Antiseptic Throat Lozenges Orange & Menthol

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amylmetacresol

Available from:

The Boots Company Plc

ATC code:

R02AA; R02AA20

INN (International Name):

Amylmetacresol

Dosage:

0.6 milligram(s)

Pharmaceutical form:

Lozenge

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antiseptics; various

Authorization status:

Not marketed

Authorization date:

2001-05-17

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Antiseptic Throat Lozenges Orange & Menthol
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amylmetacresol
0.6 mg per lozenge
Excipients:
Sucrose 1.5g
Glucose 1.0g
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lozenge
Orange, circular lozenges.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short-term symptomatic relief of sore throats.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and Children over 12 years: One throat lozenge to be sucked
when required, up to a maximum of 8 throat
lozenges in 24 hours.
Children 5-12 years: One throat lozenge to be sucked when required up
to a maximum of 4 throat lozenges in 24
hours.
The maximum dose at any one time is one throat lozenge.
Children under 5 years: Not suitable.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Keep all medicines out of the reach of children.
Do not exceed the stated dose.
If symptoms persist or worsen after 2-3 days see your doctor.
Information related specifically to the excipients in this formulation
(See Section 6.1).
Glucose: Each lozenge contains 1g glucose. This should be taken into
account by patients with diabetes mellitus.
Patients with rare glucose-galactose malabsorption should not take
this medicine.
Sucrose: Each lozenge contains 1.5g sucrose. This should be taken into
account by patients with diabetes mellitus.
Patients with rare hereditary problems of fructose intolerance,
glucose-galactose malabsorption or sucrose-isomaltase
insufficiency should not take this medicine.
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