Benfogamma

Benfogamma
(Benfothiaminum)
50 mg, coated tablets
Please read this entire leaflet carefully, as it contains important information for the patient.
This medicine is available without a prescription. However, to achieve the best treatment outcome, the medicine should be used carefully.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your pharmacist if you need advice or further information.
• If symptoms worsen or do not improve, contact your doctor.
• If any of the side effects worsen or if any side effects not listed in this leaflet occur, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. WHAT BENFOGAMMA IS AND WHAT IT IS USED FOR
The active substance in Benfogamma is benfotiamine. Benfotiamine is a lipid-soluble derivative of thiamine (vitamin B ). This solubility ensures good absorption of the drug, which is then converted into thiamine in the body.
Benfogamma is indicated for the prevention and treatment of consequences of vitamin B deficiency in the body. Vitamin B deficiency may occur in the following conditions:

• Poor nutrition low in vitamin B , intensive weight-loss (starvation) diets, hemodialysis
• Chronic alcoholism (alcohol blocks vitamin B absorption) and complications arising from chronic alcoholism.

2. IMPORTANT INFORMATION BEFORE TAKING BENFOGAMMA

When not to take Benfogamma:
Do not take Benfogamma if you are hypersensitive (allergic) to benfotiamine, thiamine, or any of the excipients.

When to exercise special caution with Benfogamma:
Benfogamma is well tolerated and there are no known conditions requiring special precautions.
Benfogamma contains sucrose and glucose syrup.
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
Benfogamma contains macrogol glycerol hydroxystearate. Therefore, this medicine may cause indigestion and diarrhoea.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, it is considered "sodium-free".

Taking other medicines:
Inform your doctor about all medicines you are currently taking, including those available without a prescription.
No interactions between Benfogamma and other medicines are known.

Pregnancy and breastfeeding
Before taking any medicine, consult your doctor or pharmacist.
Benfogamma may be used during pregnancy only if clearly needed and only under medical supervision.
During breastfeeding, consult your doctor before taking Benfogamma.

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

3. HOW TO USE BENFOGAMMA

Benfogamma should always be used as directed by the physician. In case of doubt, consult your doctor or pharmacist again.
The usual dosage is:

• for prophylactic purposes: 1 coated tablet 1 - 2 times per week
• for therapeutic purposes: 1 coated tablet 1 - 3 times daily

Coated tablets should be swallowed whole, not crushed or chewed. Take with adequate amount of water.

If you feel that the effect of Benfogamma is too strong or too weak, consult your doctor or pharmacist.
Taking more Benfogamma than recommended
If you have taken more Benfogamma than recommended, consult your doctor or pharmacist.
There are no reports of overdose with Benfogamma.
Missing a dose of Benfogamma:
Do not take a double dose to make up for a missed dose.
Stopping Benfogamma treatment:
If you have any doubts regarding the use of Benfogamma, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Benfogamma may cause adverse reactions, although not everyone will experience them.
There have been no reports of adverse reactions following oral administration of Benfogamma.
In isolated cases, skin rash may occur, probably due to allergy (hypersensitivity) to one of the components of the medicine.

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
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE BENFOGAMMA
Keep this medicine out of the sight and reach of children.
Do not use Benfogamma after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. OTHER INFORMATION

What Benfogamma contains
The active substance is benfotiamine.
One coated tablet contains 50 mg of benfotiamine.
The medicine 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
Stearic acid
Magnesium stearate

Tablet coating:
Colloidal anhydrous silica
Heavy kaolin
Macrogol glycerol hydroxystearate
Acacia gum
Sucrose
Corn starch
Sodium lauryl sulfate
Povidone K25
Talc
Titanium dioxide (E 171)
Sodium carmellose
Calcium carbonate
Glucose syrup
Macrogol 6000
Montana wax

What Benfogamma looks like and contents of the pack
White, round coated tablets.
Aluminum/PVC/PVDC foil blisters packed in a cardboard box.
Pack sizes contain:
50 coated tablets – 5 blisters with 10 tablets each
100 coated tablets – 5 blisters with 20 tablets each

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 24
71034 Böblingen
Germany

Manufacturer:
Wörwag Pharma Production GmbH & Co. KG
Gewerbeallee 1
82343 Pöcking
Germany

For further information, please contact the representative of the Marketing Authorisation Holder:
Woerwag Pharma Polska sp. z o.o.
Józefa Piusa Dziekońskiego 1 Street
00-728 Warsaw
Phone (+48) 22 863 72 81
Fax (+48) 22 877 13 70

Date of preparation of this leaflet: March 2024