Patient Medication Information: uses, side effects, how to take - Taro-Diclofenac
Serious Warnings and Precautions
Risk of Heart and Blood Vessel Problems:
Using non-steroidal anti-inflammatory drugs (NSAIDs), like TARO-DICLOFENAC, can cause
heart and blood vessel problems like heart attack, stroke, blood clots, high blood pressure and heart failure. These can lead to death.
The risk of having heart problems is higher if you use TARO-DICLOFENAC for longer periods
of time and/or in people who have heart disease.
Tell your healthcare professional if you have heart problems, high blood pressure or
diabetes.
Risk of Stomach and Intestine (Gastrointestinal) Problems:
Using NSAIDs, like TARO-DICLOFENAC, can cause stomach and intestine problems like ulcers, inflammation, bleeding, holes/perforation, blockage or pain.
Talk to your healthcare professional about any medical conditions you have and any drugs you are taking.
Pregnancy:
Do NOT use TARO-DICLOFENAC if you are pregnant.
Medicines like TARO-DICLOFENAC may cause harm to your unborn baby.
Tell your healthcare professional right away if you become pregnant, think you may be pregnant or want to get pregnant while you are using TARO-DICLOFENAC.
What is TARO-DICLOFENAC used for?
TARO-DICLOFENAC is used in adults to treat the signs and symptoms of osteoarthritis in the knee(s). It helps relieve pain, swelling and stiffness.
How does TARO-DICLOFENAC work?
TARO-DICLOFENAC belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used topically (on the skin) to reduce the chemicals produced by your body which cause pain and swelling.
TARO-DICLOFENAC only treats the symptoms and relieves pain and inflammation as long
as you use it. TARO-DICLOFENAC does not cure your arthritis or stops it from getting worse.
What are the ingredients in TARO-DICLOFENAC?
Medicinal ingredients: diclofenac sodium
Non-medicinal ingredients: dimethyl sulfoxide, ethanol, glycerin, propylene glycol, purified water.
TARO-DICLOFENAC comes in the following dosage forms:
Topical solution: 1.5% w/w
Do not use TARO-DICLOFENAC if you:
are planning to have or have recently had heart bypass surgery
have severe, uncontrolled heart failure
have active stomach or intestinal ulcers
have inflammatory bowel disease (Crohn’s disease or Ulcerative Colitis)
are allergic to diclofenac sodium, or to any of the non-medicinal ingredients in
TARO-DICLOFENAC or component of the container (see What are the ingredients in
TARO-DICLOFENAC?)
have a history of asthma, hives, growths in your nose, sinus swelling or symptoms of an
allergic reaction after taking acetylsalicylic acid (ASA) or other NSAIDs
have liver disease (active or severe)
have kidney disease (severe or worsening)
have high levels of potassium in your blood
are using other NSAIDs
are under 18 years of age
have been prescribed TARO-DICLOFENAC for longer than 3 months, TARO- DICLOFENAC
cannot be used longer than 3 months
are pregnant or breastfeeding
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TARO-DICLOFENAC. Talk about any health conditions or problems you may have, including if you:
have or have had a heart attack, chest pain, heart disease, stroke or heart failure
have asthma
have a stomach infection
have a history of ulcer or bleeding from the stomach or gut (small or large intestines)
have other bleeding or blood problems
have liver or kidney problems, urine problems or are dehydrated
have high blood pressure, high cholesterol or diabetes
have poor blood flow to your extremities (like your hands and feet)
smoke or used to smoke
drink a lot of alcohol
are planning on becoming pregnant. TARO-DICLOFENAC cannot be used if you are
pregnant
are planning to breastfeed, TARO-DICLOFENAC cannot be used if you are breastfeeding
have immune system problems
Other warnings you should know about:
Serious Skin Reactions: In rare cases, serious or life-threatening skin reactions listed below have been reported with some NSAIDs, such as TARO-DICLOFENAC.
drug reaction with eosinophilia and systemic symptoms (DRESS),
Stevens-Johnson syndrome (SJS),
toxic epidermal necrolysis (TEN),
exfoliative dermatitis and
erythema multiforme
You may be at a greater risk of experiencing a serious skin reaction during the first month of treatment.
See the Serious side effects and what to do about them table , below, for more information on these and other serious side effects.
TARO-DICLOFENAC might cause you to become more sensitive to sunlight. Sunlight or sunlamps may cause sunburn, skin blisters, skin rashes, redness, itching and discoloration or vision changes. If you have a reaction from the sun, talk to your healthcare professional.
Check-ups and Testing: You should have regular visits with your healthcare professional while you are using TARO-DICLOFENAC to monitor your health. They should:
Check your blood pressure.
Check your eyes. TARO-DICLOFENAC can cause blurred or reduced vision.
Do blood and urine tests to check your liver, kidney and blood health.
Surgery: Tell any doctor, dentist, pharmacist or healthcare professional that you see, that you are using this medicine. This is especially important if you are planning to have heart surgery.
Driving and Using Machines: Be careful about driving or doing activities that require you to be alert, as TARO-DICLOFENAC may affect your vision or nervous system. If you become drowsy, dizzy or light-headed after using TARO-DICLOFENAC, do NOT drive or operate machinery.
Adults (65 years or older): Side effects like gastrointestinal problems may happen more often. Your healthcare professional might have you start with a lower dose of TARO-DICLOFENAC. They will monitor your health during and after treatment.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with TARO-DICLOFENAC:
acetylsalicylic acid (ASA) or other NSAIDs, used to treat pain, fever and
inflammation, such as celecoxib, diclofenac, ibuprofen, naproxen
digoxin, used for heart problems
medicines used as blood thinners or to prevent blood clots, such as heparin,
warfarin, ASA, clopidogrel
oral medicines used to treat diabetes
medicines used to lower extra fluid levels (diuretics), such as furosemide,
hydrochlorothiazide
medicines used to lower blood pressure
corticosteroids used as an anti-inflammatory, such as glucocorticoids, like
prednisone
methotrexate, used to treat some cancers or arthritis
acetaminophen, used to treat pain and fevers
cyclosporine, used to lower the risk of organ rejection
lithium, used to treat bipolar disorder
medicines used to treat gout, such as probenecid and sulfinpyrazone
antibiotics used to treat bacterial infections, such as quinolone
phenytoin, used to treat seizures
voriconazole, used to treat infections\
alcohol
How to take TARO-DICLOFENAC:
Use TARO-DICLOFENAC exactly how your healthcare professional has told
you to. Talk to your healthcare professional if you are unsure.
Do not stop using TARO-DICLOFENAC or change your dose without talking to your
healthcare professional.
TARO-DICLOFENAC is for external use only. Avoid contact with your eyes and mucous
membranes.
Apply TARO-DICLOFENAC to clean, dry skin.
Do not use TARO-DICLOFENAC under bandages or dressings.
Do not apply TARO-DICLOFENAC to open, broken or infected skin.
Do not apply any other medication to the treated area
Do not use TARO-DICLOFENAC for longer than 3 months.
Usual dose:
Adults 18 years and older: Apply 40 drops to affected knee only, 4 times a day, or 50 drops, 3 times a day.
How to Apply TARO-DICLOFENAC:
Use the plastic dropper to dispense 10 drops of TARO-DICLOFENAC into your hand,
or directly onto your affected knee.
Spread TARO-DICLOFENAC evenly around the front, back and sides of your knee.
Repeat these steps until you have applied the prescribed amount of
TARO-DICLOFENAC (either 40 or 50 drops) and your knee is completely covered.
If you are using TARO-DICLOFENAC on both your knees, repeat the above steps to
treat your other knee.
Wash your hands when you are finished using TARO-DICLOFENAC.
Allow several minutes for TARO-DICLOFENAC to dry.
Overdose:
If you think you, or a person you are caring for, have taken too much TARO-DICLOFENAC, contact a healthcare professional, hospital emergency department , or regional poison control centre immediately, even if there are no symptoms.
Missed Dose:
If you miss applying a dose of TARO-DICLOFENAC, skip the missed dose. Then continue with your next dose at the usual time. Do not double the next dose to make up for a missed dose.
What are possible side effects from using TARO-DICLOFENAC?
These are not all the possible side effects you may have when taking TARO-DICLOFENAC. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
confusion, dizziness, light-headedness, spinning
diarrhea, constipation
feeling gassy
feeling of burning/prickliness/numbing
hair loss
hard to concentrate or think
headache
heartburn, indigestion
irritation on the skin where you apply TARO-DICLOFENAC including rash, itchiness,
dryness, tingling
mouth sores
muscle pain
nervousness
skin rash
sore throat
stomach upset/abdominal pain
taste disorder, thirst, dry mouth
vomiting, nausea
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |||
|---|---|---|---|---|---|
| Only if severe | In all cases | ||||
| RARE | |||||
Serious Skin Reactions: fever, severe rash, swollen lymph glands, flu-like feeling, blisters and peeling skin that may start in and around the mouth, nose, eyes and genitals and spread to other areas of the body, swelling of face and/or legs, yellow skin or eyes, shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often, less urine or dark urine. | ✓ | ||||
| UNKNOWN | |||||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✓ | ||||
Aseptic Meningitis (Inflammation of the protective lining of the brain that is not caused by infection): headaches, stiff neck, nausea, vomiting, fever, clouding of consciousness | ✓ | ||||
Blood Clots: In the leg or arm: pain, redness and swelling, skin is warm to the touch In the lung: chest pain, usually worse with breathing, shortness of breath, cough that may contain blood, dizziness, loss of consciousness | ✓ | ||||
Blood Problems (low white and/or red blood cell or platelet count): feeling tired or weak, pale skin, bruising or bleeding for longer than usual if you hurt yourself, fever, chills | ✓ | ||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||
|---|---|---|---|---|---|---|
| Only if severe | In all cases | |||||
Congestive Heart Failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise | ✓ | |||||
Depression (sad mood that will not go away): difficulty sleeping or sleeping too much, changes in appetite or weight, reduced sex drive and thoughts of death or suicide | ✓ | |||||
Gastrointestinal (GI) Problems (bleeding, blockage, holes, ulcers or inflammation in your GI tract): blood in vomit, black tarry or bloody stool, dizziness, stomach pain, bloating, loss of appetite, weight loss, nausea, vomiting, constipation or diarrhea, chills or fever | ✓ | |||||
Hypertension (high blood pressure): fatigue, dizziness or fainting, chest pain | ✓ | |||||
Liver Problems: yellowing of the skin or eyes (jaundice), right upper stomach pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness | ✓ | |||||
| Lung Problems, Asthma: increased shortness of breath, wheezing, difficulty breathing, cough and chest tightness, irregular heartbeat | ✓ | |||||
| Myocardial Infarction (heart attack): pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light- headedness, clammy skin, sweating, indigestion, anxiety, feeling faint, possible irregular heartbeat | ✓ | |||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||
|---|---|---|---|---|
| Only if severe | In all cases | |||
Stroke (bleeding or blood clot in the brain): sudden numbness, weakness or tingling of the face, arm or leg, particularly on one side of the body, sudden headache, blurry vision, difficulty swallowing or speaking, lethargy, dizziness, fainting, vomiting, trouble understanding, trouble with walking, loss of balance | ✓ | |||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store at room temperature (15-25 °C).
Store upright
Do not keep outdated medicine or medicine no longer needed.
Keep out of reach and sight of children.
If you want more information about TARO-DICLOFENAC:
Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website:
(https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.taro.com, or by calling 1-800-268-1975.