BETOPTIC 0.5 %w/v Eye Drops Solution
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
25-04-2024
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Ingredient activ:
BETAXOLOL HYDROCHLORIDE
Disponibil de la:
G & A Licensing Limited
INN (nume internaţional):
BETAXOLOL HYDROCHLORIDE
Dozare:
0.5 %w/v
Forma farmaceutică:
Eye Drops Solution
Tip de prescriptie medicala:
Product subject to prescription which may be renewed (B)
Statutul autorizaţiei:
Withdrawn
Data de autorizare:
2013-02-27
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betoptic 0.5% w/v, Eye Drops, Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Betaxolol 0.5%w/v (as hydrochloride)
Excipients-Contains Benzalkonium Chloride
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops solution
_Product imported from Greece_:
A clear, colourless to pale yellow sterile, eye drops solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betoptic 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
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.
_Adults (including the elderly)_
The usual dose is one drop to be instilled into the affected eye(s) twice daily.
_Children_
Betoptic is not recommended for use in children.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance (substances), or to any of the excipients.
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.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Like other topically applied ophthalmic agents Betaxolol is absorbed systemically. Due to beta adrenergic component,
Betaxolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta-adrenergic
blocking agents may occur. Incidence of systemic ADRs after topical ophthalmic administration is
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