sibutramine hydrochloride monohydrate, microcrystalline cellulose.
calcium stearate - 1.5 mg.
dye azorubin (E122) - 0.0570%;
indigo carmine (E132) - 0.3079%;
sodium lauryl sulfate - 0.0800%;
titanium dioxide - 1.0000%;
gelatin - up to 100%.
sodium lauryl sulfate - 0.0800%;
titanium dioxide - 2.0000%;
gelatin - up to 100%.
Goldline® PLUS is a combined preparation, the effect of which is due to its constituent components. Sibutramine is a prodrug and manifests its action 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 5HT-serotonin and adrenergic receptors, which contributes to an increase in the feeling of satiety and a decrease in the need for food, as well as an increase in thermal production. By indirectly activating beta-adrenergic receptors, sibutramine acts on brown adipose tissue.
Weight loss is accompanied by an increase in high-density lipoprotein (HDL) plasma concentration and a decrease in 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); have a low affinity for a large number of neurotransmitter receptors, including serotonin (5-HTi, 5-HTia, 5-HTm, b-NTgs), adrenergic (beta betag, betase, alpha], alpha), dopamine (Di, D2), muscarinic , histamine (Hi), benzodiazepine and glutamate (NMDA) receptors. Microcrystalline cellulose is an enterosorbent, has sorption properties and nonspecific detoxification effect.
It binds and removes from the body various microorganisms, their metabolic products, 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.
- Goldline® PLUS is indicated for weight loss in the following conditions:
- alimentary obesity with a body mass index (BMI) of 30 kg / m or more;
- alimentary obesity with a body mass index of 27 km / m2 or more in combination with type 2 diabetes mellitus and dyslipidemia.
- Installed hypersensitivity to sibutramine or to other components of the drug;
- The presence of organic causes of obesity (for example, hypothyroidism);
- Serious eating disorders - anorexia nervosa or bulimia nervosa;
- Mental illness;
- Gilles de la Tourette's syndrome (generalized tics);
- Concomitant use of MAO inhibitors (for example, phentermine, fenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or use within 2 weeks before taking Goldline® PLUS and 2 weeks after the end of its administration of other drugs acting on the central nervous system, inhibiting reuptake of serotonin (eg, antidepressants, antipsychotics); hypnotics containing tryptophan, as well as other centrally acting drugs for weight loss or for the treatment of mental disorders;
- Cardiovascular diseases (in history or currently): ischemic heart disease (myocardial infarction (MI), angina pectoris); chronic heart failure in the stage of decompensation, occlusive peripheral arterial disease, tachycardia, arrhythmia, cerebrovascular disease (stroke, transient cerebrovascular accident);
- Uncontrolled arterial hypertension (blood pressure (BP) above 145/90 mm Hg) (see also the section "Special instructions");
- Closed-angle glaucoma;
- Severe violations of liver and / or kidney function;
- Benign prostatic hyperplasia;
- Established pharmacological, drug or alcohol dependence;
- Pregnancy and the period of breastfeeding;
- Age under 18 and over 65.
The drug should be prescribed with caution in the following conditions: history of arrhythmias, chronic circulatory failure, coronary artery disease (including history), except for coronary heart disease (MI, angina pectoris); glaucoma, except for angle-closure glaucoma, cholelithiasis, arterial hypertension (controlled and in history), neurological disorders, including mental retardation and seizures (including in history), epilepsy, impaired liver and / or kidney function of mild to moderate severity , ^ history of motor and verbal tics, a tendency to bleeding, bleeding disorders, taking medications that affect hemostasis or platelet function.
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 disappear on their own after a month.
Mainly, the following side effects are observed: dry mouth, insomnia, headache, dizziness, anxiety, increased heart rate, increased blood pressure, loss of appetite, constipation, nausea, increased sweating.
Microsomal oxidation inhibitors, incl. inhibitors of the CYP3A4 isoenzyme (ketoconazole, erythromycin, cyclosporin, etc.) increase the concentration of sibutramine metabolites in the 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 can accelerate the metabolism of sibutramine.
The simultaneous use of several drugs that increase the level of serotonin in the blood plasma can lead to the development of a 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 some drugs for the treatment of migraines (sumatriptan, dihydroergotamine), with potent analgesics (pentazocine, pethidine) or antitussive drugs (dextromethorphan). Sibutramine does not affect the effect of oral contraceptives.
With the simultaneous intake of sibutramine and alcohol, there was no increase in the negative effect of alcohol. However, alcohol is absolutely not combined with the dietary measures recommended when taking sibutramine.
With the simultaneous use of other drugs with sibutramine 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, anti-cold and antiallergic drugs, which include ephedrine or pseudoephedrine.
Therefore, in cases of simultaneous administration of these drugs with sibutramine, caution should be exercised. The 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.
How to take, course of administration and dosage
Goldline Plus is taken one capsule a day in the morning. Treatment begins with a lower dosage of 10 mg. If, within 4 weeks of admission, a decrease in body weight of more than 2 kg is not achieved, they switch to a higher dosage - 15 mg.
The action of the drug develops gradually during the first month, the maximum effect is observed after 3 months of continuous use. If you skip taking the drug, you should not take a double dose the next day. Goldline Plus is recommended to be taken in a course of 6 months, since during this time not only a significant decrease in body weight is achieved, but also correct eating habits are formed.
Due to this, the partial effect after discontinuation of the drug remains up to 2 years. The maximum duration of admission should not exceed 1 year, since there are no data from clinical studies on the effectiveness and safety of longer use.
Taking Goldline Plus should be discontinued if the patient responds poorly to therapy - if, after three months of use, the body weight loss is less than 5%. It should be remembered that Goldline Plus is used only in complex therapy along with hypocaloric nutrition and physical activity.
Goldline® PLUS should be used only in cases where all non-drug measures to reduce body weight are ineffective - if the decrease in body weight within 3 months is less than 5 kg. Treatment with Goldline® PLUS should be carried out as part of a complex therapy for weight loss under the supervision of a physician with practical experience in the treatment of obesity. Complex therapy includes changes in diet and lifestyle, as well as increased physical activity. An important component of therapy is the creation of prerequisites for a persistent change in eating behavior and lifestyle, which are necessary to maintain the achieved weight loss even after drug therapy is discontinued.
Patients need to change their lifestyle and habits within the framework of therapy with Goldline® PLUS in such a way as to ensure that the achieved weight loss is maintained after the completion of treatment. Patients should clearly understand that non-compliance with these requirements will lead to repeated weight gain and repeated referral to the attending physician. Patients taking Goldline® PLUS should have their blood pressure and heart rate checked 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> \ 000910 beats per minute or systolic / diastolic pressure> 10 mmHg is detected during two consecutive visits. Art., you must stop treatment. In patients with arterial hypertension, in whom, against the background of antihypertensive therapy, blood pressure is higher than 145/90 mm Hg. Art., this control 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 on repeated measurements. Art., treatment with Goldline® PLUS should be canceled (see the "Side Effects" section).
In patients with sleep apnea, blood pressure should be particularly carefully monitored.
The simultaneous administration of drugs that increase the QT interval requires special attention. These drugs include Hi-histamine blockers (astemizole, terfenadine); antiarrhythmic drugs that increase the QT interval (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol); cisapride, gastrointestinal motility stimulator; 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 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 the relationship between taking sibutramine and the development of primary pulmonary hypertension has not been established, 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 (breathing disorder), chest pain and swelling of the legs ...
If you miss a dose of Goldline® PLUS, 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 taking Goldline® PLUS 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 taking medications that affect hemostasis or platelet function.
Although there are no clinical data on addiction to sibutramine, it should be ascertained whether the patient has had a history of drug dependence, and to 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 period of use of the Goldline® PLUS drug, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.
Hard gelatin capsules, the body of the capsule is white or almost white, the cap is blue.
The contents of the capsule are powder or compacted powder mass of white or almost white color.