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

Logo LIVOSTIN®E.D. eye drops

SCHEDULING STATUS
Schedule 2.

PROPRIETARY NAME
(and dosage form)

LIVOSTIN®E.D. eye drops

COMPOSITION
Each mL of the microsuspension contains
levocabastine hydrochloride equivalent to 0,5 mg levocabastine. Preservative: Benzalkonium chloride 0,015% m/v and Disodium edetate 0,015% m/v.
Each drop contains approximately 15 µg levocabastine.

PHARMACOLOGICAL CLASSIFICATION:
A.5.7.1 Antihistaminics.

PHARMACOLOGICAL ACTION
Livostin E.D. eye drops contains levocabastine, a selective histamine H
1 -antagonist with a prolonged elimination half-life of 30 –40 hours.
After instillation in the eyes, levocabastine is slowly and incompletely absorbed.
Typical systemic antihistaminic effects have been observed in human volunteers after oral administration of therapeutic effective doses of levocabastine following histamine provocation. Following therapeutic doses of topically applied levocabastine eye drops, there is minimal systemic absorption.

INDICATIONS
Symptoms of seasonal allergic conjunctivitis.

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients.
The safety in pregnancy and lactation has not been established.
In mice and rats, Livostin, at high systemic doses did reveal embryotoxic and teratogenic effects.

DOSAGE AND DIRECTIONS FOR USE
As Livostin E.D. eye drops is available as a microsuspension, the bottle should be shaken before each application.
ADULTS AND CHILDREN OVER 5 YEARS: The usual dose is 1 drop of Livostin E.D. eye drops per eye, twice daily. The dose may be increased to 1 drop per eye, 3 to 4 times daily. Treatment should be continued up to maximum of 8 weeks.
Livostin E.D. eye drops should be used within one month of the first opening of the bottle. Patients should be instructed to take appropriate measures to avoid contamination.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Local irritation immediately after instillation of Livostin E.D. eye drops may occur.
Headache, dry mouth, somnolence, tiredness have occurred.
As with all ophthalmic preparations containing benzalkonium chloride, patients are advised not to wear soft (hydrophillic) contact lenses while under treatment with Livostin E.D. eye drops. Also, caution should be exercised with prolonged use in patients with extensive ocular surface disease.
Livostin E.D. lacks significant sedative effects. Patients should, however, be warned that a small number of individuals may experience sedation. It is therefore advisable to determine individual response before driving or performing complicated tasks. This effect may be compounded by the simultaneous intake of alcohol and other central nervous system depressants.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Treatment is symptomatic and supportive.

IDENTIFICATION
A white homogenous microsuspension.

PRESENTATION
Livostin E.D. eye drops is available in 5 mL containers, containing 4 mL of Livostin E.D. suspension.

STORAGE INSTRUCTIONS
Store below 25°C. Protect from light.
Discard 30 days after opening the bottle.
Keep out of reach of children.

REGISTRATION NUMBER
X/5.7.1/268

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 80/11122/07)
15TH ROAD, HALFWAY HOUSE, 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
4 May 1994

JANSSEN-CILAG logo

© J-C.1997                                Z-Afrika –075053/V2 V

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