TEOPTIC Eye drops, solution Ref.[6554] Active ingredients: Carteolol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Laboratories Thea, 12 Rue Louis Blรฉriot, 63017, Clermont-Ferrand Cedex 2, France

Therapeutic indications

For the reduction of intraocular pressure e.g. in ocular hypertension, chronic open angle glaucoma, some secondary glaucomas.

Posology and method of administration

Posology

Adults

Initially one drop of 1% eye drops instilled twice daily in each affected eye. If the clinical response is not adequate the dosage may be altered to one drop of 2% eye drops twice daily in each affected eye.

Elderly population

There is no indication that dosage needs to be modified for the elderly.

Paediatric population

Safety and effectiveness of carteolol has not been established.

Method of administration

Ocular use.

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.

The dispenser remains sterile until the original closure is broken. Patients must be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures as this may contaminate the solution.

If the patient’s IOP is not at a satisfactory level with this regimen, concomitant treatment with other IOP lowering drugs may be considered.

If more than one medication needs to be instilled in the eye, an interval of at least 5 minutes between application of the different medicinal products must be allowed.

Overdose

No specific information on emergency treatment of overdose in humans is available. Should accidental ocular overdose occur, the eyes should be flushed with water or saline solution.

The most common signs and symptoms to be expected following overdose with a beta-adrenergic receptor blocking agent include dizziness, headache, shortness of breath, symptomatic bradycardia, hypotension, bronchospasm, and acute cardiac failure.

In case of overdose standard medical treatment can be administered.

Shelf life

Shelf life

Unopened: 24 months.
Opened: 28 days.

Special precautions for storage

Do not store above 25ยบC.

Nature and contents of container

1 X 5ml polyethylene dropper bottle
3 X 5ml polyethylene dropper bottle

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal.

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