Diclofenac

Tablets: The usual adult dosage ranges from 50 mg to 100 mg daily. The enteric-coated diclofenac sodium tablets are taken twice daily with food. Diclofenac potassium tablets are taken every 6 to 8 hours as needed with food. The long-acting (sustained-release, or SR) tablets are taken once daily with food or milk. The maximum recommended daily dose of diclofenac is 100 mg. The lowest effective dose of diclofenac for the shortest duration possible should be used.

Tablets should be swallowed whole with some fluid. Do not crush or chew the tablets as this can change the way the medication is absorbed into your body. It may increase the risk of side effects, such as stomach irritation or bleeding.

Suppositories: The suppositories are usually used as a substitute for the last daily dose in a 50 mg or 100 mg strength, to a maximum total daily dose of 100 mg of diclofenac.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use Teva Diclofenac Ec exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not administer a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Teva Diclofenac Ec at room temperature, protect it from moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause indigestion; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may increase your blood pressure; it may cause nausea or, rarely, vomiting; it may make your skin more sensitive to UV rays (e.g., sunlight, tanning lamps) - avoid exposure to UV rays as much as possible and protect yourself when out in the sun. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Enteric-coated tablet

25 mg
Each yellowish, tan-coloured, round, biconvex, enteric-coated tablet, printed with black ink modified "N/25" on one side and plain on the other contains 25 mg of diclofenac sodium. Nonmedicinal ingredients: magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, and sodium starch glycolate; film-coating: D&C Yellow No. 10, hypromellose, iron oxide red, iron oxide yellow, maltodextrin, methacrylic acid, polyethylene glycol, talc, titanium dioxide, and triethyl citrate; printing ink: black iron oxide, lecithin, shellac glaze, and simethicone.

50 mg
Each tan-coloured, round, biconvex, enteric-coated tablet, printed with black ink modified "N/50" on one side and plain on the other contains 50 mg of diclofenac sodium. Nonmedicinal ingredients: magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, sodium lauryl sulfate, and sodium starch glycolate; film-coating: hypromellose, iron oxide black, iron oxide red, iron oxide yellow, maltodextrin, methacrylic acid, polyethylene glycol, talc, titanium dioxide, and triethyl citrate; printing ink: black iron oxide, lecithin, shellac glaze, and simethicone.

Extended-release tablet (SR)

75 mg
Each light pink, triangular, standard biconvex, bevelled-edged, film-coated, slow-release tablet, printed "N" with black ink on one side and "SR/75" on the other, contains 75 mg of diclofenac sodium. Nonmedicinal ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and povidone; film-coating: aquacoat ECD-30, dibutyl sebacate, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, polyethylene glycol, polysorbate, and titanium dioxide; printing ink: black iron oxide, lecithin, shellac glaze, and simethicone.

100 mg
Each pink, round, biconvex, bevelled-edged, film-coated, slow-release tablet, printed "N" on one side and "SR/100" on the other, contains 100 mg of diclofenac sodium. Nonmedicinal ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and povidone; film-coating: aquacoat ECD-30, dibutyl sebacate, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, polyethylene glycol, polysorbate, and titanium dioxide; printing ink: black iron oxide, lecithin, shellac glaze, and simethicone.

K 50 mg tablet
Each round, biconvex, reddish-brown, film-coated tablet, engraved "N" on one side and "50" on the other, contains diclofenac potassium. Nonmedicinal ingredients: calcium phosphate, corn starch, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, and sodium starch glycolate; film-coating: hydroxypropyl methylcellulose, maltodextrin, polydextrose, polyethylene glycol, synthetic red iron oxide, synthetic yellow iron oxide, titanium dioxide, and triacetin.

Do not take Teva Diclofenac Ec if you:

• are allergic to diclofenac or any ingredients of the medication
• are breast-feeding
• are in the third trimester of pregnancy (after 28 weeks)
• are planning to have or have recently had heart bypass surgery
• currently have or have recently had inflammatory diseases of the stomach and intestines, such as stomach or intestinal ulcer or Ulcerative Colitis
• have bleeding in the brain or a bleeding disorder
• have had an allergic reaction to Asa or other anti-inflammatory medications
• have high levels of potassium in the blood
• have severe uncontrolled heart failure
• have severely impaired or deteriorating kidney function
• have significant liver impairment or liver disease

Do not use diclofenac suppositories if you:

• have any inflammatory lesions of the rectum or anus
• have recently had rectal or anal bleeding

Do not give Teva Diclofenac Ec to children or adolescents under 16 years old.

There may be an interaction between diclofenac and any of the following:

• acetylsalicylic acid (ASA)
• Aliskiren
• alcohol
• aminoglycoside antibiotics (e.g., Amikacin, gentamicin, tobramycin)
• angiotensin II receptor blockers (ARBs; e.g., Candesartan, Irbesartan, Losartan)
• angiotensin converting enzyme (ACE) inhibitors (e.g., Ramipril)
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
• Apixaban
• beta-blockers (e.g., Atenolol, Metoprolol, Propranolol)
• Bimatoprost
• bisphosphonates (e.g., Alendronate, etidronate, Pamidronate, Risedronate, Zoledronic Acid)
• Celecoxib
• Cholestyramine
• Clopidogrel
• Colestipol
• oral corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Cyclosporine
• dabigatran
• Dasatinib
• Deferasirox
• Desmopressin
• diabetes medications (e.g., chlorpropamide, Glyburide, insulin, Metformin, Rosiglitazone)
• Digoxin
• Dipyridamole
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, Spironolactone)
• drospirenone
• Edoxaban
• Eplerenone
• glucosamine
• Haloperidol
• Heparin
• herbal medications that affect blood clotting (e.g., ginkgo biloba, garlic, ginger, ginseng, glucosamine, milk thistle)
• Hydralazine
• Latanoprost
• lithium
• low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• Mesalamine
• Methotrexate
• mifepristone
• multiple vitamins with minerals
• Obinutuzumab
• omega-3 fatty acids
• other NSAIDs (e.g., Naproxen, Indomethacin)
• Pentoxifylline
• Porfimer
• Prasugrel
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• rifampin
• Rivaroxaban
• serotonin-norepinephrine reuptake inhibitors (SNRIs; Desvenlafaxine, Duloxetine, Venlafaxine)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Paroxetine, Fluoxetine, Citalopram, Sertraline)
• sodium phosphates
• Sulfasalazine
• Tacrolimus
• tenofovir
• Ticagrelor
• Ticlopidine
• tipranavir
• tricyclic antidepressants (e.g., Amitriptyline, Desipramine, Doxepin, Imipramine)
• vancomycin
• Voriconazole
• vitamin E
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Teva Diclofenac Ec. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Teva Diclofenac Ec.

HEALTH CANADA ADVISORY

June 8, 2021

Health Canada has issued new information concerning the use of non-steroidal anti-inflammatory drugs (NSAIDs). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

A previous advisory on non-steroidal anti-inflammatory drugs (NSAIDs) was issued on October 30, 2020.

Allergy: Some people who are allergic to other anti-inflammatory medications also experience allergic reactions to diclofenac. Before you take diclofenac, inform your doctor about any previous adverse reactions you have had to medications, especially Ketorolac or Ibuprofen. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

Bladder symptoms: Teva Diclofenac Ec can cause bladder symptoms such as frequent or painful urination and blood in urine. If you develop these symptoms, stop taking Teva Diclofenac Ec and contact your doctor immediately.

Bleeding: Like other NSAIDs, diclofenac may increase bruising, and bleeding from cuts may take longer to stop. If you have a condition where your blood does not clot easily, or if you are taking medications to prevent your blood from clotting, discuss with your doctor how Teva Diclofenac Ec may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Teva Diclofenac Ec, and whether any special monitoring is needed.

If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible.

Breathing problems: People who have Asthma, long term breathing problems, or allergic conditions such as hay fever or nasal polyps are more likely to experience difficulty breathing and allergic reactions caused by NSAIDs. If you have a history of allergic reactions to other substances, or respiratory illness, discuss with your doctor how Teva Diclofenac Ec may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Teva Diclofenac Ec, and whether any special monitoring is needed.

Drowsiness/reduced awareness: Some people have reported headache, dizziness, lightheadedness, and confusion while taking Teva Diclofenac Ec. Avoid operating motor vehicles and doing other potentially hazardous activities until you have determined how Teva Diclofenac Ec affects you.

Fertility: As with other NSAIDs, Teva Diclofenac Ec may make it more difficult for a couple to conceive if the woman is taking diclofenac. Stopping the medication allows the body's chemistry to return to normal which often resolves this issue.

Fluid retention: Diclofenac may cause fluid retention and swelling, possibly worsening high blood pressure, Congestive Heart Failure, or decreased heart function. If you have any of these conditions, discuss with your doctor how Teva Diclofenac Ec may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Teva Diclofenac Ec, and whether any special monitoring is needed. If you develop shortness of breath; fatigue; excessive weight gain; chest pain; or swelling of the legs, feet, or ankles while taking Teva Diclofenac Ec, consult your doctor immediately.

Heart problems: Like other NSAID medications, diclofenac may increase the risk of heart attacks, strokes, and Blood Clots, which may be fatal. The risk is greater with higher total daily doses and taking the medication for a long period of time. Due to this increased risk, people with the following conditions or risk factors should be closely monitored by their doctor if they use diclofenac:

• congestive heart failure
• Diabetes
• heart attack
• heart disease
• high blood pressure
• High Cholesterol
• impaired kidney function
• poor circulation
• smoking
• Stroke

If you have any of these conditions, discuss with your doctor how Teva Diclofenac Ec may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Teva Diclofenac Ec, and whether any special monitoring is needed.

Contact your doctor as soon as possible if you experience signs of decreasing heart function, such as swelling in the hands and feet, difficulty breathing when lying down, or easily becoming short of breath.

Seek medical help immediately if you experience signs of heart attack while taking Teva Diclofenac Ec. Signs of heart attack may include a crushing sensation or pain in the chest, difficulty breathing, becoming pale and sweating, or sudden development of nausea and vomiting.

Infection: Teva Diclofenac Ec may hide the signs of an infection, such as a fever or generalized achiness.

Kidney function: Decreased kidney function and Kidney Disease may cause diclofenac to build up in the body, causing side effects. If you have decreased kidney function, discuss with your doctor how Teva Diclofenac Ec may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Teva Diclofenac Ec, and whether any special monitoring is needed.

Long-term use of diclofenac may lead to a higher risk of reduced kidney function. This is most common for people who already have kidney disease, liver disease, or heart failure; for people who are taking diuretics (water pills); and for seniors. If you experience signs of decreasing kidney function, such as increased fluid retention or decreased amounts of urine being produced, see your doctor as soon as possible.

Liver function: Teva Diclofenac Ec may cause liver problems. If you have a liver condition, you may need more frequent checkups with your doctor. If you develop signs of a liver problem (such as yellow skin or eyes, dark urine, pale stools, abdominal pain, or itchy skin), stop taking the medication and see your doctor as soon as possible.

Potassium levels: Diclofenac may increase the risk of high potassium levels in the blood, especially for seniors, people who have conditions such as diabetes or kidney failure, or those taking certain other types of medications. Your doctor may order blood tests periodically during long-term treatment to monitor the amount of potassium in your blood. People who have been diagnosed with having high potassium levels in their blood should not take Teva Diclofenac Ec.

Stomach problems: Stomach ulcers, perforation, and bleeding from the stomach have been known to occur during treatment with diclofenac. These complications can occur at any time, and are sometimes severe enough to require immediate medical attention. The risk of ulcers and bleeding are increased for people taking higher doses of NSAIDs for longer periods of time.

Diclofenac should be taken under close medical supervision by people prone to irritation of the stomach and intestines, particularly those who have had a stomach ulcer, bloody stools, or diverticulosis or other inflammatory disease of the stomach or intestines (such as ulcerative colitis or Crohn's Disease). In these cases, your doctor must weigh the benefits of treatment against the possible risks.

Stop taking the medication and contact your doctor immediately if you experience symptoms or signs suggestive of stomach ulcers or bleeding in the stomach (black, tarry stools). These reactions can occur at any time during treatment without warning.

Sun sensitivity: Teva Diclofenac Ec may make your skin more sensitive to the sun. While you are using Teva Diclofenac Ec, avoid excessive sun exposure, including tanning beds and sun lamps. If you experience Sunburn with itching, swelling, and blistering, stop using Teva Diclofenac Ec and contact your doctor.

Pregnancy: When diclofenac is taken during the last 3 months of pregnancy, there is an increased risk of the child developing heart problems and the mother having a longer labour to deliver the baby. If diclofenac is taken during the earlier stages of pregnancy, there is an increased risk of miscarriage. For these reasons, Teva Diclofenac Ec is not recommended for use during pregnancy.

Breast-feeding: It is not known if diclofenac passes into breast milk. If you are a breast-feeding mother and are taking diclofenac, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Diclofenac is not recommended for children under 16 years of age. The safety, effectiveness, and dosage of Teva Diclofenac Ec for this age group have not been established.

Seniors: Seniors appear to have a higher risk of side effects with Teva Diclofenac Ec. The lowest effective dosage should be used under close medical supervision.

This medication is typically used 3 times a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Depending on the treated condition, it may be used regularly or only as needed. Follow the instructions provided by your health care professional. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. This medication should be swallowed whole. It should not be split, crushed or chewed. This medication may irritate the stomach, and should be taken with food. It is best to avoid coffee, spicy food or alcohol.