GLAUCOTIMA 50mcg/ml + 5 Mg/Ml Eye Drops Solution
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
23-01-2015
Summary of Product characteristics
(SPC)
23-01-2015
Active ingredient:
LATANOPROST, TIMOLOL MALEATE
Available from:
PharmaSwiss Ceska republika s.r.o.
ATC code:
S01ED51
INN (International Name):
LATANOPROST, TIMOLOL MALEATE
Dosage:
50mcg/ml + 5 Mg/Ml
Pharmaceutical form:
Eye Drops Solution
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Beta blocking agents
Authorization status:
Authorised
Authorization date:
2013-08-29
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLAUCOTIMA 50 MICROGRAM/5.0 MG PER ML EYE DROPS, SOLUTION
Latanoprost / Timolol
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 Glaucotima is and what it is used for
2.
What you need to know before you use Glaucotima
3.
How to use Glaucotima
4.
Possible side effects
5.
How to store Glaucotima
6.
Contents of the pack and other information
1.
WHAT GLAUCOTIMA IS AND WHAT IT IS USED FOR
Glaucotima is a combination
of two different medicines that both
contribute to lowering the pressure
in the eye, but in different ways. Timolol is one of a group
of medicines known as “beta-blockers” and
lowers the pressure in the eye
by reducing the inflow of fluid inside the
eye. Latanoprost lowers the
pressure by increasing the natural outflow of fluid
from the inside of the eye.
Latanoprost / timolol is used for lowering increased pressure
within the eye (called ocular
hypertension) and for the treatment of glaucoma.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE GLAUCOTIMA
DO NOT USE GLAUCOTIMA
-
if you have now or have had in
past respiratory problems such as asthma, severe chronic
obstructive bronchitis;
-
if you
have serious heart problems or heart rhythm d
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glaucotima 50 microgram/5.0 mg per ml eye drops, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 50 microgram latanoprost and 6.8 mg timolol maleate equivalent to 5 mg timolol.
Excipient(s) with known effect:
benzalkonium chloride 0.2 mg/ml
sodium dihydrogen phosphate, monohydrate 6.39 mg/ml
disodium phosphate, anhydrous 2.89 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.
Osmolality: 280~320 mOsmol/kg :
pH: 5.0 – 7.0.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Reduction of intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are
insufficiently responsive to topical beta-blockers or prostaglandin analogues.
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.
If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in
the affected eye(s) daily.
_Paediatric population_
Safety and effectiveness in children and adolescents has not been established.
Method of administration
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.
When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may
result in a decrease in systemic side effects and an increase in local activity.
4.3 CONTRAINDICATIONS
-
Reactive airway disease including bronchial asthma or a h
Read the complete document
