Consumer Information for: VISTITAN

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Vistitan eye drops are used to reduce high pressure in the eye in adult patients with open-angle glaucoma or ocular hypertension. If the high pressure is not reduced, it could eventually damage your sight.

What it does

Vistitan is an antiglaucoma preparation. It belongs to a group of medicines called prostamides. Your eye contains a clear, watery liquid that feeds the inside of the eye. Liquid is constantly being drained out of the eye and new liquid is made to replace this. If the liquid cannot drain out quickly enough, the pressure inside the eye builds up. Vistitan works by increasing the flow of liquid that is drained. This reduces the pressure inside the eye.

When it should not be used

You are allergic to Bimatoprost, to any of the other ingredients, or to any of the parts of the container (see section What are the ingredients).

What the medicinal ingredient is

Medicinal ingredients: Bimatoprost

What the non-medicinal ingredients are

Non-medicinal ingredients: Benzalkonium chloride 0.005% w/v as preservative, sodium chloride, sodium phosphate dibasic anhydrous, citric acid monohydrate, and purified water. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH.

What dosage form it comes in

Ophthalmic solution, 0.03% w/v

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you use Vistitan. Talk about any health conditions or problems you may have, including if you:

  • are taking, or have recently taken, any other medicines. Using Vistitan with other medicines or other antiglaucoma products may reduce their effectiveness.
  • are pregnant or planning to become pregnant. You should ask your healthcare professional for advice before taking any medicine.
  • are breastfeeding or planning to breastfeed. Ask your healthcare professional how to feed your baby while using Vistitan.
  • have an active eye infection, inflammation (e.g. uveitis) or any other eye condition.
  • develop another eye condition (an injury or an infection).
  • need to have eye surgery.
  • have liver or kidney problems

Other warnings you should know about:

Change in Eye and Eyelid Color

Vistitan has been associated with iris pigmentation (change in the colored par of the eye).This is likely to be permanent. The change may be more noticeable if you are only treating one eye. Taking too much Vistitan (overdose) may contribute to iris pigmentation. Vistitan use may also cause darkening of the eyelid skin, which may be reversible in most patients.

Hair Growth

It is possible for hair growth to occur in areas of your skin that Vistitan frequently touches. Any excess solution that drips from the eye should be blotted with a tissue or other absorbent material to reduce the chance of this happening. It is also possible for a difference in eyelash length, thickness, fullness, pigmentation, number of eyelash hairs, and/or direction of eyelash growth to occur between eyes. These differences, should they occur, will usually go away if you stop using Vistitan.

Changes in Vision

Using Vistitan may temporarily blur your vision. Do not drive or use machines until your vision has cleared.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication

No drug interaction studies with Vistitan.

Proper use of this medication

How to use Vistitan:

  • Do not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.
  • Always use Vistitan exactly as your healthcare professional has instructed you.
  • Vistitan contains a preservative called benzalkonium chloride which may discolor soft contact lenses. If you wear contact lenses, remove them before using Vistitan. Wait 15 minutes after using the drops before you put your lenses back in.
  • If you use Vistitan with another eye drop, wait at least five minutes after using Vistitan before using the other drops.
  • To help prevent infections, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle immediately after you have used it.

Follow these steps to use Vistitan properly:

  1. Wash your hands. Tilt your head back and look at the ceiling. (See illustration 1)
  2. Gently pull down the lower eyelid to create a small pocket. (See illustration 2)
  3. Turn the bottle upside down and squeeze it gently to release one drop into the eyelid pocket. If a drop misses your eye, try again. (See illustration 3)
  4. Let go of the lower lid, and close your eye for 30 seconds. (See illustration 4)

  5. Repeat steps 1 – 4 in the other eye if both eyes need treatment.

Usual adult dose:

The recommended dose is one drop of Vistitan in each eye that needs treatment, once daily, in the evening.

Overdose

If you think you have used too much Vistitan, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you accidentally use too many drops, just go back to your regular once a day dosing the next day.

Missed Dose

If you forget to take Vistitan, use a single drop as soon as you remember, and then go back to your regular routine. Do not take two doses to make up for the one that you missed.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking Vistitan. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

  • Longer eyelashes, change in eyelash color
  • Eye irritation, redness, itching, dryness
  • Burning or stinging sensation in the eye
  • Feeling that something is in your eye
  • Eye pain
  • Eye discharge
  • Abnormal vision
  • Red and itchy eyelids
  • Darkening of the eyelid
  • Inflammation of the eyelid
  • Small breaks in the surface of the eye
  • Sensitivity to light
  • Tearing
  • Tired eyes
  • Dizziness
  • Headache

Some patients (fewer than 2 in every 100) experience a change in iris color (iris pigmentation). The change is a darkening, with the eyes becoming more brown. This usually happens during the first year of treatment. Eye darkening is expected to increase as long as Vistitan is administered. It is not known what this change means over the long term. Talk to your healthcare professional if you notice a change in your iris color.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to you healthcare professional.

How to store

Vistitan should be stored in the original container at 2ºC to 25ºC.

Discard the unused portion 30 days after opening the bottle.

Do not use product if solution shows haziness, particulate matter, discoloration, or leakage.

Do not use the drops after the expiry date (marked “EXP”) on the bottle and the box.

Keep out of the reach and the sight of children.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about Vistitan:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication information by visiting the Health Canada website (https://www.canada.ca/en/health_canada.html); the manufacturer’s website Sandoz.ca, or by calling 1-800-361-3062

or by written request at:
110 Rue de Lauzon
Boucherville, Québec, Canada
J4B 1E6

or by e-mail at:
medinfo@sandoz.com

This leaflet was prepared by Sandoz Canada Inc.
VistitanTM is a trademark owned by Novartis Inc.
Last revised: January 28, 2019

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