Invitaxon

Package Leaflet: Information for the Patient

Invitaxon, 150 mg + 50 mg + 0.20 mg, Film-Coated Tablets

Benfotiamine + Pyridoxine Hydrochloride + Cyanocobalamin

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

• Keep this Package Leaflet, so you can Read it Again if Necessary.
• In Case of Any Doubts, Consult a Doctor, Pharmacist, or Nurse.
• This Medication has been Prescribed to a Specific Person. Do not Give it to Others. The Medication may Harm Another Person, even if their Disease Symptoms are the Same.
• If the Patient Experiences any Adverse Reactions, including those not Listed in this Package Leaflet, Inform a Doctor, Pharmacist, or Nurse. See Section 4.

Package Leaflet Contents:

• 1. What is Invitaxon and what is it Used for
• 2. Important Information Before Taking Invitaxon
• 3. How to Take Invitaxon
• 4. Possible Adverse Reactions
• 5. How to Store Invitaxon
• 6. Package Contents and Other Information

1. What is Invitaxon and what is it Used for

Invitaxon Contains Vitamins B, B, and B, which are Essential for Maintaining Proper Metabolism in Nerve Cells. Like other Vitamins, they are Essential Components of the Diet that Cannot be Produced by the Body.
In the Treatment of Nervous System Disorders, B Vitamins Work by Supplementing Related Vitamin B Deficiencies and Stimulating Natural Regeneration Processes in Nerve Tissues.
There are Studies Indicating the Analgesic Effect of Vitamin B.
Invitaxon is Used as a Supporting Treatment for Peripheral Nerve Disorders of Various Origins, such as Polyneuropathy, Neuralgia, and Peripheral Neuropathy.

2. Important Information Before Taking Invitaxon

When not to Take Invitaxon

• If the Patient is Allergic to Benfotiamine/Thiamine (Vitamin B), Pyridoxine Hydrochloride (Vitamin B), Cyanocobalamin (Vitamin B), or any other Component of this Medication (Listed in Section 6).
• In Children and Adolescents (Under 18 Years) Due to the High Dose of Vitamins in the Medication.

Warnings and Precautions

Before Starting Invitaxon, Discuss it with a Doctor or Pharmacist.
If the Daily Dose of Vitamin B Exceeds 50 mg for a Longer Period, or if the Daily Dose of Vitamin B Exceeds 1 g for a Shorter Period, a Prickling or Tingling Sensation may Occur in the Hands or Feet (Symptoms of Peripheral Sensory Neuropathy or Paresthesia). If the Patient Experiences Prickling or Tingling or other Adverse Reactions, Contact a Doctor who will Adjust the Dosage or Recommend Discontinuation of the Medication.

Children and Adolescents

Invitaxon should not be Used in Children and Adolescents (Under 18 Years) Due to the High Dose of Active Substances in the Medication.

Invitaxon with other Medications

Inform a Doctor or Pharmacist about all Medications Currently or Recently Taken, as well as those Planned to be Taken.

• Vitamin B may be Ineffective if Taken with the Cytostatic Medication 5-Fluorouracil (Used in Cancer Treatment).
• Antacids (Used for Hyperacidity) Reduce the Absorption of Vitamin B by the Body.
• Long-term Use of Certain Diuretics (such as Furosemide) may Cause Vitamin B Deficiency Due to Increased Excretion of Vitamin B in the Urine.
• Concomitant Use of L-Dopa (Used in Parkinson's Disease) with Vitamin B may Reduce the Effectiveness of L-Dopa.
• If Invitaxon is Taken with Medications that Lower Vitamin B Levels in the Body (such as Isoniazid, Hydralazine, Penicillamine, or Cycloserine), the Need for Vitamin B may Increase.
• Vitamin B may Reduce the Effectiveness of Altretamine (an Anticancer Medication).
• Absorption of Vitamin B may be Impaired by Proton Pump Inhibitors (such as Omeprazole), Histamine H Receptor Antagonists (such as Cimetidine), Aminosalicylic Acid (an Anti-inflammatory Medication), Colchicine (Used in Gout Treatment), and Neomycin (an Antibiotic).
• The Level of Vitamin B may be Significantly Reduced by Metformin (an Antidiabetic Medication).

Invitaxon with Food and Drink

Food Increases the Absorption of Vitamin B from the Gastrointestinal Tract, so Tablets should be Taken after Meals, with a Small Amount of Liquid.
Absorption of Vitamin B is Reduced by Alcohol and Tea.
If Vitamin B is Taken with Drinks Containing Sulfites (such as Wine), it may Break Down and Lose its Properties.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant, or Plans to have a Child, they should Consult a Doctor or Pharmacist before Taking this Medication.
Invitaxon should not be Taken during Pregnancy or Breastfeeding.
During Pregnancy and Breastfeeding, the Daily Need for Vitamins should be Covered by a Balanced Diet. Due to the High Dose of Vitamins in the Medication, Invitaxon is Intended for Use only in Vitamin Deficiency and should be Used only on the Advice of a Doctor who will Carefully Weigh the Potential Benefits and Risks.
Vitamins B, B, and B Pass into Breast Milk. High Doses of Vitamin B may Reduce Milk Secretion.
A Doctor will Decide whether Invitaxon can be Used during Pregnancy or Breastfeeding in Specific Cases.

Driving and Operating Machines

Invitaxon does not Affect the Ability to Drive or Operate Machines.
This Medication Contains:

• Mannitol: the Medication may have a Mild Laxative Effect,
• Sorbitol: the Medication Contains 15 mg of Sorbitol per Tablet.

3. How to Take Invitaxon

Take this Medication Always as Directed by a Doctor. In Case of Doubts, Consult a Doctor or Pharmacist.
The Recommended Dose is 1 Tablet per Day.
In Individual Cases, the Dose may be Increased to 1 Tablet Three Times a Day. Tablets should be Swallowed Whole, Taken after Meals, and Washed Down with a Small Amount of Liquid.

Use in Children and Adolescents

Invitaxon should not be Used in Children and Adolescents Under 18 Years.

Taking a Higher Dose of Invitaxon than Recommended

Vitamin B
Taking Doses Higher than 50 mg of Vitamin B per Day for a Longer Period (More than 6-12 Months) or Doses Exceeding 1 g of Vitamin B per Day for a Shorter Period (More than 2 Months) may Lead to Nerve Damage (Neurotoxic Effect). Taking a Dose Higher than 2 g per Day may Lead to Nerve Damage, which may be Felt as Movement Disorders, Sensory Disturbances (Tingling, Numbness), Seizures, and in Very Rare Cases, Changes in Blood Test Results and Inflammatory Skin Reactions.
Vitamin B
In Very Rare Cases, after Taking Very High Doses, Allergic Reactions, Exanthematous Skin Changes, and a Mild Form of Acne have been Observed.

Missing a Dose of Invitaxon

Do not Take a Double Dose to Make up for a Missed Dose, but Take the Next Dose at the Right Time.
In Case of Doubts about Taking the Medication, Consult a Doctor or Pharmacist.

4. Possible Adverse Reactions

Like all Medications, Invitaxon can Cause Adverse Reactions, although not Everybody gets them.
The Following Adverse Reactions have been Reported after Short-term or Long-term Use of Invitaxon:
Rare (Occurring in Less than 1 in 1,000 Patients):

• Nausea,
• Headache.

Very Rare (May Occur in Less than 1 in 10,000 People):

• Hypersensitivity Reactions such as Sweating, Rapid Heartbeat, and Skin Reactions like Itching and Urticaria.

Frequency Not Known (Cannot be Estimated from Available Data):

• Taking Doses Higher than 50 mg of Vitamin B per Day for a Longer Period (More than 6-12 Months) may Lead to the Development of Peripheral Neuropathy (Including Sensory Neuropathy) (Nerve Damage Causing a Prickling or Tingling Sensation).

Reporting Adverse Reactions

If any Adverse Reactions Occur, including those not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. Adverse Reactions 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 181 C
02-222 Warsaw
tel.: +48 22 49 21 301,
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Adverse Reactions can also be Reported to the Marketing Authorization Holder.
Reporting Adverse Reactions will Help Gather more Information on the Safety of the Medication.

5. How to Store Invitaxon

Do not Store above 30°C.
Store the Medication in a Place that is Inaccessible to Children.
Do not Use this Medication after the Expiration Date Stated on the Blister or Carton after EXP.
The Expiration Date Refers to the Last Day of the Given Month.
Medications should not be Disposed of in the Drain or Household Waste. Ask a Pharmacist how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Package Contents and Other Information

What Invitaxon Contains

• The Active Substances of Invitaxon are: Benfotiamine (Vitamin B), Pyridoxine Hydrochloride (Vitamin B), and Cyanocobalamin (Vitamin B).

1 Film-Coated Tablet Contains:
Vitamin B
150 mg
Vitamin B
50 mg
Vitamin B
0.20 mg

• Other Ingredients are: Tablet Core: Mannitol; Microcrystalline Cellulose Type 101; Sorbitol; Povidone K-30; Microcrystalline Cellulose Type 102; Crospovidone Type A; Magnesium Stearate; Silica Colloidal Anhydrous.

Coating: Polyvinyl Alcohol, Partially Hydrolyzed; Calcium Carbonate; Macrogol 4000; Talc; Iron Oxide Red (E 172).

What Invitaxon Looks Like and What the Package Contains

Red or Reddish, Round, Biconvex Film-Coated Tablet, 12 mm in Diameter.
Blisters of PVC/PE/PVDC/Aluminum in a Cardboard Box.
30, 45, 60, 90, 100, 105, or 120 Film-Coated Tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice

Date of Last Update of the Package Leaflet: