ACETYLCYSTEINE Powder for oral solution Ref.[6059] Active ingredients: Acetylcysteine

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 sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

This medicine contains aspartame, which is a source phenylalanine. This may be harmful to people with phenylketonuria.

This medicine contains a colouring agent called sunset yellow (E110), which may cause allergic reactions.

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. Upon addition of water the solution will have a citrus odour.

Drug Interactions

Antitussive drugs and acetylcysteine should not be administered concomitantly because reducing the cough reflex may lead to a build-up of bronchial secretions.

Activated charcoal may reduce the effect of acetylcysteine.

It is advisable not to mix Acetylcysteine 200 mg Powder for Oral Solution with other medicinal products.

In vitro tests have shown that when cephalosporin antibiotics and acetylcysteine are mixed, there is a degree of antibiotic inactivation. It is precautionary to advise the administration of oral antibiotics at least two hours before or after acetylcysteine.

Concurrent administration of nitroglycerin and acetylcysteine causes significant hypotension and leads to temporal artery dilation with possible onset of headache.

If concurrent administration of nitroglycerin and acetylcysteine is required, patients should be monitored and warned for hypotension that can be severe and accompanied by a headache.

Pregnancy

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Acetylcysteine 200 mg Powder for Oral Solution during pregnancy.

Breastfeeding

There is insufficient information on the excretion of acetylcysteine in human milk. A risk to the newborns/infants cannot be excluded.

No studies on the effects on the ability to drive or use machines have been performed. Acetylcysteine 200 mg Powder for Oral Solution has no known effect on the ability to drive and use machines.

Adverse reactions are listed below, by system organ class and frequency.

Uncommon (≥1/1,000, <1/100)
Rare (≥1/10,000, <1/1,000)
Very rare (<1/10,000)
Not Known

Immune system disorders

Uncommon: Hypersensitivity

Very rare: Anaphylactic shock, anaphylactic/ anaphylactoid reaction

Nervous system disorders

Uncommon: Headache

Ear and labyrinth disorders

Uncommon: Tinnitus

Cardiac disorders

Uncommon: Tachycardia

Vascular disorders

Uncommon: Hypotension

Very rare: Haemorrhage

Respiratory, thoracic and mediastinal disorders

Rare: Bronchospasm, dyspnoea

Gastrointestinal disorders

Uncommon: Vomiting, diarrhoea, stomatitis, abdominal pain, nausea

Rare: Dyspepsia

Skin and subcutaneous tissue disorders

Uncommon: Urticaria, rash, angioedema, pruritus

General disorders and administration site conditions

Uncommon: Fever

Not Known: Oedema of the face

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 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.