Berlition kaps. soft 600 mg packed No. 30

Berlition of the 600th capsule for treatment of paresthesia in diabetic polyneuropathy.

Structure

• active ingredient: thioctic acid;
• 1 capsule soft contains thioctic acid of 600 mg;
• other components: solid fat, triglycerides of an average chain;
• capsule cover: sorbite, not crystallizing solution, 70% (E 420); glycerin (85%); gelatin; titan of dioxide (E 171); karmenny varnish (E 120).

Contraindication

Hypersensitivity to thioctic acid or any other component of medicine.

Side reactions

from the immune system. Very seldom: allergic reactions, including skin rash, a small tortoiseshell (urtikarny rash), an itching, the complicated breath. It is unknown: autoimmune insulin syndrome, eczema.

Disbolism and food. Very seldom: hypoglycemia.

from nervous system. Often: dizziness. Very seldom: dysgeusia, headaches, hyperhidrosis.

from organs of sight. Very seldom: disorder of vision.

from a digestive tract. Often: nausea. Very seldom: vomiting, gastrointestinal pain, diarrhea.

General disorders. Very seldom: decrease in level of glucose in blood that is connected with improvement of digestion of glucose. Symptoms similar to hypoglycemic: dizziness, perspiration, headaches and disorders of vision.

Route of administration

Daily dose makes 1 capsule of Berlition medicine of the 600th capsule (that is equivalent to 600 mg of thioctic acid), which should be accepted as a single dose approximately in 30 minutes prior to food. In intensive paresthesias it is possible to begin treatment using infusional therapy with thioctic acid.

Capsule of Berlition medicine of the 600th capsule should be accepted on an empty stomach, swallowing entirely and washing down with enough liquid. The concomitant use of food can complicate absorption therefore to patients of whom long gastric emptying is characteristic it is especially important that medicine was applied for half an hour till a breakfast. As diabetic polyneuropathy is a chronic disease, long therapy can be required. A basis of treatment of diabetic polyneuropathy is optimum diabetic control.

Feature of use

Use during pregnancy or feeding by a breast

Berlition of the 600th capsule should be applied during pregnancy only after careful assessment of a ratio advantage/risk.

Data on penetration of thioctic acid or its metabolites in breast milk. It is necessary to make the decision on the feeding termination by a breast or phase-out of Berlition medicine of the 600th capsule taking into account advantage of feeding by a breast for the child and advantage of therapy for the woman.

by

for treatment of children and teenagers due to the lack of experience of clinical use.

Ability to influence speed of response at control of motor transport or other mechanisms

during treatment needs to be careful at control of motor transport, work with other mechanisms or occupation as other potentially dangerous types of activity requiring special attention and speed of psychomotor reactions because of possibility of such side reactions as a hypoglycemia, dizziness and a disorder of vision.

Overdose

At overdose the nausea, vomiting and headaches can arise. After accidental reception or in attempt of suicide with oral administration of thioctic acid in doses from 10 to 40 g in a combination with alcohol considerable intoxications, in certain cases with a lethal outcome were observed. At the initial stage the clinical picture of intoxication can be shown by psychomotor arousing or disturbance of consciousness and usually is followed by further developing of generalized spasms and development of lactoacidosis. Besides, as a result of intoxication the high doses of thioctic acid described a hypoglycemia, shock, a rhabdomyolysis, hemolysis, a syndrome of disseminate intravascular fibrillation, oppression of activity of marrow and multiorgan insufficiency.

Treatment. Even at suspicion of severe intoxication capsule Берлитион® 600 medicine (for example reception more than 10 capsules on 600 mg for adults or a dose over 50 mg/kg of body weight for children) showed immediate hospitalization and taking measures according to the general principles of treatment of poisonings (for example induction of vomiting, gastric lavage, intake of activated carbon, etc.). Treatment of generalized spasms, lactoacidosis and other consequences of intoxication, life-threatening, has to be focused on the principles of modern intensive care and be carried out symptomatic. Today the expediency of use of a hemodialysis, hemoperfusion or methods of filtration within the forced removal of thioctic acid is not confirmed.

Interaction with other medicines and other types of interactions

Efficiency of Cisplatinum decreases at simultaneous treatment by Berlition medicine of the 600th capsule.

Thioctic acid is a metal helator and therefore, on the basic principles of pharmacotherapy, it should not be applied along with a soyedineniyama of metals (for example, with the nutritional supplements containing iron, magnesium or with dairy products as they contain calcium). If to apply the general daily dose of Berlition medicine of the 600th capsule in 30 minutes prior to a breakfast, then the nutritional supplements containing iron and magnesium can be accepted in the afternoon or in the evening.

therefore especially at an initial stage of treatment thioctic acid showed careful control of level of glucose in blood. In order to avoid hypoglycemia symptoms in some cases there can be a need for a dose decline of insulin or oral antidiabetic means.

Regular consumption of alcoholic beverages is considerable risk factor of development and progressing of a clinical picture of neuropathy and, thus, can interfere with efficiency of treatment by capsule Берлитион® 600 medicine. Therefore to patients with diabetic polyneuropathy is strongly recommended to refuse alcohol intake. It concerns the periods when therapy is not carried out.

to Store

at a temperature not over 25C.

to Store

out of children's reach.