Vitaminum b1 + b6 + b12 g.l. pharma

Package leaflet: Information for the patient

Vitaminum B1 + B6 + B12 G.L. Pharma, 40 mg + 74.1 mg + 0.25 mg, coated tablets
(Benfothiaminum + Pyridoxinum + Cyanocobalaminum)
Please read carefully the entire leaflet before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Vitaminum B1 + B6 + B12 G.L. Pharma is and what it is used for
2. Important information before taking Vitaminum B1 + B6 + B12 G.L. Pharma
3. How to take Vitaminum B1 + B6 + B12 G.L. Pharma
4. Possible side effects
5. How to store Vitaminum B1 + B6 + B12 G.L. Pharma
6. Contents of the pack and other information

1. What Vitaminum B1 + B6 + B12 G.L. Pharma is and what it is used for

Vitaminum B1 + B6 + B12 G.L. Pharma is a vitamin preparation in the form of tablets containing vitamin B1 (benfotiamine), vitamin B6 (pyridoxine), and vitamin B12 (cyanocobalamin).
It is used in the treatment of confirmed deficiency of vitamin B1, vitamin B6, and vitamin B12 (a condition in which the body lacks sufficient amounts of these vitamins) in adults, as well as for the prevention or treatment of nerve disorders (e.g. a condition called polyneuropathy).
This deficiency may result from inadequate dietary intake of vitamin B1, vitamin B6, or vitamin B12, or from insufficient absorption of these vitamins by the body.
Deficiency of these vitamins may cause peripheral nerve diseases ("neuropathies"), leading to fatigue or pain, tingling, and numbness in the hands and feet.
This medicine should only be taken when it is known that the patient has a condition diagnosed by a doctor, and when the use of this medicine has been recommended by a physician.

2. Important information before using the medicine Vitaminum B1 + B6 + B12 G.L. Pharma

When not to use the medicine Vitaminum B1 + B6 + B12 G.L. Pharma

• If the patient is allergic to benfotiamine, thiamine, pyridoxine and its derivatives, cobalamin, or any of the other components of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Vitaminum B1 + B6 + B12 G.L. Pharma, consult your doctor or pharmacist.
Taking this medicine for longer than 6 months may cause nerve damage (neuropathy).

Vitaminum B1 + B6 + B12 G.L. Pharma and other medicines
Tell your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take.
This is particularly important for the following medicines:

• Vitamin B is inactivated by 5-fluorouracil (a medicine used in cancer treatment) or similar anticancer drugs.
• High daily doses of vitamin B may reduce blood levels of some antiepileptic drugs. Discuss with your doctor if you are taking carbamazepine, phenytoin, phenobarbital, pregabalin, topiramate, or primidone.
• Requirement for vitamin B may be increased when taking so-called "pyridoxine antagonists", such as:
• hydralazine (a medicine used to treat high blood pressure)
• isoniazid (an antibiotic used in the treatment of tuberculosis)
• D-penicillamine (a medicine used to treat rheumatoid arthritis and Wilson's disease)
• cycloserine (a medicine used in the treatment of tuberculosis)
• oral contraceptives ("oral contraceptive pill")
• Vitamin B levels are reduced during concomitant use of:
• neomycin (an antibiotic)
• aminosalicylic acid (an antibiotic used in the treatment of tuberculosis)
• omeprazole and histamine H receptor antagonists, such as cimetidine, famotidine, nizatidine, roxatidine, and ranitidine (medicines used to treat excess stomach acid)
• colchicine (a medicine used to prevent gout attacks)
• long-term use of oral contraceptives ("oral contraceptive pill")
• phenobarbital, pregabalin, primidone, or topiramate (medicines used to treat epilepsy)

When levodopa is taken together with vitamin B, the vitamin may weaken the effect of levodopa. However, this does not occur when levodopa is taken with carbidopa or benserazide, which is currently the most commonly prescribed form of this medicine. Therefore, in most cases, this is not a cause for concern. Vitamin B reduces both the activity and neurotoxicity of altretamine.

Vitaminum B1 + B6 + B12 G.L. Pharma and alcohol
Do not drink alcohol while taking this medicine, as alcohol reduces the absorption of vitamin B in the intestines and negatively affects its storage capacity and metabolism.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not take Vitaminum B1 + B6 + B12 G.L. Pharma during pregnancy or breastfeeding.

Driving and operating machinery
There is no information available on whether this medicine affects the ability to drive or operate machinery.

This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Vitaminum B1 + B6 + B12 G.L. Pharma

This medicine should always be taken according to the doctor's instructions. In case of doubt, consult
your doctor or pharmacist.
The doctor will determine the exact dosage depending on the patient's health condition.
For oral use.
The recommended dose is 1 coated tablet once daily.
In acute conditions, it may be necessary to take up to 3 coated tablets daily, particularly when nerve
diseases (e.g. a condition called polyneuropathy) are already present, and treatment is carried out under
medical supervision, with the doctor monitoring the treatment's effectiveness.
Coated tablets may be taken at any time of day, with or without food, taken with an adequate amount
of liquid.
The duration of treatment depends on the cause of vitamin B deficiency and the effectiveness of
treatment. If the patient has taken the medicine for 28 days and does not feel better, they should contact
their doctor.
Use in children and adolescents
Vitaminum B1 + B6 + B12 G.L. Pharma is not intended for use in children and adolescents under 18 years
of age, as the safety of this medicine has not been established in this age group.
Patients with impaired kidney or liver function and elderly patients
Patients with impaired kidney or liver function, as well as elderly patients, should be prescribed the
usual dose by their doctor.
Use of a higher than recommended dose of Vitaminum B1 + B6 + B12 G.L. Pharma
Medical intervention is usually not required.
Vitamin B: overdose symptoms are not expected following oral administration.
Vitamin B: High doses of vitamin B (200 mg per day for a very long time or several grams per day for a
shorter period) may cause neurotoxic effects (sensory neuropathy), characterized by changes in gait and
peripheral sensation (tingling, numbness).
Taking 100 mg or more per day over a long period may cause minor nerve-related problems. It is not
possible to precisely determine the amount of this substance that will lead to harmful effects due to
individual differences among people in their response to it. Furthermore, there is no specific treatment
available to counteract its effects.
Vitamin B: overdose symptoms are not expected following oral administration.
In patients with diabetic kidney disease, taking vitamin B together with folic acid and vitamin B may
lead to faster kidney damage and worsening of heart and blood vessel problems.
Missed dose of Vitaminum B1 + B6 + B12 G.L. Pharma
Do not take a double dose to make up for a missed dose. Instead, take the next dose at the appropriate
time.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported:

Very rare (may occur in less than 1 in 10,000 patients)

• Allergic reactions: skin reactions (e.g. itching, rash, urticaria), fever, sudden redness of the face and/or neck, dizziness, general feeling of discomfort or malaise, shortness of breath, rapid heartbeat, uncontrolled trembling or jerking movements.
• Nausea, bloating, diarrhoea, constipation, abdominal pain

Frequency unknown (frequency cannot be estimated from the available data)

• Inflammation (swelling and redness) or degeneration of peripheral nerves (nerves located outside the brain and spinal cord) causing tingling, numbness, burning sensations, mainly after long-term (more than 6 months) use of high doses of vitamin B ("peripheral neuropathy", "paresthesia")
• Headache
• Unpleasant sensation resembling an electric shock running down the back and into the limbs ("Lhermitte's sign")
• Abnormal urine colouration (may be alarming, but harmless)

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Vitaminum B1 + B6 + B12 G.L. Pharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Vitaminum B1 + B6 + B12 G.L. Pharma contains

• The active substances are: benfotiamine (vitamin B1), pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12). Each coated tablet contains: 40 mg benfotiamine, 74.1 mg pyridoxine corresponding to 90 mg pyridoxine hydrochloride and 0.25 mg cyanocobalamin.
• Other components are:
  Core of the tablet: microcrystalline cellulose (102), magnesium stearate, povidone K30, pregelatinized corn starch, sodium citrate, citric acid monohydrate, colloidal anhydrous silica.
  Coating: polyvinyl alcohol, grafted copolymer of polyethylene glycol and polyvinyl alcohol, talc, titanium dioxide (E 171), glycerol monocaprylocapronate (type I).

What Vitaminum B1 + B6 + B12 G.L. Pharma looks like and contents of the pack
Vitaminum B1 + B6 + B12 G.L. Pharma is white to off-white, round, biconvex coated tablets without a score line, with a diameter of 8.3 mm ± 0.2 mm and thickness of 4.7 ± 0.5 mm.
The tablets are packed in blisters made of cold-formable base foil (OPA/Aluminium/PVC) laminated with aluminium foil (cover foil), containing 20, 50 or 100 coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
G.L. Pharma GmbH
Schlossplatz 1,
8502 Lannach,
Austria

Manufacturer
G.L. Pharma GmbH
Industriestrasse 1
8502 Lannach
Austria

This medicinal product has been authorised in the Member States of the European Economic Area under the following names:
Slovenia: Neuromultivit 40 mg/90 mg/0,25 mg filmsko obložene tablete
Bulgaria: Бевит Трио 40 mg/90 mg/0,25 mg филмирани таблетки
Czech Republic: Neuromultivit Neo
Germany: Neuromultivit
Estonia: Neuromultivit
Hungary: NeurogerloN Neo
Latvia: Fenglavit 40 mg/90 mg/0,25 mg apvalkotas tabletes
Lithuania: Fenglavit 40 mg/90 mg/0,25 mg plėvelė dengtos tabletės
Poland: Vitaminum B1 + B6 + B12 G.L. Pharma
Romania: Neuromultivit Neuro comprimate filmate
Slovakia: Tiadel

For further information, please contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Sienna 75 St., 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]