PARACETAMOL EG*20CPR 500MG

PARACETAMOLO EG 500 mg tablets

What it is and what it is used for
PARACETAMOLO EG contains the active ingredient paracetamol, which acts as an analgesic (pain reliever) and antipyretic (fever reducer).
PARACETAMOLO EG is used to relieve mild to moderate pain (headache, toothache, neuralgia, menstrual pain) and fever in adults and children aged 11 years and over and/or weighing more than 33 kg.

Consult your doctor if you need PARACETAMOLO EG for more than 3 consecutive days.

What you need to know before taking the medicine
Do not take PARACETAMOLO EG
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
- if you have severe kidney problems (severe renal insufficiency).

Warnings and precautions
Consult your doctor or pharmacist before taking PARACETAMOLO EG:
• if your kidneys are not working properly (renal insufficiency);
• if your liver is not working properly (hepatic insufficiency);
• if you suffer from liver diseases (Gilbert's syndrome and hepatitis);
• if you have a severe infection (sepsis), as this may increase the risk of metabolic acidosis (increased production of acids by the body). Signs of metabolic acidosis may include:
- deep, rapid, difficult breathing;
- nausea, vomiting;
- loss of appetite.
If a combination of these symptoms appears, contact your doctor immediately.

Pay particular attention with PARACETAMOLO EG:
- if your symptoms do not improve after 3 days, ask your doctor for advice;
- if you experience an allergic reaction: in this case, stop the treatment and contact your doctor;
- if you have been diagnosed with glucose-6-phosphate dehydrogenase deficiency;
- if you suffer from hemolytic anemia (reduction in the number of red blood cells);
- if you suffer from eating disorders (anorexia or bulimia);
- if you suffer from chronic malnutrition and cachexia (weight loss);
- if you consume excessive alcohol (3 or more alcoholic beverages per day);
- if you are addicted to alcohol (chronic alcoholism); in these cases the daily dose should not exceed 2 grams;
- if you suffer from dehydration;
- do not take other medicines containing paracetamol at the same time: if paracetamol is taken in high doses or for a long time, it can seriously damage the liver, kidneys and blood;
- do not take a higher dose than recommended, as it can cause serious liver damage, which may require a liver transplant or lead to death.

Do not use paracetamol frequently for a long period of time: prolonged use can cause liver problems. Consult your doctor or pharmacist if you intend to take paracetamol for a longer period of time.

Do not take more PARACETAMOLO EG than recommended. A higher dose does not increase pain relief; instead, it can cause serious liver damage. Symptoms of liver damage appear after a few days. It is therefore important that you contact your doctor as soon as possible if you have taken more PARACETAMOLO EG than recommended.

Following incorrect, prolonged use of high-dose analgesics, a headache that cannot be treated with higher doses of this medicine may occur.

Normally, habitual use of analgesics, especially a combination of several analgesic substances, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy).

The sudden discontinuation of paracetamol after prolonged use can lead to the appearance of headache, fatigue, muscle pain, nervousness, dizziness or fainting. These symptoms resolve within a few days. In the meantime, avoid taking other analgesics, which should only be resumed after medical advice.

You should not take PARACETAMOLO EG for prolonged periods or in high doses without first consulting your doctor or dentist.

Children and adolescents
In children treated with 60 mg/kg/day of paracetamol, the combination with another antipyretic is not justified unless the treatment is ineffective.

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

Rare side effects (may affect up to 1 in 1000 people)
hives
itching
sweating
small bleeding under the skin (purpura)
reduction in the number of platelets (thrombocytopenia)
reduction in the number of red blood cells (anemia)
decreased production of blood cells (bone marrow depression)
allergic reactions (hypersensitivity reactions including rash and angioedema with symptoms such as swelling of the face, lips, throat and tongue)
gastrointestinal bleeding (hemorrhage)
swelling (edema)
inflammation of the pancreas (pancreatitis)
kidney disorders (nephropathies and tubular disorders)
pancreatic disorders

Very rare cases of severe skin reactions have been reported (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis).

Not known (frequency cannot be estimated from the available data)
liver diseases (hepatitis, liver failure, liver necrosis)
yellowing of the eyes (jaundice)
altered liver function
diarrhea
nausea (feeling of sickness)
vomiting
gastrointestinal disorders
dizziness
laryngeal edema
anaphylactic shock
asthma
changes in kidney function (acute renal failure)
inflammation of the kidneys (interstitial nephritis)
blood in the urine (hematuria)
reduced urine production (anuria)
reduction in the number of white blood cells (leukopenia)
reduction of a type of white blood cells (agranulocytosis)

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.