Vitamin b1+b6 g.l. pharma

Package leaflet: Information for the user

Vitaminum B1+B6 G.L. Pharma, 100 mg + 100 mg, coated tablets
(Benfotiaminum + Pyridoxini hydrochloridum)
Please read all of this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

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

Vitaminum B1+B6 G.L. Pharma is a vitamin preparation in tablet form containing vitamin B1 (benfotiamine) and vitamin B6 (pyridoxine hydrochloride). It is used in adults for the treatment of peripheral nerve disorders (neuropathies) caused by deficiency of vitamin B1 and vitamin B6 (a condition in which the body does not have sufficient amounts of these vitamins).

2. Information before using Vitaminum B1+B6 G.L. Pharma

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

• If the patient is allergic to benfotiamine, thiamine, pyridoxine hydrochloride, or any of the other ingredients of this medicine (listed in section 6).
• If the patient is pregnant or breastfeeding.

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

Vitaminum B1+B6 G.L. Pharma and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
This is particularly important in the case of 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 certain antiepileptic drugs. Discuss with your doctor if you are taking carbamazepine, phenytoin, phenobarbital, or primidone.
• Long-term use of oral contraceptives containing estrogen ("birth control pill") may increase the requirement for vitamin B.
• So-called "pyridoxine antagonists", such as:
  • hydralazine
  • isoniazid
  • D-penicillamine
  • cycloserine
    may increase the requirement for vitamin B.
• Vitamin B reduces both the activity and the neurotoxicity of altretamine (a medicine used in the treatment of cancer).

The actual interaction between vitamin B and levodopa (a medicine used in the treatment of Parkinson's disease) is clinically insignificant, because levodopa is always administered together with another substance in a single tablet, thus eliminating this effect.

Vitaminum B1+B6 G.L. Pharma with food, drink 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.
Vitaminum B1+B6 G.L. Pharma should not be taken during pregnancy or breastfeeding.

Driving and operating machinery
It is unknown whether this medicine affects the ability to drive or operate machinery.

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

This medicine should always be taken according to the instructions provided by the doctor or pharmacist. In case of any doubts,
you should consult your doctor or pharmacist.
The doctor will determine the exact dosage depending on the patient's health condition.
Oral administration.
The recommended dose is 1 coated tablet once daily.
Depending on the severity of the vitamin deficiency, it may be necessary to use lower or higher doses (up to
3 coated tablets per day).
Coated tablets can be taken at any time of day, with or without food, and should be taken with an adequate
amount of liquid.
The duration of treatment depends on the cause of vitamin B and B deficiency, signs and symptoms of the disease, and
the effectiveness of treatment. After 4 weeks, the doctor will perform a reassessment of the patient's health status. The duration of therapy
should be as short as possible. 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 G.L. Pharma is not intended for use in children and adolescents under 18 years of age due to
lack of available data.
Patients with impaired kidney or liver function and elderly patients
For patients with impaired kidney or liver function or elderly patients, the doctor will prescribe the usual dose.
Use of a higher than recommended dose of Vitaminum B1+B6 G.L. Pharma
Medical intervention is usually not required.
Vitamin B_: vitamin B has a wide therapeutic range, and symptoms of overdose are not expected following oral
administration.
Vitamin B_: high doses of vitamin B (200 mg daily for a very long time or several grams daily for a shorter period)
may cause neurotoxic effects (sensory neuropathy), characterized by changes in gait and peripheral sensation (pricking, tingling).
Missed dose of Vitaminum B1+B6 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.
Discontinuation of Vitaminum B1+B6 G.L. Pharma
Discontinuing the medicine may affect the treatment outcome. If any unpleasant adverse effects occur, they should be discussed
with the doctor.
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 may cause adverse effects, although not everyone experiences them.
It is unlikely that Vitaminum B1+B6 G.L. Pharma will cause adverse effects,
unless the patient is allergic (hypersensitive) to benfotiamine, pyridoxine, or any of the
other ingredients of this medicine. Allergic reactions to vitamin B have been reported,
but mainly when it was administered by injection.
The following adverse effects have also been reported:
Very rare (may occur in less than 1 in 10,000 patients)

• Nausea, bloating, diarrhoea, constipation, abdominal pain
• Allergic reactions (e.g. skin reactions with itching, rash, urticaria, dyspnoea, tachycardia)

Frequency unknown (frequency cannot be estimated from available data)

• "Peripheral neuropathy": Inflammation (swelling and redness) or degeneration of peripheral nerves (nerves located outside the brain and spinal cord), causing tingling, numbness, burning sensation (mainly after long-term use (over 6 months) of high doses of vitamin B). See also section 3 "Use of a higher than recommended dose of Vitaminum B1+B6 G.L. Pharma"

Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects 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 4921 301
fax: +48 22 4921 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 G.L. Pharma

Store below 25°C.
Keep in the original packaging to protect from moisture.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the box after EXP. The expiry date refers to the last day of the specified month.
Medicines must 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 G.L. Pharma contains

• The active substances are: benfotiamine (vitamin B1) and pyridoxine hydrochloride (vitamin B6). Each film-coated tablet contains: 100 mg benfotiamine and 100 mg pyridoxine hydrochloride (corresponding to 82 mg pyridoxine (vitamin B6)).
• Other components are:
  Tablet core: microcrystalline cellulose (type 102), magnesium stearate, povidone K30
  Coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc.

What Vitaminum B1+B6 G.L. Pharma looks like and contents of the pack
White to off-white, round, biconvex film-coated tablets, without a break line, with a diameter of 10.2 mm ± 0.2 mm and a thickness of approximately 4.1 mm.
Vitaminum B1+B6 G.L. Pharma is available in blisters made of PVC/PVDC/PVC/Aluminium, in packs containing 10, 20, 30, 50, 60 or 100 film-coated tablets, packed 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: Neuroduovit
Estonia: Senvalan
Latvia: Senvalan 100/100 mg apvalkotās tabletes
Lithuania: Neurobixin 100/100 mg plėvelę dengtos tabletės
Bulgaria: Bevit 100 mg/100 mg film-coated tablets
Hungary: NeurogerloN BenDuo
Poland: Vitaminum B1+B6 G.L. Pharma
Romania: Neuromultivit Duo 100 mg/100 mg comprimate filmate
Slovakia: Neuroduovit

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