BISANTIM 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:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

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:

2017-09-29

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
BISANTIM 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,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,pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What BISANTIM is and what it is used for
2.
What you need to know before you use BISANTIM
3.
How to use BISANTIM
4.
Possible side effects
5.
How to store BISANTIM
6.
Contents of the pack and other information
1.
WHAT BISANTIM IS AND WHAT IT IS USED FOR
BISANTIM 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).
BISANTIM works by reducing the production of liquid and also
increasing the amount of liquid that is
drained. This reduces the pressure inside the eye.
BISANTIM 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 BISANTIM
when other eye drops containing
beta-blockers or prostaglandin analogues have not worked sufficiently
on their own.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BISANTIM
DO NOT USE B

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BISANTIM 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 BISANTIM 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.
When using nasolacrimal occlusion or clos