Strepsils Honey & Lemon Lozenges Amylmetacresol 0.6mg 2,4-Dichlorobenzyl alcohol 1.2mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amylmetacresol; 2,4-Dichlorobenzyl alcohol

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

R02AA; R02AA03

INN (International Name):

Amylmetacresol; 2,4-Dichlorobenzyl alcohol

Dosage:

0.6 mg/1.2 milligram(s)

Pharmaceutical form:

Lozenge

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antiseptics; dichlorobenzyl alcohol

Authorization status:

Marketed

Authorization date:

1986-10-16

Patient Information leaflet

LOT:
DO NOT USE AFTER:
24
lozenges
Soothing effective relief for sore throats
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
Honey
&
Le mon
LOZENGES
LOZENGES
LOZENGES
Amylmetacresol 0.6mg
2,4-Dichlorobenzyl Alcohol 1.2mg
_DUAL_ anti-bacterial action
LOZENGES
LOZENGES
LOZENGES
LOZENGES
LOZENGES
LOZENGES
LOZENGES
LOZENGES
LOZENGES
• Remember young children can choke on lozenges.
• Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Side
effects may include rash,
stomach pain, feeling
sick, oral discomfort, rash, allergic reaction.
• Consult your doctor if symptoms persist, or
anything unusual happens. Do not take for more
than 3 days unless told to do so by your doctor.
• Contains 0.976g glucose, 1.441g sucrose, 0.3854g
fructose per dose. This should be taken into
account in patients with diabetes mellitus.
•
Do not use after the expiry date shown on the pack.
• Consult your doctor or pharmacist if you are
pregnant or breastfeeding.
KEEP ALL MEDICINES OUT OF THE
REACH AND SIGHT OF CHILDREN.
Do not store above 25ºC.
PA 979/38/2
Active Ingredients: 2,4-Dichlorobenzyl alcohol
1.2mg, Amylmetacresol 0.6mg.
Also contains: Sucrose, Glucose Syrup, Honey,
Tartaric Acid, Peppermint Oil, Terpeneless Lemon
Oil and Quinoline Yellow (E104).
Each lozenge contains 1g of glucose and 1.4g of
sucrose.
® HONEY AND LEMON LOZENGES provide fast, soothing and effective
relief from
the discomfort of sore throats. Each lozenge contains a combination of
2 anti-bacterials to
help kill the bacteria which can cause sore throats and mouth
infections. Natural honey
with lemon for an extra soothing effect on the throat.
HOW TO USE: Strepsils Lozenges are suitable for adults and children
over 6 years. D

Summary of Product characteristics

Health Products Regulatory Authority
16 July 2021
CRN00C5NY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Honey & Lemon Lozenges Amylmetacresol 0.6mg
2,4-Dichlorobenzyl alcohol 1.2mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains Amylmetacresol 600 micrograms and 2,
4-Dichlorobenzyl alcohol 1.2 mg.
Excipients with known effects:
Glucose 0.98 g (976 mg)/lozenge.
Sucrose 1.44 g (1441 mg)/lozenge.
Invert Sugar (honey) 100.9 mg/lozenge.
Wheat Starch (containing gluten present in liquid glucose) 19.52
micrograms/lozenge.
Sulphites - Sulphur Dioxide (E220) present in liquid glucose 0.125
ppm/lozenge.
Lemon flavour fragrance containing citral, d-Limonene, geraniol and
linalool.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lozenge
A yellow circular lozenge with a taste of honey and lemon, 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
Posolgy
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms. It is recommended that the
product should be used for a maximum of 3 days.
Adults:One lozenge to be dissolved slowly in the mouth every 2 – 3
hours. Do not take more than 12 lozenges in 24 hours.
Paediatric population
Children over 6 years of age: As above for adults.
Children under 6 years of age: Not suitable for children under 6 years
(see section 4.4.
Elderly: There is no need for dosage reduction in the elderly.
Method of administration
For oromucosal administration. To be dissolved slowly in the mouth.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Health Products Regulatory Authority
16 July 2021
CRN00C5NY
Page 2 of 5
Patients with rare hereditary problems of fructose intolerance,
glucose, galactose malabsorption or sucrose-isomaltase
insufficiency should not take this med