Details for: SANDOZ DICLOFENAC OPHTHA
Company: SANDOZ CANADA INCORPORATED
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02454807 | SANDOZ DICLOFENAC OPHTHA | DICLOFENAC SODIUM | 0.1 % / W/V | SOLUTION | OPHTHALMIC |
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.
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.
| 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