Betagan 0.5% eye drops

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Levobunolol hydrochloride

Saatavilla:

Necessity Supplies Ltd

ATC-koodi:

S01ED03

INN (Kansainvälinen yleisnimi):

Levobunolol hydrochloride

Annos:

5mg/1ml

Lääkemuoto:

Eye drops

Antoreitti:

Ocular

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 11060000

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
BETAGAN
® UNIT DOSE 0.5% W/V
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.
The name of your medicine is Betagan Unit Dose 0.5% w/v Eye Drops
Solutionl, but will be referred to as Betagan throughout the remainder
of
the leaflet.
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
severe chronic obstructive pulmonary disease (COPD)) where you
have difficulty breathing, wheezing or a chronic cough
•
you have or have had HEART PROBLEMS such as slow heart beat,
heart failure or heart beat disorders (irregular heart beat).
BETAGAN IS NOT

Valmisteyhteenveto

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
Reduction of intraocular pressure in chronic open-angle glaucoma and
ocular
hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly) _
The recommended adult dose is one drop of Betagan once or twice daily
in the
affected eye(s). Discard product after use.
_Paediatric Population_
Betagan is not recommended for use in children due to lack of safety
and
efficacy data.
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.
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 or 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, levobunolol is
absorbed
systemically. Due to the beta-adrenergic component of Betagan
(levobunolol),
the same types of cardiovascular, pulmonary and adverse reactions as
seen
with systemic beta-blockers may occur. Incidence of systemic ADRs
after
topical ophthalmi