Strepsils Orange with Vitamin C 100mg lozenges

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amylmetacresol; Ascorbic acid; Dichlorobenzyl alcohol

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

n/a

INN (International Name):

Amylmetacresol; Ascorbic acid; Dichlorobenzyl alcohol

Dosage:

600microgram ; 100mg ; 1.2mg

Pharmaceutical form:

Lozenge

Administration route:

Oromucosal

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 12030300; GTIN: 5000158100954 5000158100565

Summary of Product characteristics

OBJECT 1
STREPSILS ORANGE WITH VITAMIN C 100MG
Summary of Product Characteristics Updated 07-Apr-2017 | Reckitt
Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Strepsils Orange with Vitamin C 100mg
Strepsils Dry & Sore Throat
2. Qualitative and quantitative composition
Amylmetacresol BP 0.6mg
2,4-Dichlorobenzyl Alcohol HSE 1.2mg
Vitamin C, (Ascorbic Acid, Sodium Ascorbate Equivalent to EP) 100.0mg
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Orange flavoured and coloured circular lozenge.
4. Clinical particulars
4.1 Therapeutic indications
For the symptomatic relief of mouth and throat infections.
4.2 Posology and method of administration
POSOLOGY
Use the lowest dose for the shortest duration necessary to relieve
symptoms.
ADULTS:
One lozenge every 2-3 hours up to a maximum of 12 lozenges in 24
hours.
CHILDREN OVER 6 YEARS OLD:
As above for adults.
ELDERLY:
There is no need for dosage reduction in the elderly.
CHILDREN UNDER 6 YEARS OLD:
Not suitable for children under 6 years (see section 4.4).
METHOD OF ADMINISTRATION
For oral administration. To be dissolved slowly in the mouth.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Not to be given to children under 6 years
If symptoms persist, have not improved, or have worsened after 3 days,
consult a doctor or health care
professional.
Patients with rare hereditary problems of fructose intolerance,
glucose-galactose malabsorption or
sucrose-isomaltose insufficiency should not take this medicine.
4.5 Interaction with other medicinal products and other forms of
interaction
No clinically significant interactions are known.
4.6 Fertility, pregnancy and lactation
PREGNANCY
There are no or limited amount of data from the use of amylmetacresol,
2,4-dichlorbenzyl alcohol and
ascorbic acid.
As with all medicines care should be taken when using this product in
pregnancy and medical advice
sought if necessary.
BREAST-FEEDING
Ascorbic acid or metabolites are excreted in huma