EFFERALGANMED 500 MG EFFERVESCENT TABLETS, 16 TABLETS

Name
EFFERALGANMED® 500 mg effervescent tablets
paracetamol


What is it and what is it for?
Symptomatic treatment of mild to moderate pain and febrile conditions in adults and children.
Symptomatic treatment of arthritic pain.


What you need to know before taking the medicine
Hypersensitivity to paracetamol or propacetamol hydrochloride (paracetamol precursor) or to any of the excipients.


Warnings and precautions
Paracetamol should be administered with caution to patients with mild to moderate hepatic impairment (including Gilbert's syndrome), severe hepatic impairment (Child-Pugh >9), acute hepatitis, concomitant treatment with drugs that alter liver function, glucose-6-phosphate dehydrogenase deficiency, haemolytic anaemia.
Paracetamol should be administered with caution in subjects with renal insufficiency (creatinine clearance ≤ 30 ml/min).
Use with caution in case of chronic alcoholism, excessive alcohol intake (3 or more alcoholic drinks per day), anorexia, bulimia or cachexia, chronic malnutrition (low hepatic glutathione reserves), dehydration, hypovolemia.
While taking paracetamol, before taking any other medicine, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions can occur.
Also, before combining any other medication, contact your doctor.
See also the "Interactions" section.

Do not administer for more than 10 consecutive days without consulting your doctor.
High or prolonged doses of the product can cause high-risk liver disease and alterations, even serious ones, affecting the kidneys and blood.
In case of prolonged use it is advisable to monitor liver and kidney function and blood count.
Do not administer during chronic treatment with drugs that can induce hepatic monooxygenases or in case of exposure to substances that can have this effect.
In case of allergic reactions, administration must be suspended.


Possible side effects
Like all medicines, EFFERALGANMED can cause side effects, although not everybody gets them.
Skin reactions of various types and severity have been reported with the use of paracetamol, including cases of erythema multiforme, Stevens-Johnson syndrome and epidermal necrolysis.
Hypersensitivity reactions such as angioedema, laryngeal edema, and anaphylactic shock have been reported. Additionally, the following adverse reactions have been reported: thrombocytopenia, leukopenia, anemia, agranulocytosis, liver function abnormalities and hepatitis, renal abnormalities (acute renal failure, interstitial nephritis, hematuria, anuria), gastrointestinal reactions, and dizziness.
The table below lists adverse reactions, some of which have already been previously reported, associated with the administration of paracetamol, resulting from post-marketing surveillance. The frequency of the adverse reactions reported below is unknown.

Blood and lymphatic system disorders	Thrombocytopenia Neutropenia Leukopenia
Gastrointestinal disorders	Diarrhea Abdominal pain
Alterations of the hepatobiliary system	Increased liver enzymes
Immune system alterations	Anaphylactic shock Quincke's edema Hypersensitivity reactions
Diagnostic investigations	Decrease in INR values Increased INR values
Alterations of the skin and subcutaneous tissue	Urticaria Erythema Rash
Alterations of the vascular system	and Hypotension (as a symptom of anaphylaxis)

In case of overdose, paracetamol can cause hepatic cytolysis, which can lead to massive and irreversible necrosis. Following the instructions in the package leaflet reduces the risk of side effects. If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.