SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Sanderson’s throat Specific Pastilles.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active consituents	Specification	% quantity	Unit
Purified Honey	B.P.C.	7.500	w/w
Vinegar of Squill	B.P.C.	5.000	v/w
Capsicum Tinctire	B.P.C.	0.210	v/w
Tolu Tincture	B.P.C.	0.160	v/w
Menthol	B.P.	0.080	w/w
Benzoic Acid	B.P.	0.050	w/w
Eucalyptus Oil	B.P.	0.020	v/w
Cinnamic Acid	B.P.C.	0.002	v/w

3 PHARMACEUTICAL FORM

Pastilles.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For symptomatic relief of sore throat, hoarseness, loss of voice, catarrh.

4.2 Posology and method of administration

One pastille to be dissolved slowly in the mouth as required. Not recommended for children under six years of age.

Can be used for the elderly.

No dosage adjustment necessary in case of renal or liver insufficiency, dialysis, concomitant disease.

No maximum tolerated daily dose or maximum dose for an entire course of therapy.

4.3    Contraindications

None known.

4.4    Special warnings and precautions for use

If symptoms persist beyond seven days consult your doctor.

4.5    Interaction with other medicinal products and other forms of interaction

None known

4.6    Fertility, pregnancy and lactation

The is no evidence of safety in human pregnancy, but the product has been in wide use for many years without apparent ill consequence. As with other medicines it may be used during this period provided the benefits outweigh the risks.

No problems are anticipated during lactation.

4.7    Effects on ability to drive and use machines

None Known.

None Known.

4.9 Overdose

No specific problem anticipated.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

None applicable.

5.2    Pharmacokinetic properties

None applicable.

5.3    Preclinical safety data

None applicable.

6    PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Pastille base, consisting of Granulated sugar.

Glucose syrup.

Modified starch B.P.C.

(Maize and Tapioca starch)

Cooking fat.

Water.

6.2    Incompatibilities

None Known

6.3    Shelf life

As packaged for sale - 36 months

6.4    Special precautions for storage

Store at room temperature not exceeding 25°C.

6.5    Nature and contents of container

Nett contents 45 gms

Sealed bag in an individual carton.

6.6    Special precautions for disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Sanderson’s (Chemists) Ltd.

37 Oakwood Drive

Heaton

Bolton

BL15EE

8    MARKETING AUTHORISATION NUMBER(S)

PL 00415/5002R

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13 ^th Febuary 1990

10    DATE OF REVISION OF THE TEXT

27^th Febuary 1997