Strepsils +Plus Anaesthetic Throat Spray Amylmetacresol 0.29mg/spray 2,4-Dichlorobenzyl Alcohol 0.58mg/spray Lidocaine 0.78mg/spray

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amylmetacresol; 2,4-Dichlorobenzyl alcohol; Lidocaine

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

R02AA; R02AA03

INN (International Name):

Amylmetacresol; 2,4-Dichlorobenzyl alcohol; Lidocaine

Dosage:

0.29 mg/ 0.58 mg/0.78 milligram(s)

Pharmaceutical form:

Oromucosal spray

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antiseptics; dichlorobenzyl alcohol

Authorization status:

Marketed

Authorization date:

1996-07-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
STREPSILS +PLUS ANAESTHETIC THROAT SPRAY
Amylmetacresol 0.29mg/spray
2,4-Dichlorobenzyl alcohol 0.58mg/spray
Lidocaine hydrochloride 0.78mg/spray
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist or nurse has told
you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible side effects not
listed in this leaflet. See section 4.You must talk to a doctor if you
do not feel better or if you feel worse after 3
days.
WHAT IS IN THIS LEAFLET:
1.
What Strepsils +Plus Spray is and what it is used for
2.
What you need to know before you take Strepsils +Plus Spray
3.
How to take Strepsils +Plus Spray
4.
Possible side effects
5.
How to store Strepsils +Plus Spray
6.
Contents of the pack and other information
1. WHAT STREPSILS +PLUS SPRAY IS AND WHAT IT IS USED FOR
The active ingredients which make Strepsils +Plus Spray work are

Amylmetacresol and 2,4-dichlorobenzyl alcohol. These have antiseptic
properties which kill bacteria
which cause mouth and throat infections.

The spray also contains lidocaine hydrochloride, which is a local
anaesthetic to rapidly numb the pain of
a painful sore throat.
Strepsils +Plus Spray can be used for the symptomatic relief of throat
infections, including severe sore throat.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STREPSILS +PLUS SPRAY
DO NOT TAKE STREPSILS +PLUS SPRAY

if you are allergic (hypersensitive) to any of the ingredients listed
in section 6

if you are under 18 years of age

if you are pregnant or breastfeeding, unless under the supervision of
your doctor

if you have a history of allergy to local anaesthetics

if you suffer from a blood disorder called methemoglobinemia (abnormal
amounts of ha

Summary of Product characteristics

Health Products Regulatory Authority
01 March 2022
CRN00C5NT
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strepsils +Plus Anaesthetic Throat Spray
Amylmetacresol 0.29mg/spray
2,4-Dichlorobenzyl Alcohol 0.58mg/spray
Lidocaine 0.78mg/spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Strepsils +Plus anaesthetic Throat Spray contains the following active
substances:
Amylmetacresol
0.223 % w/v (0.580mg/dose)
2,4-Dichlorobenzyl alcohol
0.446 % w/v (1.16mg/dose)
Lidocaine
0.6 % w/v (1.56mg/dose)
There are two sprays per dose (each spray is 0.13ml) and each dose is
0.26 ml.
Excipients with known effects:
Ethanol (96%)
40.0% v/v (83.2mg/dose)
Sorbitol
10% v/v (33.6mg/dose)
Carmoisine Edicol (E122)
0.006% (33.6mg/dose)
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oromucosal spray
Clear, pink liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of throat infections, including severe sore
throats.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms.
Adults: Two sprays, if necessary, repeat the dose every two hours as
needed up to a maximum of eight times in 24 hours. Do
not exceed the stated dose.
PAEDIATRIC POPULATION
Not recommended for children.
ELDERLY POPULATION
There is no need for dosage modifications in the elderly.
METHOD OF ADMINISTRATION
Oromucosal use. The nozzle should be aimed at the back of the throat
and the product sprayed on to the affected area.
Health Products Regulatory Authority
01 March 2022
CRN00C5NT
Page 2 of 5
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the active ingredients or to any of the
excipients listed in section 6.1.
A history of allergy to local anaesthetics of the amide type.
In patients who have a history of or are suspected to have
methaemoglobinaemia.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not recommended for children.
Do not exceed the stated dose.
Keep all medicines out of the reach of child