March 3, 2015
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Teva-Diclofenac

(diclofenac)

DIN (Drug Identification Number)

02174685 TEVA-DICLOFENAC 100 MG RECTAL SUPPOSITORY
00808539 TEVA-DICLOFENAC EC 25MG ENTERIC-COATED TABLET
02174677 TEVA-DICLOFENAC 50 MG RECTAL SUPPOSITORY
00808547 TEVA-DICLOFENAC EC 50 MG ENTERIC-COATED TABLET
02048698 TEVA-DICLOFENAC SR 100MG EXTENDED-RELEASE TABLET
02158582 TEVA-DICLOFENAC SR 75MG EXTENDED-RELEASE TABLET
02239355 TEVA-DICLOFENAC K 50MG TABLET

How does Teva-Diclofenac work? What will it do for me?

Diclofenac belongs to the class of medications known as non-steroidal anti-inflammatories (NSAIDs). It is used to reduce pain, swelling, and inflammation.

The diclofenac sodium tablet and suppository are used to relieve pain for people with rheumatoid arthritis, osteoarthritis, and degenerative joint diseases of the hip. The diclofenac potassium tablets are used for short-term relief of pain and inflammation, such as pain caused by sprains, surgery, dental work or menstrual cramps. The eye drop is used to reduce eye inflammation before and after eye surgery (e.g., cataract surgery) and in other cases of eye inflammation where infection is not present. The powder for oral solution is used for the treatment of migraine headaches.

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 being given this medication, speak to your doctor. Do not stop using 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 use this medication if their doctor has not prescribed it.

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How should I use Teva-Diclofenac?

Tablets: The usual adult dosage ranges from 50 mg to 100 mg daily. The immediate-release diclofenac sodium tablets are taken in 3 equally divided doses with food. Diclofenac potassium tablets are taken every 6 to 8 hours with food. The long-acting (sustained-release, or SR) tablets are taken in 1 or 2 daily doses with food or milk. The maximum recommended daily dose of diclofenac is 100 mg.

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.

[For powder for oral solution (Cambria)]

Powder for oral solution:The adult dose of the powder for oral solution is 50 mg (one individual dose sachet) taken at any time during a migraine attack. To dissolve the powder, open one individual dose sachet, pour the contents into 30 to 60 ml of water, and mix to dissolve. Do not use any other liquids besides water. Taking diclofenac with a meal may delay pain relief, although food may help to reduce possible stomach upset.

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 Teva-Diclofenac come in?

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 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 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 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 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.

Suppositories

50 mg rectal suppository
Each yellowish-white-coloured, smooth, torpedo-shaped suppository contains 50 mg diclofenac sodium. Nonmedicinal ingredients: diglyceride, monoglyceridem free glycerin, free fatty acids, and triglycerides.

100 mg rectal suppository
Each yellowish-white-coloured, smooth, torpedo-shaped suppository contains 100 mg diclofenac sodium. Nonmedicinal ingredients: diglyceride, monoglyceridem free glycerin, free fatty acids, and triglycerides.

Who should NOT take Teva-Diclofenac?

Do not take this medication 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 this medication to children or adolescents less than 16 years of age.

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