Medine.co.uk

Max Remedies Mouth Ulcer Tablets

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Max Remedies Mouth Ulcer Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Ingredient

mg/tablet

Amyl Metacresol HSE

0.5

Ascorbic Acid BP

25.0

Cetyl Pyridinium Chloride BP

1.5

3    PHARMACEUTICAL FORM

Compressed lozenge

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Relief of mouth ulcers, gumboils, sore throats and other mouth and throat infections.

4.2    Posology and method of administration

Method of administration:

Oral.

Adults and children (over 5 years):

Allow one tablet to dissolve slowly in the mouth every two or three hours (not to exceed 6 in every 24 hours).

4.3    Contraindications

None known.

4.4    Special warnings and precautions for use

Dose not to exceed 6 tablets every 24 hours.

Keep out of the reach of children.

4.5    Interaction with other medicinal products and other forms of interaction

None known.

4.6    Pregnancy and lactation

None known.

No known adverse effect but as with other medicines is best avoided during the first trimester of pregnancy.

4.7    Effects on ability to drive and use machines

Not applicable.

4.8    Undesirable effects

None known.

4.9    Overdose

Generally well tolerated. Large doses may cause diarrhoea and other gastrointestinal disturbances.

5.1 Pharmacodynamic properties

Antiseptic and soothing.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not known.

6 PHARMACEUTICAL PARTICULARS


6.1 List of excipients

Icing Sugar HSE Acacia BP

Erythrosine (E127) BP Sodium Saccharin BP Magnesium Stearate BP Menthol BP Phenol BP Thymol BP Lemon Oil BP Spearmint Oil BP Clove Oil BP Cinnamon Oil HP Rose Flavour FF 2544 HSE

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months.

Special precautions for storage

6.4


None.

6.5    Nature and contents of container

20 tablets in a Polypropylene tube and cap.

6.6    Special precautions for disposal

None.

7    MARKETING AUTHORISATION HOLDER

Max Remedies Limited Stoney Gate House 2 Greenfield Road Holmfirth West Yorkshire HD9 2JT

8    MARKETING AUTHORISATION NUMBER(S)

PL 31308/0025

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

7th March 1979/ 10th July 1994/ 10th July 1999

10    DATE OF REVISION OF THE TEXT

20th July 2009