BETOPTIC 0.5 %w/v Eye Drops Solution

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

BETAXOLOL HYDROCHLORIDE

Доступна з:

Novartis Pharmaceuticals UK Ltd

Код атс:

S01ED02

ІПН (Міжнародна Ім'я):

BETAXOLOL HYDROCHLORIDE

Дозування:

0.5 %w/v

Фармацевтична форма:

Eye Drops Solution

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Beta blocking agents

Статус Авторизація:

Authorised

Дата Авторизація:

2017-05-05

Характеристики продукта

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
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___