Sturiban 0.3mg/ml eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bimatoprost

Available from:

Actavis UK Ltd

ATC code:

S01EE03

INN (International Name):

Bimatoprost

Dosage:

300microgram/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11060000; GTIN: 5012617026545 5012617026552

Patient Information leaflet

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.
•
The full name of this medicine
is Sturiban 0.3mg/ml Eye Drops
Solution but within the leaflet it will
be referred to as Sturiban.
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 d

Summary of Product characteristics

OBJECT 1
STURIBAN 0.3MG/ML EYE DROPS SOLUTION
Summary of Product Characteristics Updated 15-Jan-2018 | Accord-UK Ltd
1. Name of the medicinal product
Sturiban 0.3mg/ml Eye Drops Solution
2. Qualitative and quantitative composition
One ml of solution contains 0.3 mg bimatoprost
Excipient(s) with known effect:
One ml of solution contains 0.05 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
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 chlori