NEURO EFFEKTON B dragees, 100 pcs

Instructions for use for NEURO EFFEKTON B dragees, 100 pcs

Field of use

• The preparation is a high-dose vitamin B₁/ B₆combination and is used for:
  • neurological systemic diseases (diseases of the nervous system) due to proven deficiency of vitamins B₁ and B₆.

Active ingredients / ingredients / ingredients

100 mg pyridoxine hydrochloride
82.27 mg pyridoxine
250 mg thiamine hydrochloride
222.97 mg thiamine
Arabic gum excipient (+)
Calcium carbonate excipient (+)
Carboxymethyl starch, sodium salt excipient (+)
Carnauba wax auxiliary (+)
Cellulose, microcrystalline excipient (+)
Eudragit S excipient (+)
Glucose syrup excipient (+)
Lactose 1-water excipient (+)
Magnesium stearate excipient (+)
Povidone K30 excipient (+)
Sucrose excipient (+)
Shellac auxiliary (+)
Silicon dioxide, highly disperse auxiliary (+)
Talc excipient (+)
Titanium dioxide auxiliary (+)
Wax, bleached auxiliary (+)

Contraindications

• The medicine must not be taken,
  • if you are hypersensitive (allergic) to thiamine, pyridoxine or any of the other ingredients of the product.

dosage

• Always take the product exactly as directed. Please ask your doctor or pharmacist if you are not sure.
• Unless otherwise prescribed by the doctor, the usual dose is:
  • Adults and children over 14 years of age take one coated tablet once daily. If there is a manifest, proven deficiency, the dose can be increased to up to one coated tablet three times a day after consulting your doctor.
  • Due to the relatively high content of vitamin B₆ , a maximum of 1 coated tablet should be taken daily during pregnancy and breastfeeding.

 

• Duration of application
  • After 4 weeks at the latest, the treating doctor should decide whether the administration of vitamin B₆ and vitamin B₁ is still indicated in the high concentration present here. If necessary, a switch to a low-potency preparation should be made to reduce the risk of neuropathy associated with vitamin B₆.
  • Please talk to your doctor or pharmacist if you have the impression that the effect of the medicine is too strong or too weak.

 

• If you have taken more than you should
  • Acute symptoms of poisoning are not known, but neurotoxic effects can occur with long-term (months to years) daily intake of vitamin B₆ in doses over 50 mg and with short-term intake (2 months) in doses over 1 g/day appear. An overdose is essentially manifested by sensory polyneuropathy (nerve disease with tingling and pins and needles in the hands and feet), possibly with ataxia (coordination disorders). Extremely high doses can result in convulsions. In newborns and infants, severe sedation, low blood pressure and breathing disorders (dyspnea, apnea) may occur.
  • If acute doses of more than 150 mg vitamin B₆/kg body weight have been taken, artificially induced vomiting and the administration of activated charcoal are recommended. Vomiting is most effective in the first 30 minutes after ingestion. Intensive care measures may be 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 coated tablets are taken whole with a sufficient amount of liquid with or after meals.

Patient information

• Particular caution is required when taking the drug
  • With long-term use (several months to years) of daily doses of more than 50 mg of pyridoxine hydrochloride and with short-term use (2 months) of doses in the gram range, tingling and pins and needles on the hands and feet (signs of peripheral sensory neuropathy or paresthesia) were observed. If you notice tingling or pins and needles, please contact your doctor. This will check the amount taken and, if necessary, stop the medication.

 

• Ability to drive and use machines:
  • There is currently no evidence that the ability to actively drive or use machines is impaired during treatment with the medicine.

Pregnancy

• Before taking/using any medicines, ask your doctor or pharmacist for advice.
• Pregnancy
  • If you are pregnant, due to the amount of active ingredients, this medicine is only useful for treating a proven vitamin B₁ and B₆ deficiency. Therefore, you may only take the medicine after the treating doctor has carefully weighed up the benefits and risks. During pregnancy, the recommended daily intake for vitamin B₁ is 1.4 - 1.6 mg and for vitamin B₆ 2.4 - 2.6 mg. The safety of using doses higher than the daily recommended ones has not yet been proven.
• Lactation
  • If you are breastfeeding, due to the amount of active ingredient, this medicine is only useful for treating a proven vitamin B₁ and B₆ deficiency. Therefore, you may only take the medicine after the treating doctor has carefully weighed up the benefits and risks. During breastfeeding, the recommended daily intake for vitamin B₁ is 1.4 - 1.6 mg and for vitamin B₆ 2.4 - 2.6 mg. The safety of using doses higher than the daily recommended ones has not yet been proven. Vitamin B₁ and B₆ are excreted in breast milk. High doses of vitamin B₆ can inhibit milk production.

Hints

Miscellaneous

- Due to the relatively high vitamin B6 content, a maximum of 1 tablet should be taken daily during pregnancy and breastfeeding.
- If signs of sensory discomfort (paresthesia) occur, the amount should be checked and the medication discontinued if necessary.
- Sensory abnormalities were observed with long-term intake (more than 6-12 months) of daily amounts of more than 50 mg and with short-term intake (longer than 2 months) of amounts of more than 1 g of vitamin B6 per day.

Manufacturer:  Teofarma s.r.l., Via Fratelli Illi Cervi 8