Latop 50 microgram/ml eye drops, solution

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Latanoprost

Inapatikana kutoka:

Rowex Ltd

ATC kanuni:

S01EE; S01EE01

INN (Jina la Kimataifa):

Latanoprost

Kipimo:

50 microgram(s)/millilitre

Dawa fomu:

Eye drops, solution

Dawa ya aina:

Product subject to prescription which may not be renewed (A)

Eneo la matibabu:

Prostaglandin analogues1); latanoprost

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2011-09-09

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LATOP 50 MICROGRAM/ML EYE DROPS, SOLUTION
latanoprost
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 Latop is and what it is used for
2.
What you need to know before you use Latop
3.
How to use Latop
4.
Possible side effects
5.
How to store Latop
6.
Contents of the pack and other information
1. WHAT LATOP IS AND WHAT IT IS USED FOR
Latop contains the active substance latanoprost. Latanoprost belongs
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.
Latop is used to treat conditions known as
OPEN ANGLE GLAUCOMA
and
OCULAR HYPERTENSION
in adults.
Both of these conditions are linked with an increase in the pressure
within your eye, eventually
affecting your eye sight.
Latop is also used to treat increased eye pressure and glaucoma in all
ages of children and babies.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE LATOP
Latop can be used in adult men and women (including the elderly) and
in children from birth to 18
years of age. Latop has not been investigated in prematurely born
infants (less than 36 weeks
gestation).
DO NOT USE LATOP

If you are
ALLERGIC
to latanoprost or any of the other ingredients of this medicine
(listed in section
6)

If you are pregnant or trying to become pregnant

If you are breast-feeding.
WARNINGS AND PRECAUTIONS
Talk to your doctor or the doctor treating your child or pharmacist
before using Latop or before you
give this to

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Latop 50 microgram/ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml solution contains 50 micrograms of latanoprost (equivalent to
0.005% w/v).
Each drop contains approximately 1.5 micrograms latanoprost.
Excipient with known effect
Each ml contains 0.2 mg benzalkonium chloride (equivalent to 0.02%
w/v) and 6.34 mg/ml phosphate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution.
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
_Adults (including the elderly):_
Recommended therapy is one eye drop in the affected eye(s) once daily.
Optimal effect is obtained if ] Latop is
administered in the evening.
The dose of latanoprost 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 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 medicinal product is being used,
the medicinal products should be administered at
least five minutes apart.
_Paediatric population:_
Latop 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 < 1 year
(4 patients) are very limited (see