NACSYS

Posology Adults 1 effervescent tablet of 600 mg once daily. Paediatric population Children older than 2 years of age and adolescents The safety and efficacy is not established in children aged 2 years and older and adolescents. 3). Method of administration Precautions to be taken before handling or administering the medicinal product.

For patients with a reduced cough reflex (elderly and weakened patients) are advised to take the effervescent tablet in the mornings. Dissolve NACSYS 600 mg effervescent tablets in half a glass of water. This produces a solution that may be consumed immediately.

3). Other forms and strengths of Acetylcysteine are more suitable for children >2 and adolescents.

The table below lists the undesirable effects recorded after systemic use of oral acetylcysteine according to system/organ class. 000 to <1/1,000) Very rare (<1/10,000) Not known Skin and subcutaneous tissue disorders Facial oedema General disorders and administration site conditions Pyrexia Investigations Low blood pressure A decrease in platelet aggregation in the presence of acetylcysteine has been confirmed in various studies.

The clinical significance of this has not been determined. *Hypersensitivity reactions include bronchospasm, dyspnoea, pruritus, urticaria, rash, angioedema and tachycardia. In patients with a peptic ulcer or peptic ulcer history, acetylcysteine may have an unfavourable effect on the gastric mucosa.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme.

uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Bronchospasms may occur with the use of acetylcysteine especially in patients with asthma. If bronchospasms occur, the medicinal product should be discontinued immediately. Caution is advised in patients with a history of peptic ulcer, especially when used concomitantly with other medicinal products known to irritate the mucous membrane of the gastrointestinal tract.

Serious skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome have very rarely been reported in temporal connection with the use of acetylcysteine. In most cases, at least one other suspect medicinal product, which was more likely the cause of the mucocutaneous syndrome could be identified.

If cutaneous or mucosal alterations newly occur, immediate medical advice should be sought and the treatment with acetylcysteine should be discontinued immediately. Bronchial secretions may become more fluid and increase in volume, in particular at the start of the treatment with acetylcysteine.

When a patient is unable to cough up the secretions effectively, postural drainage and bronchoaspiration should be performed. Paediatric population Mucolytic drugs may obstruct the airways of children under 2 years of age, due to the physiological characteristics of the airways in this age group.

The ability to cough up mucus may be limited. Therefore, mucolytic drugs should not be used in children under 2 years of age. The safety and efficacy is not established in children aged 2 years and older and adolescents. A mild sulfur odour does not indicate a change in the medicinal product, but is a property of the active substance itself.

75% of the WHO recommended maximum daily intake of 2g for an adult.

1. - The tablets should not be used by children under 2 years of age.