BETOPTIC 0.5 %w/v Eye Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BETAXOLOL HYDROCHLORIDE

Available from:

Alcon Laboratories (UK) Ltd

ATC code:

S01ED02

INN (International Name):

BETAXOLOL HYDROCHLORIDE

Dosage:

0.5 %w/v

Pharmaceutical form:

Eye Drops Solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Beta blocking agents

Authorization status:

Authorised

Authorization date:

1986-08-27

Patient Information leaflet

64087-6
BETOPTIC
®
  0.5 % W/V EYE DROPS, SOLUTION
BETAXOLOL (AS HYDROCHLORIDE)
PACKAGE LEAFLET - INFORMATION FOR THE USER
CONTINUED OVER
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.
HOW TO USE
•  Wash your hands before you start.
•  Twist off the bottle cap.
•  Hold the bottle pointing down, between your
thumb and fingers.
•  Tilt your head back.
•  Pull down your lower eyelid with a finger, until
there is a ‘pocket’ between the eyelid and
your eye. The drop will go in here (picture 1).
• Bring the bottle tip close to the eye. Do this in
front of a mirror if it helps.
•  DO NOT TOUCH YOUR EYE OR EYELID,
surrounding areas or other surfaces with the
dropper. It could infect the drops.
•  GENTLY PRESS ON THE BASE of the bottle to
release one drop at a time (picture 2).
•  DO NOT SQUEEZE THE BOTTLE, only a gentle
press on the bottom is needed.
•  If you use drops in both eyes, repeat the steps
for your other eye. Put the bottle cap firmly
back on immediately after use.
• After using BETOPTIC 0.5 %, PRESS A FINGER
INTO THE CORNER OF YOUR EYE BY THE NOSE
(picture 3) for 2 minutes. This helps to stop
betaxolol getting into the rest of the body.
• IF A DROP MISSES YOUR EYE, try again.
• IF YOU MISS A DOSE, just take it as soon as
possible. However, if it is almost time for your
next dose, skip the miss

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: Benzalkonium chloride 0.01% w/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Eye drops, solution.
A clear, colourless 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 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.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For ocular use only
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 06/11/2015_
_CRN 2170176_
_page number: 1_
GENERAL: Like other topically applied ophthalmic agents, betax