Asacol HD

If you are taking mesalamine delayed-release tablets, you may notice the tablet shell or part of the tablet shell in your stool. Tell your doctor if this happens frequently.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests before and during your treatment.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking mesalamine.

Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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You should not use mesalamine if you are allergic to it, or:

• if you are allergic to aspirin, sulfasalazine, or salicylates (such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others).

To make sure mesalamine is safe for you, tell your doctor if you have:

• a stomach condition called pyloric stenosis;

• heart disease;

• kidney disease;

• liver disease; or

• a history of blockage in your digestive tract (stomach or intestines).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Mesalamine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice.

In the U.S.

• Apriso
• Asacol HD
• Delzicol
• Lialda
• Pentasa

In Canada

• Asacol 800

Available Dosage Forms:

• Capsule, Delayed Release
• Tablet, Delayed Release
• Tablet, Enteric Coated
• Capsule, Extended Release
• Tablet

Therapeutic Class: Gastrointestinal Agent

Chemical Class: Salicylate, Non-Aspirin

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Asacol® HD is indicated for the treatment of moderately active ulcerative colitis in adults.

Limitations of Use:
Safety and effectiveness of Asacol HD beyond 6 weeks have not been established.

2.1       Important Administration Instructions

• Do not substitute one Asacol HD 800 tablet for two mesalamine delayed-release 400 mg oral products [see Clinical Pharmacology (12.3)].
  
• Evaluate renal function prior to initiation of Asacol HD.
  
• Take Asacol HD tablets on an empty stomach, at least 1 hour before and 2 hours after a meal [see Clinical Pharmacology (12.3)].
  
• Swallow Asacol HD tablets whole. Do not cut, break or chew the tablets.
  
• Intact, partially intact, and/or tablet shells have been reported in the stool; Instruct patients to contact their physician if this occurs repeatedly.
  
• Protect Asacol HD tablets from moisture. Close the container tightly and leave desiccant pouches in the bottle along with the tablets.

2.2       Dosage Information

For the treatment of moderately active ulcerative colitis, the recommended dosage of Asacol HD in adults is 1600 mg (two 800 mg tablets) three times daily (total daily dosage of 4.8 grams) for a duration of 6 weeks.

Asacol HD is contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Asacol HD [see Warnings and Precautions (5.3), Adverse Reactions (6.2), and Description (11)].

More frequent side effects include: constipation, dyspepsia, skin rash, and vomiting. See below for a comprehensive list of adverse effects.

Applies to mesalamine: oral capsule delayed release, oral capsule extended release, oral tablet, oral tablet delayed release, oral tablet enteric coated

Other dosage forms:

• rectal enema, rectal suppository

Along with its needed effects, mesalamine (the active ingredient contained in Asacol HD) 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 while taking mesalamine:

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

• 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

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

Some side effects of mesalamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach cramps or pain (mild)
• diarrhea (mild)
• headache (mild)
• runny or stuffy nose
• sneezing

• Acid or sour stomach
• acne
• back or joint pain
• belching
• difficulty with moving
• excess air or gas in the stomach or intestines
• hair loss or thinning of the hair
• heartburn
• indigestion
• loss of appetite
• muscle pain or stiffness
• passing gas
• stomach discomfort or upset