Benfonerv

Package Leaflet: Information for the Patient

Benfonerv, 40 mg + 90 mg + 0,25 mg, Film-Coated Tablets

Benfothiaminum + Pyridoxini hydrochloridum + Cyanocobalaminum

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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Benfonerv and what is it used for
• 2. Important information before taking Benfonerv
• 3. How to take Benfonerv
• 4. Possible side effects
• 5. How to store Benfonerv
• 6. Contents of the pack and other information

1. What is Benfonerv and what is it used for

Benfonerv contains: benfotiamine (Benfothiaminum) (vitamin B1), pyridoxine hydrochloride (Pyridoxini hydrochloridum) (vitamin B6) and cyanocobalamin (Cyanocobalaminum) (vitamin B12)
Benfonerv is used as an adjunct in the treatment of:

• neurological disorders of inflammatory origin (nerve inflammation),
• neurological disorders with accompanying pain (neuralgia), including nerve disorders caused by diabetes or alcoholism (diabetic neuropathy, alcoholic neuropathy),
• migraine,
• painful muscle strains (muscle strains),
• nerve root irritation syndrome (radiculitis),
• cervicobrachial syndrome (cervical syndrome, shoulder syndrome),
• hemiplegia,
• facial nerve palsy,
• in prolonged convalescence.

Benfonerv is also indicated for elderly patients.

2. Important information before taking Benfonerv

When not to take Benfonerv:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding;
• in children and adolescents under 18 years of age.

Warnings and precautions

Before taking Benfonerv, discuss it with your doctor or pharmacist.
Long-term use of Benfonerv (for more than 6 months) may lead to peripheral nerve disorders.

Children and adolescents

There is no experience with the use of Benfonerv in children and adolescents (under 18 years of age).
Benfonerv should not be used in children and adolescents (under 18 years of age).

Benfonerv with other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
It is especially important to inform your doctor if you are taking or have taken any of the following medicines:

• levodopa (a medicine used to treat Parkinson's disease),
• isoniazid (INH) and cycloserine (medicines used to treat tuberculosis),
• D-penicillamine (a medicine used, among other things, to treat rheumatoid arthritis),
• oral contraceptives containing estrogen (used for a long time),
• 5-fluorouracil (a medicine used to treat cancer).

Benfonerv with food, drink or alcohol

During therapy with Benfonerv, you should avoid consuming alcohol, as it reduces the effectiveness of the treatment. Benfonerv should be taken after a meal

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Benfonerv should not be used during pregnancy, due to limited data on the impact of the vitamins that are the active substances of this medicine on pregnancy. The possible risk resulting from the use of this medicine in pregnant women is not known.
Benfonerv should not be used during breastfeeding, as each film-coated tablet contains 90 mg of vitamin B6. High levels of vitamin B6 may inhibit milk production.

Driving and using machines

Benfonerv has no influence or negligible influence on the ability to drive and use machines.

3. How to take Benfonerv

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Recommended dose
1 film-coated tablet 3 to 4 times a day. In mild inflammatory conditions and in case of improvement: 1 to 2 film-coated tablets per day.
Method of administration
Oral use.
Benfonerv should be taken after a meal, with a small amount of liquid. The tablets should be swallowed whole. The tablets can be taken at any time of the day. If you are taking more than 1 tablet per day, you should space out the intake of the next tablets, leaving at least a 4-hour interval.
Duration of treatment
The duration of treatment is determined by your doctor. If you think that the effect of Benfonerv is too strong or too weak, you should talk to your doctor or pharmacist.

Use in children and adolescents

Benfonerv is indicated for use only in adults.

Overdose of Benfonerv

In case of overdose of Benfonerv, contact your doctor or go to the nearest hospital, showing this leaflet.
Overdose of vitamin B6 may cause nerve disorders, with possible loss of muscle coordination. High doses may cause seizures.
In newborns and infants, deep sedation (lethargy, drowsiness, very deep sleep) may occur, as well as a significant drop in blood pressure or respiratory disorders.

Missed dose of Benfonerv

Do not take a double dose to make up for a missed dose. Continue taking the medicine as directed.

Stopping Benfonerv treatment

Stopping Benfonerv treatment may result in treatment failure.
If you experience any side effects, talk to your doctor for advice on further treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Benfonerv can cause side effects, although not everybody gets them.
Side effects that have occurred during treatment with Benfonerv:
Rare(may affect up to 1 in 1000 people):

• allergic reactions (hives, rash, anaphylaxis)

Very rare(may affect up to 1 in 10,000 people):

• gastrointestinal disorders, such as nausea and other gastrointestinal disorders, have been documented as individual cases in clinical trials with benfotiamine.
• acne-like and blistering rash (red rash and skin blisters).

Frequency not known(frequency cannot be estimated from the available data):

• in case of long-term use of Benfonerv, for more than 6 months, peripheral sensory neuropathy may occur (see section Warnings and precautions).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 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 Benfonerv

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
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 Benfonerv contains

• The active substances are: benfotiamine (vitamin B1), pyridoxine hydrochloride (vitamin B6) and cyanocobalamin (vitamin B12). Each film-coated tablet contains 40 mg of benfotiamine, 90 mg of pyridoxine hydrochloride and 0.25 mg of cyanocobalamin.
• The other ingredients (excipients) are: Tablet core: microcrystalline cellulose, povidone K30, sodium croscarmellose, talc, colloidal silica anhydrous. Coating (Opadry): polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, iron oxide red (E 172).

What Benfonerv looks like and contents of the pack

Pink, oval, film-coated tablets, 15 mm x 7 mm in size.
Benfonerv film-coated tablets are packaged in PVC/PVDC/Aluminum blisters, placed in a cardboard box. The pack contains 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
Poland
Tel. 81 463-48-82
Manufacturer:
Mako Pharma Sp. z o.o.
ul. Kolejowa 231A,
05-092 Dziekanów Polski

Date of last revision of the leaflet: