Benfogamma forte
Poland
Table of Contents
Patient Information Leaflet
Benfogamma Forte
300 mg, coated tablets
(Benfotiamine)
Please read this leaflet carefully before taking this medicine, as it contains important information
for the patient.
- 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 share it with others. This medicine may harm other people, 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.
Table of contents:
- What Benfogamma Forte is and what it is used for
- Important information before taking Benfogamma Forte
- How to take Benfogamma Forte
- Possible side effects
- How to store Benfogamma Forte
- Further information about Benfogamma Forte
1. What Benfogamma Forte is and what it is used for
Benfogamma Forte is a vitamin preparation.
Indications:
- Treatment of confirmed vitamin B deficiency;
- Prevention of consequences of vitamin B deficiency that cannot be effectively corrected by diet alone, in patients at risk;
- Treatment of neuropathies and cardiovascular disorders caused by vitamin B deficiency.
Clinically confirmed vitamin B deficiency may occur in the following conditions: diabetes, inadequate diet or malnutrition (e.g. beriberi), long-term parenteral nutrition, starvation, hemodialysis, malabsorption, chronic alcoholism (alcohol-induced cardiomyopathy, Wernicke's encephalopathy, Korsakoff syndrome), increased demand (e.g. pregnancy and breastfeeding).
2. Important information before taking Benfogamma Forte
When not to use Benfogamma Forte
Do not use 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
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Thiamine is deactivated by 5-fluorouracil (the active substance in drugs used in the treatment of cancer).
Food, drink and alcohol with Benfogamma Forte
No special precautions are required.
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.
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 be used during pregnancy only if vitamin B deficiency has been diagnosed and your doctor considers treatment 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 be used during breastfeeding only if vitamin B deficiency has been diagnosed and your doctor considers treatment necessary.
Vitamin B passes into human milk.
Fertility
There are no data available on the effect of Benfogamma Forte on fertility.
Driving and operating machinery
Benfogamma Forte has no influence on the ability to drive or operate machinery.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".
3. How to use Benfogamma Forte
This medicine should always be taken as advised by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
The following information applies only if your doctor has not given you different instructions. You should always take the medicine as recommended, because otherwise it may not produce the expected results.
Recommended dose
Adults
Treatment of confirmed vitamin B deficiency :
If your doctor has not advised otherwise, 1 tablet (300 mg) of Benfogamma Forte per day.
Prevention of vitamin B deficiency effects :
The usual dose is ½ tablet (150 mg) of Benfogamma Forte per day.
Treatment of neuropathy and cardiovascular disorders caused by vitamin B deficiency :
The usual dose is ½ tablet (150 mg) of Benfogamma Forte per day.
Use in children and adolescents
The efficacy and safety of this medicine have not been established in children and adolescents under 18 years of age.
Elderly patients
The standard dosage is recommended.
Patients with renal impairment
The standard dosage may be used in patients with impaired kidney function.
Patients with hepatic impairment
The safety and efficacy of this medicine have not been established in patients with impaired liver function.
Method and route of administration
The coated tablets should be swallowed with a glass of water. The tablets may be taken at any time of day. The tablet may 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 therapy, and the dose is 150 or 300 mg of Benfogamma Forte. If there is no response to treatment or an insufficient response to treatment of vitamin B deficiency, the treatment regimen should be reconsidered.
You should inform your doctor or pharmacist if the effect of Benfogamma Forte is too weak or too strong.
Taking more than the recommended dose of Benfogamma Forte
If you take more than the recommended dose of Benfogamma Forte, medical intervention is usually not required; however, 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 Benfogamma Forte
If you stop taking the medicine, its therapeutic effects may be lost. If you experience unpleasant effects from the medicine, consult your doctor.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like any medicine, this medicine may cause adverse reactions, although not everybody will experience them.
Very rare adverse reactions, which may occur in no more than 1 in 10,000 people:
- Hypersensitivity reactions (allergy) such as skin rashes, urticaria.
- In clinical studies on benfotiamine, isolated cases of gastrointestinal disturbances such as nausea have been reported.
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur,
you should inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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
Phone: +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 Forte
Keep this medicine out of 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the packaging 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
Partial long-chain glycerides
Film-coat composition (Opadry 07F28588):
Hypromellose
Talc
Titanium dioxide (E 171)
Macrogol 3350
Sodium saccharin
What Benfogamma Forte looks like and contents of the pack
White, elongated coated tablets with a division line on both sides.
Pack sizes contain 10, 30, 60, and 100 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 2471034 Böblingen
Germany
Manufacturers:
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
For further information, please contact the representative of the Marketing Authorisation 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