Betoptic 0.25% suspension eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betaxolol hydrochloride

Available from:

Waymade Healthcare Plc

ATC code:

S01ED02

INN (International Name):

Betaxolol hydrochloride

Dosage:

2.5mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11060000

Patient Information leaflet

Continued over
BETOPTIC
*
0.25% w/v eye drops, suspension
Betaxolol (as hydrochloride)
Package Leaflet - Information for the User
BETOPTIC 0.25 % belongs to a group of
medicines known as beta blockers.
It is used to treat chronic open-angle
glaucoma or ocular hypertension ( high pressure
in the eye ) by reducing the fluid pressure in
your eye ( s ).
1. What BETOPTIC 0.25 % is and
what it is used for
2. Before you use BETOPTIC 0.25 %
3. How to use BETOPTIC 0.25 %
4. Possible side effects
5. How to store BETOPTIC 0.25 %
6. Further information
Do not use BETOPTIC 0.25 % eye
drops, suspension...
• If you are allergic to betaxolol, beta-blockers
or any of the other ingredients listed in
section 6.
• If you have now or have had in the past,
respiratory problems such as severe
asthma, severe chronic obstructive
bronchitis ( severe lung condition which may
cause wheeziness, difficulty in breathing
and / or long-standing cough ).
• If you have a slow heart beat, heart failure
or disorders of heart rhythm
( irregular heart beats ).
Ask your doctor for advice.
Take special care...
Before you use this medicine, tell your doctor if
you have now or have had in the past
• coronary heart disease ( symptoms can
include chest pain or tightness,
breathlessness or choking ), heart failure,
low blood pressure ( hypotension )
• disturbances of heart rate such as slow
heart beat ( bradycardia )
• breathing problems, asthma or chronic
obstructive pulmonary disease ( lung
disease which may cause wheeziness,
difficulty in breathing and / or
long-standing cough ).
• poor blood circulation disease ( such as
Raynaud’s disease or Raynaud’s syndrome )
• diabetes, as betaxolol may mask the signs
and symptoms of low blood sugar
• overactivity of the thyroid gland as
betaxolol may mask the signs and symptoms
• angle-closure glaucoma
• dry eyes ( Sicca Syndrome )
Tell your doctor before you have an
operation that you are using BETOPTIC 0.25 %
as betaxolol may change the effects of some
medicines used during anaesthesia.
I

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
BETOPTIC 0.25% w/v Eye Drops, Suspension
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betaxolol 0.25% w/v (as hydrochloride)
Excipients
with
known
effect:
1ml
of
suspension
contains
0.1mg
benzalkonium chloride.
For a full list of excipients see Section 6.1
3
PHARMACEUTICAL FORM
Eye Drops, Suspension
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BETOPTIC SUSPENSION lowers the intraocular pressure and is indicated
in
patients with chronic open-angle glaucoma and ocular hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS (INCLUDING ELDERLY)
The recommended dose is one drop in the affected eye(s) twice daily.
In some
patients,
the
intraocular
pressure
lowering
responses
to
BETOPTIC
SUSPENSION may require a few weeks to stabilise. Careful monitoring of
glaucoma patients is advised.
If the intraocular pressure of the patient is not adequately
controlled on this
regimen,
concomitant
therapy
with
pilocarpine
and
other
miotics
and/or
adrenaline
(epinephrine)
and/or
carbonic
anhydrase
inhibitors
can
be
instituted.
CHILDREN
Safety and effectiveness in children have not been established.
The volume of each drop dispensed is 24
μ
l.
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.
•
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
GENERAL:
Like
other
topically
applied
ophthalm