Bontril SR Sustained-Release Capsules

Bontril SR Sustained-Release Capsules are used for:

The short-term management of obesity combined with a diet and exercise program.

Bontril SR Sustained-Release Capsules are an anorectic. Exactly how Bontril SR Sustained-Release Capsules works is unknown, although one of its effects is to decrease your appetite.

Do NOT use Bontril SR Sustained-Release Capsules if:

• you are allergic to any ingredient in Bontril SR Sustained-Release Capsules
• you have heart disease, glaucoma, an overactive thyroid, severe or uncontrolled high blood pressure, are highly nervous or agitated, or have a history of drug abuse
• you are taking guanadrel or guanethidine, or if you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Bontril SR Sustained-Release Capsules:

Some medical conditions may interact with Bontril SR Sustained-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have diabetes or high blood pressure

Some MEDICINES MAY INTERACT with Bontril SR Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Furazolidone, monoamine oxidase (MAO) inhibitors (eg, phenelzine), selective serotonin reuptake inhibitor (SSRI), or tramadol because the risk of severe high blood pressure, irregular heartbeat, high fever, tremors, and seizures may be increased
• Guanadrel or guanethidine because effectiveness may be decreased by Bontril SR Sustained-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bontril SR Sustained-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Bontril SR Sustained-Release Capsules:

Use Bontril SR Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Bontril SR Sustained-Release Capsules about 1 hour before the morning meal.
• Swallow Bontril SR Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of Bontril SR Sustained-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Bontril SR Sustained-Release Capsules.

Important safety information:

• Bontril SR Sustained-Release Capsules may cause dizziness or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Bontril SR Sustained-Release Capsules. Using Bontril SR Sustained-Release Capsules alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Diabetes patients - Bontril SR Sustained-Release Capsules may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Bontril SR Sustained-Release Capsules.
• Bontril SR Sustained-Release Capsules are not recommended for use in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Bontril SR Sustained-Release Capsules, discuss with your doctor the benefits and risks of using Bontril SR Sustained-Release Capsules during pregnancy. It is unknown if Bontril SR Sustained-Release Capsules are excreted in breast milk. If you are or will be breast-feeding while you are using Bontril SR Sustained-Release Capsules, check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, Bontril SR Sustained-Release Capsules may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Bontril SR Sustained-Release Capsules stops working well. Do not take more than prescribed.

When used for longer than a few weeks or at high doses, some people develop a need to continue taking Bontril SR Sustained-Release Capsules. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Bontril SR Sustained-Release Capsules, you may experience WITHDRAWAL symptoms including extreme fatigue and depression.

Possible side effects of Bontril SR Sustained-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include coma; confusion; diarrhea; nausea; panic attack; rapid breathing; seizures; severe restlessness; stomach cramps; tremor; vomiting.

Store Bontril SR Sustained-Release Capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Bontril SR Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Bontril SR Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Bontril SR Sustained-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Bontril SR Sustained-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.