Thiogamma 300 instructions for use price

Read these instructions carefully before you start taking this medicine.
• Save the instructions; you may need them again.
• If you have any questions, consult your doctor.
• This medicine is for you personally and should not be given to others because it may harm them even if they have the same symptoms as you.

Registration number:

Name of the drug:

Trade name of the drug: Thiogamma ®
Generic name: thioctic acid

Dosage form:

film-coated tablets.

Compound:

1 film-coated tablet contains:
active substance: thioctic acid – 600 mg;
Excipients: hypromellose 25.00 mg, colloidal silicon dioxide 25.00 mg, microcrystalline cellulose 69.00 mg, lactose monohydrate 69.00 mg, croscarmellose sodium 16.00 mg, talc 36.366 mg, simethicone 3.636 mg (dimethicone and colloidal silicon dioxide 96: 6), magnesium stearate 16.00 mg: shell: macrogol 6000 - 0.60 mg, hypromellose 2.80 mg, talc 2.00 mg, sodium lauryl sulfate 0.025 mg.

Description:

oblong, biconvex film-coated tablets, with a smooth and slightly shiny surface, with one dividing line on both sides, yellow in color with possible inclusions of white and dark yellow.

Pharmacotherapeutic group:

ATX code:

Pharmachologic effect:

Pharmacodynamics:
Thioctic acid is an endogenous antioxidant (binds free radicals).
In the body it is formed during the oxidative decarboxylation of alpha-keto acids.
As a coenzyme of mitochondrial multienzyme complexes, it participates in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. Helps reduce blood glucose concentrations and increase glycogen in the liver, as well as reduce insulin resistance.
Participates in the regulation of lipid and carbohydrate metabolism, affects cholesterol metabolism, improves liver function, has a detoxification effect in cases of poisoning with heavy metal salts and other intoxications. It has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effects. Improves trophism of neurons.
In diabetes mellitus, thioctic acid reduces the formation of advanced glycation end products, improves endoneurial blood flow, increases glutathione content to physiological values, which ultimately leads to an improvement in the functional state of peripheral nerve fibers in diabetic polyneuropathy.

Pharmacokinetics:
When taken orally, it is quickly and completely absorbed from the gastrointestinal tract; simultaneous intake with food reduces absorption. Bioavailability – 30-60% due to the “first pass” effect through the liver. The time to reach the maximum concentration (6 μg/ml) is about 30 minutes. Metabolized in the liver by side chain oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%), in small quantities - unchanged. Half-life 25 min.

Indications for use:

Diabetic polyneuropathy and alcoholic polyneuropathy.

Contraindications:

Hypersensitivity to thioctic acid or other components of the drug. Children under 18 years of age.
Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Pregnancy and breastfeeding period. (See section “Use during pregnancy and breastfeeding”).
• Before taking the drug, be sure to consult your doctor.

Use during pregnancy and breastfeeding:

The use of Thiogamma ® during pregnancy and lactation is contraindicated. (See section "Contraindications").

Directions for use and dosage:

Prescribe 600 mg (1 tablet) of Thiogamma ® orally once a day. The tablets are taken on an empty stomach, without chewing, with a small amount of liquid.
The duration of treatment is 30-60 days, depending on the severity of the disease. The course of treatment can be repeated 2-3 times a year.

Side effect:

The frequency of adverse reactions is given in accordance with the WHO classification:

Very rare (Gastrointestinal (GIT) disorders:
nausea, vomiting, abdominal pain, diarrhea.
Immune system disorders:
allergic reactions (up to the development of anaphylactic shock), skin rash, urticaria, itching; autoimmune insulin syndrome (AIS), clinical manifestations of AIS can be: dizziness, sweating, muscle tremors, increased heart rate, nausea, headache, confusion, impaired visual perception, loss of consciousness, coma.
Nervous system disorders:
change or disturbance of taste sensations.
Metabolic and nutritional disorders:
due to improved glucose absorption, a decrease in blood glucose concentration is possible. In this case, symptoms of hypoglycemia may occur - dizziness, increased sweating, headache, visual disturbances.
Frequency unknown (cannot be determined from available data):
Skin and subcutaneous disorders:
eczema.
• If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, Tell your doctor about this.

Overdose:

Symptoms: nausea, vomiting, headache.
When taking doses of 10 to 40 g of thioctic acid in combination with alcohol, cases of intoxication, including death, were observed.
Symptoms of acute overdose: psychomotor agitation or confusion, usually followed by the development of generalized convulsions and the formation of lactic acidosis. Cases of hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, bone marrow depression and multiorgan failure have also been described.
Treatment is symptomatic. There is no specific antidote.

Interaction with other drugs:

Thioctic acid enhances the anti-inflammatory effect of glucocorticosteroids. With the simultaneous administration of thioctic acid and cisplatin, a decrease in the effectiveness of cisplatin is observed.
Thioctic acid binds metals, so it should not be prescribed simultaneously with drugs containing metals (for example, iron, magnesium, calcium) - the interval between doses should be at least 2 hours.
With simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may be enhanced.
Ethanol and its metabolites weaken the effect of thioctic acid.
• If you are already taking other medications or are planning to take them, be sure to consult your doctor before taking Thiogamma ®.

special instructions

Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome or glucose-isomaltose deficiency should not take Thiogamma ®.
In patients with diabetes mellitus, constant monitoring of blood glucose concentrations is necessary, especially at the initial stage of therapy.
In some cases, it is necessary to reduce the dose of insulin or oral hypoglycemic drug to avoid the development of hypoglycemia.
If hypoglycemia develops, you must immediately stop taking the drug Thiogamma ®.
If symptoms of hypersensitivity appear, you must immediately stop taking the drug Thiogamma ®.
Patients taking Thiogamma ® should refrain from drinking alcohol. Alcohol consumption during therapy with Thiogamma ® reduces the therapeutic effect and is a risk factor contributing to the development and progression of neuropathy.
1 film-coated tablet of Thiogamma ® 600 mg contains less than 0.0041 bread units.
Cases of the development of autoimmune insulin syndrome (AIS) during treatment with thioctic acid have been described. The possibility of AIS is determined by the presence of the HLA-DRB1*04:06 and HLA-DRB1*04:03 alleles in patients.

Impact on the ability to drive vehicles and operate machinery:

Taking the drug Thiogamma ® does not affect the ability to drive vehicles or operate other mechanisms.

Release form:

Film-coated tablets 600 mg.
10 film-coated tablets in a blister made of PVC/PVDC/aluminum foil.
3, 6 or 10 blisters along with instructions for use in a cardboard box.

Storage conditions:

Store in a dry place, at a temperature not exceeding 25° C.
Keep out of the reach of children.

Best before date:

5 years. Do not use after the expiration date indicated on the package.

Vacation conditions:

Registration Certificate Holder

Verwag Pharma GmbH & Co. KG, Calver Strasse 7, 71034 Böblingen, Germany

Manufacturer

Dragenofarm Apotheker Püschl GmbH, Göllstrasse 1.84529 Tittmoning, Germany

Organization receiving consumer complaints:

Representative office of Verwag Pharma GmbH & Co. KG in Russia.
117587, Moscow, Varshavskoe highway, 125 Zh, bldg. 6.

Thiogamma: instructions for use and reviews

Latin name: Thiogamma

ATX code: A16AX01

Active ingredient: Thioctic acid

Manufacturer: Verwag Pharma GmbH and Co. KG (Worwag Pharma GmbH & Co. KG), Böblingen, Germany

Update of description and photo: 05/02/2018

Prices in pharmacies: from 186 rubles.

Thiogamma is a drug that regulates lipid and carbohydrate metabolism.

Release form and composition

1. solution for infusion: transparent, light yellow or yellowish-green (50 ml in a dark glass bottle, 1 or 10 bottles in a cardboard box);
2. concentrate for the preparation of a solution for infusion: a transparent yellowish-green solution (20 ml in a dark glass ampoule, 5 ampoules in a tray, 1, 2 or 4 trays in a cardboard box);
3. film-coated tablets: oblong, convex on both sides, light yellow in color with white and yellow inclusions of varying intensity, with marks on both sides; a cross-section shows a light yellow core (10 pieces in a blister, 3, 6 or 10 blisters in a cardboard box).

Active substance – thioctic acid:

1. 1 ml of solution – 12 mg (600 mg in 1 bottle);
2. 1 ml of concentrate – 30 mg (600 mg in 1 ampoule);
3. 1 tablet – 600 mg.

1. solution: macrogol 300, meglumine, water for injection;
2. concentrate: macrogol 300, meglumine, water for injection;
3. tablets: colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, simethicone (dimethicone and colloidal silicon dioxide in a ratio of 94:6), lactose monohydrate, talc, magnesium stearate, hypromellose; shell composition: hypromellose, sodium lauryl sulfate, talc, macrogol 6000.

Pharmacological properties

Pharmacodynamics

The active ingredient of the drug is thioctic (alpha-lipoic) acid. It is an endogenous antioxidant that binds free radicals. Thioctic acid is formed in the body during the oxidative decarboxylation of alpha-keto acids. It is a coenzyme of multienzyme complexes in mitochondria and is involved in the oxidative decarboxylation of alpha-keto acids and pyruvic acid.

Alpha lipoic acid helps reduce blood glucose levels, increase glycogen concentrations in the liver and overcome insulin resistance. According to the mechanism of action, it is close to B vitamins.

Thioctic acid regulates carbohydrate and lipid metabolism, improves liver function and stimulates cholesterol metabolism. It has hypolipidemic, hypoglycemic, hepatoprotective and hypocholesterolemic effects. Helps improve neuron nutrition.

When using the megluminic salt of alpha-lipoic acid (has a neutral reaction) in solutions for intravenous administration, the severity of side effects can be reduced.

Pharmacokinetics

When administered orally, thioctic acid is quickly and completely absorbed from the gastrointestinal tract. When taken simultaneously with food, absorption of the drug is reduced. Bioavailability is 30%. To achieve the maximum concentration of the active substance, it takes from 40 to 60 minutes.

Thioctic acid undergoes a first-pass effect through the liver. Metabolized in two ways: by conjugation and by oxidation of the side chain.

The volume of distribution is approximately 450 ml/kg. Up to 80–90% of the dose taken is excreted by the kidneys in the form of metabolites and unchanged. The half-life ranges from 20 to 50 minutes. The total plasma clearance of the drug is 10–15 ml/min.

The time to reach maximum plasma concentration with intravenous administration of Thiogamma is 10–11 minutes, and the maximum plasma concentration is 25–38 mcg/ml. AUC (area under the concentration-time curve) is approximately 5 mcg/h/ml.

Indications for use

Thiogamma is a drug intended for the treatment of polyneuropathy (diabetic and alcoholic).

Contraindications

1. hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption (for tablets);
2. age under 18 years;
3. pregnancy;
4. breastfeeding period;
5. hypersensitivity to the components of the drug.

Instructions for use of Thiogamma: method and dosage

Solution for infusion and concentrate for the preparation of solution for infusion

The solution, including those prepared from concentrate, is administered intravenously.

The daily dose of Thiogamma is 600 mg (1 bottle of solution or 1 ampoule of concentrate).

The drug is administered over 30 minutes (at a rate of about 1.7 ml per minute).

Preparation of a solution from the concentrate: mix the contents of 1 ampoule with 50–250 ml of 0.9% sodium chloride solution. Immediately after preparation, the solution should be immediately covered with the included light-protective case. Store for no more than 6 hours.

When using the prepared solution, remove the bottle from the cardboard packaging and immediately cover it with a light-protective case. The infusion should be carried out directly from the vial.

The duration of treatment is 2–4 weeks. If it is necessary to continue therapy, the patient is transferred to the tablet form of the drug.

Film-coated tablets

The tablets should be taken orally on an empty stomach: swallowed whole and washed down with sufficient liquid.

The recommended dose of Thiogamma is 600 mg (1 tablet) per day.

The duration of treatment, depending on the severity of the disease, is 30–60 days.

If necessary, repeated courses can be conducted 2-3 times a year.

Side effects

Solution and concentrate

Thiogamma is generally well tolerated. Rarely, including isolated cases, the following side effects occur:

1. from the endocrine system: decreased concentration of glucose in the blood (visual disturbances, increased sweating, dizziness, headache);
2. from the central nervous system: disturbance or change in taste sensations, convulsions, epileptic seizure;
3. from the hematopoietic system: hemorrhagic rash (purpura), thrombocytopenia, thrombophlebitis, pinpoint hemorrhages in the skin and mucous membranes;
4. from the skin and subcutaneous tissue: eczema, itching, rash;
5. from the organ of vision: diplopia;
6. allergic reactions: urticaria, systemic reactions (discomfort, nausea, itching) up to the development of anaphylactic shock;
7. local reactions: hyperemia, irritation, swelling;
8. other: in case of rapid administration of the drug - difficulty breathing, increased intracranial pressure (a feeling of heaviness in the head occurs).

Film-coated tablets

Thiogamma is generally well tolerated. Rarely, including isolated cases, the following side effects occur:

1. allergic reactions: urticaria, skin rash, itching, systemic reactions up to the development of anaphylactic shock;
2. from the digestive system: abdominal pain, nausea, diarrhea, vomiting;
3. from the endocrine system: decreased concentration of glucose in the blood (visual disturbances, increased sweating, dizziness, headache).

Overdose

An overdose of thioctic acid causes the following symptoms: headache, nausea and vomiting. When taking 10–40 g of Thiogamma in combination with alcohol, cases of severe intoxication, even death, have been reported.

In case of an acute overdose of the drug, confusion or psychomotor agitation occurs, usually accompanied by lactic acidosis and generalized convulsions. Cases of hemolysis, rhabdomyolysis, hypoglycemia, bone marrow suppression, disseminated intravascular coagulation, multiorgan failure and shock have been described.

Treatment is symptomatic. There is no specific antidote for thioctic acid.

special instructions

Patients with diabetes mellitus during treatment (and especially at the initial stage) need to monitor the concentration of glucose in the blood and, if necessary, adjust the dose of insulin or an oral hypoglycemic drug.

During treatment with Thiogamma, you should not drink alcoholic beverages, since ethanol reduces the therapeutic effect of thioctic acid and promotes the development and progression of neuropathy.

Each tablet contains 49 mg of lactose monohydrate, which corresponds to at least 0.0041 bread units.

Thioctic acid does not affect the ability to operate potentially dangerous machinery or drive a car.

Use during pregnancy and lactation

The drug is prohibited for use in pregnant and lactating women.

Use in childhood

According to the instructions, Tiogamma is contraindicated for children and adolescents under 18 years of age.

Drug interactions

1. ethanol and its metabolites: the effect of thioctic acid is weakened;
2. cisplatin: its effectiveness decreases;
3. glucocorticosteroids: their anti-inflammatory effect is enhanced;
4. insulin, oral hypoglycemic drugs: their effect is enhanced.

Thioctic acid binds metals (iron, magnesium), therefore, if simultaneous use of drugs containing them is necessary, at least 2-hour intervals between doses should be observed.

Thioctic acid reacts with sugar molecules [for example, with a solution of levulose (fructose)], resulting in the formation of sparingly soluble complexes.

In the form of an infusion solution, Thiogamma is incompatible with solutions that react with disulfide and SH groups, Ringer's solution and dextrose solution.

Analogs

Analogues of Thiogamma are the following drugs: Thioctacid BV, Lipoic acid, Thiolepta, Berlition 300, Thioctacid 600T.

Terms and conditions of storage

Store out of reach of children, protected from light, at temperatures up to 25 °C.

Shelf life – 5 years.

Conditions for dispensing from pharmacies

Dispensed by prescription.

Reviews about Tiogamma

The drug is quite often prescribed to patients with diabetes mellitus and a predisposition to polyneuropathy, since it is a good prophylactic agent for diseases of the peripheral nervous system.

Reviews of Thiogamma note that with a relatively short course of treatment, the severe consequences of endocrine diseases can be prevented. The advantage of using the drug is the very rare development of possible side effects.

Experts also speak positively about Thiogamma, noting its therapeutic properties, the rare development of side effects and the low likelihood of overdose.

Allergic skin reactions that may occur during treatment are most often observed in patients with a predisposition. To avoid such reactions, it is recommended to conduct an allergy test before using the drug.

Price for Tiogamma in pharmacies

Prices for Tiogamma in pharmacies:

1. film-coated tablets, 600 mg (30 pieces per package) – from 894 rubles;
2. film-coated tablets, 600 mg (60 pieces per package) – from 1835 rubles;
3. solution for infusion (50 ml bottle, 1 pc.) – from 211 rubles;
4. solution for infusion (50 ml bottle, 10 pcs.) – from 1,784 rubles.
5. concentrate for preparing a solution for infusion (20 ml ampoules, 10 pcs.) – from 1800 rubles.

Thiogamma - antioxidant, metabolic drug

Thioctic acid is an endogenous antioxidant (binds free radicals). In the body it is formed during the oxidative decarboxylation of alpha-ketoxylots. As a coenzyme of mitochondrial multienzyme complexes, it participates in the oxidative decarboxylation of pyruvic acid and alpha-keto acids.

Helps reduce blood glucose concentrations and increase glycogen in the liver, as well as reduce insulin resistance. Participates in the regulation of lipid and carbohydrate metabolism, affects cholesterol metabolism, improves liver function, and has a detoxification effect in case of poisoning with heavy metal salts and other intoxications. It has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effects. Improves trophism of neurons.

In diabetes mellitus, thioctic acid reduces the formation of advanced glycation end products, improves endoneurial blood flow, increases glutathione content to physiological values, which ultimately leads to an improvement in the functional state of peripheral nerve fibers in diabetic polyneuropathy.

Pharmacokinetics

When taken orally, it is quickly and completely absorbed from the gastrointestinal tract; simultaneous intake with food reduces absorption. Bioavailability is 30–60% due to the first pass effect through the liver. Tmax is about 30 minutes, Cmax is 4 μg/ml.

With intravenous administration, Tmax is 10–11 minutes, Cmax is about 20 mcg/ml.

Has a first pass effect through the liver. Metabolized in the liver by side chain oxidation and conjugation. Total plasma clearance is 10–15 ml/min. Thioctic acid and its metabolites are excreted by the kidneys (80–90%), in small quantities - unchanged. T1/2 - 25 min.

Indications for use

Indications for use of the drug Thiogamma are: diabetic polyneuropathy; alcoholic polyneuropathy.

Mode of application

Concentrate for the preparation of solution for infusion and solution for infusion Tiogamma

IV, in the form of infusions, is administered slowly (over 30 minutes) at a dose of 600 mg/day. The recommended course of use is 2–4 weeks. Then you can continue taking the oral form of the drug Thiogamma at a dose of 600 mg/day.

The bottle of infusion solution is removed from the box and immediately covered with the supplied light-protective case, because Thioctic acid is light sensitive. The infusion is made directly from the bottle. The injection rate is about 1.7 ml/min.

A solution for infusion is prepared from the concentrate: the contents of 1 ampoule (containing 600 mg of thioctic acid) are mixed with 50–250 ml of 0.9% sodium chloride solution. Immediately after preparation, the bottle with the resulting solution for infusion is covered with a light-protective case. The solution for infusion should be administered immediately after preparation. The maximum storage time for the prepared solution for infusion is no more than 6 hours.

Thiogamma film-coated tablets

Orally, 1 time per day, on an empty stomach, without chewing and with a small amount of liquid. The duration of treatment is 30–60 days, depending on the severity of the disease. It is possible to repeat the course of treatment 2-3 times a year.

Side effects

The frequency of adverse reactions is given in accordance with the WHO classification: very often (more than 1/10); often (less than 1/10, but more than 1/100); on occasion (less than 1/100, but more than 1/1000); rare (less than 1/1000, but more than 1/10000); very rare (less than 1/10000, including isolated cases).

From the hematopoietic and lymphatic systems: pinpoint hemorrhages in the mucous membranes, skin, thrombocytopenia, thrombophlebitis - very rarely (for d/inf. solution); thrombopathy - very rare (for concentrations for d/inf. solution); hemorrhagic rash (purpura) - very rare (for concentrations for d/infective solution and d/infective solution).

On the part of the immune system: systemic allergic reactions (up to the development of anaphylactic shock) - very rarely (for the table), in some cases (for concentrations for d/infective solution and d/infective solution).

From the side of the central nervous system: changes or disturbances in taste sensations - very rare (for all forms); epileptic seizure - very rare (for conc.

From the side of the organ of vision: diplopia - very rare (for concentration for d/inf. solution and d/inf. solution).

On the part of the skin and subcutaneous tissue: allergic skin reactions (urticaria, itching, eczema, rash) - very rarely (for the table), in some cases (for concentrations for d/infective solution and d/infective solution .).

From the gastrointestinal tract: nausea, vomiting, abdominal pain, diarrhea - very rarely (for the table).

Other adverse reactions: allergic reactions at the injection site (irritation, redness or swelling) - very rarely (for concentrated d/infective solution), in some cases (for d/infective solution); in the case of rapid administration of the drug, an increase in ICP is possible (there is a feeling of heaviness in the head), difficulty breathing (these reactions go away on their own) - often (for the concentration for the d/inf. solution), very rarely (for the d/inf. solution .); due to improved absorption of glucose, a decrease in the concentration of glucose in the blood is possible, and symptoms of hypoglycemia may occur (dizziness, increased sweating, headache, visual disturbances) - very rarely (for concentrations for solution d/inf. and table) , in some cases (for d/inf. solution).

If any of these side effects worsen or any other side effects not listed in the instructions appear, you should inform your doctor.

Contraindications

Contraindications to the use of the drug Thiogamma are: hypersensitivity to thioctic acid or other components of the drug; pregnancy; breastfeeding period; children under 18 years of age.

Additionally for coated tablets: hereditary galactose intolerance; lactase deficiency; glucose-galactose malabsorption. Before taking the drug, you should consult your doctor.

Pregnancy

Use of the drug Thiogamma Contraindicated during pregnancy and lactation.

Interaction with other drugs

With the simultaneous administration of thioctic acid and cisplatin, a decrease in the effectiveness of cisplatin is observed.

Thioctic acid binds metals, so it should not be prescribed simultaneously with drugs containing metal ions (for example, iron, magnesium, calcium).

Strengthens the anti-inflammatory effect of GCS. With simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may be enhanced.

Ethanol and its metabolites weaken the effect of thioctic acid.

Additionally for concentrate for solution for infusion and solution for infusion

Thioctic acid reacts with sugar molecules, forming poorly soluble complexes, for example with a solution of levulose (fructose). Thioctic acid infusion solutions are incompatible with dextrose solution, Ringer's solution and solutions that react with disulfide and SH groups.

Overdose

Symptoms of drug overdose Thiogamma: nausea, vomiting, headache.

When taking doses of 10 to 40 g of thioctic acid in combination with alcohol, cases of intoxication, including death, were observed.

Symptoms of acute overdose: psychomotor agitation or confusion, usually followed by the development of generalized seizures and lactic acidosis. Cases of hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, bone marrow depression and multiorgan failure have also been described.

Treatment: symptomatic. There is no specific antidote.

Storage conditions

A drug Thiogamma should be stored in a place protected from light, at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Release form

Thiogamma - concentrate for the preparation of solution for infusion, 30 mg/ml. 20 ml in ampoules made of brown glass (type I). A white dot is applied to each ampoule of paint. 5 ampoules are placed in a cardboard tray with dividers. 1, 2 or 4 pallets together with a hanging light-protective case made of black PE are placed in a cardboard box.

Thiogamma - solution for infusion, 12 mg/ml. 50 ml in bottles made of brown glass (type II), closed with rubber stoppers. The plugs are fixed using aluminum caps, on the top of which there are polypropylene gaskets. 1 or 10 bottles together with hanging light-protective cases (according to the number of bottles) made of black PE and cardboard partitions are placed in a cardboard box.

Thiogamma - film-coated tablets, 600 mg. 10 tablets each in blisters made of PVC/PVDC/aluminum foil. 3, 6 or 10 blisters are placed in a cardboard box.

Compound

1 ampoule of concentrate for the preparation of solution for infusion Tiogamma contains the active substance: meglumine thioctate 1167.7 mg (corresponds to 600 mg thioctic acid).

Excipients: macrogol 300 - 4000 mg; meglumine - 6–18 mg; water for injection – up to 20 ml

1 bottle of solution for infusion Tiogamma contains the active substance: meglumine salt of thioctic acid 1167.7 mg (corresponds to 600 mg of thioctic acid).

Excipients: macrogol 300 - 4000 mg; meglumine; water for injection - up to 50 ml.

1 film-coated tablet Tiogamma contains active substance: thioctic acid 600 mg.

Excipients: hypromellose - 25 mg; colloidal silicon dioxide - 25 mg; MCC - 49 mg; lactose monohydrate - 49 mg; carmellose sodium - 16 mg; talc - 36.364 mg; simethicone - 3.636 mg (dimethicone and colloidal silicon dioxide 94:6); magnesium stearate - 16 mg; shell: macrogol 6000 - 0.6 mg; hypromellose - 2.8 mg; talc - 2 mg; sodium lauryl sulfate - 0.025 mg.

Additionally

In patients with diabetes mellitus, constant monitoring of blood glucose concentrations is necessary, especially at the initial stage of therapy. In some cases, it is necessary to reduce the dose of insulin or oral hypoglycemic drug to avoid the development of hypoglycemia. If symptoms of hypoglycemia occur (dizziness, increased sweating, headache, visual disturbances, nausea), therapy should be stopped immediately. In isolated cases, when using the drug Thiogamma in patients with a lack of glycemic control and in severe general condition, serious anaphylactic reactions may develop.

Patients taking Thiogamma should avoid drinking alcohol. Alcohol consumption during therapy with Thiogamma reduces the therapeutic effect and is a risk factor contributing to the development and progression of neuropathy.

Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. Taking the drug Thiogamma does not affect the ability to drive a vehicle or operate other mechanisms.

Additionally for film-coated tablets.

Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome or glucose-isomaltose deficiency should not take Thiogamma.

One film-coated tablet of Thiogamma 600 mg contains less than 0.0041 XE.