Expiration date: 02/2025

Composition

Set of tablets and capsules, 1 set contains:

tablets, 1 tablet contains active substance:  

Metformin hydrochloride 850 mg

excipients: MCC — 25.5 mg; croscarmellose sodium — 51 mg; purified water — 17 mg, povidone K17 (polyvinylpyrrolidone) — 68 mg; magnesium stearate — 8.5 mg  

capsules, 1 capsule contains active substance:  

sibutramine hydrochloride monohydrate 10/15 mg

microcrystalline cellulose 158.5/153.5 mg

excipients: calcium stearate — 1.5/1.5 mg  

capsule (for dosage of 10 mg): titanium dioxide — 2%; azorubin dye — 0.0041%; diamond blue dye — 0.0441%; gelatin — up to 100%  

capsule (for dosage 15 mg): titanium dioxide — 2%; blue dye patented — 0.2737%; gelatin — up to 100%  

Description of dosage form

Tablets: oval biconvex, white or almost white scored one side.

Capsules for dosage 10 mg: ?2 blue.

Capsules for dosage 15 mg: ?2 blue.

The contents of the capsules — white or white powder with a slightly yellowish tinge.

Pharmacological action

Pharmacological action — enterosorbent, anorectic, hypoglycemic.

Pharmacodynamics

The drug Reduxin® Met contains two separate drugs in a single package: hypoglycemic agent for oral administration, the group of biguanides in the form of pills and Metformin for the treatment of obesity in the form of capsules containing sibutramine and Microcrystalline cellulose.

The simultaneous use of Metformin and sibutramine with MCC increases the therapeutic effectiveness of the combination used in patients with overweight and type 2 diabetes.

Metformin

Oral hypoglycemic drug from the group of biguanides, reduces hyperglycemia, without leading to the development of hypoglycemia. In contrast to derivatives of sulfonylurea, stimulates insulin secretion and does not cause hypoglycemic effect in healthy individuals. Increases the sensitivity of peripheral receptors to insulin and glucose utilization by cells. Inhibits gluconeogenesis in the liver. Delays the absorption of carbohydrates in the intestine. Metformin stimulates glycogen synthesis by acting on glycogen synthase. Increases the transport capacity of all types of membrane glucose carriers. In addition, it has a beneficial effect on lipid metabolism: reduces the total content of HC, LDL and triglycerides. While taking Metformin, the patient's body weight either remains stable or moderately decreases.

Sibutramine

It is a prodrug and exhibits 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 synapses increases the activity of Central 5-NT-serotonin and adrenergic receptors, which increases the feeling of saturation and reduces the need for food, as well as an increase in thermal production. Beta 3 indirectly by activating adrenergic receptors, sibutramine effect on brown adipose tissue. Weight loss is accompanied by an increase in serum concentrations of HDL and a decrease in the number of triglycerides, total Cholesterol, LDL and uric acid. Sibutramine and its metabolites do not affect the release of monoamines, do not inhibit MAO; do not have an affinity for a large number of neurotransmitter receptors, including serotonin (5-HT1-, 5-HT1A-, 5-HT1B-, 5-HT2C-), adrenergic (beta1-, beta2-, beta3-, alfa1-, alfa2-), dopamine (D1-, D2-), muscarinic, histamine (H1-), benzodiazepine and glutamate NMDA receptors.

Microcrystalline cellulose

It is an enterosorbent, has sorption properties and non-specific detoxification effect. It binds and removes from the body various microorganisms, their waste products, toxins of exogenous and endogenous nature, allergens, xenobiotics, as well as an excess of some metabolic products and metabolites responsible for the development of endogenous toxicosis.

Pharmacokinetics

Metformin

Suction. After oral administration, Metformin adequately absorbed from the gastrointestinal tract. While eating, the absorption of Metformin is reduced and delayed. Absolute bioavailability is 50-60%. Cmax in plasma is approximately 2 µg/ml or 15 µmol and is achieved after 2.5 h.

Distribution. Metformin is rapidly distributed in the body tissues. Practically does not bind to plasma proteins.

Metabolism. Very little is metabolized.

Breeding. Excreted by the kidneys. The clearance of Metformin in healthy individuals is 400 ml/min (4 times more than creatinine Cl), which indicates active tubular secretion. T1/2 is approximately 6.5 hours.

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 is rapidly absorbed from the gastrointestinal tract by at least 77%. In the primary passing through the liver biotransformation under the influence of CYP3A4 with the formation of two active metabolites (monodispersity (M1) and didemethylcitalopram (M2). After a single dose of 15 mg Cmax Ml is 4 ng/ml (3.2–4.8 ng/ml), M2 — 6.4 ng/ml (5.6–7.2 ng/ml). Cmax is reached after 1.2 hours (sibutramine), 3-4 hrs (active metabolites). Simultaneous eating lowers Cmax metabolites by 30% and increases Tmax by 3 h, without changing the AUC.

Distribution. Quickly distributed to the tissues. Protein binding is 97 (sibutramine) and 94% (Ml and M2). Css active metabolites in the blood is achieved within 4 days after the start of treatment and approximately 2 times the concentration in plasma after a single dose.

Metabolism and excretion. Active metabolites undergo hydroxylation and conjugation to form inactive metabolites, which are excreted mainly by the kidneys. T1/2 sibutramine — 1.1 h, Ml — 14 h, M2 — 16 h.

Special clinical cases

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

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

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

Liver failure. In patients with liver failure of moderate severity after a single administration of sibutramine AUC active metabolites Ml and M2 24% higher than in healthy individuals.

The testimony of the drug Reduxin® Met

To reduce body weight in the following conditions:

• nutritional obesity with BMI of 27 kg/m2 or more in combination with type 2 diabetes and dyslipidemia.
• alimentary obesity with a BMI of more than 30 kg/m2 in patients with prediabetes and additional risk factors for type 2 diabetes, in which lifestyle changes have not allowed to achieve adequate glycemic control.

Contraindications

• hypersensitivity to the drug components;
• diabetic ketoacidosis, diabetic precoma, diabetic coma;
• impaired renal function (Creatinine CL less than 45 ml/min);
• the liver;
• acute conditions in which there is a risk of renal dysfunction: dehydration (diarrhea, vomiting), severe infectious diseases, shock;
• cardiovascular disease (history and present): coronary heart disease (myocardial infarction, angina), occlusive peripheral artery disease, tachycardia, arrhythmia, cerebrovascular disease (stroke, transient disorders of cerebral circulation), chronic heart failure in the decompensation stage;
• uncontrolled arterial hypertension (HELL above 145/90 mm Hg.V. — see «Special instruction»);
• clinical manifestations of acute and chronic diseases that can lead to the development of tissue hypoxia (including respiratory failure, acute heart failure, chronic heart failure with unstable hemodynamic parameters, acute myocardial infarction);
• chronic alcoholism, acute ethanol poisoning;
• thyrotoxicosis;
• benign prostatic hyperplasia;
• pheochromocytoma;
• glaucoma;
• extensive surgery and trauma (when shown holding insulin);
• lactate-acidosis (including history);
• established pharmacological or drug dependence;
• period less than 48 hours before and within 48 hours after the radioisotope or x-ray studies with the introduction of iodine-containing contrast agent;
• adherence to a reduced-calorie diet (less than 1000 kcal/day);
• 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 (including phentermine, phenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or their use for 2 weeks before taking sibutramine and 2 weeks after its administration, other drugs acting on the Central nervous system, inhibiting the reuptake of serotonin (eg, antidepressants), neuroleptics, hypnotics containing tryptophan, as well as other drugs of Central action to reduce body weight or treat mental disorders;
• pregnancy;
• lactation;
• age up to 18 and over 65 years.

Caution: chronic heart failure; coronary artery disease (including in history), in addition to coronary heart disease (myocardial infarction, stenocardia); glaucoma, angle-closure glaucoma also; cholelithiasis; hypertension (controlled and history); neurological disorders, including mental retardation and seizures (including history); epilepsy; impaired renal function mild or moderate severity, kidney failure (Cl creatinine 45-59 ml/min); motor and verbal tics in history; tendency to bleeding, blood clotting disorders; taking drugs that affect hemostasis or platelet function; patients over 60 years, performing heavy physical work, which is associated with an increased risk of lactate acidosis.

Use during pregnancy and breast-feeding

Since until now there is not enough convincing number of studies on the safety of sibutramine exposure to the fetus, this drug is contraindicated during pregnancy.

Women with preserved reproductive potential while taking the drug Reduxin® Met needs to use contraceptives.

Contraindicated use of the drug Reduxin® Met during breastfeeding.

Side effect

Determination of 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 (<1/10000). The side effect is presented in order of decreasing importance.

Metformin

From the metabolism and nutrition: very rarely — lactate acidosis; with prolonged use may reduce the absorption of vitamin B12. Reducing the concentration of vitamin B12 should be taken into account in patients with megaloblastic anemia.

CNS: often — a violation of taste.

From the digestive system: very often — nausea, vomiting, diarrhea, abdominal pain, lack of appetite (most often these symptoms occur in the initial period of treatment and in most cases spontaneously pass); very rarely — a violation of liver function, hepatitis, after the abolition of Metformin, these adverse events disappear completely. A slow increase in the dose may improve gastrointestinal tolerability.

From the skin: 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 weaken over time. Side effects are generally mild and reversible.

From the Central nervous system: very often — dry mouth and insomnia, often marked headache, dizziness, anxiety, paresthesia, as well as changes in taste.

From the CCC: often — tachycardia, palpitations, vasodilation, increased blood PRESSURE (moderate rise in blood PRESSURE at rest on 1-3 mm Hg.article and a moderate increase in heart rate by 3-7 beats/min). In some cases, more pronounced increase in blood PRESSURE and 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). The use of the drug Reduxin® Met in patients with high blood pressure — see "Contraindications" and "Special instructions".

From the digestive system: very often — loss of appetite and constipation, often nausea and exacerbation of hemorrhoids. With a tendency to constipation in the first days, it is necessary to control the evacuation function of the intestine. When constipation occurs, the reception is stopped and a laxative is taken.

From the skin: often — increased sweating.

In isolated cases, the treatment of sibutramine describes the following undesirable clinically significant phenomena: dysmenorrhea, swelling, 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, schönlein-genoch Purple (bleeding into the skin), convulsions, thrombocytopenia, transient increase in the activity of liver enzymes in the blood.

During post-marketing studies of sibutramine has been described additional adverse reactions are listed below by organ system.

CCC: atrial fibrillation.

Allergic reactions: hypersensitivity reactions (from moderate skin rashes and urticaria to angioedema (angioedema Quincke) and anaphylaxis).

From the Central nervous system: psychosis, state of suicidal thinking, suicide and mania, short-term memory disorders, convulsions. In the event of such conditions, the drug should be discontinued.

From the sensory organs: blurred vision (blurring of vision).

From the digestive system: diarrhea, vomiting.

From the skin: alopecia.

From the urinary system: urinary retention.

Reproductive system disorders: ejaculation/orgasm disorders, impotence, menstrual irregularities, uterine bleeding.

Interaction

Metformin

Contraindicated in combination

Iodine-containing radiopaque agents. Against the background of functional renal failure in patients with diabetes mellitus, radiological examination using iodine-containing radiopaque agents can cause the development of lactate acidosis. Treatment with Metformin need to cancel depending on renal function for 48 h before or at the time of the radiological studies using iodinated Radiocontrast dye and does not resume prior to the 48 hours after, provided that in the examination of renal function was considered normal.

Deprecated combinations

Alcohol. With acute alcohol intoxication, the risk of lactate acidosis increases, especially in the case of malnutrition, compliance with a low-calorie diet and liver failure. While taking the drug should avoid alcohol and drugs, containing ethanol.

Combinations that require caution

Danazol. It is not recommended to take danazole simultaneously to avoid hyperglycemic action of the latter. If necessary, treatment with danazol and after discontinuation of the latter, a correction of the dose of Metformin under the control of glucose concentration in the blood is required.

Chlorpromazine. When taken in large doses (100 mg per day) increases the concentration of glucose in the blood, reducing the release of insulin. In the treatment of neuroleptics and after discontinuation of the latter, a correction of the dose of the drug under the control of glucose concentration in the blood is required.

GCS systemic and local actions reduce glucose tolerance, increase the concentration of glucose in the blood, sometimes causing ketosis. In the treatment of corticosteroids and after discontinuation of the latter, a correction of the dose of Metformin under the control of glucose concentration in the blood is required.

Diuretics. Concomitant administration of loop diuretics can lead to the development of lactate acidosis due to possible functional renal failure. Metformin should not be prescribed if creatinine Cl is below 60 ml/min.

Appointed by the injection of beta2-agonists. Increase the concentration of glucose in the blood due to the stimulation of beta2-adrenergic receptors. In this case, it is necessary to control the concentration of glucose in the blood. If necessary, the appointment of insulin is recommended.

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

ACE 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 sulfonylurea derivatives, insulin, acarbose, salicylates may develop hypoglycemia.

Nifedipine. Increases 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 CYP3A4 isoenzyme (including ketoconazole, erythromycin, cyclosporine). Increase in plasma concentrations of metabolites of sibutramine with increased heart rate and clinically insignificant increase in the QT interval.

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

The simultaneous use of several drugs that increase the content of serotonin in blood plasma can lead to the development of serious interaction. In rare cases, while the use of sibutramine with siosis (drugs for the treatment of depression), some drugs for the treatment of migraine (sumatriptan, dihydroergotamine), potent analgesics (pentazocin, pethidine, fentanyl) or antitussive drugs (dextrometorphan) can develop the so-called serotonin syndrome.

Sibutramine does not affect the effect of oral contraceptives.

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

While the use of other drugs with sibutramine, affecting hemostasis or platelet function, increases the risk of bleeding.

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, anti-cold and anti-allergic 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.

Dosage and administration

Inside. Metformin tablets and sibutramine capsules should be taken in the morning at the same time, without chewing and drinking enough liquid (1 glass of water) in combination with food.

The recommended initial dose is 1 table. containing 850 mg of Metformin and 1 caps. containing 10 mg of sibutramine.

It is necessary to monitor the dynamics of changes in the concentration of glucose in the blood and the dynamics of weight loss. If after 1-2 weeks the optimal values of glucose concentration in the blood are not reached, the dose of Metformin should be increased to 2 table. The usual maintenance dose of Metformin is 1700 mg/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 doses. For example, take 1 table. in the morning and 1 table. in the evening. If within 4 weeks from the start of treatment is not achieved weight loss of 2 kg, the dose of sibutramine increases to 15 mg/day.

Treatment with reducsin® met Should not continue for more than 3 months in patients who do not respond well to therapy, i.e. who within 3 months of treatment can not achieve a reduction in body weight by 5% of the baseline. Treatment should not be continued if further therapy after the achieved weight loss the patient again adds to the body weight of 3 kg or more. The duration of treatment should not exceed 1 year, because for a longer period of sibutramine data on the effectiveness and safety are not available.

Treatment with the drug Reduxin® Met should be combined with diet and exercise under the supervision of a doctor with experience treating obesity.

In prediabetes, the usual dose is 850-1700 mg/day of Metformin and 10-15 mg/day of sibutramine.

If necessary, increase the dose of Metformin to 1700 mg in the evening should take an additional 1 table. metformin's. It is recommended to regularly carry out glycemic control to assess the need for further use of the drug and the correction of the dose of Metformin.

The duration of use of the drug in diabetes mellitus type 2 and prediabetes should not exceed 1 year, since for a longer period of sibutramine intake data on efficacy and safety are not available. In the future, it is recommended to switch to Metformin monotherapy.

Overdose

Metformin

Symptoms when using Metformin at a dose of 85 g (42.5 times the maximum daily dose): hypoglycemia was not observed, but the development of lactate acidosis was noted. A significant overdose or associated risk factors can lead to the development of lactate acidosis.

Treatment: in case of signs of lactate acidosis, treatment with the drug should be stopped immediately, the patient should be urgently hospitalized and, after determining the concentration of lactate, clarify the diagnosis. The most effective measure for the excretion of lactate and Metformin is hemodialysis. Spend also symptomatic treatment.

Sibutramine

There is very limited evidence of an overdose of sibutramine.

Symptoms: 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 provide free breathing, to monitor the state of CCC, and if necessary, to carry out supportive symptomatic therapy. Timely administration 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 prescribed beta-blockers. The effectiveness of forced diuresis or hemodialysis has not been established. In case of overdose, immediately stop taking the drug Reduxin® Met.

Special instruction

Lactate-acidosis. Lactate acidosis is a rare but serious (high mortality in the absence of emergency treatment) complication that can occur due to the accumulation of Metformin. Cases of lactate acidosis when taking Metformin occurred mainly in patients with diabetes mellitus with severe renal failure. Other associated risk factors, such as decompensated diabetes mellitus, ketosis, prolonged fasting, alcoholism, liver failure and any condition associated with severe hypoxia, should be taken into account. This can help reduce the incidence of lactate acidosis.

You should consider the risk of lactate acidosis with the appearance of nonspecific signs, such as muscle cramps, accompanied by dyspeptic symptoms, abdominal pain and severe asthenia. Lactate acidosis is characterized by acidotic dyspnea, abdominal pain and hypothermia followed by coma. Diagnostic laboratory parameters are a decrease in blood pH (less than 7.25), lactate content in blood plasma over 5 mmol/l, increased anionic interval and lactate/pyruvate ratio. If you suspect a metabolic acidosis, you should stop taking the drug and immediately consult a doctor.

Surgery. The use of the drug Reduxin® Met should be discontinued for 48 hours prior to scheduled surgery and may be continued no earlier than 48 hours after, provided that in the examination of renal function was considered normal.

Kidney function. Since Metformin is excreted by the kidneys, before taking the drug reducsin® Meth and regularly thereafter, it is necessary to determine the creatinine Cl: at least 1 time a year in patients with normal renal function and 2-4 times a year in elderly patients, as well as in patients with creatinine Cl on NGN.

Special care should be taken when possible renal dysfunction in elderly patients, while the use of antihypertensive drugs, diuretics or NSAIDs. Patients are advised to continue to follow a diet with a uniform intake of carbohydrates throughout the day. Patients who are overweight are advised to continue to follow a hypocaloric diet (but not less than 1000 kcal/day).

It is recommended to regularly carry out standard laboratory tests to control diabetes.

Advised to exercise caution when using the drug Reduxin® Met in combination with insulin or other hypoglycemic agents (including sulfonylureas, Repaglinide).

Treatment with the drug Reduxin® Met must be part of a comprehensive therapy for weight loss under the supervision of a doctor with experience treating obesity. Complex therapy includes changes in diet and lifestyle, as well as increased physical activity. An important component of the therapy is the creation of prerequisites for persistent changes in eating behavior and lifestyle, which are necessary to maintain the achieved weight loss and after the abolition of drug therapy. Patients should in the treatment of drug Reduxin® Met to change your lifestyle and habits so that after completion of treatment to ensure the preservation of the achieved reduction of body weight. Patients should clearly understand that failure to comply with these requirements will lead to repeated weight gain and repeated visits to the doctor.

In patients receiving the drug Reduxin® Met, 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, during two consecutive visits, an increase in heart rate at rest ?10 BPM or SBP ?10 mm Hg is detected.art., it is necessary to stop treatment. In patients with hypertension, in which the background of hypotensive therapy blood PRESSURE ?145/90 mm Hg.this control should be carried out especially carefully and, if necessary, at shorter intervals. In patients whose blood PRESSURE twice when re-measured exceeded 145/90 mm Hg.article, the treatment of drug Reduxin® Met should be suspended (see "Side effects", From the CCC).

The use of Metformin is contraindicated in acute heart failure and CHF with unstable hemodynamic parameters. In patients with CHF the drug Reduxin® Meth increases the risk of hypoxia and renal failure, such patients need regular monitoring of heart function and kidney. In patients with sleep apnea syndrome, blood PRESSURE should be especially carefully controlled.

Special attention requires simultaneous administration of drugs that increase the QT interval. Those drugs include blockers of H1-receptors (astemizole, terfenadine); anti-arrhythmic drugs that increase the QT interval (amiodarone, quinidine, flecainide, meksiletin, propafenon, sotalol); stimulator of motility of the gastrointestinal tract 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 "Interaction").

The interval between receiving MAO inhibitors (including furazolidone, procarbazine, selegiline) and the drug Reduxin® Met shall be not less than 2 weeks. Although there is no link between taking sibutramine and the development of primary pulmonary hypertension, 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 distress), chest pain and swelling on the legs.

If you miss a dose of the drug reducsin® met Should not be taken in the next dose of a double dose of the drug, it is recommended to continue taking the drug according to the prescribed scheme.

The duration of the drug Reduxin® Met not to exceed 1 year.

With joint administration of sibutramine and other SSRIs, 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 clinical data on addiction to sibutramine are not available, it should be clarified whether the patient has a history of drug dependence, and pay attention to possible signs of drug abuse.

The use of the drug in patients with prediabetes is recommended in the presence of additional risk factors for the development of obvious type 2 diabetes, which include age less than 60 years, BMI more than 30 kg/m2, gestational diabetes mellitus in history, family history of diabetes in relatives of the first line of kinship, increased concentration of triglycerides, reduced concentration Of HDL cholesterol, hypertension.

Influence on the ability to drive vehicles and machinery. The drug Reduxin® Met may limit the ability to drive vehicles and mechanisms. During the period of use of the drug Reduxin® Met be careful when driving and occupation of other potentially hazardous activities, require high concentration and psychomotor speed reactions.

Form release

Set: tablets 850 mg + capsules 10 mg + 158.5 mg; tablets 850 mg + capsules 15 mg + 153.5 mg.

By 10, 20, 25, 30 or 60 tables. Metformin in blister from PVC film and aluminum foil printed patent. On 7, 10, 14 or 15 caps. sibutramine + Microcrystalline cellulose in blister from PVC film and aluminum foil printed patent. To 7, 10, 14, 15, 28, 30, 60, 90, 120, 150, 160 or 180 caps. sibutramine + MCC in a polymer container for drugs. To 10, 20, 25, 30, 40, 50, 60, 100 or 120 table. Metformin in a polymer jar for drugs. 1 Bank containing tablets of Metformin, and 1 container containing capsules sibutramine + microcrystalline, or 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20 22 or the contour of packages containing tablets of Metformin, and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 11 contour cell packages containing capsules sibutramine + microcrystalline, respectively, placed in a cardboard pack.

Manufacturer

OOO "Ozon".

Legal address: 11, Pesochnaya str., Zhigulevsk, Samara region, 445351, Russia.

The address of the place of production: 445351, Russia, Samara region, Zhigulevsk, street of Hydrobuilders, 6.

Tel/Fax: (84862) 3-41-09, 7-18-51.

e-mail: [email protected]

www.ozonpharm.ru

The address and phone number of the authorized organization for contacts (direction of claims and complaints): LLC "PROMOTIONAL RUS". 105005, Russia, Moscow, Malaya Pochtovaya street, 2/2, p. 1, POM. 1. 2.

Tel: (495) 640-25-28.

Conditions of supply of pharmacies

By prescription.

Storage conditions of the drug Reduxin® Met

In a dark place, at a temperature not exceeding 25 °C.

Keep out of reach of children.

The shelf life of the drug Reduxin® Met

3-year table., 3 years caps.

Do not use after the expiration date indicated on the package.