Skip to Content

REDCURRENT & ROSEHIP THROATIES ANTIBACTERIAL PASTILLES

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Redcurrant & Rosehip Throaties Anti-bacterial Pastilles

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Amylmetacresol BP 0.6 mg per Lozenge

3.

PHARMACEUTICAL FORM
Lozenge

4

CLINICAL PARTICULARS

4.1.

Therapeutic indications
For the relief of sore throat and coughs.

4.2.

Posology and method of administration
For oromucosal use.
For adults, the elderly and children aged 3 years and over:Suck one lozenge slowly as required.
Do not take more than 12 lozenges in 24 hours.
Not to be given to children under 3 years.

4.3.

Contraindications
Established hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

Keep out of reach and sight of children. If symptoms persist consult your doctor. Not to
be given to children under 3 years.
Contains a total of 2.1g of sucrose and glucose per lozenge. Patients with rare
hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.

4.5.

Interactions with other medicinal products and other forms of interaction
None known.

4.6.

Fertility, Pregnancy and Lactation
Pregnancy
There is no or inadequate evidence of the safety of the active ingredients in this medicine in
human pregnancy. The potential risk for humans is unknown.
In the absence of sufficient data, the use during pregnancy is not recommended.
Lactation
It is not known whether the active ingredients of this product are excreted in human breast
milk.
In the absence of sufficient data, the use during lactation is not recommended.
Fertility
Studies on the effects on fertility have not been investigated.

4.7.

Effects on ability to drive and use machines
None known.

4.8.

Undesirable Effects
The following adverse events have been reported during post-marketing experience with
amylmetacresol-containing products:
Immune system disorders
Frequency unknown – Hypersensitivity
Gastrointestinal disorders
Frequency unknown – Glossodynia

4.9.

Overdose
Theoretically symptoms are possible in children if at least 50 lozenges (more than 4
packs) are consumed in a short space of time. In such extreme overdose, related to
menthol ingestion, symptoms may include nausea and vomiting, diarrhoea, profuse
sweating and intense thirst.
Treatment is symptomatic.

5

PHARMACOLOGICAL PROPERTIES

5.1.

Pharmacodynamic properties
Amylmetacresol is an antiseptic.
The product base has a demulcent action.

5.2.

Pharmacokinetic properties
Pharmacokinetic considerations do not arise since the pharmacological action is local
to the oro-pharangeal cavity and the constituents are systemically innocuous in the
concentrations used.

5.3

Preclinical safety data
No relevant data on the product are available.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sucrose
Liquid glucose
Dextrose
Gelatin
Honey
Levomenthol
Redcurrant flavour
Rosehip flavour
Peach flavour

Carmoisine E122
Carnauba wax (E903)
Vegetable oil
6.2.

Incompatibilities
None known.

6.3.

Shelf life
24 months

6.4.

Special precautions for storage
Do not store above 30°C.

6.5

Nature and contents of container
Blisters of 250mic PVC coated 40gsm PVDC lidded with HT aluminium foil 20mic.
1, 2 or 3 blisters packed in secondary pack of carton or flexible laminate pack.
Pack sizes: 8 (1 x 8), 10 (1 x 10), 12 (1x12), 16 (2x8), 20 (2 x 10), 24 (2x12), 36
(3x12) lozenges.
Not all pack sizes may be marketed.

6.6.

Instructions for use, handling and disposal
None specific to the pack/product

7.

MARKETING AUTHORISATION HOLDER
Ernest Jackson & Co. Ltd.
High Street, Crediton
Devon, EX17 3AP, UK

8.

MARKETING AUTHORISATION NUMBER(S)
PL 00094/0013

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18 November 1993 / 12 February 1999

10

DATE OF REVISION OF THE TEXT
07/08/2012

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide