Patient Information Leaflet

Vitaminum B2 Teva, 3 mg, coated tablets
Riboflavinum
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

Keep this leaflet. You may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If your condition does not improve or worsens, contact your doctor.

Table of Contents:

What Vitaminum B2 Teva is and what it is used for
What you need to know before taking Vitaminum B2 Teva
How to take Vitaminum B2 Teva
Possible side effects
How to store Vitaminum B2 Teva
Contents of the pack and other information

1. What Vitaminum B2 Teva is and what it is used for

Vitaminum B2 (riboflavin) is a water-soluble vitamin of the B group. The main function of riboflavin in the body is its participation in tissue respiration processes. Riboflavin, together with other substances, plays a role in the metabolism of carbohydrates, fats, and proteins by catalyzing the oxidation processes of glucose, fatty acids, and amino acids. Vitamin B2 also participates in the process of vision in dim light. It is essential for maintaining normal function of mucous membranes and the endothelium of blood vessels. It also supports proper functioning of the nervous system and skin.

Vitamin B2 supplementation is required in individuals consuming a diet low in vitamins, or in those who have increased requirements due to physiological conditions (e.g. pregnancy, breastfeeding, physical exertion) or due to disease, as well as in patients with intestinal malabsorption disorders.

Indications for use:

Prevention and treatment of vitamin B2 deficiency
As an adjunctive therapy:
- During treatment with diuretic medications
- After antibiotic therapy
- Before and after surgical procedures
- In gastrointestinal, gastric, and liver disorders associated with persistent diarrhea
- In chronic and debilitating diseases (e.g. diabetes, infections of various origins, inflammatory skin conditions, hyperthyroidism, psychosomatic disorders, alcoholism)

2. Important information before using the medicine Vitaminum B Teva

When not to use the medicine Vitaminum B Teva:

if the patient is allergic to riboflavin or to any of the other ingredients of the medicine.

Warnings and precautions
Vitamin B should be used with caution in patients with renal insufficiency, as the drug is
excreted in urine (this may lead to excessive accumulation of vitamin B ).
When high doses of vitamin B are administered, laboratory test results may be affected
(e.g. fluorometric determination of catecholamine concentrations in urine, urobilinogen testing
using Ehrlich's reagent).
High doses of vitamin B cause dark yellow discoloration of urine (urine takes on the colour
of an aqueous solution of riboflavin).

Vitaminum B Teva and other medicines
Anticholinergic drugs, e.g.: atropine, may affect the absorption of riboflavin.
Doxorubicin may delay, and methotrexate may reduce, the action of vitamin B .
Tricyclic antidepressants and phenothiazine derivatives (e.g. chlorpromazine),
probenecid, and hormonal contraceptives, when used in high doses, may weaken the effect of
vitamin B (an increased dose of riboflavin may be required).
Vitamin B (including in combination with other vitamins) should not be used simultaneously
with tetracycline. Long-term use of other antibiotics may also reduce the effectiveness
of riboflavin.
Thiazide diuretics (e.g.: hydrochlorothiazide) may increase the excretion of vitamin B from the body.
Vitamin B enhances the action of pyridoxine and nicotinic acid.
Alcohol and tobacco reduce the absorption of vitamin B from the gastrointestinal tract.

Vitaminum B Teva with food and drink
Alcohol reduces the absorption of vitamin B from the gastrointestinal tract.

Pregnancy, breastfeeding and fertility
Consult a doctor before taking the medicine.
No risk to the fetus has been demonstrated when doses meeting the daily requirement are used
during pregnancy in women.
Vitamin B may be used during pregnancy at recommended doses.

Breastfeeding
Consult a doctor before taking the medicine.
No risk to the newborn has been demonstrated when the nursing mother uses doses meeting
the daily requirement.
Vitamin B may be used during breastfeeding at recommended doses.

Driving and operating machinery
The medicine does not affect the ability to drive or operate mechanical devices.

Vitaminum B Teva contains lactose and sucrose
The medicine contains 44 mg of lactose and 124 mg of sucrose. If the patient has previously been
diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking
the medicine. The medicine contains quinoline yellow (E104), which may cause allergic reactions.

3. How to use Vitaminum B2 Teva

Usually administered:
Prophylactically:
Children from 4 years of age, adolescents:
3 to 6 mg (1 to 2 coated tablets) daily in divided doses.
Adults:
3 to 9 mg (1 to 3 coated tablets) daily in divided doses.
Do not exceed the maximum daily dose.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Vitaminum B2 Teva
Cases of riboflavin overdose have not been described. The medicine is practically non-toxic. Excess
amounts of the medicine are excreted in urine.
In case of ingestion of a higher than recommended dose, seek immediate medical advice from a doctor or
pharmacist.
Missed dose of Vitaminum B2 Teva
Take the missed dose as soon as possible. Do not take a double dose to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, Vitaminum B2 Teva can cause adverse reactions, although they do not
occur in everyone.
Very rarely (including single cases, frequency less than 1 case per
10,000) the following may occur:
Skin and subcutaneous tissue disorders: skin allergic reactions (rash, itching, photosensitivity,
burning/stinging sensation).
Gastrointestinal disorders: nausea, vomiting.
Diagnostic investigations: disturbances in test results for urinary catecholamine concentration
measured by fluorometric method, urobilinogen concentration testing (using Ehrlich’s reagent),
following high doses of vitamin B2.
Hypersensitivity reactions have unknown frequency (frequency cannot be determined from
available data).
Vitamin B2 may cause dark yellow discoloration of urine. This symptom should not be a cause
for concern.
In some individuals, other adverse reactions not listed in this leaflet may occur during the use of Vitaminum B2 Teva. If any such adverse symptoms occur, the physician should be informed.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist.
Adverse reactions 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
Reporting adverse reactions allows the collection of further information on the safety of the medicine.

5. How to store Vitaminum B Teva

Keep this medicine out of sight and reach of children.
Store below 30°C.
Do not use Vitaminum B Teva after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use.

6. Contents of the pack and other information

What Vitaminum B2 Teva contains
The active substance is riboflavin 3 mg.
Excipients:
core: sucrose, lactose monohydrate, talc, potato starch, gum arabic, stearic acid,
coating: talc, gum arabic, sucrose, quinoline yellow (E104), Opaglos 6000 white (a suspension containing ethanol, shellac, carnauba wax (E903), beeswax (E901)).

What the medicine looks like and contents of the pack:
50 dragees (2 blisters with 25 pieces each) in a cardboard box.

Marketing authorisation holder and manufacturer:
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer:
Teva Operations Poland Sp. z o.o.
Mogilska 80
31-546 Kraków