ALPHA VIBOLEX 300 mg paresthesia, polyneuropathy

• 300 mg DL-α-lipoic acid

• Hard fat
• Triglycerides, medium chain
• Sorbitol 70
• Glycerol 85%
• Glycerol 85%
• gelatin
• Titanium dioxide
• Amaranth

Indication / application

• Thioctic acid, the active ingredient in this drug, is a substance formed in higher organisms in the body's own metabolism that influences certain metabolic functions of the body. In addition, thioctic acid has antioxidant properties that protect nerve cells from reactive degradation products.
• The capsules are used for paresthesia caused by diabetic nerve damage (polyneuropathy).

dosage

• Always take the capsules exactly as directed. Please ask your doctor or pharmacist if you are not sure.
• Unless otherwise prescribed by your doctor, the usual dose is:
  • Unless otherwise prescribed, the daily dose is 2 soft capsules (equivalent to 600 mg thioctic acid), which should be taken as a single dose about 30 minutes before the first meal.

• How long should you take the capsules?
  • Since diabetic nerve damage is a chronic condition, you may need to take the capsules permanently. Your treating doctor will decide on a case-by-case basis.

• If you take more than you should
  • In the event of an overdose, nausea, vomiting and headache may occur.
  • In individual cases, heavy, z. Sometimes life-threatening symptoms of poisoning were observed (such as generalized seizures, derailment of the acid-base balance with lactic acidosis, severe blood clotting disorders).
  • Therefore, if a significant overdose or accidental ingestion is suspected (e.g. more than 10 capsules of 600 mg in adults and more than 50 mg / kg body weight in children), immediate hospitalization and measures according to the general treatment principles of Cases of poisoning required.

• If you forget to take a dose
  • Do not take a double dose to make up for a forgotten dose.

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

way

• How and when should you take the capsules?
  • The capsules should be swallowed whole and with sufficient liquid on an empty stomach. Ingesting food at the same time can impede the passage of thioctic acid into the bloodstream. Therefore, especially in patients who also have a prolonged gastric emptying time, it is important that the intake takes place half an hour before the meal / breakfast.

Side effects

• Like all medicines, these can have side effects, although not everybody gets them.
• When evaluating side effects, the following frequencies are used as a basis:
  • Very common: affects more than 1 in 10 people
  • Common: affects more than 1 in 100 people
  • Uncommon: affects more than 1 in 1,000 patients
  • Rare: affects more than 1 in 10,000 people
  • Very rare: affects 1 or less in 10,000 people
  • Not known: frequency cannot be estimated from the available data
• Possible side effects:
  • Gastrointestinal tract
    • Very rare: nausea, vomiting, stomach and intestinal pain and diarrhea
  • Hypersensitivity reactions
    • Very rare: allergic reactions such as skin rash, hives (urticaria) and itching
  • Nervous system
    • Very rare: change or disturbance of taste sensation
  • immune system
    • Frequency not known: disorder of the blood sugar regulating hormones with a sharp drop in the blood sugar level (insulin autoimmune syndrome).
  • Body overall
    • Very rare: the blood sugar level may drop due to improved glucose utilization. Symptoms such as hypoglycaemia with dizziness, sweating, headaches and visual disturbances were described.
• Countermeasures:
  • If you observe the above-mentioned side effects, the capsules should not be taken again.
  • Notify your doctor so he can decide the severity and any additional measures that may be required.
  • At the first signs of a hypersensitivity reaction, the drug should be discontinued and a doctor should be contacted immediately.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

Interactions

• Taking with other medicines
  • Please tell your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.
  • Please note that this information can also apply to recently used drugs.
  • It cannot be ruled out that concomitant use of this medicinal product may lead to a loss of effectiveness of cisplatin (a cancer medicine).
  • Thioctic acid, the active ingredient in this medicinal product, easily forms chemical compounds with metals (metal chelator) and should therefore not be given at the same time as metal compounds (e.g. iron supplements, magnesium supplements, dairy products due to the calcium content) because of the loss of effectiveness can. If the entire daily dose is taken 30 minutes before breakfast, iron and magnesium supplements can be taken at noon or in the evening.
  • The blood sugar-lowering effect of anti-diabetes medicines (insulin or other medicines for diabetes that are taken) may be increased. Therefore, a close blood sugar control is indicated, especially at the beginning of the therapy. In individual cases, in order to avoid symptoms of hypoglycaemia, it may be necessary to reduce the insulin dose or the dose of the anti-diabetic agent according to the instructions of the attending physician.
• Take with food and drink
  • Regular consumption of alcohol represents a significant risk factor for the development and progression of diseases that are associated with damage to the nerves and can therefore also impair the success of treatment with this preparation. Therefore, patients with diabetic nerve damage (polyneuropathy) are generally recommended to avoid alcohol as much as possible. This also applies to therapy-free intervals.

Contraindications

• The capsules must not be taken
  • if you are allergic (hypersensitive) to thioctic acid or any of the other ingredients.

pregnancy and breast feeding period

• Ask your doctor or pharmacist for advice before taking / using any medicine.
• It corresponds to the general principles of pharmacotherapy that drugs should only be used during pregnancy and breastfeeding after careful risk-benefit analysis.
• Pregnant and breastfeeding women should only undergo treatment with thioctic acid after careful recommendation and supervision by their doctor, as there is no experience with this group of patients. Special studies on animals have not produced any indications of fertility disorders or teratogenic effects.
• Nothing is known about a possible transfer of thioctic acid into breast milk.

Patient information

• Take special care when taking it
  • Patients with a certain HLA (human leukocyte antigen system) genotype (which is more common in patients from Japan and Korea, but is also found in Caucasians) are more prone to developing insulin autoimmune syndrome (a disorder of the blood sugar regulating hormones) when treated with thioctic acid with a sharp drop in blood sugar levels).
  • Children:
    • Children and adolescents should be excluded from treatment as there is insufficient experience for this age group.

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

additional Information

- The basis of diabetic polyneuropathy therapy is optimal diabetes adjustment.

- During treatment with the drug, alcohol should not be drunk, as alcohol can weaken the effect of the drug.