April 24, 2014
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Drug Factsheets

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Arthrotec

(diclofenac sodium - misoprostol)

DIN (Drug Identification Number)

01917056 ARTHROTEC 50MG/200G TABLET
02229837 ARTHROTEC 75MG/200G TABLET

How does Arthrotec work? What will it do for me?

This combination product contains two medications: diclofenac sodium and misoprostol.

Diclofenac sodium belongs to the class of medications known as nonsteroidal anti-inflammatories (NSAIDs). It reduces pain and inflammation.

Misoprostol helps to protect the stomach from irritation and stomach ulcers that can be caused by diclofenac.

Diclofenac sodium - misoprostol is used to treat the pain and swelling of rheumatoid arthritis and osteoarthritis.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use Arthrotec?

The recommended adult dose of diclofenac sodium - misoprostol contains 50 mg of diclofenac taken 2 times a day. If this dose does not provide enough relief, or you are experiencing a flare-up of your arthritis, your doctor may increase your dose to a maximum of 150 mg daily. This may be taken as 50 mg 3 times a day or 75 mg taken 2 times a day. Seniors should not take more than 100 mg of diclofenac daily.

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 this medication 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.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next 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 this medication 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.





What form(s) does Arthrotec come in?

Arthrotec 50
Each white to off-white, round and biconvex tablet, engraved "SEARLE" over "1411" on one side, 4×"A" around the circumference of the reverse side with "50" in the middle, contains an enteric-coated core of diclofenac sodium 50 mg, surrounded by an outer mantle containing misoprostol 200 µg. 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 reverse side with a "75" in the middle, contains an enteric-coated core of diclofenac sodium 75 mg, surrounded by an outer mantle containing misoprostol 200 µg. Nonmedicinal ingredients: hydrogenated castor oil, microcrystalline cellulose, colloidal silicon dioxide, corn starch, crospovidone, hypromellose, lactose, magnesium searate, methacrylic acid copolymer, povidone K-30, sodium hydroxide, talc, triethyl citrate.

Who should NOT take Arthrotec?

Do not take this medication 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 asthma or a history of asthma
  • 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

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