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Microsoft word - 160552 salofalk suspension.apm.docx
PART III: CONSUMER INFORMATION
Mesalamine Rectal Suspension USP
2 g/60 g, 4 g/60 g
This leaflet is part III of a three-part "Product Monograph" and is designed specifically for Consumers. This leaflet is a
summary and will not tell you everything about SALOFALK®. Contact your doctor or pharmacist if you have any
questions about the drug.
ABOUT THIS MEDICATION
What the medication is used for:
SALOFALK® rectal suspension, 4 g/60 g is used in the management of distal ulcerative colitis (inflammation of the lining of the
large bowel and rectum) and may also be used in preventing the symptoms of the disease from recurring. SALOFALK® rectal
suspension (4 g/60 g) can be used in combination with other drugs.
The lower strength of SALOFALK® rectal suspension, 2 g/60 g may also be used in preventing the symptoms of distal ulcerative
colitis from recurring.
What it does:
SALOFALK® is believed to work by interfering in the activity of certain mediators of inflammation (e.g., prostaglandins) which
helps reduce the inflammation (swelling and pain) in the rectum and lower part of the large bowel. When it should not be used:
SALOFALK® should not be used if:
patients with severe kidney (renal) impairment (GFR<30ml/min/1.73m2) and/or severe liver (hepatic) impairment (see
You are allergic to mesalamine or to any ingredient in the formulation (see What the non-
medicinal ingredients are
You have a sensitivity to salicylates, for example acetylsalicylic acid (Aspirin®)
You have stomach or small intestinal ulcers
The patient is an infant under two years of age
What the medicinal ingredient is:
SALOFALK® contains mesalamine (me-SAL-a-meen), also known as 5-aminosalicylic acid, 5-ASA or mesalazine. What the non-medicinal ingredients are:
SALOFALK® rectal suspension contains carbomer, edetate disodium, potassium acetate, potassium metabisulfite, purified water,
sodium benzoate and xanthan gum.
SALOFALK® rectal suspension is gluten-free and phthalate-free. What dosage forms it comes in:
SALOFALK® rectal suspensions, 2 g/60 g and 4 g/60 g are available for single-use. Each unit contains a rectal dosing package
designed for self-administration and disposal. A removable protective sheath covers the pre-lubricated suspension nozzle until
ready for use. A one-way valve allows the suspension to flow from the bottle through the applicator nozzle and into the rectum
as the patient squeezes the thin walled collapsible bottle.
WARNINGS AND PRECAUTIONS
BEFORE you use SALOFALK® talk to your doctor or pharmacist if:
You have a pre-existing liver disease. There have been reports of liver (hepatic) failure and increased liver enzymes in
patients treated with 5-ASA or mesalazine (=mesalamine) products.
You have mild to moderate liver function impairment. Your doctor will decide if this product is right for you.
You ever had any unusual or allergic reaction to mesalamine (5-ASA), sulfasalazine (SAS), salicylates (Aspirin®), or
SALOFALK® (mesalamine rectal suspension USP) Page 20 of 25 Aptalis Pharma Canada Inc.
You have bleeding or clotting disorders
Your doctor has said you have higher than normal blood urea nitrogen (BUN) levels (renal function test)
You are pregnant or breastfeeding. Mesalamine is excreted in human breast milk. Discuss with your doctor.
Discontinue use at first sign of rash or fever.
You may have your blood or urine tested regularly to monitor your kidney function since prolonged use of SALOFALK® may damage your kidneys.
INTERACTIONS WITH THIS MEDICATION
Interaction between azathioprine, 6-mercaptopurine, and aminosalicylates (such as SALOFALK®) has been reported. Drug interactions with coumarin, methotrexate, probenecid, sulfinpyrazone, spironolactone, furosemide, rifampicin, and Varicella Virus Vaccine (chicken pox vaccine) may be possible. Possible interference with measurements, by liquid chromatography, of urinary normetanephrine causing a false-positive test result have been observed in patients exposed to sulfasalazine or its metabolite, mesalamine/mesalazine.
PROPER USE OF THIS MEDICATION
Usual adult dose:
SALOFALK® rectal suspension, 4 g/60 g is self-administered on a daily basis during acute episodes of disease. Usually one
unit-dose rectal suspension (4 g) is taken upon retiring (bedtime) and best results occur when retained in the rectum during the
entire rest period. Discard unused portion. Prevention or relapses:
SALOFALK® rectal suspension, 2 g/60 g is self-administered in the same manner as above on a daily basis to prevent relapse
(recurrence of symptoms).
Continued use for a certain period may be recommended by your doctor to prevent symptoms from recurring. Check with your
doctor should symptoms such as diarrhoea and rectal bleeding recur. Overdose:
If you believe you have used too much, or in case of accidental oral ingestion, contact your doctor, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
If you miss a dose of SALOFALK®, use it as soon as possible, unless it is almost time for the next dose. Do not use two
SALOFALK® doses at the same time to make up for a missed dose.
How to Use the Rectal Suspension:
Best results are achieved if the bowel is emptied immediately before the suspension is given. 1. Preparing the medication for administration:
a) Shake the bottle well to make sure that the suspension is homogeneous.
b) Remove the protective sheath from the applicator tip. Hold the bottle at the neck so as not to cause any of the
2. Assuming the correct body position:
a) Best results are obtained by lying on the left side with left leg extended and the right leg flexed forward for balance, or
SALOFALK® (mesalamine rectal suspension USP) Page 21 of 25 Aptalis Pharma Canada Inc.
b) An alternative to lying on the left side is the “knee-chest” position.
3. Administering the rectal suspension:
a) Gently insert lubricated applicator tip into the rectum, pointed slightly toward the navel (umbilicus).
b) Grasp the bottle firmly, then tilt slightly so that the nozzle is aimed toward the back, and squeeze slowly to instill the
medication. Steady hand pressure will discharge most of the suspension. After administering withdraw and discard the used unit.
c) Remain in position for at least 30 minutes to allow thorough distribution of the medication internally. Retain the
NOTE: SALOFALK® rectal suspension will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Rash, fever, and dizziness are common in patients allergic to sulfasalazine. Stop therapy at the first sign of a rash and contact your doctor. Worsening of ulcerative colitis may occur and may include the following symptoms: abdominal or stomach cramps or pain (severe) and diarrhoea. Other reported side effects reported with SALOFALK® suspension include abdominal pain or discomfort, abdominal cramps, abnormal coloration of the urine, constipation, cough, diarrhoea, dizziness, feeling of incomplete defecation, fever, flatulence, hair loss, headache, itching, lower back pain, rash and stools discoloured.
SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND
WHAT TO DO ABOUT THEM
Symptom / effect
your doctor or
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with symptoms such as severe abdominal pain, nausea, vomiting, yellowing of the skin and eyes, drop in appetite, bloating and distension. Acute intolerance
syndrome with symptoms such as cramping, stomach pain, bloody and excessive stools, fever, headache and rash.
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SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND
WHAT TO DO ABOUT THEM
Symptom / effect
your doctor or
pneumonia (lung abnormality with scarring) with symptoms such as difficulty in breathing, dry cough, fever, and persistent unwell feeling. Aplastic anaemia
(shortage of one or more types of blood cells) with symptoms such as fatigue, difficulty in breathing with exertion, rapid or irregular heartbeat, pale skin, frequent or prolonged infections, unexplained or easy bruising, nosebleeds and bleeding gums, prolonged bleeding from cuts, skin rash, dizziness, and headache.
This is not a complete list of side effects. For any unexpected effects while taking SALOFALK®, contact your doctor or
HOW TO STORE IT
Store SALOFALK® rectal suspension at room temperature, preferably under 25°C. The expiration date and lot number are printed on the bottle. Suspension colour may vary from off white to brown. Keep the medicine from light and air. Keep out of reach of children.
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REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated
with the use of health products to the Canada Vigilance
Program by one of the following 3 ways:
Report online at www.healthcanada.gc.ca/medeffect
Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701D
Postage paid labels, Canada Vigilance Reporting Form and the
adverse reaction reporting guidelines are available on the
MedEffect™ Canada Web site at
NOTE: Should you require information related to the
management of side effects, contact your health professional.
The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.aptalispharma.com or by contacting the sponsor, Aptalis Pharma Canada Inc. at: 1-800-565-3255 This leaflet was prepared by Aptalis Pharma Canada Inc. Last revised: January 11, 2013 SALOFALK® is a registered trademark of Aptalis Pharma Canada Inc. Aspirin® is a registered trademark of Bayer Aktiengellschaft.
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PART I: HEALTH PROFESSIONAL INFORMATION
ACTION AND CLINICAL PHARMACOLOGY
DOSAGE FORMS, COMPOSITION AND PACKAGING
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