ACETYLCYSTEINE

Posology Adults and adolescents over the age of 12 years: 200 mg (1 sachet) 3 times a day. Maximum recommended daily dose 600 mg/day. The duration of therapy is dependent on the nature and severity of the illness and should be decided by the doctor treating the patient for adults and adolescents.

Abundant fluid intake supports the mucolytic effect of acetylcysteine.

Children under 12 years old:

Children under 12 years of age cannot take this medicine. There are other presentations more suitable for this population. Method of administration Empty the contents of one sachet into a glass containing 150 ml of water and stir using a teaspoon until it dissolves completely (within 5 minutes).

It is important to drink all of the mixture. This medicine can be taken with or without food. Concomitant intake of the medicine with food does not affect its effectiveness. If the patient does not improve or worsens after 5 days of treatment, the clinical situation should be evaluated.

Adverse reactions are listed below, by system organ class and frequency. Frequency/Adverse ReactionsSystem Organ Class Uncommon (≥ 1/1,000, < 1/100) Rare (≥ 1/10,000, < 1/1,000) Very rare (< 1/10,000) Not known Immune system disorders Hypersensitivity Anaphylactic shock, anaphylactic/ anaphylactoid reaction Nervous system disorders Headache Sleepiness Ear and labyrinth disorders Tinnitus Cardiac disorders Tachycardia Vascular disorders Haemorrhage Respiratory, thoracic and mediastinal disorders Bronchospasm, dyspnoea Gastrointestinal disorders Vomiting, diarrhoea, stomatitis, abdominal pain, nausea Dyspepsia Skin and subcutaneous tissue disorders Urticaria, rash, angioedema, pruritus General disorders and administration site conditions Fever Oedema of the face Additional explorations Hypotension The occurrence of serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in temporal association with the use of acetylcysteine.

In most of these cases reported, at least one other drug was administered at the same time, which may have possibly enhanced the described mucocutaneous effects. In case of recurrence of skin and mucosal lesions, medical advice should be sought at once and the use of acetylcysteine terminated immediately.

A decreased blood platelet aggregation in the presence of acetylcysteine has been confirmed by various studies. The clinical relevance has not yet been clarified to date. 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.

Mucolytic agents may induce respiratory obstruction in children under 2 years of age. Due to the physiological characteristics of the airways in this age group, expectoration capacity may be limited. 3 Contraindications). Patients with bronchial asthma should be closely monitored during therapy; if bronchospasm occurs, treatment with Acetylcysteine 200 mg Powder for Oral Solution should be discontinued immediately.

Administration of acetylcysteine, especially at the beginning of treatment, may liquefy bronchial secretions and, at the same time, increase their volume. If the patient is unable to expectorate efficiently, to avoid retention of secretions postural drainage and tracheal suction should be used.

There are no studies on the efficacy and safety of acetylcysteine 200 mg three times daily in adolescent population. However, mild to severe adverse reactions have been reported with the use of IV acetylcysteine in adults and adolescents.

This medicine contains sucrose and lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains less than 1 mmol sodium (23 mg) per, that is to say, essentially ‘sodium-free’.

Acetylcysteine can cause interference with the colorimetric assay method for the determination of salicylates. Acetylcysteine can interfere with tests for ketones in urine. Upon opening the sachet, the powder may smell of sulphur (rotten egg smell).

This is a normal characteristic of the active substance. Caution is recommended in the use of the product in patients with peptic ulcer or a history of peptic ulcer, especially in concomitant administration with other drugs with known effect of irritation of gastric mucosa.

If the appearance of gastric discomfort is observed, the clinical situation should be reevaluated. Acetylcysteine can affect histamine metabolism in a moderate way, therefore it should be administered with caution in long-term treatment in patients with histamine intolerance, since symptoms of intolerance (headache, vasomotor, rhinitis, pruritus) may occur.

1, is present. • Do not administer to children under 2 years of age.