Vitaminum B6 Teva

Package Leaflet: Information for the User

Vitaminum B Teva, 50 mg, Tablets

Pyridoxine Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in the Package Leaflet or as Directed by a Doctor, Pharmacist, or Nurse.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Need Advice or Additional Information, Consult a Pharmacist.
• If You Experience any Undesirable Effects, Including any Possible Undesirable Effects not Listed in the Package Leaflet, Inform Your Doctor, Pharmacist, or Nurse. See Section 4.

Package Leaflet Contents

• 1. What is Vitaminum B Teva and What is it Used for
• 2. Important Information Before Taking Vitaminum B Teva
• 3. How to Take Vitaminum B Teva
• 4. Possible Undesirable Effects
• 5. How to Store Vitaminum B Teva
• 6. Package Contents and Other Information

1. What is Vitaminum B Teva and What is it Used for

Vitaminum B Teva Contains Vitamin B (Pyridoxine), Which, After Conversion into its Active Form, Pyridoxal Phosphate, Participates in Many Metabolic Processes of Carbohydrates, Proteins, and Fats. It Affects the Functions of the Nervous System, Blood System, Immune System, and Skin. It Eliminates Neuro-Muscular Disorders Associated with Deficiency, and in Higher Doses (up to 300 mg per Day) it has a Central Effect (Sedative, even Sleep-Inducing). It Relieves Nausea and Vomiting. It Facilitates the Absorption of Vitamin B, Iron, and Magnesium.

Similarly, as with Other B Vitamins, Pyridoxine Reserves in the Body are Small, and Therefore, it Must be Supplied Regularly through Diet or Supplements. The Daily Requirement for Vitamin B in Adults is Approximately 2 mg/Day. The Requirement for Vitamin B Increases in Pregnant and Breastfeeding Women (approximately 3 mg/Day) and in Individuals who Abuse Alcohol.

Vitamin B Deficiency Often Accompanies Deficiency of Other B Vitamins. Deficiency States are Most Often Caused by an Improper Diet. Deficiencies have also been Observed in Pregnant Women, Infants, and During the Use of Certain Medications.

Inadequate Utilization of Vitamin B in the Body can also be a Result of Congenital Metabolic Disorders.

Pyridoxine is Absorbed Mainly in the Small Intestine. The Medication is Metabolized in the Liver and Excreted Mainly in the Urine, in the Form of Metabolites.

Vitamin B Administration is Required for Individuals with Inadequate Dietary Intake or Increased Demand.

Indications for Use:

• Vitamin B Deficiency States;
• Diseases and Conditions Requiring Pyridoxine Administration:
• Peripheral Polyneuropathies (a Syndrome Characterized by Weakness and Muscle Weakness in the Area of Several Nerves);
• Prevention of Peripheral Neuropathy During Isoniazid Use;
• Use of Oral Contraceptives;
• Malabsorption Syndromes, e.g., in Liver Diseases Caused by Alcoholism;
• Sunburn and Post-Burn Pigmentary Changes in the Skin (Prophylactically);
• Skin and Mucous Membrane Inflammation (including Oral Ulcers - Acrodynia) and Tongue Inflammation;
• Erythroderma (Redness and Skin Exfoliation), Seborrhea,
• Parodontopathy (Periodontal Disease);
• Congenital Metabolic Disorders (Cystathioninuria, Homocystinuria - Excretion of Sulfur-Containing Amino Acids in Urine - Cystathionine and Homocysteine, Hyperoxaluria - Excessive Excretion of Oxalic Acid in Urine, Xanthurenic Aciduria - Excretion of Xanthurenic Acid in Urine with Increased Urine pH);
• Isoniazid Poisoning;
• Cycloserine Poisoning;

As an Aid:

• Sideroblastic Anemia (Caused by Abnormal Utilization of Intracellular Iron for Hemoglobin Production), Leukopenia (Decreased White Blood Cell Count) and Agranulocytosis (Lack of Granulocytes in the Blood);
• Pregnancy-Related Nausea and Vomiting;
• Depressive States;
• Sleep Disorders (Insomnia);
• Vegetative Neurosis (as a Mild Symptomatic, Sedative Medication);
• Post-Radiation Disease.

2. Important Information Before Taking Vitaminum B Teva

When Not to Take Vitaminum B Teva

• If the Patient is Allergic to Vitamin B or any Other Component of this Medication (Listed in Section 6);
• Parkinson's Disease Treated with Levodopa Without a Decarboxylase Inhibitor.

Warnings and Precautions

There are no Special Warnings or Precautions Apart from those Listed in the "Contraindications" and "Pregnancy, Breastfeeding, and Fertility" Sections.

The Medication Contains Lactose. If the Patient has Previously been Diagnosed with Intolerance to Some Sugars, the Patient Should Consult a Doctor Before Taking the Medication.

The Medication Contains Sucrose. If the Patient has Previously been Diagnosed with Intolerance to Some Sugars, the Patient Should Consult a Doctor Before Taking the Medication.

Vitaminum B Teva and Other Medications

Medications: Cycloserine, Hydralazine, Penicillamine, Immunosuppressive Agents, Oral Contraceptives Containing Estrogen, and Isoniazid Increase the Demand for Vitamin B.

Vitamin B Reduces the Effectiveness of Levodopa Used Without a Decarboxylase Inhibitor in the Treatment of Parkinson's Disease.

The Medication May Reduce the Blood Level of Phenytoin.

Vitamin B Facilitates the Absorption of Iron and Magnesium.

When Administered with Amiodarone, it May Cause Sensitivity to Sunlight.

Inform Your Doctor or Pharmacist About all Medications You are Currently Taking or Have Recently Taken, as well as any Medications You Plan to Take.

Vitaminum B Teva with Food and Drink

The Presence of Food Does not Affect the Absorption of Pyridoxine from the Gastrointestinal Tract.

Pregnancy, Breastfeeding, and Fertility

If You are Pregnant or Breastfeeding, Think You May be Pregnant, or Plan to Have a Child, Consult Your Doctor or Pharmacist Before Taking this Medication.

Your Doctor May Recommend Vitamin B During Pregnancy in Doses not Exceeding 50 mg per Day.

Vitamin B May be Used During Pregnancy in Recommended Doses.

Vitamin B Passes into Breast Milk. Your Doctor May Recommend Using Vitamin B During Breastfeeding with Special Precautions.

Vitamin B May be Used During Breastfeeding in Recommended Doses.

Driving and Operating Machinery

In High Doses (Above 300 mg/Day), Pyridoxine May Affect Psychophysical Performance Due to the Possibility of Causing Sedation and Drowsiness.

3. How to Take Vitaminum B Teva

This Medication Should Always be Taken Exactly as Described in the Package Leaflet or as Directed by a Doctor, Pharmacist, or Nurse.

Recommended Dose:

• Therapeutically: Usually 50 to 100 mg (1 to 2 Tablets) 3 Times a Day;
• Prevention of Peripheral Neuropathy During Isoniazid Use: 1 Tablet per Day;
• Prevention of Sunburn and Post-Burn Pigmentary Changes in the Skin: 150 to 200 mg Once or in Divided Doses;
• Metabolic Disorders: up to 450 mg per Day in 3 Divided Doses;
• Post-Radiation Disease: 50 to 100 mg per Day;
• Auxiliary in the Treatment of Insomnia and Vegetative Neurosis: 50 mg to 300 mg per Day, in Divided Doses.
• Children:
• Therapeutically: 25 to 150 mg/Day (1/2 - 3 Tablets), in 2-3 Divided Doses.

If You Feel that the Medication is Too Strong or Too Weak, Consult Your Doctor.

Do not Exceed the Maximum Daily Dose.

Using a Higher Than Recommended Dose of Vitaminum B Teva

During the Use of High Doses of Vitamin B (from 300 mg to Several Grams) for a Longer Period (2 to 4 Months), Symptoms of Severe Peripheral Neuropathy have been Observed, Characterized by Numbness and Tingling in the Limbs, Impaired Vibration and Position Sense, Especially in the Lower Limbs, and Sleep Disorders.

Small Children are More Sensitive to Vitamin B Overdose.

Despite the Fact that Peripheral Neuropathy Disappears After Discontinuation of Pyridoxine, a Feeling of Weakness may Persist.

In Case of Overdose, the Doctor will Administer Symptomatic Treatment.

In Case of Taking a Higher Than Recommended Dose, Consult Your Doctor or Pharmacist Immediately.

Missing a Dose of Vitaminum B Teva

Take the Medication as Soon as Possible.

Do not Take a Double Dose to Make up for a Missed Dose.

4. Possible Undesirable Effects

Like all Medications, this Medication can Cause Undesirable Effects, although they may not Occur in Everyone.

High Doses of Vitamin B Used for a Long Time may Cause Sleep Disorders. With Long-Term Use of Doses Significantly Exceeding the Recommended Therapeutic Doses, there is a Possibility of Developing Peripheral Sensory Neuropathy.

Rare Cases of Allergic Reactions and Phototoxicity (Hypersensitivity Reactions) have been Reported, with an Unknown Frequency.

Using Pyridoxine in Doses of 200 mg for More than a Month may Lead to the Development of Dependence Syndrome.

In Some Individuals, Other Undesirable Effects may Occur During the Use of Vitaminum B Teva.

If You Experience any Other Undesirable Effects not Listed in this Package Leaflet, Inform Your Doctor.

Reporting Undesirable Effects

If You Experience any Undesirable Effects, Including any Possible Undesirable Effects not Listed in the Package Leaflet, Inform Your Doctor, Pharmacist, or Nurse.

Undesirable Effects can be Reported Directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Undesirable Effects can also be Reported to the Marketing Authorization Holder.

By Reporting Undesirable Effects, it will be Possible to Gather More Information on the Safety of the Medication.

5. How to Store Vitaminum B Teva

Store the Medication in a Place Invisible and Inaccessible to Children.

Store in a Temperature Below 25°C. Store in a Dry Place, Protect from Light.

Store in the Original Packaging.

Do not Use Vitaminum B Teva After the Expiration Date Stated on the Packaging.

The Expiration Date is the Last Day of the Specified Month.

Medications Should not be Disposed of in Sewers or Household Waste Containers. Ask Your Pharmacist How to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Vitaminum B Teva Contains

The Active Substance of the Medication is 50 mg of Pyridoxine Hydrochloride.

Other Ingredients are: Sucrose, Lactose Monohydrate, Potato Starch, Magnesium Stearate, Talc, Gelatin.

What the Package Contains

The Package Contains 50 Tablets.

Marketing Authorization Holder

Teva Pharmaceuticals Polska Sp. z o.o.

ul. Emilii Plater 53

00-113 Warsaw

tel.: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Krakow

Date of Last Update of the Package Leaflet:April 2022