CARBOCISTEINE Oral solution in sachet (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Carbocisteine unither pharmaceuticals 750mg/10ml sugar-free oral solution in sachet. Carbocisteine 750mg/10ml sugar-free oral solution in sachet.
Qualitative and quantitative composition
Each 10 ml of oral solution contains 750 mg of carbocisteine Excipients with known effect: sodium methyl para-hydroxybenzoate (E219) 15mg per dose sorbitol liquid (non-crystallising) 1.3g per dose maltitol, ...
Pharmaceutical form
Oral solution in sachet. Limpid, viscous, light brown solution.
Therapeutic indications
This medicine is indicated in adults and children over 15 years for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways ...
Posology and method of administration
For adults and children over 15 years only. Oral route. One 10 ml sachet contains 750 mg of carbocisteine. The standard dose is 750 mg, 3 times a day (i.e. 2250mg), or 1 sachet, 3 times a day. The dose ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Active peptic ulceration.
Special warnings and precautions for use
Special warning Productive coughs that represent a fundamental element in bronchial-pulmonary defences should be respected. The association of bronchial mucous modifiers with anti-cough medicines and/or ...
Interaction with other medicinal products and other forms of interaction
The combination of mucolytics with antitussives and/or substances that dry out secretions (atropinic) is not rational.
Pregnancy and lactation
Pregnancy Animal studies have not shown any teratogenic effects. In the absence of teratogenic effects in animals, malformations are not expected in humans. Currently, substances responsible for malformations ...
Effects on ability to drive and use machines
The medicinal product has negligible influence on the ability to drive and use machines.
Undesirable effects
The evaluation of undesirable effects is based on the following information on frequencies: Very common (≥1/10), Rare (≥1/10,000 to <1/1,000). Immune system disorders There have been reports of anaphylactic ...
Overdose
Gastric lavage may be beneficial, followed by observation. Gastrointestinal disorders is the most likely symptom of overdosage. In such cases, it is advised to reduce the dosage.
Pharmacodynamic properties
Pharmacotherapeutic group: mucolytic ATC code: R05CB03 (R: respiratory system) Carbocisteine is a mucolytic agent that modifies mucous secretions. It acts during the mucous gel phase, most likely by breaking ...
Pharmacokinetic properties
After oral administration, carbocisteine is quickly absorbed; maximum plasma concentration is reached in two hours. Its bioavailability is low, less than 10% of the administered dose, most likely via intraluminal ...
Preclinical safety data
Tests in a wide range of animal species have revealed no significant toxicity. Serious adverse events associated with the use of carbocisteine have not been reported. Even symptomatic adverse events are ...
List of excipients
Saccharin sodium Sodium methyl para-hydroxybenzoate (E219) Hydroxyethylcellulose Caramel/vanilla flavouring (contains ethanol) Sorbitol liquid (non-crystallising) Maltitol liquid Sodium hydroxide* Purified ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
10 ml sachet (PET/Aluminium/PE); box of 10, 12 or 15. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Intrapharm Laboratories Limited, The Courtyard Barns, Choke Lane, Cookham Dean, Maidenhead, Berkshire, SL6 6PT, UNITED KINGDOM
Marketing authorization number(s)
PL 17509/0074
Date of first authorization / renewal of the authorization
26<sup>th</sup> March 2015
Date of revision of the text
7<sup>th</sup> November 2017
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