Betoptic 0.5% w/v Eye Drops, solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Betaxolol hydrochloride

Available from:

PCO Manufacturing Ltd.

ATC code:

S01ED; S01ED02

INN (International Name):

Betaxolol hydrochloride

Dosage:

0.5% percent weight/volume

Pharmaceutical form:

Eye drops, solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents1); betaxolol

Authorization status:

Authorised

Authorization date:

2005-06-10

Patient Information leaflet

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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
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
1.
WHAT BETOPTIC 0.5% IS AND WHAT IT IS USED FOR
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).
2.
BEFORE YOU USE BETOPTIC 0.5%
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

Summary of Product characteristics

Health Products Regulatory Authority
24 September 2020
CRN009X8M
Page 1 of 6
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
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution
_Product imported from Greece._
Clear, colourless to pale yellow sterile, eye drops solution.
4 CLINICAL PARTICULARS
As per PA0290/061/001
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 lowe