PARACETAMOL MY "120 MG/5 ML ORAL SOLUTION" 1 BOTTLE OF 120 ML"

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


What is it and what is it 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:
- treatment of fever
- the treatment of moderate pain of various origins (headache, nerve pain, muscle pain).

Talk to your doctor if you or your child does not feel better or if you 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 serious blood disease (haemolytic anaemia)
- if you suffer from severe liver problems (hepatocellular insufficiency).


Warnings and precautions
Talk to 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 contact your doctor.

Talk to your doctor before using Paracetamol Mylan Generics in particular:
- if the person taking the medicine uses alcohol chronically or excessively (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 in which a person eats excessive amounts 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 thinness, reduced muscle mass and thinning of the skin due to chronic diseases)
- if the person taking the medicine has been following 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 glucose-6-phosphate dehydrogenase levels
- 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 (liver failure, hepatitis, Gilbert's syndrome - a disease in which 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 of Paracetamol Mylan Generics for long periods can cause 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, tell your doctor if you have 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 taking this medicine and contact your doctor immediately :
- allergic reactions with: skin rash with redness of the skin or hives
- swelling of the larynx
- swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema)
- severe, potentially fatal allergic reaction (anaphylactic shock)
Furthermore, those taking the medicine may experience the following side effects, for which there are not enough data to establish the frequency.
- red skin lesions that may affect the mouth and other areas of the body (erythema multiforme)
- rare skin condition with severe blistering and bleeding of the lips, eyes, mouth, nose, and genitals (Stevens-Johnson syndrome)
- serious skin disease (toxic epidermal necrolysis)
- reduction of platelets in the blood (thrombocytopenia)
- reduction of white blood cells in the blood (leukopenia, agranulocytosis)
- reduction in red blood cells (anemia)
- liver problems (hepatitis, reduced liver function)
- kidney problems (reduced kidney function, interstitial nephritis, blood in the urine, reduced or no urine production) - blood in the urine (hematuria)
- cessation or reduction in urine production (anuria)
- stomach and intestinal problems
- dizziness.

Very rare cases of serious skin reactions have been reported.

Reporting of side effects
If you experience 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.