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REDCURRENT & ROSEHIP THROATIES ANTIBACTERIAL PASTILLES
NAME OF THE MEDICINAL PRODUCT
Redcurrant & Rosehip Throaties Anti-bacterial Pastilles
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amylmetacresol BP 0.6 mg per Lozenge
For the relief of sore throat and coughs.
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.
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.
Interactions with other medicinal products and other forms of interaction
Fertility, Pregnancy and Lactation
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.
It is not known whether the active ingredients of this product are excreted in human breast
In the absence of sufficient data, the use during lactation is not recommended.
Studies on the effects on fertility have not been investigated.
Effects on ability to drive and use machines
The following adverse events have been reported during post-marketing experience with
Immune system disorders
Frequency unknown – Hypersensitivity
Frequency unknown – Glossodynia
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.
Amylmetacresol is an antiseptic.
The product base has a demulcent action.
Pharmacokinetic considerations do not arise since the pharmacological action is local
to the oro-pharangeal cavity and the constituents are systemically innocuous in the
Preclinical safety data
No relevant data on the product are available.
List of excipients
Carnauba wax (E903)
Special precautions for storage
Do not store above 30°C.
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
Not all pack sizes may be marketed.
Instructions for use, handling and disposal
None specific to the pack/product
MARKETING AUTHORISATION HOLDER
Ernest Jackson & Co. Ltd.
High Street, Crediton
Devon, EX17 3AP, UK
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
18 November 1993 / 12 February 1999
DATE OF REVISION OF THE TEXT
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.