Expiration date: 03/2026

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Release form and composition:

Capsules solid gelatin, size #2, with a yellow body and a blue lid the contents of the capsules-powder from white to almost white.

1 caps.

sibutramine hydrochloride monohydrate 10 mg

Excipients: lactose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.

The composition of the capsule body: dye sunset yellow, dye quinoline yellow, titanium dioxide, sodium lauryl sulfate, gelatin.

The composition of the capsule cap: fuchsin acid dye (DampC33), diamond blue dye, titanium dioxide, sodium lauryl sulfate, gelatin.

10 PCs. - blisters (1) - cardboard packs.

10 PCs. - blisters (3) - cardboard packs.

Capsules solid gelatin, size #2, with a white body and a blue lid the contents of the capsules-powder from white to almost white.

1 caps.

sibutramine hydrochloride monohydrate 15 mg

Excipients: lactose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.

Capsule body composition: titanium dioxide, sodium lauryl sulfate, gelatin.

The composition of the capsule cap: fuchsin acid dye (DampC33), diamond blue dye, titanium dioxide, sodium lauryl sulfate, gelatin.

10 PCs. - blisters (1) - cardboard packs.

10 PCs. - blisters (3) - cardboard packs.

Pharmacological action:

The drug for the treatment of obesity of Central action. Sibutramine is a prodrug and manifests its action in viv due to metabolites (primary and secondary amines) inhibiting the reuptake of monoamines (mainly serotonin and norepinephrine). Increasing the content of neurotransmitters in synapses increases the activity of Central serotonin 5NT receptors and adrenoreceptors, which contributes to an increase in the feeling of satiety and reduce the need for food, as well as an increase in thermal production. Indirectly activate beta3-adrenergic receptors, sibutramine effect on brown adipose tissue.

Weight loss is accompanied by an increase in serum HDL concentrations and a decrease in 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 affinity for a large number of neurotransmitter receptors, including serotonin (5HT1-, 5HT1A-, 5HT1B-, 5NT2A-, 5NT2C-), adrenergic (beta1-, beta2-, beta3-, apha1-, apha2-) , dopamine (D1-, D2-), muscarinic, histamine (H1-), benzodiazepine and NMDA receptors.

Pharmacokinetics:

Suction

After ingestion is rapidly absorbed from the gastrointestinal tract by at least 77%. During the first passage through the liver undergoes biotransformation under the influence of cytochrome P450 3A4 isoenzyme with the formation of two active metabolites (mono-and didesmethylsibutramine). After a single dose of 15 mg Cmax monodesmethylsibutramine is 4 ng / ml (3.2-4.8 ng / ml), Cmax didesmethylsibutramine-6.4 ng / ml (5.6-7.2 ng / ml). Tmax of sibutramine-1.2 h, Tmax of active metabolites-3-4 h. Simultaneous intake of food reduces Cmax of metabolites by 30% and increases the time of its achievement by 3 h, without changing the AUC.

Distribution

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

Metabolism and excretion

T1 / 2 sibutramina-1.1 h, monodesmetilsibutramina-14 h, didesmetilsibutramina -16 h. Active metabolites undergo hydroxylation and conjugation to form inactive metabolites, which are excreted mainly by the kidneys.

Indications:

• alimentary obesity with a body mass index (BMI) of 330 kg / m2
• alimentary obesity with a BMI of 27 kg / m2 in combination with type 2 diabetes mellitus or dyslipoproteinemia.

Dosage regimen:

Goldline assign inside 1 time/day. The dose is set individually, depending on the tolerability and clinical efficacy. It is recommended that the initial dose of 10 mg, with poor tolerance, you can take 5 mg. Capsules should be taken in the morning, without chewing and drinking a sufficient amount of liquid (a glass of water). The drug can be taken on an empty stomach or combined with meals. If within 4 weeks from the beginning of treatment is not achieved weight loss of 5% or more, the dose is increased to 15 mg / day.

Goldline treatment 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 5% reduction in body weight from the baseline. Treatment should not be continued if, with further therapy, after the achieved weight loss, the patient again adds 3 kg or more to the body weight. The duration of treatment should not exceed 2 years, since there are no data on the effectiveness and safety of sibutramine for a longer period of administration.

Goldline treatment should be carried out in conjunction with diet and exercise under the supervision of a doctor with practical experience in the treatment of obesity.

Side effect:

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 and, depending on the effects on organs and organ systems, are presented in the following order: often (1-10%), sometimes (1-10%), rarely (t 1%).

From the CNS: often-insomnia sometimes-headache, dizziness, anxiety, paresthesia.

From the cardiovascular system: sometimes-tachycardia, palpitations, increased blood PRESSURE, symptoms of vasodilation (including hyperemia of the skin), exacerbation of hemorrhoids. There is a moderate rise in blood PRESSURE at rest at 1-3 mm Hg. rapid and moderate increase in heart rate by 3-7 beats / min. in some cases, more pronounced increases in blood PRESSURE and heart rate are not excluded. Clinically significant changes in blood PRESSURE and heart rate are recorded mainly at the beginning of treatment (in the first 4-8 weeks).

From the digestive system: often-dry mouth, loss of appetite and constipation sometimes-nausea, taste changes.

Dermatological reactions: sometimes-increased sweating.

In isolated cases, the treatment with sibutramine describes the following undesirable clinically significant phenomena: 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-Genoch purpura (skin hemorrhages), convulsions, thrombocytopenia, transient increase in the activity of liver enzymes in the blood.

One patient with schizoaffective disorder, which supposedly existed before treatment, developed acute psychosis after treatment.

Withdrawal reactions such as headache or increased appetite are rare.

There is no evidence that withdrawal, withdrawal, or mood disorders occur after treatment.

Contraindications:

• the presence of organic causes of obesity (eg, hypothyroidism)
• serious eating disorders (anorexia nervosa or bulimia nervosa)
• mental illness
• Gilles de La Tourette syndrome (generalized tics)
• simultaneous administration of MAO inhibitors or their use for 2 weeks before the appointment of the drug Goldline
• the use of other drugs acting on the Central nervous system (eg, antidepressants, neuroleptics)
• the use of drugs prescribed for sleep disorders containing tryptophan, as well as other drugs of Central action to reduce body weight
• Coronary heart disease, decompensated chronic heart failure, congenital heart disease, occlusive peripheral artery disease, tachycardia, arrhythmia, cerebrovascular disease (stroke, transient cerebral circulation disorders)
• uncontrolled hypertension (blood PRESSURE above 145/90 mm Hg. st.)
• thyrotoxicosis
• severe impairment of liver and/or kidney function
• benign prostatic hyperplasia
• pheochromocytoma
• glaucoma
• established pharmacological, drug or alcohol dependence
• pregnancy
• lactation (breastfeeding)
• age under 18 and over 65 years
• established hypersensitivity to sibutramine or to other components of the drug.

With caution, the drug should be prescribed for the following conditions: a history of arrhythmia, chronic circulatory failure, coronary artery disease (incl. history), cholelithiasis, hypertension (controlled and anamnesis), neurological disorders, including mental retardation and seizures (incl. history), impaired liver and / or kidney function of mild to moderate severity, motor and verbal tics in history.

Pregnancy and lactation:

Since there is not a sufficiently convincing amount of research on the safety of the effects of sibutramine on the fetus, this drug should not be used in pregnancy.

You should not take Goldline during breast-feeding.

Women of childbearing age should use contraceptives while taking Goldline.

Special instruction:

Goldline should be used only in cases where all non-drug measures to reduce body weight are ineffective, if the weight loss within 3 months was less than 5 kg.

Treatment with Goldline should be carried out within the framework of complex therapy for weight loss under the supervision of a doctor with practical experience in the treatment of obesity. Complex therapy includes both diet and lifestyle changes and increased physical activity. An important component of therapy is the creation of prerequisites for persistent changes in eating habits and lifestyle, which are necessary to maintain the achieved weight loss and after the withdrawal of drug therapy. Patients need to change their lifestyle and habits as part of Goldline therapy in such a way that after the completion of treatment, 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 Goldline, blood PRESSURE and heart rate should be measured. In the first 2 months of treatment, these parameters should be monitored every 2 weeks, and then monthly. In patients with hypertension, in which the background of hypotensive therapy, the blood PRESSURE level is higher than 145/90 mm Hg. however, this monitoring should be carried out especially carefully and, if necessary, at shorter intervals. In patients whose blood PRESSURE twice exceeded the level of 145/90 mm Hg at repeated measurement. therefore, treatment with Goldline should be suspended.

Special attention is required by the simultaneous administration of drugs that increase THE Qt interval. These drugs include histamine H1 receptor blockers (astemizole, terfenadine), antiarrhythmic drugs that increase the QT interval (amiodorone, quinidine, flecainide, mexiletine, propafenone, sotalol), cisapride, pimoside, sertindol and tricyclic antidepressants. This also applies to conditions that can lead to an increase in THE Qt interval, such as hypokalemia and hypomagnesemia.

The interval between taking MAO inhibitors and Goldline should be at least 2 weeks.

Although no link has been established between the use of Goldline 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, chest pain and swelling in the legs.

If you miss a dose of Goldline, you should not take a double dose of the drug in the next dose, it is recommended to continue taking the drug according to the prescribed scheme.

The duration of Goldline should not exceed 2 years.

Influence on the ability to drive vehicles and control mechanisms

Taking Goldline may limit the ability to drive and operate machinery.

Overdose:

There are very limited data on sibutramine overdose. The specific signs of overdose are unknown, however, should take into account the possibility of more pronounced side effects. You should notify your doctor in case of suspected overdose.

The most common symptoms are: tachycardia, increased blood PRESSURE, headache, dizziness.

Treatment: there is no specific treatment or antidote. It is necessary to ensure free breathing, monitor the state of the cardiovascular system, as well as, if necessary, to carry out supportive symptomatic therapy. Timely application of activated charcoal can reduce the absorption of sibutramine in the intestine. Gastric lavage also reduces the absorption of the drug. Patients with high blood PRESSURE and tachycardia can be prescribed beta-blockers. The effectiveness of forced diuresis or hemodialysis has not been established.

Drug interaction:

Inhibitors of microsomal oxidation, including inhibitors of the isoenzyme A3A4 (ketoconazole, erythromycin, cyclosporine), increase plasma concentrations of sibutramine metabolites 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 serotonin in the blood can lead to the development of serious interaction.

Serotonin syndrome can develop in rare cases with the simultaneous use of Goldline drug with selective serotonin reuptake inhibitors (drugs for the treatment of depression), with some drugs for the treatment of migraine (sumatriptan, dihydroergotamine), with opioid analgesics (pentazocin, pethidine, fentanyl) or antitussive drugs (dextromethorphan).

Sibutramine does not affect the action of oral contraceptives.

Drugs that increase blood PRESSURE or heart rate (ephedrine, phenylpropanolamine, pseudoephedrine, as well as combined drugs for the treatment of colds, containing these drugs), increase the risk of increased blood PRESSURE and heart rate.

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

Storage terms and conditions:

The drug should be stored in a dry, inaccessible to children at a temperature not higher than 25°C. shelf Life-2 years.