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|Tessalon

BENZONATATE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Tessalon

In Canada—

• Tessalon

Generic name product may be available in the U.S.

Category

• Antitussive

Description

Benzonatate (ben-ZOE-na-tate) is used to relieve coughs due to colds or influenza (flu). It is not to be used for chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm (pronounced flem) with the cough.

Benzonatate relieves cough by acting directly on the lungs and the breathing passages. It may also act on the cough center in the brain.

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

• Oral
• Capsules (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 benzonatate, the following should be considered:

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

Pregnancy—Studies on effects in pregnancy have not been done in either humans or animals.

Breast-feeding—It is not known whether benzonatate 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—It is very important that children do not chew or suck on the capsule before swallowing it. If the benzonatate contained in the capsules comes in contact with the mouth, it may cause the mouth and throat to become numb (loss of feeling) and choking may occur.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of benzonatate in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases 2 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 any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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

• Mucus or phlegm with cough—Since benzonatate decreases coughing, it makes it difficult to get rid of the mucus that may collect in the lungs and airways with some diseases

Proper Use of This Medicine

It is very important that you do not chew or suck on the capsule before swallowing it. If the benzonatate contained in the capsules comes in contact with the mouth, it may cause the mouth and throat to become numb (loss of feeling) and choking may occur.

Dosing—The dose of benzonatate 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 benzonatate. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (capsules):
  • For cough:
    • Adults—100 milligrams (mg) three times a day as needed.
    • Children—
      • Up to 10 years of age: Use and dose must be determined by your doctor.
      • 10 years of age and older: 100 mg three times a day as needed.

Missed dose—If you must take this medicine regularly and you miss a dose, 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—To store this medicine:

• Store away from heat and direct light.
• Keep out of the reach of children.
• Do not store this medicine 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.

Precautions While Using This Medicine

If your cough has not become better after 7 days or if you have a high fever, skin rash, or continuing headache with the cough, check with your doctor. These signs may mean that you have other medical problems.

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 may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Other side effects may occur that 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 health care professional if any of the following side effects continue or are bothersome:

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

Revised: 08/13/1998

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