Reduxin Met - instructions for use, dose, side effects, contraindications

Active substanceMetformin + [Sibutramine + Microcrystalline Cellulose]Metformin + [Sibutramine + Microcrystalline Cellulose]

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Reduxin® Met

capsulespills inwards

Promomed Rus, Open Company Russia

Dosage form: & nbspSet: tablets + capsules.

Composition:

Each tablet contains active substance:

- metformin hydrochloride 850 mg.

Excipients: cellulose microcrystalline - 25.5 mg, croscarmellose sodium - 51.0 mg, water purified - 17.0 mg, povidone (polyvinylpyrrolidone) - 68.0 mg, magnesium stearate - 8.5 mg.

Each capsule dosage 10 mg + 158,5 mg contains active substances:

- sibutramine hydrochloride monohydrate - 10 mg,

- cellulose microcrystalline - 158.5 mg.

Excipients: calcium stearate 1.5 mg.

Capsule composition: titanium dioxide - 2,0000 %, dye azorubin - 0.0041%, dye brilliant blue - 0.0441%, gelatin - up to 100%.

Each capsule dosage 15 mg + 153,5 mg contains active substances:

- sibutramine hydrochloride monohydrate - 15 mg,

- cellulose microcrystalline - 153.5 mg.

Excipients: calcium stearate 1.5 mg.

Capsule composition: titanium dioxide - 2,0000 %, the dye is blue patented - 0.2737%, gelatin - up to 100%.

Description:

Metformin

Oval biconvex tablets white or almost white with a risk on one side.

Sibutramine + microcrystalline cellulose

Capsules number 2 of blue color for a dosage of 10 mg + 158.5 mg or blue for a dosage of 15 mg + 153.5 mg. The contents of the capsules are white or white powder with a slightly yellowish hue.

Pharmacotherapeutic group:An agent for the treatment of obesity. Hypoglycemic agent of the biguanide group for oral administration.

ATX: & nbsp

A.08.A Preparations for the treatment of obesity (excluding dietary products)

Pharmacodynamics:

Reduxin® Met contains two separate medicines in one package: a hypoglycemic agent for oral administration of a group of biguanides in a tablet dosage form - metformin, and an agent for treating obesity in a capsule dosage form comprising, in its composition sibutramine and microcrystalline cellulose.

Metformin

Oral hypoglycemic agent from the biguanide group, reduces hyperglycemia, without leading to the development of hypoglycemia. Unlike derivatives of sulfonylurea, it does not stimulate insulin secretion and does not cause hypoglycemic effect in healthy individuals. Increases the sensitivity of peripheral receptors to insulin and the utilization of glucose by cells. It inhibits gluconeogenesis in the liver.Delays the absorption of carbohydrates in the intestine. Metformin stimulates the synthesis of glycogen, affecting 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 content of total cholesterol, low-density lipoproteins and triglycerides.

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

Sibutramine

Is a prodrug and shows its effect in vivo due to metabolites (primary and secondary amines) inhibiting the reuptake of monoamines (serotonin, norepinephrine and dopamine). An increase in the content of neurotransmitters in the synapses increases the activity of central 5HT-serotonin and adrenergic receptors, which contributes to an increase in satiety and a decrease in the need for food, as well as an increase in thermal production. By indirectly activating betas-adrenergic receptors, sibutramine affects the brown adipose tissue. The decrease in body weight is accompanied by an increase in the concentration of high-density lipoprotein (HDL) in the blood serum and a decrease in the amount of triglycerides, total cholesterol, low-density lipoprotein (LDL), and uric acid. Sibutramine and its metabolites do not affect the release of monoamines, do not inhibit monoamine oxidase (MAO); do not have an affinity for a large number of neurotransmitter receptors, including serotonin (5-HT₁, 5-HT_1a, 5-HT_1b, 5-HT_2c ), adrenergic (beta₁, beta₂, beta₃, alpha₁, alpha₂), dopamine (D₁, D₂), muscarinic, histamine (H₁), benzodiazepine and glutamate NMDA receptors.

Microcrystalline cellulose

It is an enterosorbent, it possesses sorption properties and nonspecific detoxification action. Binds and removes from the body various microorganisms, the products of their vital functions, toxins of exogenous and endogenous nature, allergens, xenobiotics, as well as an excess of certain metabolic products and metabolites responsible for the development of endogenous toxicosis. The simultaneous use of metformin and sibutramine with microcrystalline cellulose increases the therapeutic efficacy of the combination used in patients with overweight and type 2 diabetes mellitus.

Pharmacokinetics:

Metformin

Suction

After taking the drug inside metformin sufficiently absorbed from the gastrointestinal tract (GIT). With simultaneous intake of food, absorption of metformin is reduced and delayed.Absolute bioavailability is 50-60%. FROM_max in plasma is approximately 2 μg / ml or 15 μmol and is achieved after 2.5 hours.

Distribution

Metformin is quickly distributed into the tissues of the body. Virtually does not bind to plasma proteins.

Metabolism

To a very small extent, is exposed to metabolism.

Excretion

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

Half-life (T_1/2) is about 6.5 hours.

Pharmacokinetics in special clinical cases

In patients with renal insufficiency T_1/2 increases, there is a risk of cumulation of metformin in the body.

Sibutramine

Suction

After oral administration, it is rapidly absorbed from the gastrointestinal tract (GIT) by at least 77%. At the "primary passage" through the liver undergoes biotransformation under the influence of the isoenzyme CYP3A4 with the formation of two active metabolites (monodesmethylsibutramine (M1) and didesselmethylsibutramine (M2)). After taking a single dose of 15 mg, the maximum concentration in the blood (C_max) 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). FROM_max achieved after 1.2 hours (sibutramine), 3-4 hours (active metabolites). Simultaneous food intake lowers C_max metabolites by 30% and increases the time it takes to reach 3 hours without changing the area under the concentration-time curve (AUC).

Distribution

Quickly distributed to tissues. The connection with proteins 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 approximately 2 times higher than the concentration in the blood plasma after taking a single dose.

Metabolism and excretion

Active metabolites undergo hydroxylation and conjugation with the formation of 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 limited data do not indicate the existence of clinically significant differences in pharmacokinetics in men and women.

Pharmacokinetics in the elderly

Pharmacokinetics in elderly healthy individuals (mean age 70 years) is similar to that in young adults.

Renal insufficiency

Renal failure does not affect AUC active metabolites M1 and M2, in addition to the M2 metabolite in patients with terminal stage of renal failure who are on dialysis.

Liver failure

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

Indications:

Reduxin® Meth is indicated for reducing body weight with alimentary obesity with a body mass index of 27 kg / m² and more in combination with type 2 diabetes and dyslipidemia.

Contraindications:

hypersensitivity to the components of the drug;
Diabetic ketoacidosis, diabetic precoma, diabetic coma;
impaired renal function (creatinine clearance (CK) less than 60 ml / min);
abnormal liver function;
acute conditions at which there is a risk of kidney dysfunction: dehydration (with diarrhea, vomiting), severe infectious diseases, shock;
cardiovascular diseases (in the anamnesis and at present) ischemic heart disease (myocardial infarction (MI), angina pectoris), chronic heart failure in the stage of decompensation,occlusive diseases of peripheral arteries, tachycardia, arrhythmia, cerebrovascular diseases (stroke, transient disorders of cerebral circulation);
uncontrolled arterial hypertension (blood pressure (BP) above 145/90 mm Hg) (see also 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 myocardial infarction);
chronic alcoholism, acute ethanol poisoning;
thyrotoxicosis;
benign prostatic hyperplasia;
pheochromocytoma;
angle-closure glaucoma;
extensive surgery and trauma (when carrying out insulin therapy);
lactoacidosis (including in the anamnesis);
established pharmacological or drug dependence;
pregnancy and the period of breastfeeding;
age is 18 years and over 65;
period not less than 48 hours before and within 48 hours after radioisotope or radiographic studies with the introduction of iodine-containing contrast agent;
compliance with hypocaloric diet (less than 1000 kcal / day);
the presence of organic causes of obesity (eg, hypothyroidism);
severe eating disorders - anorexia nervosa or bulimia nervosa;
mental illness;
Gilles de la Tourette syndrome (generalized tics);
simultaneous administration of MAO inhibitors (eg, phentermine, fenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or their use 2 weeks prior to taking sibutramine and 2 weeks after the end of its intake of other drugs acting on the central nervous system that inhibit serotonin reuptake (for example, antidepressants, neuroleptics); hypnotics containing tryptophan, as well as other central drugs to reduce body weight or treat psychiatric disorders.

Carefully:

Carefully should prescribe the drug at the following conditions: an arrhythmia in the anamnesis; chronic circulatory failure; diseases of the coronary arteries (including in the anamnesis), in addition to coronary heart disease (myocardial infarction, angina pectoris); glaucoma, except for closed-angle glaucoma; cholelithiasis; arterial hypertension (controlled and in anamnesis); neurological disorders,including mental retardation and convulsions (including in history); epilepsy; renal dysfunction of mild and moderate severity; motor and verbal tics in the anamnesis; propensity to bleed, bleeding disorder; taking drugs that affect hemostasis or platelet function; people over 60 years of age who perform heavy physical work, which is associated with an increased risk of developing lactic acidosis.

Pregnancy and lactation:

Since there is not yet a sufficiently convincing number of studies regarding the safety of sibutramine exposure to fetus, this the drug is contraindicated during pregnancy. Women who are of reproductive age should take contraceptives while taking Reduxin® Met.

Contraindicated in the use of Reduxin® Met during breastfeeding.

Dosing and Administration:

The recommended initial dose is 1 tablet containing 850 mg of metformin and 1 capsule containing 10 mg of sibutramine. Tablets and capsules should be taken in the morning at the same time, without chewing and drinking with a sufficient amount of liquid (1 glass of water) in combinationwith food intake.

It is necessary to monitor the dynamics of changes in blood glucose concentration and the dynamics of weight loss. If after one or two weeks the optimal values of glucose concentration in the blood are not reached, the dose of metformin should be increased to 2 tablets. The usual maintenance dose of metformin is 1700 mg per day. The maximum daily dose of metformin is 2550 mg. To reduce side effects from the gastrointestinal tract, the daily dose of metformin can be divided into 2 divided doses. For example, take 1 tablet in the morning and 1 tablet in the evening.

If within 4 weeks from the beginning of treatment there is no reduction in body weight by 2 kg, the dose of sibutramine increases to 15 mg / day. Treatment with Reduxin® Meth should not last more than 3 months in patients who do not respond well enough to therapy, i.e. who during the 3 months of treatment can not achieve a reduction in body weight by 5% of the baseline. Treatment should not be continued if, in the further treatment after the achieved weight loss, the patient again adds 3 kg or more in the body mass. Duration of treatment should not exceed 1 year, since there is no data on efficacy and safety for a longer period of sibutramine intake.

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

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). Side effect is presented in order of decreasing importance.

Metformin

From the side of metabolism and nutrition: very rarely - lactic acidosis; with prolonged use, it is possible to reduce the absorption of vitamin B12. Reducing the concentration of vitamin B12 must be taken into account in patients with megaloblastic anemia. From the nervous system: often - a violation of taste.

From 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 pass. Slow increase in dose may improve gastrointestinal tolerance.

From the skin and subcutaneous tissues: very rarely skin reactions, such as erythema, pruritus, rash.

From the liver and bile ducts: very rarely - a violation of the liver function, hepatitis, after the withdrawal of metformin, these undesirable phenomena completely disappear.

Sibutramine

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 light and reversible. Side effects, depending on the effect on organs and organ systems, are presented in the following order: very often (≥ 1/10), often (≥ 1/100, < 1/10).

From the central nervous system: very frequent side effects are dry mouth and insomnia, headache, dizziness, anxiety, paresthesia, and taste changes are often noted.

From the cardiovascular system: often there are tachycardia, palpitations, increased blood pressure, vasodilation.

On the part of the digestive system: loss of appetite and constipation are frequent, often nausea and exacerbation of hemorrhoids. With a tendency to constipation in the first days, control over the evacuation function of the intestine is necessary. If there is constipation, stop taking and take a laxative.

From the skin: often there is increased sweating.

In single cases, the following undesirable clinically significant events are described in the treatment of sibutramine: dysmenorrhea, edema, flu-like syndrome, skin itching, back pain, abdominal pain, paradoxical appetite increase, thirst, rhinitis, depression, drowsiness, emotional lability, anxiety, irritability, nervousness, acute interstitial nephritis, bleeding, purpura Shenlen-Henoch (hemorrhages in the skin), convulsions, thrombocytopenia, transient increase in the activity of "hepatic" enzymes in the blood.

Disorders from the cardiovascular system. There is a moderate rise in blood pressure at rest by 1-3 mm Hg. and a moderate increase in heart rate at 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 registered mainly at the beginning of treatment (in the first 4-8 weeks).

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

During post-marketing studies of sibutramine, additional side reactions, listed below for organ systems, were described.

From the cardiovascular system: atrial fibrillation.

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

Disorders of the psyche: psychosis, the state of suicidal thinking, suicide and mania. If such conditions occur, the drug should be discarded.

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

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

From the gastrointestinal tract: diarrhea, vomiting.

From the skin and subcutaneous tissue: alopecia.

From the side of the kidneys and urinary tract: retention of urine.

From the genitals and the breast: impaired ejaculation / orgasm, impotence, menstrual irregularity, uterine bleeding.

Overdose:

Metformin

Symptoms when metformin was used at a dose of 85 g (42.5 times the maximum daily dose), no hypoglycemia was observed, but lactoacidosis was noted.

Significant overdose or associated risk factors may lead to the development of lactic acidosis.

Treatment: in the case of the appearance of signs of lactic acidosis, the drug should be discontinued immediately, the patient must be hospitalized urgently and, by determining the concentration lactate, clarify the diagnosis. The most effective measure for excretion from the body of lactate and metformin is hemodialysis. Conduct also symptomatic treatment.

Sibutramine

There are extremely limited data on the overdose of sibutramine. The most common adverse reactions associated with overdose: tachycardia, increased blood pressure, headache, dizziness. You should notify your doctor if there is an alleged overdose.

Treatment: there is no specific treatment or specific antidotes. It is necessary to carry out general measures: to ensure free breathing, to observe the state of the cardiovascular system, and also, if necessary, to carry out maintenance symptomatic therapy. The timely use of activated carbon,as well as gastric lavage can reduce the intake of sibutramine in the body. Patients with high blood pressure and tachycardia can be assigned beta-blockers. The effectiveness of forced diuresis or hemodialysis is not established.

In case of an overdose, you should immediately cancel the use of Reduxin® Met.

Interaction:

Contraindicated combinations

Iodine-containing radiopaque agents: on the background of functional renal insufficiency in patients with diabetes mellitus, a radiological study using iodine-containing radiocontrast agents can cause the development of lactic acidosis. Treatment with metformin should be canceled depending on the function of the kidneys 48 hours before or during the X-ray study using iodine-containing radiopaque means and not to resume earlier 48 hours after, provided that during the examination the renal function was recognized normal.

Unrecommended combinations

Alcohol: acute alcohol intoxication increases the risk of developing lactic acidosis, especially in the case of: malnutrition, low-calorie diet; hepatic insufficiency.When taking the drug, avoid drinking alcohol and medications containing ethanol.

Combinations that require caution

Danazol: It is not recommended to take danazol concurrently to avoid hyperglycemic action of the latter. If it is necessary to treat danazol and after stopping the latter, a dose adjustment of metformin is required under the control of the glucose concentration in the blood.

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 stopping the intake of the latter, correction of the dose of the drug under the control of the concentration of glucose in the blood is required.

Glucocorticosteroids (GCS) systemic and local effects 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, correction of the dose of metformin is required under the control of the concentration of glucose in the blood.

Diuretics: simultaneous administration of "loop" diuretics can lead to the development of lactic acidosis due to possible functional renal failure. Do not assign metformin, if the SC is below 60 ml / min.

Assigned in the form of injections beta₂-adrenomimetiki: increase the concentration of glucose in the blood due to stimulation of beta₂adrenoreceptors. 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 medicines, 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 treatment and after its termination.

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.

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

Nifedipine increases absorption and C_max metformin.

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

Sibutramine

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

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

The simultaneous use of several drugs that increase serotonin levels in blood plasma can lead to the development of 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 certain medications for the treatment of migraine (sumatriptan, dihydroergotamine), with potent analgesics (pentazocine, pethidine, fentanyl) or antitussive drugs (dextromethorphan). Sibutramine does not affect the effect of oral contraceptives.

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

With simultaneous use with sibutramine other drugs that affect hemostasis or platelet function, the risk of bleeding increases. 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-catarrhal and antiallergic drugs, which include ephedrine or pseudoephedrine. Therefore, in cases of simultaneous administration of these drugs with sibutramine, care should be taken.

Combined use of sibutramine with drugs to reduce body weight, 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 severe (high mortality in the absence of emergency treatment) complication that may occur due to cumulation metformin. The cases of lactic acidosis with metformin were developed mainly in diabetic patients with severe renal insufficiency.

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

The risk of developing lactic acidosis when nonspecific signs appear, such as muscle cramps, accompanied by dyspeptic symptoms, abdominal pain and severe asthenia, should be considered. 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), a lactate content in the blood plasma above 5 mmol / l, an increased anion gap and a lactate / pyruvate ratio.If you suspect a metabolic acidosis, stop taking the medication and consult a doctor immediately.

Surgical operations

The use of Reduxin® Meth should be discontinued 48 hours before planned surgical procedures and can be continued no earlier than 48 hours after, provided that during the examination the renal function was found to be normal.

Kidney function

Because the metformin is excreted by the kidneys before starting the preparation Reduxin® Met and regularly it is necessary to determine the clearance of creatinine (CC) in the subsequent period: at least once a year in patients with normal renal function, and 2-4 times a year in elderly patients, and also patients with QC at the lower limit of the norm.

Care should be taken if there is a possible impairment of kidney function in elderly patients, while using antihypertensive drugs, diuretics or non-steroidal anti-inflammatory drugs. Patients are encouraged to continue to follow a diet with an even intake of carbohydrates throughout the day. Patients with excessive body weight are encouraged to continue to observe a hypocaloric diet (but not less than 1000kcal / day).

It is recommended that regular laboratory tests be performed on a regular basis to control diabetes mellitus.

Caution is advised when using Reduxin® Meth in combination with insulin or other hypoglycemic agents (including sulfonylurea derivatives, repaglinide).

Reduxin® Meta should be used only in those cases when all non-medicamentous measures to reduce body weight are ineffective - if the reduction in body weight within 3 months was less than 5 kg. Treatment with Reduxin® Meth should be carried out within the framework of complex therapy for weight loss under the supervision of a doctor who has practical experience in the treatment of obesity. Complex therapy includes both changing diet and lifestyle, and increasing physical activity. An important component of therapy is the creation of the prerequisites for a persistent change in eating behavior and lifestyle that are necessary to maintain the achieved weight loss and after the abolition of drug therapy. Patients need to change their lifestyle and habits within the framework of therapy with the drug Reduxin® Met in such a way that after the completion of the treatment it is ensured that the achieved reduction in body weight is maintained.Patients should clearly realize that failure to comply with these requirements will lead to a second increase in body weight and repeated calls to the treating physician.

In patients taking Reduxin® Met, blood pressure and heart rate should be measured. In the first 3 months of treatment, these parameters should be monitored every 2 weeks, and then monthly. If, during two visits in a row, there is an increase in the heart rate at rest ≥ 10 beats per minute or systolic / diastolic pressure ≥ 10 mm Hg, it is necessary to stop treatment. In patients with arterial hypertension who have blood pressure above 145/90 mm Hg against a background of antihypertensive therapy, This control should be carried out particularly carefully and, if necessary, at shorter intervals. In patients who had twice the arterial blood pressure for repeated measurement, 145/90 mm Hg. The treatment with Reduxin® Meth must be suspended (see the section "Side effects: cardiovascular disorders").

Patients with sleep apnea syndrome need to carefully monitor blood pressure.

Special attention should be paid to the simultaneous administration of drugs that increase the interval QT. These drugs are H₁-gistaminoblockers (astemizole, terfenadine); antiarrhythmic drugs that increase the interval QT (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol); stimulator of gastrointestinal motility of cisapride; pimozide, sertindole and tricyclic antidepressants. This also applies to states that are capable of increasing interval QT, such as hypokalemia and hypomagnesemia (see section "Interaction with other drugs").

The interval between the intake of MAO inhibitors (including furazolidone, procarbazine, selegiline) and the Reduxin® Meth preparation should be at least 2 weeks.

Although there is no relationship between sibutramine intake and primary pulmonary hypertension, however, given the generally known risk of drugs in this group, with regular medical supervision, special attention should be paid to symptoms such as progressive dyspnea (breathing disorder), chest pain and swelling on the legs .

If a dose of Reduxin® Meth is missed, the double dose of the drug should not be taken in the next dose, it is recommended to continue taking the drug according to the prescribed schedule.

Duration of reception of the drug Reduxin® Meta should not exceed 1 year.

With the joint administration of sibutramine and other serotonin reuptake inhibitors, there is an increased risk of bleeding. In patients who are prone to bleeding, as well as taking drugs that affect hemostasis or platelet function, sibutramine should be used with caution.

Although clinical data on addiction to sibutramine are not available, it should be ascertained whether there has been a history of drug dependence in the patient's history and pay attention to possible signs of drug abuse.

Effect on the ability to drive transp. cf. and fur:

The use of Reduxin® Meta may limit the ability to drive vehicles and mechanisms. During the period of use of the Reduxin® Met preparation, care must be taken when driving vehicles and engaging in other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Set: tablets 850 mg + capsules 10 mg + 158.5 mg; tablets 850 mg + capsules 15 mg + 153.5 mg.

Packaging:For 10, 60 tablets of metformin in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

By 7, 10, 14 or 15 capsules of sibutramine + cellulose microcrystalline in a contour cell packaging made of polyvinylchloride film and aluminum foil printed lacquered.

At 7, 10, 14, 15, 28, 30, 60, 90, 120, 150, 160 or 180 capsules of sibutramine + cellulose microcrystalline in a polymer container for medicines.

10, 20, 30, 40, 50, 60, 100 or 120 tablets of metformin in cans of polymeric for medicines.

1 bank containing metformin tablets and 1 container containing microcrystalline cellulose sibutramine + cellulose capsules or 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20 or 22 contour cell packs containing metformin tablets and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 11 contour cells containing the capsules of sibutramine + cellulose microcrystalline, respectively, together with the instructions for use are placed in a pack of cardboard.

Storage conditions:In the dark place at a temperature of no higher than 25 ° C. The drug should be stored in places inaccessible to children.

Shelf life:3 years (tablets 3 years, capsules 3 years).
Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002403

Date of registration:18.03.2014

The owner of the registration certificate:Promomed Rus, Open CompanyPromomed Rus, Open Company Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp05.10.2015

Illustrated instructions

Instructions

Reduxin® Met (Reduxin® Met)