Latanoprost 50micrograms/ml eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Latanoprost

Available from:

Zentiva Pharma UK Ltd

ATC code:

S01EE01

INN (International Name):

Latanoprost

Dosage:

50microgram/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: 5000283655053

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LATANOPROST 0.005% W/V EYE DROPS SOLUTION
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE
YOU (OR A CHILD IN YOUR CARE) START USING
THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leafl et. 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
leafl et. See section 4.
IN THE NEXT SECTIONS, THE WORD ‘YOU’
MEANS YOU OR A CHILD IN YOUR CARE.
WHAT IS IN THIS LEAFL ET
1. What Latanoprost eye drops are and what
they are used for
2. What do 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 belongs to a group of
medicines called prostaglandin analogues.
Latanoprost eye drops lower the pressure
within your eye by increasing the natural
fl ow of fl uid from inside the eye into the
blood stream.
Latanoprost eye drops are used to
treat open angle glaucoma and ocular
hypertension. These conditions are caused
by an increase in the pressure in your eye.
If they are not treated they may affect your
eyesight.
Latanoprost eye drops can be used in adult
men and women (including the elderly)
and in children from birth to 18 years of
age. Latanoprost eye drops has not been
investigated in prematurely born infants (less
than 36 weeks gestation).
2 WHAT DO YOU NEED TO KNOW
BEFORE YOU USE LATANOPROST
EYE DROPS
DO NOT USE LATANOPROST EYE DROPS
- if you are ALLERGIC to the active substance
latanoprost or any of the other ingredients of
this medicine (listed in section 6).
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist be

Summary of Product characteristics

OBJECT 1
LATANOPROST 0.005% W/V EYE DROPS SOLUTION
Summary of Product Characteristics Updated 23-May-2018 | Zentiva
1. Name of the medicinal product
Latanoprost 0.005% w/v eye drops solution.
2. Qualitative and quantitative composition
1 ml eye drops solution contains 50 micrograms latanoprost.
One drop contains approximately 1.5 micrograms 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.
4. Clinical particulars
4.1 Therapeutic indications
Reduction of elevated intraocular pressure
• in patients with open angle glaucoma and ocular hypertension.
• 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 eye drops is administered in the evening.
The dosage of Latanoprost eye drops 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.
As with any eye drops, to reduce possible systemic absorption, it is
recommended that the lachrymal sac
is 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 medicinal product is being used,
the medicinal products should be
administered at least five minutes apart.
_Paediatric population_
Latanoprost eye drops may be used in paediatric patients at the same
posology as in adults. No data are
available for preterm infants (less than 36 weeks gestational age).
Data in the age group <