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MAX REMEDIES ANTIBACTIC TABLETS

Active substance(s): AMYLMETACRESOL / CETYLPYRIDINIUM CHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Max Remedies Antibactic Tablets

2

3

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ingredient

mg/tablet

Amyl Metacresol HSE
Cetyl Pyridinium Chloride BP

0.5
1.5

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).

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
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

PHARMACOLOGICAL PROPERTIES

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

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

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