Bimatoprost STADA 0,3 mg/ml, oogdruppels, oplossing

País: Países Bajos

Idioma: neerlandés

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

Ingredientes activos:

BIMATOPROST

Disponible desde:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

Código ATC:

S01EE03

Designación común internacional (DCI):

BIMATOPROST

formulario farmacéutico:

Oogdruppels, oplossing

Composición:

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

Vía de administración:

Oculair gebruik

Área terapéutica:

Bimatoprost

Resumen del producto:

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

Fecha de autorización:

2014-03-04

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BIMATOPROST STADA 0,3 MG/ML OOGDRUPPELS, OPLOSSING
Bimatoprost
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 BIMATOPROST STADA 0.3 mg/ml is and what it is used for
2. What you need to know before you use BIMATOPROST STADA 0.3 mg/ml
3. How to use BIMATOPROST STADA 0.3 mg/ml
4. Possible side effects
5. How to store BIMATOPROST STADA 0.3 mg/ml
6. Contents of the pack and other information
1. WHAT BIMATOPROST STADA 0.3 MG/ML IS AND WHAT IT IS USED FOR
BIMATOPROST STADA is an antiglaucoma preparation. It belongs to a
group of medicines
called prostamides.
BIMATOPROST STADA is used to reduce high pressure in the eye. This
medicine may be
used on its own or with other drops called beta-blockers which also
reduce pressure.
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. This
medicine works by increasing
the amount of liquid that is drained. This reduces the pressure inside
the eye. If the high
pressure is not reduced, it could lead to a disease called glaucoma
and eventually damage
your sight.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BIMATOPROST STADA 0.3 MG/ML
DO NOT USE BIMATOPROST STADA 0.3 MG/ML:

If you are allergic to bimatoprost or any of the other ingredients of
this medicine (listed in
section 6).

If you have had to stop using eye drops in the p

Ficha técnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Bimatoprost STADA 0,3 mg/ml, oogdruppels, oplossing
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 0.3 mg bimatoprost.
One drop contains approximately 7.5 micrograms bimatoprost.
Excipient(s) with known effect
One ml of solution contains 0.05 mg benzalkonium chloride and 0.95 mg
phosphates.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, solution.
Clear, colourless solution, practically free from particles.
pH 6.8 – 7.8; osmolality 260 – 330 mOsmol/kg.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bimatoprost is indicated in reduction of elevated intraocular pressure
in chronic open-angle
glaucoma and ocular hypertension in adults (as monotherapy or as
adjunctive therapy to
beta-blockers).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one drop in the affected eye(s) once daily,
administered in the
evening. The dose should not exceed once daily as more frequent
administration may lessen
the intraocular pressure lowering effect.
SPECIAL POPULATIONS
_Renal and hepatic impairment _
Bimatoprost has not been studied in patients with renal or moderate to
severe hepatic
impairment and should therefore be used with caution in such patients.
In patients with a
history
of
mild
liver
disease
or
abnormal
alanine
aminotransferase
(ALT),
aspartate
aminotransferase
(AST)
and/or
bilirubin at
baseline,
bimatoprost
0.3 mg/ml
eye drops,
solution had no adverse effect on liver function over 24 months.
_ _
_Paediatric population _
The safety and efficacy of bimatoprost in children aged 0 to 18 years
has not yet been
established.
Method of administration
2
If more than one topical ophthalmic medicinal product is being used,
each one should be
administered at least 5 minutes apart.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Bimatoprost 0.3 mg/ml eye drops, solution is contraindicated in
patients who