Berlition 300 - instructions for use, dose, side effects, contraindications

Excipients: lactose monohydrate - 60.00 mg, croscarmellose sodium - 24.00 mg, silicon colloidal dioxide - 18.00 mg, microcrystalline cellulose - 165.00 mg, povidone (K = 30) - 21.00 mg, magnesium stearate -12.00 mg.

Film sheath: Opadine OY-S-22898 yellow - 12.00 mg, consisting of: hypromellose - 6.5970 mg, titanium dioxide (E 171) - 3.9134 mg, sodium lauryl sulfate - 0.7096 mg, paraffin liquid - 0 , 6760 mg, dye quinoline yellow (E 104) - 0.0750 mg, dye solar sunset yellow (E 110) - 0.0290 mg; paraffin liquid - 3.00 mg.

Description:

Round biconvex tablets covered with a film coat, pale yellow, with a risk on one side.

Cross-sectional view: uneven, granular surface, light yellow color.

Pharmacotherapeutic group:Metabolic means

ATX: & nbsp

A.16.A.X.01 Thioctic acid

Pharmacodynamics:

Thioktovaya (alpha lipoic) acid is an endogenous antioxidant of direct (binds free radicals) and indirect (restores the intracellular level of glutathione, increases the activity of superoxide dismutase) of the action. As a coenzyme mitochondrial multienzyme complexes is involved in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. Helps reduce blood glucose and increases glycogen concentrations in the liver, and also reduces insulin resistance. Thioctic acid is an endogenous vitamin-like substance and by the nature of its biochemical action is close to the vitamins of group B. It improves the trophic of neurons, participates in the regulation of lipid and carbohydrate metabolism, stimulates the cholesterol metabolism, improves liver function.

Pharmacokinetics:

When ingested quickly absorbed, from the gastrointestinal tract (eating reduces absorption). Time to reach the maximum concentration in the blood plasma - 25-60 min.Absolute bioavailability of thioctic acid when ingested is 30%. Has the effect of "first pass" through the liver. The formation of metabolites occurs as a result of oxidation of the side chain and conjugation.

The volume of distribution is about 450 ml / kg. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). The elimination half-life is 25 minutes. The total plasma clearance is 10-15 ml / min / kg.

Indications:

- diabetic polyneuropathy;

- alcoholic polyneuropathy.

Contraindications:

- hypersensitivity to thioctic acid or other components of the drug;

- deficiency of lactase, hereditary lactose intolerance, glucose-galactose malabsorption syndrome;

- pregnancy, lactation;

- children under 18 years of age (efficacy and safety of the drug are not established).

Pregnancy and lactation:

The use of Berlition® 300 during pregnancy is contraindicated because there is a lack of clinical experience with the use of thioctic acid in pregnancy. Reproductive toxicity studies did not reveal any risks with respect to fertility, effects on fetal development and any embryotoxic properties of the drug.

The use of Berlition® 300 during lactation is contraindicated because there is no data on the penetration of thioctic acid into breast milk.

Dosing and Administration:

Take inside 2 tablets (600 mg) of the drug Berlition®, 300 once a day. The daily dose is 600 mg.

Tablets are taken on an empty stomach, approximately 30 minutes before meals, without chewing, squeezed with enough liquid. Possible long-term use of the drug.

The duration of the course of treatment and the possibility of its recurrence is determined by the doctor.

Side effects:

Possible side effects with Berlition® 300 are given below in the descending frequency of occurrence: very often (1 ≥ 1/10), often (≥ 1/100, <1/10), infrequently (≥ 1/1000, <1/100), rarely (≥ 1/10000, <1/1000), very rarely (<1/10000). Correlations of the incidence of side effects with the sex or age of patients are not observed.

From the nervous system:

Very rarely: change or violation of taste sensations;

From the gastrointestinal tract:

Very rarely: nausea, vomiting, abdominal pain, diarrhea;

From the side of metabolism:

Very rare: a decrease in the concentration of glucose in the blood (due to improved absorption of glucose).Complaints have been reported that indicate a hypoglycemic condition, such as dizziness, increased sweating, headache and visual impairment.

From the immune system:

Very rarely: allergic reactions, such as a skin rash, urticaria (urticaria rash), itching, in some cases - anaphylactic shock.

Overdose:

Symptoms: nausea, vomiting, headache.

In severe cases (with the intake of more than 20 tablets of 300 mg for adults or a dose> 50 mg / kg of body weight in children): psychomotor agitation or turbidity, generalized convulsions, severe acid-base balance with lactic acidosis, hypoglycemia development of coma), acute necrosis of skeletal muscles, hemolysis, DIC-syndrome, suppression of bone marrow activity, multi-organ failure.

Treatment: If there is a suspicion of severe intoxication with thioctic acid,

emergency hospitalization and the beginning of the application of measures in accordance with the general principles adopted for accidental poisoning (calling up vomiting, washing the stomach, taking activated charcoal, etc.). ' Treatment of generalized seizures, lactoacidosis-and

other life-threatening consequences of intoxication should be conducted in accordance with the principles of modern, intensive, therapy and should be symptomatic.

There is no specific antidote. Hemodialysis; hemoperfusion or filtration methods with forced excretion of thioctic acid are not effective.

Interaction:

Simultaneous application of the drug Berlition® 300- with cisplatin reduces the effectiveness of the latter.

Simultaneous reception of the drug Berlition®, 300 and preparations of iron, magnesium, and the use of dairy products (due to the content of calcium in them) is not recommended (due to the formation of complexes, with metals). The interval between doses should be at least 2 hours. The drug Berlition® 300 enhances the hypoglycemic action of insulin and oral hypoglycemic agents.

Ethanol reduces the therapeutic activity of the drug Berlition® 300.

Special instructions:

In patients with diabetes mellitus, who take insulin or oral hypoglycemic agents, a constant control of the concentration of glucose in the blood plasma is necessary, especially at the initial stage of therapy.In some cases, it may be necessary to reduce the dose of insulin or an oral hypoglycemic agent in order to avoid the development of hypoglycemia.

Simultaneous eating can interfere with the absorption of the drug. Drinking alcohol reduces the effectiveness of treatment with Berlition® 300, therefore patients should be refrained from drinking alcohol during the course of treatment, and, if possible, during breaks between courses, during the treatment with Berlition® 300.

Effect on the ability to drive transp. cf. and fur:

The effect of the preparation Berlition® 300 on the ability to drive vehicles and control mechanisms has not been specifically studied, therefore, during the treatment with Berlition® 300, caution should be exercised when driving vehicles and engaging in potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Film coated tablets shell, 300 mg.

Packaging:

10 tablets in a contour cell packing (blister) [PVC / PVDC / aluminum foil].

By 3, 6 or 10 blisters together with instruction on the use of the roomThey put them into a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep the medicine out of the reach of children!

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N011433 / 01

Date of registration:06.07.2011 / 26.09.2014

Expiration Date:Unlimited

The owner of the registration certificate:BERLIN-PHARMA, CJSC BERLIN-PHARMA, CJSC Russia

Manufacturer: & nbsp

HAUPT PHARMA WOLFRATSHAUSEN, GmbH Czech Republic

BERLIN-PHARMA, CJSC Russia

Information update date: & nbsp23.01.2017

Illustrated instructions

Instructions

Berlition® 300 (Berlithion® 300)