Lumigan

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

bimatoprost

זמין מ:

AbbVie Deutschland GmbH & Co. KG

קוד ATC:

S01EE03

INN (שם בינלאומי):

bimatoprost

קבוצה תרפויטית:

Prostaglandin analogues, Ophthalmologicals

איזור תרפויטי:

Glaucoma, Open-Angle; Ocular Hypertension

סממני תרפויטית:

Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension (as monotherapy or as adjunctive therapy to beta-blockers).,

leaflet_short:

Revision: 37

מצב אישור:

Authorised

תאריך אישור:

2002-03-08

עלון מידע

50
B. PACKAGE LEAFLET
51
PACKAGE LEAFLET: INFORMATION FOR THE USER
LUMIGAN 0.1 MG/ML, EYE DROPS, SOLUTION
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 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 LUMIGAN 0.1 mg/ml is and what it is used for
2.
What you need to know before you use LUMIGAN 0.1 mg/ml
3.
How to use LUMIGAN 0.1 mg/ml
4.
Possible side effects
5.
How to store LUMIGAN 0.1 mg/ml
6.
Contents of the pack and other information
1.
WHAT LUMIGAN 0.1 MG/ML IS AND WHAT IT IS USED FOR
LUMIGAN is an antiglaucoma preparation. It belongs to a group of
medicines called prostamides.
LUMIGAN eye drops are 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 LUMIGAN 0.1 MG/ML
DO NOT USE LUMIGAN 0.1 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 past because of a side
effect of the preservative
benzalkonium chloride.
WAR

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
LUMIGAN 0.1 mg/ml eye drops, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 0.1 mg bimatoprost.
Excipient with known effect:
One ml of solution contains 0.2 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, solution.
Colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
_Paediatric population: _
The safety and efficacy of LUMIGAN in children aged 0 to 18 years has
not yet been established.
Patients with hepatic and renal impairment:
LUMIGAN 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.
Method of administration
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.
LUMIGAN 0.1 mg/ml is contraindicated in patients who have had a
suspected previous adverse
reaction to benzalkonium chloride that has led to discontinuation.
3
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Ocular
Before treatment is initiated, patients should be informed of the
possibility of prostaglandi