Latanoprost 50 microgram/ml eye drops, solution

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Latanoprost

Inapatikana kutoka:

Actavis Group PTC ehf

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:

Marketed

Idhini ya tarehe:

2011-01-28

Taarifa za kipeperushi

BBBA5531
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Details
LATANOPROST EYE DROPS 50MCG/0.005% 2.5ML VIAL DROPS PIL - UK
Black
BBBA5531
RH
19-07-19
135 x 440
8.5pt
Siegfried
19-07-19
19-07-19
01
Version 2
01.11.2017
LATANOPROST 50 MICROGRAMS/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
an

Tabia za bidhaa

Health Products Regulatory Authority
22 January 2019
CRN008QS1
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Latanoprost 50 microgram/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 is administered in the evening.
The dosage of Latanoprost should not exceed once daily since it has
been shown
that more frequent administration decreases the intraocular pressure
lowering effect.
Health Products Regulatory Authority
22 January 2019
CRN008QS1
Page 2 of 13
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 drug
should be
administered at least five minutes apart.
_Paediatric population_
Latanoprost eye drops may be used in paediatric patients at the same
po