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

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

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

Beschikbaar vanaf:

S.C. Rompharm Company S.R.L. Eroilor Street, no. 1A 075100 OTOPENI (ROEMENIË)

ATC-code:

S01ED51

INN (Algemene Internationale Benaming):

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

farmaceutische vorm:

Oogdruppels, oplossing

Samenstelling:

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

Toedieningsweg:

Oculair gebruik

Therapeutisch gebied:

Timolol, Combinations

Product samenvatting:

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

Autorisatie datum:

2018-04-18

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
BIMATOPROST/TIMOLOL ROMPHARM 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 Bimatoprost/Timolol Rompharm is and what it is used for
2.
What you need to know before you use Bimatoprost/Timolol Rompharm
3.
How to use Bimatoprost/Timolol Rompharm
4.
Possible side effects
5.
How to store Bimatoprost/Timolol Rompharm
6.
Contents of the pack and other information
1.
WHAT BIMATOPROST/TIMOLOL ROMPHARM IS AND WHAT IT IS USED FOR
Bimatoprost/Timolol Rompharm 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). Bimatoprost/Timolol Rompharm works by reducing the
production of liquid and also
increasing the amount of liquid that is drained. This reduces the
pressure inside the eye.
Bimatoprost/Timolol Rompharm 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
Bimatoprost/Timolol

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bimatoprost/Timolol Rompharm 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).
Excipient with known effect
Each ml of solution contains 0.05 mg of benzalkonium chloride.
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 Bimatoprost/Timolol Rompharm 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
If more than one topical ophthalmic medicinal product is to be used,
each one should be instilled at
least 5 minutes apart.
W