Azopt
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
29-03-2023
Charakterystyka produktu
(SPC)
29-03-2023
Sprawozdanie z oceny publicznego
(PAR)
18-06-2014
Składnik aktywny:
brinzolamide
Dostępny od:
Novartis Europharm Limited
Kod ATC:
S01EC04
INN (International Nazwa):
brinzolamide
Grupa terapeutyczna:
Ophthalmologicals
Dziedzina terapeutyczna:
Glaucoma, Open-Angle; Ocular Hypertension
Wskazania:
Azopt is indicated to decrease elevated intraocular pressure in:ocular hypertension;open-angle glaucomaas monotherapy in adult patients unresponsive to beta-blockers or in adult patients in whom beta-blockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues.
Podsumowanie produktu:
Revision: 28
Status autoryzacji:
Authorised
Data autoryzacji:
2000-03-09
Ulotka dla pacjenta
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
AZOPT 10 MG/ML EYE DROPS, SUSPENSION
brinzolamide
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 or your 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What AZOPT is and what it is used for
2.
What you need to know before you use AZOPT
3.
How to use AZOPT
4.
Possible side effects
5.
How to store AZOPT
6.
Contents of the pack and other information
1.
WHAT AZOPT IS AND WHAT IT IS USED FOR
AZOPT contains brinzolamide which belongs to a group of medicines
called carbonic anhydrase
inhibitors. It reduces pressure within the eye.
AZOPT eye drops are used to treat high pressure in the eye. This
pressure can lead to an illness called
glaucoma.
If the pressure in the eye is too high, it can damage your sight.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE AZOPT
DO NOT USE AZOPT
-
if you have severe kidney problems.
-
if you are allergic to brinzolamide or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are allergic to medicines called sulphonamides. Examples
include medicines used to treat
diabetes and infections and also diuretics (water tablets). AZOPT may
cause the same allergy.
-
if you have too much acidity in your blood (a condition called
hyperchloraemic acidosis).
If you have further questions, ask your doctor for advice.
23
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using AZOPT:
-
if you have kidney or liver problems.
-
if you have dry eyes or cornea problems.
-
if you are taking other sulphonamide medicines
-
if you have a specific form
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
AZOPT 10 mg/ml eye drops, suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of suspension contains 10 mg brinzolamide.
Excipient with known effect
Each ml of suspension contains 0.1 mg benzalkonium chloride.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension.
White to off-white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AZOPT is indicated to decrease elevated intraocular pressure in:
•
ocular hypertension
•
open-angle glaucoma
as monotherapy in adult patients unresponsive to beta-blockers or in
adult patients in whom beta-
blockers are contraindicated, or as adjunctive therapy to
beta-blockers or prostaglandin analogues (see
also section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
When used as monotherapy or adjunctive therapy, the dose is one drop
of AZOPT in the conjunctival
sac of the affected eye(s) twice daily. Some patients may have a
better response with one drop
three times a day.
_Special populations_
_Elderly population _
No dose adjustment in elderly patients is necessary.
_Hepatic and renal impairment _
AZOPT has not been studied in patients with hepatic impairment and is
therefore not recommended in
such patients.
AZOPT has not been studied in patients with severe renal impairment
(creatinine clearance
< 30 ml/min) or in patients with hyperchloraemic acidosis. Since
brinzolamide and its main metabolite
are excreted predominantly by the kidney, AZOPT is therefore
contra-indicated in such patients (see
also section 4.3).
3
_Paediatric population _
The safety and efficacy of AZOPT in infants, children and adolescents
aged 0 to 17 years have not
been established. Currently available data are described in sections
4.8 and 5.1. AZOPT is not
recommended for use in infants, children and adolescents.
Method of administration
For ocular use.
Nasolacrimal occlusion or gently closing the eyelid after instillation
is recommended. This may redu
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