Amylmetacresol/2,4-Dichlorobenzyl alcohol Mylan 0.6 mg/1.2 mg honey & lemon lozenges

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

2,4 DICHLOROBENZYL ALCOHOL; Amylmetacresol

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

R02AA; R02AA03

INN (International Name):

2,4 DICHLOROBENZYL ALCOHOL; Amylmetacresol

Dosage:

0.60/1.2 milligram(s)

Pharmaceutical form:

Lozenge

Therapeutic area:

Antiseptics; dichlorobenzyl alcohol

Authorization status:

Not marketed

Authorization date:

2021-02-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMYLMETACRESOL/2,4-DICHLOROBENZYL ALCOHOL MYLAN 0.6 MG/1.2 MG HONEY &
LEMON LOZENGES
amylmetacresol
2,4-dichlorobenzyl alcohol
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 have
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. 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 Amylmetacresol/2,4-Dichlorobenzyl alcohol Mylan is and what it is
used for
2.
What you need to know before you take
Amylmetacresol/2,4-Dichlorobenzyl alcohol Mylan
3.
How to take Amylmetacresol/2,4-Dichlorobenzyl alcohol Mylan
4.
Possible side effects
5.
How to store Amylmetacresol/2,4-Dichlorobenzyl alcohol Mylan
6.
Contents of the pack and other information
1.
WHAT AMYLMETACRESOL/2,4-DICHLOROBENZYL ALCOHOL MYLAN IS AND WHAT IT IS
USED FOR
Amylmetacresol/2,4-Dichlorobenzyl alcohol Mylan contains
amylmetacresol and 2,4-dichlorobenzyl
alcohol. These ingredients are both mid antiseptics and are are used
for the symptomatic relief of
mouth and throat infections.
The action of sucking the lozenge allows the active ingredients to
work in the area of the discomfort
and also helps lubricate and soothe the painful area. This helps
relieve the soreness and discomfort of
mouth and throat.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AMYLMETACRESOL/2,4-DICHLOROBENZYL ALCOHOL
MYLAN
This medicine is recommended for adults, children (over 6 years old)
and the elderly. Children under
6 years old should not use this product.
DO NOT TAKE AMYLMETACRESOL/2,4-DICHLOROBENZYL AL

Summary of Product characteristics

Health Products Regulatory Authority
01 March 2021
CRN008K7J
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amylmetacresol/2,4-Dichlorobenzyl alcohol Mylan 0.6 mg/1.2 mg honey &
lemon lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 0.6 mg amylmetacresol and 1.2 mg
2,4-dichlorobenzyl alcohol.
Excipients with known effect
Each lozenge contains 1.83 g of isomalt (E953), 0.46 g of maltitol
liquid (E965) and approximately 0.01 mg of sunset yellow
(E110).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lozenge
An orange-yellow, round, honey-lemon flavoured lozenge with a diameter
of 19 mm ± 1 mm.
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. It is recommended that the
product should be used for a maximum of 3 days.
_ _
_Adults_
One lozenge every 2 or 3 hours, as needed, up to a maximum of 8
lozenges in 24 hours.
_Paediatric population_
_ _
_Children over 6 years of age_
One lozenge every 2 or 3 hours, as needed, up to a maximum of 4
lozenges in 24 hours, with a minimum of 2 hours between
the lozenges.
_Children under 6 years of age_
Amylmetacresol/2,4-Dichlorobenzyl alcohol Mylan should not be used in
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. Do
not swallow, chew or bite.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Health Products Regulatory Authority
01 March 2021
CRN008K7J
Page 2 of 4
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product is not recommended for young children due to a risk of
choking (see section 4.2).
Patients should be advised to consult the doctor if symptoms persist
or if