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