Vitaminum B2 Teva

Package Leaflet: Information for the User

Vitaminum B Teva, 3 mg, Chewable Tablets

Riboflavin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist or nurse.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist or nurse. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

• 1. What is Vitaminum B Teva and what is it used for
• 2. Important information before taking Vitaminum B Teva
• 3. How to take Vitaminum B Teva
• 4. Possible side effects
• 5. How to store Vitaminum B Teva
• 6. Contents of the pack and other information

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

Vitamin B belongs to the group of water-soluble B vitamins. The most important function of riboflavin in the body is its participation in tissue respiration processes. Riboflavin, together with other substances, participates in the metabolism of carbohydrates, fats, and proteins, catalyzing the oxidation processes of glucose, fatty acids, and amino acids. Vitamin B also participates in the twilight vision process. It is necessary for maintaining the proper function of mucous membranes and the epithelium of blood vessels. It also conditions the proper functioning of the nervous system and skin.
Taking vitamin B is required by people who consume a vitamin-deficient diet or those who, for physiological reasons (e.g., pregnancy, breastfeeding, physical exertion) or due to illness, have an increased demand for vitamins, as well as patients with intestinal absorption disorders.
Indications for use:

• prophylaxis and supplementation of vitamin B deficiency,
• auxiliary:
• in therapy with diuretics,
• after antibiotic therapy,
• before and after surgical procedures,
• in disorders of liver, stomach, and intestine function, combined with persistent diarrhea,
• in chronic and debilitating diseases (diabetes, infections of various origins, skin inflammatory conditions, hyperthyroidism, psychosomatic diseases, alcoholism).

2. Important information before taking Vitaminum B Teva

When not to take Vitaminum B Teva:

• if the patient is allergic to riboflavin or 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 medicine is excreted in the urine (which may lead to an excessive concentration of vitamin B).
During the administration of high doses of vitamin B, laboratory test results may be disturbed (determination of catecholamine levels in urine by fluorometry, determination of urobilinogen levels using Ehrlich's reagent).
High doses of vitamin B can cause a change in urine color to dark yellow (urine takes on the color of a water solution of riboflavin).

Vitaminum B Teva and other medicines

Anticholinergic medicines, e.g., atropine, may affect the absorption of riboflavin.
Doxorubicin may delay, and methotrexate may reduce the effect of vitamin B.
Tricyclic antidepressants and phenothiazine derivatives (e.g., chlorpromazine), probenecid, hormonal contraceptives, used in high doses, may weaken the effect of vitamin B (an increase in the dose of riboflavin may be required).
Vitamin B should not be taken (also in combination with other vitamins) at the same time as tetracycline. Also, long-term use of other antibiotics may reduce the effect of riboflavin.
Thiazide diuretics (e.g., hydrochlorothiazide) may increase the excretion of vitamin B from the body.
Vitamin B enhances the effect 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

Before taking the medicine, you should consult your doctor.
No risk to the fetus has been demonstrated during the use of doses covering the daily requirement in pregnant women.
Vitamin B may be used during pregnancy in the recommended doses.

Breastfeeding

Before taking the medicine, you should consult your doctor.
No risk to the newborn has been demonstrated during the use of doses covering the daily requirement by the breastfeeding mother.
Vitamin B may be used during breastfeeding in the recommended doses.

Driving and using machines

The medicine does not affect the ability to drive vehicles and operate machinery.

Vitaminum B Teva contains lactose and sucrose

The medicine contains 44 mg of lactose and 124 mg of sucrose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine. The medicine contains yellow dye (E104), which may cause allergic reactions.

3. How to take Vitaminum B Teva

Usually, the following is taken:
Prophylactically:
Children from 4 years of age, adolescents:
3 to 6 mg (1 to 2 chewable tablets) per day in divided doses.
Adults:
3 to 9 mg (1 to 3 chewable tablets) per day in divided doses.
You should not exceed the maximum daily dose.
If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor.

Taking a higher dose of Vitaminum B Teva than recommended

There have been no reports of riboflavin overdose. The medicine is practically non-toxic. Excess medicine is excreted in the urine.
If you have taken a higher dose of the medicine than recommended, you should immediately consult your doctor or pharmacist.

Missing a dose of Vitaminum B Teva

You should take the medicine as soon as possible. You should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Vitaminum B Teva can cause side effects, although not everybody gets them.
Very rare (including single cases, frequency less than 1 case per 10,000):
Disorders of the skin and subcutaneous tissue: skin allergic reactions (rash, itching, sensitivity to light, burning/stinging sensation).
Disorders of the stomach and intestines: nausea, vomiting.
Diagnostic tests: disturbances of catecholamine levels in urine determined by fluorometry, urobilinogen levels determined using Ehrlich's reagent, after high doses of vitamin B.
With unknown frequency (frequency cannot be estimated from available data), hypersensitivity reactions occur.
Vitamin B may cause dark yellow discoloration of urine. This symptom should not cause concern.
In some people, during the use of Vitaminum B Teva, other side effects may occur.
In case of other side effects not listed in this leaflet, you should inform your doctor.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Vitaminum B Teva

The medicine should be stored out of sight and reach of children.
Store at a temperature below 30°C.
You should not use the Vitaminum B Teva preparation after the expiry date stated on the packaging.
The expiry date means the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed.

6. Contents of the pack and other information

What Vitaminum B Teva contains

The active substance of the medicine is riboflavin in the amount of 3 mg.
The excipients are:
core:
sucrose, lactose monohydrate, talc, potato starch, gum arabic, stearyl acid,
coating:
talc, gum arabic, sucrose, yellow dye (E104), Opaglos 6 000 white (a suspension of ethanol, shellac, carnauba wax (E903), beeswax (E901)).

What the medicine looks like and what the pack contains:

50 chewable tablets (2 blisters of 25 tablets each), in a cardboard box.

Marketing authorization holder and manufacturer:

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer:

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow

Date of last revision of the leaflet: April 2022