Uses of Phendimetrazine Extended-Release Capsules:

• It is used to treat obesity.

What do I need to tell my doctor BEFORE I take Phendimetrazine Extended-Release Capsules?

• If you have an allergy to phendimetrazine or any other part of this medicine (phendimetrazine extended-release capsules).
• If you are allergic to this medicine (phendimetrazine extended-release capsules); any part of this medicine (phendimetrazine extended-release capsules); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have ever had any of these health problems: Heart disease like heart failure or a heartbeat that is not normal, drug abuse, high blood pressure, or stroke.
• If you have any of these health problems: Glaucoma, agitation, anxiety, or overactive thyroid.
• If you have blood vessel problems.
• If you have high pressure in the lungs.
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are taking another drug for weight loss or have taken one within the last year.
• If the patient is a child. This medicine is not approved for use in children.
• If you are pregnant or may be pregnant. Do not take this medicine (phendimetrazine extended-release capsules) if you are pregnant.
• If you are breast-feeding. Do not breast-feed while you take this medicine (phendimetrazine extended-release capsules).

This is not a list of all drugs or health problems that interact with this medicine (phendimetrazine extended-release capsules).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (phendimetrazine extended-release capsules) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Phendimetrazine Extended-Release Capsules?

• Tell all of your health care providers that you take this medicine (phendimetrazine extended-release capsules). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (phendimetrazine extended-release capsules) affects you.
• If you have been taking this medicine (phendimetrazine extended-release capsules) for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine (phendimetrazine extended-release capsules) stops working well. Do not take more than ordered.
• If you have been taking this medicine (phendimetrazine extended-release capsules) for many weeks, talk with your doctor before stopping. You may want to slowly stop this medicine (phendimetrazine extended-release capsules).
• This medicine may be habit-forming; avoid long-term use. Tell your doctor if you have a history of drug or alcohol abuse.
• Do not take this medicine (phendimetrazine extended-release capsules) for longer than you were told by your doctor.
• You may need to have some heart tests before starting this medicine (phendimetrazine extended-release capsules). If you have questions, talk with your doctor.
• Check blood pressure and heart rate as the doctor has told you.
• If you have high blood sugar (diabetes) and take drugs to lower blood sugar, talk with your doctor. Weight loss may raise the chance of low blood sugar if you take drugs to lower blood sugar. Call your doctor right away if you have signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
• People who take drugs for weight loss like this medicine (phendimetrazine extended-release capsules) may have a higher chance of having raised pressure in the lungs. This is rare but is often deadly. Talk with your doctor.
• Follow the diet and workout plan that your doctor told you about.
• Talk with your doctor before you drink alcohol.

How is this medicine (Phendimetrazine Extended-Release Capsules) best taken?

Use this medicine (phendimetrazine extended-release capsules) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take 30 to 60 minutes before breakfast.
• Swallow whole. Do not chew, break, or crush.

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.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Mood changes.
• Chest pain or pressure or passing out.
• Shortness of breath.
• Blurred eyesight.
• Passing urine more often.
• Trouble passing urine.
• Shakiness.
• Sweating a lot.
• Change in sex interest.
• Some people taking drugs like this one have had heart valve problems. Call your doctor right away if you have dizziness, tiredness, or weakness that will not go away; fast heartbeat or a heartbeat that does not feel normal; swelling in your arms or legs; or trouble breathing.

What are some other side effects of Phendimetrazine Extended-Release Capsules?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Restlessness.
• Trouble sleeping.
• Headache.
• Dry mouth.
• Constipation.
• Stomach pain or diarrhea.
• Upset stomach.
• Flushing.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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.

How do I store and/or throw out Phendimetrazine Extended-Release Capsules?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (phendimetrazine extended-release capsules), please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.