Minims artificial tears

Minims artificial tears Medicine

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Overdose

Overdose would not be expected to produce symptoms.

Shelf life

24 months

List of excipients

Purified water

Borax

Boric acid

Pharmaceutical form

Sterile single-use eye drop.

Undesirable effects

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

Preclinical safety data

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

Therapeutic indications

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

Pharmacotherapeutic group

Artificial tears and other indifferent preparations, ATC code: S01XA20

Pharmacodynamic properties

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.

Pharmacokinetic properties

Not applicable.

Date of revision of the text

October 2015

Name of the medicinal product

Minims Artificial Tears

Marketing authorisation holder

Bausch & Lomb UK Limited

Bausch & Lomb House

106 London Road

Kingston-upon-Thames

Surrey, UK

KT2 6TN

Special precautions for storage

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

Nature and contents of container

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.

Marketing authorisation number(s)

PL 03468/0067

Fertility, pregnancy and lactation

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.

Qualitative and quantitative composition

Clear, colourless, sterile eye drops containing hyetellose 0.44% w/w and sodium chloride 0.35% w/w.

Special warnings and precautions for use

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

Effects on ability to drive and use machines

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

Dosage (Posology) and method of administration

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

Special precautions for disposal and other handling

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.

Date of first authorisation/renewal of the authorisation

11 January 1990

Interaction with other medicinal products and other forms of interaction

None known.