Lialda

Serious side effects have been reported with Lialda. See “Lialda Precautions” section.

Common side effects of Lialda include:

• headache
• flatulence
• abdominal pain
• diarrhea

Other less common side effects include:

• abnormal liver function tests
• hair loss
• itching
• upset stomach
• back pain
• rash
• joint pain
• fatigue
• hypertension

This is not a complete list of Lialda side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Mesalamine affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Mesalamine is used to treat ulcerative colitis, proctitis, and proctosigmoiditis. Mesalamine is also used to prevent the symptoms of ulcerative colitis from recurring.

Mesalamine may also be used for purposes not listed in this medication guide.

This section provides information on the proper use of a number of products that contain mesalamine. It may not be specific to Lialda. Please read with care.

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

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 Lialda® 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.

Take the Asacol® HD tablet on an empty stomach, at least 1 hour before or 2 hours after a meal.

If you have trouble swallowing the Delzicol® capsule, carefully open the capsule and take out the 4 tablets. Swallow the tablets whole and make sure all 4 are taken at the same time as one dose. Do not cut, break, crush, or chew them.

The contents of the Pentasa® capsule may be sprinkled on applesauce or yogurt if needed. The mixture must be swallowed right away without chewing.

If you are taking the delayed-release capsule, extended-release capsule, or delayed-release tablet, part of the capsule or tablet may pass into your stool after your body has absorbed the medicine. Contact your doctor if this happens more often than 1 or 2 times.

Dosing

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 ulcerative colitis:
  • For long-acting oral dosage form (delayed-release capsules):
    • Adults—800 milligrams (mg) 3 times a day.
    • Children 5 years and older—Dose is based on body weight and must be determined by your doctor. The dose is usually not more than 2400 mg per day, divided in 2 doses.
    • Children younger than 5 years—Use and dose must be determined by your doctor.
  • For long-acting oral dosage form (delayed-release tablets):
    • Adults—
      • For Asacol® HD: 1600 milligrams (mg) 3 times a day for 6 weeks.
      • For Lialda®: 2.4 to 4.8 grams once a day as a single dose.
    • Children—Use and dose must be determined by your doctor.
  • For long-acting oral dosage form (extended-release capsules):
    • Adults—
      • For Apriso™: 1.5 grams once a day as a single dose in the morning.
      • For Pentasa®: 1 gram 4 times a day.
    • Children—Use and dose must be determined by your doctor.
• For prevention of ulcerative colitis:
  • For long-acting oral dosage form (delayed-release capsules):
    • Adults—1600 milligrams (mg) per day, taken in divided doses.
    • Children—Use and dose must be determined by your doctor.
  • For long-acting oral dosage form (delayed-release tablets):
    • Adults—2.4 grams once a day as a single dose.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

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.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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

Store the delayed-release capsules and delayed-release tablets in a tightly-closed container to protect them from moisture.

Use Lialda as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• To gain the most benefit, do not miss doses.
• Take with a full glass of water.
• Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take Lialda.
• Swallow whole. Do not chew, break, or crush.
• If you have trouble swallowing, talk with your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain or heartburn.
• Headache.
• Hard stools (constipation).
• Loose stools (diarrhea).
• Dizziness.
• Gas.
• Runny nose.
• Stuffy nose.
• Sore throat.
• Muscle or joint pain.
• Back pain.
• Upset stomach or throwing up.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• 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.

Pregnancy

Pregnancy Category B. Reproduction studies with mesalamine have been performed in rats at doses up to 1000 mg/kg/day (1.8 times the maximum recommended human dose based on a body surface area comparison) and rabbits at doses up to 800 mg/kg/day (2.9 times the maximum recommended human dose based on a body surface area comparison) and have revealed no evidence of impaired fertility or harm to the fetus due to mesalamine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Mesalamine is known to cross the placental barrier.

Nursing Mothers

Low concentrations of mesalamine and higher concentrations of its N-acetyl metabolite have been detected in human breast milk. The clinical significance of this has not been determined and there is limited experience of nursing women using mesalamine. Caution should be exercised if Lialda is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Lialda in pediatric patients have not been established.

Geriatric Use

Reports from uncontrolled clinical studies and postmarketing reporting systems suggested a higher incidence of blood dyscrasias, i.e., neutropenia and pancytopenia in patients who were 65 years or older who were taking mesalamine-containing products such as Lialda. Caution should be taken to closely monitor blood cell counts during mesalamine therapy.

Clinical trials of Lialda did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Systemic exposures are increased in elderly subjects. [see Clinical Pharmacology (12.3)]. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concurrent disease or other drug therapy in elderly patients.

Lialda is an aminosalicylate, and symptoms of salicylate toxicity may include tinnitus, vertigo, headache, confusion, drowsiness, sweating, seizures, hyperventilation, dyspnea, vomiting, and diarrhea. Severe intoxication may lead to disruption of electrolyte balance and blood-pH, hyperthermia, dehydration, and end organ damage.

There is no specific known antidote for mesalamine overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage. Fluid and electrolyte imbalance should be corrected by the administration of appropriate intravenous therapy. Adequate renal function should be maintained.

Each Lialda delayed-release tablet for oral administration contains 1.2 g 5-aminosalicylic acid (5-ASA; mesalamine), an anti-inflammatory agent. Mesalamine also has the chemical name 5-amino-2-hydroxybenzoic acid and its structural formula is:

Molecular formula: C7H7NO3

Molecular weight: 153.14

The tablet is coated with a pH dependent polymer film, which breaks down at or above pH 6.8, normally in the terminal ileum where mesalamine then begins to be released from the tablet core. The tablet core contains mesalamine with hydrophilic and lipophilic excipients and provides for extended release of mesalamine.

The inactive ingredients of Lialda are sodium carboxymethylcellulose, carnauba wax, stearic acid, silica (colloidal hydrated), sodium starch glycolate (type A), talc, magnesium stearate, methacrylic acid copolymer types A and B, triethylcitrate, titanium dioxide, red ferric oxide and polyethylene glycol 6000.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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 Lialda) 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