ACEPIRO

Posology Adults: 600 mg acetylcysteine once daily.

Paediatric population:

Children aged 2 years and older, and adolescents The safety and efficacy of Acepiro in children aged 2 years and older, and adolescents, have not been established. 4). Duration of therapy Duration of therapy should be determined by the clinician, depending on the nature and severity of the condition Method of administration For oral use Before oral use the tablet should be dissolved in half a glass of water.

Acepiro should be taken after food. Hepatic and renal impairment Hepatic and renal impairment can reduce clearance and increase acetylcysteine plasma levels which may results in an increase in adverse drug reactions due to drug accumulation.

The following table shows undesirable effects after oral use of acetylcysteine according to system organ class (SOC). Undesirable effect System organ class Uncommon (>1/1,000 to <1/100) Rare (>1/10,000 to <1/1,000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Immune system disorders Hypersensitivity reactions Anaphylactic reactions, anaphylactic shock Nervous system disorders Headache Ear and labyrinth disorders Tinnitus Cardiac disorders Tachycardia1 Vascular disorders Haemorrhage1 Respiratory, thoracic and mediastinal disorders Dyspnoea2, bronchospasm1,2 Gastrointestinal disorders Stomatitis, abdominal pain, nausea, vomiting, diarrhoea Dyspepsia Skin and subcutaneous tissue disorders Pruritus1, urticaria1, exanthema1, rash1, angioedema1 Stevens- Johnson syndrome, Lyell syndrome General disorders and administration site conditions Pyrexia Facial oedema Investigations Lowered blood pressure1 1Associated with hypersensitivity reactions 2 Mainly in patients with a hyper-reactive bronchial system associated with asthma There have been very rare reports of the occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell’s syndrome with a temporal connection to acetylcysteine administration.

In the majority of these reported cases, at least one other pharmaceutical substance that may possibly have potentiated the mucocutaneous effects described was being taken. Therefore, medical advice should be sought promptly and administration of acetylcysteine stopped if new skin and mucous membrane changes occur.

Administration of acetylcysteine must be stopped immediately A decrease in platelet aggregation in the presence of acetylcysteine has been confirmed in various studies. The clinical significance of this has not yet been established.

In patients with peptic ulcer or a history thereof, acetylcysteine may have an undesirable effect on the gastric mucosa. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Acepiro should be used with caution in patients with asthma or a history of bronchospasm. Should bronchospasm occur, use should be discontinued immediately. Very rarely, serious skin reactions such as Stevens-Johnson syndrome and Lyell syndrome have been reported in temporal association with the use of acetylcysteine.

Patients should be advised to seek immediate medical advice if new skin or mucosal lesions occur and use should be discontinued as a precaution. g. elderly or frail patients). Particularly at the beginning of treatment, the volume of bronchial secretions may be increased due to liquefaction.

In patients unable to cough up bronchial secretions effectively, postural drainage and broncho-aspiration should be performed. 2). Not fully dissolved tablets present a risk of choking and aspiration, particularly to elderly patients.

This product should be used with caution by patients with bronchial asthma and patients with a history of peptic ulcer disease. Caution is required in patients with histamine intolerance. g. headache, runny nose, itching). Paediatric population Mucolytic medicinal products may obstruct the airways of children below 2 years of age, due to infant physiology.

The ability to cough up mucus may be limited. Mucolytic medicinal products must not be used in children under 2 years of age. The safety and efficacy is not established children aged 2 years and older and adolescents. Hepatic and renal impairment Hepatic and renal impairment can reduce clearance and increase acetylcysteine plasma levels which may results in an increase in adverse drug reactions due to drug accumulation.

94% of the WHO recommended maximum daily intake of 2 g sodium for an adult. This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. 4). Due to the high active substance content Acepiro must not be used in children and adolescents. Other strengths are available.