Bimatoprost Accord 0.3mg/ml eye drops solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BIMATOPROST

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

S01EE03

INN (International Name):

BIMATOPROST 0.3 mg/ml

Pharmaceutical form:

EYE DROPS, SOLUTION

Composition:

BIMATOPROST 0.3 mg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Withdrawn

Authorization date:

2016-01-20

Patient Information leaflet

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
BIMATOPROST ACCORD 0.3 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 Bimatoprost Accord is and what it is used for
2.
What you need to know before you use Bimatoprost Accord
3.
How to use Bimatoprost Accord
4.
Possible side effects
5.
How to store Bimatoprost Accord
6.
Contents of the pack and other information
1.
WHAT BIMATOPROST ACCORD IS AND WHAT IT IS USED FOR
Bimatoprost Accord is an antiglaucoma preparation. It belongs to a
group of medicines called
prostamides.
Bimatoprost Accord 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 BIMATOPROST ACCORD
DO NOT USE BIMATOPROST ACCORD:
-
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
preservati

Summary of Product characteristics

Page 1 of 9
1.
NAME OF THE MEDICINAL PRODUCT
Bimatoprost Accord 0.3 mg/ml eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 0.3 mg bimatoprost
Excipient 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 Bimatoprost Accord in children aged 0 to 18
years has not yet been
established.
_Patients with hepatic and renal impairment _
Bimatoprost Accord 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.
Page 2 of 9
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
Bimatoprost Accord is contraindicated in patients who have had a
suspected previous adverse
reaction to benzalkonium chloride that has led to discontinuation.
4.4
SPECIAL WARNI