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ACETYLCYSTEINE Powder for oral solution (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Acetylcysteine 200 mg Powder for Oral Solution.

Qualitative and quantitative composition

Each sachet contains Acetylcysteine 200 mg. Excipient(s) with known effect: Aspartame (E95l): 26 mg per sachet Sorbitol (E420): 723.34 mg per sachet Sunset yellow (El10): 0.66 mg per sachet For the full ...

Pharmaceutical form

Powder for oral solution. White to slightly pink powder.

Therapeutic indications

Mucolytic adjuvant in the therapy of respiratory disorders associated with thick, viscous, mucus hypersecretion.

Posology and method of administration

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 ...

Contraindications

Acetylcysteine 200 mg Powder for Oral Solution must not be used when: Hypersensitivity to the active substance, other chemically similar substance (for example carbocisteine, erdosteine or mecysteine) ...

Special warnings and precautions for use

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 ...

Interaction with other medicinal products and other forms of interaction

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 ...

Pregnancy and lactation

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 ...

Effects on ability to drive and use machines

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.

Undesirable effects

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 ...

Overdose

An acute overdose of acetylcysteine can cause gastrointestinal symptoms such as nausea, vomiting and diarrhoea. Treatment of Overdose Treatment of overdose is to be symptomatic and supportive treatment ...

Pharmacodynamic properties

Pharmacotherapeutic group: Mycolytics ATC code: R05CB01 N-acetyl-L-cysteine (NAC), the active ingredient in Acetylcysteine 200 mg Powder for Oral Solution exerts an intense mucolytic-fluidizing action ...

Pharmacokinetic properties

Absorption Following oral administration, acetylcysteine is rapidly and almost completely absorbed and metabolised in the liver to cysteine (the pharmacologically active metabolite), diacetylcysteine, ...

Preclinical safety data

Acute toxicity studies in rats and mice, by oral, intraperitoneal and intravenous administration showed acetylcysteine to be of low toxicity. LD<sub>50</sub> values greater than 7 g/kg in mice and 6 g/kg ...

List of excipients

Aspartame (E951) Sorbitol (E420) Lemon flavour (contains maltodextrin, a form of glucose) Sunset yellow (E110)

Incompatibilities

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

Shelf life

3 years. After reconstitution, the product must be administered immediately.

Special precautions for storage

Store in the original package to protect from moisture.

Nature and contents of container

Paper/aluminium/polyethylene sachet containing l g powder for oral solution, packaged in a cardboard box, in the following pack sizes: 10, 18, 20, 30 sachets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal. Any unused product should be disposed of in accordance with local requirements.

Marketing authorization holder

Colonis Pharma Limited, Quantum House, Hobson Industrial Estate, Burnopfield County Durham, NE16 6EA, United Kingdom

Marketing authorization number(s)

PL 41344/0057

Date of first authorization / renewal of the authorization

05/07/2016

Date of revision of the text

04/07/2018

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