Bimatoprost/Timolol OmniVision 0,3 mg/ml + 5 mg/ml oogdruppels, oplossing

Country: Netherlands

Language: Dutch

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

Active ingredient:

BIMATOPROST 0,3 mg/ml ; TIMOLOLMALEAAT 6,8 mg/ml SAMENSTELLING overeenkomend met ; TIMOLOL 0-WATER 5 mg/ml

Available from:

OmniVision GmbH Lindberghstrasse 9 82178 PUCHHEIM (DUITSLAND)

ATC code:

S01ED51

INN (International Name):

BIMATOPROST 0,3 mg/ml ; TIMOLOLMALEAAT 6,8 mg/ml SAMENSTELLING overeenkomend met ; TIMOLOL 0-WATER 5 mg/ml

Pharmaceutical form:

Oogdruppels, oplossing

Composition:

BENZALKONIUMCHLORIDE ; CITROENZUUR 1-WATER (E 330) ; DINATRIUMWATERSTOFFOSFAAT 7-WATER (E 339) ; NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; WATER, GEZUIVERD ; ZOUTZUUR (E 507),

Administration route:

Oculair gebruik

Therapeutic area:

Timolol, Combinations

Product summary:

Hulpstoffen: BENZALKONIUMCHLORIDE; CITROENZUUR 1-WATER (E 330); DINATRIUMWATERSTOFFOSFAAT 7-WATER (E 339); NATRIUMCHLORIDE; NATRIUMHYDROXIDE (E 524); WATER, GEZUIVERD; ZOUTZUUR (E 507);

Authorization date:

2018-04-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BIMATOTIM-VISION 0,3 MG/ML + 5 MG/ML OOGDRUPPELS, OPLOSSING
Bimatoprost/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, please 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 BimatoTim-Vision is and what it is used for
2.
What you need to know before you use BimatoTim-Vision
3.
How to use BimatoTim-Vision
4.
Possible side effects
5.
How to store BimatoTim-Vision
6.
Contents of the pack and other information
1.
WHAT BIMATOTIM-VISION IS AND WHAT IT IS USED FOR
BimatoTim-Vision contains two different active substances (bimatoprost
and timolol) that both reduce
pressure in the eye. Bimatoprost belongs to a group of medicines
called prostamides, a prostaglandin
analogue. Timolol belongs to a group of medicines called
beta-blockers.
Your eye contains a clear, watery liquid that feeds the inside of the
eye. Liquid is constantly being drained
out of the eye and new liquid is made to replace this. If the liquid
cannot drain out quickly enough, the
pressure inside the eye builds up and could eventually damage your
sight (an illness called glaucoma).
BimatoTim-Vision works by reducing the production of liquid and also
increasing the amount of liquid that
is drained. This reduces the pressure inside the eye.
BimatoTim-Vision eye drops are used to treat high pressure in the eye
in adults, including the elderly. This
high pressure can lead to glaucoma. Your doctor will prescribe you
BimatoTim-Vision when other eye drops
containing beta-blockers or prostaglandin analogues have not worked
sufficiently on their

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BimatoTim-Vision 0,3 mg/ml + 5 mg/ml oogdruppels, oplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 0.3 mg of bimatoprost and 5 mg of timolol
(as 6.8 mg of timolol maleate).
Excipients with known effect
This medicine contains approximately 1.3 microgram benzalkonium
chloride in each drop which is
equivalent to 0.05 mg/ml.
This medicine contains 0.024 mg phosphates in each drop which is
equivalent to 0.95 mg/ml.For the full list
of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Colourless to slightly yellow solution.
The pH of solution is 6.5 to 7.8, the osmolality is 260 to 320
mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction of intraocular pressure (IOP) in adult patients with
open-angle glaucoma or ocular hypertension
who are insufficiently responsive to topical beta-blockers or
prostaglandin analogues.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Recommended dosage in adults (including older people) _
The recommended dose is one drop of BimatoTim-Vision in the affected
eye(s) once daily, administered
either in the morning or in the evening. It should be administered at
the same time each day.
Existing literature data for bimatoprost/timolol suggest that evening
dosing may be more effective in IOP
lowering than morning dosing. However, consideration should be given
to the likelihood of compliance
when considering either morning or evening dosing (see section 5.1).
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.
_Renal and hepatic impairment _
Bimatoprost/timolol has not been studied in patients with hepatic or
renal impairment. Therefore caution
should be used in treating such patients.
_Paediatric population _
The safety and efficacy of bimatoprost/timolol in children aged 0 to
18 years has not been established. No
data are available.
Method of administration