What Salofalk Suppositories is used for and how to use it
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Salofalk Suppositories - 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: Rectal
Ingredients: mesalamine, witepsol H-15 (suppository wax base), gluten-free, phthalate-free

SALOFALK

Mesalamine Suppositories

500 mg, 1000 mg

About this Medication

What the medication is used for

SALOFALK suppositories 500 or 1000 mg, are used in the management of ulcerative proctitis (inflamed rectum) and as adjunctive therapy in more extensive distal ulcerative colitis (inflammation of the lining of the large bowel and rectum).

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 suppositories contain Witepsol H-15 (suppository wax base). SALOFALK Suppositories are gluten-free and phthalate-free.

What dosage form it comes in

SALOFALK suppositories 500 or 1000 mg are available in strips of 6 suppositories; boxes of 30 suppositories.

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

One 500 mg SALOFALK suppository is self-administered on a twice a day or three times a day basis. One 1000 mg SALOFALK suppository is self-administered on a once daily basis, at bedtime. The usual adult dose is 1.0 - 1.5 g/day and dosing is continued until a significant response is achieved or until the patient achieves remission. Dose tapering is recommended. Abrupt discontinuation is not recommended. Best results are expected with prolonged retention.

The suppository should be retained in the rectum for one to three hours or longer, if possible, to achieve the maximum benefit.

How to use SALOFALK suppositories

NOTE: SALOFALK suppositories will cause staining of direct contact surfaces, including but not limited to fabrics, flooring, painted surfaces, marble, granite, vinyl, and enamel.

Patient Instructions

  • Detach one suppository from the strip of suppositories.
  • Hold suppository upright and carefully remove the plastic wrapper.
  • Avoid excessive handling of suppository, which is designed to melt at body temperature.
  • Insert suppository completely into rectum with gentle pressure, pointed end first.
  • A small amount of lubricating gel may

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 suppositories at the same time to make up for a missed dose.

Side Effects, how often they Happen 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 suppositories include abdominal cramps, abdominal pain or discomfort, anal itching, anorectal discomfort, bloating, constipation, cough, diarrhoea, dizziness, flatulence, fever, frequent bowel movements, hair loss, headache, itching, lower back pain, mucus in stools, nausea, pain, painful bowel movements, rash, rectal discharge, rectal pain, stools discoloured and vomiting.

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.
Liver problems
with symptoms
such as severe
abdominal pain,
nausea, vomiting,
yellowing of the
skin and eyes,
drop in appetite,
bloating and
distension.
Unknown 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

SALOFALK suppositories must be stored below 25°C (77oF). Can be refrigerated. Keep away from direct heat, light and humidity. 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