Expiration date: 09/2026

Release form

Film-coated tablets

Dosage form

The tablets are oval biconvex with a dividing risk on one side, covered with a white film coating. In the cross section, the core is almost white in color

Composition

Each tablet contains a dosage:

Active ingredients:

metformin hydrochloride - 850.0 mg; sibutramine hydrochloride monohydrate - 10mg, 15mg;

Auxiliary substances:

microcrystalline cellulose, sodium croscarmellose, povidone K-25, magnesium stearate;

Excipients of the film shell:

Ready-made coating system Opadray II 85F48105 white (polyvinyl alcohol, macrogol, talc, titanium dioxide)

The pharmacotherapeutic group

of obesity is a means of treatment

Pharmacodynamics

Metformin

An oral hypoglycemic drug from the biguanide group reduces hyperglycemia without leading to the development of hypoglycemia. Unlike sulfonylurea derivatives, it does not stimulate insulin secretion and does not cause hypoglycemic effect in healthy people. Increases the sensitivity of peripheral receptors to insulin and the utilization of glucose by cells. Inhibits gluconeogenesis in the liver. It delays the absorption of carbohydrates in the intestine and stimulates the production of GPP-1 (a physiological appetite regulator). Metformin stimulates glycogen synthesis by acting on glycogen synthase. Increases the transport capacity of all types of membrane glucose transporters. In addition, it has a beneficial effect on lipid metabolism: it reduces the concentration of total cholesterol, low-density lipoproteins and triglycerides.

While taking metformin, the patient's body weight either remains stable or decreases moderately.

Sibutramine

It is a prodrug and exerts its effect in vivo due to metabolites (primary and secondary amines) that inhibit the reuptake of monoamines (serotonin, norepinephrine and dopamine). An increase in the content of neurotransmitters in synapses increases the activity of central 5NT-serotonin and adrenergic receptors, contributes to the physiological regulation of appetite by increasing the feeling of satiety and reducing the need for food, as well as an increase in thermal production (internal energy consumption). Indirectly activating it ?z-adrenergic receptors, sibutramine affects brown adipose tissue. Weight loss when taking sibutramine is accompanied by an increase in serum concentrations of high-density lipoproteins (HDL) and a decrease in the concentration of triglycerides, total cholesterol, low-density lipoproteins (LDL) and uric acid. Sibutramine and its metabolites do not affect the release of monoamines, do not inhibit monoamine oxidase (MAO); they do not have affinity for a large number of neurotransmitter receptors, including serotonin (5-HT1, 5-HT1A, 5-HT1B, 5-HT2C), adrenergic (?1, ?2, ?3, ?1, ?2), dopamine (D1, D2), muscarinic, histamine (H1), benzodiazepine and glutamate NMDA receptors.

The simultaneous use of metformin and sibutramine increases the effectiveness of therapy in obese patients. By regulating appetite, reducing hunger, increasing energy consumption and regulating lipid and carbohydrate metabolism, Reduxin®Forte reduces human body weight and restores metabolic health.

Clinical efficacy and safety (Results of clinical trials)

In a clinical study in the group of the drug Reduxin® What is the percentage of patients who have achieved clinically significant weight loss ?5% in 3 months of therapy (the proportion of early responders to therapy) exceeded 90%. During 6 months of therapy, 91.67% of patients in the Reduxin® group Forte achieved a body weight reduction of 10% or more. The decrease in body weight was accompanied by a clinically significant decrease in waist circumference and an improvement in the lipid profile, which proves the effectiveness of the drug in reducing the risk of complications and meets the main goals of obesity therapy.

During the study, there was no negative effect of the drug Reduxin® Forte affects the cardiovascular system when used in obese patients.

Pharmacokinetics

Suction

After taking the drug orally, metformin is completely absorbed from the gastrointestinal tract. With simultaneous intake of food, the absorption of metformin decreases and is delayed. The absolute bioavailability is 50-60%. The maximum plasma concentration (Cmax) is approximately 2 micrograms/ml or 15 micromoles and is reached after 2.5 hours.

Distribution

Metformin is rapidly distributed in body tissues. It practically does not bind to plasma proteins.

Metabolism

It undergoes metabolism to a small extent.

Withdrawal

It is excreted by the kidneys. The clearance of metformin in healthy people is 400 ml/min (4 times higher than creatinine clearance), which indicates active tubular secretion

The half-life (T1/2) is approximately 6.5 hours.

Pharmacokinetics in special clinical cases

In patients with renal insufficiency T1/2 increases, there is a risk of accumulation of metformin in the body.

Sibutramine

Suction

After oral administration, it is rapidly absorbed from the gastrointestinal tract by at least 77%. During the "primary passage" through the liver, it undergoes biotransformation under the influence of the CYP3A4 isoenzyme with the formation of two active metabolites (monodesmethylsibutramine (M1) and didesmethylsibutramine (M2)). After taking a single dose of 15 mg, the maximum blood concentration (Cmax) of monodesmethylsibutramine (M1) is 4 ng/ ml (3.2-4.8 ng/ ml), didesmethylsibutramine (M2) is 6.4 ng/ml (5.6-7.2 ng/ml). The Cmax is reached after 1.2 hours (sibutramine), 3-4 hours (active metabolites). Simultaneous intake of food reduces the Cmax of metabolites by 30% and increases the time to reach it by 3 hours, without changing the area under the concentration-time curve (AUC).

Distribution

It is quickly distributed in tissues. The protein binding is 97% (sibutramine) and 94% (M1 and M2). The equilibrium concentration of active metabolites in the blood is reached within 4 days after the start of treatment and is approximately 2 times higher than the concentration in blood plasma after taking a single dose.

Metabolism and excretion

Active metabolites undergo hydroxylation and conjugation to form inactive metabolites, which are excreted mainly by the kidneys. The half-life of sibutramine is 1.1 hours, M1 - 14 hours, M2 - 16 hours.

Pharmacokinetics in special clinical cases

Currently available data do not indicate the existence of clinically significant differences in pharmacokinetics in men and women.

Pharmacokinetics in the elderly

Pharmacokinetics in elderly healthy people (average age 70 years) it is similar to that of the young.

Kidney failure

Renal insufficiency has no effect on the AUC of active metabolites M1 and M2, except for the M2 metabolite in patients with end-stage renal insufficiency on dialysis.

Liver failure

In patients with moderate hepatic insufficiency after a single dose of sibutramine, the AUC of active metabolites M1 and M2 is 24% higher than in healthy people.

Indications

The drug Reduxin® Forte is indicated for correcting body weight and improving lipid and carbohydrate metabolism in patients:

• with a body mass index (BMI) of more than 30 kg/m2 (alimentary obesity);
• with a BMI of 27 kg/m2 or more in combination with type 2 diabetes mellitus and dyslipidemia;
• with a BMI of 30 kg/m2 or more, with prediabetes and additional risk factors for type 2 diabetes, in whom lifestyle changes did not allow adequate glycemic control to be achieved

Contraindications

• hypersensitivity to the components of the drug;
• diabetic ketoacidosis, diabetic precoma, diabetic coma;
• impaired renal function (creatinine clearance (CC) less than 45 ml/min);
• impaired liver function;
• acute conditions in which there is a risk of developing renal dysfunction: dehydration (with diarrhea, vomiting), severe infectious diseases, shock;
• cardiovascular diseases (in the anamnesis and currently): coronary heart disease (myocardial infarction (MI), angina pectoris), chronic heart failure in the decompensation stage, occlusive diseases of peripheral arteries, tachycardia, arrhythmia, cerebrovascular diseases (stroke, transient disorders of cerebral circulation);
• uncontrolled arterial hypertension (blood pressure (BP) above 145/90 mmHg) (see also the section "Special instructions");
• clinically pronounced manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (including respiratory failure, heart failure, acute MI);
• chronic alcoholism, acute ethanol poisoning;
• thyrotoxicosis;
• benign prostatic hyperplasia;
• pheochromocytoma;
• angle-closure glaucoma;
• extensive surgical operations and injuries (when insulin therapy is indicated);
• lactic acidosis (including in the anamnesis);
• established pharmacological or drug dependence;
• pregnancy and breastfeeding;
• age under 18 and over 65;
• a period of less than 48 hours before and for 48 hours after conducting radioisotope or X-ray examinations with the introduction of an iodine-containing contrast agent;
• compliance with a hypocaloric diet (less than 1000 kcal / day);
• the presence of organic causes of obesity (e.g. hypothyroidism);
• serious eating disorders - anorexia nervosa or bulimia nervosa;
• mental illness;
• Gilles de la Tourette syndrome (generalized tics);
• simultaneous administration of MAO inhibitors (for example, phentermine, fenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or their use for 2 weeks before taking sibutramine and 2 weeks after taking it; other drugs acting on the central nervous system that inhibit serotonin reuptake (for example, antidepressants, neuroleptics); sleeping pills containing tryptophan, as well as other drugs of central action for weight loss or treatment of mental disorders.

Method of administration and dosage

The drug Reduxin® Forte is prescribed orally 1 time per day. The dose is set individually depending on tolerability and clinical efficacy.

An initial dose of 850 mg + 10 mg per day is recommended.

The drug should be taken in the morning without chewing and washed down with a sufficient amount of liquid (a glass of water). The drug can be taken on an empty stomach or combined with a meal. An increase in the dose to 850 mg + 15 mg is possible if a decrease in body weight of 2 kg or more is not achieved within a month, but not earlier than 4 weeks after the start of treatment.

Treatment with the drug Reduxin® Forte should not last more than 3 months in patients who, during 3 months of treatment, fail to achieve 5% of the body weight loss level from the initial level when taking the drug at the maximum dose.

In obese patients without additional disorders of carbohydrate metabolism, the use of the drug Reduxin® is recommended Forte for 6 months to develop proper eating habits and maintain the achieved result of weight loss. Treatment with the drug Reduxin® Forte should not be continued if, with further therapy, after the achieved weight loss, the patient again adds 3 kg or more in body weight.

It is recommended to take the drug for a long time to reduce body weight by 5-10% and maintain the result, which reduces health risks, as well as improve the course of diseases associated with obesity.

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

The duration of continuous treatment should not exceed 1 year.

Side effects

Determining the frequency of side effects: very often (?1/10), often (?1/100, <1/10), infrequently (?1/1000, <1/100), rarely (?1/10 000, <1/1000), very rarely (<1/10 000).

The side effect is presented in order of decreasing importance.

Metformin

Metabolic and nutritional disorders: very rarely - lactic acidosis; with prolonged use, vitamin B12 absorption may decrease. A decrease in vitamin B12 concentration should be taken into account in patients with megaloblastic anemia.

Disorders of the nervous system: often - a violation of taste.

Disorders of the gastrointestinal tract: very often - nausea, vomiting, diarrhea, abdominal pain, lack of appetite. Most often, these symptoms occur during the initial period of treatment and in most cases spontaneously go away. A slow increase in the dose may improve gastrointestinal tolerance.

Disorders of the liver and biliary tract: very rarely - impaired liver function, hepatitis, after discontinuation of metformin, these adverse events completely disappear.

Disorders of the skin and subcutaneous tissue: very rarely - skin reactions such as erythema, itching, rash.

Sibutramine

Most often, side effects occur at the beginning of treatment (in the first 4 weeks). Their severity and frequency decrease over time. The side effects are generally mild and reversible.

Disorders of the nervous system: very often - dry mouth and insomnia, often - headache, dizziness, anxiety, paresthesia, as well as a change in taste.

Cardiac disorders: often - tachycardia, palpitations.

Vascular disorders: increased blood pressure, vasodilation. There is a moderate rise in blood pressure at rest by 1-3 mmHg and a moderate increase in heart rate by 3-7 beats per minute. In some cases, a more pronounced increase in blood pressure and an increase in heart rate are not excluded. Clinically significant changes in blood pressure and pulse are recorded mainly at the beginning of treatment (in the first 4-8 weeks). Disorders of the gastrointestinal tract: 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 monitor the evacuation function of the intestine. If constipation occurs, the intake is stopped and a laxative is taken.

Disorders of the skin and subcutaneous tissues: often - increased sweating.

In isolated cases, the following undesirable clinically significant phenomena have been described during treatment with sibutramine: dysmenorrhea, edema, flu-like syndrome, itchy skin, back pain, abdominal pain, paradoxical increase in appetite, thirst, rhinitis, depression, drowsiness, emotional lability, anxiety, irritability, nervousness, acute interstitial nephritis, bleeding, Schenlein purpura-Genoha (skin hemorrhages), seizures, thrombocytopenia, transient increase in the activity of "liver" enzymes in the blood.

The use of the drug Reduxin® Forte in patients with high blood pressure: see the sections "Contraindications" and "Special instructions".

In the course of post-marketing studies of sibutramine, additional adverse reactions were described, listed below by organ systems:

Disorders of the immune system: hypersensitivity reactions (from moderate skin rashes and urticaria to angioedema (Quincke's edema) and anaphylaxis).

Mental disorders: psychosis, states of suicidal thinking, suicide and mania. In case of occurrence of such

The drug must be discontinued.

Disorders of the nervous system: seizures, short-term memory disorders. Visual organ disorders: blurred vision ("veil in front of the eyes"). Cardiac disorders: atrial fibrillation.

Disorders of the gastrointestinal tract: diarrhea, vomiting.

Disorders of the skin and subcutaneous tissue: alopecia.

Disorders of the kidneys and urinary tract: urinary retention.

Disorders of the genital organs and breast: ejaculation/orgasm disorders, impotence, menstrual cycle disorders, uterine bleeding.

Overdose

Metformin

Symptoms: when metformin was administered at a dose of 85 g (42.5 times the maximum daily dose), hypoglycemia was not observed, but lactic acidosis was noted.

A significant overdose or associated risk factors can lead to the development of lactic acidosis.

Treatment: in case of signs of lactic acidosis, treatment with the drug should be stopped immediately, the patient should be urgently hospitalized and, having determined the lactate concentration, clarify the diagnosis. The most effective measure for the elimination of lactate and metformin from the body is hemodialysis. Symptomatic treatment is also carried out.

Sibutramine

There is extremely limited data on sibutramine overdose. The most common adverse reactions associated with overdose are tachycardia, increased blood pressure, headache, dizziness. You should notify your doctor in case of a suspected overdose.

Treatment: there is no special treatment or specific antidotes. It is necessary to carry out general measures: to ensure free breathing, monitor the state of the cardiovascular system, as well as, 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. Can patients with high blood pressure and tachycardia be prescribed ?- adrenoblockers. The effectiveness of forced diuresis or hemodialysis has not been established. In case of overdose, the drug Reduxin® should be discontinued immediately Forte

With caution

The drug should be used in the following conditions: a history of arrhythmias; chronic circulatory insufficiency; coronary artery diseases (including in the anamnesis), except for coronary heart disease (MI, angina pectoris); glaucoma, except angle-closure glaucoma; cholelithiasis; arterial hypertension (controlled and in the anamnesis); neurological disorders, including mental retardation seizures (including in the anamnesis); epilepsy; impaired renal function (CC 45-59 ml/min); motor and verbal tics in the anamnesis; tendency to bleeding; impaired blood clotting; taking drugs that affect hemostasis or platelet function; persons over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis.

Use during pregnancy and breastfeeding

Since there is still not a sufficiently convincing amount of research on the safety of sibutramine's effects on the fetus, this drug is contraindicated during pregnancy. Women of reproductive age while taking the drug Reduxin® Forte should use contraceptives.

The use of the drug Reduxin® is contraindicated Forte during breastfeeding

Drug interaction

Metformin

Contraindicated combinations

Iodine-containing radiopaque agents: against the background of functional renal insufficiency in patients with diabetes mellitus, radiological examination using iodine-containing radiopaque agents can cause the development of lactic acidosis. Treatment with metformin should be discontinued, depending on renal function, 48 hours before or during an X-ray examination using iodine-containing radiopaque agents and should not be resumed earlier than 48 hours after the examination, provided that renal function was recognized as normal during the examination.

Not recommended combinations

Alcohol: acute alcohol intoxication increases the risk of lactic acidosis, especially in cases of:

• insufficient nutrition, low-calorie diet;
• liver failure.

Alcohol and drugs containing ethanol should be avoided while taking the drug.

Combinations that require caution

Danazol: simultaneous administration of danazol is not recommended in order to avoid the hyperglycemic effect of the latter. If treatment with danazol is necessary and after discontinuation of the latter, a dose adjustment of metformin is required under the control of blood glucose concentration.

Chlorpromazine: when taken in high doses (100 mg per day) increases the concentration of glucose in the blood, reducing the release of insulin. When treating with neuroleptics and after discontinuation of the latter, dose adjustment of the drug is required under the control of blood glucose concentration.

Glucocorticosteroids (GCS) of systemic and local action reduce glucose tolerance, increase the concentration of glucose in the blood, sometimes causing ketosis. In the treatment of GCS and after discontinuation of the latter, metformin dose adjustment is required under the control of blood glucose concentration.

Diuretics: simultaneous use of "loop" diuretics can lead to the development of lactic acidosis due to possible functional renal failure. Metformin should not be prescribed if the CC is below 60 ml/min.

Prescribed in the form of injections of beta2-adrenomimetics: increase the concentration of glucose in the blood due to stimulation of beta2-adrenergic receptors. In this case, it is necessary to monitor the concentration of glucose in the blood. If necessary, the appointment of insulin is recommended.

With the simultaneous use of the above drugs, more frequent monitoring of blood glucose concentration may be required, especially at the beginning of treatment. If necessary, the dose of metformin can be adjusted during and after treatment.

Angiotensin converting enzyme inhibitors and other antihypertensive drugs can reduce the concentration of glucose in the blood. If necessary, the dose of metformin should be adjusted.

The hypoglycemic effect of metformin can be reduced by phenothiazides, glucagon, estrogens, oral contraceptives, phenytoin, sympathomimetics, nicotinic acid, isoniazid, blockers of "slow" calcium channels, sodium levothyroxine. Concomitant use with cimetidine reduces the rate of metformin elimination, which can lead to the development of lactic acidosis. In healthy volunteers, with the simultaneous use of metformin and propranolol, as well as with the use of metformin and ibuprofen, there was no change in their pharmacokinetic parameters. Metformin may reduce the effect of indirect anticoagulants.

Substrates of the organic cation transporter 1 and 2 (OST1 and OST2)

Metformin is a substrate of the organic cations OST1 and OST2. When used in combination with metformin:

• OST1 inhibitors (such as verapamil) they can reduce the hypoglycemic effect of metformin.
• OST1 inducers (such as rifampicin) can increase the absorption of metformin in the gastrointestinal tract and enhance its hypoglycemic effect.
• OST2 inhibitors (such as cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole) can reduce the excretion of metformin by the kidneys and lead to an increase in its concentration in blood plasma.

OST1 and OST2 inhibitors (such as crizotinib, olaparide) can reduce the hypoglycemic effect of metformin.

With the simultaneous use of metformin with sulfonylurea derivatives, insulin, acarbose, salicylates, hypoglycemia may develop.

Nifedipine increases the absorption and Cmax of metformin.

Cationic drugs (amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim and vancomycin) secreted in the renal tubules compete with metformin for tubular transport systems and can lead to an increase in its Cmax.

Sibutramine

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

Rifampicin, macrolide antibiotics, phenytoin, carbamazepine, phenobarbital and dexamethasone can accelerate the metabolism of sibutramine.

Simultaneous use of several drugs that increase the content of serotonin in blood plasma can lead to the development of a serious interaction. The so-called serotonin syndrome can develop in rare cases with the simultaneous use of sibutramine with selective serotonin reuptake inhibitors (drugs for the treatment of depression), with some drugs for the treatment of migraines (sumatriptan, dihydroergotamine), with potent analgesics (pentazocin, pethidine, fentanyl), or antitussive drugs (dextromethorphan). Sibutramine does not affect the effect of oral contraceptives.

When taking sibutramine and alcohol at the same time, there was no increase in the negative effects of alcohol. However, alcohol is absolutely not combined with the dietary measures recommended when taking sibutramine.

When used concomitantly with sibutramine, other drugs that affect hemostasis or platelet function increase the risk of bleeding. The drug interaction with the simultaneous use of sibutramine with drugs that increase blood pressure and heart rate is currently insufficiently studied. This group of drugs includes decongestants, antitussive, antipruritic and antiallergic drugs, which include ephedrine or pseudoephedrine. Therefore, in cases of simultaneous administration 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

Special instructions

Lactic acidosis

Lactic acidosis is a rare but serious (high mortality in the absence of urgent treatment) complication that may occur due to accumulation of metformin. Cases of lactic acidosis when taking metformin occurred mainly in patients with diabetes mellitus with severe renal insufficiency.

Other associated risk factors should also be taken into account, such as decompensated diabetes mellitus, ketosis, prolonged fasting, alcoholism, liver failure and any condition associated with severe hypoxia. This can help reduce the incidence of lactic acidosis.

The risk of lactic acidosis should be considered when non-specific signs appear, such as muscle cramps accompanied by dyspeptic symptoms, abdominal pain and severe asthenia. Lactic acidosis is characterized by acidotic dyspnea, abdominal pain and hypothermia followed by coma. Diagnostic laboratory indicators are a decrease in blood pH (less than 7.25), lactate content in blood plasma above 5 mmol / l, increased anion gap and lactate/pyruvate ratio. If metabolic acidosis is suspected, it is necessary to stop taking the drug and immediately consult a doctor.

Surgical operations

The use of the drug Reduxin® Forte should be discontinued 48 hours before elective surgery and may be continued no earlier than 48 hours after, provided that renal function was found to be normal during the examination.

Kidney function

Since metformin is excreted by the kidneys, before taking the drug Reduxin® Forte and regularly thereafter, it is necessary to determine QC: at least once a year in patients with normal renal function, and 2-4 times a year in elderly patients, as well as in patients with QC at the lower limit of the norm.

Special caution should be exercised in case of possible renal dysfunction in elderly patients, with the simultaneous use of antihypertensive drugs, diuretics or nonsteroidal anti-inflammatory drugs.

Patients are advised to continue to follow a diet with an even intake of carbohydrates throughout the day. Overweight patients are recommended to continue to follow a hypocaloric diet (but not less than 1000 kcal / day).

It is recommended to regularly perform standard laboratory tests to control diabetes mellitus.

It is recommended to exercise caution when using the drug Reduxin® Forte in combination with insulin or other hypoglycemic agents (including sulfonylurea derivatives, repaglinide).

Treatment with the drug Reduxin® Forte should be carried out as part of a comprehensive weight loss therapy under the supervision of a doctor with practical experience in the treatment of obesity. Complex therapy includes both a change in diet and lifestyle, as well as an increase in physical activity. An important component of therapy is the creation of prerequisites for a persistent change in eating behavior and lifestyle, which are necessary to maintain the achieved weight loss even after discontinuation of drug therapy. Patients need to be treated with the drug Reduxin® Forte should change his lifestyle and habits in such a way that, after completing treatment, he ensures that the achieved weight loss is maintained. Patients should be clear that failure to comply with these requirements will lead to repeated weight gain and repeated visits to the attending physician.

In patients taking the drug Reduxin® Forte, it is necessary to measure blood pressure and heart rate. In the first 3 months of treatment, these parameters should be monitored every 2 weeks, and then monthly. If an increase in resting heart rate is detected during two consecutive visits?10 beats per minute or systolic/diastolic pressure ?10 mmHg, it is necessary to stop treatment. In patients with arterial hypertension, whose blood pressure is higher than 145/90 mmHg on the background of antihypertensive therapy. Of course, this control should be carried out especially carefully and, if necessary, at shorter intervals. In patients whose blood pressure exceeded 145 / 90 mmHg twice during repeated measurement, treatment with Reduxin® Forte should be suspended (see the section "Side effect", subsections "Cardiac disorders", "Vascular disorders").

In patients with sleep apnea syndrome, blood pressure should be monitored especially carefully.

Special attention should be paid to the simultaneous administration of drugs that increase the QT interval. These drugs include H1-histamine receptor blockers (astemizole, terfenadine); antiarrhythmic drugs that increase the QT interval (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol); gastrointestinal motility stimulant cisapride; pimozide, sertindole and tricyclic antidepressants. This also applies to conditions that can lead to an increase in the QT interval, such as hypokalemia and hypomagnesemia (see the section "Interaction with other drugs").

The interval between taking MAO inhibitors (including furazolidone, procarbazine, selegiline) and the drug Reduxin Forte should be at least 2 weeks old.

Although there is no established link between taking sibutramine and the development of primary pulmonary hypertension, however, given the well-known risk of drugs in this group, with regular medical monitoring, special attention should be paid to symptoms such as progressive dyspnea (respiratory disorders), chest pain and swelling on the legs

When skipping a dose of the drug Reduxin® Forte should not take a double dose of the drug in the next dose, it is recommended to continue further taking the drug according to the prescribed regimen.

When taking sibutramine and other serotonin reuptake inhibitors together, there is an increased risk of bleeding. In patients predisposed to bleeding, as well as taking drugs that affect hemostasis or platelet function, sibutramine should be used with caution.

Although there is no clinical data on addiction to sibutramine, it should be clarified whether the patient has a history of drug dependence and pay attention to possible signs of drug abuse.

Influence on the ability to drive vehicles and mechanisms

Taking the drug Reduxin® Forte may limit the ability to drive vehicles and machinery. During the period of use of the drug Reduxin® Forte must be careful when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Storage temperature

from 2℃ to 25℃