Benfogamma

PATIENT INFORMATION LEAFLET: USER INFORMATION

Benfogamma

(Benfothiaminum)
50 mg, sugar-coated tablets

Please read this leaflet carefully, as it contains important information for the patient.

This medicinal product is available without a prescription. However, to achieve the best treatment results, the medicinal product should be used with caution.

• This leaflet should be kept in case it needs to be read again.
• A pharmacist should be consulted if advice or additional information is needed.
• If symptoms worsen or do not improve, a doctor should be consulted.
• If any of the side effects worsen or any side effects not listed in the leaflet occur, the doctor or pharmacist should be informed. See section 4.

Table of contents of the leaflet:

• 1. What is Benfogamma and what is it used for
• 2. Important information before using Benfogamma
• 3. How to use Benfogamma
• 4. Possible side effects
• 5. How to store Benfogamma
• 6. Other information

1. WHAT IS BENFOGAMMA AND WHAT IS IT USED FOR

The active substance of Benfogamma is benfotiamine. Benfotiamine is a fat-soluble derivative of thiamine (vitamin B1). This solubility ensures good absorption of the medicinal product, which is converted into thiamine in the body.
Benfogamma is indicated for the prevention and treatment of vitamin B1 deficiency in the body. Vitamin B1 deficiency may occur in the following cases:

• improper diet poor in vitamin B1, intensive slimming diet (starvation), hemodialysis
• chronic alcoholism (alcohol blocks the absorption of vitamin B1) and complications resulting from chronic alcoholism.

2. IMPORTANT INFORMATION BEFORE USING BENFOGAMMA

When not to use Benfogamma:

Benfogamma should not be used if there is hypersensitivity (allergy) to benfotiamine, thiamine, or any of the excipients.

When to exercise special caution when using Benfogamma:

Benfogamma is well tolerated, and there are no known situations in which precautions should be taken.
Benfogamma contains sucrose, glucose syrup.
If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicinal product.
Benfogamma contains macrogol glycerol hydroxystearate. Therefore, the medicinal product may cause gastrointestinal disorders and diarrhea.
The medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicinal product is considered "sodium-free".

Using other medicinal products:

The doctor should be informed about all medicinal products taken recently, including those available without a prescription.
No interactions between Benfogamma and other medicinal products are known.

Pregnancy and breastfeeding

Before using any medicinal product, a doctor or pharmacist should be consulted.
Benfogamma may be used during pregnancy only if necessary and only on the doctor's prescription.
During breastfeeding, before using Benfogamma, a doctor should be consulted.

Driving and using machines

Benfogamma does not affect the ability to drive and use machines.

3. HOW TO USE BENFOGAMMA

Benfogamma should always be used according to the doctor's recommendations. In case of doubts, the doctor or pharmacist should be consulted again.
Usually, the recommended dose is:

• for preventive purposes: 1 sugar-coated tablet 1-2 times a week
• for therapeutic purposes: 1 sugar-coated tablet 1-3 times a day Sugar-coated tablets should be swallowed whole, without chewing or crushing. They should be washed down with a sufficient amount of water.

If it is felt that the effect of Benfogamma is too strong or too weak, a doctor or pharmacist should be consulted.

Using a higher dose of Benfogamma than recommended

In case of taking a higher dose of Benfogamma than recommended, a doctor or pharmacist should be consulted.
There are no reports of Benfogamma overdose.

Missing a dose of Benfogamma:

A double dose should not be taken to make up for a missed dose.

Stopping the use of Benfogamma:

In case of doubts related to the use of Benfogamma, a doctor or pharmacist should be consulted.

4. POSSIBLE SIDE EFFECTS

Like all medicinal products, Benfogamma can cause side effects, although they may not occur in everyone.
There are no reports of side effects after oral administration of Benfogamma.
In individual cases, skin rash may occur, probably as a result of an allergy (hypersensitivity) to one of the components of the medicinal product.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the doctor or pharmacist or nurse should be informed. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to 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
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for the collection of more information on the safety of the medicinal product.

5. HOW TO STORE BENFOGAMMA

The medicinal product should be stored in a place inaccessible and invisible to children.
Benfogamma should not be used after the expiry date stated on the packaging.
The expiry date means the last day of the given month.
Store in a temperature below 25°C.
Medicinal products should not be disposed of via wastewater or household waste containers. A pharmacist should be asked what to do with unused medicinal products. This will help protect the environment.

6. OTHER INFORMATION

What Benfogamma contains

The active substance is benfotiamine.
One sugar-coated tablet contains 50 mg of benfotiamine.
The medicinal product contains excipients with known effects: sucrose, glucose syrup, macrogol glycerol hydroxystearate (see section 2 of the leaflet)
Excipients:
Tablet core:
Corn starch
Sucrose
Gelatin
Talc
Stearyl acid
Magnesium stearate
Tablet coating:
Colloidal anhydrous silica
Heavy kaolin
Macrogol glycerol hydroxystearate
Arabic gum
Sucrose
Corn starch
Sodium lauryl sulfate
Povidone K25
Talc
Titanium dioxide (E 171)
Sodium carmellose
Calcium carbonate
Glucose syrup
Macrogol 6000
Montan wax

What Benfogamma looks like and what the pack contains

White, round, sugar-coated tablets.
Aluminum/PVC/PVDC foil blisters packaged in a cardboard box.
Packaging contains:
50 sugar-coated tablets – 5 blisters of 10 each
100 sugar-coated tablets – 5 blisters of 20 each

Marketing authorization holder and manufacturer

Marketing authorization holder:

Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 24
71034 Böblingen
Germany

Manufacturer:

Wörwag Pharma Production GmbH & Co. KG
Gewerbeallee 1
82343 Pöcking
Germany
To obtain more detailed information, the representative of the marketing authorization holder should be contacted:
Woerwag Pharma Polska sp. z o.o.
ul. Józefa Piusa Dziekońskiego 1
00-728 Warsaw
tel. (+48) 22 863 72 81
fax (+48) 22 877 13 70

Date of revision of the leaflet: March 2024