THIOCTACID 600 HR film-coated tablets, 60 pcs

Instructions for use for THIOCTACID 600 HR film-coated tablets, 60 pcs

Field of use

• Thioctic acid (alpha-lipoic acid) is a substance formed in higher organisms through the body's own metabolism that influences certain metabolic processes in the body. In addition, thioctic acid has (antioxidant) properties that protect the nerve cell from reactive degradation products.
• The medicine is used for
  • Abnormal sensations due to diabetic nerve damage (polyneuropathy).

Active ingredients / ingredients / ingredients

600 mg DL-alpha-lipoic acid
Quinoline yellow, aluminum salt excipient (+)
Hyprolose excipient (+)
Hyprolose (5.0 - 16.0% hydroxypropoxy groups) excipient (+)
Hypromellose excipient (+)
Indigo carmine, aluminum salt excipient (+)
Macrogol 6000 excipient (+)
Magnesium stearate excipient (+)
Talc excipient (+)
Titanium dioxide auxiliary (+)

Contraindications

• The medicine should not be taken
  • if you are allergic to thioctic acid or any of the other ingredients.

dosage

• Always take this medicine exactly as described or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
• The recommended dose is:
  • 1 Film-coated tablet of thioctic acid (equivalent to 600 mg thioctic acid) as a single dose approximately 30 minutes before the first meal.

 

• Duration of application
  • Since diabetic nerve damage is a chronic disease, you may need to take thioctic acid long-term.
  • Your treating doctor will decide in individual cases.
  • Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

 

• If you have taken more than you should
  • Overdose may cause nausea, vomiting and headaches.
  • In individual cases, severe, e.g. T. life-threatening symptoms of poisoning have been observed (such as generalized seizures, imbalance in the acid-base balance with lactic acidosis, severe blood clotting disorders).
  • Therefore, if a significant overdose is suspected (e.g. more than 10 tablets of 600 mg in adults and more than 50 mg/kg body weight in children), immediate hospitalization and the initiation of measures in accordance with the general principles of treatment of cases of poisoning are necessary.

 

• If you forget to take it
  • Do not take a double dose if you forget to take the previous dose.

 

• If you have any further questions about using the medicine, ask your doctor or pharmacist.

 

Intake

• The film-coated tablets should be taken without chewing and with sufficient liquid on an empty stomach. Concomitant consumption of food may hinder the transfer of thioctic acid into the bloodstream. It is therefore important, particularly in patients who also have a prolonged gastric emptying time, that it is taken half an hour before a meal/breakfast.

Patient information

• Warnings and Precautions
  • Please talk to your doctor, pharmacist or nurse before taking the medicine.
  • Children and young people
    • Children and adolescents should be excluded from treatment as there is no clinical experience for this age group.

 

• Ability to drive and use machines:
  • There are no special precautions required.

   

Pregnancy

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine
• It is in accordance with the general principles of pharmacotherapy to use drugs during pregnancy and breastfeeding only after careful risk-benefit assessment.
• Pregnant and breastfeeding women should only undergo treatment with alpha-lipoic acid after careful recommendation and monitoring by a doctor, as there is currently no experience with this patient group. Special studies on animals have shown no evidence of fertility disorders or teratogenic effects.
• Nothing is known about the possible excretion of alpha-lipoic acid into breast milk.

  

Hints

Miscellaneous

- The basis of the treatment is the optimal diabetes control.

- Taking the tablet while eating can hinder the absorption of the active ingredient.

- Regular consumption of alcohol represents a significant risk factor for the development and progression of nerve disorders and can therefore also affect the success of treatment with the drug. Therefore, in the case of nerve disease caused by diabetes (diabetic polyneuropathy), it is generally recommended to avoid drinking alcohol as much as possible. This also applies to treatment-free sections.

- The active ingredient is a metal chelator and therefore, for fundamental reasons, should not be given at the same time as metal compounds (e.g. iron preparations, magnesium preparations, dairy products due to the calcium content).
- If the entire daily dose is taken 30 minutes before breakfast, iron and magnesium supplements can be taken at lunch or in the evening.

Manufacturer:  Viatris Healthcare GmbH, Benzstraße 1