Brinzolamide Actavis Eye Drops Suspension 10mg/ml

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

BRINZOLAMIDE

Dostupné s:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC kód:

S01EC04

INN (Mezinárodní Name):

BRINZOLAMIDE 10 mg/ml

Léková forma:

EYE DROPS, SUSPENSION

Složení:

BRINZOLAMIDE 10 mg/ml

Druh předpisu:

POM

Terapeutické oblasti:

OPHTHALMOLOGICALS

Stav Autorizace:

Withdrawn

Datum autorizace:

2016-01-26

Informace pro uživatele

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRINZOLAMIDE ACTAVIS 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Brinzolamide Actavis is and what it is used for
2.
What you need to know before you use Brinzolamide Actavis
3.
How to use Brinzolamide Actavis
4.
Possible side effects
5.
How to store Brinzolamide Actavis
6.
Contents of the pack and other information
1.
WHAT BRINZOLAMIDE ACTAVIS IS AND WHAT IT IS USED FOR
BRINZOLAMIDE ACTAVIS CONTAINS BRINZOLAMIDE WHICH BELONGS TO A GROUP OF
MEDICINES called
carbonic anhydrase inhibitors. It reduces pressure within the eye.
BRINZOLAMIDE ACTAVIS IS 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 BRINZOLAMIDE ACTAVIS
DO NOT USE BRINZOLAMIDE ACTAVIS:
-
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).
Brinzolamide Actavis 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.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Brinzolamide
A

Charakteristika produktu

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Brinzolamide Actavis 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 0.15 mg benzalkonium chloride.
For the 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
Brinzolamide Actavis 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 Brinzolamide Actavis 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 _
Brinzolamide has not been studied in patients with hepatic impairment
and is therefore not
recommended in such patients.
Page 2 of 10
Brinzolamide 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, Brinzolamide
Actavis is therefore contra-
indicated in such patients (see also section 4.3).
_ _
_ _
_Paediatric population _
The safety and efficacy of Brinzolamide Actavis in infants, children
and adolescents aged 0 to 17
years has not been established. Currently available data are described
in sections 4.8 and 5.1.
Brinzolamide Actavis is not recommended for use in infants, children
and adolescents.
Method of ad