INDICATIONS

Asacol (mesalamine delayed-release tablets) tablets are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.

INSTRUCTIONS

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without first checking with your doctor.

Keep taking this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

You should take the delayed-release tablets with food. All other brands of capsules and tablets can be taken with or without food.

Swallow the capsule or tablet whole. Do not open, break, crush, or chew it before swallowing.

Do not change to another brand without checking with your doctor. The number of capsules or tablets that you take depends on the brand and strength of the medicine. If you refill your medicine and it looks different, check with your pharmacist. One tablet of Asacol® HD 800 milligrams (mg) tablet may not work the same way as two Asacol® 400 mg tablets.

If you are taking the extended-release capsule or the delayed-release tablet, part of the capsule or tablet may pass into your stool after your body has absorbed the medicine. This is normal and nothing to worry about.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

DOSAGE 

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For the treatment of mildly to moderately active ulcerative colitis:

The usual dosage in adults is two 400-mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks.

For the maintenance of remission of ulcerative colitis:

The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was 6 months.

Two Asacol (mesalamine delayed-release tablets) 400 mg tablets have not been shown to be bioequivalent to one Asacol® HD (mesalamine) delayed-release 800 mg tablet.

STORAGE 

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the delayed-release tablets in a tightly-closed container to protect them from moisture. Putting desiccant pouches in the container may also help to keep the tablets from getting moist.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

SAFETY INFORMATION

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make.

Before using Asacol tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Asacol (mesalamine delayed-release tablets) tablets are contraindicated in patients with hypersensitivity to salicylates or to any of the components of the Asacol (mesalamine delayed-release tablets) tablet.

Patients with pyloric stenosis may have prolonged gastric retention of Asacol tablets which could delay release of mesalamine in the colon.

Exacerbation of the symptoms of colitis has been reported in 3% of Asacol (mesalamine delayed-release tablets) -treated patients in controlled clinical trials. This acute reaction, characterized by cramping, abdominal pain, bloody diarrhea, and occasionally by fever, headache, malaise, pruritus, rash, and conjunctivitis, has been reported after the initiation of Asacol tablets as well as other mesalamine products. Symptoms usually abate when Asacol (mesalamine delayed-release tablets) tablets are discontinued.

Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to Asacol tablets or to other compounds which contain or are converted to mesalamine.

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Urine or blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have abdominal or stomach pain, bloody diarrhea, cramps, fever, headache, or a rash while you are using this medicine. These may be symptoms of a condition called mesalamine-induced acute intolerance syndrome.

Do not take antacids (e.g., Amphojel®, Maalox®, Mylanta®, Tums®) while you are taking the Apriso™ extended-release capsules. Using these medicines together may change the amount of medicine that is released in the body.

Tell your doctor if you have had an allergic reaction to sulfasalazine (Azulfidine®).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

SIDE EFFECTS

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common:

• Abdominal or stomach pain (severe)
• bloody diarrhea
• rectal bleeding

Less common:

• Abdominal or stomach cramps (severe)
• blurred vision
• dizziness
• fever
• full or bloated feeling
• headache (severe)
• nervousness
• pounding in the ears
• pressure in the stomach
• skin rash and itching
• slow or fast heartbeat
• swelling of the abdominal or stomach area
• unusual tiredness or weakness

Rare:

• Anxiety
• back pain (severe)
• blue or pale skin
• chest pain, possibly moving to the left arm, neck, or shoulder
• chills
• nausea or vomiting
• shortness of breath
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• Confusion
• deep or fast breathing with dizziness
• diarrhea (severe or continuing)
• difficult or labored breathing
• dizziness or lightheadedness
• drowsiness (severe)
• feeling of constant movement of self or surroundings
• headache (severe or continuing)
• hearing loss or ringing or buzzing in the ears (continuing)
• nausea or vomiting (continuing)
• numbness of the feet, hands, and around the mouth
• seizures
• sensation of spinning
• sweating
• tightness in the chest
• wheezing