What Asacol 400 is used for and how to use it
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Asacol 400 - Consumer Medicine Information

Manufacture: Warner Chilcott
Country: Canada
Condition: Ulcerative Colitis
Class: Gastrointestinal agents
Form: Tablets
Ingredients: 5-aminosalicylic aciddibutyl phthalate, edible black ink (ammonium hydroxide, n-butyl alcohol, shellac glaze [modified] in SD-45, synthetic black iron oxide and propylene glycol), iron oxide red, iron oxide yellow, lactose, magnesium stearate, Eudragit-S {methacrylic acid copolymer Type B (USP)}, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate, colloidal silicon dioxide and talc


5-aminosalicylic acid Enteric Coated Tablets,

400 mg, Mfr. Std.

About this Medication

What the medication is used for

Asacol is used for the treatment of mild to moderate ulcerative colitis and the maintenance of remission of mild to moderate ulcerative colitis.

What it does

Ulcerative colitis involves chronic inflammation of the inner lining of the colon and rectum. Asacol reduces inflammation right at the site.

When it should not be used

Asacol is not suitable for everyone. It should not be used if:

  • You are allergic to this drug or to any ingredient in the formulation or component of the container (see below for ingredient listing)
  • You have a history of sensitivity to salicylates, for example acetylsalicylic acid (i.e. Aspirin)
  • You have severe liver problems
  • You have severe kidney problems
  • You have stomach or intestinal ulcer
  • You have urinary tract obstruction
  • You are unable to swallow the intact tablet
  • The patient in question is an infant under 2 years of age

What the medicinal ingredient is

5-aminosalicylic acid (5-ASA)

What the important nonmedicinal ingredients are

Each tablet contains the following inactive ingredients: dibutyl phthalate, edible black ink (ammonium hydroxide, n-butyl alcohol, shellac glaze [modified] in SD-45, synthetic black iron oxide and propylene glycol), iron oxide red, iron oxide yellow, lactose, magnesium stearate, Eudragit-S {methacrylic acid copolymer Type B (USP)}, polyethylene glycol, polyvinylpyrrolidone, sodium starch glycolate, colloidal silicon dioxide and talc.

What dosage forms it comes in

Asacol 400 mg tablets are available for oral administration as brown-red, capsule-shaped, enteric-coated tablet, printed in black ink with “0752 DR”.

Asacol (400 mg tablets) is supplied in bottles of 180 tablets each.

Warnings and Precautions

Some patients who have experienced an allergic reaction to sulfasalazine may have a similar reaction to Asacol or to other products that contain, or are converted to, 5-ASA. Asacol does not contain sulfa.

The development of some cases of liver function problems, including liver failure, have been reported in patients who were using medication similar to or the same as that contained in Asacol.

Serious Warnings and Precautions
If you have an allergic reaction to Asacol, stop taking the medication and either consult your doctor or go to the nearest emergency department. Symptoms of allergic reaction may include itching, hives, swelling in face or hands, tightness in chest, trouble breathing.
Kidney failure has been reported in patients taking products with mesalamine, the active ingredient in Asacol. If you have a history of kidney problems, you should tell your doctor before using Asacol, as it may worsen your kidney condition. Your doctor may require certain tests to check your kidney function before starting Asacol therapy and periodically while you continue Asacol therapy.

Talk with your doctor about your medical history and if you have any questions about your medication. It's also important to visit your doctor periodically to monitor your condition and discuss how your treatment plan is working for you

BEFORE you use Asacol talk to your doctor or pharmacist if:

  • You have any liver or kidney problems
  • You are pregnant, become pregnant, or are a nursing mother. Small amounts of 5-aminosalicylic acid and its metabolite have been found in human breast milk. Dibutyl phthalate (DBP), an inactive ingredient in the enteric coating of Asacol tablets, and its primary metabolite monobutyl phthalate (MBP) are also excreted into human milk. Caution should be taken when using Asacol while you are nursing. Discuss with your doctor.
  • You have pyloric stenosis (a narrowing of the outlet fromthe stomach that causes contents of the stomach to remain there for a longer period of time). Pyloric stenosis may keep the Asacol tablet from reaching the colon as quickly as it normally would.

Interactions with this Medication

If taken with some other medicines, the effects of Asacol or the effects of other medicines may be changed. Please check with your doctor or pharmacist before taking other medications with Asacol.

Asacol tablets should not be taken with drugs that can change the acidity level of the stool, such as lactulose.

Asacol can be taken with or without food.

Proper Use of this Medication

Ulcerative colitis rarely disappears completely. Therefore it is important to closely follow your doctor’s dosage instructions. This can reduce the risk of symptoms re-appearing.

Do not stop taking the medication abruptly.

Usual dose


The usual daily adult dose is 2 to 8 Asacol tablets, taken orally, in divided doses. In severe disease the dose may be increased to 12 Asacol tablets daily.

Maintenance of remission

The recommended daily dosage in adults is 4 Asacol tablets, taken orally, in divided doses.

When taking Asacol, you should

  1. Swallow tablets whole. Take care not to break or chew the tablet, as this breaks the special outer coating.
  2. Take Asacol tablets only as prescribed. Do not change the number or frequency of tablets ingested without first consulting your doctor.
  3. What appears to be intact or partially intact tablets may infrequently appear in the stool. If this occurs repeatedly, consult your doctor.

If you have questions about your medication, please contact your doctor or pharmacist.


In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not take double the dose.

Side Effects and what to do about them

Asacol is generally well tolerated, however, side effects may occur with its use.

The most commonly reported side effects included nausea, diarrhea, abdominal pain and headache. Other common adverse reactions seen with Asacol were worsening of ulcerative colitis symptoms, abnormal liver function tests and rash.

Inform your doctor, if you experience worsening of your ulcerative colitis symptoms, fever, rash, chest pain or stomach pain, or difficulty breathing while taking Asacol.

Important Side Effects, how often they Happen and what to do about them
Symptom / EffectTalk with your
doctor or
Stop taking
drug and call
your doctor or
Only if
In all
Common (more than 1 in 100)
Worsening of your
ulcerative colitis
Rare (less than 1 in 1,000)
Allergic and skin reactions such as: hives; rash (with or without blisters); swelling of face, lips, tongue, or throat; difficult or painful swallowing; trouble breathing
Kidney problems
which may include
symptoms such as:
changes in urine output,
cloudy or tea-coloured
urine, blood in the urine,
weight gain (from
retaining fluid),
confusion, swelling of the
eyes, hands, legs, and
Additional less specific
symptoms may include:
drowsiness, fatigue,
nausea, vomiting, rash,
persistent itching, and
back pain
Liver problems which
may include symptoms
such as: severe
abdominal pain or
distension, nausea,
vomiting, drop in
appetite, and bloating,
together with yellowing
of the skin and eyes.

This is not a complete list of side effects.

For any unexpected effects while taking ACTONEL DR, contact your doctor or pharmacist.

How to Store it

Asacol should be stored at controlled room temperature (15°C - 30°C).

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
  • 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

More information can be found on the Internet at: http://www.actonel.ca.

This document plus the full product monograph, prepared for health professionals is available by contacting the sponsor, Warner Chilcott Canada Co. at: 1-855-892-8766.