INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo TEARS NATURALE® PRESERVATIVE FREE (Ophthalmic solution)

SCHEDULING STATUS:
Not Scheduled

PROPRIETARY NAME
(and dosage form):

TEARS NATURALE® PRESERVATIVE FREE (Ophthalmic solution)

COMPOSITION:
Each mL contains:
Dextran 70 1,0 mg
Hydroxypropyl methylcellulose (4000 cps) 3,0 mg

in a sterile, preservative free isotonic solution.

PHARMACOLOGICAL CLASSIFICATION:
A.15.4 Ophthalmic preparations, other.

PHARMACOLOGICAL ACTION:
The dextran and hydroxypropyl methylcellulose polymers in TEARS NATURALE
®PRESERVATIVE FREE mimic the action of conjunctival mucin helping mucin-deficient states and increasing the ocular retention time in aqueous-deficient states through the adsorption action of the polymers attaching to the ocular surface. The adsorption effect is independent of the viscosity thus ensuring a prolonged wetting action with a low viscosity.
TEARS NATURALE
®PRESERVATIVE FREE increases corneal wetting as judged by a greatly reduced contact angle on the clean corneal surface (18 - 21°). (Normal saline: 48 - 52°).
It increases precorneal tearfilm stability, evidenced by tearfilm break up studies.

INDICATIONS:
An artificial tear treatment for both mucin-deficient and aqueous-deficient dry eye conditions.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.

WARNINGS:
Do not re-use. Once opened, discard.

DOSAGE AND DIRECTIONS FOR USE:
Instill one or two drops as frequently as required to relieve eye irritation symptoms or as directed by your doctor.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
None.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
None

IDENTIFICATION:
A colourless, clear to slightly turbid liquid.

PRESENTATION:
Supplied in single dose containers containing 0,4 mL each, packed in cartons of 30 units.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
29/15.4/0216

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ALCON Laboratories (S.A.)(Pty) Ltd.
Surrey Avenue, RANDBURG 2194

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
3 November 1994

87 DA 413 270

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