INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
HYPOTEARS PLUS Eye Drops

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

HYPOTEARS PLUS Eye Drops

COMPOSITION:
Each 1 mL contains:
Polyvidone 50 mg; Benzalkonium Chloride 0,005% m/v (as preservative)

PHARMACOLOGICAL CLASSIFICATION:
15.4 Ophthalmic Preparations - others.

PHARMACOLOGICAL ACTION:
Hypotears Plus eye drops functions as an artificial tear solution by the physico-chemical properties of its active ingredient Polyvidone. Polyvidone is a water soluble macromolecule which is absorbed onto the ocular surface and forms a lubricating film. This hydrophillic layer increases the wettability of the corneal surface and hence the tear film stability.

INDICATIONS:
A tear fluid substitute for the symptomatic treatment of dry eye conditions.

CONTRA-INDICATIONS:
Known hypersensitivity to the active ingredients or the preservative. The safety in pregnancy and lactation has not been established.

WARNINGS:

(i)	No contact lenses should be worn during instillation. They can be reinserted after an interval of at least 30 minutes.
(ii)	There is no interaction with other medications, but in order to prevent the active substance from being washed out, there should be an application interval of at least 5 minutes between the two medications. Hypotears Plus eye drops should always be the last medication instilled.
(iii)	Avoid driving motor vehicles or operating machines if vision becomes blurred immediately after instillation.
(iv)	As the possibility of adverse effects on corneal permeability and the danger of disruption of corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required.
(v)	Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.

DOSAGE AND DIRECTIONS FOR USE:
Instill one drop four times daily into the conjunctival sac of the eye.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Mild transient burning or sticky sensation on occasion, and very rarely irritation or hypersensitivity reactions.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No known cases.

IDENTIFICATION:
Hypotears Plus eye drops is a clear, colourless to slightly yellow aqueous solution.

PRESENTATION:
Transparent LDPE dropper bottle with a white HDPE cap, containing 10 mL of solution.

STORAGE DIRECTIONS:
Store below 25°C.
Keep out of reach of children.
Discard contents of bottle 30 days after opening.

REGISTRATION NUMBER:
32/15.4/0401

NAME AND BUSINESS ADDRESS OF APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston, Ext. 77
Private Bag X69
Bryanston, 2021

Under licence from Novartis Ophthalmics Ltd

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
15/05/1998

New addition to this site: May 2004
Source: Pharmaceutical Industry
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