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Details for: DICLOFENAC

Company: PHARMA STULLN INC.

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02475065DICLOFENACDICLOFENAC 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 DICLOFENAC (diclofenac sodium) solution, 0.1% w/v for you which is a non-steroidal anti-inflammatory drug (NSAID), used to treat eye inflammation after cataract surgery and eye inflammation after a non-penetrating eye injury.

What it does

DICLOFENAC eye drops reduce pain and inflammation by reducing the production of certain substances called prostaglandins.

When it should not be used

DO NOT USE DICLOFENAC eye drops if you are allergic to diclofenac sodium, any other ingredient in the formulation (see What the non-medicinal 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.

DICLOFENAC 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, Trometamol, Macrogolglycerol Ricinoleate, Sodium Hydroxide, Purified Water.

What dosage form it comes in

0.1% (diclofenac sodium) w/v ophthalmic solution is available in plastic unit dose container of 0.3 mL.

Warnings and precautions

BEFORE taking DICLOFENAC, tell your doctor or pharmacist if you:

  • are pregnant or intend to become pregnant while taking this medication;
  • are breast feeding or planning to breastfeed;
  • are taking a topical corticosteroid. Taking DICLOFENAC 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 DICLOFENAC 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 DICLOFENAC while wearing soft contact lenses. Remove lenses before application and reinsert no earlier than 15 minutes after use.

WHILE taking DICLOFENAC:

  • 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 DICLOFENAC 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 DICLOFENAC, 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

DICLOFENAC 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 this medication:

Open the drops container just before you want to use it. After using the drops, throw away what is left. This is because the drops cannot be kept free of bacteria after being opened.

  1. First wash your hands and then break off a single dose container from the strip. Then twist open the top of the single dose container as shown. Each single dose container contains enough solution for both eyes. If you wear contact lenses, remove them before using your eye drops.
  2. Pull down your lower eyelid with a clean finger until there is a ‘pocket’ between the eyelid and your eye. This is where the drop will go. Bring the single dose container close to the eye. Do this in front of the mirror if it helps.
  3. Close your eyelid and gently press the inner corner of your eye with your forefinger for 2 minutes.
  4. Wipe any excess liquid from your face with a tissue. If you must use more than 1 drop in the same eye, wait at least 5 minutes before applying the next drop. Eye ointments should be applied last.
  5. Wash your hands to remove any medication. Discard unused portion.

Overdose

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

Overdosage will not usually cause sudden problems. If DICLOFENAC is accidentally ingested, fluids should b e taken to dilute the medication.

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 DICLOFENAC 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, eye discharge, eyelid reddening, swelling or rash, eye crusting, eye discomfort, slower healing 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 DICLOFENAC after cataract surgery, you may feel increased eye pressure (intraocular pressure).

If you are using DICLOFENAC 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.

What Diclofenac UD looks like and contents of the pack
Unit dose containers made of LDPE with:
10 x 0.3 ml
20 x 0.3 ml
50 x 0.3 ml

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 get immediate medical help
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 DICLOFENAC, contact your doctor or pharmacist.

How to store

Store the unique dose container at room temperature between 15°and 30 °C. Protect from light.

Keep 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

For more information, please contact your doctor, pharmacist or other healthcare professional.

This leaflet plus the full product monograph,
prepared for health professionals, can be found in the
Health Canada website or by contacting.

Pharma Stulln Inc.
6500 TransCanada Highway, Suite 400
Pointe Claire, Quebec
H9R 0A5

E-mail: info@pharmastulln.ca

Last revised: June 19, 2018

Date modified: