Betoptic 0.5% w/v Eye Drops, Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Betaxolol hydrochloride

Available from:

Imbat Limited

ATC code:

S01ED; S01ED02

INN (International Name):

Betaxolol hydrochloride

Dosage:

0.5 Base %w/v

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:

2011-11-04

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETOPTIC
® 0.5% W/V EYE DROPS, SOLUTION
(Betaxolol (as hydrochloride))
Your medicine is available using the above name but will be referred
to as Betoptic 0.5% throughout
the leaflet.
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.
CONTENTS OF THE PACK AND OTHER 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%...

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

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: Benzalkonium chloride 0.01% w/v.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
_Product imported from: UK_
A clear, colourless to pale yellow, sterile eye drops solution.
4 CLINICAL PARTICULARS
As per PA 0290/061/001
5 PHARMACOLOGICAL PROPERTIES
As per PA 0290/061/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Disodium edetate
Sodium chloride
Benzalkonium chloride
Sodium hydroxide (for pH-adjustment)
Hydrochloric acid (for pH-adjustment)
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
After opening: 4 weeks.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25
°
C. Store in the original package in order to protect from light.
Discard remaining contents 4 weeks after first opening.
6.5 NATURE AND CONTENTS OF CONTAINER
A plastic bottle with a screw cap containing 5ml of solution
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM