VISCOTEARS Eye gel Ref.[27756] Active ingredients: Carbomer

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Dr. Gerhard Mann chem.-pharm. Fabrik GmbH, Brunsbรผtteler Damm 165-173, 13581 Berlin, Germany

4.1. Therapeutic indications

Substitute tear fluid for the management of dry eye conditions including keratoconjunctivitis sicca, and for unstable tear film.

4.2. Posology and method of administration

For ocular use.

Adults

1 drop 3-4 times daily or as required, depending upon the severity of the disease.

Elderly

No dosage amendment is necessary in the elderly.

Children and adolescents aged to 18 years

The safety and efficacy of Viscotears SDU in children and adolescents at the posology recommended in adults has been established by clinical experience, but no clinical trial data are available.

Viscotears SDU contains a sterile gel until the original closure is broken. The tip of the container should not come into contact with any surface including the eye, as this may cause injury to the eye.

Viscotears Single Dose Unit should be used immediately after opening and discarded after use.

4.9. Overdose

Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, nor in the event of accidental ingestion of the contents of one tube.

Although this is unlikely to occur, should patients experience any untoward symptoms after applying too much Viscotears or accidental ingestion, treatment should be symptomatic.

6.3. Shelf life

2 years.

For single use only. Use immediately after first opening.

6.4. Special precautions for storage

Do not store above 25ยฐC. Keep containers in outer carton.

6.5. Nature and contents of container

Transparent LDPE single-dose container containing 0.6ml of gel.

Available in packs of 5, 10, 15, 20 and 30 single dose units.

6.6. Special precautions for disposal and other handling

Not applicable.

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