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

Logo TEARS NATURALE® II Ophthalmic Solution

35637-D
        356373

SCHEDULING STATUS:
0

PROPRIETARY NAME
(and dosage form)

TEARS NATURALE® II Ophthalmic Solution

COMPOSITION:
Each mL contains 1 mg
dextran 70 and 3 mg hydroxypropyl methylcellulose, preserved with POLYQUAD® (polyquaternium-1) 0,001% (m/v).

PHARMACOLOGICAL CLASSIFICATION:
A.15.4 Ophthalmic preparations, other.

PHARMACOLOGICAL ACTION:
The dextran and hydroxypropyl methylcellulose polymers in TEARS NATURALE® II 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 II increases corneal wetting as judged by 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:
None known.

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

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
None.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
None known.

IDENTIFICATION:
A practically clear, colourless solution.

PRESENTATION:
Low density polyethylene bottle containing 15 mL.

STORAGE INSTRUCTIONS:
Store in a cool place, below 25°C.
KEEP OUT OF REACH OF CHILDREN.
DO NOT USE MORE THAN 30 DAYS AFTER OPENING.

REGISTRATION NUMBER:
J/15.4/315

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alcon Laboratories (SA) (Pty) Ltd
65 Peter Place
Bryanston Extension 13
2191

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 October 2004

        ALCON LOGO

0404        35637-D

Updated on this site: April 2005
Source: Hospital Pharmacy

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