LUMIGAN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BIMATOPROST

Available from:

ALLERGAN ISRAEL LTD

ATC code:

S01EE03

Pharmaceutical form:

OPHTHALMIC SOLUTION

Composition:

BIMATOPROST 0.3 MG/ML

Administration route:

OCULAR

Prescription type:

Required

Manufactured by:

ALLERGAN INC., USA

Therapeutic group:

BIMATOPROST

Therapeutic area:

BIMATOPROST

Therapeutic indications:

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

Authorization date:

2012-04-30

Patient Information leaflet

1
PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS
(PREPARATIONS) – 1986
The dispensing of this medicine requires a doctor's prescription
LUMIGAN
SOLUTION FOR EYE TREATMENT
ACTIVE INGREDIENT:
bimatoprost 0.3
mg/ml 0.03%
)
)
Inactive ingredients and allergens in the medicine: see Section 2, in
the subsection
"Important information about some of the ingredients of LUMIGAN" and
Section 6,
"FURTHER INFORMATION".
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about the medicine. If you have further questions,
refer to the doctor or
pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to
others. It may harm them, even if it seems to you that their ailment
is similar.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Lumigan is intended for reducing pressure in the eye in patients with
chronic open-angle
glaucoma. It is used on its own or together with drops which contain
beta-blockers.
THERAPEUTIC GROUP: prostaglandin analogues called prostamides.
Your eye contains a clear, watery liquid that feeds the inside of the
eye. The 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.
BEFORE USING THE MEDICINE
_ _
SPECIAL WARNINGS REGARDING USE OF THIS MEDICINE
BEFORE BEGINNING TREATMENT WITH LUMIGAN, TELL THE DOCTOR IF:
•
You have any breathing problems
•
You have liver or kidney problems
•
You have had a cataract surgery in the past
•
You have dry eye
•
You have or have had any problems with your cornea (front transparent
part of the eye)
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to bimatoprost or to any of the other
ingre

Summary of Product characteristics

Lumigan IL SPC 03.2019-Notification
Page 1 of 7
_The format of this leaflet was determined by the Ministry of Health
and its content was checked and _
_approved by the Ministry of Health in December 2016_
_and updated according to the Ministry of _
_Health`s guidelines in March 2019 _
PHYSICIAN’S PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
LUMIGAN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of solution contains 0.3 mg bimatoprost.
Excipient with known effect:
One ml of solution contains 0.05 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ophthalmic 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 ophthalmic 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 0.3 mg/ml is contraindicated in patients who have h