EYEZEP azelastine (as hydrochloride) 0.457 mg/mL eye drops bottle

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

azelastine hydrochloride, Quantity: 0.5 mg/mL (Equivalent: azelastine, Qty 0.457 mg/mL)

Saatavilla:

Viatris Pty Ltd

Lääkemuoto:

Eye Drops

Koostumus:

Excipient Ingredients: sodium hydroxide; benzalkonium chloride; water for injections; disodium edetate; hypromellose; sorbitol solution (70 per cent) (crystallising)

Antoreitti:

Ophthalmic

Kpl paketissa:

6 mL, 10 mL

Prescription tyyppi:

(S2) Pharmacy Medicine

Käyttöaiheet:

EYEZEP is indicated for the treatment and prevention of the symptoms of seasonal and non-seasonal (perennial) allergic conjunctivitis in adults and children 4 years and older.

Tuoteyhteenveto:

Visual Identification: Clear colourless solution; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2005-04-29

Pakkausseloste

EYEZEP
®
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®
ACTIVE INGREDIENT(S): _azelastine hydrochloride (azel-as-teen
hydro-klor-ide) eye drops_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
EYEZEP. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR
PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU
HAVE ANY CONCERNS OR QUESTIONS ABOUT USING EYEZEP.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using EYEZEP?
2. What should I know before I use EYEZEP?
3. What if I am taking other medicines?
4. How do I use EYEZEP?
5. What should I know while using EYEZEP?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING EYEZEP?
EYEZEP CONTAINS THE ACTIVE INGREDIENT AZELASTINE
HYDROCHLORIDE. EYEZEP belongs to a group of medicines
called antihistamines. It works by blocking the action of
histamine and other substances produced by the body, which
are causing your allergies.
EYEZEP IS USED FOR THE TREATMENT AND PREVENTION
OF SEASONAL AND NON-SEASONAL (PERENNIAL) ALLERGIC
CONJUNCTIVITIS, CAUSED BY ALLERGIES, SUCH AS TO POLLEN (HAY
FEVER) OR HOUSE DUST MITES. The effects are red, itchy and/
or watery eyes, sometimes together with sneezing or a runny,
itchy or blocked nose.
EYEZEP is not addictive.
2.
WHAT SHOULD I KNOW BEFORE I USE EYEZEP?
WARNINGS
DO NOT USE EYEZEP IF YOU HAVE AN ALLERGY TO EYEZEP OR
ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET.
Always check the ingredients to make sure you can use this
medicine.
DO NOT GIVE EYEZEP TO A CHILD UNDER 4 YEARS, UNLESS
DIRECTED BY THE CHILD’S DOCTOR.
The safety and effectiveness of EYEZEP in children under 4
years have not been established.
DO NOT USE EYEZEP AFTER THE EXPIRY DATE PRINTED ON THE
PACK.
DO NOT USE EYEZEP AFTER 4 WEEKS OF FIRST OPENING THE
BOTTLE.
DO NOT USE EYEZEP IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
CHECK WITH YOUR DOCTOR OR PHARMACIST IF YOU:
•
have kidney disease
•
take any medicines for any other condition
•
have allergies to any other substances, such as foods,
preservatives or dyes.
•
Are wear

Valmisteyhteenveto

AUSTRALIAN PRODUCT INFORMATION
EYEZEP
®
_Azelastine (as hydrochloride) eye drops _
1
NAME OF THE MEDICINE
Azelastine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EYEZEP eye drops contain 0.5 mg/mL azelastine hydrochloride as the
active ingredient (equivalent to 0.457
mg/mL azelastine base). EYEZEP eye drops also contains 0.125 mg/mL of
benzalkonium chloride and 0.5
mg/mL of disodium edetate as antimicrobial preservatives.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
EYEZEP (azelastine hydrochloride) eye drops is a clear, colourless,
isotonic aqueous solution with a pH of 5.5-
6.5.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prevention of the symptoms of seasonal and non-seasonal
(perennial) allergic conjunctivitis in
adults and children 4 years and older.
4.2
DOSE AND METHOD OF ADMINISTRATION
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
EYEZEP eye drops should be administered
prophylactically, prior to exposure.
Non-seasonal (perennial) 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. 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.
4.3
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The preservative in EYEZEP eye drops, benzalkonium chloride, may cause
eye irritation and discolour soft
contact lenses. Where appropriate, contact lenses should be removed
before application of the eye drops and not
replaced for at least 15 minutes following application.
EYEZEP eye drops are not intended for treatment of eye infections.
EYEZEP
®
– PRODUCT INFORMATION
2
USE IN RENA