Betagan Unit Dose 0.5% eye drops 0.4ml unit dose

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Levobunolol hydrochloride

Dostępny od:

AbbVie Ltd

Kod ATC:

S01ED03

INN (International Nazwa):

Levobunolol hydrochloride

Dawkowanie:

5mg/1ml

Forma farmaceutyczna:

Eye drops

Droga podania:

Ocular

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 11060000; GTIN: 5016007364507

Ulotka dla pacjenta

1
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”)
2
•
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 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
suffer

Charakterystyka produktu

OBJECT 1
BETAGAN UNIT DOSE
Summary of Product Characteristics Updated 10-Jan-2018 | Allergan Ltd
1. Name of the medicinal product
Betagan Unit Dose
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