SNO Tears

1. Name Of The Medicinal Product

Sno* tears

2. Qualitative And Quantitative Composition

Polyvinyl Alcohol 1.4% w/v.

3. Pharmaceutical Form

Multidose eye drops.

4. Clinical Particulars

4.1 Therapeutic Indications

Sno tears is used topically to provide tear-like lubrication for the symptomatic relief of dry eyes and eye irritation associated with deficient tear production (usually in cases of keratoconjunctivitis sicca and xerophthalmia).

Sno tears is also used as an ocular lubricant for artificial eyes.

4.2 Posology And Method Of Administration

Adults (including the elderly) and children:

The dose depends on the need for lubrication. Usually one or more drops should be used as required, or as prescribed.

4.3 Contraindications

Hypersensitivity to any component of the preparation.

This product contains benzalkonium chloride, therefore, soft contact lenses should be removed during treatment with Sno tears.

4.4 Special Warnings And Precautions For Use

If irritation persists or worsens or headache, eye pain, vision changes or continued redness occurs, discontinue use and consult a physician.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is no evidence of safety of the drug in human pregnancy, but it has been in widespread use for many years without apparent ill consequence. If any therapy is needed in pregnancy, this preparation can be used if recommended by a physician.

4.7 Effects On Ability To Drive And Use Machines

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

4.8 Undesirable Effects

May cause transient, mild stinging or temporarily blurred vision.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Polyvinyl alcohol is a wetting agent and as such enables the formation of a tear film to relieve the symptoms of dry eye.

5.2 Pharmacokinetic Properties

There are not expected to be any systemic reactions occurring following the use of Sno tears.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzalkonium Chloride

Disodium Edetate

Hydroxyethylcellulose

Sodium Chloride

Sodium Hydroxide

Purified Water

6.2 Incompatibilities

None known.

6.3 Shelf Life

Unopened: 36 months

Opened: 1 month

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

A 10ml polyethylene bottle fitted with a polyethylene plug and a tamper evident polystyrene or polyethylene pilfer proof cap.

6.6 Special Precautions For Disposal And Other Handling

Discard any remaining solution 1 month after first opening the container.

7. Marketing Authorisation Holder

Chauvin Pharmaceuticals Ltd

106 London Road

Kingston-upon-Thames

Surrey

KT2 6TN

England

8. Marketing Authorisation Number(S)

PL 0033/0097

9. Date Of First Authorisation/Renewal Of The Authorisation

15.2.83 14.02.98

15.2.84

10. Date Of Revision Of The Text

October 1997

November 2002