"U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration, today seized tainted dietary supplements from Globe All Wellness, LLC (Globe All), in Hollywood, Fla. The products may be unsafe because they contain an undisclosed active "...
(lorcaserin hydrochloride) tablets
Read the Patient Information that comes with BELVIQ before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about BELVIQ, talk to your doctor or pharmacist.
What is BELVIQ?
BELVIQ should be used with a reduced-calorie diet and increased physical activity. It is not known if BELVIQ is safe and effective when taken with other prescription, over-thecounter, or herbal weight loss products.
It is not known if BELVIQ changes your risk of heart problems or stroke or of death due to heart problems or stroke.
It is not known if BELVIQ is safe when taken with some other medicines that treat depression, migraines, mental problems, or the common cold (serotonergic or antidopaminergic agents).
It is not known if BELVIQ is safe and effective in children under 18 years old.
Who should not take BELVIQ?
Do not take BELVIQ if you:
- are pregnant or planning to become pregnant. BELVIQ may harm your unborn baby.
What should I tell my healthcare provider before taking BELVIQ?
Before you take BELVIQ, tell your doctor if you:
- have or have had heart problems including:
- congestive heart failure
- heart valve problems
- slow heart beat or heart block
- have diabetes
- have a condition such as sickle cell anemia, multiple myeloma, or leukemia
- have a deformed penis, Peyronie's disease, or ever had an erection that lasted more than 4 hours
- have kidney problems
- have liver problems
- are pregnant or plan to become pregnant.
- are breast feeding or plan to breastfeed. It is not known if BELVIQ passes into your breastmilk. You and your doctor should decide if you will take BELVIQ or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
BELVIQ may affect the way other medicines work, and other medicines may affect how BELVIQ works.
Especially tell your doctor if you take medicines for depression, migraines or other medical conditions such as:
- triptans, used to treat migraine headache
- medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, selective serotonin uptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), or antipsychotics
- linezolid, an antibiotic
- dextromethorphan, an over-the-counter medicine used to treat the common cold or cough
- Rver-the-counter supplements such as tryptophan or St. John's Wort
- medicines to treat erectile dysfunction
Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
Know all the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I take BELVIQ?
- Take BELVIQ exactly as your doctor tells you to take it.
- Your doctor will tell you how much BELVIQ to take and when
to take it.
- Take 1 tablet 2 times each day.
- Do not increase your dose of BELVIQ.
- BELVIQ can be taken with or without food.
- Your doctor should start you on a diet and exercise program when you start taking BELVIQ. Stay on this program while you are taking BELVIQ.
- Your doctor should tell you to stop taking BELVIQ if you do not lose a certain amount of weight within the first 12 weeks of treatment.
- If you take too much BELVIQ or overdose, call your doctor or go to the nearest emergency room right away.
What should I avoid while taking BELVIQ?
- Do not drive a car or operate heavy machinery until you know how BELVIQ affects you. BELVIQ can slow your thinking.
What are the possible side effects of BELVIQ?
BELVIQ may cause serious side effects, including:
- Serotonin Syndrome or Neuroleptic Malignant Syndrome
BELVIQ and certain medicines for depression, migraine, the common cold, or other medical problems may affect each other causing serious or life-threatening side effects. Call your doctor right away if you start to have any of the following symptoms while taking BELVIQ:
- mental changes such as agitation, hallucinations, confusion, or other changes in mental status
- coordination problems, uncontrolled muscle spasms, or muscle twitching (overactive reflexes)
- racing or fast heart beat, high or low blood pressure
- sweating or fever
- nausea, vomiting, or diarrhea
- muscle rigidity (stiff muscles)
- Valvular heart disease. Some people taking medicines
like BELVIQ have had problems with the valves in their heart. Call your doctor
right away if you have any of the following symptoms while taking BELVIQ:
- trouble breathing
- swelling of the arms, legs, ankles, or feet
- dizziness, fatigue, or weakness that will not go away
- fast or irregular heartbeat
- Changes in your attention or memory.
- Mental problems. Taking BELVIQ in high doses may
cause psychiatric problems such as:
- feeling high or in a very good mood (euphoria)
- feelings of standing next to yourself or out of your body (disassociation)
- Depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
- Low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus. Weight loss can cause low blood sugar in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus (such as insulin or sulfonylureas). You should check your blood sugar before you start taking BELVIQ and while you take BELVIQ.
- Painful erections (priapism). The medicine in BELVIQ can cause painful erections that last more than 6 hours. If you have an erection lasting more than 4 hours whether it is painful or not, stop using BELVIQ and call your doctor or go to the nearest emergency room right away.
- Slow heart beat. BELVIQ may cause your heart to beat slower. Tell your doctor if you have a history of your heart beating slow or heart block.
- Decreases in your blood cell count. BELVIQ may cause your red and white blood cell count to decrease. Your doctor may do tests to check your blood cell count while you are taking BELVIQ.
- Increase in prolactin. The medicine in BELVIQ may increase the amount of a certain hormone your body makes called prolactin. Tell your doctor if your breasts begin to make milk or a milky discharge or if you are a male and your breasts begin to increase in size.
The most common side effects of BELVIQ include:
- dry mouth
- low blood sugar (hypoglycemia) in patients with diabetes
- back pain
Tell to your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of BELVIQ. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.
How do I store BELVIQ?
Store BELVIQ at room temperature between 59°F to 86°F (15°C to 30°C).
Safely throw away medicine that is out of date or no longer need.
Keep BELVIQ and all medicines out of the reach of children.
General information about the safe and effective use of BELVIQ.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BELVIQ for a condition for which it was not prescribed. Do not give BELVIQ to other people, even if they have the same symptoms you have. It may harm them.
This Patient Information leaflet summarizes the most important information about BELVIQ. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about BELVIQ that is written for health professionals.
For more information, go to www.BELVIQ.com Website or call 1-888-274-2378.
What are the ingredients in BELVIQ?
Active Ingredient: lorcaserin hydrochloride
Inactive Ingredients: silicified microcrystalline cellulose; hydroxypropyl cellulose NF; croscarmellose sodium NF; colloidal silicon dioxide NF; polyvinyl alcohol USP; polyethylene glycol NF; titanium dioxide USP; talc USP; FD&C Blue #2 aluminum lake; and magnesium stearate NF.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 7/5/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Belviq Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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