Consumer Information for: PMS-SULFASALAZINE 500MG/TAB USP

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

pms-SULFASALAZINE and pms-SULFASALAZINE-E.C. contain sulfasalazine, which are anti-inflammatory drugs indicated as an adjunctive therapy in the treatment of severe ulcerative colitis (bowel inflammation), proctitis (inflammation of the rectum) or distal ulcerative colitis and Crohn’s disease.

pms-SULFASALAZINE-E.C. contains sulfasalazine in delayedrelease tablets, indicated for the treatment of active rheumatoid arthritis, when treatment with an adequate conventional first line therapy has failed.

What it does

The way in which pms-SULFASALAZINE and pms-SULFASALAZINE work is unclear and thought to involve three actions:

  • anti-inflammatory action, which blocks the production and effect of certain substances in the body (cyclooxygenase, prostaglandins and others), which are involved in producing inflammation;
  • bacteriostatic (anti-bacterial) action, which preventsthe growth of several kinds of bacteria which are possibly involved in inflammation;
  • immunosuppressive action (which reduces a patient’s overly active immune response, which has been linked to inflammatory diseases).

All of these actions likely work together to reduce symptoms of gut inflammation, diarrhea, swelling and bleeding.

When it should not be used

Do not use pms-SULFASALAZINE or pms-SULFASALAZINE-E.C. if you have:

  • a hypersensitivity (allergic reactions) to sulfasalazine, its metabolites, sulfonamides, salicylates or any other component of this product (see What the non- medicinal ingredients are);
  • an intestinal or urinary obstruction;
  • porphyria (disease of pigment production in tissues).
  • experienced sudden asthmatic attacks, urticaria, rhinitis, or other allergic-type reactions to acetylsalicylic acid or other nonsteroidal anti-inflammatory, as these attacks are serious and can be fatal (see WARNINGS AND PRECAUTIONS for a complete list of conditions where pms-SULFASALAZINE and pms-SULFASALAZINE E.C. should not be used);
  • severe kidney (renal) impairment and/or severe liver (hepatic) impairment (see Side Effects and What to Do About Them)

This drug is not to be used in infants under 2 years of age.

What the medicinal ingredient is

Sulfasalazine

What the non-medicinal ingredients are

pms-SULFASALAZINE tablets contain: Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose, Povidone

pms-SULFASALAZINE-E.C contain: Acrylic Resin, Croscarmellose Sodium, Iron Oxide Red, Iron Oxide Yellow, Macrogol, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Propylene Glycol, Sodium Carboxymethylcellulose, Sodium Citrate Dihydrate, Talc, Titanium Dioxide.

What dosage form it comes in
  • pms-SULFASALAZINE: Tablets. Available in bottles of 100 and 500.
  • pms-SULFASALAZINE-E.C: Delayed-release tablets. Available in bottles of 100 and 500.

Warnings and precautions

BEFORE you use pms-SULFASALAZINE or pms-SULFASALAZINE-E.C., talk to your doctor or pharmacist if you:

  • have had any allergic reactions to any sulfonamides, furosemide or thiazide diuretics (water pills), dapsone, sulfoxone, oral hypoglycemics (diabetes drugs you take by mouth), glaucoma medicines you take by mouth (for example, acetazolamide, dichlorophenamide, methazolamide), or salicylates (for example, acetylsalicylic acid);
  • are pregnant or intend to become pregnant while taking this medicine;
  • are breastfeeding an infant. Sulfonamides pass into the breast milk in small amounts and may cause unwanted effects in infants with glucose-6-phosphate dehydrogenase (G6PD) deficiency. There have been reports of bloody stools or diarrhea in infants who were breastfeeding from mothers on sulfasalazine.
  • intend to father a child (low sperm count);
  • have any of the following medical problems:
    • Blockage of the stomach, intestines, or urinarytract
    • Blood problems
    • Glucose-6-phosphate dehydrogenase (G6PD) deficiency
    • Kidney disease
    • Liver disease
    • Porphyria
    • History of recurring or chronic infections. If you develop a new infection while taking pms-SULFASALAZINE or pms-SULFASALAZINE-E.C., talk to your doctor.
  • are now taking any other medicines (See Interactions with this medicine).
  • before having any kind of surgery, including dental surgery, with a general anesthetic, tell the physician or dentist in charge that you are taking a sulfonamide.

Stop taking pms-SULFASALAZINE or pms-SULFASALAZINE-E.C. immediately and tell your doctor if you develop the following symptoms:

  • Skin rash, fever, swollen lymph nodes, lesions inside your mouth or nose;
  • Sore throat, fever, pallor (pale skin), swollen lymph nodes, purple discoloration of the skin which does not blanch under pressure or jaundice (yellowing of your skin or white porting of your eye).

Do not give this medication to infants under 2 years of age.

Interactions with this medication

If taken with some other medicines, the effects of pms-SULFASALAZINE and pms-SULFASALAZINE-E.C. or the other medications may change. Please check with your doctor or pharmacist before taking any other medications with pms-SULFASALAZINE or pms-SULFASALAZINE, such as:

  • Anthralin
  • Antibiotics
  • Anticoagulants, coumarin- or indandione-type (blood thinners)
  • Antidiabetic agents, oral (diabetes medicines you take by mouth)
  • Azathioprine
  • Coal tar
  • Dapsone
  • Digitalis glycosides (heart medicine)
  • Dipyrone
  • Diuretics (water pills or high blood pressure medicine)
  • Ethotoin
  • Folic acid
  • Furazolidone
  • Mephenytoin
  • Methenamine
  • Methotrexate
  • Methoxsalen
  • Nalidixic acid
  • Nitrofurantoin
  • Other sulfonamides
  • Oxyphenbutazone
  • Phenothiazines(tranquilizers)
  • Phenylbutazone
  • Phenytoin
  • Primaquine
  • Probenecid
  • Sulfinpyrazone
  • Sulfoxone
  • Tetracyclines
  • Thiopurine 6-mercaptopurine
  • Trioxsalen
  • Vitamin K

Drug interactions with antibiotics, anticoagulants, coumarin- or indandione-derivative, anticonvulsants, oral antidiabetic agents, digitalis glycosides or folic acid, methenamine, methotrexate, oxyphenbutazone or phenylbutazone, photosensitizing medications, probenecid, sulfinpyrazone, thiopurine methyltransferase (TPMT) are possible.

Sulfasalazine may interfere with some medical tests. Your healthcare provider will evaluate your results depending on your symptoms.

Proper use of this medication

Usual adult dose

Take pms-SULFASALAZINE or pms-SULFASALAZINE-E.C. as directed by your doctor, at regular and even intervals over the 24-hour period. If you are taking pms-SULFASALAZINE or pms-SULFASALAZINE E.C. tablets for an intestinal inflammatory disease, the night-time doses interval should not exceed 8 hours.

pms-SULFASALAZINE and pms-SULFASALAZINE-E.C. tablets are best taken after meals or with food to lessen stomach upset. If stomach upset continues or is bothersome, check with your doctor.

Each dose of pms-SULFASALAZINE and pms-SULFASALAZINE should also be taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water helps prevent unwanted side effects of the sulfonamide.

For patients taking the delayed-release tablet form of this medicine:

  • Swallow tablets whole. Do not break or chew.
  • Contact your doctor if you notice any undisintegrated tablet in your stool.

Keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

If your symptoms (including diarrhea) do not improve within a month or two or if they become worse, check with you doctor. It is important that your doctor checks your progress at regular visits.

Laboratory and blood tests may be scheduled for you by your doctor before and during treatment.

Overdose

If you think you have taken too much pms-SULFASALAZINE or pms-SULFASALAZINE-E.C., contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you do miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, do not take the missed dose or double your next dose. Instead, go back to your regular dosing schedule.

Side effects and what to do about them

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects appear very often, when they do occur they may require medical attention.

Other side effects (than those mentioned in the following table) may occur, which usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:
More Common: Diarrhea, dizziness, loss of appetite, nausea or vomiting, headache, itching, skin rash, upset stomach.
Less Common: rash, itching, hives, fever.
Rare: blood problems

In some patients this medicine may also cause the urine to become orange-yellow, or may stain contact lenses yellow. This side effect does not require medical attention.

Some people who take sulfonamides may become more sensitive to sunlight than they are normally. When you begin to take this medicine, avoid too much sun or too much use of a sunlamp until you see how you react, especially if you tend to burneasily. You may still be more sensitive to sunlight or sunlamps for many months after you stop taking this medicine. If you have a severe reaction, check with your doctor.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
More common
Low sperm counts (oligospermia), with infertility, have been observed with men taking sulfasalazine, which is reversible within several months of stopping the medication.     ✔
Increased sensitivity of the skin to sunlight   ✔  
Less Common
Aching in joints and muscles, difficulty in swallowing, fever, pale skin, redness, blistering, peeling or loosening of the skin, sore throat, unusual bleeding or bruising, unusual tiredness or weakness, yellowing of the eyes or skin, mouth sores, ringing in the ears     ✔
Rare
- Kidney problems with symptoms such as blood in the urine, lower back pain, pain or burning when urinating, swelling of the front part of the neck
- Liver problems including liver failure, with symptoms such as abdominal pain, nausea, yellowing of the eyes or skin
- Interstitial lung disease with symptoms such as shortness of breath and difficulty breathing
- Hypersensitivity (allergic) reactions including death with symptoms such as rash, swelling of the mouth, throat, lips, other tissues, and difficulty in breathing These symptoms have been associated with sulfasalazine use 		    ✔

This is not a complete list of side effects. For any unexpected effects while taking pms-SULFASALAZINE or pms-SULFASALAZINE-E.C., contact your doctor or pharmacist.

How to store

Store between 15-30°C. Avoid freezing and keep out of the reach and sight of children. Do not store in the bathroom medicine cabinet because the heat or moisture may cause the medicine to break down. Do not keep outdated medicine or medicine no longer needed.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Pharmascience Inc. at 1-888-550-6060.

This leaflet was prepared by:

    Pharmascience Inc.
    Montréal, Canada
    H4P 2T4

www.pharmascience.com

Last revised: April 30, 2020

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