EFFERALGANMED*16 effervescent tablets 500mg

EFFERALGANMED ADULTI 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 (e.g., those associated with influenza, respiratory tract illnesses);
- the symptomatic treatment of mild to moderate pain of various origins and natures (e.g., headache, neuralgia, myalgia, and other moderate painful manifestations).

Consult your doctor if you/your child do not feel better or if you feel worse.

What you need to know before taking the medicine
Do not take/give EFFERALGANMED to your child
- if you and/or your child are allergic to paracetamol or propacetamol hydrochloride (a precursor to paracetamol) or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions
Use caution and talk to your doctor or pharmacist before taking/giving EFFERALGANMED to your child if:
- you chronically or excessively consume alcohol (3 or more alcoholic drinks per day)
- you and/or your child suffer from anorexia (an eating disorder characterized by a lack or reduction of appetite)
- you and/or your child suffer from bulimia (an eating disorder where a person ingests an excessive amount of food and then resorts to various methods to eliminate it to avoid gaining weight, such as vomiting, using laxatives, purges, fasting, and intense physical exercise)
- you and/or your child suffer from cachexia (a condition characterized by extreme thinness, reduced muscle mass, and thinning skin due to chronic illnesses)
- you and/or your child suffer from chronic malnutrition
- you and/or your child suffer from dehydration (severe loss of water/fluids from the body)
- you and/or your child suffer from hypovolemia (reduced blood volume in circulation, which is the most common cause of hypotension, low blood pressure)
- you and/or your child suffer from mild/moderate reduced liver function (including Gilbert's syndrome, a disease characterized by excessive bilirubin production, a substance that causes a yellowish discoloration of the skin and eyes)
- you and/or your child suffer from severe liver problems
- you and/or your child suffer from acute hepatitis, an inflammation that causes the death of liver cells
- you and/or your child are taking medicines that alter liver function
- you and/or your child suffer from glucose-6-phosphate dehydrogenase deficiency (a substance normally present in the human body, whose deficiency can cause hemolytic anemia)
- you and/or your child suffer from hemolytic anemia, a disease due to the destruction of certain blood cells, red blood cells
- you and/or your child suffer from kidney problems.

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

If you/your child experience allergic reactions while taking EFFERALGANMED, stop treatment with this medicine (see section 4).

Children and adolescents
This medicine can be given to children (weighing over 13 kg) and adolescents.

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

If you/your child experience the following side effects, STOP treatment with this medicine and contact your doctor immediately:
• allergic reactions:
- laryngeal edema (swelling of the throat)
- angioedema (swelling of the hands, feet, ankles, face, lips, tongue, and/or throat) - anaphylactic shock (severe allergic reaction).

Additionally, you/your child may experience the following side effects, for which there is not enough data to establish the frequency.

Effects on the blood
• 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)

Effects on the nervous system
• dizziness

Effects on the stomach and intestines
• diarrhea
• abdominal pain

Effects on the liver
• abnormal liver function
• hepatitis (inflammation of the liver)
• increased liver enzymes

Effects on the skin and tissue under the skin
• erythema multiforme (a condition characterized by the appearance of red spots on the skin with a bull's-eye appearance associated with itching)
• Stevens-Johnson syndrome/epidermal necrolysis (severe skin lesions characterized by erythema, bullous lesions with areas of skin detachment)
• urticaria (appearance of wheals on the skin accompanied by itching)
• erythema (redness of the skin)
• rash (skin eruption)

Effects on the kidneys and urinary tract
• acute renal failure (reduction of kidney function)
• interstitial nephritis (inflammation of the kidneys)
• hematuria (blood in the urine)
• anuria (cessation or reduction of urine production by the kidney)

Effects on the vascular system
• hypotension (low blood pressure), as a symptom of a severe allergic reaction

Diagnostic investigations
• decrease in INR value, an index used to express the time it takes for blood to clot
• increase in INR value, an index used to express the time it takes for blood to clot

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.