PARACETAMOL EG "500 MG TABLETS" 20 TABLETS IN PVC/AL BLISTER"

Name
PARACETAMOL EG 500 mg tablets


What is it and what is it for?
PARACETAMOLO EG contains the active ingredient paracetamol, which acts as an analgesic (pain reliever) and antipyretic (fever reducer).
PARACETAMOL 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.

Contact your doctor if you need PARACETAMOL EG for more than 3 consecutive days.


What you need to know before taking the medicine
Do not take PARACETAMOL 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 failure).


Warnings and precautions
Talk to your doctor or pharmacist before taking PARACETAMOL EG:
- if your kidneys are not working well (renal failure);
- if your liver is not working well (liver failure);
- if you suffer from liver disease (Gilbert's syndrome and hepatitis);
- if you have a serious infection (sepsis), as it may increase the risk of metabolic acidosis (increased acid production by the body). Signs of metabolic acidosis may include:
- deep, rapid, labored breathing;
- nausea, vomiting;
- loss of appetite.
If you experience a combination of these symptoms, contact your doctor immediately.

Take special care with PARACETAMOLO EG:
- if the symptoms of your illness do not improve after 3 days, ask your doctor for advice;
- if you experience an allergic reaction: in this case, stop treatment and contact your doctor;
- if you have been diagnosed with glucose-6-phosphate dehydrogenase deficiency;
- if you suffer from haemolytic anaemia (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 drink excessive amounts of alcohol (3 or more alcoholic drinks a 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.

While taking Paracetamol EG, tell your doctor immediately if:
- suffer from 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.

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

Do not take more Paracetamol EG than recommended . A higher dose does not increase pain relief; instead, it may 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 Paracetamol EG than recommended.

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

As a rule, habitual use of painkillers, especially a combination of several painkillers, can lead to permanent kidney damage with the risk of kidney failure (painkiller nephropathy).

Suddenly stopping paracetamol after prolonged use may cause headache, fatigue, muscle pain, nervousness, dizziness, or fainting. These symptoms resolve within a few days. In the meantime, avoid taking other painkillers, which should be resumed only under medical advice.

You should not take PARACETAMOL EG for prolonged periods or at 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 1,000 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 skin 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 serious skin reactions (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported.

Not known (frequency cannot be estimated from the available data)
- liver diseases (hepatitis, liver failure, liver necrosis);
- yellowing of the eyes (jaundice);
- impaired liver function;
- diarrhea;
- nausea (feeling sick);
- vomit;
- gastrointestinal disorders;
- dizziness;
- laryngeal edema;
- anaphylactic shock;
- asthma;
- alterations 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 cell (agranulocytosis);
- 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).

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.