BETOPTIC 0.5 Base %w/v Eye Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BETAXOLOL HYDROCHLORIDE

Available from:

LTT Pharma Limited

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)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

LEAFLET DETAILS
Licence Number:
PPA 1562/047/001 Betoptic 0.5% w/v Eye Drops, Solution
Leaflet size:
148mm x 340mm, Portrait double sided - 2 columns on each side
Column width: 
66.5mm
Text Free Border:
5mm (around edge & between columns)
Font:
Arial
Font Size:
Title = 14pt 
Generic Name = 12pt
Main Section Headings = 9pt
Sub Headings = 8pt
Main Text = Font 8pt / Leading 9.5pt
Statement for Blind = 12pt
Colour:
Black print on white paper
UK Leaflet:
Alcon, November 2013
Lexon Revision date:
14/07/2014
Ref: 047/001/140714/1/F & Ref: 047/001/140714/1/B = 
Betopic 0.5% w/v Eye Drops, Solution (Front & Back)
_This is the final mock-up._
_This leaflet has been user tested _
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.
Your medicine is called Betopic 0.5% but will be
referred to as Betopic 0.5% throughout the leaflet.
IN THIS LEAFLET:
What Betoptic 0.5% is and what it
is used for
Before you use Betoptic 0.5%
How to use Betoptic 0.5%
Possible side effects
How to store Betoptic 0.5%
Further information
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).
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 (seve

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 effects: Benzalkonium chloride 0.01% w/v.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Eye drops, solution.
_Product imported from the UK:_
A clear, colourless to pale yellow sterile, 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 betaxolol, 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 27/08/2014_
_CRN 2151358_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For