What Asacol 800 is used for and how to use it
Россия
  • Россия
  • Украина

Asacol 800 - Consumer Medicine Information

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

Asacol 800

Mesalamine Delayed-Release Tablets, Mfr. Std.

About this Medication

What the medication is used for

Asacol 800 (800 mg tablet) is used for the treatment of moderately active ulcerative colitis. Ulcerative colitis involves chronic inflammation of the inner lining of the colon and rectum.

What it does

Asacol 800 (800 mg tablet) has a special outer coating that is designed to remain intact, to protect the active ingredient, mesalamine (5-aminosalicylic acid, also referred to as 5-ASA), until it reaches the terminal ileum and colon where the tablet releases its contents. The active ingredient mesalamine is believed to reduce inflammation right at the site, where the medication is needed.

When it should not be used

Asacol 800 (800 mg tablet) 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)
  • If you have severe liver problems
  • If you have severe kidney problems
  • You have an existing 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

Each red-brown capsule-shaped enteric coated tablet of Asacol 800 (800 mg tablet) contains 800 mg mesalamine, otherwise known as 5-aminosalicylic acid or 5-ASA.

What the important nonmedicinal ingredients are

Asacol 800 (800 mg tablet) colon-targeted tablets are coated with a special acrylic-based resin, Eudragit-S {methacrylic acid copolymer Type B (USP)}, that delays release of the mesalamine until the tablets reach the terminal ileum.

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

What dosage form it comes in

Asacol 800 (800 mg tablet) tablets are available for oral administration as red-brown, capsule-shaped, enteric coated tablets, printed in black ink with “WC 800”.

Asacol 800 (800 mg tablet) colon-targeted tablets are supplied in bottles of 180 tablets each.

Warnings and Precautions

Serious Warnings and Precautions

If you have an allergic reaction to Asacol 800 (800 mg tablet), 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 800 (800 mg tablet). If you have a history of kidney problems, you should tell your doctor before using Asacol 800 (800 mg tablet), as it may worsen your kidney condition. Your doctor may require certain tests to check your kidney function before starting Asacol 800 (800 mg tablet) therapy and periodically while you continue Asacol 800 (800 mg tablet) therapy.

Some patients who have experienced an allergic reaction to sulfasalazine may have a similar reaction to Asacol 800 (800 mg tablet) or to other products that contain, or are converted to, mesalamine. Asacol 800 (800 mg tablet) 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 800.

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 800 (800 mg tablet) talk to your doctor or pharmacist if:

  • You have any liver or kidney problems.
  • You have pyloric stenosis (a narrowing of the outlet from the stomach that causes contents of the stomach to remain there for a longer period of time). Pyloric stenosis may keep the Asacol 800 (800 mg tablet) tablet from reaching the colon as quickly as it normally would.
  • You are pregnant, become pregnant, or are a nursing mother. Small amounts of 5-aminosalicyclic acid and its metabolite have been found in human breast milk. Dibutyl phthalate (DBP) an inactive ingredient in the enteric coating of Asacol 800 (800 mg tablet), and its primary metabolite mono-butyl phthalate (MBP) are also excreted into human milk. Caution should be taken when using Asacol 800 (800 mg tablet) while you are nursing. Discuss with your doctor.

Interactions with this Medication

There has been no specific drug interaction studies performed with Asacol 800 (800 mg tablet). In addition, interactions with herbal products or laboratory tests have not been established. If you are on other prescription medications or on over-the-counter products, including herbal supplements, or are undergoing a laboratory test, please consult your doctor or pharmacist.

Asacol 800 (800 mg tablet) can be taken with or without food.

Proper Use of this Medication

Usual dose

For the treatment of moderately active ulcerative colitis

The usual daily adult dose is 6 Asacol 800 (800 mg tablet) tablets, taken orally in divided doses. Asacol 800 (800 mg tablet) may be given with or without food.

Ulcerative colitis rarely disappears completely. Abrupt discontinuation of medication is not recommended, as it may trigger the symptoms to appear again. It is important to closely follow your doctor’s dosage instructions, to help reduce the risk of symptoms re-appearing.

When taking Asacol 800 (800 mg tablet), 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 800 (800 mg tablet) 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.

Overdose

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 800 (800 mg tablet) 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 include worsening of ulcerative colitis symptoms, abnormal liver function tests and rash.

Inform your doctor, if you experience any of the following symptoms while taking Asacol 800 (800 mg tablet): worsening of your ulcerative colitis symptoms, fever, rash, chest pain or stomach pain, or difficulty breathing.

Important 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
Common (more than 1 in 100)
Worsening of your
ulcerative colitis
symptoms
X
Rare (less than 1 in 1,000)
FeverX
Allergic reactions
which may include
symptoms such as:
itching; rash, swelling of face or hands,
tightness in chest,
trouble breathing
X
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
feet
Additional less specific
symptoms may include:
drowsiness, fatigue,
nausea, vomiting, rash,
persistent itching, and
back pain
X
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.
X

This is not a complete list of side effects. For any other side effects or health concerns while taking Asacol 800 (800 mg tablet), contact your doctor or pharmacist.

How to Store it

Asacol 800 (800 mg tablet) should be stored at controlled room temperature (15°C - 30°C).

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

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.