SIMBRINZA 10mgml + 2mgml eye drops suspension

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

BRINZOLAMIDE; BRIMONIDINE TARTRATE

Dostopno od:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (mednarodno ime):

BRINZOLAMIDE; BRIMONIDINE TARTRATE

Enote v paketu:

5ml mL

Izdeluje:

ALCON COUVREUR N.V

Navodilo za uporabo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
SIMBRINZA
® EYE DROPS, SUSPENSION
Brinzolamide 10mg/ml + Brimonidine Tartrate 2mg/ml
1
WHAT IS IN THIS LEAFLET
1.
What Simbrinza is used for
2.
How Simbrinza works
3.
Before you use Simbrinza
4.
How to use Simbrinza
5.
While you are using Simbrinza
6.
Side effects
7.
Storage and Disposal of
Simbrinza
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT SIMBRINZA IS USED FOR
SIMBRINZA is used to lower
pressure in the eyes in adult patients
(aged 18 years and over) who have
eye conditions known as glaucoma or
ocular hypertension and whose high
pressure in the eyes cannot be
controlled effectively by one
medicine alone.
HOW SIMBRINZA WORKS
Works by decreasing intraocular
pressure in adult patients with open-
angle glaucoma or ocular
hypertension.
BEFORE YOU USE SIMBRINZA
_- When you must not use it _
DO NOT USE SIMBRINZA
_ _
_ _
•
If you are allergic to
brimonidine tartrate,
brinzolamide or any of the other
ingredients of this medicine.
•
If you are allergic to
sulphonamides (examples
include medicines used to treat
diabetes and infections and also
diuretics (water tablets)).
•
If you are taking a monoamine
oxidase (MAO) inhibitors
(examples include medicines to
treat depression or Parkinson’s
disease) or certain
antidepressants.
You must inform your doctor if
you are taking any
antidepressant medicines.
•
If you have severe kidney
problems.
•
If you have too much acidity in
your blood (a condition called
hyperchloraemic acidosis).
•
In babies and infants aged less
than 2 years.
Talk to your doctor or pharmacist
before using SIMBRINZA if you
have now or have had in the past:
-
liver problems
-
a type of high pressure in the
eyes called narrow-angle
glaucoma
-
dry eyes or cornea problems
-
coronary heart disease
(symptoms can include chest
pain or tightness, breathlessness
or choking), heart failure, high
or low blood pressure
-
depression
-
disturbed or poor blood
circulation (such as Raynaud’s
disease,

Lastnosti izdelka

Novartis
Page 1
Malaysian Package Insert
22-Mar-2019
Simbrinza
®
1
Regulatory Affairs
SIMBRINZA
®
(brinzolamide 10 mg/mL /brimonidine 2 mg/mL)
Eye drops, suspension
MALAYSIAN PACKAGE INSERT
(SEP 19, EU 02 SEP 2019)
_ _
Effective date:
22-Mar-2019
Safety
Label
Change
(SLC) Tracking Number:
2019-PSB/GLC-1047-s
Document status:
Final
Novartis
Page 2
Malaysian Package Insert
22-Mar-2019
Simbrinza
®
2
1.
NAME OF THE MEDICINAL PRODUCT
SIMBRINZA 10 mg/mL + 2 mg/mL eye drops, suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of suspension contains 10 mg of brinzolamide and 2 mg of
brimonidine tartrate equivalent to 1.3 mg
of brimonidine.
Excipient with known effect
Each mL of suspension contains 0.03 mg of benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension (eye drops).
White-to-off-white uniform suspension, pH 6.5 (approximately).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SIMBRINZA eye drops contains brinzolamide, a carbonic anhydrase
(CA-II) inhibitor, and brimonidine
tartrate, an alpha-2 adrenergic agonist.
Decrease of elevated intraocular pressure (IOP) in adult patients with
open-angle glaucoma or ocular
hypertension for whom monotherapy provides insufficient IOP reduction
(see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Use in adults, including the elderly _
The recommended dose is one drop of SIMBRINZA in the affected eye(s)
two times daily.
_Missed dose _
If a dose is missed, treatment should be continued with the next dose
as planned.
_Hepatic and/or renal impairment _
SIMBRINZA has not been studied in patients with hepatic impairment and
caution is therefore
recommended in this population (see section 4.4).
SIMBRINZA has not been studied in patients with severe renal
impairment (CrCl <30 mL/min) or in
patients with hyperchloraemic acidosis. Since the brinzolamide
component of SIMBRINZA and its
metabolite are excreted predominantly by the kidney, SIMBRINZA is
contraindicated in such patients
(see sectio