Azelastinehydrochloride Devatis 0,5 mg/ml, oogdruppels, oplossing in verpakking voor éénmalig gebruik

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

AZELASTINEHYDROCHLORIDE 0,5 mg/ml SAMENSTELLING overeenkomend met ; AZELASTINE 0,46 mg/ml

Beschikbaar vanaf:

Devatis GmbH Spitalstrasse 22 795 39 LORRACH (DUITSLAND)

ATC-code:

S01GX07

INN (Algemene Internationale Benaming):

AZELASTINEHYDROCHLORIDE 0,5 mg/ml SAMENSTELLING overeenkomend met ; AZELASTINE 0,46 mg/ml

farmaceutische vorm:

Oogdruppels, oplossing

Samenstelling:

DINATRIUMEDETAAT(HYDRAAT VORM ONBEKEND) ; HYPROMELLOSE (E 464) ; NATRIUMHYDROXIDE (E 524) ; SORBITOL, VLOEIBAAR, KRISTALLISEERBAAR (E 420) ; WATER VOOR INJECTIE,

Toedieningsweg:

Oculair gebruik

Therapeutisch gebied:

Azelastine

Product samenvatting:

Hulpstoffen: DINATRIUMEDETAAT(HYDRAAT VORM ONBEKEND); HYPROMELLOSE (E 464); NATRIUMHYDROXIDE (E 524); SORBITOL, VLOEIBAAR, KRISTALLISEERBAAR (E 420); WATER VOOR INJECTIE;

Autorisatie datum:

2015-04-29

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
AZELASTINEHYDROCHLORIDEDEVATIS 0,5 MG/ML, OOGDRUPPELS, OPLOSSING IN
VERPAKKING VOOR
ÉÉNMALIG GEBRUIK
Azelastinehydrochloride
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 2 days. Relief of
symptoms of allergic conjunctivitis should be noticed after 15-30
minutes.
WHAT IS IN THIS LEAFLET
1.
What Azelastine Devatis is and what it is used for
2.
What you need to know before you use Azelastine Devatis
3.
How to use Azelastine Devatis
4.
Possible side effects
5.
How to store Azelastine Devatis
6.
Contents of the pack and other information
1. WHAT AZELASTINE DEVATIS IS AND WHAT IT IS USED FOR
Azelastine Devatis contains azelastine which belongs to a group of
medicines called antihistamines.
Antihistamines work by preventing the effects of substances such as
histamine that the body produces
as part of an allergic reaction. Azelastine has been shown to reduce
inflammation of the eye.
Azelastine Devatis is used to treat and prevent the ocular symptoms of
hay fever (seasonal allergic
conjunctivitis), in adults and children age 4 years and above.
Azelastine Devatis is used for eye disorders caused by an allergy to
substances such as house dust
mites or animal hair (perennial allergic conjunctivitis) in adults and
children age 12 years and above.
Azelastine Devatis is not suitable for treating eye infections.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE AZELASTINE DEVATIS
DO NOT USE:
-
If you are allergic (hypersensitive) to azelastine hydrochloride or
any of the o

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Azelastinehydrochloride Devatis 0,5 mg/ml, oogdruppels, oplossing in
verpakking voor éénmalig
gebruik
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 0.5 mg azelastine hydrochloride in a preservative
free formulation.
One drop contains 0.015 mg azelastine.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drop solution in single dose container for administration by
instillation in the conjunctival sac.
Clear, colourless to nearly colourless, slightly viscous solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
Treatment and prevention of the symptoms of seasonal allergic
conjunctivitis in adults and
children aged 4 years and older.
-
Treatment of the symptoms of non-seasonal (perennial) allergic
conjunctivitis in adults and
children aged 12 years and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ocular use
POSOLOGY
Seasonal allergic conjunctivitis
The usual dosage in adults and children aged 4 years and older is one
drop in each eye twice daily (in
the morning and in the evening) that can be increased if necessary to
four times daily.
Non-seasonal (perennial) allergic conjunctivitis
The usual dosage in adults and children aged 12 years and older is one
drop in each eye twice daily (in
the morning and in the evening) that can be increased, if necessary to
four times daily. As safety and
efficacy have been demonstrated in clinical trials for a period of up
to 6 weeks, the duration of any
treatment cycle should be limited to a maximum of 6 weeks.
Avoid contact with soft contact lenses (See section 4.4).
Advice for use without prescription: Patients should be advised to
contact their doctor if symptoms
worsen or do not improve after 48 hours. It should be pointed out,
that use for more than 6 weeks must
take place under medical supervision even in seasonal conjunctivitis.
Paediatric population
Safety and efficacy of Azelastine Devatis in children aged less than 4
years has not been established.