Betoptic 0.5% eye drops

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betaxolol hydrochloride

Available from:

Lexon (UK) Ltd

ATC code:

S01ED02

INN (International Name):

Betaxolol hydrochloride

Dosage:

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

Package Leaflet - Information for the User
BETOPTIC
*
0.5 % w / v eye drops, solution
Betaxolol ( as hydrochloride )
Read all of this leaflet carefully before you start using this
medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your
pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
IN THIS LEAFLET
1.
What BETOPTIC 0.5 % is and what
it is used for
2. Before you use BETOPTIC 0.5 %
3. How to use BETOPTIC 0.5 %
4. Possible side effects
5. How to store BETOPTIC 0.5 %
6. Further information
WHAT BETOPTIC
*
0.5 % IS AND WHAT IT IS USED FOR
1
BETOPTIC 0.5 %
belongs to a group of medicines
known as beta blockers.
It is used to treat glaucoma or ocular hypertension
( high pressure in the eye ) by reducing the fluid pressure
in your eye ( s ).
BEFORE YOU USE BETOPTIC 0.5 %
2
Do not use BETOPTIC 0.5 % eye drops,
solution...
•
If you are allergic to betaxolol, beta-blockers
or any of the other ingredients listed in section 6. Ask
your doctor for advice.
•
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 heartbeats ).
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 ca

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: 1ml of solution contains 0.1mg
benzalkonium
chloride.
For a full list of excipients see Section 6.1
3
PHARMACEUTICAL FORM
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
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.
•
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
ophthalmic
agents,
betaxolol
is
absorbed systemically. Due to the 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 lower than for
systemic
administration. To reduce the systemic absorption, see section 4.2.
CARDIAC DISORDERS: In patients with cardiovascular diseases (e.g