Medine.co.uk

Max Remedies Antibactic Tablets

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Max Remedies Antibactic Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Ingredient    mg/tablet

Amyl Metacresol HSE    0.5

Cetyl Pyridinium Chloride BP    1.5

3    PHARMACEUTICAL FORM

Compressed tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Minor infections of the mouth and throat.

4.2    Posology and method of administration

Method of administration:

Oral

Adults and children (over 5 years):

One lozenge to be dissolved slowly in the mouth every two or three hours (not more than 6 to be taken in 24 hours).

Contraindications

4.3


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

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.

PHARMACOLOGICAL PROPERTIES

5


5.1 Pharmacodynamic properties

Antiseptic and bacteriocidal.

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

Liquid Glucose BPC 1963 Tartaric Acid BP Erythrosine (E127) USP Sodium Saccharin BP Magnesium Stearate BP Blackcurrant Flavour GW9559 HSE

6.2 Incompatibilities

None known.

6.3 Shelf life

36 months

6.4


Special precautions for storage


None.


6.5


Nature and contents of container

20 tablets in a HD Polyethylene 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 31308/0028


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