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Alcon Laboratories (U.K) Limited
Pentagon Park, Boundary Way, Hemel Hempstead, Hertfordshire, HP2 7UD Telephone: +44 (0)1442 341 234 Fax: +44 (0)1442 341 200 Need to contact this company?

Summary of Product Characteristics last updated on the eMC: 14/10/2009

SPC	Tears Naturale

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
Administrative Data
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Tears Naturale

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Dextran 70 0.1% w/v

Hypromellose 0.3% w/v

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3. PHARMACEUTICAL FORM

Eye drops, solution.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

As a lubricant and artificial tear in dry eye and other ocular irritation syndromes associated with deficient tear or mucous secretion.

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4.2 Posology and method of administration

Adults, children and the elderly:

One or two drops as required or directed instilled into the conjunctival sac.

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4.3 Contraindications

This product contains benzalkonium chloride and should not be used when soft contact lenses are being worn.

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4.4 Special warnings and precautions for use

If irritation persists or if the condition does not improve, the patient should seek further advice from their doctor.

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4.5 Interaction with other medicinal products and other forms of interaction

None known.

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4.6 Pregnancy and lactation

There is insufficient evidence as to the safety in pregnancy and lactation. Therefore, this product should only be used in pregnancy and lactation if it is considered essential by the physician.

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4.7 Effects on ability to drive and use machines

None known.

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4.8 Undesirable effects

None known.

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4.9 Overdose

Not applicable.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Pharmacotherapeutic Group: Artificial Tears

ATC Code: S01X A

The combination of Dextran 70 and hypromellose in an aqueous presentation provides a soothing lubricant preparation for the relief of dry eye syndrome associated with deficient tear secretion or deficient mucous.

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5.2 Pharmacokinetic properties

Not applicable.

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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.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Benzalkonium chloride

Disodium edetate