EFFERALGANMED*16FC TAB 500MG

Efferalganmed 500 mg effervescent tablets
Paracetamol

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

Efferalganmed is used in adults, adolescents and children weighing over 13 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 Efferalganmed
• if the person taking the medicine is allergic to paracetamol or propacetamol hydrochloride (a precursor of paracetamol) or any of the other ingredients of this medicine (listed in paragraph 6).

Warnings and precautions
Use caution and consult your doctor or pharmacist before using Efferalganmed if the person taking the medicine:
• chronically uses alcohol. Alcohol consumption during therapy is not recommended.
• suffers from anorexia (an eating disorder characterized by lack or reduction of appetite)
• suffers 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)
• suffers from cachexia (a condition characterized by extreme thinness, reduction of muscle mass, and thinning of the skin due to chronic diseases)
• suffers from chronic malnutrition
• suffers from dehydration (severe loss of water/fluids from the body)
• suffers from hypovolemia (reduced blood volume circulating in the body)
• suffers from mild/moderate reduction in liver function (including Gilbert's syndrome, a disease characterized by excessive production of bilirubin, a substance that causes yellowing of the skin and eyes)
• suffers from severe liver problems
• is affected by acute hepatitis (acute inflammation of the liver)
• is taking medicines that stimulate liver enzymes (increase the way the liver works)
• suffers from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, the deficiency of which can cause hemolytic anemia)
• suffers from hemolytic anemia (a disease due to the destruction of certain blood cells, red blood cells)
• suffers from kidney failure (kidney diseases).

Paracetamol can cause severe skin reactions that can be fatal. The use of Efferalganmed should be stopped 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 alterations affecting the kidney and blood. 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 13 kg and adolescents (see paragraph 3 How to use Efferalganmed).

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 which 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)
- purpura (appearance of purple skin patches of different sizes)
- Stevens-Johnson syndrome (a severe form of erythema multiforme)
- epidermal necrolysis (a 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 all over the body)
• allergic reactions which may manifest as
- laryngeal oedema (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).

In addition, the following side effects may occur, for which there are insufficient 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 renal failure (reduced kidney function)
• interstitial nephritis (inflammation of the kidneys)
• hematuria (blood in the urine)
• anuria (cessation or reduction of urine production by the kidney)

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.