Arthrotec

The recommended adult dose of diclofenac sodium – misoprostol contains 50 mg of diclofenac taken 2 times a day. The maximum total daily dose of diclofenac is 100 mg.

Many things can affect the dose of a 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 taking the medication without consulting your doctor.

To reduce the chance of Arthrotec causing stomach upset, take diclofenac sodium – misoprostol immediately after a meal or with food or milk. Swallow the tablets whole. Do not crush or chew them. You should remain sitting or standing upright for 15 to 30 minutes after taking Arthrotec in order to avoid irritation that can lead to trouble swallowing.

It is important that Arthrotec be taken exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take 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 Arthrotec at room temperature and keep out of 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 diarrhea; it may cause indigestion; 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.

Arthrotec 50
Each white-to-off-white, round, biconvex tablet, engraved "SEARLE" over "1411" on one side, 4 × "A" around the circumference of the other side with "50" in the middle, contains an enteric-coated core of 50 mg of diclofenac sodium, surrounded by an outer mantle containing 200 µg of misoprostol. Nonmedicinal ingredients: hydrogenated castor oil, microcrystalline cellulose, colloidal silicon dioxide, corn starch, crospovidone, hypromellose, lactose, magnesium stearate, methacrylic acid copolymer, povidone K-30, sodium hydroxide, talc, triethyl citrate.

Arthrotec 75
Each white-to-off-white, round and biconvex tablet, engraved "SEARLE" over "1421" on one side, 4 × "A" around the circumference of the other side with a "75" in the middle, contains an enteric-coated core of 75 mg of diclofenac sodium, surrounded by an outer mantle containing 200 µg of misoprostol. Nonmedicinal ingredients: hydrogenated castor oil, microcrystalline cellulose, colloidal silicon dioxide, corn starch, crospovidone, hypromellose, lactose, magnesium stearate, methacrylic acid copolymer, povidone K-30, sodium hydroxide, talc, triethyl citrate.

Do not take Arthrotec if you:

• are allergic to diclofenac sodium, misoprostol, or any ingredients of the medication
• are allergic to medications similar to misoprostol (prostaglandins and their analogues)
• have had an allergic reaction to Asa or other non-steroidal anti-inflammatory medications (NSAIDs)
• are currently taking other NSAIDs
• are pregnant or may be pregnant
• are breast-feeding or planning to breast-feed
• have, or have recently had, inflammatory diseases of the stomach and intestines, such as Crohn's Disease or Ulcerative Colitis
• have an active stomach or intestinal ulcer
• have bleeding from the stomach
• have a known electrolyte imbalance, particularly high potassium
• have a history of Asthma after taking ASA or other NSAIDs
• have bleeding in or around the brain or any other diseases involving bleeding
• have recently had or are planning to have heart bypass surgery
• have severe, uncontrolled heart failure
• have severely impaired or deteriorating kidney function
• have significant liver impairment or liver disease

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

• 5-ASA medications (e.g., Mesalamine, olsalzine, Sulfasalazine)
• alcohol
• Aliskiren
• aminoglycoside antibiotics (e.g., Amikacin, gentamicin, tobramycin)
• angiotensin converting enzyme (ACE) inhibitors (e.g., Captopril, Ramipril)
• angiotensin II receptor blockers (e.g., Irbesartan, Losartan)
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
• antidiabetes medications (e.g., Glyburide, insulin, Metformin, Repaglinide, Rosiglitazone)
• anti-platelet medications (e.g., Clopidogrel, Ticagrelor, Ticlopidine)
• Apixaban
• ASA
• beta-adrenergic blockers (e.g., Metoprolol, Atenolol)
• bisphosphonates (e.g., Alendronate, etidronate)
• Celecoxib
• Cholestyramine
• Colesevelam
• Colestipol
• corticosteroids (e.g., Dexamethasone, Prednisone)
• Cyclosporine
• dabigatran
• Deferasirox
• Desmopressin
• Digoxin
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, Spironolactone)
• drospirenone
• Edoxaban
• Enzalutamide
• Eplerenone
• fluconazole
• glucosamine
• Haloperidol
• heparin
• Hydralazine
• lithium
• low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• lumacaftor and Ivacaftor
• metformin
• Methotrexate
• multiple vitamin/mineral supplements
• other NSAIDs (e.g., Ketorolac, Ibuprofen, Naproxen, Indomethacin)
• Obinutuzumab
• omega-3 fatty acids
• Pentoxifylline
• protein kinase inhibitors (e.g., Dasatinib, imatinib, Nilotinib)
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• rifampin
• Rivaroxaban
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Escitalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, Duloxetine, Venlafaxine)
• sodium phosphates
• herbal preparations that affect blood clotting (e.g., chamomile; evening primrose; feverfew; garlic; American, Panax, and Siberian ginseng)
• Tacrolimus
• tenofovir
• tipranavir
• tricyclic antidepressants (e.g., Amitriptyline, Desipramine, Nortriptyline)
• vancomycin
• vitamin E
• Voriconazole
• 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 this medication. 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 taking 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 take this medication.

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 acetylsalicylic acid or other anti-inflammatory medications also experience allergic reactions to diclofenac. Before you take diclofenac – misoprostol, inform your doctor about any previous adverse reactions you have had to medications, especially anti-inflammatory pain relievers. 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 problems: Arthrotec may cause bladder pain, painful or difficult urination, or increased frequency of urination. If these symptoms occur without an explanation (e.g., infection), stop taking Arthrotec and contact your doctor.

Blood clotting: Arthrotec may reduce the ability of the blood to clot. If you are taking anticoagulants (e.g., Warfarin, Heparin) or have Hemophilia or other blood disorders (e.g., low platelets), discuss with your doctor how Arthrotec may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Arthrotec, and whether any special monitoring is needed. If you have a bleeding disorder, do not take Arthrotec.

Drowsiness/reduced alertness: Headache, dizziness, lightheadedness, and confusion have been reported by some people who take Arthrotec. Avoid activities requiring mental alertness, such as driving, operating machinery, or performing hazardous work, while taking Arthrotec until you are certain that your ability to perform these tasks is not impaired.

Fertility: As with other NSAIDs, this medication 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 and electrolyte balance: Fluid retention and edema have been reported with use of diclofenac sodium – misoprostol. Taking Arthrotec is more likely to cause fluid retention for people who:

• are recovering from a surgical operation under general anesthesia
• have any other condition that might lead to fluid retention
• have certain heart conditions (e.g., Congestive Heart Failure)
• have high blood pressure
• have Kidney Disease or reduced kidney function

There is a risk of high blood potassium with use of Arthrotec. People most at risk are seniors, those who have conditions such as Diabetes or kidney failure, and those taking beta-adrenergic blockers, angiotensin converting enzyme (ACE) inhibitors, or some diuretics (water pills).

Contact your doctor as soon as possible if you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat.

Gastrointestinal problems: The presence of misoprostol in this medication is intended to protect against the damaging effects of diclofenac on the inside lining of the stomach wall. Serious problems such as stomach ulcers, perforation, and stomach bleeding (with or without symptoms) may still occur in patients treated with diclofenac sodium – misoprostol. These complications can occur at any time, and are sometimes severe enough to require immediate medical attention. Taking higher doses of Arthrotec for longer periods of time increases your risk for ulcers and bleeding.

Minor stomach problems such as heartburn are common, and usually develop early in therapy. Take diclofenac sodium – misoprostol under close medical supervision if your stomach and intestines are easily irritated, especially if you have had a stomach ulcer, bloody stools, diverticulosis, or other inflammatory disease of the stomach or intestines (such as ulcerative colitis, or Crohn's disease). If you have a history of any of these conditions, discuss with your doctor how Arthrotec may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stop taking the medication and contact your doctor immediately if you experience symptoms or signs suggestive of stomach ulcers or bleeding in the stomach, such as black, tarry stools, or spitting up blood. There may not be any pain associated with bleeding in the stomach and these reactions can occur at any time during treatment, without warning.

Heart disease: As with other NSAIDs, diclofenac sodium – misoprostol may lead to an increased risk of heart failure, heart attack, or stroke which can be fatal. The risk of this occurring appears to increase with higher doses, the length of time Arthrotec is used, and is also increased for people who have already had a heart attack or have heart disease. The lowest effective dose of Arthrotec should be used for the shortest period of time. If you have a history of heart problems, or are at risk of developing heart problems, discuss the risks and benefits of using Arthrotec with your doctor.

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 Arthrotec. 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: Arthrotec may mask signs of infection such as fever or muscle aches. If you notice other symptoms of infection (e.g., painful or frequent urination, sore throat, cough), contact your doctor.

Kidney function: Decreased kidney function and kidney disease may cause diclofenac to build up in the body, causing side effects. Long-term use of diclofenac sodium – misoprostol may lead to a higher risk of reduced kidney function. This is most common for people who already have kidney disease, diabetes or heart failure; people who take diuretics (water pills); and seniors. If you have any of these conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Arthrotec, and whether any special monitoring is needed. Contact your doctor as soon as possible if you experience signs of decreasing kidney function while you are taking Arthrotec.

Liver function: Decreased liver function or liver disease may cause diclofenac sodium – misoprostol to build up in the body and lead to side effects. It may also reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how Arthrotec may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Arthrotec, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Arthrotec.

Contact your doctor immediately if you experience symptoms of liver problems, such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin.

Stroke: As with other NSAIDs, diclofenac sodium – misoprostol may lead to an increased risk of "mini-strokes" or strokes, which can be fatal. If you experience signs of stroke while taking Arthrotec, seek immediate medical attention. Signs of stroke may include sudden headache, weakness or numbness in an arm or leg, difficulty speaking or understanding, or sudden change in vision.

Pregnancy: Misoprostol is known to cause miscarriage when taken during pregnancy. It is not recommended for a woman to become pregnant while taking diclofenac sodium – misoprostol. Stop using Arthrotec and contact your doctor immediately if you suspect you are pregnant.

Breast-feeding: Misoprostol passes into breast milk and may cause infants to have severe diarrhea. If you are a breast-feeding mother and are taking diclofenac sodium – misoprostol, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Arthrotec have not been established for children. Arthrotec is not recommended for children under 18 years of age.

Seniors: Seniors appear to have a higher risk of side effects and should use the lowest effective dosage under close medical supervision.

This medication is typically used twice 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. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. 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.