For the symptomatic relief of burning, irritation and discomfort due to dryness of the eye. For use as a protectant against further irritation or to relieve dryness of the eye.

Posology

Adults and Elderly
Instill 1 or 2 drops in the eye(s), as necessary.

Paediatric Populations
The safety and efficacy of Tears Naturale Free Eye Drops, Solution in children has not been established. However, considering the extensive experience with medicinal products for ocular use containing the listed active substances /excipients/, no dosage adjustment is necessary in these patients.

Hepatic and renal impairment
No studies have been conducted with Tears Naturale Free Eye Drops, Solution in patients with hepatic or renal impairment. However, considering the extensive experience with medicinal products for ocular use containing the listed active substances /excipients/, no dosage adjustment is necessary in these patients

Method of administration

For ocular use

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

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

Multidose products: To avoid contamination, do not touch tip of container to any surface. Replace cap after using.

Unit dose products: Do not reuse. Once opened, discard.

If patients experience headache, eye pain, vision changes, irritation of the eyes, persistent redness or if the condition worsens or persists, they are to discontinue use and consult their doctor.

No clinically relevant interactions have been described.

Fertility

There is no adequate data regarding the impact of Tears Naturale Free Eye drops, Solution on fertility. All of the components 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 Free Eye drops, Solution in pregnant women. All of the components 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.
Tears Naturale Free Eye drops, Solution can be used during pregnancy.

Breast-feeding
There is no adequate data regarding the impact of [Dextran 70 - Hypromellose, Eye drops, Solution] on lactation. All of the components 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.

Tears Naturale Free Eye drops, Solution can be used during breast-feeding.

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs after instillation, the patient must wait until the vision clears before driving or using machinery.

The following adverse reactions have been reported during clinical studies with [Dextran 70 -Hypromellose Eye Drops, Solution] and are classified according to the subsequent 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) and very rare (<1/10,000).

Additional adverse reactions identified from post-marketing surveillance include the following. Frequencies cannot be estimated from the available data.

Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, nor in the event of accidental ingestion of the contents of one bottle.

Pharmacotherapeutic group: artificial tears and other indifferent preparations, ATC code: S01XA20

Mechanism of action
Dextran 70 - Hypromellose Eye Drops, Solution, which is composed of dextran 70 and hypromellose, a water-soluble polymeric system, which combines, with the existing tears of the eye to promote corneal wetting. Through synergy with the existing tear components, it provides a layer on the corneal surface which is maintained through adsorption.

Dextran 70 - Hypromellose Eye Drops, Solution enhances the tear film stability through physiological blending, thus providing a natural lubricant to the cornea. It provides extended tear retention time in the eye even though it is not a highly viscous solution. It increases corneal wetting and increases tear film resistance as evidenced by numerous tear film break up time studies.

Absorption

Hypromellose (HPMC)

No information regarding the pharmacokinetics or absorption of Hypromellose (hydroxypropyl methylcellulose, HPMC) by any route of administration in human is available. There is no reported data available following ocular administration of HPMC in any species. In rat, minimal systemic absorption of HPMC was observed by the oral route following single or multiple administrations.

Dextran-70
There is no data available for ocular absorption with Dextran-70. FITC labeled low molecular weight dextrans demonstrated very low permeability across intact corneas but higher permeability was observed across conjunctiva.
FITC dextrans greater than 20 and 40 k daltons resulted in no apparent permeability across an epithelial cell layer.

Distribution

Hypromellose (HPMC)
Following oral administration to rat, essentially all of the HPMC material remains in the gastrointestinal tract with less than 2% reaching the systemic circulation. Of this, less than 0.2% was found to be distributed into the carcass, skin and tissues.

Dextran 70
Dextran-70 distribution into rabbit liver was 20-fold higher than lung, kidney and spleen following intravenous administration. This binding to the liver appears to be non-specific.
Following intravenous of 14C labeled dextran to dogs, the highest activity was associated with liver, lymph node, adrenal, spleen, muscle, skin, hair and kidney.

Biotransformation

Hypromellose (HPMC)
Following oral administration to rat, essentially all of a HPMC dose was eliminated as intact material.

Dextran 70
Dextran has been shown to undergo hydrolysis to dextran-like polyglucosides in rabbit liver tissue. The enzyme responsible for the hydrolysis is an acid α-exopolyglucosidase, which has also been identified in human liver, spleen and kidney. Anaerobic bacteria of the Bacteroides genus located in the human colon are capable of dextran degradation with dextrose as the major product.

Elimination

Hypromellose (HPMC)
Following oral administration to rat, greater than 99% of a single HPMC dose was recovered unchanged in the feces.

Dextran 70
Intravenous administration of up to 2 liters of dextran to human patients resulted in lower molecular weight chains of dextran excreted in urine.

Following intravenous of 14C labeled dextran to dogs, a major portion of the administered dextran is rapidly excreted in urine.

Linearity/non-linearity
No dose ranging studies have been reported regarding systemic exposures of HPMC or Dextran 70.

Pharmacokinetic/pharmacodynamic relationship(s)

No PK/PD studies have been reported for HPMC or Dextran 70.

Non-clinical data reveal no special hazard for humans based on conventional studies or risk assessments of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.

Sodium chloride
Potassium chloride
Sodium borate (decahydrate)
Sodium hydroxide and/or hydrochloric acid (to adjust pH)
Purified water

Not applicable.

Store below 25°C.
Do not use this medicine after the expiry date which is stated on the packaging.
Discard 4 weeks after first opening.
Keep this medicine out of the sight and reach of children

Single dose container containing 0.9 mL solution.

Any unused product or waste material should be disposed of in accordance with local requirements.