BETAGAN 0.5 %w/v Eye Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LEVOBUNOLOL HYDROCHLORIDE

Available from:

LTT Pharma Limited

INN (International Name):

LEVOBUNOLOL HYDROCHLORIDE

Dosage:

0.5 %w/v

Pharmaceutical form:

Eye Drops Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Authorised

Authorization date:

0000-00-00

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betagan 0.5% w/v Eye Drops, Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains 5.0 mg levobunolol hydrochloride, equivalent to 4.4 mg levobunolol.
Excipient (s): Contains benzalkonium chloride 0.04 mg/ml.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Eye Drops, Solution
_Product imported from the UK:_
A clear, colourless to light yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the control 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 dosage is one drop of Betagan in the affected eye(s) once or twice daily.
_Paediatric Population_
Betagan is not recommended for use in children due to lack of safety and efficacy data (see Section 5.1).
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, 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.
IRISH MEDICINES BOARD
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