Lorcaserin hydrochloride Oral tablet

What is this medicine?

LORCASERIN (lor ca SER in) is used to promote and maintain weight loss in obese patients. This medicine should be used with a reduced calorie diet and, if appropriate, an exercise program.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• anatomical deformation of the penis, Peyronie’s disease, or history of priapism (painful and prolonged erection)

• diabetes

• heart disease

• history of blood diseases, like sickle cell anemia or leukemia

• history of irregular heartbeat

• kidney disease

• liver disease

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• an unusual or allergic reaction to lorcaserin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• cabergoline

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for erectile dysfunction

• certain medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

• dextromethorphan

• linezolid

• lithium

• medicines for diabetes

• other weight loss products

• tramadol

• St. John’s Wort

• stimulant medicines for attention disorders, weight loss, or to stay awake

• tryptophan

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This medicine is intended to be used in addition to a healthy diet and appropriate exercise. The best results are achieved this way. Your doctor should instruct you to stop taking this medicine if you do not lose a certain amount of weight within the first 12 weeks of treatment, but it is important that you do not change your dose in any way without consulting your doctor or health care professional. Visit your doctor or health care professional for regular checkups. Your doctor may order blood tests or other tests to see how you are doing.

Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of treatment or after a change in dose, call your health care professional.

Contact your doctor or health care professional right away if you are a man with an erection that lasts longer than 4 hours or if the erection becomes painful. This may be a sign of serious problem and must be treated right away to prevent permanent damage.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• abnormal production of milk

• breast enlargement in both males and females

• breathing problems

• changes in emotions or moods

• changes in vision

• confusion

• erection lasting more than 4 hours or a painful erection

• fast or irregular heart beat

• feeling faint or lightheaded, falls

• fever or chills, sore throat

• hallucination, loss of contact with reality

• high or low blood pressure

• menstrual changes

• restlessness

• slow or irregular heartbeat

• stiff muscles

• sweating

• suicidal thoughts or other mood changes

• swelling of the ankles, feet, hands

• unusually weak or tired

• vomiting

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• back pain

• constipation

• cough

• dry mouth

• nausea

• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.