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Arthrotec

(diclofenac sodium - misoprostol)

In this factsheet:
• How does Arthrotec work? What will it do for me?
• How should I use Arthrotec?
• What form(s) does Arthrotec come in?
• Who should NOT take Arthrotec?
• What side effects are possible with Arthrotec?
• Are there any other precautions or warnings for Arthrotec?
• What other drugs could interact with Arthrotec?

DIN (Drug Identification Number)

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

Diclofenac sodium - misoprostol is used to treat symptoms of rheumatoid arthritis and osteoarthritis. Diclofenac 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.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. 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 is 50 mg (referring to the diclofenac portion of the medication) taken 2 or 3 times a day, or 75 mg taken twice 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, diclofenac sodium - misoprostol should be taken immediately after a meal or with food or milk.

It is important to take this medication 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: colloidal silicon dioxide, cornstarch, crospovidone, hydrogenated castor oil, hypromellose, lactose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone K-30, sodium hydroxide, talc, and 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: colloidal silicon dioxide, cornstarch, crospovidone, hydrogenated castor oil, hypromellose, lactose, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, povidone K-30, sodium hydroxide, talc, and triethyl citrate.

Who should NOT take Arthrotec?

Diclofenac sodium - misoprostol should not be taken by anyone who:

• is or may be allergic to diclofenac sodium, misoprostol, or to any of the ingredients of the medication
• is or may be allergic to medications similar to misoprostol (prostaglandins and their analogues)
• is currently taking other NSAIDs
• is pregnant or breast-feeding
• currently has or recently had inflammatory diseases of the stomach and intestines such as stomach or intestinal ulcer or ulcerative colitis
• has a known electrolyte imbalance
• has asthma or a history of asthma
• has bleeding in or around the brain or any other diseases involving bleeding
• has had an allergic reaction to ASA or other anti-inflammatory medications
• has inflammatory bowel disease
• has recently had a coronary artery bypass graft
• has severely uncontrolled heart failure
• has severely impaired or deteriorating kidney function
• has significant liver impairment or liver disease

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