Paracetamol Mylan 120mg/5ml Syrup Oral Solution 120ml bottle

Paracetamol -based oral solution with antipyretic and analgesic action.

Therapeutic indications

Paracetamol Mylan Generics is used: - For the treatment of fever - For the treatment of moderate pain of various origins (headache, nerve pain, muscle pain). Talk to your doctor if you do not feel better or if you feel worse after 3 days of treatment.

Paracetamol Mylan is a medicine that works by relieving pain (analgesic action) and lowering the body temperature in case of fever (antipyretic action).

Dosage and posology

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

• Adults

The recommended dose is 20 ml at a time (corresponding to 480 mg), to be repeated if necessary after 4 hours, without exceeding 6 doses per day. The maximum recommended dose is 3,000 mg per day.

• Use in children and adolescents

For children it is essential to respect the recommended dose according to their body weight. Approximate ages as a function of body weight are given for information only. For children under three months, in case of jaundice (which occurs with yellowing of the skin and whites of the eyes), it is necessary to reduce the single dose. In the package you will find a measuring cup with indicated the level marks corresponding to the capacities of 2.5 ml, 5 ml and 10 ml;

Children weighing between 7 and 10 kg (approximately between 6 and 18 months): 5 ml at a time (corresponding to 120 mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding 4 doses per day.

Children weighing between 11 and 12 kg (approximately between 18 and 24 months): 5 ml at a time (corresponding to 120 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 doses per day.

Children weighing between 13 and 20 kg (approximately between 2 and 7 years): 7.5-10 ml at a time (corresponding respectively to 180 and 240 mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding the 4 administrations per day.

Children weighing between 21 and 25 kg (approximately between 6 and 10 years): 10 ml at a time (corresponding to 240 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 doses per day.

Children weighing between 26 and 40 kg (approximately between 8 and 13 years): 15-20 ml at a time (corresponding respectively to 360 and 480 mg of paracetamol), to be repeated if necessary after 6 hours, without exceeding 4 doses per day.

Boys weighing between 41 and 50 kg (approximately between 12 and 15 years): 20 ml at a time (corresponding to 480 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 doses per day.

Children weighing more than 50 kg (approximately over 15 years): 20 ml at a time (corresponding to 480 mg of paracetamol), to be repeated if necessary after 4 hours, without exceeding 6 doses per day.

To facilitate the calculation of the dose according to body weight, use the dosage ruler that you will find inside the package.

Overdose

If you accidentally take very large doses of this medicine the symptoms of intoxication are lack or decreased appetite, nausea and vomiting followed by marked worsening of your general condition; these symptoms usually appear within the first 24 hours. In case of overdose of this medicine, liver damage can occur which can become severely worse and lead to coma and death.

In addition, changes in the levels of various substances contained in the blood may occur in the 12-48 hours following ingestion (increase in hepatic transaminases, lactic dehydrogenase, and bilirubinemia and reduction in prothrombin levels). In case of accidental intake / ingestion of an excessive dose of this medicine, notify your doctor immediately or go to the nearest hospital emergency department.

Contraindications

Do not take Paracetamol Mylan Generics:

• if you are allergic to paracetamol or any of the other ingredients of this medicine
• if you have a severe blood disorder (haemolytic anemia)
• if you have severe liver problems.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. This medicine can cause the following side effects:

• red skin lesions that can 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)
• severe skin disease (epidermal necrolysis)
• allergic reactions such as rash with red skin or hives, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing and breathing (angioedema), swelling of the larynx, severe potentially fatal allergic reaction (anaphylactic shock)
• reduction in blood platelets (thrombocytopenia)
• reduction of white blood cells (leukopenia, agranulocytosis)
• reduction in red blood cells (anemia)
• liver problems (hepatitis, impaired liver function)
• kidney problems (reduced kidney function, interstitial nephritis, blood in the urine, decreased or no urine production) - stomach and bowel problems
• dizziness

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you are pregnant or breast-feeding, use this medicine only when clearly needed and always under the direct supervision of your doctor.

Special warnings

Talk to your doctor or pharmacist before taking Paracetamol Mylan Generics. If you experience allergic reactions after using this medicine, stop taking Paracetamol Mylan Generics and contact your doctor. Talk to your doctor first especially:

• if you have low levels of an enzyme known as glucose-6-phosphate dehydrogenase
• if you are taking other medicines: make sure that none of the other medicines you take contain paracetamol as the administration of high doses of paracetamol can cause serious side effects
• if you have kidney or liver problems or suffer from a condition called Gilbert's syndrome (a disease in which the liver produces more bilirubin than normal).
• In this case, the intake of Paracetamol Mylan Generics must be carried out only if actually necessary and under the direct supervision of the doctor.

Taking high doses and for long periods of Paracetamol Mylan Generics can cause serious damage to the liver, kidney and blood.

Paracetamol Mylan Generics contains sucrose and para-hydroxy benzoates. This medicine contains 42 g of sucrose. To be taken into consideration in people with diabetes mellitus and in patients on a low-sugar diet (hypocaloric diet). When the product is taken according to the recommended doses, 1 measuring spoon of 10 ml contains 3.5 g of sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicinal product contains para-hydroxy benzoates which may cause allergic reactions (including delayed).

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

100ml Paracetamol Mylan Generics Oral Solution contain:

Active principle

2.4 g of paracetamol.

Excipients

Sucrose, macrogol 6000, sodium citrate, anhydrous citric acid, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, strawberry / mandarin flavor, purified water.