What is the most important information I should know about MERIDIA?
Some people taking MERIDIA can have a large increase in blood pressure or heart rate (pulse). Do
not take MERIDIA if your blood pressure is not well controlled. Contact your doctor if you experience
an increase in blood pressure while taking MERIDIA.
Your doctor should check your blood pressure and heart rate before you start MERIDIA and continue
checking it regularly while you are using MERIDIA. It is important to have regular check-ups while tak-
ing MERIDIA.
What is MERIDIA?
MERIDIA is a medicine that may help obese people, as determined by their doctor, lose weight and
keep weight off. MERIDIA may help with weight loss because it affects areas of the brain that control
hunger. You should use MERIDIA with a low calorie diet.
The use of MERIDIA for more than 2 years has not been studied.
MERIDIA has not been studied in children under 16 years of age.
Who should not take MERIDIA?
Do not take MERIDIA if you:
have uncontrolled or poorly controlled high blood pressure.
are taking or have taken a medicine called a monoamine oxidase inhibitor (MAOI). Ask your doctor or pharmacist if you are not sure if any of your medicines are MAOIs. Do not take MAOIs for at least 2 weeks before using MERIDIA. Do not take MAOIs for at least 2 weeks after stopping MERIDIA.
have an eating disorder called anorexia nervosa or bulimia nervosa.
are taking weight loss medicines to control your appetite.
are allergic to MERIDIA. The active ingredient is sibutramine hydrochloride monohydrate. See the end of this leaflet for a complete list of ingredients in MERIDIA
What should I avoid while taking MERIDIA?
MERIDIA may not be the right medicine for you if you have certain medical conditions. Tell your doctor about all of your medical conditions, especially if you:
have high blood pressure.
have or had heart problems such as a heart attack, heart failure, chest pain or an irregular heart beat.
had a stroke or stroke symptoms.
have liver or kidney problems.
have an eye problem called glaucoma.
have a thyroid problem (hypothyroidism).
have or had seizures (convulsions, fits).
have bleeding problems.
have or had gallstones.
have depression.
are over age 65.
are under age 16.
are pregnant or planning to become pregnant. The effects of MERIDIA on your unborn baby are not known. If you can become pregnant, you should use birth control while taking MERIDIA. Tell your doctor right away if you get pregnant while taking MERIDIA.
are breastfeeding. It is not known if MERIDIA passes into your milk. The effects of MERIDIA on your baby are not known. You should not breastfeed while taking MERIDIA.
Tell your doctor about all the medicines you take, including prescription and non-prescription
medicines, vitamins, and herbal supplements. Taking MERIDIA and certain other medicines may
affect each other and may cause serious and in some cases life-threatening side effects. Make sure
you tell your doctor if you take:
What are the possible side effects of MERIDIA?
Common side effects of MERIDIA include: dry mouth, headache, loss of appetite, trouble sleeping, and constipation.
The following serious side effects have been reported with MERIDIA:
a rare, but life-threatening problem called "serotonin syndrome." It may occur when people take drugs that affect a brain chemical called serotonin along with MERIDIA. Do not take other medicines with MERIDIA unless your doctor has told you it is okay to do so. Get medical help right away if you have any of the following symptoms especially when taking other medicines with MERIDIA:
feel weak, restless, confused, or anxious
lose consciousness
have a fever, vomiting, sweating, shivering or shaking
have a fast heartbeat
Certain weight loss medicines have been associated with a rare, but life-threatening condition that
affects the blood pressure in lungs (pulmonary hypertension). Because the condition is so rare it is
not known if MERIDIA may cause this disease. If you experience new or worsening shortness of
breath notify your doctor immediately.
Tell your doctor if you get a rash or hives while taking MERIDIA. You may be having an allergic reaction.
Tell your doctor if you get effects that bother you or that do not go away.
These are not all the side effects of MERIDIA. For more information, ask your doctor or pharmacist.
MERIDIA is a controlled substance (CIV). This means that MERIDIA can be a target for people who
abuse prescription medicines. Keep your MERIDIA in a safe place. Selling or giving away MERIDIA
is against the law.
How should I store MERIDIA?
Store MERIDIA at room temperature between 59 to 86 F (15 to 30 C). Never leave it in a hot or moist place.
Safely throw away MERIDIA that is out of date or no longer needed.
Keep MERIDIA and all medicines out of reach of children. If your child accidentally takes MERIDIA, call their doctor or Poison Control Center right away, or take your child to the emergency room.
What are the ingredients in MERIDIA?
Active Ingredient: sibutramine hydrochloride monohydrate
Inactive Ingredients: lactose monohydrate, NF; microcrystalline cellulose, NF; colloidal silicon dioxide,
NF; and magnesium stearate, NF in a hard-gelatin capsule [which contains titanium dioxide, USP; gel-
atin; FD&C Blue No. 2 (5- and 10-mg capsules only); D&C Yellow No. 10 (5- and 15-mg capsules only),
and other inactive ingredients].
Dosage and Administration
The recommended starting dose of MERIDIA is 10 mg administered once daily with or without food. If there is inadequate weight loss, the dose may be
titrated after four weeks to a total of 15 mg once daily. The 5 mg dose should be reserved for patients who do not tolerate the 10 mg dose. Blood pressure
and heart rate changes should be taken into account when making decisions regarding dose titration
Doses above 15 mg daily are not recommended. In most of the clinical trials, MERIDIA was given in the morning.
Analysis of numerous variables has indicated that approximately 60% of patients who lose at least 4 pounds in the first 4 weeks of treatment with a given
dose of MERIDIA in combination with a reduced-calorie diet lose at least 5% (placebo-subtracted) of their initial body weight by the end of 6 months to
1 year of treatment on that dose of MERIDIA. Conversely, approximately 80% of patients who do not lose at least 4 pounds in the first 4 weeks of treatment
with a given dose of MERIDIA do not lose at least 5% (placebo-subtracted) of their initial body weight by the end of 6 months to 1 year of treatment on
that dose. If a patient has not lost at least 4 pounds in the first 4 weeks of treatment, the physician should consider reevaluation of therapy which may
include increasing the dose or discontinuation of MERIDIA.
The safety and effectiveness of MERIDIA, as demonstrated in double-blind, placebo-controlled trials, have not been determined beyond 2 years at this time.
