Betoptic S 2.5mg/ml, eye drops, suspension

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BETAXOLOL HYDROCHLORIDE

Available from:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

ATC code:

S01ED02

INN (International Name):

BETAXOLOL HYDROCHLORIDE 2.5 mg/ml

Pharmaceutical form:

EYE DROPS, SUSPENSION

Composition:

BETAXOLOL HYDROCHLORIDE 2.5 mg/ml

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Authorised

Authorization date:

2006-01-19

Patient Information leaflet

PACKAGE LEAFLET - INFORMATION FOR THE
PATIENT
BETOPTIC
® S, 2.5 MG/ML, EYE DROPS, SUSPENSION
betaxolol hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
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 you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. WHAT BETOPTIC S IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BETOPTIC S
3. HOW TO USE BETOPTIC S
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE BETOPTIC S
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT BETOPTIC S IS AND WHAT IT IS USED FOR
BETOPTIC S, eye drops, suspension is specially formulated for improved
ocular comfort upon
administration and is packed in plastic bottles of 5 and 10 ml.
BETOPTIC S are eye drops against elevated eye pressure.
BETOPTIC S eye drops is indicated for lowering the intraocular
pressure (pressure inside the eye) in
patients with chronic open-angle glaucoma and/or elevated ocular
pressure. It may be used alone or in
combination with other ocular pressure lowering medications.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE BETOPTIC S
DO NOT USE BETOPTIC S
-
if you are allergic to betaxolol, or any of the other ingredients of
this medicine (listed in section 6).
-
if you have now or have had in 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 heartbeat, heart failure or disorders of heart
rhythm (irregular heartbeats).
WARNINGS AND PRECAUTIONS
Only use Betoptic S for dropping in your eye(s). Talk to your doctor
or pharmacist before usin

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BETOPTIC S, 2.5 mg/ml, eye drops, suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BETOPTIC S.: betaxolol hydrochloride equiv. betaxolol base 2.5 mg/ml.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops, suspension.
Isotonic, sterile, aqueous suspension for topical ocular
administration, specially formulated for improved ocular
comfort upon administration.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
BETOPTIC S ophthalmic suspension lowers the intraocular pressure and
is indicated in patients with chronic
open-angle glaucoma and/or ocular hypertension. It may be used alone
or in combination with other intraocular
pressure lowering medications.
4.2. POS
OLOGY AND METHOD OF ADMINISTRATION
Shake well before each use.
After cap is removed, if tamper evident snap collar is loose, remove
before using product.
The recommended dosage is one drop of BETOPTIC S in the treated
eye(s), twice daily. In some patients,
the intraocular pressure lowering responses to BETOPTIC S. may require
a few weeks to stabilize. As with any
new medication, careful monitoring of patients is advised.
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.
If the i
ntraocular pressure of the patient is not adequately controlled on
this regimen, concomitant therapy
with pilocarpine and other miotics, epinephrine or carbonic anhydrase
inhibitors can be instituted.
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Use in children
There are limited clinical studies to establish the safety and
efficacy in children .
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 de