Meridia Sibutramine 10mg

General Information

What is MERIDIA?

MERIDIA (sibutramine hydrochloride monohydrate) is indicated for the management of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet. MERIDIA (sibutramine hydrochloride monohydrate) is recommended for obese patients with an initial body mass index ≥ 30 kg/m², or ≥ 27 kg/m² in the presence of other risk factors (e.g., diabetes, dyslipidemia, controlled hypertension).

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.

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 taking MERIDIA

MERIDIA® (sibutramine hydrochloride monohydrate) is an orally administered agent for the treatment of obesity.

Dosage and Administration

How should I take MERIDIA?

• Take MERIDIA exactly as prescribed. Your doctor may adjust your dose. Do not change your dose unless your doctor tells you to do so.
• You can take MERIDIA with or without food.
• The recommended starting dose of Meridia is 10 mg.
• If you miss a dose of MERIDIA, just skip it. Do not take an extra dose to make up for missed doses.
• If you take too much MERIDIA, call your doctor or Poison Control Center right away, or go to the emergency room.

Tell your doctor if you do not lose at least 4 pounds in the first 4 weeks of taking MERIDIA and eating a low calorie diet. Your doctor may change your dose or stop MERIDIA. MERIDIA does not work for everyone.

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 heartbeat.
• 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.

Do not drive, operate heavy machinery or do other dangerous activities until you know how MERIDIA affects you. 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:

• medicines called MAOIs, see "Who should not take MERIDIA?"
• other weight loss medicines
• cough and cold medicines
• migraine medicines
• depression medicines
• narcotic pain-killers
• lithium
• tryptophan
• medicines that increase bleeding
• antibiotic medicines Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get new medicine. They can tell you if it is okay to take MERIDIA with other medicines.

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 large increase in blood pressure or heart rate in some people. See "What is the most important information I should know about MERIDIA?"

• seizures
• bleeding
• 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.

What other drugs will affect Meridia?

Before using Meridia, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Meridia.

Ask your doctor before taking any decongestants, cough medicine, or other diet pills.

The following drugs can interact with Meridia. Tell your doctor if you are using any of these:

• lithium (Lithobid, Eskalith, and others);
• tryptophan or L-tryptophan;
• ketoconazole (Nizoral);
• an antibiotic such as erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);
• an antidepressant such as citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), fluoxetine (Prozac, Sarafem, Symbyax), paroxetine (Paxil), sertraline (Zoloft), venlafaxine (Effexor), and others;
• ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), ergotamine (Ergomar), or methylergonovine (Methergine).
• migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig); or
• narcotic pain medication such as fentanyl (Actiq, Duragesic, Fentora, Onsolis), meperidine (Demerol), pentazocine (Talwin).

This list is not complete and other drugs may interact with Meridia.

Storage

Store MERIDIA at room temperature between 59° to 86° F (15° to 30° C). Never leave it in a hot or moist place. Keep MERIDIA and all medicines out of reach of children.