CARBOSAN Gel (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Carbosan 2% w/w Gel.
Qualitative and quantitative composition
Each 5 g of Carbosan Gel contains 100 mg carbenoxolone sodium. Excipient(s) with known effect: 0.60% w/w parahydroxybenzoic acid esters, sodium salt 0.10% w/w lemon oil containing limonene in a range of ...
Pharmaceutical form
Gel. A translucent, colourless gel with a lemon odour.
Therapeutic indications
Carbosan Gel is indicated in the symptomatic relief and treatment of lip sores, mouth ulcers or aphthous changes in the oral mucous membranes.
Posology and method of administration
Route of Administration For cutaneous use. Recommended Dosage Schedule Adults and children over 3 years only: Apply thickly to lesions after meals and at bedtime.
Contraindications
Carbosan Gel is contra-indicated in patients suffering from severe cardiac, renal and hepatic impairment, patients with hypertension or those who are receiving cardiac glycosides. Carbosan Gel is contra-indicated ...
Special warnings and precautions for use
If bacterial infection is superimposed, appropriate therapy should be instituted. If symptoms persist for more than 2 weeks consult your doctor. Carbosan contains parahydroxybenzoate. May cause allergic ...
Interaction with other medicinal products and other forms of interaction
Carbosan Gel should not be used by patients who are receiving cardiac glycosides.
Pregnancy and lactation
Carbosan Gel should not be used during pregnancy or lactation.
Effects on ability to drive and use machines
The use of Carbosan Gel is unlikely to result in any impairment of the ability of patients to drive or operate machinery.
Undesirable effects
Side effects to the use of Carbosan Gel have not been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. ...
Overdose
No specific data is available.
Pharmacodynamic properties
Carbenoxolone Sodium is a derivative of enoxolone with anti-inflammatory and anti-diuretic properties.
Pharmacokinetic properties
Not applicable.
Preclinical safety data
Not applicable.
List of excipients
Polyoxyethylene-30-cetylstearyl alcohol Polyol fatty acid ester Iso-Octyl stearate Imidazolidinyl urea Sodium methylparahydroxybenzoic acid Sodium ethylparahydroxybenzoic acid Sodium propylparahydroxybenzoic ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Replace cap tightly after use. Do not store above 25°C.
Nature and contents of container
The immediate container for Carbosan Gel is an aluminium tube that has an external white lacquer and a gold coloured internal lacquer coating. The tube has a white screw-on cap. Pack size: 5g.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Rowa Pharmaceuticals Limited, Newtown, Bantry, Co. Cork, Ireland
Marketing authorization number(s)
PA0074/011/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 13 March 1987 Date of last renewal: 13 March 2007
Date of revision of the text
November 2020
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