Carbocisteine unither pharmaceuticals 750mg/10ml sugar-free oral solution in sachet

Nazione: Regno Unito

Lingua: inglese

Fonte: myHealthbox

Compra

Scarica Foglio illustrativo (PIL)
27-05-2024
Scarica Scheda tecnica (SPC)
27-05-2024

Principio attivo:

carbocisteine

Commercializzato da:

Intrapharm Laboratories Limited

Codice ATC:

R05CB03

INN (Nome Internazionale):

carbocisteine

Dosaggio:

750mg/10m

Forma farmaceutica:

Oral solution in sachet

Via di somministrazione:

Oral use

Confezione:

box of 10, 12 or 15 sachets

Tipo di ricetta:

POM - Prescription Only Medicine

Prodotto da:

Unither liquid manufacturing

Gruppo terapeutico:

mucolytic

Indicazioni terapeutiche:

It is indicated in adults and children over 15 years for recent respiratory disorder with expectoration difficulties (difficulty rejecting by spitting out sputum).

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2015-03-26

Scheda tecnica

                                Carbocisteine 750mg/10ml sugar­free oral solution in sachet
Summary of Product Characteristics Updated 07­Aug­2015 | Intrapharm Laboratories Limited
1. Name of the medicinal product
Carbocisteine unither pharmaceuticals 750mg/10ml sugar­free oral solution in sachet
Carbocisteine 750mg/10ml sugar­free 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 para­hydroxybenzoate (E 219) 15mg per dose
sorbitol liquid (non­crystallising)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 bronchial­pulmonary defences should be respected.
The association of bronchial mucous modifiers with anti­cough medicines and/or substances that dry out secretions
(atropinic) is not ra
                                
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