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|Allegra 12 Hour

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FEXOFENADINE (Systemic)

Some commonly used brand names are:

In the U.S.—

Allegra

In Canada—

Allegra 12 Hour
Allegra 24 Hour

Description

Fexofenadine (fex-oh-FEN-a-deen) is an antihistamine. It is used to relieve the symptoms of hay fever and hives of the skin.

Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. Also, in some persons histamine can close up the bronchial tubes (air passages of the lungs) and make breathing difficult. Histamine can also cause some persons to have hives, with severe itching of the skin.

This medicine is available only with your doctor"s prescription, in the following dosage form:

Oral
Capsules (U.S.)
Tablets (U.S. and Canada)

Before Using This Medicine

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. For fexofenadine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to fexofenadine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—In animal studies, this medicine did not cause birth defects but did cause a decrease in weight of the infant. Discuss with your doctor whether or not you should continue to use this medicine if you become pregnant.

Breast-feeding—It is not known whether fexofenadine passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—This medicine has been tested in children 6 years of age and older and, in effective doses, has not been shown to cause different side effects or problems than it does in adults. There is no specific information comparing use of fexofenadine in children up to 6 years of age.

Older adults—Fexofenadine has been tested in patients 65 years of age and older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking or using any other prescription or nonprescription (over-the-counter [OTC]) medicine, especially antacids that contain aluminum and magnesium hydroxide (e.g., Maalox, Mylanta).

Other medical problems—The presence of other medical problems may affect the use of fexofenadine. Make sure you tell your doctor if you have any other medical problems, especially:

Kidney disease—Effects of fexofenadine may be increased because of slower removal from the body

Proper Use of This Medicine

Dosing—You should always take this medicine with water . Do not take it with juice such as grape, orange or apple juice.

You should NOT take antacids that contain aluminum or magnesium hydroxide within 15 minutes of taking this medicine. If you are uncertain about this, ask your doctor or pharmacist.

The dose of fexofenadine may 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 fexofenadine. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage form (capsules, tablets):
- For symptoms of hay fever:
  - Adults and children 12 years of age and older—60 milligrams (mg) two times a day , or 180 mg once a day.
  - Children 6 to 11 years of age—30 mg two times a day
  - Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For symptoms of chronic hives
  - Adults and children 12 years of age and older—60 mg two times a day, or 180 mg once a day.
  - Children 6 to 11 years of age—30 mg two times a day.
  - Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as you remember. 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—To store this medicine:

Keep out of the reach of children.
Store away from heat and direct light in a tightly closed container.
Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Side Effects of This Medicine

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 seek medical attention immediately.

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

Incidence rare

Chest tightness ; feeling of warmth, redness of the face, neck, arms and occasionally, upper chest; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; shortness of breath, difficult or labored breathing

The following side effects usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

Less common

Back pain; body aches or pain; chills; coughing; difficulty in moving; dizziness; drowsiness; ear congestion; earache; fever; headache; joint pain; loss of voice; muscle aching or cramping; muscle pains or stiffness; nasal congestion; nausea; pain in arms or legs; pain or tenderness around eyes or cheekbones; painful menstrual bleeding; ringing or buzzing in ears; runny or stuffy nose; sneezing; sore throat; stomach upset; swollen joints; unusual feeling of tiredness or weakness; viral infection (such as cold and flu)

Incidence rare

Nervousness; rash; sleeplessness; terrifying dreams; trouble sleeping

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 08/12/1998
Revised: 11/02/2005

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