ACECIL

Posology Adults 600 mg (1 effervescent tablet) once daily. 3). Children 2 years of age and older, and adolescents The safety and efficacy is not established in children aged 2 years and older and adolescents. Other forms and strengths of acetylcysteine are more suitable for these patient groups.

Method of administration Administer the required dose by dissolving an effervescent tablet in half a glass of water, to obtain a solution which can be ingested directly. Patients with a muffled cough reflex (elderly and debilitated patients) are advised to take the tablet in the morning.

In below table adverse effects after systemic use of oral acetylcysteine are indicated according to organ class. 000) Not known Immune system disorders Hypersensitivity reactions* Anaphylacti c shock, anaphylacti c/ anaphylatoi d reactions Nervous system disorders Headache Ear and labyrinth disorders Tinnitus Vascular disease Haemorrhag e Gastrointestinal disorders Stomatitis, abdominal pain, nausea, vomiting, diarrhoea Dyspepsia Skin and subcutaneous tissue disorders Facial oedema General disorders and administration site disorders Pyrexia Investigations Hypotension * Hypersensitivity reactions include bronchospasm, dyspnoea, pruritus, urticarial, rash, angioedema and tachycardia.

A decrease in platelet aggregation in the presence of acetylcysteine is confirmed in several studies. The clinical significance of this is not yet established. In patients with 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

In very rare cases, the occurrence of serious skin reactions such as Stevens- Johnson syndrome and Lyell's syndrome have been reported when acetylcysteine was used in the same time period. In most cases at least one co suspected drug could be identified, which was more likely the cause of the mucocutaneous syndrome.

If new skin or mucosal changes are seen immediate medical advice should be sought and treatment with acetylcysteine should be discontinued. Mainly at the beginning of the treatment with acetylcysteine bronchial secretion can become fluid and increase in volume.

When a patient is unable to effectively cough up the secretions, postural drainage and broncho- aspiration have to be performed. AceCil 600 mg Effervescent Tablets are sugar-free and can therefore be used by diabetics. 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Caution is advised in patients on a controlled sodium diet. In homozygous patients with phenylketonuria the amount of phenylalanine supplied by aspartame in this product should be taken into account in their dietary prescription. Paediatric population Mucolytics can block the airways of children under the age of 2 due to physiological characteristics of the respiratory system in this age group.

The ability to cough up mucus may be limited. Therefore mucolytics should not be used in children younger than 2 years. The safety and efficacy is not established in children aged 2 years and older and in adolescents. 2). Not fully dissolved tablets present a risk of choking and aspiration, particularly to elderly patients.

1. The tablets should not be used in children under 2 years of age. The tablets should not be used in children and pregnant women with phenylketonuria.