IMPORTANT: PLEASE READ

 Current pregnancy (after 28 weeks of

pregnancy)
 Currently breastfeeding (or planning to
breastfeed)
CONSUMER INFORMATION  Allergy (hypersensitivity) to diclofenac
Pr
sodium, or ASA (Acetylsalicylic Acid) or
VOLTAREN* other NSAIDs (Nonsteroidal Anti-
Pr
VOLTAREN* SR Inflammatory Drugs), or any of the
(diclofenac sodium) nonmedicinal ingredients in VOLTAREN* or
VOLTAREN* SR
Read this information each time you refill your  Ulcer (active)
prescription in case new information has been  Bleeding or perforation from the stomach or
added. gut (active)
 Inflammatory bowel disease (Crohn’s Disease
This leaflet is Part III of a three-part "Product or Ulcerative Colitis)
Monograph" published when VOLTAREN* and  Liver disease (active or severe)
VOLTAREN*SR were approved for sale in  Kidney disease (severe or worsening)
Canada and is designed specifically for  High potassium in the blood
Consumers. This leaflet is a summary and will
NOT tell you everything about VOLTAREN* or Do not use VOLTAREN* suppositories if you
VOLTAREN*SR. Contact your doctor or have inflammation of the rectum or anus or have
pharmacist if you have any questions about the a recent history of bleeding from the rectum or
drug. anus.
ABOUT THIS MEDICATION Patients who took a drug in the same class as
VOLTAREN* and VOLTAREN* SR after a type
What the Medication is used for: of heart surgery (coronary artery bypass grafting
(CABG)) were more likely to have heart attacks,
Your health care provider has prescribed strokes, blood clots in the leg(s) or lung(s), and
VOLTAREN* or VOLTAREN* SR for you to infections or other complications than those who
relieve pain and swelling in rheumatoid arthritis and did NOT take that drug.
osteoarthritis, including degenerative joint disease of
the hip. VOLTAREN* and VOLTAREN* SR should NOT
be used in patients under 16 years of age since the
What it does: safety and effectiveness have NOT been established.
VOLTAREN* and VOLTAREN* SR (diclofenac What the medicinal ingredient is:
sodium), as nonsteroidal anti-inflammatory drugs
(NSAIDs), can reduce the chemicals prostaglandins diclofenac sodium.
produced by your body which cause pain and
swelling. What the non-medicinal ingredients are:
VOLTAREN* and VOLTAREN* SR, as The enteric coated 50 mg tablets (VOLTAREN*)
nonsteroidal anti-inflammatory drugs (NSAIDs) do contain black ink, castor oil derivatives, colloidal
NOT cure your illness or prevent it from getting silicon dioxide, corn starch, hypromellose, iron
worse. VOLTAREN* or VOLTAREN* SR can only oxides, lactose, magnesium stearate, microcrystalline
relieve pain and reduce swelling as long as you cellulose, polyethylene glycol, povidone, sodium
continue to take it. starch glycolate, talc, titanium dioxide.

When it should not be used: The slow-release 75 mg and 100 mg tablets

(VOLTAREN* SR) contain black ink, carnauba wax,
DO NOT TAKE VOLTAREN* or VOLTAREN* cellulose compounds, cetyl alcohol, colloidal silicon
SR if you have any of the following conditions: dioxide, hypromellose magnesium stearate,
 Heart bypass surgery (planning to have or polysorbate 80, povidone, red iron oxide, sucrose,
recently had) talc, titanium dioxide.
 Severe, uncontrolled heart failure
 Bleeding in the brain or other bleeding
disorders

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 IMPORTANT: PLEASE READ

The 50 mg and 100 mg suppositories contain semi- Before taking this medication, tell your health care
synthetic glycerides. provider if you have any of the following:

What dosage forms it comes in:  Disease of the heart or blood vessels (also called
cardiovascular disease, including uncontrolled
VOLTAREN* 50 mg (enteric-coated) tablet: light high blood pressure, congestive heart failure,
brown, round, VOLTAREN on one side and 50 on established ischemic heart disease, or peripheral
the other. arterial disease), as treatment with VOLTAREN*
and VOLTAREN* SR in these cases is not
VOLTAREN* 75 mg Slow Release (SR) tablet: light recommended.
pink, triangular, VOLTAREN on one side and SR  Risk factors for cardiovascular disease (see
75 on the other. above) such as high blood pressure, abnormally
high levels of fat (cholesterol, triglycerides) in
VOLTAREN* 100 mg Slow Release (SR) tablet: your blood, diabetes, or if you smoke.
pink, round, VOLTAREN SR on one side and 100  Diabetes mellitus or on a low sugar diet
on the other.  Atherosclerosis
 Poor circulation to your extremities
VOLTAREN* 50 mg and 100 mg Suppositories:  Kidney disease or urine problems
Bullet shaped, white to yellowish-white colour, with  Previous ulcer or bleeding from the stomach or
a smooth surface with a fat like odour. gut
 Previous bleeding in the brain
Check with your pharmacist if the identifying  Bleeding problems
markings or colour appear different.  Family history of allergy to NSAIDs, such as
acetylsalicylic acid (ASA), celecoxib, diclofenac,
WARNINGS AND PRECAUTIONS diflunisal, etodolac, fenoprofen, flurbiprofen,
ibuprofen, indomethacin, ketoprofen, ketorolac,
If you have, or previously had, any of the mefenamic acid, meloxicam, nabumetone,
following conditions, see your health care naproxen, oxaprozin, piroxicam, rofecoxib,
provider to discuss treatment options other sulindac, tenoxicam, tiaprofenic acid, tolmetin,
than VOLTAREN* or VOLTAREN* SR: or valdecoxib (NOT a complete list)
• Heart Attack or Angina  Family history of asthma, nasal polyps, long-
• Stroke or Mini-stroke term swelling of the sinus (chronic sinusitis) or
• Loss of Vision hives
• Current Pregnancy (less than 28 weeks)
• Congestive Heart Failure Also, before taking this medication, tell your health
 High blood pressure care provider if you are planning to get pregnant.
 Diabetes
 High levels of fats in your blood While taking this medication:
 Smoking  Tell any other doctor, dentist, pharmacist or other
health care professional that you see, that you are
It is important to take the lowest dose of taking this medication, especially if you are
VOLTAREN* and VOLTAREN* SR that planning to have heart surgery;
relieves your pain and/or swelling and for the  Do NOT drink alcoholic beverages while taking
shortest time possible in order to keep your risk this medication because you would be more
of side effects on the heart and blood vessels as likely to develop stomach problems;
small as possible.  Fertility may be decreased. The use of
VOLTAREN* or VOLTAREN* SR is not
Use of NSAIDS, such as VOLTAREN* or and recommended in women trying to get pregnant.
VOLTAREN*SR can result in increased blood In women who have difficulty conceiving,
pressure and /or worsening of congestive heart stopping VOLTAREN* or VOLTAREN* SR
failure. should be considered.
 If you have cardiovascular disease or risks for
Use of NSAIDs, such as VOLTAREN* and cardiovascular disease, your doctor will
VOLTAREN* SR, may cause stomach and periodically re-evaluate whether you should
bowel problems (such as ulceration, continue treatment with VOLTAREN* or
perforation, obstruction and bleeding). VOLTAREN* SR.

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 IMPORTANT: PLEASE READ

 Your doctor will monitor your kidney function,  Digoxin (a medicine used for heart problems)
your liver function and your blood count to  Diuretics (medicines used to increase the amount
decide if VOLTAREN* or VOLTAREN* SR of urine)
needs to be discontinued or if the dose needs to e.g. furosemide, hydrochlorothiazide
be changed.  Lithium
 Methotrexate (a medicine used to treat some
If, at any time while taking VOLTAREN* or kinds of cancer or arthritis)
VOLTAREN* SR you experience any signs or  Oral hypoglycemics (diabetes medications)
symptoms of problems with your heart or blood  Phenytoin (a medicine used to treat seizures).
vessels such as chest pain, shortness of breath,  Probenecid
weakness, or slurring of speech, contact your doctor  Quinolone antibacterials (medicines used against
immediately. infection)
 Sulfinpyrazone (a medicine used to treat gout)
Long-term use of VOLTAREN* or VOLTAREN*  Tacrolimus (a medicine primarily used in patients
SR might increase the risk of heart attacks or who have received organ transplants)
strokes.  Trimethroprim (a medicine used to prevent or
treat urinary tract infection)
VOLTAREN* or VOLTAREN* SR is NOT  Voriconazole (a medicine used to treat fungal
recommended for use in patients under 16 years infections)
of age since safety and effectiveness have NOT
been established. Your health care provider may prescribe low dose
ASA (acetylsalicylic acid) as a blood thinner to
INTERACTIONS WITH THIS MEDICATION reduce your risk of having a heart attack or stroke
while you are taking VOLTAREN* or VOLTAREN*
What About Taking Other Drugs At The Same SR. Take only the amount of ASA prescribed by
Time? your health care provider. You are more likely to
upset or damage you stomach if you take both
See your health care provider and pharmacist if you VOLTAREN* or VOLTAREN* SR and ASA than if
are taking any other medication (prescription or non- you took VOLTAREN* or VOLTAREN* SR alone.
prescription) such as any of the following (NOT a
complete list): PROPER USE OF THIS MEDICATION
 Acetaminophen
 Acetylsalicylic Acid (ASA) or other NSAIDs VOLTAREN* and VOLTAREN SR* is used for
e.g. ASA, celecoxib, diclofenac, ibuprofen, maintenance therapy only.
indomethacin, ketorolac, meloxicam, naproxen
 Alcohol Usual Dose for patients 16 years of age and older:
 Antacids
 Anti-depressants Medical Maintenance Maximum Dose
 Selective Serotonin Reuptake Inhibitors (SSRIs) Condition Dose (per day)
e.g. citalopram, fluoxetine, paroxetine, sertraline
 Blood pressure medications VOLTAREN* 50 mg enteric-coated tablets
- ACE (angiotensin converting enzyme) Rheumatoid 50 mg twice 100 mg
inhibitors Arthritis daily
e.g. enalapril, lisinopril, perindopril, ramipril
- ARBs (angiotensin II receptor blockers) 50 mg twice
Osteoarthritis 100 mg
e.g. candesartan, irbesartan, losartan, valsartan daily
- Beta-blockers VOLTAREN* SR 75 & 100 mg slow-release tablets
e.g. metoprolol Rheumatoid 75 mg once 100 mg
 Blood thinners (medicine used to prevent blood- Arthritis daily
clotting)
e.g. warfarin, ASA, clopidogrel 75 mg once
Osteoarthritis 100 mg
 Corticosteroids (including glucocorticoids) daily
(medicines used to provide relief for inflamed VOLTAREN* 50 mg and 100 mg suppositories
areas of the body) Rheumatoid 50 mg once 100 mg
e.g. prednisone Arthritis daily
 Cyclosporin (a medicine primarily used in
patients who have received organ transplants) Osteoarthritis 50 mg once 100 mg

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 IMPORTANT: PLEASE READ

daily
Overdose:

If you have accidentally taken more than the

Take VOLTAREN* or VOLTAREN* SR only as prescribed dose of VOLTAREN* tablets,
directed by your health care provider. Do NOT take suppositories or VOLTAREN* SR tablets, contact
more of it, do NOT take it more often and do NOT your doctor, pharmacist or poison control centre
take it for a longer period of time than your health immediately or go to the hospital emergency unit
care provider recommended. If possible, you at once. You may require medical attention.
should take the lowest dose of this medication for
the shortest time period. Taking too much
SIDE EFFECTS AND WHAT TO DO ABOUT
VOLTAREN* or VOLTAREN* SR may increase
THEM
your chances of unwanted and sometimes dangerous
side effects, especially if you are elderly, have other VOLTAREN* or VOLTAREN* SR may cause some
diseases or take other medications. side effects, especially when used for a long time or
in large doses. When these side effects occur, you
If you will be using VOLTAREN* or VOLTAREN* may require medical attention. Report all symptoms
SR for more than 7 days, see your health care or side effects to your health care provider.
provider regularly to discuss whether this medicine is
working for you and if it is causing you any VOLTAREN* or VOLTAREN* SR may cause you
unwanted effects. to become drowsy or tired. Be careful about driving
or participating in activities that require you to be
Swallow the tablet whole with water, do not chew or alert. If you become drowsy, dizzy or light-headed
divide the tablet. It is best to take your dose at the after taking VOLTAREN* or VOLTAREN* SR, do
same time each day. NOT drive or operate machinery.
To help reduce the possibility of stomach upset you VOLTAREN* or VOLTAREN* SR may cause you
should take VOLTAREN* or VOLTAREN* SR to become more sensitive to sunlight. Any exposure
tablets immediately after a meal or with food or milk. to sunlight or sunlamps may cause sunburn, skin
Also, you should remain standing or sitting upright blisters, skin rash, redness, itching or discolouration,
(i.e. do not lie down) for about 15-30 minutes after or vision changes. If you have a reaction from the
taking the medicine. This helps to prevent irritation sun, check with your health care provider.
that may lead to trouble swallowing. If stomach
upset (indigestion, nausea, vomiting, stomach pain or Check with your health care provider
diarrhea) occurs and continues, contact your doctor. IMMEDIATELY if you develop chills, fever, muscle
aches or pains, or other flu-like symptoms, especially
Using Suppositories if they occur before or together with a skin rash.
VOLTAREN* suppositories (50 and 100 mg) are These symptoms may be the first signs of a
wrapped in a plastic film. Make sure that the plastic SERIOUS ALLERGIC REACTION to this
wrapping is fully removed before inserting the medication.
suppository into the rectum. It is best to take the
suppositories after emptying your bowels.
SERIOUS SIDE EFFECTS AND WHAT TO DO
ABOUT THEM
Do not take suppositories by mouth.
Symptom STOP taking STOP
Voltaren* or taking
This medication has been prescribed specifically Voltaren* SR and Voltaren* or
for you. Do NOT give it to anyone else. It may get emergency Voltaren*
harm them, even if their symptoms seem to be medical attention SR and talk
similar to yours. IMMEDIATELY to your
physician
or
Missed dose: pharmacist
Bloody or black √
tarry stools,
If you forget to take your scheduled dose, you should vomiting blood
not double the next scheduled dose to make up for Spontaneous √
the missed dose. bleeding or

Page 4 of 6
 IMPORTANT: PLEASE READ

SERIOUS SIDE EFFECTS AND WHAT TO DO SERIOUS SIDE EFFECTS AND WHAT TO DO
ABOUT THEM ABOUT THEM
Symptom STOP taking STOP Symptom STOP taking STOP
Voltaren* or taking Voltaren* or taking
Voltaren* SR and Voltaren* or Voltaren* SR and Voltaren* or
get emergency Voltaren* get emergency Voltaren*
medical attention SR and talk medical attention SR and talk
IMMEDIATELY to your IMMEDIATELY to your
physician physician
or or
pharmacist pharmacist
bruising (signs of or without itchy
thrombocytopenia) skin
Shortness of breath, √ Malaise, fatigue, √
wheezing, any loss of appetite or «
trouble flu-like »
breathing or chest symptoms
tightness Headaches, stiff √
Skin rash, hives, √ neck, fever, nausea,
swelling or itching vomiting (signs of
Skin rash with √ aseptic meningitis)
flacking or peeling Mental confusion, √
(signs of dermatitis depression
exfoliative). Dizziness, √
Purple skin patches √ lightheadedness
(signs of purpura or Hearing problems √
Henoch-Schonlein Rectal itching or √
purpura if caused bleeding
by an allergy). Right upper √
Blurred vision, or √ abdominal
any visual discomfort or pain
disturbance
Any change in the √
amount or colour of This is NOT a complete list of side effects. If you
your develop any other symptoms while taking
urine (red or VOLTAREN* and/or VOLTAREN* SR, see your
brown) health care provider.
Any pain or √
difficulty HOW TO STORE IT
experienced while
urinating Protect tablets from heat (i.e., store at temperatures
Swelling of the √ between 15°C-30°C) and humidity.
feet, lower legs;
weight gain Protect suppositories from heat (i.e., store at
Swelling mainly of √ temperatures between 15°C-30°C).
the face and throat
(signs of Do NOT keep outdated medicine or medicine no
angioedema) longer needed. Any outdated or unused medicine
Vomiting or √ should be returned to your pharmacist.
persistent
indigestion, nausea, Keep this and all medication out of the reach of
stomach pain or children.
diarrhea
Yellow √
discolouration of REPORTING SUSPECTED SIDE EFFECTS
the skin or eyes
(signs of liver
failure), with

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 IMPORTANT: PLEASE READ

REPORTING SUSPECTED 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:
 Report online at
[Link]/medeffect
 Call toll-free at 1-866-234-2345
 Complete a Canada Vigilance Reporting Form
and:
o Fax toll-free to 1-866-678-6789, or
o 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 MedEffect TM Canada Web site at
[Link]/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 at:
[Link]

or by contacting the sponsor, Novartis

Pharmaceuticals Canada Inc., at:
1-800-363-8883

If you have any additional question about your

individual condition, you should contact your health
care professional.

This leaflet was prepared by Novartis

Pharmaceuticals Canada Inc.
385, Boulevard Bouchard
Dorval, Québec H9S 1A9

Last revised: July 29, 2014

*VOLTAREN is a registered Trademark

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