Tiavella forte
Poland
Table of Contents
Package leaflet: Information for the patient
Tiavella forte, 300 mg, coated tablets
Benfotiaminum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any further 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 any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of the leaflet
- What Tiavella forte is and what it is used for
- Important information before taking Tiavella forte
- How to take Tiavella forte
- Possible side effects
- How to store Tiavella forte
- Contents of the pack and other information
1. What Tiavella forte is and what it is used for
Tiavella forte 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 levels of the vitamin), which cannot be corrected by an adequate 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 through 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 of the vitamin from the body (e.g. in urine), if there has been excessive alcohol consumption in the past, or if the patient is pregnant or breastfeeding.
Tiavella forte is indicated for use in adult patients.
2. Important information before taking Tiavella forte
When not to take Tiavella forte
Do not take Tiavella forte if you are allergic to benfotiamine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Tiavella forte.
Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age due to insufficient data.
Tiavella forte and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Vitamin B is inactivated by 5-fluorouracil (a medicine used in the treatment of cancer).
If you are taking furosemide (a diuretic causing removal of excess fluid from the body) for a prolonged period and have heart failure, your doctor may recommend taking benfotiamine.
Taking Tiavella forte with food, drink and alcohol
Vitamin B should not be taken simultaneously with beverages containing sulfites (e.g. wine), as they may cause excessive metabolism of vitamin B, thus reducing its effectiveness.
Do not consume alcohol while taking this medicine, as alcohol reduces intestinal absorption of vitamin B and negatively affects the body's ability to store and metabolize it.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
This medicine is intended only for the treatment of vitamin B deficiency. Therefore, your doctor will prescribe Tiavella forte only after carefully considering the risks and benefits.
There have been no signs of negative effects on fertility observed to date.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
Tiavella forte 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 forte
This medicine should always be taken as directed by the physician. In case of any doubts, please
consult your doctor or pharmacist.
The exact dose will be determined by the physician according to the patient's condition.
The usual daily dose is 150 to 300 mg of benfotiamine, corresponding to ½ or 1 coated tablet per day.
Doses lower than 150 mg cannot be administered using 300 mg tablets.
Depending on the severity of the deficiency, the physician may decide to use a lower or higher dose.
Use in children and adolescents
Tiavella forte 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 if the patient has any existing liver function disorders.
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 than the recommended dose of Tiavella forte
Medical intervention is usually not required.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like any medicinal product, this medicine may cause adverse reactions, although not everyone experiences them.
It is unlikely that Tiavella forte will cause adverse reactions unless the patient
has an allergy (hypersensitivity) 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 out of 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 effects 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 can also be reported to the marketing authorization holder.
Reporting of adverse reactions allows further information on the safety of the medicine to be collected.
5. How to store Tiavella forte
Do not store above 30°C.
Keep the medicine in a place invisible and inaccessible to 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 package and other information
What Tiavella forte contains
- The active substance is benfotiamine (vitamin B1). Each coated tablet contains 300 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, containing: 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, oblong (18.1 x 5.1 mm), biconvex coated tablets with a break line on both sides.
The tablet may be divided into equal doses.
Tiavella forte is available in blister packs 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.
Bulk packs containing 500, 1000 or 5000 coated tablets are also available.
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]