Lysopadol Mint 20mg Lozenges

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AMBROXOL HYDROCHLORIDE

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

R05CB; R05CB06

INN (International Name):

AMBROXOL HYDROCHLORIDE

Dosage:

20 milligram(s)

Pharmaceutical form:

Lozenge

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Mucolytics; ambroxol

Authorization status:

Not marketed

Authorization date:

2004-02-10

Patient Information leaflet

2
PACKAGE
LEAFLE
T: INFORMATION FOR THE
USER
LYSOPADOL® MINT
20 MG LOZENGES
ambroxol
hydrochloride
RE
AD ALL OF THIS
LEAFLE
T
CARE
FULLY
BE
FORE YOU
S
TART TAKING THIS
ME
DICINE
BECAUS
E IT CONTAINS
IMPORTANT
INFORMATION FOR
YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist 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. 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 Lysopadol Mint is and what it is used
for
2.
What you need to know before you take
Lysopadol Mint
3.
How to take
Lysopadol Mint
4.
Possible side
effects
5.
How to store
Lysopadol Mint
6.
Contents of the pack and other
information
1.
WHAT
LYSOPADOL MINT IS AND WHAT IT IS
USE
D
FOR
Lysopadol Mint contains the active substance ambroxol hydrochloride.
The active substance is the part
of
the
lozenges that gives the therapeutic effect you
need.
Lysopadol Mint has a local anaesthetic effect which relieves the pain
in acute sore
throat.
Within 20 minutes, the main clinical study showed a positive onset of
action in 73% of the patients.
The
duration of effect will last for at least 3
hours.
Lysopadol Mint is used
to:
-
relieve the pain in mild to moderate symptoms of acute sore
throat
2.
WHAT YOU
NEE
D TO KNOW
BE
FORE YOU TAKE
LYSOPADOL MINT
DO NOT TAKE
LYSOPADOL MINT
-
If you are allergic to ambroxol hydrochloride or any of the other
ingredients of this medicine (listed
in
section
6).
-
WARNINGS AND
PRECAUTIONS
Talk to your doctor or pharmacist before taking
Lysopadol Mint.
-
You should not use Lysopadol Mint for more than 3 days. If you still
have symptoms after 3 days or
if
you
have a high fever, please consult a
doctor.
-
If you have been told by your doctor that you have an intolerance to
some types of su

Summary of Product characteristics

Health Products Regulatory Authority
10 December 2020
CRN009QDN
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lysopadol Mint 20mg Lozenges
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One lozenge contains 20 mg of ambroxol hydrochloride.
Excipient(s) with known effect: sorbitol (1.37 g per lozenge), lactose
monohydrate (less than 1 mg per lozenge) (see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lozenge
Round, white tablet, both sides flat with bevelled edges.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pain relief of mild to moderate symptoms of acute sore throat.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 12 years of age: up to 6 lozenges to be
sucked per day.
Lysopadol Mint 20 mg Lozenges should not be used for more than 3 days.
In case of persistent symptoms or high fever, the
patient should consult a doctor.
_Paediatric population_
Lysopadol Mint 20 mg Lozenges should not be used in children under 12
years of age.
Method of administration
Oromucosal use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
There have been reports of severe skin reactions such as erythema
multiforme, Stevens-Johnson syndrome (SJS)/toxic
epidermal necrolysis (TEN) and acute generalised exanthematous
pustulosis (AGEP) associated with the administration of
ambroxol hydrochloride. If symptoms or signs of a progressive skin
rash (sometimes associated with blisters or mucosal lesions)
are present, ambroxol hydrochloride treatment should be discontinued
immediately and medical advice should be sought.
Dyspnoea may be observed in the context of an underlying disease e.g.
swollen throat. Local allergic reactions (see section 4.8:
angioneurotic oedema) may also cause dyspnoea. The local anaesthetic
properties of ambroxol may contribute to an altered
perception in the pharyngeal space (see section 4.8: oral and
pharyngeal