PARACETAMOL MY*120MG/5ML120ML

Paracetamol Mylan Generics 120 mg/5 ml oral solution
Equivalent Medicine

What it is and what it is used for
This medicine contains the active ingredient paracetamol, which works by relieving pain (analgesic action) and lowering body temperature in case of fever (antipyretic action).

Paracetamol Mylan Generics is used in adults, adolescents, and children weighing 7 kg or more for:
- the treatment of fever
- the treatment of moderate pain of various origins (headache, nerve pain, muscle pain).

Consult your doctor if you or your child do not feel better or feel worse after 3 days of treatment.

What you need to know before taking the medicine
Do not use Paracetamol Mylan Generics
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
- if you suffer from a severe blood disorder (haemolytic anaemia)
- if you suffer from severe liver disorders (hepatocellular insufficiency).

Warnings and precautions
Consult your doctor or pharmacist before using Paracetamol Mylan Generics.

If you experience allergic reactions after using this medicine, stop treatment with Paracetamol Mylan Generics and consult your doctor.

Consult your doctor before using Paracetamol Mylan Generics, in particular:
- if the person taking the medicine chronically or excessively consumes alcohol (3 or more alcoholic drinks per day)
- if the person taking the medicine suffers from anorexia (an eating disorder characterized by lack or reduction of appetite)
- if the person taking the medicine suffers from bulimia (an eating disorder where a person ingests an excessive amount of food and then resorts to various methods to eliminate it)
- if the person taking the medicine suffers from cachexia (a condition characterized by extreme emaciation, reduction of muscle mass, and thinning of the skin due to chronic diseases)
- if the person taking the medicine has followed an incorrect diet for a long time (chronic malnutrition)
- if the person taking the medicine suffers from dehydration (severe loss of water/fluids from the body)
- if the person taking the medicine suffers from hypovolemia (reduced blood volume in circulation)
- if the person taking the medicine has low levels of glucose-6-phosphate dehydrogenase
- if you are taking other medicines (see section "Other medicines and Paracetamol Mylan Generics"): make sure that none of the other medicines you are taking contain paracetamol, as the administration of high doses of paracetamol can cause serious side effects.
- if the person taking the medicine has liver problems (hepatic insufficiency, hepatitis, Gilbert's syndrome - a condition where the liver produces more bilirubin than normal).
- if the person taking the medicine suffers from haemolytic anaemia (destruction of red blood cells).

Use of high doses and/or for prolonged periods
Taking high doses and for long periods of Paracetamol Mylan Generics can cause even serious damage to the liver, kidneys, and blood. In this case, your doctor will monitor liver and kidney function and blood composition over time through appropriate tests. Before using this medicine, inform your doctor if the person taking the medicine suffers from kidney or liver disease.

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

If you or your child experience the following side effects, STOP treatment with this medicine and contact your doctor immediately:
- allergic reactions with: skin rash with skin redness or hives
- swelling of the larynx
- swelling of the face, lips, mouth, tongue or throat that may cause difficulty swallowing and breathing (angioedema)
- severe potentially fatal allergic reaction (anaphylactic shock)
Furthermore, the person taking the medicine might experience the following side effects, for which there is not enough data to establish the frequency.
- red skin lesions that may affect the mouth and other areas of the body (erythema multiforme)
- a rare skin condition with severe blistering and bleeding of the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome)
- severe skin disease (toxic epidermal necrolysis)
- reduction of platelets in the blood (thrombocytopenia)
- reduction of white blood cells in the blood (leukopenia, agranulocytosis)
- reduction of red blood cells (anaemia)
- liver problems (hepatitis, reduced liver function)
- kidney problems (reduced kidney function, interstitial nephritis, blood in the urine, reduced or absent urine production) - blood in the urine (haematuria)
- cessation or reduction of urine production (anuria)
- stomach and intestinal problems
- dizziness.

Very rare cases of severe skin reactions have been reported.

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.