Goldline Plus, 10 mg+158, 5 mg capsules 90 pcs

Goldline® PLUS is a combination drug whose action is due to its constituent components. Sibutramine is a prodrug and exerts its effect in vivo due to metabolites (primary and secondary amines) that inhibit monoamine reuptake (serotonin, norepinephrine, dopamine).

The increase of neurotransmitters in synapses increases the activity of central 5NT-serotonin and adrenergic receptors, which contributes to an increased feeling of satiety and decreased need for food, as well as increased heat production. By activating betaz-adrenoreceptors indirectly, sibutramine affects brown adipose tissue. Reduction of body weight is accompanied by an increase in plasma concentration of high density lipoproteins (HDL) and a decrease in 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); have low affinity for a large number of neurotransmitter receptors, including serotonin (5-HTi, 5-HTia, 5-HTm, b-NTgs), adrenergic (beta, betaz, alpha], alphag), dopamine (Di, D2), muscarinic, histamine (Hi), benzodiazepine and glutamate (NMDA) receptors. Microcrystalline cellulose is an enterosorbent, has sorption properties and non-specific detoxifying action. It binds and removes from the body various microorganisms, products of their vital functions, toxins of exogenous and endogenous nature, allergens, xenobiotics as well as excess of certain metabolic products and metabolites responsible for the development of endogenous toxicosis.

Indications

Type 2 Diabetes, Obesity

• 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 BMI of 27 km/m2 or more in combination with type 2 diabetes and dyslipidemia.

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Active ingredient

Sibutramine, Microcrystalline cellulose

Composition

Active ingredients:

sibutramine hydrochloride monohydrate,

cellulose microcrystalline.

Excipients:

calcium stearate – 1.5 mg.

Contents of the capsule shell:

caps:

dye azorubin (E122) – 0.0570 %;

indigo carmine (E132) – 0.3079 %;

p> sodium lauryl sulfate – 0.0800 %;

titanium dioxide – 1.0000 %;

gelatin – up to 100%.

Case:

sodium lauryl sulfate – 0.0800 %;

titanium dioxide – 2.0000 %;

gelatin – up to 100%.

How to take, the dosage

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

The treatment starts with a smaller dosage of 10 mg. If within 4 weeks of taking the drug weight loss of more than 2 kg is not achieved, the larger dosage of 15 mg is switched to. The drug action 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, as during this time is achieved not only a significant reduction in body weight, but also formed the correct eating habits. Due to this partial effect after stopping the drug remains up to 2 years. The maximum duration of use should not exceed 1 year, because there are no data from clinical studies on the efficacy and safety of longer use.

Prescription of Goldline Plus should be discontinued if the patient responds poorly to therapy – if in three months of use the decrease in body weight was less than 5%. Remember that Goldline Plus is only used in combination therapy with a hypocaloric diet and exercise.

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Interaction

Microsomal oxidation inhibitors, including CYP3A4 isoenzyme inhibitors (ketoconazole, erythromycin, cyclosporine, etc.) increase plasma concentrations of sibutramine metabolites with increased heart rate and clinically not significant increase in QT interval. Rifampicin, antibiotics from macrolide group, phenytoin, carbamazepine, phenobarbital and dexamethasone may accelerate sibutramine metabolism. Simultaneous use of several drugs that increase serotonin levels in blood plasma may lead to the development of serious interaction. So-called serotonin syndrome may develop in rare cases when sibutramine is used simultaneously with selective serotonin reuptake inhibitors (drugs for treatment of depression), with some drugs for treatment of migraine (sumatriptan, dihydroergotamine), with potent analgesics (pentazocine, pethidine, fentanyl) or anti-cough medications (dextromethorphan). Sibutramine does not affect the effect of oral contraceptives.

When taking sibutramine and alcohol concomitantly, no increase in the negative effects of alcohol has been noted. However, alcohol is absolutely not combined with the recommended dietary measures when taking sibutramine.

When concomitant use with sibutramine of other drugs that affect hemostasis or platelet function, the risk of bleeding increases. Drug interaction when using sibutramine concomitantly with drugs that increase blood pressure and heart rate has not been fully studied. This group of drugs includes decongestants, anti-cough, anti-inflammatory and anti-allergic drugs containing ephedrine or pseudoephedrine. Therefore, in cases of concomitant use of these drugs with sibutramine, caution should be exercised. Concomitant 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

Goldline® PLUS should be used only in cases where all non-medicinal weight loss measures are ineffective – if the weight loss within 3 months is less than 5 kg. Treatment with Goldline® PLUS should be carried out as part of a comprehensive therapy for weight loss under the supervision of a physician with practical experience in treating obesity. Complex therapy includes both changes in diet and lifestyle and an increase in physical activity.

An important component of therapy is the creation of the prerequisites for lasting changes in eating habits and lifestyle, which are necessary to maintain the achieved weight loss even after withdrawal of drug therapy. As part of therapy with Goldline® PLUS, patients need to change their lifestyle and habits so that the achieved weight loss can be maintained after treatment ends. Patients should clearly understand that failure to comply with these requirements will result in a second weight gain and a second visit to the attending physician. In patients taking Goldline® PLUS, blood pressure and heart rate should be 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 blood pressure >10 mmHg is detected during two consecutive visits, treatment should be discontinued. In patients with arterial hypertension whose blood pressure is higher than 145/90 mm Hg during hypotensive therapy, this monitoring should be performed especially carefully and at shorter intervals, if necessary.

In patients whose blood pressure exceeded 145/90 mm Hg twice during repeated measurement, treatment with Goldline® PLUS should be canceled (see section “Side effects”).

In patients with sleep apnea syndrome it is necessary to monitor the blood pressure particularly carefully.

Special attention is required by the simultaneous administration of drugs that increase the QT interval. These drugs include Hi-histamine blockers (astemizole, terfenadine); antiarrhythmic drugs that prolong the QT interval (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol); gastrointestinal motility stimulator cisapride; pimozide, sertindol and tricyclic antidepressants. This also applies to conditions that may prolong the QT interval, such as hypokalemia and hypomagnesemia (see also section “Interaction with other medicinal products”).

The interval between taking MAO inhibitors (including furazolidone, procarbazine, selegiline) and the preparation Goldline® PLUS must be at least 2 weeks.

Although there is no established association between sibutramine intake and the development of primary pulmonary hypertension, however, given the well-known risks of drugs of this group, during regular medical monitoring special attention should be paid to such symptoms as progressive dyspnea (breathing disorders), pain in the chest and edema in the legs.

If you miss a dose of Goldline® PLUS, do not take a double dose of the drug at the next appointment, it is recommended to continue further administration of the drug according to the prescribed schedule.

The duration of Goldline® PLUS administration should not exceed 1 year.

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

Although there are no clinical data on addiction to sibutramine, one should find out 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 Goldline® PLUS may limit the ability to drive vehicles and mechanisms. During the use of the drug Goldline® PLUS care must be taken when driving vehicles and engaging in other potentially dangerous activities requiring high concentration and quick psychomotor reactions.

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Contraindications

• Determined hypersensitivity to sibutramine or other drug components;
• Presence of organic causes of obesity (e.g., hypothyroidism);
• Serious eating disorders – anorexia nervosa or bulimia nervosa;
• Psychiatric disorders;
• Gilles de la Tourette syndrome (generalized tics);

• Cardiovascular disease (history or current): Coronary heart disease (myocardial infarction (MI), angina pectoris); chronic heart failure in decompensation, peripheral artery occlusive disease, tachycardia, arrhythmia, cerebrovascular disease (stroke, transient cerebrovascular disorders);
• Uncontrolled arterial hypertension (blood pressure (BP) above 145/90 mmHg.Hg) (see also
• Special Indications

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• Tyrotoxicosis;
• Severe hepatic and/or renal impairment;
• Benign prostatic hyperplasia;
• Pheochromocytoma;
• An established pharmacological, drug or alcohol dependence;
• Pregnancy and breastfeeding period;
• Age under 18 years and over 65 years.

With caution, the drug should be used in the following conditions: history of arrhythmias, chronic circulatory failure, coronary artery disease (including history).coronary artery disease (including in anamnesis), except coronary heart disease (MI, angina pectoris); glaucoma, except for closed-angle glaucoma, cholelithiasis, arterial hypertension (controlled and in anamnesis), neurological disorders, including mental retardation and convulsions (including in anamnesis).Motor and verbal tics, history of bleeding, coagulation disorders, taking drugs that affect hemostasis or platelet function.

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Side effects

In general, the side effects when taking Goldline Plus are observed during the first month of use, they are not severe, do not require pharmacological correction and go away on their own after a month.

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