BETOPTIC Eye drops, suspension Ref.[6484] Active ingredients: Betaxolol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

Therapeutic indications

BETOPTIC SUSPENSION lowers the intraocular pressure and is indicated in patients with chronic open-angle glaucoma and ocular hypertension.

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 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 24 μl.

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.

Overdose

In case of accidental ingestion, symptoms of overdose from beta blockade may include bradycardia, hypotension, cardiac failure and bronchospasm.

If overdose with Betaxolol Eye Drops occurs, treatment should be symptomatic and supportive.

A topical overdose of BETOPTIC SUSPENSION may be flushed from the eye(s) with warm tap water.

Shelf life

Shelf life: 24 months.

Special precautions for storage

Store the bottle in the outer carton in order to protect from light.

Nature and contents of container

BETOPTIC SUSPENSION is packaged as a 5 ml label fill in a 5 ml and a 10 ml label fill in a 10 ml natural low density polyethylene (LDPE), DROP-TAINER with a LDPE dispensing plug and a 15 mm white polypropylene closure. The DROP-TAINER utilizes a tamper evident closure with a breakaway ring.

Special precautions for disposal and other handling

Shake before each use. Discard product 1 month after first opening.

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