Sandoz Diclofenac SR
(diclofenac)
Diclofenac belongs to the class of medications known as non-steroidal anti-inflammatories (NSAIDs). It is used to reduce pain, swelling, and inflammation.
Available form
Dosage
12-Hour Release Tablet
75MG
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Sandoz Diclofenac SR information
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 Sandoz Diclofenac Sr 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 Sandoz Diclofenac Sr 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.
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes Sandoz Diclofenac Sr. If you are concerned about side effects, discuss the risks and benefits of Sandoz Diclofenac Sr with your doctor.
The following side effects have been reported by at least 1% of people taking Sandoz Diclofenac Sr. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- abdominal or stomach cramps, pain, or discomfort (mild to moderate)
- dizziness
- drowsiness
- headache (mild to moderate)
- heartburn
- nausea
- sun sensitivity
Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- confusion
- decreased hearing, any other change in hearing, or ringing or buzzing in ears
- difficulty swallowing
- discoloration of the skin
- "flu-like" symptoms (malaise, fatigue, loss of appetite)
- increased blood pressure
- persistent indigestion, nausea, stomach pain, or Diarrhea
- rectal itching or bleeding
- shortness of breath, wheezing, or chest tightness
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
- signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- signs of heart failure (e.g., shortness of breath; fatigue; swelling in legs, ankles, feet)
- signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- signs of Meningitis not caused by infection (e.g., headache [severe], throbbing, or with stiff neck or back)
- swelling of face, feet, or lower legs
- symptoms of urinary tract problems (e.g., bladder pain, pain when urinating, increased need to urinate, change in urine colour or odour)
- unexplained, unexpected, or unusually heavy vaginal bleeding
- vision changes
Stop taking the medication and seek immediate medical attention if any of the following occur:
- large hive-like swellings on face, eyelids, mouth, lips, or tongue
- severe and continuing nausea, heartburn, vomiting
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
- signs of a Heart Attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
- signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with Fever or discomfort
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Sandoz Diclofenac Sr.
Suppositories
50 mg rectal suppository
Each bullet-shaped, white-to-yellowish-white suppository with a smooth surface and fat-like odour contains 50 mg of diclofenac sodium. Nonmedicinal ingredients: semi-synthetic glycerides.
100 mg rectal suppository
Each bullet-shaped, white-to-yellowish-white suppository with a smooth surface and fat-like odour contains 100 mg of diclofenac sodium. Nonmedicinal ingredients: semi-synthetic glycerides.
Enteric-coated tablet
25 mg
Each yellow, round, slightly biconvex tablet, with "S" on one side and "25" on the other, contains 25 mg of diclofenac sodium. Nonmedicinal ingredients: black ink, castor oil derivatives, colloidal silicon dioxide, corn starch, hypromellose, iron oxides, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, talc, and titanium dioxide.
50 mg
Each light brown, round, slightly biconvex tablet, with "S" on one side and "50" on the other, contains 50 mg of diclofenac sodium. Nonmedicinal ingredients: black ink, castor oil derivatives, colloidal silicon dioxide, corn starch, hypromellose, iron oxides, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, talc, and titanium dioxide.
Extended-release tablet (SR)
75 mg
Each light pink, triangular, biconvex tablet with "S" on one side and "SR 75" on the other contains 75 mg of diclofenac sodium. Nonmedicinal ingredients: black ink, carnauba wax, cellulose compounds, cetyl alcohol, colloidal silicon dioxide, hypromellose, magnesium stearate, polysorbate 80, povidone, red iron oxide, sucrose, talc, and titanium dioxide.
100 mg
Each pink, round, biconvex tablet with "S" on one side and "SR100" on the other contains 100 mg of diclofenac sodium. Nonmedicinal ingredients: black ink, carnauba wax, cellulose compounds, cetyl alcohol, colloidal silicon dioxide, hypromellose, magnesium stearate, polysorbate 80, povidone, red iron oxide, sucrose, talc, and titanium dioxide.
Sandoz Diclofenac Rapide 50 mg tablet
Each reddish-brown, round, biconvex, sugar-coated tablet, printed "S" in white on one side and "50-K" on the other contains 50 mg of diclofenac potassium. Nonmedicinal ingredients: carnauba wax, cellulose, colloidal silicon dioxide, corn starch, ferric oxide, magnesium stearate, polyethylene glycol, povidone, sodium carboxymethyl starch, sucrose, talc, titanium dioxide, tribasic calcium phosphate, and white ink.
Do not take Sandoz Diclofenac Sr 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 Sandoz Diclofenac Sr 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 Sandoz Diclofenac Sr. 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 Sandoz Diclofenac Sr.
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: Sandoz Diclofenac Sr can cause bladder symptoms such as frequent or painful urination and blood in urine. If you develop these symptoms, stop taking Sandoz Diclofenac Sr 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 Sandoz Diclofenac Sr may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Diclofenac Sr, 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 Sandoz Diclofenac Sr may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Diclofenac Sr, and whether any special monitoring is needed.
Drowsiness/reduced awareness: Some people have reported headache, dizziness, lightheadedness, and confusion while taking Sandoz Diclofenac Sr. Avoid operating motor vehicles and doing other potentially hazardous activities until you have determined how Sandoz Diclofenac Sr affects you.
Fertility: As with other NSAIDs, Sandoz Diclofenac Sr 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 Sandoz Diclofenac Sr may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Diclofenac Sr, 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 Sandoz Diclofenac Sr, 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 Sandoz Diclofenac Sr may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Diclofenac Sr, 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 Sandoz Diclofenac Sr. 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: Sandoz Diclofenac Sr 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 Sandoz Diclofenac Sr may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Sandoz Diclofenac Sr, 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: Sandoz Diclofenac Sr 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 Sandoz Diclofenac Sr.
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: Sandoz Diclofenac Sr may make your skin more sensitive to the sun. While you are using Sandoz Diclofenac Sr, avoid excessive sun exposure, including tanning beds and sun lamps. If you experience Sunburn with itching, swelling, and blistering, stop using Sandoz Diclofenac Sr 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, Sandoz Diclofenac Sr 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 Sandoz Diclofenac Sr for this age group have not been established.
Seniors: Seniors appear to have a higher risk of side effects with Sandoz Diclofenac Sr. The lowest effective dosage should be used under close medical supervision.
All material © 1996-2024 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health providers with any questions you may have regarding a medical condition.
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