Betagan 0.5% w/v Unit Dose Eye Drops, Solution

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Levobunolol hydrochloride

Disponibbli minn:

Allergan Pharmaceuticals Ireland

Kodiċi ATC:

S01ED; S01ED03

INN (Isem Internazzjonali):

Levobunolol hydrochloride

Dożaġġ:

0.5 percent weight/volume

Għamla farmaċewtika:

Eye drops, solution

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

Beta blocking agents1); levobunolol

L-istatus ta 'awtorizzazzjoni:

Marketed

Data ta 'l-awtorizzazzjoni:

1993-10-11

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
BETAGAN
®
0.5% W/V UNIT DOSE EYE DROPS, SOLUTION
Levobunolol hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

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. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
WHAT BETAGAN IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BETAGAN
3.
HOW TO USE BETAGAN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE BETAGAN
6.
FURTHER INFORMATION
1. WHAT BETAGAN IS AND WHAT IT IS USED FOR
BETAGAN is an eye drop. It is used to treat GLAUCOMA by lowering the
pressure
that builds up in the eye.
Your eyeball contains a watery liquid, which is constantly being
drained out of the
eye, and new liquid is made to replace this. Glaucoma can occur when
the liquid
does not drain out quickly enough. This leads to raised pressure
within the
eyeball which can eventually damage your sight. BETAGAN works by
reducing
the production of liquid. This reduces the pressure inside the eye.
BETAGAN belongs to a group of medicines called beta blockers.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETAGAN
DO NOT USE BETAGAN IF

you are allergic to:
LEVOBUNOLOL
any other ingredients (see section 6 “Further information”)

you have or have had ASTHMA or other lung diseases (for example
chronic
obstructive pulmonary disease (COPD)) where you have difficulty
breathing,
wheezing or a chronic cough

If you have or have had HEART PROBLEMS such as slow heart beat, heart
failure or heart beat disorders (irregular heart beat).
BETAGAN IS NOT RECOMMENDED FOR USE IN CHILDREN
TAKE SPECIAL CARE WITH BETAGAN
Talk to your doctor before using BETAGAN if you suffer from, or have
in the past
suffered from:

Karatteristiċi tal-prodott

Health Products Regulatory Authority
26 November 2018
CRN008JYW
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betagan 0.5% w/v Unit Dose Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains 5.0 mg levobunolol hydrochloride, equivalent
to 4.4 mg
levobunolol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye Drops, Solution.
A clear, colourless to brown solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the management of patients with ocular hypertension; those with
glaucoma of
the chronic open angle type, including aphakic patients, those with
secondary
glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly):_
The recommended dosage is one drop of Betagan in the affected eye(s)
once or
twice daily. Discard product after use.
_Paediatric Population_
Betagan is not recommended for use in children due to lack of safety
and efficacy
data (see section 5.1).
Intraocular pressure should be measured approximately four weeks after
starting
treatment with Betagan as a return to normal ocular pressure can take
a few weeks.
_Method of administration:_ topical into the conjunctival sac.
Health Products Regulatory Authority
26 November 2018
CRN008JYW
Page 2 of 9
When using nasolacrimal occlusion or closing the eyelids for 2
minutes, the systemic
absorption is reduced. This may result in a decrease in systemic side
effects and an
increase in local activity.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Reactive airway disease including bronchial asthma or a history of
bronchial asthma,
severe chronic obstructive pulmonary disease.
Sinus bradycardia, sick sinus syndrome, sino-atrial block second and
third-degree
atrioventricular block not controlled with a pace maker, overt cardiac
failure or
cardiogenic shock.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Like other topically applied ophthalmic agents, Betagan is absorbed