Consumer Information for: MIOSTAT OPHTHALMIC LIQ 0.01%

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

MIOSTAT* is used to:

  • Constrict the pupil (miosis) during eye surgery
  • Reduce the level of intraocular pressure (IOP) increase during the first 24 hours following cataract surgery
What it does

MIOSTAT* contains carbachol, which constricts the iris (part of the eye which controls the pupil size) and the ciliary body (part of the eye that controls the shape of the lens) of the eye, thereby lowering the pressure in the eye (IOP).

When it should not be used

Do not use MIOSTAT* if you are allergic (hypersensitive) to carbachol, natural rubber (latex) or any of the other ingredients of this medicine (see What the important nonmedicinal ingredients are).

What the medicinal ingredient is

Carbachol, 0.01% w/v

What the non-medicinal ingredients are

Calcium chloride dihydrate, magnesium chloride hexahydrate, potassium chloride, sodium acetate trihydrate, sodium citrate dihydrate, sodium chloride, sodium hydroxide and/or hydrochloric acid (to adjust pH) and water for injection.

What dosage form it comes in

MIOSTAT* is a sterile salt-balanced solution and is available in 1.5 mL glass vials.

Warnings and precautions

BEFORE you use MIOSTAT* talk to your doctor or pharmacist if you:

  • Have heart problems
  • Have asthma
  • Have a urinary tract obstruction (e.g. difficultly urinating)
  • Have stomach ulcers (peptic ulcers)
  • Have an overactive thyroid (hyperthyroidism)
  • Have painful stomach cramping sensations
  • Parkinson’s disease
  • Are allergic to natural rubber (latex). The vial stopper contains latex.

MIOSTAT* may increase eye inflammation following eye surgery.

Driving and Using Machinery
MIOSTAT* may cause blurred vision and difficulty in seeing in low light. Do not drive or use machinery until these effects have worn off.

Pregnancy and Breastfeeding
If you are pregnant, may be pregnant, are breastfeeding, or planning to breastfeed , talk to your doctor before using MIOSTAT*.

Interactions with this medication

Tell your doctor about all the drugs you are using or planning to use, including those without a prescription. No drug interaction studies have been done for MIOSTAT*.

Proper use of this medication

Usual Adult Dose

MIOSTAT* is for injection into the eye and should only be administered by your doctor.

Overdose

If excess MIOSTAT* is given, your doctor may need to give you an injection of an anticholinergic agent to control symptoms

Symptoms of an overdose may include: headache, excess saliva, fainting, slow heart rate, a drop in blood pressure, abdominal cramps, vomiting, asthma and diarrhea.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Side effects and what to do about them

Like all medicines, MIOSTAT* can cause side effects, although not everybody gets them.

Side effects include:

  • Headache, flushing, sweating, stomach cramps, vomiting, bladder tightness (e.g. pressure in the bladder, feeling the need to urinate)
  • Visual impairment (some difficulty in seeing), clouding of the eye surface, eye inflammation, blurred vision, eye swelling, eye pain, eye redness, increased eye pressure, decrease in pupil size

This is not a complete list of side effects. For any unexpected effects while taking MIOSTAT* , contact your doctor or pharmacist.

How to store

Your doctor or another healthcare professional will store MIOSTAT*at controlled room temperature (15oC to 30oC), and keep it out of the reach and 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 three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

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

This document plus the full prescribing information, prepared for health professionals can be found at:
http://www.alcon.ca
or by contacting the sponsor, Alcon Canada Inc. at:
1-800-613-2245

This leaflet was prepared by Alcon Canada Inc

Last revised: May 13, 2015

©2015 Novartis *a trademark of Novartis

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