Mucoangin Spray 2,5 mg, spray voor oromucosaal gebruik

Pays: Pays-Bas

Langue: néerlandais

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingrédients actifs:

AMBROXOLHYDROCHLORIDE SAMENSTELLING overeenkomend met ; AMBROXOL

Disponible depuis:

Genzyme Europe B.V. Paasheuvelweg 25 1105 BP AMSTERDAM

Code ATC:

R05CB06

DCI (Dénomination commune internationale):

AMBROXOLHYDROCHLORIDE COMPOSITION corresponding to ; AMBROXOL

forme pharmaceutique:

Spray voor oromucosaal gebruik

Composition:

CITROENZUUR 1-WATER (E 330) ; DINATRIUMWATERSTOFFOSFAAT 2-WATER (E 339) ; ETHANOL 0,84 mg/ml ; EUCALYPTUS-MENTHOL SMAAKSTOF ZL-753-218-0 ; POLYSORBAAT 20 (E 432) ; PROPYLEENGLYCOL (E 1520) ; SUCRALOSE (E 955) ; VERKOELENDE SMAAKSTOF ; WATER, GEZUIVERD,

Mode d'administration:

Oromucosaal gebruik

Domaine thérapeutique:

Ambroxol

Descriptif du produit:

Hulpstoffen: CITROENZUUR 1-WATER (E 330); DINATRIUMWATERSTOFFOSFAAT 2-WATER (E 339); ETHANOL 0,84 mg/ml; EUCALYPTUS-MENTHOL SMAAKSTOF ZL-753-218-0; POLYSORBAAT 20 (E 432); PROPYLEENGLYCOL (E 1520); SUCRALOSE (E 955); VERKOELENDE SMAAKSTOF; WATER, GEZUIVERD;

Date de l'autorisation:

2015-12-14

Notice patient

181220
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
MUCOANGIN SPRAY 2,5MG, SPRAY VOOR OROMUCOSAAL GEBRUIK
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 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 Mucoangin spray is and what it is used for
2.
What you need to know before you take Mucoangin spray
3.
How to take Mucoangin spray
4.
Possible side effects
5.
How to store Mucoangin spray
6.
Contents of the pack and other information
1.
WHAT MUCOANGIN SPRAY IS AND WHAT IT IS USED FOR
Mucoangin spray contains the active substance ambroxol hydrochloride.
The active substance is the part of
the spray that gives the therapeutic effect you need.
Mucoangin spray has a local anaesthetic effect which relieves the pain
in acute sore throat.
Mucoangin spray is used to:
-
relieve the pain in acute sore throat for 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MUCOANGIN SPRAY
DO NOT TAKEMUCOANGIN SPRAY
-
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 Mucoangin spray.
-
You should not use Mucoangin spray 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 liver or kidney problems, ask your doctor before using
Mucoangin spray.
-
Mucoangin spr

Résumé des caractéristiques du produit

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
011120
1.
NAME OF THE MEDICINAL PRODUCT
Mucoangin Spray 2,5 mg, spray voor oromucosaal gebruik
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One actuation of the spray contains 2.5 mg of ambroxol hydrochloride.
One ml of the spray contains 17.86 mg of ambroxol hydrochloride.
Excipient(s) with known effect:
This medicinal product contains small amounts of ethanol (alcohol),
less than 100 mg per dose (4 actuations)
and very small amounts of propylene glycol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oromucosal spray, solution
Clear and almost colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pain relief in acute sore throat for adults and children over 12 years
of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over 12 years of age: one dose of 10 mg (4
actuations) to be sprayed into the back of the
throat up to 6 times per day.
Mucoangin 2.5 mg/actuation oromucosal spray, solution can be used for
up to 3 days. In case of persistent
symptoms or high fever, the patient should consult a doctor.
_Paediatric population _
Mucoangin 2.5 mg/actuation oromucosal spray, solution should not be
used in children under 12 years of age
(see section 4.4).
_ _
Method of administration
Oromucosol use.
Prior to use, the pump should be actuated 5 times so that an even
spray mist is released. After not having
used the spray for a longer time, the pump should be actuated once
before applying the product again.
For application the spray bottle should be used in an upright position
with the nozzle targeted at the back of
the throat whilst pushing down the pump head completely.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance (ambroxol) or to any of the
excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
3
011120
Mucoangin 2.5 mg/actuation oromucosal spray, solution can be used for
up to 3 days. If symptoms worsen or
still persist after 3 days or if the patient has a high fever, a