Simbrinza
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
19-12-2022
Karatteristiċi tal-prodott
(SPC)
19-12-2022
Rapport ta 'Valutazzjoni Pubblika
(PAR)
31-07-2014
Ingredjent attiv:
brinzolamide, brimonidine tartrate
Disponibbli minn:
Novartis Europharm Limited
Kodiċi ATC:
S01EC54
INN (Isem Internazzjonali):
brinzolamide, brimonidine tartrate
Grupp terapewtiku:
Ophthalmologicals
Żona terapewtika:
Ocular Hypertension; Glaucoma, Open-Angle
Indikazzjonijiet terapewtiċi:
Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.
Sommarju tal-prodott:
Revision: 10
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2014-07-18
Fuljett ta 'informazzjoni
25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIMBRINZA 10 MG/ML + 2 MG/ML EYE DROPS, SUSPENSION
brinzolamide/brimonidine tartrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, optometrist
(optician) or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, optometrist
(optician) or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What SIMBRINZA is and what it is used for
2.
What you need to know before you use SIMBRINZA
3.
How to use SIMBRINZA
4.
Possible side effects
5.
How to store SIMBRINZA
6.
Contents of the pack and other information
1.
WHAT SIMBRINZA IS AND WHAT IT IS USED FOR
SIMBRINZA contains two active substances, brinzolamide and brimonidine
tartrate. Brinzolamide
belongs to a group of medicines called carbonic anhydrase inhibitors
and brimonidine tartrate belongs
to a group of medicines called alpha-2 adrenergic receptor agonists.
Both substances work together to
reduce pressure within the eye.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SIMBRINZA
DO NOT USE SIMBRINZA
-
if you are allergic to brinzolamide or brimonidine tartrate or any of
the other ingredients of this
medicine (listed in section 6)
-
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
dep
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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
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 section 4.3).
_Paediatric population _
The safety and efficacy of SIMBRINZA in children and adolescents aged
2 to 17 years have not been
established. No data are available.
SIMBRINZA is contraindicated in neonates and infants aged less than 2
years in the decrease of
elevated intraocular pressure (IOP) with open-angle glaucoma or ocular
hypertension for whom
monotherapy provides insufficient IOP reduction because of safety
concerns (see section 4.3).
3
Method of administration
For ocular use.
Patie
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