英文药名: Meridia(sibutramine capsules) 中文药名: 西布曲明胶囊和片剂 品牌药生产厂家: Abbott 药物名称 商品名称：曲美 通用名称：盐酸西布曲明胶囊(运动员慎用) 本品适用于饮食控制、运动不能减轻和控制体重的肥胖症治疗，包括减轻体重和维持体重的减轻，治疗应与低热量饮食和运动结合进行。 化学名：（±）N-｛1-[1-（4-氯苯基）环丁基]-3-甲基丁基｝-N，N-二甲胺盐酸盐-水合物,分子量：334.33 【性状】本品为胶囊剂，内容物为白色或类白色粉末。 药理作用 本品为作用于中枢的肥胖症治疗药。主要通过其胺类（仲胺和伯胺类）代谢产物而产生作用，其主要机理为抑制去甲肾上腺素、5-羟色胺和多巴胺的再摄取而增强饱食感，而对去甲肾上腺素、5-羟色胺和多巴胺的释放无明显影响。研究还表明，本品及其胺类活性代谢产物无明显抗胆碱、抗组胺和单胺氧化酶抑制作用。 吸收、分布、消除：据资料报道，口服盐酸西布曲明后迅速在消化道吸收，血药浓度达峰时间为1.2小时，口服清除率1750L/h，半衰期为1.1小时。单次服药平均最少可吸收77%。盐酸西布曲明经肝脏首过效应，体外试验表明，动物放射标记实验表明药物可迅速、广泛地分布到组织中，浓度最高的为清除器官：肝和肾。单次服药后大约85%（68?95%）的放射剂量由尿和粪便排泄。 适应症 盐酸西布曲明适用于饮食控制、运动不能减轻和控制体重的肥胖症治疗，包括减轻体重和维持体重的减轻，治疗应与低热量饮食和运动结合进行。推荐用于治疗体重指数≥30?/?或≥27?/?（有其它危险因素如高血压、糖尿病、血脂异常等）的肥胖症患者。 用法与用量 推荐起始剂量为每天服药一次，每次10mg，可于早晨单独服用或与食物同服。如体重减轻不足，4周后剂量可调整至每天15mg。若病人无法耐受10mg剂量，可降至5mg。应根据患者的血压、心率情况调整剂量。不推荐使用15mg/日以上的剂量。 如果您有任何疑问，请遵医嘱。 包装规格： Meridia (sibutramine hydrochloride monohydrate) Capsules (WEIGHT LOSS) DRUG DESCRIPTION MERIDIA® (sibutramine hydrochloride monohydrate) is an orally administered agent for the treatment of obesity. Chemically, the active ingredient is a racemic mixture of the (+) and (-) enantiomers of cyclobutanemethanamine, 1-(4-chlorophenyl)-N,N-dimethyl-α-(2-methylpropyl)-, hydrochloride, monohydrate, and has an empirical formula of C17H29Cl2NO. Its molecular weight is 334.33. The structural formula is shown below: Sibutramine hydrochloride monohydrate is a white to cream crystalline powder with a solubility of 2.9 mg/mL in pH 5.2 water. Its octanol: water partition coefficient is 30.9 at pH 5.0. Each MERIDIA capsule contains 5 mg, 10 mg, and 15 mg of sibutramine hydrochloride monohydrate. It also contains as 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; gelatin; 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]. INDICATIONS MERIDIA 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 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). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patient's weight, in kg, and dividing by the patient's height, in meters, squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. 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 (see PRECAUTIONS). 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. SIDE EFFECTS In placebo-controlled studies, 9% of patients treated with sibutramine (n = 2068) and 7% of patients treated with placebo (n = 884) withdrew for adverse events. In placebo-controlled studies, the most common events were dry mouth, anorexia, insomnia, constipation and headache. Adverse events in these studies occurring in ≥ 1% of sibutramine treated patients and more frequently than in the placebo group are shown in the following table. The following additional adverse events were reported in ≥ 1% of all patients who received sibutramine in controlled and uncontrolled pre-marketing studies. Body as a Whole fever. Digestive System diarrhea, flatulence, gastroenteritis, tooth disorder. Metabolic and Nutritional peripheral edema. Musculoskeletal System arthritis. Nervous System agitation, leg cramps, hypertonia, thinking abnormal. Respiratory System bronchitis, dyspnea. Skin and Appendages pruritusiri. Special Senses amblyopia. Urogenital System menstrual disorders. Other Adverse Events Clinical Studies Seizures Convulsions were reported as an adverse event in three of 2068 (0.1%) sibutramine treated patients and in none of 884 placebo-treated patients in placebo-controlled premarketing obesity studies. Two of the three patients with seizures had potentially predisposing factors (one had a prior history of epilepsy; one had a subsequent diagnosis of brain tumor). The incidence in all subjects who received sibutramine (three of 4,588 subjects) was less than 0.1%. Ecchymosis/Bleeding Disorders Ecchymosis (bruising) was observed in 0.7% of sibutramine treated patients and in 0.2% of placebo-treated patients in pre-marketing placebo-controlled obesity studies. One patient had prolonged bleeding of a small amount which occurred during minor facial surgery. Sibutramine may have an effect on platelet function due to its effect on serotonin uptake. Interstitial Nephritis Acute interstitial nephritis (confirmed by biopsy) was reported in one obese patient receiving sibutramine during pre-marketing studies. After discontinuation of the medication, dialysis and oral corticosteroids were administered; renal function normalized. The patient made a full recovery. Altered Laboratory Findings Abnormal liver function tests, including increases in AST, ALT, GGT, LDH, alkaline phosphatase and bilirubin, were reported as adverse events in 1.6% of sibutramine-treated obese patients in placebo-controlled trials compared with 0.8% of placebo patients. In these studies, potentially clinically significant values (total bilirubin ≥ 2 mg/dL; ALT, AST, GGT, LDH, or alkaline phosphatase ≥ 3 × upper limit of normal) occurred in 0% (alkaline phosphatase) to 0.6% (ALT) of the sibutramine treated patients and in none of the placebo-treated patients. Abnormal values tended to be sporadic, often diminished with continued treatment, and did not show a clear dose-response relationship. Postmarketing Reports Voluntary reports of adverse events temporally associated with the use of sibutramine are listed below. It is important to emphasize that although these events occurred during treatment with sibutramine, they may have no causal relationship with the drug. Obesity itself, concurrent disease states/risk factors, or weight reduction may be associated with an increased risk for some of these events. Psychiatric Cases of depression, suicidal ideation and suicide have been reported rarely in patients on sibutramine treatment. However, a relationship has not been established between the occurrence of depression and/or suicidal ideation and the use of sibutramine. If depression occurs during treatment with sibutramine, further evaluation may be necessary. Hypersensitivity Allergic hypersensitivity reactions ranging from mild skin eruptions and urticaria to angioedema and anaphylaxis have been reported (see PRECAUTIONS-Information For Patients, and other reports of allergic reactions listed below). Other Postmarketing Reported Events: Body as a Whole anaphylactic shock, anaphylactoid reaction, chest pressure, chest tightness, facial edema, limb pain, sudden unexplained death. Cardiovascular System angina pectoris, atrial fibrillation, congestive heart failure, heart arrest, heart rate decreased, myocardial infarction, supraventricular tachycardia, syncope, torsade de pointes, vascular headache, ventricular tachycardia, ventricular extrasystoles, ventricular fibrillation. Digestive System cholecystitis, cholelithiasis, duodenal ulcer, eructation, gastrointestinal hemorrhage, increased salivation, intestinal obstruction, mouth ulcer, stomach ulcer, tongue edema. Endocrine System goiter, hyperthyroidism, hypothyroidism. Hemic and Lymphatic System anemia, leukopenia, lymphadenopathy, petechiae, thrombocytopenia. Metabolic and Nutritional hyperglycemia, hypoglycemia. Musculoskeletal System arthrosis, bursitis. Nervous System abnormal dreams, abnormal gait, amnesia, anger, cerebrovascular accident, concentration impaired, confusion, depression aggravated, Gilles de la Tourette's syndrome, hypesthesia, libido decreased, libido increased, manic reaction, mood changes, nightmares, serotonin syndrome, short term memory loss, speech disorder, transient ischemic attack, tremor, twitch, vertigo. Respiratory System epistaxis, nasal congestion, respiratory disorder, yawn. Skin and Appendages alopecia, dermatitis, photosensitivity (skin), urticaria. Special Senses abnormal vision, blurred vision, dry eye, eye pain, increased intraocular pressure, otitis externa, otitis media, photosensitivity (eyes), tinnitus. Urogenital System abnormal ejaculation, hematuria, impotence, increased urinary frequency, micturition difficulty, urinary retention. Drug Abuse And Dependence Controlled Substance MERIDIA is controlled in Schedule IV of the Controlled Substances Act (CSA). Abuse and Physical and Psychological Dependence Physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., drug development of tolerance, incrementation of doses, drug seeking behavior). DRUG INTERACTIONS CNS Active Drugs: The use of MERIDIA in combination with other CNS-active drugs, particularly serotonergic agents, has not been systematically evaluated. Consequently, caution is advised if the concomitant administration of MERIDIA with other centrally-acting drugs is indicated. In patients receiving monoamine oxidase inhibitors (MAOIs) (e.g., phenelzine, selegiline) in combination with serotonergic agents (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine), there have been reports of serious, sometimes fatal, reactions ("serotonin syndrome;" see below). Because sibutramine inhibits serotonin reuptake, MERIDIA should not be used concomitantly with a MAOI. At least 2 weeks should elapse between discontinuation of a MAOI and initiation of treatment with MERIDIA. Similarly, at least 2 weeks should elapse between discontinuation of MERIDIA and initiation of treatment with a MAOI. The rare, but serious, constellation of symptoms termed "serotonin syndrome" has also been reported with the concomitant use of selective serotonin reuptake inhibitors and agents for migraine therapy, such as Imitrex® (sumatriptan succinate) and dihydroergotamine, certain opioids, such as dextromethorphan, meperidine, pentazocine and fentanyl, lithium, or tryptophan. Serotonin syndrome has also been reported with the concomitant use of two serotonin reuptake inhibitors. The syndrome requires immediate medical attention and may include one or more of the following symptoms: excitement, hypomania, restlessness, loss of consciousness, confusion, disorientation, anxiety, agitation, motor weakness, myoclonus, tremor, hemiballismus, hyperreflexia, ataxia, dysarthria, incoordination, hyperthermia, shivering, pupillary dilation, diaphoresis, emesis, and tachycardia. Because sibutramine inhibits serotonin reuptake, in general, it should not be administered with other serotonergic agents such as those listed above. However, if such a combination is clinically indicated, appropriate observation of the patient is warranted. Drugs That May Raise Blood Pressure and/or Heart Rate Concomitant use of MERIDIA and other agents that may raise blood pressure or heart rate have not been evaluated. These include certain decongestants, cough, cold, and allergy medications that contain agents such as ephedrine, or pseudoephedrine. Caution should be used when prescribing MERIDIA to patients who use these medications. Alcohol In a double-blind, placebo-controlled, crossover study in 19 volunteers, administration of a single dose of ethanol (0.5 mL/kg) together with 20 mg of sibutramine resulted in no psychomotor interactions of clinical significance between alcohol and sibutramine. However, the concomitant use of MERIDIA and excess alcohol is not recommended. Oral Contraceptives The suppression of ovulation by oral contraceptives was not inhibited by sibutramine. In a crossover study, 12 healthy female volunteers on oral steroid contraceptives received placebo in one period and 15 mg sibutramine in another period over the course of 8 weeks. No clinically significant systemic interaction was observed; therefore, no requirement for alternative contraceptive precautions are needed when patients taking oral contraceptives are concurrently prescribed sibutramine. PRECAUTIONS Pulmonary Hypertension Certain centrally-acting weight loss agents that cause release of serotonin from nerve terminals have been associated with pulmonary hypertension (PPH), a rare but lethal disease. In pre-marketing clinical studies, no cases of PPH have been reported with sibutramine capsules. Because of the low incidence of this disease in the underlying population, however, it is not known whether or not MERIDIA may cause this disease. Seizures During premarketing testing, seizures were reported in < 0.1% of sibutramine treated patients. MERIDIA should be used cautiously in patients with a history of seizures. It should be discontinued in any patient who develops seizures. Bleeding There have been reports of bleeding in patients taking sibutramine. While a causal relationship is unclear, caution is advised in patients predisposed to bleeding events and those taking concomitant medications known to affect hemostasis or platelet function. Gallstones Weight loss can precipitate or exacerbate gallstone formation. Renal Impairment MERIDIA should be used with caution in patients with mild to moderate renal impairment. MERIDIA should not be used in patients with severe renal impairment, including those with end stage renal disease on dialysis. Hepatic Dysfunction Patients with severe hepatic dysfunction have not been systematically studied; MERIDIA should therefore not be used in such patients. Interference With Cognitive and Motor Performance Although sibutramine did not affect psychomotor or cognitive performance in healthy volunteers, any CNS active drug has the potential to impair judgment, thinking or motor skills. Information For Patients Physicians should instruct their patients to read the patient package insert before starting therapy with MERIDIA and to reread it each time the prescription is renewed. Physicians should also discuss with their patients any part of the package insert that is relevant to them. In particular, the importance of keeping appointments for follow-up visits should be emphasized. Patients should be advised to notify their physician if they develop a rash, hives, or other allergic reactions. Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, especially weight-reducing agents, decongestants, antidepressants, cough suppressants, lithium, dihydroergotamine, sumatriptan (Imitrex®), or tryptophan, since there is a potential for interactions. Patients should be reminded of the importance of having their blood pressure and pulse monitored at regular intervals. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity Sibutramine was administered in the diet to mice (1.25, 5 or 20 mg/kg/day) and rats (1, 3, or 9 mg/kg/day) for two years generating combined maximum plasma AUC's of the two major active metabolites equivalent to 0.4 and 16 times, respectively, those following a daily human dose of 15 mg. There was no evidence of carcinogenicity in mice or in female rats. In male rats there was a higher incidence of benign tumors of the testicular interstitial cells; such tumors are commonly seen in rats and are hormonally mediated. The relevance of these tumors to humans is not known. Mutagenicity Sibutramine was not mutagenic in the Ames test, in vitro Chinese hamster V79 cell mutation assay, in vitro clastogenicity assay in human lymphocytes or micronucleus assay in mice. Its two major active metabolites were found to have equivocal bacterial mutagenic activity in the Ames test. However, both metabolites gave consistently negative results in the in vitro Chinese hamster V79 cell mutation assay, in vitro clastogenicity assay in human lymphocytes, in vitro DNA-repair assay in HeLa cells, micronucleus assay in mice and in vivo unscheduled DNA-synthesis assay in rat hepatocytes. Impairment of Fertility In rats, there were no effects on fertility at doses generating combined plasma AUC's of the two major active metabolites up to 32 times those following a human dose of 15 mg. At 13 times the human combined AUC, there was maternal toxicity, and the dams' nest-building behavior was impaired, leading to a higher incidence of perinatal mortality; there was no effect at approximately 4 times the human combined AUC. Pregnancy Teratogenic Effects Pregnancy Category C Radiolabeled studies in animals indicated that tissue distribution was unaffected by pregnancy, with relatively low transfer to the fetus. In rats, there was no evidence of teratogenicity at doses of 1, 3, or 10 mg/kg/day generating combined plasma AUC's of the two major active metabolites up to approximately 32 times those following the human dose of 15 mg. In rabbits dosed at 3, 15, or 75 mg/kg/day, plasma AUC's greater than approximately 5 times those following the human dose of 15 mg caused maternal toxicity. At markedly toxic doses, Dutch Belted rabbits had a slightly higher than control incidence of pups with a broad short snout, short rounded pinnae, short tail and, in some, shorter thickened long bones in the limbs; at comparably high doses in New Zealand White rabbits, one study showed a slightly higher than control incidence of pups with cardiovascular anomalies while a second study showed a lower incidence than in the control group. No adequate and well controlled studies with sibutramine have been conducted in pregnant women. The use of MERIDIA during pregnancy is not recommended. Women of childbearing potential should employ adequate contraception while taking MERIDIA. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant while taking MERIDIA. Nursing Mothers It is not known whether sibutramine or its metabolites are excreted in human milk. MERIDIA is not recommended for use in nursing mothers. Patients should be advised to notify their physician if they are breast-feeding. Pediatric Use The efficacy of sibutramine in adolescents who are obese has not been adequately studied. Sibutramine's mechanism of action inhibiting the reuptake of serotonin and norepinephrine is similar to the mechanism of action of some antidepressants. Pooled analyses of short-term placebo-controlled trials of antidepressants in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), and other psychiatric disorders have revealed a greater risk of adverse events representing suicidal behavior or thinking during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No placebo-controlled trials of sibutramine have been conducted in children or adolescents with MDD, OCD, or other psychiatric disorders. In a study of adolescents with obesity in which 368 patients were treated with sibutramine and 130 patients with placebo, one patient in the sibutramine group and one patient in the placebo group attempted suicide. Suicidal ideation was reported by 2 sibutramine-treated patients and none of the placebo patients. It is unknown if sibutramine increases the risk of suicidal behavior or thinking in pediatric patients. The data are inadequate to recommend the use of sibutramine for the treatment of obesity in pediatric patients. Geriatric Use Clinical studies of sibutramine did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Pharmacokinetics in elderly patients are discussed in "CLINICAL PHARMACOLOGY." PATIENT INFORMATION MERIDIA® (mer-ID-dee-uh) (sibutramine hydrochloride monohydrate) Capsules CS-IV Read the Patient Information that comes with MERIDIA before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment. 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. 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. 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. 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. 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 migrraine 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. 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. General information about MERIDIA. Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use MERIDIA for a condition for which it was not prescribed. Do not give MERIDIA to other people, even if they have the same symptoms you have. It may harm them and it is against the law. This leaflet summarizes the most important information about MERIDIA. If you would like more information, talk to your doctor. You can also ask your doctor or pharmacist for information that is written for health professionals. For more information call Abbott Laboratories at 1-800-633-9110 or visit www.Meridia.net. 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; gelatin; 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]. STORAGE Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP controlled room temperature]. Protect capsules from heat and moisture. Dispense in a tight, light-resistant container as defined in USP.