OPTILAST Eye drops Ref.[6238] Active ingredients: Azelastine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Therapeutic indications

Treatment and prevention of the symptoms of seasonal allergic conjunctivitis in adults and children 4 years and older.

Treatment of the symptoms of non-seasonal (perennial) allergic conjunctivitis in adults and children 12 years and older.

Posology and method of administration

Seasonal allergic conjunctivitis: The usual dosage in adults and children 4 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily. If allergen exposure is anticipated Optilast should be administered prophylactically, prior to the exposure.

Non-seasonal (perennial) allergic conjunctivitis: The usual dosage in adults and children 12 years and older is one drop in each eye twice daily that can be increased, if necessary to four times daily.

As safety and efficacy have been demonstrated in clinical trials for a period of up to 6 weeks, the duration of any course should be limited to a maximum of 6 weeks.

Patients should be advised to contact their doctor if symptoms worsen or do not improve after 48 hours.

Overdose

No specific reactions after ocular overdosage are known, and with the ocular route of administration, overdosage reactions are not anticipated.

There is no experience with the administration of toxic doses of azelastine hydrochloride in humans. In the case of overdose or intoxication, disturbances of the central nervous system are to be expected based on the results of animal experiments. Treatment of these disorders must be symptomatic. There is no known antidote.

Shelf life

3 years.

Do not use for longer than 4 weeks after first opening.

Special precautions for storage

No special precautions for storage.

Nature and contents of container

10 ml opaque HDPE bottle and LDPE dropper with white HDPE screw cap. One bottle contains either 6 ml, 8 ml or 10 ml solution. Not all volume fill sizes are marketed in all Member States.

Special precautions for disposal and other handling

This medicinal product does not require any special storage conditions.

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