suffers from kidney disease (renal insufficiency)
• suffers from severe liver disease (severe hepatic insufficiency, acute hepatitis, mild to moderate hepatocellular insufficiency - including Gilbert's syndrome)
• is taking medicines that alter how the liver works
• suffers from a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (an inherited disease that leads to a decrease in red blood cell count)
• suffers from a disease due to the destruction of certain blood cells, red blood cells (hemolytic anemia)
• suffers from a chronic inflammatory disease with difficulty breathing (asthma)
• fasts or eats little. In this case, the proposed dosages must be reduced to avoid toxicity even at normal recommended doses (see "ACETAMOL PRIMA INFANZIA with food and drink" section)
• is 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 PRIMA INFANZIA" section)
• has suffered from breathing difficulties due to narrowing of the airways (bronchospasm) after taking acetylsalicylic acid or anti-inflammatory medicines (aspirin, NSAIDs)
• is taking other medicines (see "Other medicines and ACETAMOL PRIMA INFANZIA" section) Prolonged use or excessive doses of this medicine can cause liver diseases, kidney problems, or blood problems, even severe.

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

Children
Consult your doctor before administering the medicine to a child.

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

If, during treatment, the child experiences 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 an unknown frequency (frequency cannot be estimated from the available data):

• reduction in the number of platelets in the blood (thrombocytopenia)
• reduction in hemoglobin, a substance that carries oxygen in the blood (anemia)
• reduction in the number of granulocytes in the blood, a type of white blood cell (agranulocytosis)
• liver function disorders
• inflammation of the liver (hepatitis)
• kidney disease (acute renal failure)
• inflammation of the kidneys (interstitial nephritis)
• presence of blood in the urine (hematuria)
• lack of urine production (anuria)
• 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, 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.