Betoptic 0.25% eye drops suspension 0.25ml unit dose

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betaxolol hydrochloride

Available from:

Immedica Pharma AB

ATC code:

S01ED02

INN (International Name):

Betaxolol hydrochloride

Dosage:

2.5mg/1ml

Pharmaceutical form:

Eye drops

Administration route:

Ocular

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11060000; GTIN: 5015664035027

Patient Information leaflet

BETOPTIC
®
SUSPENSION SINGLE DOSE 0.25% W/V EYE DROPS
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 SUSPENSION SINGLE DOSE IS AND WHAT IT IS USED FOR
2.
BEFORE YOU USE BETOPTIC SUSPENSION SINGLE DOSE
3.
HOW TO USE BETOPTIC SUSPENSION SINGLE DOSE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE BETOPTIC SUSPENSION SINGLE DOSE
6.
FURTHER INFORMATION
1. WHAT BETOPTIC SUSPENSION SINGLE DOSE
IS AND WHAT IT IS USED FOR
BETOPTIC SUSPENSION SINGLE DOSE 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 SUSPENSION
SINGLE DOSE
DO NOT USE BETOPTIC SUSPENSION SINGLE DOSE EYE DROPS, SUSPENSION...
•
If you are ALLERGIC to betaxolol, beta-blockers or any of the other
ingredients listed in section 6.
•
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).
Ask your doctor for advice.
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)
•
BREATHI

Summary of Product characteristics

OBJECT 1
BETOPTIC SUSPENSION SINGLE DOSE
Summary of Product Characteristics Updated 16-Apr-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
BETOPTIC SUSPENSION SINGLE DOSE 0.25% w/v, Eye Drops
2. Qualitative and quantitative composition
Betaxolol 0.25% w/v (as hydrochloride).
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye Drop Suspension.
4. Clinical particulars
4.1 Therapeutic indications
BETOPTIC SUSPENSION SINGLE DOSE lowers the intraocular pressure and is
indicated in patients
with chronic open-angle glaucoma and ocular hypertension.
4.2 Posology and method of administration
ADULTS (INCLUDING ELDERLY)
The recommended dose is one drop in the affected eye(s) twice daily.
In some patients the intraocular
pressure lowering responses to BETOPTIC SUSPENSION SINGLE DOSE may
require a few weeks to
stabilise. Careful monitoring of glaucoma patients is advised.
If the intraocular pressure of the patient is not adequately
controlled on this regimen, concomitant therapy
with pilocarpine and other miotics and/or adrenaline (epinephrine)
and/or carbonic anhydrase inhibitors
can be instituted.
CHILDREN
Safety and effectiveness in children have not been established.
The volume of each drop dispensed is 36μl.
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.
4.3 Contraindications
• Hypersensitivity to the active substance or to any of the
excipients listed in Section 6.
• 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 i