Geibroxol 20mg mint flavour Lozenges

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

AMBROXOL HYDROCHLORIDE

Disponible depuis:

Geiser Pharma, S.L. Camino Labiano 45B, 31192 Multiva (Navarra), , Spain

Code ATC:

R02AD

DCI (Dénomination commune internationale):

AMBROXOL HYDROCHLORIDE 20 mg

forme pharmaceutique:

LOZENGE

Composition:

AMBROXOL HYDROCHLORIDE 20 mg

Type d'ordonnance:

OTC

Domaine thérapeutique:

THROAT PREPARATIONS

Statut de autorisation:

Withdrawn

Date de l'autorisation:

2019-03-13

Notice patient

Page
1
of
5
PACKAGE LEAFLET: INFORMATION FOR THE USER
GEIBROXOL 20MG MINT FLAVOUR LOZENGES
Ambroxol hydrochloride
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 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 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 Geibroxol 20mg mint flavour lozenges is and what it is used
for
2. What you need to know before you take Geibroxol 20mg mint flavour
lozenges
3. How to take Geibroxol 20mg mint flavour lozenges
4. Possible side effects
5. How to store Geibroxol 20mg mint flavour lozenges
6. Contents of the pack and other information
1.
WHAT GEIBROXOL 20MG MINT FLAVOUR LOZENGES IS AND WHAT IT IS USED FOR
Geibroxol 20mg mint flavour lozenges contains the active substance
ambroxol hydrochloride. The
active substance is the part of the lozenges that gives the
therapeutic effect you need.
Geibroxol 20mg mint flavour lozenges has a local anaesthetic effect
which relieves the pain in acute
sore throat in adults and children over 12 years of age. You must talk
to a doctor if you do not feel
better or if you feel worse after 3 days.
Geibroxol 20mg mint flavour lozenges is used to:
-pain relief of mild to moderate symptoms of acute sore throat.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GEIBROXOL 20MG MINT FLAVOUR
LOZENGES
DO NOT TAKE GEIBROXOL 20MG MINT FLAVOUR LOZENGES
- If you are allergic (hypersensitive) to the active substance
(ambroxol hydrochloride) or any other
ingredient of this medicine (listed in section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Geibroxol 20mg mint
flavour lozenges
- You shoul

Résumé des caractéristiques du produit

Page
1
of
6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Geibroxol 20mg mint flavour lozenges
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One lozenge contains 20 mg of ambroxol hydrochloride.
Excipient with known effect:
Each lozenge contains 2.412 grams of isomalt
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Lozenge
Clear to white round mint flavoured lozenges with 18±1 mm of
diameter.
Both sides are flat.
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 per day,
with a maximum of 1
lozenge per dose.
Geibroxol 20mg mint flavour 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: _
Geibroxol 20mg mint flavour 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.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Geibroxol 20mg mint flavour lozenges should not be used for more than
3 days.
Page
2
of
6
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
. 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.
Dyspnea is viewed in the context of underlying diseases, such as
swollen throat. Local
allergic reactions (see section 4.8: angioneurotic edema) may also
cause dyspnea.
The local anaesthetic properties of ambroxol may contribute to an
altered perception in the
pharyngeal space (see section 4