1. WHAT IS VITAMIN B6 AND WHAT IS IT USED FOR
Vitamin B6 (pyridoxine) is involved in the formation and metabolism of biologically active substances in the body. Together with other vitamins of this group, it helps convert carbohydrates into glucose, the main source of energy for the body. Vitamin B6 is necessary for the normal development and functioning of the nervous system and liver, for the formation of red blood cells (erythrocytes) and cells of the immune system. It belongs to the so-called "anti-stress" vitamins, as it stimulates the immune system. It is necessary for maintaining muscle tone of the gastrointestinal tract, for the normal functioning of the skin and eyes.
It is used to treat vitamin B6 deficiency in:
impaired absorption of the vitamin by the body (malabsorption syndrome) associated with liver and bile diseases (biliary obstruction, cirrhosis, alcoholism), intestinal disease (Crohn's disease), gluten intolerance (celiac disease);
treatment with products that disrupt vitamin B6 metabolism.
Vitamin B6 Sopharma is used in the complex treatment of acute poisoning with isoniazid (a drug for the treatment of tuberculosis).
2. BEFORE USING VITAMIN B6 SOPHARMA
Do not use Vitamin B6 Sopharma
if you are allergic (hypersensitive) to the active substance pyridoxine or to any of the other ingredients of the medicine.
Take special care when using Vitamin B6 Sopharma
if you experience burning pain in the heels and impaired coordination of movements (ataxia). These symptoms may appear 1 month to 3 years after the start of treatment. Inform your doctor if they occur.
Vitamin B6 may cause false-positive results in the determination of urobilinogen with the Ehrlich reagent.
Using other medicines
Please inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Inform your doctor if you are taking levodopa (a medicine for the treatment of Parkinson's disease). Vitamin B6 reduces the effect of this medicine and its dose may need to be adjusted.
Pregnancy and breast-feeding
Ask your doctor before using any medicine.
Pregnancy: Vitamin B6 can be administered in therapeutic doses during pregnancy. When administered in high doses, it may lead to pyridoxine dependence in the newborn.
Breast-feeding: The use of vitamin B6 is not recommended during breast-feeding. If treatment with vitamin B6 is necessary for the mother, breast-feeding should be discontinued.
Driving and using machines
Vitamin B6 does not adversely affect attention and speed of reactions.
Important information about some of the ingredients of Vitamin B6 Sopharma
The medicinal product contains methyl parahydroxybenzoate as an excipient, which may cause allergic reactions with urticaria (rash) and bronchospasm.
3. HOW TO USE VITAMIN B6 SOPHARMA
Always use Vitamin B6 exactly as your doctor has told you. If you are not sure about something, ask your doctor or pharmacist.
Vitamin B6 Sopharma injection solution is administered intramuscularly or intravenously by qualified medical personnel. The dose and duration of treatment are determined by your doctor.
The usual dose is:
Adults - 50-200 mg (1/2-2 ampoules) to 600 mg (6 ampoules) daily.
Children - 10 to 100 mg daily.
If you are not sure about something, ask your doctor.
If more than the required dose of Vitamin B6 Sopharma has been administered
Vitamin B6, administered in high doses (2 to 6 g daily) for several months, can cause severe neuropathy, progressing from an unsteady gait to numbness and clumsiness of the hands. This condition is reversible and disappears when treatment is stopped, although there may be residual phenomena such as weakness.
If you forget to administer Vitamin B6 Sopharma
Do not administer a double dose to make up for the missed dose. If you have any further questions on the use of this product, please ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines. Vitamin B6 Sopharma can cause side effects, although not everybody gets them.
The product is well tolerated.
Rarely observed:
Neurological disorders: polyneuropathy (tingling of the extremities), seizures, dizziness. These reactions are rarely observed with prolonged treatment in high doses.
Hypersensitivity reactions: rashes.
Adverse reactions disappear when treatment is discontinued. If any of the adverse drug reactions becomes serious or you notice other adverse reactions not described in this leaflet, please inform your doctor.
5. HOW TO STORE VITAMIN B6 SOPHARMA
In the original packaging, in order to protect from light.
Store below 25°C.
Do not freeze!
Keep out of the reach of children!
Do not use Vitamin B6 Sopharma after the expiry date stated on the packaging.
Medicines should not be thrown away in the sewer or household waste container.
Ask your doctor
our pharmacist how to dispose of your medicines no longer required.
These measures will help protect the environment
6. FURTHER INFORMATION
What Vitamin B6 Sopharma contains
The active substance is: pyridoxine hydrochloride 100 mg in 2 ml injection solution.
The other ingredients are: sodium sulfite, anhydrous: methyl para-hydroxybenzoate: water for injections.
What Vitamin B6 Sopharma looks like and contents of the pack
Pale yellow, clear solution in brown glass ampoules with a capacity of 2 ml, 10 ampoules in a PVC foil blister.
1 or 5 blisters in a cardboard box, together with a leaflet.