Strepsils Warm Lozenges Amylmetacresol 0.6 mg 2, 4-Dichlorobenzyl alcohol 1.2 mg

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Amylmetacresol; 2, 4-dichlorobenzyl alcohol

Предлага се от:

Reckitt Benckiser Ireland Ltd

АТС код:

R02AA; R02AA03

INN (Международно Name):

Amylmetacresol; 2, 4-dichlorobenzyl alcohol

дозиране:

0.6 mg/1.2 milligram(s)

Лекарствена форма:

Lozenge

Вид предписание :

Product not subject to medical prescription

Терапевтична област:

Antiseptics; dichlorobenzyl alcohol

Статус Оторизация:

Marketed

Дата Оторизация:

2009-07-24

Листовка

PLEASE NOTE:
This is a peel and reveal leaflet which was submitted with the Renewal
application back in 2013,
incorporating a label and a patient information leaflet
This artworks only applies to the Tetra pack - small, round tube
containing 10 lozenges, which is not
currently marketed.
PATIENT INFORMATION LEAFLET
STREPSILS WARM LOZENGE
2,4-Dichlorobenzyl alcohol 1.2mg
Amylmetacresol 0.6mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Strepsils Warm
carefully to get the best results from it

Keep this leaflet. You may need to read it again.

Ask you pharmacist if you need more information or advice.

You must talk to a doctor if your symptoms worsen or do not improve
after 3 days.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Strepsils Warm Lozenges are and what they are uses for
2.
What you need to know before you take Strepsils Warm Lozenges
3.
How to take Strepsils Warm Lozenges
4.
Possible side effects
5.
How to store Strepsils Warm Lozenges
6.
Contents of the pack and other information
1.
WHAT STREPSILS WARM LOZENGES ARE AND WHAT THEY ARE USED FOR
Strepsils Warm Lozenges contains two antiseptic ingredients for use in
throat preparations and are
used for the symptomatic relief of mouth and throat infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE STREPSILS WARM LOZENGES
This product is recommended for adults, children (over 12 years old)
and the elderly. Children under
12 years old should not use this product.
DO NOT TAKE THIS PRODUCT IF YOU:

Are allergic (hypersensitive to amylmetacresol, 2,4-dichlorobenzyl
alcohol or any of the
other ingredients shown in section 6

If you are under 12 years old

IF you have rare hereditary problems with fructose intolerance,
glucose-galactose
malabsorption or su

Данни за продукта

Health Products Regulatory Authority
16 July 2021
CRN00C5NY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Warm Lozenges Amylmetacresol 0.6 mg 2, 4-Dichlorobenzyl
alcohol 1.2 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains:
Amylmetacresol 0.6 mg
2,4-Dichlorobenzyl alcohol 1.2 mg
Excipients with known effects:
Glucose 1.10 g (1102 mg)/lozenge.
Sucrose 1.38 g (1384 mg)/lozenge.
Wheat Starch (containing gluten present in liquid glucose) 22.04
micrograms/lozenge.
Sulphites - Sulphur Dioxide (E220) present in liquid glucose 0.141
ppm/lozenge.
Flavouring fragrances containing citral, cinnamol, citranellol,
eugenol, farnesol, geraniol, isoeugenol and linalool.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Lozenge
A circular, biplanar red to purple lozenge with a characteristic warm
taste of plum and ginger, embossed on both sides with
strepsils brand icon.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of mouth and throat infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms.
ADULTS AND CHILDREN (OVER 12 YEARS): One lozenge to be dissolved
slowly in the mouth every 2-3 hours or as directed by a
physician. It is recommended that the product should be used for a
maximum of 3 days. Do not take more than 12 lozenges in
24 hours.
ELDERLY: There is no need for dosage reduction in the elderly.
Not suitable for children under 12 years.
METHOD OF ADMINISTRATION
For oral administration.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Patients with rare hereditary problems of fructose intolerance,
glucose, galactose malabsorption or sucrose-isomaltase
insufficiency should not take this medicine.
Health Products Regulatory Authority
16 July 2021
CRN00C5NY
Page 2 of 5
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Keep all medicines out of the sight