Tiavella

Package leaflet: Information for the patient

Tiavella, 50 mg, coated tablets
Benfotiamine
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as directed by the
physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your condition does not improve or worsens, contact your doctor.

Table of contents

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

1. What is Tiavella and what is it used for

Tiavella is a vitamin preparation containing benfotiamine (vitamin B ).
It is used in the treatment of vitamin B deficiency (a condition in which the body does not have sufficient
amounts of the vitamin), which cannot be corrected by appropriate diet alone.
Vitamin B occurs naturally in many food products (especially in yeast, whole grains, meat, and beans),
but sometimes the body requires additional supplementation. This may be due to insufficient intake of
vitamin B in the diet or inadequate absorption by the body. The patient may also have an increased
requirement for vitamin B (e.g. in diabetes), particularly if there is rapid excretion from the body (e.g.
in urine), if the patient previously consumed excessive amounts of alcohol, or if the patient is pregnant or
breastfeeding.
Tiavella is indicated for use in adults.

2. Important information before taking Tiavella

When not to take Tiavella
If the patient is allergic to benfotiamine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Tiavella, discuss this with your doctor or pharmacist.

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age due to insufficient data.

Tiavella and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

Vitamin B(_1) is inactivated by 5-fluorouracil (a medicine used in the treatment of cancer).

If the patient is taking furosemide (a diuretic causing removal of excess fluid from the body) for a prolonged period and has heart failure, the doctor will likely recommend taking benfotiamine.

Taking Tiavella with food, drink and alcohol
Vitamin B(_1) should not be taken simultaneously with beverages containing sulfites (e.g. wine), as they may cause excessive metabolism of vitamin B(_1), thereby reducing its effectiveness.

Alcohol should not be consumed during treatment with this medicine, as it reduces the absorption of vitamin B(_1) in the intestine and negatively affects the body's ability to store and metabolize it.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

To date, there have been no signs of negative effects on fertility.

Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.

Tiavella contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially "sodium-free".

3. How to take Tiavella

This medicine should always be taken exactly as described in the patient leaflet or as directed by a physician or pharmacist. If in doubt, consult a doctor or pharmacist.
The physician will determine the exact dosage depending on the patient's health condition.
The usual daily dose is 150 to 300 mg of benfotiamine (3 to 6 coated tablets per day).

Use in children and adolescents
Tiavella is not intended for use in children and adolescents under 18 years of age due to lack of available data.

Patients with impaired kidney function
In case of impaired kidney function, the physician will prescribe the usual dose.

Patients with impaired liver function
Inform the physician about any existing liver function disorders in the patient.

Method of administration
For oral use.
The coated tablet may be taken with or without food and should be swallowed whole, without chewing, with a glass of water.
The tablet may be divided into two equal doses.

Duration of treatment
The duration of treatment depends on the cause of vitamin B deficiency and the response to therapy. After approximately 4 weeks, the physician will reassess the patient's health status.

Taking more Tiavella than recommended
Medical intervention is usually not necessary.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.
It is unlikely that Tiavella will cause adverse reactions unless the patient is allergic (hypersensitive) to benfotiamine or any of the excipients in the coated tablets.
Allergic reactions to vitamin B have been reported, but mainly when administered by injection.
The following adverse reactions have also been reported:
Rare (may occur in less than 1 in 1,000 people)

• Allergic reactions (e.g. excessive sweating, rapid heartbeat, skin reactions with itching and urticaria).
• Gastrointestinal disturbances, nausea.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 181 C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions may also be reported to the responsible entity.
Reporting adverse reactions enables further collection of information on the safety of the medicine.

5. How to store Tiavella

Do not store above 30°C.
Keep the medicine in a place out of sight and out of reach of children.
Do not use this medicine after the expiry date stated on the box after: EXP.
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. This will help protect the environment.

6. Contents of the packaging and other information

What Tiavella contains

• The active substance is benfotiamine (vitamin B). One coated tablet contains 50 mg of benfotiamine.
• Other ingredients are:
  Tablet core: microcrystalline cellulose, povidone K30, sodium croscarmellose, talc (E 553b), colloidal anhydrous silica, glycerol dibehenate.
  Coating: Opadry II white, composed of: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b).

What Tiavella looks like and contents of the pack
White or almost white, round (6.6 mm in diameter), biconvex coated tablets with a division line on one side.
The tablet may be divided into equal doses.
Tiavella is available in blisters containing 7, 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 80, 84, 90, 98 or 100 coated tablets, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH
Schloßplatz 1
8502 Lannach
Austria

For further information and information on the medicinal product names in other EEA countries, please contact the representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
Sienna 75 Street; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]