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

Logo SOFTAB® effervescent tablets
SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

SOFTAB® effervescent tablets

COMPOSITION:
Each tablet contains 0,065 mg sodium dichloroisocyanurate equal to 0,04 mg available chlorine in an effervescent base.

PHARMACOLOGICAL CLASSIFICATION:
A 34 Contact lens preparations.

PHARMACOLOGICAL ACTION:
Sodium dichloroisocyanurate is an oxidising compound which releases chlorine to produce hypochlorous acid and hypochlorite ion in the presence of water. It is generally considered that the lethal action on organisms is due to chlorination of cell protein or enzyme systems by nonionised hypochlorous acid.
Chlorine-releasing substances are bactericidal to most Gram-positive and Gram-negative bacteria, some bacterial spores and some viruses.

INDICATIONS:
SOFTAB tablets are dissolved in an unpreserved saline solution for the daily disinfection of soft, hydrophilic contact lenses.

CONTRA-INDICATIONS:
Chlorine hypersensitivity.

WARNINGS:
Not to be used for the disinfection of tinted lenses.
Do not mix the tablets or solution with other fluids except as recommended.

DOSAGE AND DIRECTIONS FOR USE:
Clean lenses as directed and rinse thoroughly with sterile unpreserved saline to remove tear secretions and cell debris. Place the lenses in the SOFTAB lens holder in the appropriate compartments.
Fill the cup with sterile unpreserved saline (10 mL approx.) to the fill line and add one SOFTAB tablet. Close the cup and allow to stand for at least four hours (usually overnight). At the end of the soaking period, rinse the lenses thoroughly with fresh sterile unpreserved saline. Wash and dry the hands and place the lenses in the eyes.

PRECAUTIONS:
Use only sterile physiological saline (non-preserved) to dissolve these tablets. Do not use SOFTAB in conjunction with other soaking solutions. If changing to SOFTAB after having used other disinfecting or soaking solutions, it is recommended that the lenses be cleaned by an optical practitioner. If eye irritation or any other adverse reaction is experienced consult a doctor or optical practitioner.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
No finality has been reached on the long term safety of soft contact lens preparations.

IDENTIFICATION:
White, round tablets.

PRESENTATION:
Cartons containing 30 tablets in laminated aluminium foil strip packs.

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

REGISTRATION NUMBER:
V/34/76

NAME AND BUSINESS ADDRESS OF APPLICANT:
Alcon Laboratories (SA) (Pty) Limited,
Surrey Avenue
RANDBURG
2194

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8 September 1987.
1190

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