Benfogamma Forte

Package Leaflet: Information for the Patient

Benfogamma Forte
300 mg, coated tablets
(Benfothiamin)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Benfogamma Forte and what is it used for

Benfogamma Forte is a vitamin preparation.
Indications for use:

• treatment of confirmed vitamin B deficiency;
• prevention of the effects of vitamin B deficiency, which cannot be effectively compensated by diet, in patients at risk;
• treatment of neuropathy and cardiovascular disorders caused by vitamin B deficiency.

Clinically confirmed vitamin B deficiency may occur in the following cases: diabetes, inadequate diet or malnutrition (e.g., beriberi), long-term parenteral nutrition, starvation, hemodialysis, impaired absorption, chronic alcoholism (alcoholic cardiomyopathy, Wernicke's encephalopathy, Korsakoff's syndrome), increased demand (e.g., pregnancy and breastfeeding).

2. Important information before taking Benfogamma Forte

When not to take Benfogamma Forte

Do not take this medicine if you are hypersensitive (allergic) to benfotiamine, thiamine, or any of the other ingredients of this medicine (listed in section 6).

Benfogamma Forte and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Thiamine is inactivated by 5-fluorouracil (an active substance of medicines used to treat cancer).

Benfogamma Forte with food, drink, and alcohol

No special precautions are required.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The recommended daily intake of vitamin B during pregnancy is 1.4 to 1.6 mg. The safety of higher daily doses has not been documented.
Benfogamma Forte should only be used during pregnancy if a vitamin B deficiency has been confirmed in the patient and the doctor considers the use of the medicine necessary.
Breastfeeding
The recommended daily intake of vitamin B during breastfeeding is 1.4 to 1.6 mg.
The safety of higher daily doses has not been documented.
Benfogamma Forte should only be used during breastfeeding if a vitamin B deficiency has been confirmed in the patient and the doctor considers the use of the medicine necessary.
Vitamin B passes into breast milk.
Fertility
No data are available on the effect of Benfogamma Forte on fertility.

Driving and using machines

Benfogamma Forte does not affect the ability to drive and use machines.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially 'sodium-free'.

3. How to take Benfogamma Forte

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
The following information applies only if your doctor has not prescribed otherwise. Always take the medicine as directed, as otherwise, it may not have the desired effect.
Recommended dose
Adults
Treatment of confirmed vitamin B deficiency:
If your doctor has not prescribed otherwise, 1 tablet (300 mg) of Benfogamma Forte per day.
Prevention of the effects of vitamin B deficiency:
Usually, the dose is ½ tablet (150 mg) of Benfogamma Forte per day.
Treatment of neuropathy and cardiovascular disorders caused by vitamin B deficiency:
Usually, the dose is ½ tablet (150 mg) of Benfogamma Forte per day.
Use in children and adolescents
The efficacy and safety of the medicine in children and adolescents under 18 years have not been established.
Elderly patients
Normal dosing is recommended.
Patients with renal impairment
Normal dosing can be used in patients with renal impairment.
Patients with hepatic impairment
The safety and efficacy of the medicine in patients with hepatic impairment have not been established.
Method and route of administration
Swallow the coated tablets with a glass of water. The tablets can be taken at any time of day. The tablet can be divided into equal doses.
Duration of treatment
The duration of treatment with Benfogamma Forte depends on the response to treatment.
Benfogamma Forte should initially be taken for at least 3 weeks. Then, maintenance treatment depends on the response to treatment, and the dose is 150 or 300 mg of Benfogamma Forte. If there is no response to treatment or an insufficient response to vitamin B deficiency treatment, the treatment regimen should be reconsidered.
Tell your doctor or pharmacist if the effect of Benfogamma Forte is too weak or too strong.

Taking a higher dose of Benfogamma Forte than recommended

In case of taking a higher dose of Benfogamma Forte than recommended, usually no medical intervention is necessary, but you should contact your doctor as soon as possible.

Missing a dose of Benfogamma Forte

Do not take a double dose to make up for a missed dose. Take Benfogamma Forte as usual, at the scheduled time, trying to remember to take the medicine regularly.

Stopping treatment with Benfogamma Forte

If you stop taking the medicine, its effects may be lost. If you experience unpleasant effects, consult your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare side effects, which may occur in less than 1 in 10,000 people:

• Allergic reactions (allergy) such as skin rash, hives.
• In clinical studies with benfotiamine, single cases of gastrointestinal disorders such as nausea have been reported.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Benfogamma Forte

Keep the medicine out of the sight and reach of children.
Do not use Benfogamma Forte after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Benfogamma Forte contains

The active substance is benfotiamine.
Each coated tablet contains 300 mg of benfotiamine.
Excipients:
Microcrystalline cellulose
Talc
Povidone (K30)
Colloidal anhydrous silica
Sodium croscarmellose
Long-chain partial glycerides
Coating (Opadry 07F28588):
Hypromellose
Talc
Titanium dioxide (E 171)
Macrogol 3350
Sodium saccharin

What Benfogamma Forte looks like and contents of the pack

White, oblong coated tablets with a dividing line on both sides.
Pack sizes: 10, 30, 60, and 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

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

Manufacturer:

Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning
Germany
Wörwag Pharma Operations Sp. z o. o.
ul. gen. Mariana Langiewicza 58,
95-050 Konstantynów Łódzki
Poland
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Woerwag Pharma Polska sp. z o.o.
ul. Józefa Piusa Dziekońskiego 1
00-728 Warsaw
phone (+48) 22 863 72 81
fax (+48) 22 877 13 70

Date of last revision of the leaflet: July 2024