ACETAMOL ADULTS 1 G SUPPOSITORIES 10 SUPPOSITORIES

Name
ACETAMOL ADULTS 1 g suppositories
ACETAMOL 500 mg suppositories
ACETAMOL CHILDREN 250 mg suppositories
ACETAMOL EARLY CHILDHOOD 125 mg suppositories
Paracetamol


What is it and what is it used for?
ACETAMOL is a medicine based on paracetamol.
ACETAMOL is used to treat the symptoms of fever and mild to moderate pain in children (see section "How to use/give ACETAMOL to your child"), adolescents and adults .

Contact 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 with other medicines containing paracetamol. If paracetamol is taken in high doses, serious side effects may occur, including severe liver disease and changes to the kidneys and blood.

Do not use/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 used to treat pain (analgesics) and to reduce fever (antipyretics);
- together with other medicines containing the same active ingredient because, if paracetamol is taken in high doses, serious side effects may occur (see section "Other medicines and ACETAMOL").


Warnings and precautions
Talk to your doctor or pharmacist before using/giving ACETAMOL to your child.
While taking ACETAMOL, tell your doctor immediately if:
• has pain or fever whose cause is uncertain;
• suffers from kidney disease (renal failure);
• suffer from liver disease, even severe ones (severe liver failure, acute hepatitis, mild to moderate hepatocellular insufficiency - including Gilbert's syndrome);
• are taking medicines that change the way your liver works;
• suffers from a deficiency of an enzyme called glucose-6-phosphate dehydrogenase (a hereditary disease that leads to a lowering of the red blood cell count);
• suffers from a disease caused by the destruction of some blood cells, the red blood cells (hemolytic anemia);
• suffers from a chronic inflammatory disease with difficulty breathing (asthma);
• fasts, eats little, or abuses alcohol. In this case, the recommended dosages must be reduced to avoid toxicity even at the normal recommended doses (see the section "ACETAMOL with food, drinks, and alcohol");
• you 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");
• has suffered from breathing difficulties due to a reduction in the width of the airways (bronchospasm) following the intake of acetylsalicylic acid or anti-inflammatory medicines (aspirin, NSAIDs);
• are taking other medicines (see section "Other medicines and ACETAMOL").

If you have serious illnesses, including severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients with these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties with rapid, deep breathing, drowsiness, nausea, and vomiting.

Prolonged use or excessive doses of this medicine can cause liver disease, kidney problems or blood problems, even serious ones.

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

Children and adolescents
Consult your doctor before giving this 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 experiences allergic reactions, even serious 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 an unknown frequency (the frequency cannot be estimated from the available data):
• a serious condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2);
• reduction in the number of platelets in the blood (thrombocytopenia);
• reduction of hemoglobin, the substance that carries oxygen in the blood (anemia);
• reduction 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);
• failure to produce urine (anuria);
• hemorrhage (bleeding);
• abdominal pain;
• diarrhea;
• nausea;
• vomit;
• dizziness.

Side effects with very rare frequency:
• condition characterized by the appearance of red spots on the skin with a "bull's eye" appearance associated with itching (erythema multiforme);
• serious skin disease characterized by erythema, bullous lesions with areas of skin detachment (Stevens-Johnson syndrome);
• serious 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 experience 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.