BRIMOGAN (Brimonidine Tartrate Ophthalmic Solution (0.15%) 1.5mgml)

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

BRIMONIDINE TARTRATE

Mevcut itibaren:

ARMS PHARMA SDN. BHD.

INN (International Adı):

BRIMONIDINE TARTRATE

Paketteki üniteler:

5 ml

Tarafından üretildi:

INDOCO REMEDIES LIMITED

Bilgilendirme broşürü

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
BRIMOGAN
OPHTHALMIC SOLUTION
Brimonidine tartrate (1.5 mg/ml)
WHAT IS IN THIS LEAFLET
1.
What BRIMOGAN is used for
2.
How BRIMOGAN works
3.
Before you use BRIMOGAN
4.
How to use BRIMOGAN
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
BRIMOGAN
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT BRIMOGAN IS USED FOR
BRIMOGAN is used to lower pressure in
the eye of people with glaucoma or high
pressure in the eye.
HOW BRIMOGAN WORKS
BRIMOGAN is an eye drop solution that
reduces the amount
of fluid flowing into
the eye and increases the amount of fluid
flowing out
of the eye.
This reduces the
pressure inside the eye.
BEFORE YOU USE BRIMOGAN
-
_When you must not use it_
Do not use BRIMOGAN:
-
If
you are allergic (hypersensitive
to Brimonidine tartrate,
or
any of
the
other
ingredients
of
BRIMOGAN.
(For
a
full
list of
ingredients,
see
section
“PRODUCT DESCRIPTION”).
-
If
you
are
taking
monoamine
oxidase antidepressant
medication
(MAO)
-
For neonates and infants (children
under the age of 2 years)
If you are not sure whether you should
start
using BRIMOGAN,
talk to your
doctor.
-
_Pregnancy and lactation_
Discuss with your
doctor
the possible
risks
and
benefits
of
using
BRIMOGAN during pregnancy.
Discuss with your
doctor
the possible
risks
and
benefits
of
using
BRIMOGAN when breast-feeding.
-
_Children_
The
safe
and
effective
use
of
BRIMOGAN in children under the age
of 2 has not been established.
-
_Before you start use it_
Tell your doctor if:
1.
You have had an allergy to any
other
medicines
or
any
other
substances,
such
as
foods,
preservatives or dyes.
2.
You have or have had any medical
conditions,
especially
the
following:
-
Liver or kidney disease
- Severe,
uncontrolled
heart
disease,
poor
blood flow to the
heart
or
recurring inflammation
and clotting of small and medium
blood vessels of
the hands and
feet.
-
Poor blood flow to the brain
-
Depression
-
Raynaud’s phenomenon.
This is
a
condition

Ürün özellikleri

to the foetus.
LACTATION
It is not known whether brimonidine is excreted in human milk,
although in animal studies, Brimogan tartrate has
been shown to be excreted in breast milk. A decision should be made
whether to discontinue nursing or to
discontinue the drug, taking into account the importance of the drug
to the mother.
PAEDIATRIC USE
The safety and effectiveness have not been studied in paediatric
patients below the age of 2 years. BRIMOGAN is
not recommended for use in paediatric patients under the age of 2
years.
GERIATRIC USE
No overall differences in safety or effectiveness have been observed
between elderly and other adult patients.
UNDESIRABLE EFFECTS
Side effects occurring are oral dryness, ocular hyperemia, burning and
stinging, headache, blurring foreign body
sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic
reactions and ocular pruritus.
The following adverse reactions can be reported rarely: lid crusting,
conjunctival hemorrhage, abnormal taste.
insomnia, conjunctival discharge, depression, hypertension, anxiety,
palpitations/arrhythmias, nasal dryness
and syncope.
Events occurring also included corneal staining/erosion, photophobia,
eyelid erythema, ocular ache/pain, ocular
dryness, tearing, upper respiratory symptoms, eyelid edema,
conjunctival edema, dizziness, blepharitis, ocular
irritation, gastrointestinal symptoms asthenia, conjunctival
blanching, abnormal vision and muscular pain.
The following events have been identified during post-marketing use of
BRIMOGAN in clinical practice. Because
they are reported voluntarily from a population of unknown size,
estimates of frequency cannot be made. The
events, which have been chosen for inclusion due to either their
seriousness, frequency of reporting, possible
causal connection to BRIMOGAN or a combination of these factors,
include: bradycardia; hypotension; iritis;
miosis; skin reactions (including erythema, eyelid pruritus, rash, and
vasodilation); and tachycardia.
Apnea, bradycardia, hypotension, hypothermia, hypotonia, a