Bontril PDM

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Phendimetrazine should be taken only for a short time, such as a few weeks.

Phendimetrazine is usually taken once daily. Follow your doctor's instructions.

Take phendimetrazine on an empty stomach, 30 to 60 minutes before your morning meal.

Do not crush, chew, break, or open the extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You should lose at least 4 pounds during the first 4 weeks of taking phendimetrazine and eating a low calorie diet. Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks.

Do not stop using phendimetrazine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using phendimetrazine.

Never take more of this medication than is prescribed for you. Too much phendimetrazine could be very dangerous to your health. Talk with your doctor if you have increased hunger or if you otherwise think the medication is not working properly. Taking more of this medication will not make it more effective and can cause serious, life-threatening side effects.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of phendimetrazine can be fatal.

Overdose symptoms of a phendimetrazine overdose include nausea, vomiting, diarrhea, stomach cramps, confusion, panic, hallucinations, extreme restlessness, feeling tired or depressed, ringing in your ears, chest pain, slow heart rate, weak pulse, fainting, seizure, or slow breathing (breathing may stop).

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.

A dose taken too late in the day will cause insomnia.

Contraindications

Hypersensitivity

History of cardiovascular disease (eg, coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension, pulmonary hypertension)

Hyperthyroidism

Glaucoma

Agitated states

History of drug abuse

Pregnancy

Breast feeding

Coadministration with other anorectic agents or CNS stimulants

Do not administer within 14 days of administration of MAO inhibitors

Cautions

Impairs ability to drive or operate heavy machinery

Primary pulmonary hypertension associated with treatment

Use with other anorectic agents

Possibility of addiction

Caution advised; increased exposure expected when administered to patients with renal impairment; excreted in urine

Pregnancy Category: X; weight loss offers no potential benefit to a pregnant woman and may result in fetal harm; a minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese

Lactation: Contraindicated; do not nurse if taking this drug

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of phendimetrazine can be fatal.

Overdose symptoms of a phendimetrazine overdose include nausea, vomiting, diarrhea, stomach cramps, confusion, panic, hallucinations, extreme restlessness, feeling tired or depressed, ringing in your ears, chest pain, slow heart rate, weak pulse, fainting, seizure, or slow breathing (breathing may stop).

Tell your doctor about all other medicines you use, especially:

• insulin or oral diabetes medications;

• certain blood pressure medications, such as doxazosin (Cardura), prazosin (Minipress), or terazosin (Hytrin); or

• any other diet pills.

This list is not complete and other drugs may interact with phendimetrazine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

In the U.S.

• Bontril
• Bontril PDM
• Bontril Slow-Release
• Melfiat
• Obezine
• Phendiet
• Phendiet-105
• Prelu-2

Available Dosage Forms:

• Tablet
• Capsule
• Capsule, Extended Release

Therapeutic Class: Appetite Suppressant, Centrally Acting

Chemical Class: Phendimetrazine

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

Take this medicine only 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. If too much is taken, it may become habit-forming (causing mental or physical dependence).

This medicine is available in 3 forms: extended-release capsules, slow-release capsules, and tablets. Ask your doctor which dosage form is right for you.

Swallow the extended-release capsule whole. Do not crush, break, or chew it.

Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. Talk with your doctor before starting any exercise program.

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 weight loss:
  • For oral dosage form (extended-release capsules):
    • Adults and teenagers 17 years of age and older—One capsule or 105 milligrams (mg) once a day, taken 30 to 60 minutes before the morning meal.
    • Children younger than 17 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (slow-release capsules):
    • Adults and teenagers—One capsule or 105 milligrams (mg) once a day, taken 30 to 60 minutes before the morning meal.
    • Children younger than 12 years of age—Use is not recommended.
  • For oral dosage form (tablets):
    • Adults—One tablet or 35 milligrams (mg) two or three times a day, taken one hour before meals. Your doctor may adjust your dose as needed. However, the dose is usually not more than 2 tablets three times a day.
    • 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

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

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.

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

• Take 1 hour before meals.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Applies to phendimetrazine: oral capsule, oral capsule extended release, oral tablet

Along with its needed effects, phendimetrazine (the active ingredient contained in Bontril PDM) 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 phendimetrazine:

• Seeing, hearing, or feeling things that are not there
• severe mental changes

• Anxiety
• burning while urinating
• chest pain or discomfort
• decreased ability to exercise
• difficult or painful urination
• dizziness
• dry mouth
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• headache
• hyperventilation
• increased need to urinate
• irritability
• nausea
• numbness or tingling in the arms or legs
• pain or discomfort in the arms, jaw, back, or neck
• passing urine more often
• redness of the face, neck, arms, and occasionally, upper chest
• restlessness
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• sweating
• swelling of the feet or lower legs
• trembling or shaking of the hands or feet
• trouble with breathing
• trouble with sleeping
• trouble with thinking, speaking, or walking
• vomiting
• weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking phendimetrazine:

• Abdominal or stomach cramps
• blurred vision
• change in consciousness
• convulsions
• diarrhea
• discouragement
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, slow, or irregular heartbeat
• feeling sad or empty
• lack of appetite
• lightheadedness
• loss of consciousness
• loss of interest or pleasure
• overactive reflexes
• panic
• physical attempt to injure
• pounding in the ears
• rapid breathing
• sweating
• tiredness
• trouble with concentrating
• unusual tiredness or weakness
• violent actions

Some side effects of phendimetrazine 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:

• Decreased interest in sexual intercourse
• difficulty having a bowel movement (stool)
• inability to have or keep an erection
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• loss in sexual ability, desire, drive, or performance
• sleeplessness
• stomach pain
• unable to sleep