Berlithion® (Lipoic Acid/Thioctic Acid) 600 mg (30 capsules)

Composition - 1 capsule contains an active substance - thioctic acid 600 mg
excipients: solid fat, medium chain triglycerides.

Indications for use

- Paresthesia in diabetic polyneuropathy

Method of administration and dosage

Dosage

The daily dose is 1 capsule of Berlithion® 600 capsules (corresponds to 600 mg of thioctic acid), which is taken once, approximately 30 minutes before the first meal.

With severe paresthesia, you can first carry out infusion therapy with thioctic acid.

Children and adolescents

Berlithion® 600 capsules should not be taken by children and adolescents.

Mode of application

Berlithion® 600 capsules should be taken on an empty stomach, swallowed whole and washed down with plenty of fluids. Simultaneous food intake can impede absorption. Therefore, for patients who are characterized by a long time for gastric emptying, it is especially important that the medicine is taken half an hour before breakfast.

Since diabetic polyneuropathy is a chronic disease, long-term therapy may be necessary.

The mainstay of treatment for diabetic polyneuropathy is optimal control of the course of diabetes.

Side effects

Often (≥ 1/100 - <1/10)
- dizziness
- nausea
Very rare (<1/10000)
- allergic reactions such as skin rashes, hives and itching
- hypoglycemia
- dysgeusia, headache, hyperhidrosis
- visual impairment
- vomiting, stomach and intestinal pain, diarrhea
- due to improved absorption of glucose, a decrease in blood glucose levels is possible.

Complaints indicative of a hypoglycemic state have been reported, such as dizziness, sweating, headache, and blurred vision.

Contraindications

• Hypersensitivity to the active substance or any of the excipients


• The drug Berlithion® 600 capsules is not intended for treatment in children and adolescents under 18 years of age, since there is no clinical experience in this population


• Lactation period

Drug interactions

With the simultaneous administration of Berlithion® 600 capsules, there is a decrease in the effect of cisplatin.

Thioctic acid is a metal chelating agent, and therefore, based on fundamental considerations, it is not recommended to prescribe it simultaneously with metal compounds (for example, iron, magnesium, dairy products, due to the calcium content in them). When taking the full daily dose of Berlithion® 600 capsules 30 minutes before breakfast, iron and magnesium preparations can be taken at lunchtime or in the evening.

The sugar-lowering effect of insulin and oral antidiabetic agents may be enhanced. Therefore, careful control of blood sugar is indicated, especially at the initial stage of thioctic acid therapy.

In some cases, in order to avoid the phenomena of hypoglycemia, it may be necessary to reduce the dose of insulin or the dose of an oral antidiabetic agent.

Note:

Regular intake of alcoholic beverages is a significant risk factor for the onset and progression of the clinical picture of neuropathy and may interfere with the success of treatment with Berlithion® 600 capsules. Therefore, patients with diabetic polyneuropathy are advised to avoid alcohol intake as much as possible. This also applies to the periods between courses of therapy.

Special instructions

Berlithion® 600 capsules contains sorbitol. Patients with a rare hereditary disease - impaired fructose intolerance, this drug should not be taken.

Pregnancy and lactation

Pregnancy

In animal studies, no direct or indirect harmful effects of the drug in terms of toxicity to reproductive organs have been established. The drug Berlithion® 600 capsules during pregnancy can only be used after a careful assessment of the balance of benefits and risks.

Lactation

Nothing is known about the possible transition of thioctic acid or its metabolites into human milk. It is necessary to decide whether to interrupt breastfeeding or to discontinue / abstain from therapy with Berlithion® 600 capsules, taking into account the benefits of breastfeeding for the child and the benefits of therapy for women.

Fertility

Reproductive toxicity studies have not found any data regarding effects on fertility.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Berlithion® 600 does not affect or has a slight effect on the ability to drive vehicles and maintain mechanisms.

Overdose

In case of overdose, nausea, vomiting and headaches may appear.

When taken - accidentally or for suicidal purposes - an oral dose of 10 to 40 g of thioctic acid in combination with alcohol was observed severe intoxication, in some cases - with a lethal outcome. The clinical picture of intoxication can first be expressed in psychomotor agitation or clouding of consciousness and further proceeds typically - with attacks of generalized seizures and the development of lactic acidosis. In addition, hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation (DIC), bone marrow suppression and multiple organ failure have been described as consequences of high-dose thioctic acid intoxication.

Therapeutic measures for intoxication

With only one suspicion of intoxication with Berlithion® 600 capsules (for example,> 10 600 mg capsules in adults and> 50 mg / kg body weight in children), immediate referral to the hospital and measures are indicated in accordance with generally accepted principles of treatment in cases of intoxication (for example, induction of vomiting, gastric lavage, activated charcoal, etc.). Treatment of seizures of generalized seizures, lactic acidosis and all other life-threatening consequences of intoxication should comply with modern principles of intensive care and be symptomatic. Currently, there is no certainty about the benefits of using hemodialysis, as part of the forced elimination of thioctic acid, or hemoperfusion or hemofiltration methods.

Storage conditions

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children!

Storage period - 3 years

Do not use after the expiration date!