Package leaflet: Information for the user

VITENBI 100 mg + 100 mg coated tablets

Vitamin B1 + Vitamin B6
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, contact your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 4 weeks.

Contents of this leaflet

What VITENBI is and what it is used for
What you need to know before taking VITENBI
How to take VITENBI
Possible side effects
How to store VITENBI
Contents of the pack and other information

1. What VITENBI is and what it is used for

VITENBI is a combination of B-complex vitamins containing vitamin B1 and vitamin B6.
VITENBI is used for the treatment of systemic neurological diseases due to proven deficiencies of vitamins B1 and B6.
Note:
Deficiencies of vitamins B1 and B6 rarely occur in isolation. Before starting therapy, it is therefore necessary to check whether other vitamin deficiencies are present.
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms.

2. What you need to know before using VITENBI

Do not use VITENBI

if you are allergic to thiamine hydrochloride, pyridoxine hydrochloride, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using VITENBI.
Tingling and numbness in the hands and feet (signs of peripheral sensory neuropathy and paresthesia, respectively) have been observed with long-term intake of daily doses exceeding 50 mg, as well as with short-term intake of gram-level doses. If tingling or numbness occurs, contact your doctor. Your doctor will assess the amount taken and, if necessary, discontinue the medicine.
In case of hypersensitivity reactions such as skin rash, itching (urticaria), light sensitivity (photosensitivity), or anaphylactic reactions, use of VITENBI must be discontinued and, if necessary, appropriate treatment initiated.

Other medicines and VITENBI
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effect of VITENBI may be influenced as follows:

Reduction of effect
Concomitant administration of drugs that have an antagonistic effect on vitamin B6 (pyridoxine antagonists such as isoniazid, cycloserine) may increase the requirement for vitamin B6.
Alcohol and prolonged use of oral contraceptives, including estrogens, may lead to vitamin B6 deficiency.
Vitamin B1 loses its effect when administered concomitantly with 5-fluorouracil, a drug used in cancer treatment.
Stomach acid medications (containing magnesium salts) reduce the absorption and effect of vitamin B1.
Long-term treatment with furosemide, a diuretic drug used for high blood pressure, may lead to vitamin B1 deficiency by increasing the amount of vitamin B1 excreted in the urine.

VITENBI's influence on the effect of other medicines
Vitamin B6 in daily doses of 5 mg or more may reduce the effect of levodopa, a medicine used to treat Parkinson's disease.

VITENBI with food, drinks and alcohol
Alcohol and black tea reduce the absorption and effect of vitamin B1.
Simultaneous consumption of beverages containing sulfites, such as wine, may degrade and render vitamin B1 ineffective.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy and breastfeeding, daily vitamin requirements should be met through a balanced diet.

Pregnancy
This medicine (based on its active ingredient) is useful only for the treatment of vitamin deficiency and should therefore be taken only after careful assessment of the benefit-risk ratio by the doctor. There are no systematic studies on vitamin B intake during pregnancy.

Breastfeeding
Vitamins B1 and B6 are excreted in breast milk.
Very high doses of vitamin B6 may inhibit breast milk production.

Driving and using machines
No special precautions are required.

3. How to use VITENBI

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose for adults is 1 VITENBI tablet per day (equivalent to 100 mg of
vitamins B1 and B6).
Method of administration
VITENBI tablets may be taken regardless of meals.
Swallow the tablets whole (without chewing) with sufficient liquid, for example a full glass
of water.
Duration of use
After four weeks of treatment, your doctor must decide whether further treatment is necessary
(see section 2 "Warnings and precautions").
If you take more VITENBI than you should
Long-term administration (from months to years) of vitamin B6 in doses exceeding 50 mg/day, as well as
short-term administration (2 months) exceeding 1 g/day, may cause neurotoxic effects (see
section 2 "Warnings and precautions").
Vitamin B6 overdose mainly manifests with sensory neuropathy, possibly accompanied by
coordination disorders (ataxia). Extremely high doses may lead to seizures.
Newborns and infants may experience severe sedation, low blood pressure
(hypotension), and respiratory disorders such as difficulty breathing or respiratory arrest (dyspnea, apnea);
see section 2 "Warnings and precautions".
Symptoms affecting the nervous system usually resolve spontaneously upon discontinuation of
vitamin B6.
Treatment of overdose
If acute doses exceeding 150 mg/kg body weight have been ingested, induced vomiting and administration of activated charcoal are recommended. Vomiting is most effective within the first 30 minutes after ingestion. Intensive care therapy might be necessary.
If you forget to take VITENBI
Do not take a double dose to make up for the forgotten tablet.
Continue using the medicine as described at the beginning of this section.
If you stop treatment with VITENBI
Consult your physician.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rarely (may affect up to 1 in 10,000 people), hypersensitivity reactions may occur, including sweating, rapid heartbeat (palpitations), skin reactions with itching and swelling (wheals).
In case of overdose of vitamin B6 (for more than 2 months at a dosage exceeding 1 g/day), nerve-related adverse effects may occur.
Long-term intake of daily doses of vitamin B6 exceeding 50 mg, as well as short-term intake of gram-level doses, may cause discomfort predominantly in the hands and feet (peripheral sensory neuropathy); see section 2 "Warnings and precautions".
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VITENBI

Keep this medicine out of the sight and reach of children.
Storage conditions
Do not use this medicine after the expiry date stated on the carton and vial after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use.
This will help protect the environment.

6. Package contents and other information

What VITENBI contains

The active substances are: thiamine hydrochloride and pyridoxine hydrochloride. One tablet contains 100 mg of thiamine hydrochloride (vitamin B1) and 100 mg of pyridoxine hydrochloride (vitamin B6).
The other components are: microcrystalline cellulose, hypromellose, crospovidone, talc, propylene glycol, magnesium stearate, stearic acid, anhydrous colloidal silica, stearic acid macrogol, calcium carbonate, iron oxide red (E 172), macrogol 35000, iron oxide yellow (E 172).

Description of the appearance of VITENBI and contents of the pack
VITENBI are orange, film-coated, round, convex tablets.
VITENBI is available in glass bottles containing 20, 50 or 100 film-coated tablets.
The plastic cap contains a desiccant. DO NOT remove the desiccant from the cap.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
mibe pharma Italia S.r.l.
via Leonardo da Vinci 20/B
39100 Bolzano
Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna