EMADINE 0.05% STERILE OPTHALMIC SOLUTION

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

EMEDASTINE DIFUMARATE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

EMEDASTINE DIFUMARATE

Unit dalam pakej:

5ml mL

Dikeluarkan oleh:

ALCON LABS INC

Risalah maklumat

EMADINE EYE DROPS
Emedastine difumarate (0.5mg/ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Emadine is used for
2.
How Emadine works
3.
Before you use Emadine
4.
How to use Emadine
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Emadine
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT EMADINE IS USED FOR
Emadine is indicated for the temporary
relief of the signs and symptoms of
allergic conjunctivitis, which is an eye
inflammation caused by an allergic
reaction.
HOW EMADINE WORKS
Contains emedastine which works by
blocking certain natural substances
(histamines) that cause allergic
symptoms.
BEFORE YOU USE EMADINE
-
_When you must not use it _
Do not use Emadine
•
If you are allergic (hypersensitive)
to emedastine or any of the other
ingredients of this medicine.
•
If you have liver or kidney
impairment.
•
In elderly.
_ _
Safety and effectiveness in children
below the age of 3 years have not been
established.
_Pregnancy and breast-feeding _
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
or pharmacist for advice before using
this medicine.
_ _
_ _
-
_Before you start to use it _
Talk to your doctor or pharmacist
before using Emadine.
-
_Taking other medicines _
Tell your doctor or pharmacist if you
are using, have recently used or might
use any other medicines.
If you are using other eye drop or eye
ointment medicines, wait at least 5
minutes between each medicine. Eye
ointments should be administered last.
HOW TO USE EMADINE
Always use this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
•
Only use Emadine for dropping in
your eye(s).
•
After cap is removed, if tamper
evident snap collar is loose, remove
before using product.
-
_How much to use _
One drop in the affected eye.
-
_When to use it _
Use twice per day, and if needed, up to
four times daily or use a

Ciri produk

1. NAME OF THE MEDICINAL PRODUCT
Emadine ® (emedastine difumarate ophthalmic solution) 0.05%
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains emedastine 0.5 mg (as difumarate)
Excipients: Benzalkonium chloride 0.1 mg/ml.
For the full list of excipients, see section 6.1.
3. PHARM ACEUTICAL FORM
Eye Drops, Solution
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
Emadine is indicated for the temporary relief of the signs and symptoms of allergic conjunctivitis.
4.2. Posology and Method of Administration
Recommended Dose and Dosage Adjustment
The recommended dose is one drop in the affected eye twice per day, and if needed, up to four times daily.
Pediatric population
Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Geriatric population
EMADINE has not been studied in elderly patients older than 65 years, and therefore its use is not
recommended on this population.
Use in hepatic and renal impairment
EMADINE has not been studied in patients with hepatic disease or renal impairment and therefore its use
is not recommended on this population.
Method of administration
• For ocular use.
• To prevent contamination of the dropper tip and solution, care should be taken not to touch the
eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
• Keep the bottle tightly closed when not in use. Do not use if the solution has become discolored.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients.
4.4. Special Warnings and Precautions for Use
EMADINE contains benzalkonium chloride which may cause eye irritation and is known to discolor soft
contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses
prior to application of EMADINE and wait at least 15 minutes before reinsertion.
4.5. Interaction with other Medicinal Products and Other Forms of Interaction
No interaction studies have been performed.
4.6. Pregnancy and Lactation
Fertility