• 687.38 mg α-lipoic acid, ethylenediamine salt (2:1)

• water for injections
• ethylenediamine

Paraesthesia, diabetes mellitus, Diabetic polyneuropathy, BIOMO-lipon indication

• Alpha-lipoic acid is a substance formed in higher organisms in the body's own metabolism, which influences certain metabolic processes in the body. In addition, alpha-lipoic acid has antioxidative properties that protect nerve cells from reactive degradation products.
• The drug is used in
  • Paraesthesia with diabetic nerve damage (polyneuropathy)

dosage Paraesthesia, diabetes mellitus, Diabetic polyneuropathy, BIOMO-lipon

• Always use the medicine exactly as directed. Please check with your doctor or pharmacist if you are not sure.
• Unless otherwise prescribed by the doctor, is the usual dose
  • In the case of severe abnormal sensations associated with diabetic polyneuropathy, a once-daily infusion of 1 ampoule (equivalent to 600 mg alpha-lipoic acid) in isotonic saline solution is recommended for adults.
  • After the contents have been mixed with 250 ml isotonic saline solution, the intravenous administration should take place over at least 30 minutes as a short infusion. Due to the photosensitivity of the active ingredient, the short infusion should only be prepared shortly before use. The infusion solution should be protected from light with aluminum foil. Protected from light, the infusion solution can be stored for approx. 6 hours. It must be ensured that the minimum infusion time of 30 minutes is observed.
  • The drug is used as an infusion with isotonic saline solution over a period of 2-4 weeks in the initial phase of treatment.
  • As a further therapy, 300 - 600 mg alpha-lipoic acid should be taken daily in the form of capsules, tablets or coated tablets.
  • Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

• If you use more than you should
  • Overdose may cause nausea, vomiting and headaches.
  • In individual cases, severe, e.g. T. life-threatening symptoms of poisoning observed (such as generalized seizures, derailment of the acid-base balance with lactic acidosis, severe blood clotting disorders).
  • Therefore, if a significant overdose is suspected, immediate hospital admission and the initiation of measures according to the general treatment principles for cases of poisoning are required.

• If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

way Paraesthesia, diabetes mellitus, Diabetic polyneuropathy, BIOMO-lipon

• The preparation may only be administered as an infusion in isotonic saline solution

side Paraesthesia, diabetes mellitus, Diabetic polyneuropathy, BIOMO-lipon effects

• Like all medicines, the preparation can have side effects, although not everyone gets them.
• The evaluation of side effects is based on the following frequency information:
  • very common: more than 1 in 10 people treated
  • Common: less than 1 in 10 but more than 1 in 100 people treated
  • uncommon: less than 1 in 100 but more than 1 in 1000 people treated
  • rare: less than 1 in 1000 but more than 1 in 10,000 people treated
  • very rare: less than 1 in 10,000 people treated, including isolated cases
• After rapid intravenous injection, pressure in the head and shortness of breath often occur, which resolve spontaneously.
• Taste disturbances occur very rarely.
• Injection site reactions have been reported very rarely. Allergic reactions of the skin with hives (urticaria), itching, eczema and skin rash as well as hypersensitivity of the whole body up to shock can occur.
• Very rarely, after intravenous administration of alpha-lipoic acid, seizures, double vision, spontaneous bleeding in small patches in the skin (purpura) and functional disorders of the blood platelets and thus blood clotting (thrombopathies) have been observed.
• Very rarely, due to improved glucose utilization, blood sugar levels may drop. Symptoms like hypoglycaemia with dizziness, sweating, headaches and visual disturbances were described.
• countermeasures
  • If you notice the side effects mentioned above, the drug should not be used again. Notify your doctor so he can decide on the severity and any further action that may be needed.
  • At the first sign of a hypersensitivity reaction, the drug should be discontinued and a doctor contacted immediately.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

Paraesthesia, diabetes mellitus, Diabetic polyneuropathy, BIOMO-lipon interactions

• When used with other medicines
  • Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.
  • It cannot be ruled out that concomitant use will lead to a loss of effectiveness of cisplatin (a cancer drug).
  • The blood sugar-lowering effect of insulin or oral antidiabetics can be increased. Close blood sugar monitoring is therefore indicated, particularly in the early stages of therapy. In individual cases, it may be necessary to reduce the insulin dose or the dose of the oral antidiabetic in accordance with the instructions of the attending physician in order to avoid symptoms of hypoglycaemia.
• When used with food and drink
  • The regular consumption of alcohol represents a significant risk factor for the development and progression of neuropathic diseases and can thus also impair the success of a treatment. Therefore, patients with diabetic polyneuropathy are generally recommended to avoid the consumption of alcohol as far as possible. This also applies to therapy-free intervals.

Contraindications

• The medicine must not be used
  • if you are allergic (hypersensitive) to alpha-lipoic acid or any of the other ingredients

pregnancy and breast feeding period

• It is in accordance with the general principles of pharmacotherapy to use drugs during pregnancy and breastfeeding only after carefully weighing the benefits and risks.
• Pregnant and breastfeeding women should only undergo treatment with alpha-lipoic acid after careful recommendation and monitoring by their doctor, as there is no experience with this group of patients to date. Special studies on animals have not produced any indications of fertility disorders or teratogenic effects.
• Nothing is known about a possible transfer of alpha-lipoic acid into breast milk.

patient Paraesthesia, diabetes mellitus, Diabetic polyneuropathy, BIOMO-lipon notes

• Particular caution in use is required
  • Allergic reactions (hypersensitivity reactions up to life-threatening shock (sudden circulatory failure) have been observed in connection with the use of alpha-lipoic acid as an injection or infusion solution. For this reason, your treating doctor will monitor you during use for the occurrence of early symptoms (e.g. itching , nausea, malaise, etc.) If these occur, the therapy must be stopped immediately and further therapy measures may be necessary.
  • Alpha-lipoic acid reacts in vitro with metal ion complexes (e.g. with cisplatin), alpha-lipoic acid forms poorly soluble complex compounds with sugar molecules (e.g. levulose solution). The medicinal product is incompatible with glucose solution, Ringer's solution and with solutions known to react with SH groups or disulfide bridges. Only isotonic saline solution should be used as the carrier solution for the infusion application.
  • children
    • Children and adolescents should be excluded from treatment as there is no clinical experience in this age group.

• Driving and using machines
  • There are no special precautions required.