IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

LORCASERIN – ORAL

(lor-KA-ser-in)

COMMON BRAND NAME(S): Belviq

USES: Lorcaserin is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life. Lorcaserin belongs to a class of drugs known as serotonin receptor agonists. It is thought to work by affecting a certain part of the brain that helps control your appetite.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking lorcaserin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually 2 times each day. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Lorcaserin may be habit forming. Do not increase your dose or take this drug more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

If you do not lose a certain amount of weight within the first 12 weeks of treatment, you may not benefit from taking this medication and your doctor may direct you to stop taking it. Talk to your doctor for details.

SIDE EFFECTS: Nausea, dry mouth, headache, dizziness, constipation, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, enlarged breasts or abnormal breast milk production, mental/mood changes (such as confusion, depression, thoughts of suicide, unusual agitation, difficulty with attention/memory), shaking/twitching muscles, shortness of breath, slow/fast/irregular heartbeat, swelling ankles/feet/hands, unexplained fever.

If you are taking medication to treat diabetes, lorcaserin can increase your risk for low blood sugar (hypoglycemia). Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. Tell your doctor immediately about the reaction and the use of this product. Your doctor may need to adjust your medication(s).

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Side Effects section.

Before taking lorcaserin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (such as heart valve disease, heart failure, slow heartbeat, heart block), kidney problems, liver problems, conditions that can increase the risk of prolonged/painful erections in men (such as Peyronie’s disease, deformed penis, sickle cell anemia, multiple myeloma, leukemia).

This drug may make you dizzy or slow your thinking. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you have diabetes, this product may affect your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of low blood sugar (see Side Effects section). Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include dextromethorphan, among others.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: hallucinations, feeling “high,” feelings of standing next to yourself (disassociation).

NOTES: Do not share this medication with others. It is against the law and may cause harm. Keep this medicine in a safe place to prevent theft, misuse, or abuse.

Laboratory and/or medical tests (such as complete blood count, prolactin levels) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised April 2015. Copyright(c) 2015 First Databank, Inc.