Visclair Tablets 100mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Visclair Tablets 100mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: - Mecysteine Hydrochloride (Methylcysteine) 100mg
3 PHARMACEUTICAL FORM
Sugar and Enteric coated tablets
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
As an adjunct in the management of conditions such as chronic obstructive pulmonary disease (COPD), when characterised by thick viscid or glutinous mucus, including the symptomatic relief of cough with sputum.
4.2 Posology and method of administration
Adults (including the elderly)
1-2 tablets three to four times daily before meals with a little water.
A rapid clinical effect can be achieved by giving 2 tablets 4 times daily for the first 2 days of therapy.
The standard dose, 2 tablets three times a day, is given for 6 weeks and thereafter the dose should be reduced to 2 tablets twice daily.
Children over 5 years One tablet three times daily.
Children under 5 years
Not recommended.
The tablets should be swallowed whole.
4.3 Contraindications
VISCLAIR is contra-indicated in patients with known hypersensitivity to Methylcysteine, Carbocysteine or N-acetylcysteine.
4.4 Special warnings and precautions for use
VISCLAIR is well tolerated and serious toxic effects have not been reported. It is important that the tablets, which are enteric coated, should be swallowed whole.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, Pregnancy and lactation
VISCLAIR is not recommended during pregnancy and lactation.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
None known.
4.9 Overdose
Overdosage may cause excessive production of bronchial secretions and hence result in respiratory embarrassment. In such cases postural drainage and suction would be advisable.
Experience regarding overdosage is limited and treatment in such cases should comprise general supportive symptomatic measures.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Methylcysteine hydrochloride is a systemically active mucolytic agent.
Double blind clinical trials have demonstrated a significant reduction of cough and sputum in bronchitic patients.
5.2 Pharmacokinetic properties
The sulphydryl groups in mecysteine are a readily assimilable supply of sulphur which can intervene in the synthesis of mucoproteins to produce mucus of a more normal viscosity : as the tissue becomes saturated with the drug, the disulphide bonds uniting glucoprotein molecules can be severed, breaking down the mucin gel responsible for sputum viscosity.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose Anhydrous USP.
Povidone BP.
Magnesium Stearate BP.
Shellac.
Stearic Acid (1973) BPC.
Polyvinylacetate Phthalate Acacia BP.
Gelatin BP.
Sucrose BP.
Calcium Carbonate BP.
Talc BP.
Titanium Dioxide (El 71) BP. Quinoline Yellow (El04) Sunset Yellow (El 10) Aluminium Oxide, Hydrated. White Beeswax BP.
Camauba Wax BP.
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
Aluminium/Polythene foil laminate to take 10 tablets.
2 or 10 Laminates per carton. Pack sizes are 20 and 100 tablets.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Ranbaxy (UK) Limited Building 4, Chiswick Park 566 Chiswick High Road
London, W4 5YE United Kingdom
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MARKETING AUTHORISATION NUMBER(S)
PL 14894/0730
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/06/2003
DATE OF REVISION OF THE TEXT
02/08/2013
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