Inside, 1 time per day, in the morning, without chewing and drinking a sufficient amount of liquid (a glass of water). The drug can be taken both on an empty stomach and combined with food intake.

The dose is set individually, depending on tolerance and clinical efficacy. The recommended starting dose is 10 mg, with poor tolerance, 5 mg may be taken. If, within 4 weeks from the start of treatment, a decrease in body weight of less than 2 kg is achieved, then the dose is increased to 15 mg / day.

Treatment with Reduxin® should not last more than 3 months in patients who do not respond well enough to therapy, i.e. who, within 3 months of treatment, fail to achieve a decrease in body weight by 5% of the initial indicator. Treatment should not be continued if, with further therapy, after the achieved weight loss, the patient's body weight increases by 3 kg or more.

The duration of treatment should not exceed 1 year, since there are no data on efficacy and safety for a longer period of taking sibutramine.

Treatment with Reduxin® should be carried out in combination with diet and exercise under the supervision of a physician with practical experience in the treatment of obesity.

  Application during pregnancy and lactation:

Since until now there is not a sufficiently large number of studies regarding the safety of the effect of sibutramine on the fetus, this drug is contraindicated during pregnancy.

Women of reproductive age should use contraceptives while taking Reduxin®.

It is contraindicated to take Reduxin® while breastfeeding.

Established hypersensitivity to sibutramine or other components of the drug;

the presence of organic causes of obesity (for example, hypothyroidism);

severe eating disorders (anorexia nervosa or bulimia nervosa);

mental illness;

Gilles de la Tourette's syndrome (generalized tics);

simultaneous administration of MAO inhibitors (for example, phentermine, fenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or their use within 2 weeks before taking the drug Reduxin® and 2 weeks after the end of its administration; other drugs that act on the central nervous system that inhibit serotonin reuptake (for example, antidepressants), antipsychotics, hypnotics containing tryptophan, as well as other centrally acting drugs for reducing body weight or for treating mental disorders;

cardiovascular diseases (in history and at present): ischemic heart disease (myocardial infarction (MI), angina pectoris); chronic heart failure in the stage of decompensation, occlusive peripheral arterial diseases, tachycardia, arrhythmia, cerebrovascular diseases (stroke, transient cerebrovascular accident);

uncontrolled arterial hypertension (blood pressure above 145/90 mm Hg - see also "Special instructions");

thyrotoxicosis;

severe impairment of liver and / or kidney function;

benign prostatic hyperplasia;

pheochromocytoma;

angle-closure glaucoma;

established pharmacological, drug or alcohol dependence;

pregnancy;

lactation period;

age under 18 and over 65.

With care: history of arrhythmia, chronic circulatory failure, coronary artery disease (including history), except for coronary heart disease (MI, angina pectoris); glaucoma, except for angle-closure glaucoma, cholelithiasis, arterial hypertension (controlled and in history), neurological disorders, including mental retardation and seizures (including in history), epilepsy, impaired liver and / or kidney function of mild to moderate severity , a history of motor and verbal tics, a tendency to bleeding, bleeding disorders, taking medications that affect hemostasis or platelet function.

Most often, side effects occur at the beginning of treatment (in the first 4 weeks). Their severity and frequency diminish over time. Side effects are generally mild and reversible. Side effects, depending on the effect on organs and organ systems, are presented in the following order: very often (≥10%); often (≥1%, but <10%).

From the side of the central nervous system: very often - dry mouth and insomnia; often - headache, dizziness, anxiety, paresthesia, and taste changes.

From the CVS: often - tachycardia, palpitations, increased blood pressure, vasodilation.

There is a moderate rise in blood pressure at rest by 1-3 mm Hg. Art. and a moderate increase in heart rate by 3–7 beats / min. In some cases, more pronounced increases in blood pressure and heart rate are not excluded. Clinically significant changes in blood pressure and heart rate are recorded mainly at the beginning of treatment (in the first 4–8 weeks).

Use of the drug Reduxin® in patients with high blood pressure: see "Contraindications" and "Special instructions".

On the part of the digestive system: very often - loss of appetite and constipation, often - nausea and exacerbation of hemorrhoids. With a tendency to constipation in the early days, it is necessary to control the evacuation function of the intestine. If constipation occurs, they stop taking and take a laxative.

On the part of the skin: often - increased sweating. In isolated cases, during the treatment with sibutramine, the following undesirable clinically significant phenomena have been described: dysmenorrhea, edema, flu-like syndrome, itching of the skin, back pain, abdominal pain, paradoxical increase in appetite, thirst, rhinitis, depression, drowsiness, emotional lability, anxiety, irritability, nervousness, acute interstitial nephritis, bleeding, Shenlein-Henoch purpura (bleeding into the skin), convulsions, thrombocytopenia, transient increase in the activity of hepatic enzymes in the blood.

In the course of post-marketing studies, additional adverse reactions listed below have been described for organ systems:

From the CCC side: atrial fibrillation.

From the immune system: hypersensitivity reactions (from mild skin rashes and urticaria to angioedema (angioedema) and anaphylaxis).

Mental disorders: psychosis, states of suicidal thinking, suicide and mania. If such conditions occur, the drug must be canceled.

From the nervous system: convulsions, short-term memory impairment.

From the side of the organ of vision: blurred vision (veil before the eyes).

From the digestive system: diarrhea, vomiting.

On the part of the skin and subcutaneous tissue: alopecia.

From the kidneys and urinary tract: urinary retention.

From the reproductive system: ejaculation / orgasm disorders, impotence, menstrual irregularities, uterine bleeding.

Microsomal oxidation inhibitors, incl. inhibitors of the isoenzyme CYP3A4 (including ketoconazole, erythromycin, cyclosporine), increase the plasma concentration of sibutramine metabolites with an increase in heart rate and a clinically insignificant increase in the QT interval.

Rifampicin, macrolide antibiotics, phenytoin, carbamazepine, phenobarbital and dexamethasone can speed up the metabolism of sibutramine. The simultaneous use of several drugs that increase the level of serotonin in the blood plasma can lead to the development of a serious interaction. In rare cases, with the simultaneous use of the drug Reduxin® with SSRIs (drugs for the treatment of depression), some drugs for the treatment of migraines (sumatriptan, dihydroergotamine), potent analgesics (pentazocine, pethidine, fentanyl) or antitussive drugs (dextromethorphan) may develop so-called. serotonin syndrome.

Sibutramine does not interfere with the effect of oral contraceptives.

With the simultaneous administration of sibutramine and alcohol, there was no increase in the negative effect of alcohol. However, alcohol is absolutely not combined with the dietary measures recommended when taking sibutramine.

With the simultaneous use of other drugs with sibutramine that affect hemostasis or platelet function, the risk of bleeding increases.

The drug interaction with the simultaneous use of sibutramine with drugs that increase blood pressure and heart rate is currently not fully understood. This group of drugs includes decongestants, antitussives, anti-cold and antiallergic drugs, which include ephedrine or pseudoephedrine. Therefore, in cases of concomitant use of these drugs with sibutramine, caution should be exercised. The combined use of sibutramine with drugs for weight loss, acting on the central nervous system, or drugs for the treatment of mental disorders is contraindicated.

Symptoms: There is very limited data on sibutramine overdose. The most common adverse reactions associated with overdose: tachycardia, increased blood pressure, headache, dizziness. The patient should notify their doctor in case of suspected overdose. Overdose may increase the severity of side effects.

Treatment: There is no specific treatment or specific antidote. It is necessary to carry out general measures: to ensure free breathing, monitor the state of the CVS, and, if necessary, carry out supportive symptomatic therapy. Timely use of activated charcoal, as well as gastric lavage, can reduce the intake of sibutramine into the body. Patients with high blood pressure and tachycardia - the appointment of beta-blockers. The effectiveness of forced diuresis or hemodialysis has not been established.