Carbocisteine 750mg/10ml Sugar-Free Oral Solution In Sachet
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 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
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml of oral solution contains 750 mg of carbocisteine Excipients with known effect:
sodium methyl para-hydroxybenzoate (E 219) 15mg per dose
sorbitol liquid (non-crystallising)1.3g per dose
maltitol, liquid 1.3g per dose
sodium 97.5mg per dose
ethanol (trace)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution in sachet.
Limpid, viscous, light brown solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
This medicine is indicated in adults and children over 15 years for recent respiratory disorder with expectoration difficulties (difficulty rejecting by spitting out sputum).
4.2 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, or 1 sachet, 3 times a day.
This medicine is appropriate for patients following a low sugar or low calorie diet.
Treatment duration:
It should be short and not exceed 5 days.
4.3 Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Active peptic ulceration
4.4 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 substances that dry out secretions (atropinic) is not rational.
This medicine contains sodium methyl para-hydroxybenzoate (E219) and can cause allergic reactions (sometimes late onset).
This medicine contains maltitol and sorbitol. It is not recommended for fructose-intolerant patients (rare hereditary disease).
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per sachet.
This medicine contains sodium. This medicine contains 97.5 mg (4.24 mmol) of sodium per dose.
This should be taken into account in patients following strict low sodium diets. Precautions for use
Since mucolytics may disrupt the gastric mucosal barrier, caution should be taken in patients with a history of peptic ulcers.
4.5 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.
4.6 Fertility, 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 in humans were found to be teratogenic in animals during properly carried out studies in two different species.
From a clinical point of view, no malformations or foetotoxicity have occurred.
However, the follow-up of pregnancies in which there is exposition to carbocisteine is not sufficient to exclude all risks.
Consequently, carbocisteine should not be used during pregnancy unless necessary. Breast-feeding
There is no data on carbocisteine passing into breast milk.
However, given its low toxicity, the potential risk for children seems negligible if being treated with this medicine. Consequently, breast feeding is possible.
4.7 Effects on ability to drive and use machines
The medicinal product has negligible influence on the ability to drive and use machines.
4.8 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)
Gastrointestinal disorders
very common: stomach pains, nausea, diarrhoea.
In such cases, it is advised to reduce the dosage.
Skin and subcutaneous tissue disorders
Rare: itching, rash, erythematous rash, or swelling in the face
4.9 Overdose
Gastrointestinal disorders is the most likely symptom of overdosage. In such cases, it is advised to reduce the dosage.
5.1 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 up the disulfide bonds in glycoproteins, thereby favouring expectoration.
5.2 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 metabolism with a significant hepatic first pass effect.
Elimination half-life is about 2 hours. Carbocisteine and its metabolites are excreted primarily through the kidneys.
5.3 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 very rare.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Saccharin sodium
Sodium methyl para-hydroxybenzoate (E 219) Hydroxyethylcellulose
Caramel/vanilla flavouring (contains ethanol)
Sorbitol liquid (non-crystallising)
Maltitol liquid Sodium hydroxide1
Purified water.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years.
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
10 ml sachet (PET/Aluminium/PE); box of 10, 12 or 15.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
UNITHER PHARMACEUTICALS 151 RUE ANDRE DUROUCHEZ ESPACE INDUSTRIEL NORD 80084 AMIENS CEDEX 2 - FRANCE
8 MARKETING AUTHORISATION NUMBER(S)
PL 41322/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 25/06/2013
10 DATE OF REVISION OF THE TEXT
22/12/2014
sodium hydroxide pellets or sodium hydroxide 30 % solution can be used