BETOPTIC 0.5 %w/v Eye Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BETAXOLOL HYDROCHLORIDE

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

S01ED02

INN (International Name):

BETAXOLOL HYDROCHLORIDE

Dosage:

0.5 %w/v

Pharmaceutical form:

Eye Drops Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents

Authorization status:

Authorised

Authorization date:

2017-05-05

Summary of Product characteristics

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 with known effect: Benzalkonium chloride 0.01% w/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
A clear, colourless 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
_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.
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.
After cap is removed, if tamper evident snap collar is loose, remove
before using product.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in 6.1.
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
For ocular use only
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