Eyreida 0.3mg/ml eye drops

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Bimatoprost

Dostupno od:

Aspire Pharma Ltd

ATC koda:

S01EE03

INN (International ime):

Bimatoprost

Doziranje:

300microgram/1ml

Farmaceutski oblik:

Eye drops

Administracija rute:

Ocular

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 11060000; GTIN: 5060209731841

Uputa o lijeku

PACKAGE LEAFLET:
INFORMATION FOR THE USER
0.3MG/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 Eyreida is and what it is
used for
2. What you need to know before you
use Eyreida
3. How to use Eyreida
4. Possible side effects
5. How to store Eyreida
6. Contents of the pack and other
information
1. WHAT EYREIDA IS AND WHAT
IT IS USED FOR
Eyreida is an anti-glaucoma
preparation. It belongs to a group of
medicines called prostamides.
Eyreida is used to reduce high
pressure in the eye in adults. 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.
Eyreida eye drops solution is a sterile
solution that does not contain a
preservative.
2. WHAT YOU NEED TO KNOW
BEFORE YOU USE EYREIDA
DO NOT USE EYREIDA:
• if you are allergic to bimatoprost or
any of the other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist
before using Eyreida.
PLEASE TELL YOUR DOCTOR OR
PHARMACIST, IF:
• you have a

Svojstava lijeka

OBJECT 1
EYREIDA 0.3MG/ML EYE DROPS, SOLUTION
Summary of Product Characteristics Updated 06-Mar-2018 | Aspire Pharma
Ltd
1. Name of the medicinal product
Eyreida 0.3mg/ml eye drops, solution
2. Qualitative and quantitative composition
1 ml of solution contains 0.3mg of bimatoprost.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye drops, solution.
Clear, colourless, eye drops.
Osmolality: 261-319 mOsm/Kg
pH: 6.8 – 7.8
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.
Eyreida eye drops solution is a sterile solution that does not contain
a preservative.
_Paediatric population:_
The safety and efficacy of Eyreida in children aged 0 to 18 years has
not yet been established. No data are
currently available.
_Hepatic or renal impairment_
Eyreida 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 (preserved formulation), 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.
_Before instillation of the eye drops_
- Users should be instructed to wash their hands before opening the
bottle.
- Users should also be instructed to not use this medicine if they
notice that the tamper-proof seal on the
bottle neck is broken before