Minims Artificial Tears, Eye drops solution

For the relief of dry eye syndromes associated with deficient tear secretion.

One or two drops instilled into the affected eye three or four times daily, or as often as is required.

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

If irritation persists or worsens or continued redness occurs, discontinue use and consult a physician or ophthalmologist.

None known.

There is no evidence of safety of the drug in human pregnancy but it has been in wide use for many years without apparent ill consequence. If drug therapy is needed in pregnancy this preparation can be used if recommended by a physician and it is considered that the benefits outweigh the possible risks.

May cause transient blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is clear.

May cause transient mild stinging or temporarily blurred vision.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard

Overdose would not be expected to produce symptoms.

Pharmacotherapeutic group: Artificial tears and other indifferent preparations,

ATC code: S01XA20

The viscolising properties of hyetellose combined with sodium chloride have been shown to increase the tear break-up time in animal models, whilst also acting as a lubricating agent for dry eyes.

Not applicable.

No adverse safety issues were detected during the development of this formulation. The active ingredients are well-established in clinical ophthalmology.

Purified water

Borax

Boric acid

Not applicable

18 months.

Store below 25° C. Do not freeze. Protect from light.

A sealed conical shaped polypropylene container fitted with a twist and pull off cap. Each Minims unit is overwrapped in an individual polypropylene/paper pouch.

Each Minims unit should be discarded after a single use.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.