500mcg/mL (0.05% w/v)
OPHTHALMIC DROPS
VASOCONSTRICTOR
PATIENT INFORMATION LEAFLET

Product Description:

Tetrahydrozoline HCI (Visine) is a clear, colorless to slightly yellow, sterile ophthalmic solution containing 0.05% w/v Tetrahydrozoline with  lubricants, packed in a translucent, tear-drop shaped, low density polyethylene (LDPE) bottle (15 ml) with a dropper tip, and a two-piece, "push & turn" child-resistant screw cap.

What is in the Medicine?

Each ml contains:

Tetrahydrozoline Hydrochloride... 500mcg

What is the Medicine used for?

Temporarily relieves hyperemia (redness) of the eye secondary to minor eye irritations.

How much and how often should you use this Medicine?

Unless otherwise required by local authorities, these products should be administered as follows:

Adults and children 6 years of age and older:

Instill 1 or 2 drops in the affected eye(s) up to four times a day.

Children under 6 years of age and older:

Use under the supervision of a healthcare professional.

FOR EXTERNAL USE ONLY

When should you not take this Medicine?

Do not use in patients with known hypersensitivity to tetryzoline or to any of the ingredients.

Do not use in patients with narrow angle glaucoma.

Do not use in patients under 2 years of age.

Care that should be taken when taking this Medicine?

If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists or new symptoms occur, discontinue use and consult a physician.

When using this product, pupils may become enlarged temporarily.

Overuse or continuous use of this product may produce increased redness of the eye.

Remove contact lenses before using this product.

To avoid contamination of this product, do not touch tip of container to any surface. Replace cap after using. Do not use if this solution changes in color or becomes cloudy.

Undesirable effects of this Medicine

Clinical Trial Data

The safety of tetryzoline from clinical trial data was based on data from 5 clinical trials (Skilling et al 2005, 0152-8/72, A35B1001, TMC-C-3 and TMC-C-2) tor thetreatmentof ocular irritation.

Table 1 includes adverse events that occurred where greater than one event was reported, and the incidence was greater than placebo and in 1% of patients or more.

Table 1. ADRs Reported by >1% Tetryzoline-treated adult subjects in Single Dose Randomized Placebo Controlled Clinical Trials

Post Marketing Data

Adverse drug reactions (ADRs) identified during Post-marketing experience with tetryzoline are included in Table 3 and Table 4.

The frequencies are provided according to the following convention:

Very common ≥ 1/10

Common ≥ 1/100 and < 1/10

Uncommon ≥ 1/1,000 and < 1/100

Rare ≥ 1/10,000 and < 1/1,000

Very rare < 1/10,000

Not known (cannot be estimated from the available data)

To accommodate different local requirements, two tables are presented. It should be determined locally which format is preferable to the local health authority.

In Table 2, ADRs identified are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available or 2) when incidence is unavailable, frequency category is listed as Not known.

In Table 3, the same ADRs are presented with ADR frequency categories estimated from spontaneous reporting rates where the numerator represents total number of reported Company ADRs under given PT or medical concept and denominator represents exposure data calculated from sales data.

Table 2. Adverse Drug Reactions Identified During Post-Marketing Experience with Tetryzoline by Frequency Category Estimated from Clinical Trials or Epidemiology Studies