Tears substitute for the symptomatic treatment of moderate to severe dry eye, including keratoconjunctivitis sicca.

Instill 1 or 2 drops into the conjunctival sac of the affected eye(s) as needed, up to once every 1-2 hours or as prescribed by the physician.

Adults, children, and the elderly

These drops may be used by both adults and children.

Method of administration

For ocular use

Patients must not use this product if the solution becomes cloudy or changes colour.

Do not reuse. Once opened, discard.

Hypersensitivity to dextran 70, hypromellose or to any of the excipients.

• For ocular use only. Not for injection or ingestion

• If patients experience headaches, eye pain, changes in vision, persistent redness or irritation of the eyes, or if the condition worsens or persists for more than 3 days, they are to discontinue use and consult a doctor.

If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.

Fertility

There is no adequate data regarding the impact of Tears Naturale on fertility. Dextran 70 and hypromellose are pharmacologically inert compounds or generally classified as non-toxic and non-irritating (See Section 5.3). Therefore, no effects on fertility are anticipated

Pregnancy

There is no adequate data from the use of TEARS NATURALE SINGLE DOSE in pregnant women. Dextran 70 and hypromellose are pharmacologically inert compounds or generally classified as non-toxic and non-irritating (See Section 5.3); therefore, no adverse effects during pregnancy are anticipated. These components are not expected to be absorbed systemically, to demonstrate any systemic toxicity or to have any effect on reproduction or embryofetal development.

TEARS NATURALE SINGLE DOSE can be used during pregnancy.

Breast-feeding

There is no adequate data regarding the impact of TEARS NATURALE SINGLE DOSE on lactation. Dextran 70 and hypromellose are pharmacologically inert compounds or generally classified as non-toxic and non-irritating (See Section 5.3); therefore, no adverse effects during breast-feeding are anticipated. It is unknown whether dextran 70, hypromellose or any of the components are excreted in human milk. Nonetheless, discontinuation of product use during breast-feeding is not considered necessary.

TEARS NATURALE SINGLE DOSE can be used during breast-feeding.

TEARS NATURALE SINGLE DOSE has no or negligible influence on the ability to drive or use machines. As with any eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must not drive or use machinery until the vision is completely cleared.

a. Summary of the safety profile

The most frequently occurring adverse reaction during clinical trials was vision blurred.

b. Tabulated list of adverse reactions

The following adverse reactions are classified according to the following convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions were obtained from clinical trials and post marketing spontaneous reports.

Reporting of side effects

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 at: www.mhra.gov.uk/yellowcard

• No case of overdose has been reported.

• An overdoseof TEARS NATURALE SINGLE DOSE can easily be washed out of the eye with lukewarm tap water.

ATC Code S01X A20

TEARS NATURALE SINGLE DOSE is an unpreserved physiological tear product that exerts a physical, not a pharmacologic action, and it contains the ionic components of the human tear: calcium, magnesium, sodium, potassium, zinc, bicarbonate and chloride ions. TEARS NATURALE SINGLE DOSE also contains the DUASORB system, which consists of two water-soluble polymers: Dextran 70 and hypromellose. The system provides a lubricant and emollient effect to the cornea. The surface tension and viscosity of TEARS NATURALE SINGLE DOSE are similar to those of natural tears.

An animal model study demonstrated that a tear solution with physiologic electrolyte composition, including bicarbonate, can provide an environment for the cornea which is conducive to recovery from epithelial damage. This suggests that artificial tears containing bicarbonate may also be of benefit in the treatment of the compromised ocular surface epithelium of dry eye patients. An open-label, non-randomized, parallel group study was conducted in which 14 patients with keratoconjunctivitis sicca received treatment with TEARS NATURALE SINGLE DOSE. This study demonstrated that TEARS NATURALE SINGLE DOSE provided objective improvement in ocular surface desiccation, cell pathology and symptomatic complaints as compared with a control formulation without bicarbonate. Although statistical comparisons were not conducted between or within treatments, results were considered clinically significant.

The pharmacokinetics of Dextran 70 and hypromellose have not been studied in this product. Due to the high molecular weights of these polymers, penetration into the cornea and conjunctiva is expected to be low.

The preclinical safety of TEARS NATURALE SINGLE DOSE was demonstrated in an exaggerated treatment regimen with 12 applications of the product to rabbits' eyes over a 5.5-hour period. Prior to instillation, the test samples had been opened, stored at room temperature for 10 days, followed by storage at 45° C for 50 hours, in order to increase the pH to approximately 8.8. Under this exaggerated treatment regimen, the product was found to be well tolerated.

Sodium chloride

Potassium chloride

Calcium chloride (dihydrate)

Magnesium chloride (hexahydrate)

Zinc chloride

Sodium hydrogen carbonate

Carbon dioxide (to adjust pH)

Purified water

None known.

2 years.

Discard four days after first opening the aluminum overwrap.

After opening, the contents of a single-dose container should be used immediately.

Do not store above 25 ° C.

Do not freeze.

Keep in original container

28 x 0.4 ml single-dose LDPE containers.

The carton contains seven aluminium overwraps, each of which contains four single-dose containers.

Ensure that the single-dose container is intact before use.

Separate one container. To open, completely TWIST off tab; do not PULL off.

Do not touch the tip of the container to any surface in order to avoid contamination of the contents.

The solution should not be used if it changes colour or becomes cloudy.

Single use only. Discard the open container after use.