Vitaminum B compositum

Leaflet attached to the packaging: patient information

VITAMINUM B compositum, chewable tablets

Please read the contents of the leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as advised by
the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Vitaminum B compositum and what is it used for
• 2. Important information before using Vitaminum B compositum
• 3. How to use Vitaminum B compositum
• 4. Possible side effects
• 5. How to store Vitaminum B compositum
• 6. Contents of the packaging and other information

1. What is Vitaminum B compositum and what is it used for

Vitaminum B compositum is a multivitamin medicine containing a set of B vitamins necessary for the proper course of metabolic processes. The vitamins contained in the medicine participate in many processes occurring in the body, e.g., in tissue respiration, in the metabolism of central nervous system mediators (substances that mediate the transmission of stimuli). B vitamins are water-soluble, do not accumulate in the body, as excess amounts are excreted in the urine.
Vitaminum B compositum is used:

• for the prevention and treatment of complex B vitamin deficiencies during periods of increased demand (febrile conditions, burns, alcoholism, pregnancy, and breastfeeding), chronic and debilitating diseases, convalescence, gastrointestinal disorders associated with impaired vitamin absorption, and digestive disorders;
• as an auxiliary treatment for nervous system diseases, inflammatory conditions of mucous membranes, e.g., lips, oral cavity, in cases of angular cheilitis and acne.

2. Important information before using Vitaminum B compositum

When not to use Vitaminum B compositum

• if the patient is allergic to thiamine nitrate (vitamin B1), riboflavin (vitamin B2), pyridoxine hydrochloride (vitamin B6), niacinamide (vitamin PP), calcium pantothenate (vitamin B5), or any of the other ingredients of this medicine (listed in section 6).
• 6).

Warnings and precautions

Before starting to use Vitaminum B compositum, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised when using Vitaminum B compositum in patients with hypercalcemia (elevated calcium levels in the blood), urolithiasis, or renal insufficiency.
In patients with significant renal insufficiency, the dose of the medicine should be reduced - see section 3 below.

Vitaminum B compositum and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Concomitant use of this medicine with medicines containing levodopa (some medicines used in Parkinson's disease) may reduce their effectiveness.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and operating machinery

The medicine does not reduce psychophysical fitness, the ability to drive vehicles, or operate machinery.

Vitaminum B compositum contains lactose, sucrose, and orange yellow S (E 110)

The medicine contains lactose and sucrose; if the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Each tablet contains 34.65 mg of lactose monohydrate.
The medicine may cause allergic reactions.

3. How to use Vitaminum B compositum

This medicine should always be used exactly as described in the patient leaflet or as advised by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Oral administration.
Adults: 3 to 5 times a day, 1 chewable tablet.
Children: 1 to 3 times a day, 1 chewable tablet.
In patients with significant renal insufficiency, the dose of the medicine should be reduced to 1 chewable tablet per day.

Using a higher dose of Vitaminum B compositum than recommended

The occurrence of overdose symptoms is very unlikely, as the medicine contains water-soluble vitamins that are quickly excreted from the body.

4. Possible side effects

Like all medicines, Vitaminum B compositum can cause side effects, although not everybody gets them.
No side effects have been observed when using the recommended doses of the medicine.
After exceeding the recommended doses, the following may occur: skin redness, facial flushing, rash, urticaria, weakness, headache, irritability, insomnia, accelerated heart rate, diarrhea.
During the use of the medicine, a yellow discoloration of the urine may occur due to the presence of vitamin B2 (riboflavin) - this is a normal symptom.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Vitaminum B compositum

Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
The medicine should be stored out of sight and reach of children.
Warning:the container contains a desiccant marked in English Donot eat. It is not suitable for consumption and should remain in the container for the entire duration of the medicine's use. Store the container tightly closed to protect from moisture.
The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

• The active substances of the medicine are: thiamine nitrate (vitamin B1), riboflavin (vitamin B2), pyridoxine hydrochloride (vitamin B6), niacinamide (vitamin PP), calcium pantothenate (vitamin B5). Each chewable tablet contains 3 mg of vitamin B1, 5 mg of vitamin B2, 5 mg of vitamin B6, 40 mg of vitamin PP, and 5 mg of calcium pantothenate.
• The other ingredients are: lactose monohydrate, povidone K-25, talc, magnesium stearate, sucrose, sodium carmellose, povidone K-30, colloidal silica anhydrous, polysorbate 80, titanium dioxide, talc, orange yellow S (E 110), and Capol wax.

What Vitaminum B compositum looks like and what the packaging contains

Vitaminum B compositum is a round, biconvex, orange-colored tablet with a coating and core.
The packaging contains 50 chewable tablets in Al/PVC/PVDC blisters in a cardboard box or 50 chewable tablets in a polyethylene container with a lid and a desiccant, in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., Production Plant in Nowa Dęba, ul. Metalowca 2, 39-460 Nowa Dęba
Date of last revision of the leaflet:December 2024