Latanoprost/Timolol Apotex 50 microgram/ml + 5 mg/ml oogdruppels, oplossing

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

LATANOPROST ; TIMOLOLMALEAAT SAMENSTELLING overeenkomend met ; TIMOLOL 0-WATER

Beschikbaar vanaf:

Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN

ATC-code:

S01ED51

INN (Algemene Internationale Benaming):

LATANOPROST ; TIMOLOLMALEAAT COMPOSITION corresponding to ; TIMOLOL 0-WATER

farmaceutische vorm:

Oogdruppels, oplossing

Samenstelling:

BENZALKONIUMCHLORIDE ; DINATRIUMWATERSTOFFOSFAAT 0-WATER (E 339) ; NATRIUMCHLORIDE ; NATRIUMDIWATERSTOFFOSFAAT 1-WATER (E 339) ; NATRIUMHYDROXIDE (E 524) ; WATER VOOR INJECTIE ; ZOUTZUUR (E 507),

Toedieningsweg:

Oculair gebruik

Therapeutisch gebied:

Timolol, Combinations

Product samenvatting:

Hulpstoffen: BENZALKONIUMCHLORIDE; DINATRIUMWATERSTOFFOSFAAT 0-WATER (E 339); NATRIUMCHLORIDE; NATRIUMDIWATERSTOFFOSFAAT 1-WATER (E 339); NATRIUMHYDROXIDE (E 524); WATER VOOR INJECTIE; ZOUTZUUR (E 507);

Autorisatie datum:

2014-09-16

Bijsluiter

LATANOPROST/TIMOLOL APOTEX 50 MICROGRAM/ML + 5 MG/ML
OOGDRUPPELS, OPLOSSING
MODULE 1.3
Product Information- NL
Version: 2019-08
MODULE 1.3.1
Package Leaflet
Replaces : 2017-12-18
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LATANOPROST/TIMOLOL APOTEX 50 MICROGRAM/ML + 5 MG/ML OOGDRUPPELS,
OPLOSSING
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 Latanoprost/Timolol Apotex is and what it is used for
2.
What you need to know before you use Latanoprost/Timolol Apotex
3.
How to use Latanoprost/Timolol Apotex
4.
Possible side effects
5.
How to store Latanoprost/Timolol Apotex
6.
Contents of the pack and other information
1.
WHAT LATANOPROST/TIMOLOL APOTEX IS AND WHAT IT IS USED FOR
Latanoprost/Timolol Apotex contains two medicines: latanoprost and
timolol. Latanoprost
belongs to a group of medicines known as prostaglandin analogues.
Timolol belongs to a group of
medicines known as beta-blockers. Latanoprost works by increasing the
natural outflow of fluid
from the eye into the bloodstream. Timolol works by slowing the
formation of fluid in the eye.
Latanoprost/Timolol Apotex is used to reduce the pressure in your eye
if you have conditions
known as open angle glaucoma or ocular hypertension. Both these
conditions are linked to an
increase in the pressure within your eye, eventually affecting your
eyesight. Your doctor will
usually prescribe you this medicine when other medicines have not
worked adequately.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST/TIMOLOL APOT

Productkenmerken

LATANOPROST/TIMOLOL APOTEX 50 MICROGRAM/ML + 5 MG/ML
OOGDRUPPELS, OPLOSSING
MODULE 1.3
Product Information - NL
Version: 2019-08
MODULE 1.3.1
Summary of Product Characteristics
Replaces : 2017-12-
18
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Latanoprost/Timolol Apotex 50 microgram/ml + 5 mg/ml oogdruppels,
oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains latanoprost 50 micrograms and timolol maleate
6.8 mg equivalent to 5 mg
timolol.
Each drop contains approximately 1.44 micrograms latanoprost and 144
micrograms timolol.
Excipient with known effect: Benzalkonium chloride 200 microgram/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution of approximately pH 6.0 and 290 mOsmols/L.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Latanoprost/Timolol is indicated in adults (including the elderly) for
the 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
ADULTS (INCLUDING THE ELDERLY)
_ _
Recommended therapy is one eye drop in the affected eye(s) once daily.
LATANOPROST/TIMOLOL APOTEX 50 MICROGRAM/ML + 5 MG/ML
OOGDRUPPELS, OPLOSSING
MODULE 1.3
Product Information - NL
Version: 2019-08
MODULE 1.3.1
Summary of Product Characteristics
Replaces : 2017-12-
18
2
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 _
The
safety and
efficacy of Latanoprost/Timolol
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 (see section 4.4).
If more than one topical ophthalmic drug is being used, the drugs
should be administered at least
5 minutes apart.
Wh