Azelastine OmniVision 0,5 mg/ml Ögondroppar, lösning

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

azelastinhydroklorid

Available from:

OmniVision GmbH

ATC code:

S01GX07

INN (International Name):

azelastine hydrochloride

Dosage:

0,5 mg/ml

Pharmaceutical form:

Ögondroppar, lösning

Composition:

azelastinhydroklorid 0,5 mg Aktiv substans; sorbitol Hjälpämne

Class:

Apotek

Prescription type:

Receptbelagt

Therapeutic area:

Azelastin

Product summary:

Förpacknings: Droppbehållare, 6 ml

Authorization status:

Godkänd

Authorization date:

2014-05-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AZELASTINE OMNIVISION 0.5 MG/ML EYE DROPS, SOLUTION
azelastine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.
-
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.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use 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.
WHAT IS IN THIS LEAFLET
1. What [nationally completed name] is and what it is used for
2. What you need to know before you use [nationally completed name]
3. How to use [nationally completed name]
4. Possible side effects
5. How to store [nationally completed name]
6. Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[nationally completed name]
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.
[nationally completed name]
is used to treat and prevent the ocular symptoms of hay fever
(seasonal allergic conjunctivitis

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Azelastine OmniVision 0.5 mg/ml eye drops, solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL contains 0.5 mg azelastine hydrochloride.
Each drop contains 0.015 mg azelastine hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear and 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 4 years and older.
Treatment of the symptoms of non-seasonal allergic conjunctivitis in
adults and children
12 years and older.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Seasonal allergic conjunctivitis
The usual dosage in adults and children 4 years and older is one drop
in each eye twice daily
that can be increased, if necessary to four times daily. If allergen
exposure is anticipated,
[nationally completed name] should be administered prophylactically,
prior to the exposure.
N
on-seasonal (perennial) allergic conjunctivitis:
The usual dosage in adults and children 12 years and older is one drop
in each eye twice
daily 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 course should be limited to a maximum of 6 weeks.
_Paediatric population_
Safety and efficacy of [nationally completed name]in children aged
less than 4 years
has not been established.
Method of administration
Ocular use.
For detailed information on how to use [nationally completed name],
please refer to the
Package Leaflet, section 3. “How to use [nationally completed
name]”.
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
[nationally completed name]is not intended for treatment of eye
infections.
4.5.
INTERACTION WITH OTHER ME