BENFO-

BENFO-biomo 300 mg film-coated tablets

Important notes (mandatory information)

benfo-biomo 300 mg film-coated tablets. Active ingredient: Benfotiamine. Areas of application: for the treatment of vitamin B1 deficiency (if your body does not have enough vitamin B1), if this cannot be remedied by an appropriate diet.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR USERS

benfo-biomo 300 mg film-coated tablets for use in adults
Active ingredient: Benfotiamine

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse, contact your doctor.

What this package leaflet contains

1. WHAT IS BENFO-BIOMO AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BENFO-BIOMO?
3. HOW TO TAKE BENFO-BIOMO?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD BENFO-BIOMO BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS BENFO-BIOMO AND WHAT IS IT USED FOR?

benfo-biomo is a vitamin preparation that contains benfotiamine. benfo-biomo is used to treat vitamin B1 deficiency (if your body does not have enough vitamin B1), if this cannot be remedied by an appropriate diet. Although vitamin B1 occurs naturally in many foods (especially in yeasts, whole grains, meat and beans), your body sometimes needs a supplement. This may be because your diet does not contain enough vitamin B1 or because you cannot absorb enough of it from your diet. You may also have a special need for additional vitamin B1 (e.g. if you have diabetes), especially if you excrete it from your body more quickly (e.g. via your urine), if you have consumed excessive amounts of alcohol or if you are pregnant or breastfeeding. benfo-biomo is intended for use in adults.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BENFO-BIOMO?

benfo-biomo must not be taken if you are allergic to benfotiamine, thiamine (chemical name for vitamin B1) or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions
Please talk to your doctor before taking benfo-biomo.

Children and adolescents

Due to insufficient data, benfo-biomo should not be used in children and adolescents under 18 years of age.

Taking benfo-biomo with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Vitamin B1 is rendered ineffective by 5-fluorouracil (a medicine used to treat cancer). If you are taking furosemide ("water tablets") over a long period of time and suffer from heart failure, your doctor may recommend that you take benfo-biomo.

Taking benfo-biomo with drinks and alcohol

benfo-biomo should not be taken at the same time as drinks containing sulphites (e.g. wine), as this can increase the breakdown of vitamin B1 and thus render it ineffective. You should not drink alcohol while taking this medicine, as this reduces the absorption of vitamin B1 in the intestine and impairs its storage and metabolism.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This medicine is only used to treat vitamin B1 deficiency. Therefore, benfo-biomo should only be used after careful consideration of the benefits and risks by your doctor. So far, no evidence of a negative effect on your fertility has been found.

Driving and using machines

This medicine is not known to impair the ability to drive or operate machinery.

benfo-biomo contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, i.e. it is virtually "sodium-free".

3. HOW TO TAKE BENFO-BIOMO?

Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended daily dose is 150 mg to 300 mg benfotiamine. This corresponds to 1/2 or 1 film-coated tablet per day. Doses below 150 mg cannot be administered with this strength. The dose may need to be adjusted by your doctor to suit your health condition. Depending on the severity of the deficiency, lower/higher doses may also be required.

Use in children and adolescents

Due to insufficient data, benfo-biomo is not suitable for use in children and adolescents under 18 years of age.

Use in patients with impaired kidney function

If you have impaired kidney function, you can take the usual dose after consulting your doctor.

Use in patients with impaired liver function

Tell your doctor if you have impaired liver function.

Method of administration

For oral use. The film-coated tablet should be swallowed whole with a glass of water. The tablet can be divided into equal doses.

Duration of use

The duration of use depends on the cause of the vitamin B1 deficiency and is based on the therapeutic success. You should see your doctor for a check-up after about four weeks.

If you have taken more benfo-biomo than you should

Medical measures are generally not necessary.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. benfo-biomo is unlikely to cause side effects unless you are allergic to benfotiamine or any of the other ingredients of the film-coated tablets. Allergic reactions to vitamin B1 have been reported, but mostly when it was given by injection.

The following side effects have also been reported

Rare (may affect up to 1 in 1,000 people):

• allergic reactions (e.g. increased sweating, rapid heartbeat, skin reactions with itching and hives)
• gastrointestinal disorders, nausea

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD BENFO-BIOMO BE STORED?

Do not store above 30°C. Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister pack after "use by" or "exp.". The expiry date refers to the last day of the month indicated.

Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. This helps to protect the environment. For more information, see www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What benfo-biomo contains

The active ingredient is benfotiamine. 1 film-coated tablet contains 300 mg benfotiamine. The other ingredients are:

• Tablet core: Microcrystalline cellulose, povidone (K30), croscarmellose sodium, talc, highly dispersed silicon dioxide, glyceryl dibehenate (Ph.Eur.).
• Film coating Opadry II white consisting of: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.

What benfo-biomo looks like and contents of the pack

benfo-biomo 300 mg are almost white, oblong (18.1 x 5.1 mm), curved film-coated tablets with a break notch on both sides. benfo-biomo 300 mg is available in blister packs of 10, 14, 20, 28, 30, 40, 42, 50, 56, 60, 70, 80, 84, 90, 98, 100 and 150 film-coated tablets. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

biomo pharma GmbH
Josef-Dietzgen-Straße 3
53773 Hennef
Germany
Phone: 02242 8740-0
Fax: 02242 8740-499
E-mail: biomo@biomopharma.de

This package leaflet was last revised in September 2022.

Source: Package leaflet information
Status: 05/2024
Active ingredient: Benfotiamine. Areas of application: for the treatment of vitamin B1 deficiency (if your body does not have enough vitamin B1), if this cannot be remedied by an appropriate diet.