SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Mecysteine Hydrochloride 100 mg Gastro-resistant Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

100 mg Mecysteine Hydrochloride For excipients, see section 6.1

3    PHARMACEUTICAL FORM

Gastro-resistant Tablets.

Round, biconvex, yellow, sugar-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 or 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 3 times daily.

Children under 5 years Not recommended.

The tablets should be swallowed whole.

4.3    Contraindications

Mecysteine hydrochloride is contra-indicated in patients with known hypersensitivity to mecysteine, carbocysteine, N-acetylcysteine or to any of the excipients.

4.4    Special warnings and precautions for use

Mecysteine hydrochloride 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.

Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medication.

4.5    Interaction with other medicinal products and other forms of interaction

None known.

4.6    Pregnancy and lactation

Mecysteine hydrochloride 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 overdoage is limited and treatment in such cases should comprise general supportive symptomatic measures.

5.1    Pharmacodynamic properties

Mecysteine hydrochloride is a systemically active mucolytic agent. Double blind clinical trials have been 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

There are no preclinical data of relevance to the prescriber, which are additional to that included in other sections of the SPC

6    PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core:

Lactose Anhydrous Povidone

Magnesium Stearate Kaolin Heavy

Gastro-resistant coat: Stearic Acid

Polyvinylacetate Phthalate

Sugar coat:

Acacia

Gelatin

Sucrose

Calcium Carbonate Talc

Aluminium Oxide, Hydrated

Colour coat:

Titanium Dioxide (E171) Quinoline Yellow (E104) Sunset Yellow (E110)

White Beeswax Carnauba Wax Shellac

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.

10 Laminates per carton. Pack size 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

8    MARKETING AUTHORISATION NUMBER(S)

PL 14894/0297

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

24/02/2006

10 DATE OF REVISION OF THE TEXT

24/10/2013