OPTILAST

Country: ইস্রায়েল

ভাষা: ইংরেজি

সূত্র: Ministry of Health

সক্রিয় উপাদান:

AZELASTINE HYDROCHLORIDE

থেকে পাওয়া:

MEGAPHARM LTD

এটিসি কোড:

S01GX07

ফার্মাসিউটিকাল ফর্ম:

EYE DROPS, SOLUTION

রচনা:

AZELASTINE HYDROCHLORIDE 0.05 %

প্রশাসন রুট:

OCULAR

প্রেসক্রিপশন টাইপ:

Required

Manufactured by:

MEDA PHARMA GmbH & CO.KG, GERMANY

Therapeutic group:

AZELASTINE

Therapeutic area:

AZELASTINE

থেরাপিউটিক ইঙ্গিত:

Symptomatic treatment and prevention of seasonal allergic conjunctivitis.

অনুমোদন তারিখ:

2015-02-28

তথ্য লিফলেট

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS - 1986
This medicine is dispensed with a
physician’s prescription only
OPTILAST, EYE DROPS
ACTIVE INGREDIENT:
Azelastine hydrochloride 0.05%
Each drop contains 0.015 mg Azelastine
hydrochloride
For a list of inactive and allergenic ingredients
in the preparation - see section 6. See also
“Important information about some of the
medicine’s ingredients” in section 2.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet
contains concise information about the
medicine. If you have any further questions,
consult your physician or pharmacist.
This medicine has been prescribed to treat
your illness. Do not pass it on to others. It
may harm them even if it seems to you that
their illness is similar.
This medicine is not intended for children
and infants below 4 years of age.
1. WHAT IS THE MEDICINE USED FOR?
Optilast is used for symptomatic treatment
and prevention of seasonal allergic
conjunctivitis.
THERAPEUTIC GROUP: Antihistamines
Antihistamines prevent the effect of a
substance called histamine which is
produced by the body as part of an allergic
reaction. Azelastine hydrochloride reduces
inflammation of the eye.
OPTILAST IS NOT INTENDED FOR TREATMENT OF
EYE INFECTIONS!
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
-
You are sensitive )allergic( to the active
ingredient, azelastine hydrochloride, or
to any of the other ingredients contained
in the medicine )see section 6(.
SPECIAL WARNINGS REGARDING THE USE OF
THE MEDICINE
BEFORE THE TREATMENT WITH OPTILAST, TELL
YOUR PHYSICIAN:
• If you are unsure whether your eye
symptoms are caused by an allergy. In
particular, if the symptoms appear only in
one eye. If your vision quality is impaired or
the eye hurts and no symptoms are felt in
the nose, you may have an infection rather
than an allergy.
• If the symptoms worsen or last longer than
48 hours without significant improvement,
despite the treatment with Optilast.
• If you wear contact lens

পণ্য বৈশিষ্ট্য

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SUMMARY OF PRODUCT CHARACTERISTICS OPTILAST®
1.
NAME OF THE MEDICINAL PRODUCT
OPTILAST
0.5 mg/ml, Eye Drops, solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Azelastine hydrochloride 0.05% (0.5 mg/ml). Each drop contains 0.015
mg
azelastine hydrochloride.
Excipients with known effect: 1 ml contains 0.125 mg of Benzalkonium
chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Symptomatic treatment and prevention of seasonal allergic
conjunctivitis.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Seasonal allergic conjunctivitis:
Unless otherwise prescribed, the usual dosage in adults and children 4
years
and older is one drop in each eye twice daily. This dosage can be
increased, if
necessary to up to four times daily.
If allergen exposure is, anticipated OPTILAST eye drops should be
administered
prophylactically, prior to the exposure.
Patients should be advised to contact their doctor if symptoms worsen
or do
not improve after 48 hours.
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
OPTILAST is not intended for treatment of eye infections. Further
warnings see
4.5 and 4.6.
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OPTILAST
eye
drops
contains
the
preservative
benzalkonium
chloride.
Benzalkonium chloride may cause eye irritations,
especially with dry eyes or
disorders of the cornea. Contact with soft contact lenses should be
avoided.
Contact lenses should be removed prior to application and the patient
should
wait at least 15 minutes before reinsertion. Known to discolour soft
contact
lenses.
4.5.
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
No specific interaction studies with OPTILAST have been performed.
Interaction studies at high oral doses of Azelastine have been
performed;
however,
they
bear
no
relevance
to
OPTILAST,
as
systemic
levels
after
administration