Manufacturer: Izvarino Pharma LLC Russia

Release form: Solid dosage forms. Capsules.

General characteristics. Compound:

Active ingredients: 300 mg L-carnitine-L-tartrate (180 mg L-carnitine), 30 mg alpha-lipoic acid (24 mg lipoic acid).

The new product Goldline Light was developed for people suffering from excess body weight who actively use physical activity to lose weight.

Pharmacological properties:

Pharmacodynamics. Reception of Goldline Light:

Accelerates fat burning during exercise
- increases endurance when performing physical exercises
- increases mental and physical activity
- helps improve overall tone

Indications for use:

Recommended as a dietary supplement - a source of L-carnitine and alpha-lipoic acid. The selection of ingredients was based on data from numerous clinical studies, which have shown that both L-carnitine and alpha lipoic acid promote increased use of free fatty acids as an energy source by muscle tissue during exercise. As a result, fat burning occurs more intensely.

Important! Get to know the treatment

Directions for use and dosage:

Adults: 1 capsule 2 times a day with meals. Duration of treatment is 3 weeks. If necessary, the reception can be repeated.

Features of application:

Side effects:

Allergic reactions.

Contraindications:

Individual intolerance to Goldline Light components, pregnancy, breastfeeding.

Storage conditions:

The drug should be stored in a dry place, out of reach of children, at a temperature not exceeding 25 °C. Shelf life - 2 years.

Vacation conditions:

Over the counter

Package:

30, 60 or 90 capsules in blister packs and cardboard packs.

The first niche in the list of modern drugs for obesity is rightfully occupied by Goldline Plus. This is a new generation medicine that has successfully proven itself in the fight against excess weight. Taking capsules helps to get rid of fat deposits in a short time without exhausting physical activity and low-calorie diets. Regular use of the drug actively affects the amount of food consumed, reduces appetite, thereby affecting adipose tissue.

In contact with

One drug name includes several types:

Goldline Light– a light-acting drug that is intended for people leading an active lifestyle. The basis of the medicine is alpha-lipoic acid and L-carnitine.

Goldline Plus(most often called simply Goldline) is a potent drug based on sibutramine, a substance actively influencing on symptoms of obesity of varying degrees.

Due to the fact that one of the drugs was made two-component, a significant difference between Goldline and Goldline Plus appeared. Since the substance sibutramine belongs to the group of potent drugs, it has been prohibited to dispense it without a doctor’s prescription, form 148, since 2008. Due to the fact that manufacturers have added microcrystalline cellulose to the drug formula, the drug can be freely purchased at any pharmacy. In other words, the manufacturer made sure that the medicine was available to almost every consumer by simply adding “Plus” to the name.

If we compare the composition and effects of Goldline Plus drugs, regular Goldline and Goldline Light, then the differences will be significant. In this case, not only the composition differs, but also the strength of its effect on the female body. In the first two options we are talking about serious treatment for obesity of the 2nd and 3rd degrees, and Goldline Light is a dietary supplement and is designed for minor weight loss when playing sports.

Goldline Light

This dietary supplement works great in combination with regular physical activity and is used to more effectively burn excess calories and obtain energy. As a result - fast and natural weight loss.

Action and composition of Goldline Light

The main active components of the dietary supplement are:

• Alpha lipic acid
• L-carnitine

L-carnitine

The resulting energy from the absorption of the substance is distributed as efficiently as possible, ensuring proper fat burning, and also increases mental and physical activity and performance. When present in living cells, carnitine itself has the following effects: impact on body processes:

• Improves metabolism
• Promotes the development and regeneration of cells in the body of any age
• Positively affects life expectancy

Ensuring the breakdown of fat and preventing its deposits in cells is the main function of L-carnitine. Such abilities appear due to the delivery of fatty acids from the blood to the cells and subsequently to the mitochondria for energy production. In other words, the body's endurance and activity are significantly increased with the effect of carnitine on the breakdown of fats.

Alpha lipic acid

This is the second main component of the light version of Goldline. It has an active effect on digestion. When reacting with enzymes, the acid acquires the following capabilities:

The complex effect of the drug Goldline Light, provided it is taken regularly, ensures an increase in overall tone and acceleration of fat burning, resulting in effective weight loss.

Goldline Light: instructions for use

Take a supplement It is recommended to take 1 capsule during breakfast and lunch. The period of admission can reach several years, the main thing is to do this with short breaks. It is advisable to maintain a one-week interval between 21-day dietary supplement treatments.

Contraindications

The drug has no special contraindications, but during lactation or pregnancy, as well as in case of allergies to the components of the drug you should refuse to take it.

Goldline Plus (Goldline): instructions for use

There are many disputes between those losing weight and specialists regarding the issue of taking Goldline and Goldline Plus. The reason for the disagreement was the sibutramine contained in the drug, which is included in the list of potent substances and is prohibited in some countries. Despite this, the effect of the drug is achieved incredibly fast and effortless. Women who have been unable to lose excess weight for a long time are able to lose kilos without diets and physical activity, which are contraindicated for many due to complications in severe obesity.

Goldline Plus: composition and action

The main active ingredients sibutramine and microcrystalline cellulose determine the effectiveness of the drug in comparison with most other weight loss products.

Sibutramine

The substance sibutramine is not just an easy way to lose weight, it is a full-fledged substance of an official drug sold in pharmacies. Doctors around the world use medications with sibutramine in therapy for patients with significant excess weight. The abilities of this substance:

• Suppressing the feeling of hunger, for which certain areas of the brain are responsible.
• Removal of split fat tissue deposited in problem areas.
• In one month, weight loss can be up to 10–15 kg, depending on the individual characteristics of the body.

Microcrystalline cellulose

The next ingredient of the medicine is microcrystalline cellulose, consisting of plant fibers. Its effect is similar to the effect of consuming fiber:

• Absorbing harmful substances, cellulose, which cannot be digested, moves through the gastrointestinal tract and then naturally removes them out.
• Natural cleansing normalizes stool and improves the functioning of the stomach and intestines.
• A feeling of fullness, lack of overeating, decreased appetite and reduced calorie intake - all this occurs due to the swelling of cellulose in the stomach.

Similar properties made microcrystalline cellulose the No. 1 substance in many weight loss products.

When taken orally, the active ingredients of Goldline Plus capsules are quickly absorbed into the blood and distributed throughout the tissues. Approximately on the fourth day of regular use of the drug, the maximum level of concentration of the active components is reached, so the medication becomes most effective on the 4th–5th day of administration.

Goldline Plus is a drug that really helps to get rid of not only a few extra pounds, but also severe obesity. Another advantage of the drug is that it is approved for use even people suffering from diabetes.

General information about the drug

It is not recommended to take Goldline on your own, as it is a potent medicine. The side effects caused by these capsules can be severe and have irreversible consequences. That is why only a doctor who can control the course of therapy should make a prescription. The patient must strictly adhere to the dosage and recommendations throughout the the entire course of treatment.

Dosage of Goldline capsules:

• 5 mg – recommended for poor or partial tolerance of active substances.
• 10 mg – standard starting dose
• 15 mg – if weight loss over a month of taking the drug was less than 5%, this dosage is prescribed

How to use?

The main feature of the drug Goldline is that it is prescribed only when other methods have not worked. If a patient is diagnosed with obesity with a BMI of more than 30 and 27 with type II diabetes, the doctor prescribes the drug. Under other circumstances, taking the medicine is not advisable.

Side effects of Goldline

Especially at the beginning of treatment, Goldline can cause side effects and cause problems with the central nervous system and brain. They cannot lead to serious consequences, but they will cause, at a minimum, a lot of discomfort, so when taking the medicine it is important to monitor behind possible symptoms:

In case of an overdose, similar signs may also appear. If they are detected, you should drink activated carbon, provide yourself with access to fresh air and call a doctor.

When is Goldline contraindicated?

If the rules for taking the drug are not followed, as well as contraindications are ignored, serious consequences may occur, including loss of consciousness and serious brain problems.

The drug should not be taken if:

During work activities that require increased concentration or driving, it is important not to take medication During a long time.

Goldline price

At a dosage of 15 mg, the average price for the drug in pharmacies is:

• 1500 rubles for 30 tablets
• 2500 rubles for 60 tablets
• 3500 rubles for 90 tablets (course for 3 months)

A more expensive analogue of the drug Goldline is known by the name and has a price that is almost 2 times higher than Goldline - from 3 thousand to 7 thousand rubles per package. The light version of Goldline has a more affordable price - about 1,300 rubles for a three-month course.

If you monitor your health, do not exceed the prescribed dosage of the drug, engage in moderate physical activity, follow your doctor’s recommendations and fully follow the instructions, you can easily use Goldline capsules get rid of extra pounds without effort and harm to your health.

Sibutramine is a potent drug that affects the central nervous system and changes the amount of neurotransmitters in the brain. Under the influence of a medicinal substance, the speed of the body's reactions may change, which causes the development of side effects, as well as undesirable effects of the drug "Goldline".

Goldline tablets for weight loss are strong anorexigenic drugs used to change the eating behavior of patients suffering from severe obesity. As a rule, this is excess body weight when its index exceeds 30. The drug is not a drug of choice. Doctors and nutritionists recommend resorting to its help only if there is no effect from other weight loss methods.

The beneficial effect of “Goldline” in case of excess weight can be used to correct the figure in type 2 diabetes mellitus, which is often accompanied by serious metabolic disorders leading to an excessive gain of fat mass. Three forms of the drug are offered on the modern pharmaceutical market:

• "Goldline";
• "Goldline PLUS";
• "Goldline Light".

All three forms differ in their composition, having one indication for use - the fight against excess weight.

Composition and effect on the body

Goldline capsules contain pure sibutramine. Available in two forms: 10 mg and 15 mg of active substance. The mechanism of its action on the body is that sibutramine is converted in the body into more active substances that increase the level of serotonin (an active neurotransmitter of the brain) at the junction of neurons - synapses. This leads to the following effects:

• the excitability of the hunger center in the brain decreases;
• appetite is radically reduced;
• metabolites stimulate an increase in body temperature;
• due to a calorie deficit, brown fat is consumed first;
• the patient loses body weight and his figure improves.

The Goldline product activates the combustion of fat reserves and improves the absorption of protein compounds used by the body as an energy source. This happens by creating a significant calorie deficit.

Product “with a plus”

Goldline PLUS capsules, in addition to sibutramine, contain methylcrystalline cellulose. The anorexigenic effect of the main component is supported by the action of an excipient that works as an additional source of dietary fiber. The patient receives additional effects from the swelling of cellulose in the stomach:

• prolonged feeling of fullness;
• improvement of intestinal peristaltic activity;
• the component absorbs toxic substances, cleansing the body.

According to patient reviews, a feeling of the drug’s effectiveness appears already on the fourth day from the start of treatment. At this time, a certain concentration of the active substance accumulates in the body, suppressing the hunger center. This provokes a decrease in appetite to a minimum, and the patient feels light and cheerful.

Light version

“Goldline Light” refers to dietary supplements intended for weight loss, which have a completely different basis. Unlike the original drug, the composition of this product does not contain sibutramine, which makes it possible to purchase it at a pharmacy without a prescription.

L-carnitine and alpha-lipoic acid act as stimulants for the weight loss process in this medicine. Carnitine is a conductor of fat molecules into the intracellular space, or more precisely, to mitochondrial structures that fully process lipid-containing compounds with the release of an increased amount of energy. Alpha lipoic acid improves metabolic processes, accelerates metabolism, and stimulates regeneration processes in the body.

Thanks to this dietary supplement, weight loss, based on physical effort, accelerates significantly, is easier and more intense. On the modern market there are analogues of Goldline capsules, also containing sibutramine. These include "", "Merinda".

Instructions for use "Goldline"

The prescription of the drug should be made by a doctor or nutritionist who will conduct appropriate research and assess the need for the drug. An important point when prescribing Goldline is to examine the body for contraindications. The attentive attitude of a specialist will facilitate the process of losing weight without compromising your health.

The initial dosage of Goldline capsules is 10 mg once a day. The product is taken before or during breakfast. If the drug is well tolerated, the indicated dose is maintained for a month. If the start of treatment is associated with unpleasant sensations, the initial dose is reduced to 5 mg.

If there is no sharp weight loss within a month, and in total the patient loses up to 5% of excess weight, the Goldline dosage regimen is changed and the dose is increased to 15 mg. The dynamics are observed for another two months. If a significant decrease does not occur, the drug should be discontinued. If weight loss is successful, it is possible to extend the course of treatment until the patient reaches the desired value on the scale. The maximum course should not last more than two years.

When treating obesity with Goldline, the following rules are adhered to:

• drug treatment– the use of any medications is agreed upon with a specialist;
• giving up drinking– the negative compatibility of Goldline tablets with alcohol requires avoiding the use of alcohol;
• dieting– give preference to low-carbohydrate foods, as well as foods rich in proteins;
• compulsory meals– even if there is no appetite at all, the patient should eat three times a day, in small portions;
• physical exercise– any exercises feasible for the patient are performed.

The Goldline dietary supplement is taken twice a day in the morning and lunchtime. Taking capsules at night may cause insomnia.

Dangers on the way to an ideal figure

The anti-obesity drug “Goldline” is a serious drug with strong action. Its use is associated with risks to the patient's physical and mental health. It is for this reason that drugs with sibutramine in Europe are prescribed only in hospital settings, and for the last ten years the use of the drug for the treatment of excess weight has been suspended.

The use of "Goldline PLUS" is prohibited in case of insufficiency or functional disorders of the following organs:

• liver and gallbladder;
• kidney;
• of cardio-vascular system;

Contraindications also include anorexia and bulimia, as well as depression, psychotic disorders, insomnia and neurasthenia. The drug is completely prohibited during pregnancy and breastfeeding. When planning a pregnancy, you should give preference to safer drugs, although sibutramine may increase the possibility of conception.

People who are addicted to alcohol or drugs should refrain from losing weight on Goldline. If metabolic disorders are caused by hypothyroidism or other diseases of the thyroid gland, the endocrine system is first treated and only then weight correction begins.

Only if you take Goldline correctly, after coordinating treatment with your doctor and following his instructions, can you avoid the risk of overdose. It is fraught with disturbances in the functioning of the heart and nervous system, even to the point of unconsciousness.

Side effects

Even full compliance with all recommendations does not guarantee the absence of side effects that disrupt the usual rhythm of life and cause discomfort. According to reviews, they all pass as the body adapts to the drug. Side effects of Goldline include:

• increased blood pressure;
• increased heart rate;
• dizziness;
• headache;
• nervousness;
• sleep disorders;
• constipation;
• dry mouth;
• redness of the skin.

To prevent the occurrence of unwanted reactions, do not exceed the dose prescribed by your doctor. Increasing it on your own will not speed up the results, but can significantly undermine the patient’s health.

Doctors' opinion

There is no consensus among doctors and nutritionists regarding the advisability of Goldline therapy for obesity. The reason for this is the dual effect of the drug on the body. It really helps lose weight for already desperate people who are ready to do anything to return to a normal rhythm of life. On the other hand, obesity is almost always accompanied by one or more conditions that are contraindications for the use of the drug, and the doctor has to take responsibility and take risks when recommending the drug to the patient.

For this reason, radical doctors demand a complete ban on the use of Goldline in home treatment for obesity, and leave the prerogative of its use only for inpatient treatment and for special indications. For example, to eliminate appetite after gastric resection.

Since the benefits and harms of Goldline are difficult to compare, in order to join one of the opposing camps, it remains to focus on the positive reviews of patients who treated obesity with this drug.

As an active substance, as well as microcrystalline cellulose (Cellulose microcrystalline), lactose (Lactose), colloidal silicon dioxide (Silicium dioxide colloidal), magnesium stearate (Magnesii stearas).

The composition of the capsule body Goldline 10 mg includes: gelatin (Gelatine), titanium dioxide (Titanium dioxide), sodium lauryl sulfate (Sodium lauryl sulfate), dyes (sunset yellow and quinoline yellow).

For the manufacture of capsule bodies Goldline 15 mg used: gelatin (Gelatine), titanium dioxide (Titanium dioxide), sodium lauryl sulfate (Sodium lauryl sulfate).

Composition of the capsule cap: gelatin (Gelatine), titanium dioxide (Titanium dioxide), sodium lauryl sulfate (Sodium lauryl sulfate), dyes (diamond blue and acid fuchsin D&C33).

Release form

The release form of the drug Goldline is hard gelatin capsules of size No. 2. The body of 10 mg capsules is yellow, the body of 15 mg capsules is white. The lid is blue. The capsules are filled with white or almost white contents.

pharmachologic effect

The drug belongs to the category of drugs that are intended to regulate appetite and treat patients suffering from obesity.

Pharmacodynamics and pharmacokinetics

Goldline is a central mechanism of action drug for the treatment of obesity .

Its active substance is sibutramine - is a prodrug that exhibits its pharmacological properties in vivo due to primary and secondary amines - products of drug metabolism that are characterized by the ability to inhibit reuptake monoamines (mainly and norepinephrine ).

The use of the medicine allows you to increase the feeling of satiety, reduce the need for food, and also increase thermal production. These effects are achieved by increasing the content neurotransmitters at synapses and therefore increased activity central serotonin (5-HT type) and adrenergic receptors .

Also sibutramine has the ability to influence brown adipose tissue due to indirect activation β3-adrenergic receptors .

Weight loss, in turn, is accompanied by an increase in the serum concentration of high-density drugs and a decrease in the concentration of low-density drugs, uric acid and triglycerides.

Neither sibutramine , nor the products of its metabolism:

• do not inhibit the enzyme monoamine oxidase (MAO);
• have no effect on release monoamines ;
• have no affinity with a sufficiently large number neurotransmitter receptors (including serotonin types 5NT1-, 5NT1A-, 5NT1V-, 5NT2A-, 5NT2S-; adrenergic beta 1, 2 and 3, as well as alpha 1 and 2; dopamine D1 and D2; benzodiazepines , muscarinic ,NMDAR, histamine H1-).

After receiving p/os sibutramine absorbed from digestive tract at least 77%. On the first passage through liver substance metabolized under influence isoenzyme P4503A4 to , which are its active metabolites .

The substance is quickly distributed throughout the tissues. Binding rate proteins For sibutramine - 97%, for him metabolites — 94%.

T1/2 sibutramine — 1.1 hours, metabolites — 14 and 16 hours (for mono- and didesmethylsibutramine respectively). After hydroxylation and conjugation, active metabolites are biotransformed into inactive ones, which are eliminated mainly by kidneys .

Indications for use

The use of Goldline capsules is indicated as part of complex supportive treatment of overweight patients with alimentary (exogenous-constitutional) obesity with a body mass index (BMI) of 30 kg/sq. m or more, as well as with a BMI of 27 kg/sq. m or more, if there are other risk factors associated with excess weight (including dyslipidemia or non-insulin dependent diabetes mellitus ).

Contraindications

The drug has a number of contraindications, including:

• hypersensitivity to its components;
• the patient has organic causes of obesity;
• mental illness ;
• congenital heart defects ;
• bulimia nervosa or anorexia ;
• Tourette's disease ;
• decompensated heart failure ;
• obliterating atherosclerosis of arteries lower extremities;
• cerebrovascular diseases (including but not limited to transient cerebral circulatory disorders and strokes );
• arterial hypertension (when blood pressure is more than 145/90 mm Hg);
• kidney or liver dysfunction in severe form;
• pheochromocytoma ;
• , which is accompanied by the appearance of residual urine;
• angle-closure glaucoma ;
• taken in combination with MAO inhibitors or other drugs that affect central nervous system (and also if less than 14 days have passed since their cancellation);
• simultaneous use of others anorecigenic drugs ;
• established alcohol, drug or drug addiction;
• age over 65 years and under 18 years.

It is recommended to prescribe Goldline with caution to patients with mild to moderate disorders of liver and/or kidney function ; neurological disorders (including mental retardation and increased convulsive activity, including a history), motor or verbal tics (including history); chronic circulatory failure, coronary diseases arteries (including history); cholelithiasis , arrhythmia in the anamnesis; controlled arterial hypertension , as well as if hypertension is noted in the anamnesis.

Side effects

The most common side effects associated with the use of the drug Goldline occur in the first weeks of treatment (they are usually observed during the first month). Over time, their severity and frequency of occurrence decrease.

In general, side effects associated with taking the drug do not pose a threat to health and are reversible.

The most common adverse events (occurring in at least every 10 patients):

• insomnia;
• loss of appetite;
• feeling of dry mouth;
• constipation.

Sometimes (occur with a frequency of 1-10%) the following may appear:

• headache;
• increased anxiety;
• dizziness;
• paresthesia ;
• vasodilator effect (including hyperemia of the skin);
• moderate increase in heart rate (on average 3-7 beats per minute);
• tachycardia ;
• increase in blood pressure (at rest they increase by an average of 1-3 mm Hg);
• heartbeat;
• exacerbation;
• nausea and change in taste;
• increased sweating.

At the initial stages of treatment with Goldline, a more significant change in blood pressure and pulse rate is possible (usually such phenomena are observed in the first 4-8 weeks of taking the drug).

In isolated cases, such clinically significant side effects were recorded as: skin itching, development influenza-like syndrome , back and abdominal pain, swelling, paradoxical increase in appetite, drowsiness, bleeding, convulsions, increased thirst, runny nose, depression, mood lability, irritability, nervousness, anxiety, acute interstitial nephritis , rheumatic purpura , transient increase in activity liver enzymes in the blood , thrombocytopenia .

One patient with schizoaffective psychosis , which most likely existed before the start of treatment with the drug, developed after stopping its use. acute psychosis .

The body's response to stopping Goldline, which manifests itself in the form of headaches and increased appetite, rarely develops.

Evidence that after cessation of treatment there may be withdrawal syndrome , withdrawal syndrome or mood disorders are absent.

Goldline tablets: instructions for use

How to take Goldline capsules

The starting dose of the drug is 10 mg/day. If the expected effect is not observed when using it (in situations where body weight decreases by less than 2 kg during a month of treatment), as well as if the drug is well tolerated, the dose is increased to 15 mg/day.

If there is no effect even when using a higher dosage (weight decreases by less than 2 kg per month), treatment sibutramine stop.

In patients who do not adequately respond to the prescribed treatment, that is, within three months their weight decreases by less than five percent of the original, the duration of use of Goldline should not exceed 3 months.

The maximum duration of treatment is two years. This is due to the lack of reliable data on the safety and effectiveness of use sibutramine over a longer period of time.

You should not continue taking the drug if, after achieving weight loss during further treatment, the patient again gains three (or more) kilograms.

It is considered advisable to supplement therapy with physical activity and diet. Training should be carried out under the supervision of a specialist who has sufficient practical experience in treating people suffering from obesity.

Instructions for Goldline Light

Goldline Light is a drug produced by the pharmaceutical company Izvarino Pharma LLC.

The official website of the tablets states that this product is not a drug and is used by overweight people who actively use physical activity to lose weight, as a dietary supplement.

The daily dose of the drug contains 48 mg lipoic acid and 360 mg (vitamin BT).

In combination with moderate physical activity and a low-calorie diet, weight loss with the use of the product increases by 22% with regular use for six months. In this case, the concentration α-lipoic acid should be at least 1% of the weight of the total amount of food eaten.

With moderate intensity physical activity, fat burning increases by 36-55%.

Besides, α-lipoic acid is good antioxidant , which, due to its ability to dissolve in both non-polar and polar solvents, exhibits its properties both in cells and in the extracellular space.

It also inhibits activity that influences human eating behavior cATP-dependent protein kinase , resulting in increased energy expenditure and decreased food intake.

The effect of using the drug is dose-dependent.

In accordance with the instructions, take 1 or 2 Goldline Light capsules approximately 15-20 minutes before the start of training and then within 60-90 minutes after it ends.

It is a medicine prescribed for cirrhosis or fatty liver , And chronic hepatitis . Lipoic acid is not available without a prescription, as it often causes the following side effects:

• expressed allergic reactions (this may be skin itching, or systemic allergic reactions);

At the same time, in the instructions supplied with the Goldline Light dietary supplement, the manufacturer does not warn about the possibility of developing such side effects.

You should also remember that taking capsules should not be combined with taking any multivitamin complexes , drugs for treatment anemia and other products containing calcium, potassium, iron or magnesium ions.

Overdose

To date, there is not enough data on overdose sibutramine . An increase in the severity of adverse reactions is considered the most likely.

If a suspected overdose of Goldline occurs, you should notify your doctor.

There are no specific antidotes or special treatment. It is recommended to provide the patient with free breathing and keep the condition under control. of cardio-vascular system . Further therapy is symptomatic.

Timely intake and rinsing procedure stomach , allow you to reduce the absorption of the drug in intestinal tract .

Patients who have elevated levels may be prescribed β-blockers .

Efficiency or forced diuresis not installed.

Interaction

Simultaneous use sibutramine With inhibitors of microsomal oxidation (including the CYP3A4 isoenzyme) helps to increase the plasma concentration of its metabolites, heart rate and provokes a clinically insignificant increase in the QT interval.

Metabolism of sibutramine accelerates when used in combination with phenytoin , And macrolide antibiotics . , pethidine ).

Sibutramine does not affect the action oral contraceptives .

When used simultaneously sibutramine With , pseudoephedrine , and combination medications containing these substances increase the risk of increased blood pressure and heart rate.

The substance does not enhance the negative effects of ethanol, however, drinking alcohol during treatment with Goldline reduces the effectiveness of dietary measures.

Terms of sale

On prescription.

Storage conditions

Goldline capsules must be stored in a dry place, the optimum temperature is no more than 25°C.

Best before date

24 months.

special instructions

Goldline diet pills are prescribed only in cases where all other measures aimed at weight loss are ineffective. Treatment should be carried out under the supervision of a specialist who has sufficient experience in weight correction for obesity as part of complex treatment (including physical activity, review of diet, habitual lifestyle, diet).

The period of taking Goldline at a dose of 15 mg should be limited in time.

In the first 8 weeks of treatment, heart rate and blood pressure should be monitored every 2 weeks. After this time, monitoring is carried out once a month.

Patients with arterial hypertension (when the pressure is at the level of 145/90 mmHg) It is recommended to monitor blood pressure and heart rate more often and more carefully. If the pressure rises above the specified values ​​2 times, treatment with Goldline is stopped.

The appearance during treatment with the drug of chest pain, swelling of the legs, as well as progressive dyspnea may indicate that the patient is developing pulmonary hypertension (Such conditions require consultation with a doctor).

Women of childbearing age should use effective contraception throughout the entire course of use.

Sibutramine

It is also not established whether sibutramine or its metabolites pass into breast milk.

This excludes the possibility of using the drug by pregnant women and during breastfeeding.

Digestive tract and metabolism

Obesity treatment. Sibutramine belongs to the list of potent substances approved by Decree of the Government of the Russian Federation of December 29, 2007 No. 964.

Release forms

• 10 - blisters (1) - cardboard packs. 10 - blisters (3) - cardboard packs. 10 - blisters (1) - cardboard packs. 10 - blisters (3) - cardboard packs. 10 - blisters (1) - cardboard packs. 10 - blisters (3) - cardboard packs. 10 - blisters (1) - cardboard packs. 10 - blisters (3) - cardboard packs. 10 - blisters (1) - cardboard packs. 10 - blisters (6) - cardboard packs. 10 - blisters (1) - cardboard packs. 10 - blisters (9) - cardboard packs. 10 - blisters (6) - cardboard packs. 10 - blisters (9) - cardboard packs. 30 capsules per pack 60 capsules per pack 90 capsules per pack per package 30 pcs. per pack 60 pcs. per pack 90 pcs.

Description of the dosage form

• capsules Capsules 10 mg + 158.5 mg: hard gelatin capsules No. 2, capsule body yellow, cap blue. The contents of the capsule are powder or compacted powder mass of white or almost white color. Capsules 15 mg + 153.5 mg: hard gelatin capsules No. 2, capsule body white or almost white, cap blue. The contents of the capsule are powder or compacted powder mass of white or almost white color. Hard gelatin capsules, size No. 2, with a white body and a blue cap; the contents of the capsules are white to almost white powder. Hard gelatin capsules, size No. 2, with a white body and a blue cap; the contents of the capsules are white to almost white powder. Hard gelatin capsules, size No. 2, with a white body and a blue cap; the contents of the capsules are white to almost white powder. Hard gelatin capsules, size No. 2, with a yellow body and a blue cap; the contents of the capsules are white to almost white powder. Hard gelatin capsules, size No. 2, with a yellow body and a blue cap; the contents of the capsules are white to almost white powder.

pharmachologic effect

Goldline® PLUS is a combination drug, the effect of which is determined by the components included in its composition. Sibutramine is a prodrug and exhibits 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 5HT-serotonin and adrenergic receptors, which increases the feeling of satiety and reduces the need for food, as well as an increase in thermal production. By indirectly activating beta-adrenergic receptors, sibutramine acts on brown adipose tissue. A decrease in body weight is accompanied by an increase in plasma concentrations of high-density lipoproteins (HDL) 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 and 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-HTgs), adrenergic (beta betatag, betaz, alpha], alphag), dopamine (Di, D2), muscarinic , histamine (Hi), benzodiazepine and glutamate (NMDA) receptors. Microcrystalline cellulose is an enterosorbent, has sorption properties and a nonspecific detoxification effect. 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.

Pharmacokinetics

Absorption After oral administration, it is rapidly absorbed from the gastrointestinal tract (GIT) by at least 77%. During the “primary passage” through the liver, it undergoes biotransformation under the influence of the CYP3A4 isoenzyme with the formation of two active metabolites (monodesmethylsibutramine (Ml) and didesmethylsibutramine (M2)). After taking a single dose of 15 mg, the maximum plasma concentration (Cmax) of Ml is 4 ng/ml (3.2-4.8 ng/ml), M2 - 6.4 ng/ml (5.6-7.2 ng /ml). Stach is reached after 1.2 hours (sibutramine), 3-4 hours (Ml and M2). Simultaneous food intake reduces the Cmax of metabolites by 30% and increases the time to reach it by 3 hours, without changing the area of ​​the concentration-time curve (AUC). Distribution Quickly distributed throughout tissues. Protein binding is 97% (sibutramine) and 94% (Ml and M2). The equilibrium concentration of active metabolites in the blood plasma is achieved within 4 days after the start of use and is approximately 2 times higher than the concentration in the blood plasma after taking a single dose. Metabolism and excretion Active metabolites undergo hydroxylation and conjugation to form inactive metabolites, which are excreted primarily by the kidneys. The half-life of sibutramine is -1.1 hours, M1-14 hours, M2 -16 hours. Pharmacokinetics in special clinical cases The limited data currently available do not indicate the existence of clinically significant differences in pharmacokinetics in men and women. Pharmacokinetics in elderly healthy individuals (average age 70 years) are similar to those in young people. Renal failure Renal failure has no effect on the AUC of the active metabolites Ml and M2, except for the M2 metabolite in patients with end-stage renal disease on dialysis. Liver failure In patients with moderate liver failure, after a single dose of sibutramine, the AUC of the active metabolites Ml and M2 is 24% higher than in healthy individuals.

Special conditions

Goldline® PLUS should be used only in cases where all non-drug measures for weight loss are ineffective - if the weight loss over 3 months is less than 5 kg. Treatment with Goldline® PLUS should be carried out as part of complex weight loss therapy under the supervision of a physician with practical experience in the treatment of obesity. Complex therapy includes both changing diet and lifestyle, as well as increasing physical activity. An important component of therapy is to create the prerequisites for persistent changes in eating behavior and lifestyle, which are necessary to maintain the achieved weight loss even after drug therapy is discontinued. As part of treatment with Goldline® PLUS, patients need to change their lifestyle and habits in such a way as to ensure that the achieved weight loss is maintained after completion of treatment. Patients should be clear that failure to comply with these requirements will lead to repeated weight gain and repeated visits to their doctor. Patients taking Goldline® PLUS should have their blood pressure and heart rate measured regularly. During 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 resting heart rate > 10 beats per minute or systolic/diastolic pressure > 10 mmHg is detected. Art., it is necessary to stop treatment. In patients with arterial hypertension whose blood pressure is above 145/90 mm Hg during antihypertensive therapy. Art., this control should be carried out especially carefully and, if necessary, at shorter intervals. In patients whose blood pressure exceeded 145/90 mmHg twice during repeated measurements. Art., treatment with Goldline® PLUS should be discontinued (see section “Side Effects”). In patients with sleep apnea, blood pressure must be monitored especially carefully. 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); gastrointestinal motility stimulator 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. See also 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 a connection has not been established between taking sibutramine and the development of primary pulmonary hypertension, however, given the well-known risk of drugs in this group, with regular medical monitoring it is necessary to pay special attention to symptoms such as progressive dyspnea (breathing difficulty), chest pain and swelling in 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 regimen. 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. In patients predisposed to bleeding or taking drugs that affect hemostasis or platelet function, sibutramine should be used with caution. Although there is no clinical evidence of addiction to sibutramine, the patient's history of drug dependence should be assessed and attention should be paid to possible signs of drug abuse. Effect on the ability to drive vehicles and machinery Taking Goldline® PLUS may limit the ability to drive vehicles and machinery. During the period of use of the drug Goldline® PLUS, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Compound

• 1 caps. sibutramine hydrochloride monohydrate 10 mg Excipients: lactose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. Composition of the capsule body: sunset yellow dye, quinoline yellow dye, titanium dioxide, sodium lauryl sulfate, gelatin. Composition of the capsule cap: acid fuchsin dye (D&C33), brilliant blue dye, titanium dioxide, sodium lauryl sulfate, gelatin. L-carnitine L-tartrate 300 mg (180 mg L-carnitine) and alpha lipoic acid 30 mg (24 mg lipoic acid). Active ingredients: Sibutramine hydrochloride monohydrate - 10.0 mg, microcrystalline cellulose - 158.5 mg. Excipients: Calcium stearate - 1.5 mg. Composition of the capsule shell: Cap: azorubine dye (E122) - 0.0570%; indigo carmine (E132) - 0.3079%; sodium lauryl sulfate - 0.0800%; titanium dioxide - 1.0000%; gelatin - up to 100%. Body: sunset yellow dye (E110) - 0.0027%; yellow quinoline dye (E104) - 0.9193%; sodium lauryl sulfate - 0.0800%; titanium dioxide -2.0000%; gelatin - up to 100%. Active substances: Sibutramine hydrochloride monohydrate - 15.0 mg, microcrystalline cellulose - 153.5 mg, Excipients: Calcium stearate - 1.5 mg. Composition of the capsule shell: Cap: azorubine dye (E122) - 0.0570%; indigo carmine (E132) - 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%, Active substances: Sibutramine hydrochloride monohydrate - 15.0 mg, microcrystalline cellulose - 153.5 mg, Excipients: Calcium stearate - 1.5 mg. Composition of the capsule shell: Cap: azorubine dye (E122) - 0.0570%; indigo carmine (E132) - 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%, sibutramine hydrochloride monohydrate 10 mg Excipients: lactose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. Composition of the capsule body: sunset yellow dye, quinoline yellow dye, titanium dioxide, sodium lauryl sulfate, gelatin. Composition of the capsule cap: acid fuchsin dye (D&C33), brilliant blue dye, titanium dioxide, sodium lauryl sulfate, gelatin. sibutramine hydrochloride monohydrate 15 mg Excipients: lactose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. sibutramine hydrochloride monohydrate 15 mg Excipients: lactose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. Capsule body composition: titanium dioxide, sodium lauryl sulfate, gelatin. Composition of the capsule cap: acid fuchsin dye (D&C33), brilliant blue dye, titanium dioxide, sodium lauryl sulfate, gelatin. sibutramine hydrochloride monohydrate 15 mg Excipients: lactose, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate. Capsule body composition: titanium dioxide, sodium lauryl sulfate, gelatin. Composition of the capsule cap: acid fuchsin dye (D&C33), brilliant blue dye, titanium dioxide, sodium lauryl sulfate, gelatin.

Goldline indications for use

• Goldline Light is recommended as a dietary supplement - a source of L-carnitine and alpha-lipoic acid. The selection of ingredients was based on data from numerous clinical studies, which have shown that both L-carnitine and alpha lipoic acid promote increased use of free fatty acids as an energy source by muscle tissue during exercise. As a result, fat burning occurs more intensely

Goldline contraindications

• - presence of organic causes of obesity (for example, hypothyroidism); - serious eating disorders (anorexia nervosa or bulimia nervosa); - mental illness; - Gilles de la Tourette syndrome (generalized tics); - simultaneous use of MAO inhibitors or their use within 2 weeks before prescribing Goldline; - use of other drugs acting on the central nervous system (for example, antidepressants, antipsychotics); - use of drugs prescribed for sleep disorders containing tryptophan, as well as other centrally acting drugs for weight loss; - IHD, decompensated chronic heart failure, congenital heart defects, occlusive diseases of peripheral arteries, tachycardia, arrhythmia, cerebrovascular diseases (stroke, transient cerebrovascular accidents); - uncontrolled arterial hypertension (BP above 145/90 mm Hg); - thyrotoxicosis; - severe dysfunction of the liver and/or kidneys;

Goldline dosage

• 10 mg 10 mg + 158.5 mg 15 mg 15 mg + 153.5 mg

Goldline side effects

• 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. Side effects, depending on the effect on organs and organ systems, are presented in the following order: very often (> 10%), often (> 1%, but

Drug interactions

Inhibitors of microsomal oxidation, incl. inhibitors of the CYP3A4 isoenzyme (ketoconazole, erythromycin, cyclosporine, etc.) increase plasma concentrations of sibutramine metabolites 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 serious interactions. The so-called serotonin syndrome can develop in rare cases when sibutramine is used simultaneously with selective serotonin reuptake inhibitors (drugs for the treatment of depression), with certain drugs for the treatment of migraines (sumatriptan, dihydroergotamine), with potent analgesics (pentazocine, pethidine, fentanyl) or antitussives drugs (dextromethorphan). Sibutramine does not affect the effect of oral contraceptives. When sibutramine and alcohol were taken simultaneously, there was no increase in the negative effects of alcohol. However, alcohol is absolutely not compatible with the dietary measures recommended when taking sibutramine. When used simultaneously with sibutramine, other drugs that affect hemostasis or platelet function increase the risk of bleeding. Drug interactions with the simultaneous use of sibutramine with drugs that increase blood pressure and heart rate have not been fully studied at present. This group of drugs includes decongestants, cough suppressants, cold and allergy medications that contain ephedrine or pseudoephedrine. Therefore, in cases of simultaneous use of these drugs with sibutramine, caution should be exercised. The combined use of sibutramine with drugs for weight loss that act on the central nervous system or drugs for the treatment of mental disorders is contraindicated.

Overdose

There are extremely limited data on sibutramine overdose. The most common adverse reactions associated with overdose: tachycardia, increased blood pressure, headache, dizziness. You should notify your doctor in case of suspected overdose. In case of overdose, you must immediately stop using the drug. There is no special treatment or specific antidotes. It is necessary to carry out general measures: ensure free breathing, monitor the state of the cardiovascular system, and, if necessary, carry out supportive symptomatic therapy. Timely use 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.

Storage conditions

• store in a dry place
• keep away from children
• store in a place protected from light

Information provided