Package leaflet: Information for the patient

Vitaminum B1 Richter, 25 mg, tablets
Thiamini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Vitaminum B1 Richter is and what it is used for
Important information before taking Vitaminum B1 Richter
How to take Vitaminum B1 Richter
Possible side effects
How to store Vitaminum B1 Richter
Contents of the pack and other information

1. What Vitaminum B1 Richter is and what it is used for

Thiamine hydrochloride, also known as vitamin B1, the active substance in Vitaminum B1 Richter, belongs to the group of vitamins involved in regulating glucose metabolism in the body. Vitamin B1 has beneficial effects on the nervous and muscular systems and on heart function. Symptoms of vitamin B1 deficiency primarily affect the nervous system. Gastrointestinal symptoms may also occur, such as nausea, loss of appetite, constipation, and heart failure.

In certain conditions—such as during pregnancy, breastfeeding, prolonged physical exertion, or mental stress (stress)—the requirement for vitamin B1 increases, and therefore higher doses should be taken.

Elderly individuals and patients with alcohol abuse have an increased need for vitamin B1.

Vitaminum B1 Richter is used:

for the treatment of vitamin B1 deficiency (beriberi disease), and for the prevention of deficiency when the patient is on an elimination diet (a diet excluding certain food components);
for the treatment of functional disorders of the nervous system, heart, and skeletal muscles associated with vitamin B1 deficiency;
to correct vitamin B1 deficiency in alcoholism and cardiovascular disorders.

2. Important information before using Vitaminum B Richter

When not to use Vitaminum B Richter

if the patient is allergic (hypersensitive) to thiamine hydrochloride or any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include rash, itching, swelling of the face, lips, tongue, or difficulty breathing (if any of these symptoms occur, contact a doctor immediately).

Warnings and precautions
No special precautions are required when taking Vitaminum B Richter in any patient group, except for patients with known intolerance to certain sugars (see below).

Vitaminum B Richter and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Medicines that neutralize gastric acid, used in peptic ulcer disease, may reduce the absorption of vitamin B.

Vitaminum B Richter with food, drink and alcohol
This medicine may be taken independently of meals. Alcohol and tea may reduce the absorption of vitamin B.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Vitaminum B Richter may be used during pregnancy and breastfeeding.

Driving and operating machinery
Vitaminum B Richter has no effect on the ability to drive or operate machinery.

Vitaminum B Richter contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Vitaminum B1 Richter

This medicine should always be taken exactly as directed by the physician or pharmacist.
In case of doubt, consult your physician or pharmacist.
Alcohol-dependent patients
The usual dose is 4 to 6 tablets (100 to 150 mg) per day.
Other patients
The usual dose is 1 to 4 tablets (25 to 100 mg) per day.
Vitaminum B1 Richter is administered orally. Tablets should preferably be taken at the same time
each day, regardless of meals. Doses exceeding 2 tablets per day should be divided into two portions,
taken in the morning and in the evening.
If you feel that the effect of Vitaminum B1 Richter is too strong or too weak, consult your physician.
Taking more Vitaminum B1 Richter than prescribed
Taking a higher than recommended dose does not pose a health risk, as larger amounts
(which could be harmful) are not absorbed from the gastrointestinal tract.
Missing a dose of Vitaminum B1 Richter
Take the next dose at the scheduled time.
Stopping treatment with Vitaminum B1 Richter
Treatment of disorders and diseases for which Vitaminum B1 Richter is used is long-term.
Do not discontinue treatment without consulting your physician, even if you feel better.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Vitaminum B1 Richter is a medicine that is very well tolerated.
Both severe and mild adverse reactions occur very rarely and exclusively after
intravenous injection of high doses of vitamin B .
Oral administration of Vitaminum B1 Richter has not caused significant adverse reactions.
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's use.

5. How to store Vitaminum B1 Richter

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Vitaminum B Richter contains
The active substance is thiamine hydrochloride.
The other ingredients are: microcrystalline cellulose, crospovidone, colloidal anhydrous silica,
magnesium stearate, Ludipress (monohydrate lactose, povidone, crospovidone).

What Vitaminum B Richter looks like and contents of the pack
Vitaminum B Richter is in the form of white tablets. On one side of the tablet the marking “B1” is imprinted, and on the other side “25”.
The pack contains 50 tablets.

Marketing Authorisation Holder and Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
Tel.: +48 (22) 755 50 81

For further information, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22) 755 96 48
[email protected]

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