Sno Tears 1.4% Eye Drops Solution
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sno Tears 1.4% Eye Drops, Solution.
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 Contra-Indications
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 Special 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. Interactions 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.
PHARMACOLOGICAL PROPERTIES
5
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. Pre-clinical 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:
Opened:
36 months 1 month
Special Precautions for Storage
6.4.
Store below 25°C.
6.5. Nature and Content 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
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
8. MARKETING AUTHORISATION NUMBER
PL 00033/0097
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
08/08/2008
08/08/2008