Tiavella forte

Leaflet included in the packaging: patient information

Tiavella forte, 300 mg, coated tablets

Benfotiamine

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• It is necessary to keep this leaflet, so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific reason. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Tiavella forte and what is it used for

Tiavella forte is a vitamin tablet containing benfotiamine (vitamin B).
It is used to treat vitamin B deficiency (a condition in which the body does not have enough vitamin), which cannot be controlled by a suitable diet.
Vitamin B occurs naturally in many food products (especially in yeast, whole grains, meat, and beans), but sometimes the body requires supplementation. This can be due to the fact that the diet does not contain enough vitamin B or the body does not absorb it in sufficient quantities. The patient may also have an increased need for vitamin B (e.g., in the case of diabetes), especially if there is rapid excretion of it from the body (e.g., in urine), if the patient has consumed excessive amounts of alcohol in the past, or if the patient is pregnant or breastfeeding.
Tiavella forte is intended for use in adult patients.

2. Important information before taking Tiavella forte

When not to take Tiavella forte

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 forte, the patient should discuss it with their doctor or pharmacist.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age due to the lack of sufficient data.

Tiavella forte and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Vitamin B is inactivated by 5-fluorouracil(a medicine used to treat cancer).
If the patient is taking furosemide(a diuretic that causes the removal of excess fluid from the body) for a long time and has heart failure, the doctor will probably recommend taking benfotiamine.

Taking Tiavella forte with food, drink, and alcohol

Vitamin B should not be taken at the same time as drinks containing sulfites (e.g., wine), as they may cause excessive metabolism of vitamin B, resulting in loss of its effect.
During treatment with this medicine, the patient should not consume alcohol, as it reduces the absorption of vitamin B in the intestine and has a negative effect on its storage and metabolism.

Pregnancy, breastfeeding, and fertility

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 taking this medicine.
This medicine is intended only for the treatment of vitamin B deficiency. Therefore, the doctor will prescribe Tiavella forte only after careful consideration of the risk and benefit.
So far, no signs of a negative effect on fertility have been found.

Driving and using machines

This medicine does not affect the ability to drive and use machines.

Tiavella forte contains sodium

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

3. How to take Tiavella forte

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will decide on the exact dose depending on the patient's condition.
Usually, the daily dose is 150-300 mg of benfotiamine, which corresponds to ½ or 1 coated tablet per day. Doses less than 150 mg cannot be administered using 300 mg tablets.
Depending on the severity of the deficiency, the doctor may decide to use a smaller or larger dose.

Use in children and adolescents

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

Patients with kidney function disorders

In case of kidney function disorders, the doctor will prescribe the usual dose.

Patients with liver function disorders

The patient should inform their doctor about any liver function disorders they have.

Method of administration

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

Duration of treatment

The duration of treatment depends on the cause of the vitamin B deficiency and the success of the treatment. After about 4 weeks, the doctor will re-evaluate the patient's health status.

Taking a higher dose of Tiavella forte than recommended

Usually, no medical intervention is necessary.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, Tiavella forte can cause undesirable effects, although not everybody gets them.
It is unlikely that Tiavella forte will cause undesirable effects, unless the patient is allergic (hypersensitive) to benfotiamine or any of the ingredients of the coated tablets.
Allergic reactions to vitamin B have been reported, but mainly when administered by injection.
The following undesirable effects have been reported:
Rare(may affect up to 1 in 1000 people)

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

Reporting undesirable effects

If any undesirable effects occur, including any undesirable effects not mentioned in this leaflet, the patient should inform their doctor or pharmacist or nurse. Undesirable effects can be reported directly to the Department of Monitoring of Undesirable Effects of Medicinal Products 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: ndl@urpl.gov.pl
Undesirable effects can also be reported to the marketing authorization holder.
Reporting undesirable effects helps to gather more information on the safety of the medicine.

5. How to store Tiavella forte

Do not store above 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP.
The expiry date refers to the last day of the month stated.
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

What Tiavella forte contains

• The active substance is benfotiamine (vitamin B). One coated tablet contains 300 mg of benfotiamine.
• The other ingredients are: Tablet core: microcrystalline cellulose, povidone K30, sodium croscarmellose, talc (E 553b), silica colloidal anhydrous, glycerol dibehenate Coating: Opadry II white with the composition: polyvinyl alcohol (E 1203), titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b)

What Tiavella forte looks like and contents of the pack

White or almost white, elongated (18.1 x 5.1 mm), biconvex coated tablets with a dividing line on both sides.
The tablet can be divided into equal doses.
Tiavella forte 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 in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH
Schloβplatz 1
8502 Lannach
Austria

To obtain more detailed information and information on the names of the medicinal product in other EEA member states, please contact the representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of last revision of the leaflet: