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Details for: SANDOZ DICLOFENAC OPHTHA

Company: SANDOZ CANADA INCORPORATED

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02454807SANDOZ DICLOFENAC OPHTHADICLOFENAC SODIUM0.1 % / W/VSOLUTIONOPHTHALMIC
Search Reported Side Effects Report a Side Effect

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

Your doctor has prescribed Sandoz Diclofenac Ophtha (Diclofenac Sodium ophthalmic solution), 0.1% w/v for you which is a nonsteroidal anti-inflammatory drug (NSAID), used to treat eye inflammation after cataract surgery and eye inflammation after a non-penetrating eye injury.

What it does

Sandoz Diclofenac Ophthaeye drops reduce pain and inflammation by reducing the production of certain substances called prostaglandins.

When it should not be used

DO NOT USE Sandoz Diclofenac Ophtha if you are allergic to diclofenac sodium, any other ingredient in the formulation (see What the nonmedicinal ingredients are), or other medications of the NSAID group, such as acetylsalicylic acid, diflunisal, ibuprofen, flurbiprofen, ketoprofen, indomethacin, mefenamic acid, piroxicam, sulindac, or tiaprofenic acid.
Sandoz Diclofenac Ophtha is not for use in children under 18 years of age.

What the medicinal ingredient is

Diclofenac sodium, 0.1% w/v

What the non-medicinal ingredients are

Boric acid,
Edetate Disodium,
Cremophor EL,
Tromethamine (TRIS),
Sorbic Acid.
Water

What dosage form it comes in

Sandoz Diclofenac Ophtha is available in:
Preserved multi-dose bottles of 5mL and twin pack containing 2 bottles of 5 mL per box.

Warnings and precautions

BEFORE taking Sandoz Diclofenac Ophtha , tell your doctor or pharmacist if you:

  • are pregnant or are planning to become pregnant while taking this medication;
  • are breastfeeding or planning to breastfeed;
  • are taking a topical corticosteroid. Taking Sandoz Diclofenac Ophtha and a corticosteroid at the same time may slow wound healing;
  • have (had) complicated eye surgery, pre-existing corneal problems, diabetes, problems with your eye surface (such as dry eye), rheumatoid arthritis or multiple eye surgeries. You may be a higher risk for developing serious eye side effects. Taking Sandoz Diclofenac Ophtha more than 24 hours before eye surgery or for more than 14 days after surgery may also increase your risk for developing serious eye side effects;
  • have any other medical problem(s);
  • wear soft contact lenses. DO NOT administer Sandoz Diclofenac Ophtha while wearing soft contact lenses. Remove lenses before application and reinsert no earlier than 15 minutes after use.

WHILE taking Sandoz Diclofenac Ophtha:

  • check with your doctor if you are not getting any relief or if any problems develop, such as an eye infection or bleeding problems;
  • report any reactions to your doctor. This is very important because it will help in the early detection and prevention of problems;
  • If you experience any vision problems, in particular blurring of vision, DO NOT drive or operate any machinery.

STOP using Sandoz Diclofenac Ophtha and talk to your doctor if you experience any serious problems with your eye(s).
Your regular medical check-ups, including monitoring of eye pressure, are essential.

Interactions with this medication

BEFORE taking Sandoz Diclofenac Ophtha , tell your doctor or pharmacist if you are taking any other drug (either prescription or non-prescription) such as:

  • corticosteroids
  • medications that prolong bleeding time
  • antibiotics
Proper use of this medication

Sandoz Diclofenac Ophtha is for topical use only.

Usual adult dose

Cataract surgery
Before surgery: Apply 1 drop into the affected eye(s) up to 5 times during the 3 hours before your scheduled surgery.

After surgery: Apply 1 drop into the affected eye(s) 15, 30 and 45 minutes following surgery. Then apply 1 drop 3 to 5 times per day for up to 4 weeks.

Inflammation from non-penetrating wounds
Apply 1 drop into the affected eye(s) 4 to 5 times per day as directed by your physician.

How to use

  • Wash your hands and sit or stand comfortably. If you wear contact lenses, remove them before using your eye drops.
  • Visually inspect the dropper tip to make sure that it is not chipped or cracked.
  • Avoid touching the dropper tip against your eye or anything else to avoid contamination. Eye drops and eye dropper must be kept clean.
  • Pull down your lower eyelid with a clean finger until there is a 'pocket' between the eyelid and your eye. The drop will go in here (picture 1).
  • Bring the bottle tip close to the eye. Do this in front of a mirror if it helps.
  • Gently press on the base of the bottle to release one drop of Sandoz Diclofenac Ophtha at a time.
  • DO NOT squeeze the bottle: it is designed so that a gentle press on the bottom is all that it needs (picture 2).
  • Close your eyelid and gently press the inner corner of your eye with your forefinger for 2 minutes (picture 3).
  • If you use drops in both eyes, repeat the steps for your other eye.
  • Close the bottle cap firmly immediately after use. DO NOT wipe or rinse the dropper tip.
  • If a drop misses your eye, try again.
  • Wipe any excess liquid from your face with a tissue.
  • If you are to use more than one drop in the same eye, wait at least 5 minutes before applying the next drop. Eye ointments should be applied last.
  • Wash your hands to remove any medication.

Overdose

Overdosage will not usually cause sudden problems. If Sandoz Diclofenac Ophtha is accidentally ingested, fluids should be taken to dilute the medication.

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.

Missed Dose

If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. DO NOT double doses.

Side effects and what to do about them

Occasionally you may experience a mild to moderate burning sensation when Sandoz Diclofenac Ophtha is instilled in the eye. This symptom usually disappears rapidly, but if it or any other side effects persist, check with your doctor.

Less frequently observed eye side effects are allergic reaction, itchy eye(s), reddening of eye and blurred vision immediately after instillation of the eye drops, eye pain, eye surface inflammation with surface damage, sensitivity to light, abnormal vision, eye allergy, eye swelling, clouding of the eye surface, eyelid swelling, eye irritation, eyelid reddening, swelling or rash, and a stainable cornea.

Uncommon side effects in the rest of the body are bad taste, feeling of pressure, abdominal pain, feeling weak, chills, dizziness, swelling of the face, fever, headache, problems sleeping, nausea, pain, nose irritation, a viral infection, hives, rash, eczema, skin redness, cough, allergic reaction and vomiting.

If you are using Sandoz Diclofenac Ophtha after cataract surgery, you may feel increased eye pressure (intraocular pressure).

If you are using Sandoz Diclofenac Ophtha after refractive surgery, you may notice tearing.

If you use corticosteroids, have infections or have rheumatoid arthritis, you may develop ulcers, thinning or inflammation of your cornea, which may cause loss of vision.

Report any reactions to your doctor. This is very important because it will help in the early detection and prevention of problems.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and talk with your doctor or pharmacist
Uncommon
Ulcer, thinning or swelling of your cornea    
Outer layer defects of your cornea    
Shortness of breath    
Increase in signs and symptoms of asthma    
Severe allergic reaction    
Unknown
Tiny tears (perforations) in your cornea    

This is not a complete list of side effects. For any unexpected effects while taking Sandoz Diclofenac Ophtha contact your doctor or pharmacist.

How to store

Store at 20oC to 25oC with excursions permitted to 15oC to 30oC. Protect from light.

Keep bottle tightly closed when not in use. Keep this and all medication in a safe place out of the reach 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 product monograph, prepared for health professionals can be found on the Health Canada website or by contacting the sponsor,

1-800-361-3062

Or by written request at:
Sandoz Canada Inc.
145 Jules Léger
Boucherville, Quebec, Canada
J4B 7K8

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

This leaflet was prepared by Sandoz Canada Inc.
Last revised: December 16, 2016

Date modified: