EFFERALGAN*30COATED TABLETS 500MG

Efferalgan 500 mg tablets
Paracetamol

What it is and what it is used for
Efferalgan contains the active ingredient paracetamol, which acts by relieving pain (analgesic) and reducing fever (antipyretic).

Efferalgan is used in adults, adolescents, and children weighing over 26 kg for:
• the treatment of symptoms of febrile conditions;
• the symptomatic treatment of mild to moderate pain.

Consult your doctor if the person taking the medicine does not feel better or feels worse after 3 days of treatment.

What you need to know before taking the medicine
Do not use Efferalgan
• if the person taking the medicine is allergic to paracetamol or propacetamol hydrochloride (a precursor of paracetamol) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Use caution and consult your doctor or pharmacist before using Efferalgan. During treatment with Efferalgan, immediately inform your doctor if:
• you chronically consume alcohol. Alcohol consumption during therapy is not recommended;
• you suffer from anorexia (an eating disorder characterized by a lack or reduction of appetite);
• you suffer from bulimia (an eating disorder in which a person ingests an excessive amount of food and then resorts to various methods to eliminate it to avoid gaining weight);
• you suffer from cachexia (a state characterized by extreme thinness, reduction of muscle mass, and thinning of the skin due to chronic diseases);
• you suffer from chronic malnutrition;
• you suffer from dehydration (severe loss of water/fluids from the body);
• you suffer from hypovolemia (reduced blood volume circulating in the body);
• you suffer from mild/moderate reduction in liver function (including Gilbert's syndrome, a disease characterized by excessive production of bilirubin, a substance that causes a yellowish discoloration of the skin and eyes);
• you suffer from severe liver problems;
• you have acute hepatitis (acute inflammation of the liver);
• you are taking medicines that stimulate liver enzymes (increase the way the liver works);
• you suffer from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, whose deficiency can cause hemolytic anemia);
• you suffer from hemolytic anemia (a disease due to the destruction of certain blood cells, red blood cells);
• you suffer from kidney failure (kidney diseases);
• prolonged fasting;
• you suffer from severe diseases, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients in these situations, a severe condition called metabolic acidosis (an abnormality of blood and fluids) has been reported when paracetamol is used at regular doses for 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.

Paracetamol can cause severe skin reactions that can be fatal.
The use of Efferalgan should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity/allergy.

Use of high doses and/or for prolonged periods
The use of high or prolonged doses of this medicine can cause severe liver disorders and even severe kidney and blood alterations. In these cases, the doctor will monitor liver and kidney function and blood composition through appropriate tests.

Prolonged use of analgesics (for more than 3 months) in patients with chronic headache, especially if repeated and frequent, can increase or worsen the headache. In these cases, it is necessary to consult a doctor.

Children and adolescents
This medicine can be given to children weighing over 26 kg and adolescents (see paragraph 3 How to use Efferalgan).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the person taking the medicine experiences the following side effects, STOP treatment with this medicine and contact your doctor immediately:
• skin reactions that may manifest as:
- urticaria (appearance of hives on the skin accompanied by itching);
- skin rash;
- erythema (redness of the skin);
- erythema multiforme (appearance of red spots on the skin with a bull's-eye appearance associated with itching);
- Stevens-Johnson syndrome (a severe form of erythema multiforme);
- epidermal necrolysis (severe skin disease characterized by redness, blistering lesions with areas of detachment and death of the skin);
- acute generalized exanthematous pustulosis (eruption of hundreds of superficial pustules spread over the entire body);
- fixed drug eruption (red/purplish skin eruption).

• allergic reactions that may manifest as:
- laryngeal edema (swelling of the throat);
- angioedema (swelling of hands, feet, ankles, face, lips, tongue and/or throat);
- anaphylactic reaction (severe allergic reaction) including hypotension (low blood pressure);
- hypersensitivity;
- anaphylactic shock (severe allergic reaction);
- bronchospasm (excessive and prolonged contraction of the airway muscles causing breathing difficulties)

In addition, the following side effects may occur, for which there are not enough data to establish the frequency:
• thrombocytopenia (reduction in the number of platelets in the blood);
• leukopenia/agranulocytosis/neutropenia (reduction in the number of white blood cells in the blood);
• anemia (reduction of hemoglobin in the blood, a substance that carries oxygen in the blood);
• diarrhea;
• abdominal pain;
• stomach and intestinal reactions;
• abnormal liver function;
• hepatitis (inflammation of the liver);
• altered INR (value used to express the time it takes for blood to clot);
• increased liver enzymes;
• headache;
• dizziness;
• acute kidney failure (reduced kidney function);
• interstitial nephritis (kidney inflammation);
• hematuria (blood in the urine);
• anuria (cessation or reduction of urine production by the kidney);
• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a severe disease who use paracetamol (see paragraph 2) with unknown frequency (frequency cannot be defined based on available data).

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.