Sturiban Eye Drops Solution 0.1mg/ml

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

BIMATOPROST

Prieinama:

Actavis Group PTC ehf

ATC kodas:

S01EE03

INN (Tarptautinis Pavadinimas):

BIMATOPROST

Vaisto forma:

EYE DROPS, SOLUTION

Sudėtis:

BIMATOPROST 0.1 mg/ml

Recepto tipas:

POM

Gydymo sritis:

OPHTHALMOLOGICALS

Autorizacija statusas:

Authorised

Pakuotės lapelis

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
STURIBAN 0.1 MG/ML EYE DROPS, SOLUTION
Bimatoprost
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 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 Sturiban is and what it is used for
2.
What you need to know before you use Sturiban
3.
How to use Sturiban
4.
Possible side effects
5.
How to store Sturiban
6.
Contents of the pack and other information
1.
WHAT STURIBAN IS AND WHAT IT IS USED FOR
Sturiban is an antiglaucoma preparation. It belongs to a group of
medicines called prostamides.
Sturiban eye drops are used to reduce high pressure in the eye. This
medicine may be used on its own
or with other drops called beta-blockers which also reduce pressure.
Your eye contains a clear, watery liquid that feeds the inside of the
eye. Liquid is constantly being
drained out of the eye and new liquid is made to replace this. If the
liquid cannot drain out quickly
enough, the pressure inside the eye builds up. This medicine works by
increasing the amount of liquid
that is drained. This reduces the pressure inside the eye. If the high
pressure is not reduced, it could
lead to a disease called glaucoma and eventually damage your sight.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE STURIBAN
DO NOT USE STURIBAN:
-
if you are allergic to bimatoprost or any of the other ingredients of
this medicine (listed in
section 6).
-
if you have had to stop using eye drops in the past because of a side
effect of the preservative
benzalkonium chloride.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Sturiban

Prekės savybės

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sturiban 0.1 mg/ml eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 0.1 mg bimatoprost
Excipient with known effect:
One ml of solution contains 0.2 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution, free from visible particulate matter.
The pH of the solution is 6.8-7.8 and the osmolality is 270-310
mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in chronic open-angle
glaucoma and ocular
hypertension in adults (as monotherapy or as adjunctive therapy to
beta-blockers).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one drop in the affected eye(s) once daily,
administered in the evening.
The dose should not exceed once daily, as more frequent administration
may lessen the intraocular
pressure lowering effect.
_Paediatric population_
The safety and efficacy of Sturiban in children aged 0 to 18 years has
not yet been established.
_Patients with hepatic and renal impairment _
Sturiban has not been studied in patients with renal or moderate to
severe hepatic impairment and
should therefore be used with caution in such patients. In patients
with a history of mild liver
disease or abnormal alanine aminotransferase (ALT), aspartate
aminotransferase (AST) and/or
bilirubin at baseline, bimatoprost 0.3 mg/ml eye drops, solution had
no adverse effect on liver
function over 24 months.
Method of administration
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If more than one topical ophthalmic medicinal product is being used,
each one should be
administered at least 5 minutes apart.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
Sturiban is contraindicated in patients who have had a suspected
previous adverse reaction to
benzalkonium chloride that has led to discontinuation.
4.4
SPECIAL WARNINGS AN