Goldline Plus capsules 10mg+158.5mg 90pcs

Composition

Active ingredients:

sibutramine hydrochloride monohydrate,

microcrystalline cellulose. Auxiliary substances:

calcium stearate – 1.5 mg.

Capsule shell composition:

cap:

dye azorubin (E 122) – 0.0570%

; indigo carmine (E 132) – 0.3079%;

sodium lauryl sulfate-0.0800%;

titanium dioxide-1.0000%;

gelatin – up to 100%.

Body:

sodium lauryl sulfate-0.0800%;

titanium dioxide-2.0000%;

gelatin – up to 100%.

Pharmacological action

Goldline ® PLUS is a combination drug, the action of which is determined by the components included in its composition. Sibutramine is a prodrug and shows its effect in vivo due to metabolites (primary and secondary amines) that inhibit the reuptake of monoamines (serotonin, norepinephrine, dopamine).

An increase in the content of neurotransmitters in synapses increases the activity of central 5 HT-serotonin and adrenergic receptors, which increases the feeling of satiety and reduces the need for food, as well as increases thermal production. Indirectly activating betase-adrenergic receptors, sibutramine affects brown adipose tissue. Weight loss is accompanied by an increase in the concentration of high-density lipoproteins (HDL) in blood plasma and a decrease in the amount 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 have a low affinity for a large number of neurotransmitter receptors, including serotonin (5-HTi,5-HTiA,5-HTm, b-HTgs), adrenergic (beta (betag, betase, alpha], alphag), dopamine (Di, D2), muscarinic, histamine (Hi), benzodiazepine and glutamate (NMDA) receptors. Microcrystalline cellulose is an enterosorbent, has sorption properties and a non-specific detoxification effect. Binds and removes from the body various microorganisms, products of their vital activity, 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.

Indications

• Goldline ® PLUS is indicated for weight loss in the following conditions:
• alimentary obesity with a body mass index (BMI) of 30 kg / m2 or more;
• alimentary obesity with a body mass index of 27 km/m2 or more in combination with type 2 diabetes and dyslipidemia.

Contraindications

• Established hypersensitivity to sibutramine or other components of the drug;
• The presence of organic causes of obesity (for example, hypothyroidism).
• Serious eating disorders – anorexia nervosa or bulimia nervosa.
• Mental illnesses;
• Gilles de la Tourette syndrome (generalized tics);
• Simultaneous reception of MAO inhibitors (eg, phentermine, fenfluramine, dexfenfluramine, etilamfetamine, ephedrine) or use within 2 weeks prior to taking the drug Goldline® PLUS and 2 weeks after the intake of other drugs acting on the Central nervous system, inhibiting the reuptake of serotonin (e. g., antidepressants, neuroleptics); sleeping pills that contain tryptophan, as well as other centrally acting drugs for weight loss or to treat mental disorders;

• Cardiovascular diseases (in the anamnesis or at present): ischemic heart disease (myocardial infarction (MI), angina pectoris); chronic heart failure in the decompensation stage, occlusive diseases of the peripheral arteries, tachycardia, arrhythmia, cerebrovascular diseases (stroke, transient disorders of the cerebral circulation);
• Uncontrolled arterial hypertension (blood pressure (BP) above 145/90 mm Hg) (see also the section “Special instructions”);
• Angle-closure glaucoma;
• Thyrotoxicosis;
• Severe liver and/or kidney function disorders;
• Benign prostatic hyperplasia;
• Pheochromocytoma;
• Established pharmacological, drug or alcohol dependence;
• Pregnancy and breast-feeding period;
• Under 18 years of age and over 65 years of age.

With caution, the drug should be prescribed for the following conditions: arrhythmia in the anamnesis, chronic circulatory insufficiency, coronary artery diseases (including in the anamnesis), except for coronary heart disease (MI, angina pectoris); glaucoma, except for angle-closure glaucoma, cholelithiasis, arterial hypertension (controlled and in the anamnesis), neurological disorders, including mental retardation and seizures (including in the anamnesis) a history of motor and verbal tics, a tendency to bleed, blood clotting disorders, and medications that affect hemostasis or platelet function.

Side effects

Basically, side effects when taking Goldline Plus are observed during the first month of admission, they are not severe, do not require pharmacological correction and pass independently after a month.

The main side effects observed are dry mouth, insomnia, headache, dizziness, anxiety, increased heart rate, increased blood pressure, loss of appetite, constipation, nausea, increased sweating.

Interaction

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 may 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 when sibutramine is co-administered with selective serotonin reuptake inhibitors (drugs for the treatment of depression), with certain drugs for the treatment of migraines (sumatriptan, dihydroergotamine), with strong analgesics (pentazocine, pethidine, fentanyl) or antitussive drugs (dextromethorphan). Sibutramine does not affect the effect of oral contraceptives. No increase in the negative effects of alcohol was observed when sibutramine and alcohol were taken simultaneously. However, alcohol is absolutely not combined with the dietary measures recommended when taking sibutramine. When sibutramine is co-administered with other drugs that affect hemostasis or platelet function, the risk of bleeding increases. The drug interaction with the simultaneous use of sibutramine with drugs that increase blood pressure and heart rate is currently not fully understood. This group of drugs includes decongestants, antitussives, antipruritic and anti-allergic drugs, which include ephedrine or pseudoephedrine. Therefore, caution should be exercised in cases of concomitant use of these drugs with sibutramine. 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.

How to take, course of use and dosage

Goldline Plus is taken one capsule a day in the first half of the day.

Treatment begins with a lower dosage of 10 mg. If during the 4 weeks of use no weight loss of more than 2 kg is achieved, switch to a higher dosage-15 mg. The effect of the drug develops gradually during the first month, the maximum effect is observed after 3 months of continuous use. If you miss taking the drug, you should not take a double dose the next day. Goldline Plus is recommended to take a course of 6 months, since during this time not only a significant reduction in body weight is achieved, but also correct eating habits are formed. Due to this, the partial effect after discontinuation of the drug persists for up to 2 years. The maximum duration of use should not exceed 1 year, since there are no data from clinical studies on the effectiveness and safety of longer-term use.

Goldline Plus should be discontinued if the patient does not respond well to therapy – if the body weight loss was less than 5% over three months of use. It should be remembered that Goldline Plus is used only in complex therapy along with hypocaloric nutrition and physical activity.

Special instructions

Goldline ® PLUS should be used only in cases where all non-drug measures for weight loss are ineffective – if the weight loss within 3 months was less than 5 kg. Treatment with Goldline ® PLUS 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 persistent changes in eating behavior and lifestyle, which are necessary to maintain the achieved weight loss even after the drug therapy is discontinued. Patients need to change their lifestyle and habits as part of Goldline PLUS therapy in such a way as to ensure that the achieved weight loss is maintained after the treatment is completed.Patients should clearly understand that failure to comply with these requirements will lead to repeated weight gain and repeated visits to the attending physician. Patients taking Goldline® PLUS should have their blood pressure and heart rate measured regularly.

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 >00910 beats per minute or systolic/diastolic pressure >> 10 mmHg is detected during two consecutive visits, treatment should be discontinued. In patients with arterial hypertension who have a blood pressure above 145/90 mm Hg on the background of antihypertensive therapy, this monitoring should be carried out especially carefully and, if necessary, at shorter intervals. In patients whose blood pressure exceeded 145/90 mm Hg twice on repeated measurement, treatment with Goldline ® PLUS should be discontinued (see section “Side effects”). In patients with sleep apnea, especially careful monitoring of blood pressure is necessary. Special attention should be paid to the simultaneous use of drugs that increase the QT interval. These drugs include Hi-histamine blockers (astemizole, terfenadine); antiarrhythmic drugs that increase the QT interval (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol); gastrointestinal motility stimulator cisapride; pimozide, sertindol and tricyclic antidepressants. This also applies to conditions that can lead to an increase in the QT interval, such as hypokalemia and hypomagnesemia (see also the section “Interaction with other drugs”). The interval between taking MAO inhibitors (including furazolidone, procarbazine, selegiline) and Goldline PLUS should be at least 2 weeks. Although no association has been established between the use of 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 dyspnoea( respiratory disorders), chest pain and swelling on the legs. If you miss a dose of Goldline PLUS, you should not take a double dose of the drug at the next dose, it is recommended to continue taking the drug according to the prescribed schedule. The duration of taking Goldline PLUS should not exceed 1 year. When sibutramine and other serotonin reuptake inhibitors are co-administered, there is an increased risk of bleeding. Sibutramine should be used with caution in patients predisposed to bleeding and taking medications that affect hemostasis or platelet function. Although there are no clinical data on addiction to sibutramine, it is necessary to find out if the patient has a history of drug addiction, and pay attention to possible signs of drug abuse. Effects on the ability to drive vehicles and mechanisms Taking Goldline® PLUS may limit the ability to drive vehicles and mechanisms. While using Goldline® PLUS, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Solid gelatin capsules, the capsule body is white or almost white in color, the cap is blue in color.

The contents of the capsule are white or almost white powder or compacted powder mass.

Active ingredient

Sibutramine, Microcrystalline Cellulose

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

For adults as directed by your doctor

Indications

Type 2 Diabetes, Obesity