TEARS NATURALE SINGLE DOSE eye drops, solution

1 ml of TEARS NATURALE SINGLE DOSE contains:

Dextran 70........... 1.0 mg

Hypromellose........... 3.0 mg

For excipients, see 6.1.

Eye drops, solution

Clear, colourless solution

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.

Hypersensitivity to any of the components of the medication.

Only for topical ophthalmic use.

If patients experience eye pain, changes in vision, persistent redness or irritation of the eyes, or if the condition worsens or persists for more than 72 hours, they are to discontinue use and consult a doctor.

If other topically applied eye drops are instilled concomitantly, wait as directed per labeling instructions, or 10-15 minutes, and then instill TEARS NATURALE SINGLE DOSE.

The use of this product by patients while wearing contact lenses has not been investigated. Such patients should remove their contact lenses, instill the product and wait 10-15 minutes before re-inserting their contact lenses.

To avoid contamination, do not touch the tip to the eye or any surface. Discard the open vial after use.

Interactions of TEARS NATURALE SINGLE DOSE with other medications have not been specifically evaluated. If other topically applied eye drops are instilled concomitantly, wait as directed per labeling instructions, or 10-15 minutes, and then instill TEARS NATURALE SINGLE DOSE.

Information on the use of these eye drops during pregnancy and lactation is not available. Therefore, this product should only be used in pregnancy and lactation if it is considered essential by a physician.

As with any ocular medication, if transient blurred vision occurs at instillation, the patient must not drive or use machinery until the vision is completely cleared.

TEARS NATURALE SINGLE DOSE was administered in clinical studies involving 89 patients. The most frequently reported treatment-related adverse events and local symptoms were blurred vision (4.5%) and ocular discomfort (3.4%).

The following undesirable effects for TEARS NATURALE SINGLE DOSE were assessed as definitely, probably, or possibly related to treatment were reported during clinical trials with TEARS NATURALE SINGLE DOSE. Their incidence was common (1.0% to 10.0%, maximum observed actual incidence of 4.5%) and no undesirable effects were reported at an incidence less than 1.0% (uncommon) or 0.1% (rare). No systemic undesirable effects were reported as related to treatment with TEARS NATURALE SINGLE DOSE.

Ocular Effects

Common: blurred vision (4.5%), ocular discomfort (burning and/or stinging) (3.4%), ocular fatigue (1.1%), foreign body sensation (1.1%), ocular hyperemia (1.1%), ocular pruritus (1.1%).

Clinical Practice

The following events have been identified during postmarketing use of BION TEARS (identical product to TEARS NATURALE SINGLE DOSE). Since these are reported voluntarily from a population of unknown size, exact determination of frequency cannot be made. The most frequently reported events include ocular discomfort, ocular irritation, ocular hyperemia and blurred vision.

If overdose with TEARS NATURALE SINGLE DOSE occurs, flush the eye with warm 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^oC 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.

Alcon Laboratories (UK) Ltd.,

Pentagon Park,

Boundary Way,

Hemel Hempstead,

Herts. HP2 7UD,

U.K.

PL 00649/0170

28/10/2005

21/08/2007