BETOPTIC SUSPENSION SINGLE DOSE 0.25 %w/v Eye Drops Suspension

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

BETAXOLOL HYDROCHLORIDE

MAH:

Novartis Pharmaceuticals UK Ltd

ATC_code:

S01ED02

INN:

BETAXOLOL HYDROCHLORIDE

dosage:

0.25 %w/v

pharmaceutical_form:

Eye Drops Suspension

prescription_type:

Product subject to prescription which may be renewed (B)

therapeutic_area:

Beta blocking agents

authorization_status:

Authorised

authorization_date:

2017-05-05

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betoptic Suspension Single Dose 0.25% w/v, Eye Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Betaxolol (as hydrochloride) 0.25% w/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, suspension
A white to off white suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BETOPTIC SUSPENSION SINGLE DOSE eye drops contain a cardioselective
beta-adrenergic receptor blocker which
is indicated for the reduction of elevated intraocular pressure in
patients with ocular hypertension and chronic open-
angle glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Shake well before each use.
ADULTS (INCLUDING THE ELDERLY)
The usual dose is one drop twice daily. Standard ocular hypotensive
agents may be used to supplement this treatment.
CHILDREN
Clinical studies to establish the safety and efficacy in children have
not been performed up to now.
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
Hypersensitivity to beta-adrenoceptor blockers.
Reactive airway disease including severe bronchial asthma or a history
of severe bronchial asthma, severe
chronic obstructive pulmonary disease.
Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or
third degree atrioventricular block not
controlled with pace-maker. Overt cardiac failure, cardiogenic shock
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