Latanoprost 50micrograms/ml eye drops

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Latanoprost

Disponível em:

Accord-UK Ltd

Código ATC:

S01EE01

DCI (Denominação Comum Internacional):

Latanoprost

Dosagem:

50microgram/1ml

Forma farmacêutica:

Eye drops

Via de administração:

Ocular

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 11060000; GTIN: 5012617021632

Folheto informativo - Bula

AAAI4212
_Continued top of next column_
Latanoprost Eye Drops 50mcg/0.005% vial drops leaflet - UK
item no:
print proof no:
origination date:
originated by:
revision date:
revised by:
dimensions:
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1. Profile
2.
3.
date sent:
supplier:
technically app. date:
min pt size:
TECHNICAL APPROVAL
AAAI4212
7
22.10.15
jh
06.01.16
jh
Siegfried
135 x 440
8.5
22.10.15
02.11.15
LATANOPROST 50MICROGRAMS/ML
EYE DROPS SOLUTION
_Continued over page_
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 the doctor treating your
child or your pharmacist.
•
This medicine has been prescribed for
you or for your child 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 or your child get any side
effects, talk to your doctor or the
doctor treating your child or your
pharmacist. This includes any possible
side effects not listed in this leaflet.
See section 4.
•
The full name of this medicine is
Latanoprost 50micrograms/ml Eye
Drops Solution but within the leaflet it
will be referred to as Latanoprost eye
drops.
WHAT IS IN THIS LEAFLET:
1 WHAT LATANOPROST EYE DROPS ARE
AND WHAT THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE
YOU USE LATANOPROST EYE DROPS
3 HOW TO USE LATANOPROST EYE
DROPS
4 POSSIBLE SIDE EFFECTS
5
HOW TO STORE LATANOPROST EYE
DROPS
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT LATANOPROST EYE DROPS
ARE AND WHAT THEY ARE USED FOR
Latanoprost eye drops belong to a group
of medicines known as prostaglandin
analogues. It works by increasing the
natural outflow of fluid from inside the
eye into the bloodstream.
Latanoprost eye drops are used to
treat conditions known AS OPEN ANGLE
GLAUCOMA and OCULAR HYPERTENSION.
Both of these conditions are linked with
an increase in the press

Características técnicas

OBJECT 1
LATANOPROST 50MICROGRAMS/ML EYE DROPS
SOLUTION
Summary of Product Characteristics Updated 06-Jul-2017 | Accord-UK Ltd
1. Name of the medicinal product
Latanoprost 50micrograms/ml Eye Drops Solution
2. Qualitative and quantitative composition
One ml eye drops, solution, contains 50 microgram latanoprost.
One drop contains approximately 1.5 microgram latanoprost.
Excipient with known effect: Benzalkonium chloride 0.2 mg/ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye drops, solution
The solution is a clear colourless liquid. pH 6.4-7.0.
Osmolality 240-290 mOsm/kg.
4. Clinical particulars
4.1 Therapeutic indications
Reduction of elevated intraocular pressure in patients with open angle
glaucoma and ocular hypertension.
Reduction of elevated intraocular pressure in paediatric patients with
elevated intraocular pressure and
paediatric glaucoma.
4.2 Posology and method of administration
Posology
_Recommended dosage for adults (including the elderly)_
Recommended therapy is one eye drop in the affected eye(s) once daily.
Optimal effect is obtained if
Latanoprost 50micrograms/ml Eye Drops Solution is administered in the
evening.
The dosage of Latanoprost 50micrograms/ml Eye Drops Solution should
not exceed once daily since it
has been shown that more frequent administration decreases the
intraocular pressure lowering effect.
If one dose is missed, treatment should continue with the next dose as
normal.
Method of administration
As with any eye drops, to reduce possible systemic absorption, it is
recommended that the lachrymal sac
be compressed at the medial canthus (punctal occlusion) for one
minute. This should be performed
immediately following the instillation of each drop.
Contact lenses should be removed before instillation of the eye drops
and may be reinserted after 15
minutes.
If more than one topical ophthalmic drug is being used, the drugs
should be administered at least five
minutes apart.
_Paediatric population_
Latanoprost 50micrograms/ml Eye Drops Solution may be use