Tiavella

Package Leaflet: Information for the Patient

Tiavella, 50 mg, Coated Tablets

Benfotiamine

It is Essential to Carefully Read the Contents of this Leaflet Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist.

• This Leaflet Should be Kept in Case it Needs to be Read Again.
• If Advice or Additional Information is Needed, a Pharmacist Should be Consulted.
• If the Patient Experiences any Undesirable Effects, Including any Possible Undesirable Effects not Listed in the Leaflet, the Doctor or Pharmacist Should be Informed. See Section 4.
• If there is no Improvement or the Patient Feels Worse, the Doctor Should be Contacted.

Table of Contents of the Leaflet

• 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 Pack and Other Information

1. What is Tiavella and What is it Used for

Tiavella is a Vitamin Supplement Containing Benfotiamine (Vitamin B1).
It is Used to Treat Vitamin B1 Deficiency (a Condition in Which the Body Does not Have a Sufficient Amount of Vitamin B1), Which Cannot be Controlled by an Appropriate Diet.
Vitamin B1 Occurs Naturally in Many Food Products (Especially in Yeast, Whole Grains, Meat, and Beans), but Sometimes the Body Requires its Supplementation. This can be Due to the Fact that the Diet Does not Contain a Sufficient Amount of Vitamin B1 or the Body does not Absorb it in Sufficient Quantities. The Patient may also Have an Increased Demand for Vitamin B1 (e.g., in the Case of Diabetes), Especially if there is Rapid Elimination 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 is Indicated for Use in Adult Patients.

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 Medication (Listed in Section 6).

Warnings and Precautions

Before Starting to Take Tiavella, the Doctor or Pharmacist Should be Consulted.

Children and Adolescents

This Medication Should not be Used in Children and Adolescents Under 18 Years of Age Due to the Lack of Sufficient Data.

Tiavella and Other Medications

The Doctor or Pharmacist Should be Informed about all Medications Currently Being Taken by the Patient or Recently Taken, as well as any Medications that the Patient Plans to Take.
Vitamin B1 is Inactivated by 5-Fluorouracil(a Medication 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 with Food, Drink, and Alcohol

Vitamin B1 Should not be Taken at the Same Time as Drinks Containing Sulfites (e.g., Wine), as they can Cause Excessive Metabolism of Vitamin B1, Resulting in Loss of its Effect.
During Treatment with this Medication, Alcohol Should not be Consumed, as it Reduces the Absorption of Vitamin B1 in the Intestine and has a Negative Effect on its Storage and Metabolism.

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant, Breastfeeding, or Thinks they may be Pregnant, they Should Consult a Doctor or Pharmacist Before Taking this Medication.
So far, no Negative Effects on Fertility have been Observed.

Driving and Operating Machines

This Medication does not Affect the Ability to Drive and Operate Machines.

Tiavella Contains Sodium

This Medication Contains Less than 1 mmol of Sodium (23 mg) per Tablet, which Means it is Essentially "Sodium-Free".

3. How to Take Tiavella

This Medication Should Always be Taken Exactly as Described in the Patient Leaflet or as Advised by a Doctor or Pharmacist. In Case of Doubt, the Doctor or Pharmacist Should be Consulted.
The Doctor will Decide on the Exact Dosage Depending on the Patient's Health Condition.
Usually, the 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 the Lack of Available Data.

Patients with Renal Impairment

In the Case of Renal Impairment, the Doctor will Prescribe the Usual Dose.

Patients with Hepatic Impairment

The Doctor Should be Informed about any Hepatic Impairment in the Patient.

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 B1 Deficiency and the Success of the Treatment. After About 4 Weeks, the Doctor will Reassess the Patient's Health Condition.

Taking a Higher Dose of Tiavella than Recommended

Usually, no Medical Intervention is Necessary.
In Case of any Further Doubts Related to the Use of this Medication, the Doctor or Pharmacist Should be Consulted.

4. Possible Side Effects

Like all Medications, Tiavella can Cause Side Effects, although not Everybody Gets them.
It is Unlikely that Tiavella will Cause Side Effects, unless the Patient is Allergic (Hypersensitive) to Benfotiamine or any of the Ingredients of the Coated Tablets.
Allergic Reactions to Vitamin B1 have been Reported, but Mainly when Administered by Injection.
The Following Side Effects have also 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 Side Effects

If any Undesirable Effects Occur, Including any Possible Undesirable Effects not Listed in the Leaflet, the Doctor, Pharmacist, or Nurse Should be Informed. Side Effects can be Reported Directly to the Department of Monitoring of Adverse Reactions 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: [email protected]
Side Effects can also be Reported to the Marketing Authorization Holder. By Reporting Side Effects, more Information can be Collected on the Safety of the Medication.

5. How to Store Tiavella

Do not Store Above 30°C.
The Medication Should be Stored in a Place that is Inaccessible to Children.
Do not Use this Medication After the Expiry Date Stated on the Carton after EXP.
The Expiry Date Refers to the Last Day of the Specified Month.
Medications Should not be Disposed of via Wastewater or Household Waste. The Pharmacist Should be Asked how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Contents of the Pack and Other Information

What Tiavella Contains

• The Active Substance is Benfotiamine (Vitamin B1). 1 Coated Tablet Contains 50 mg of Benfotiamine.
• The Other Ingredients are: Tablet Core: Microcrystalline Cellulose, Povidone K30, Sodium Carboxymethylcellulose, Talc (E 553b), Silica Colloidal Anhydrous, Glycerol Dibehenate; Coating: Opadry II White Consisting 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 Score Line on one Side.
The Tablet can 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 in a Cardboard Box.
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

G.L. Pharma GmbH
Schloßplatz 1
8502 Lannach
Austria

For More Detailed Information and Information on the Product Name in other EEA Member States, the Representative of the Marketing Authorization Holder Should be Contacted:

G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]

Date of Last Revision of the Leaflet: