Monopost Unidose 50 micrograms/ml eye drops, solution in single-dose container

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Latanoprost

Available from:

Laboratoires Thea

ATC code:

S01EE; S01EE01

INN (International Name):

Latanoprost

Dosage:

50 microgram(s)/millilitre

Pharmaceutical form:

Eye drops, solution in single-dose container

Prescription type:

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

Therapeutic area:

Prostaglandin analogues1); latanoprost

Authorization status:

Marketed

Authorization date:

2012-09-24

Patient Information leaflet

MODULE 1 -
ADMINISTRATIVE INFORMATION AND PRESCRIBING
INFORMATION
1.3
P
RODUCT
I
NFORMATION
1.3.1
SPC, LABELLING AND PACKAGE LEAFLET
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MONOPOST
UNIDOSE
50 MICROGRAMS/ML EYE DROPS, SOLUTION IN SINGLE-DOSE CONTAINER
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 or
nurse.
-
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 or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What MONOPOST UNIDOSE is and what it is used for
2.
What you need to know before you use MONOPOST UNIDOSE
3.
How to use MONOPOST UNIDOSE
4.
Possible side effects
5.
How to store MONOPOST UNIDOSE
6.
Contents of the pack and other information
1.
WHAT MONOPOST UNIDOSE IS AND WHAT IT IS USED FOR
MONOPOST UNIDOSE belongs to a group of medicines known as
prostaglandins. It lowers
the pressure within your eye by increasing the natural outflow of
fluid from inside the eye into
the bloodstream.
MONOPOST UNIDOSE is used to treat conditions known as open angle
glaucoma
and
ocular hypertension. Both of these conditions are linked with an
increase in the pressure
within your eye, eventually affecting your eye sight.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MONOPOST UNIDOSE
DO NOT USE MONOPOST UNIDOSE
•
If you are allergic (hypersensitive) to latanoprost or any of the
other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, or pharmacist or nurse before using MONOPOST
UNIDOSE if you think
any of the following apply to you:
•
If you are about to have or have had eye surgery (including cataract
surgery).
•
If you suffer from eye proble

Summary of Product characteristics

Health Products Regulatory Authority
05 May 2022
CRN00CW4D
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Monopost Unidose 50 micrograms/ml eye drops, solution in single-dose
container
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml eye drops solution contains 50 micrograms of latanoprost.
One drop contains approximately 1.5 micrograms of latanoprost.
Excipient with known effect: 1 ml eye drops solution contains 50 mg of
macrogolglycerol hydroxystearate 40 (castor oil
polyoxyl hydrogenated).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution in single-dose container.
The solution is a slightly yellow and opalescent solution.
pH: 6.5 – 7.5
Osmolality: 250-310 mosmol/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of elevated intraocular pressure in patients with open angle
glaucoma and ocular hypertension.
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 Monopost Unidose is
administered in the evening.
The dosage of Monopost Unidose 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.
_Paediatric population:_
No data are available with Monopost Unidose formulation.
Method of administration
Ocular use.
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.
Health