What Salofalk Rectal Suspension is used for and how to use it
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Salofalk Rectal Suspension - Consumer Medicine Information

Manufacture: Actavis
Country: Canada
Condition: Crohn's Disease, Maintenance, Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis, Ulcerative Colitis, Active, Ulcerative Colitis, Maintenance, Ulcerative Proctitis
Class: 5-aminosalicylates
Form: Liquid solution, Rectal
Ingredients: mesalamine, carbomer, edetate disodium, potassium acetate, potassium metabisulfite, purified water, sodium benzoate, xanthan gum

SALOFALK

Mesalamine Rectal Suspension USP

2 g/60 g, 4 g/60 g

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 WARNINGS AND PRECAUTIONS).
  • 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
  • You have urinary tract obstructions
  • 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 form it comes in

SALOFALK rectal suspensions, 2 g/60 g and 4 g/60 g areavailable 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 sulphites
  • You have liver or kidney disease
  • 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.

WHILE using SALOFALK:

  • 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 bepossible.

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

Acute episodes

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.

Missed Dose

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:
    1. Shake the bottle well to make sure that the suspension is homogeneous.
    2. Remove the protective sheath from the applicator tip. Hold the bottle at the neck so as not to cause any of the medication to be discharged.
  2. Assuming the correct body position:
    1. Best results are obtained by lying on the left side with left leg extended and the right leg flexed forward for balance, or the other way around if lefthanded.
    2. An alternative to lying on the left side is the “kneechest” position.
  3. Administering the rectal suspension:
    1. Gently insert lubricated applicator tip into the rectum, pointed slightly toward the navel (umbilicus).
    2. 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.
    3. Remain in position for at least 30 minutes to allow thorough distribution of the medication internally. Retain the suspension all night, if possible.

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 / EffectTalk with your
doctor or
pharmacist
Stop taking
drug and call
your doctor or
pharmacist
Only if
severe
In all
cases
Uncommon Chest pain
Unknown Pancreatis
(inflammation of
the pancreas)
with symptoms
such as
abdominal pain,
nausea, vomiting,
fever, rapid
hearbeat, and
feeling tired.
Allergic
(hypersensitivity)
reaction with
symptoms such
as rash, itching,
fever, swelling of
the mouth and
throat, difficulty
in breathing.
Myocarditis/
Pericarditis
(inflammation of
the heart muscle
and lining around
the heart) with
symptoms such
as pain in the
chest, abnormal
heartbeat, fatigue,
fever, difficulty
in breathing,
accumulation of
fluid in the lung,
and coughing.
Unknown Liver problems
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.
Interstitial
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 pharmacist.

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.

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
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

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.

More Information

This document plus the full product monograph, prepared for health professionals can be found by contacting the importer, Actavis Specialty Pharmaceuticals Co., at 1-855-892-8766