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Seldane

PATIENT INFORMATION

Patient Package Insert

This leaflet is a summary of important information about terfenadine. Be sure to ask your doctor if you have any questions or want to know more.

What is Terfenadine and What is it Used For? Terfenadine is an antihistamine. It is used to relieve symptoms of seasonal allergies or hay fever. These symptoms include runny nose, sneezing, itching of the nose or throat, and itchy watery eyes.

Clinical studies conducted to date with terfenadine have not demonstrated effectiveness in relieving the symptoms of the common cold.

How Do I Take Terfenadine? Take terfenadine only as needed when you have symptoms of seasonal allergy or hay fever.

  • The recommended dose of terfenadine is one tablet taken twice a day.DO NOT TAKE MORE OFTEN THAN ONE TABLET EVERY TWELVE HOURS
  • Follow any other instructions your doctor gives you.

What Are the Important Warnings About Using terfenadine? WARNING: DO NOT USE TERFENADINE IF YOU ARE USING KETOCONAZOLE (NIZORAL), ITRACONAZOLE (SPORANOX), ERYTHROMYCIN, CLARITHROMYCIN (BIAXIN), OR TROLEANDOMYCIN (TAO). IF YOU HAVE ANY LIVER OR HEART PROBLEMS, TALK TO YOUR DOCTOR BEFORE YOU USE TERFENADINE.

Do not use terfenadine with any other prescription or nonprescription medicines without first talking to your doctor and pharmacist.

If you faint, become dizzy, have any unusual heartbeats, or any other unusual symptoms while using terfenadine, contact your doctor.

If you become pregnant or are nursing a baby, talk your doctor about whether you should take terfenadine. Your doctor will decide whether you should take terfenadine based on the benefits and the risks.

What Are the Risks of Using Terfenadine? The side effects which occur most often are headaches and mild stomach or intestinal problems.

In rare cases, terfenadine has caused IRREGULAR HEARTBEATS which may cause serious problems like fainting, dizziness, cardiac arrest, or death. In these rare cases, this occurred when terfenadine was taken:

  • in more than the recommended dose (remember, do not take more often than one tablet every twelve hours);
  • with the antifungal drugs ketoconazole (Nizoral), or itraconazole (Sporanox);
  • with the antibiotic drugs erythromycin, clarithromycin (Biaxin), or troleandomycin (TAO);
  • by patients with serious liver disease.

How do I Store Terfenadine? Terfenadine should be stored in a tightly closed container, in a cool place, out of direct sunlight. It should be kept away from children.

 

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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