Benfonerv

Patient Information Leaflet

Benfonerv, 40 mg + 90 mg + 0.25 mg, coated tablets
Benfothiaminum + Pyridoxini hydrochloridum + Cyanocobalaminum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not give it to 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.
• If your condition does not improve or worsens, contact your doctor.

Table of Contents

1. What Benfonerv is and what it is 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 Benfonerv is and what it is used for

Benfonerv contains: benfotiamine (Benfothiaminum) (vitamin B1), pyridoxine hydrochloride (Pyridoxini hydrochloridum) (vitamin B6), and cyanocobalamin (Cyanocobalaminum) (vitamin B12).

Benfonerv is indicated as supportive treatment in:

• Neurological disorders of inflammatory origin (neuritis),
• Neurological disorders associated with pain (neuralgia), including nerve disorders caused by diabetes or alcoholism (diabetic neuropathy, alcoholic neuropathy),
• Migraine,
• Painful muscle strains (muscle overexertion),
• Irritation (compression) of spinal nerve roots (radiculitis),
• Cervicobrachial syndrome (cervical sciatica, shoulder sciatica),
• Herpes zoster,
• Facial nerve paralysis,
• Prolonged convalescence.

Benfonerv is also indicated in elderly patients.

2. Important information before using Benfonerv

When not to use Benfonerv:

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

Warnings and precautions
Before starting treatment with Benfonerv, discuss this with your doctor or pharmacist.
Long-term use of Benfonerv (for longer than 6 months) may lead to the occurrence of peripheral nerve dysfunction.
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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is especially important to inform the doctor if the patient is taking or has taken any of the following medicines:

• levodopa (a medicine used in the treatment of Parkinson's disease),
• isoniazid (INH) and cycloserine (medicines used in the treatment of tuberculosis),
• D-penicillamine (a medicine used, among others, in the treatment of rheumatoid arthritis),
• contraceptive medicines containing estrogen (used for a prolonged period),
• 5-fluorouracil (a medicine used in the treatment of cancer).

Benfonerv with food, drink or alcohol
During treatment with Benfonerv, alcohol consumption should be avoided, as it reduces the effectiveness of treatment. Benfonerv should be taken after a meal.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The use of Benfonerv during pregnancy is not recommended due to limited data on the effects of the vitamins, which are the active substances of this medicine, on pregnancy. The potential risk associated with the use of this medicine in pregnant women is unknown.
The use of Benfonerv during breastfeeding is not recommended, as each coated tablet contains 90 mg of vitamin B6. High concentrations of vitamin B6 may inhibit milk secretion.
Driving and operating machinery
Benfonerv has no effect or has a negligible effect on the ability to drive vehicles and operate machinery.

3. How to take Benfonerv

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
1 coated tablet 3 to 4 times daily. In mild inflammatory conditions and when improvement is observed:
1 to 2 coated tablets per day.
Method of administration
Oral administration.
Benfonerv tablets should be taken after a meal, with a small amount of liquid. Tablets should be
swallowed whole. Tablets may be taken at any time of day. If more than 1 tablet is taken per day,
doses should be divided throughout the day, maintaining an interval of at least 4 hours between doses.
Duration of treatment
The duration of treatment is determined by the physician. If the patient feels that the effect of Benfonerv is too strong
or too weak, they should consult a doctor or pharmacist.
Use in children and adolescents
Benfonerv is indicated for use only in adults.
Taking a higher than recommended dose of Benfonerv
If a higher than recommended dose of Benfonerv is taken, contact a doctor or go to the nearest hospital,
bringing along the medicine's package leaflet.
Vitamin B6 overdose may cause neurological disturbances, including loss of muscle coordination.
High doses may induce seizures.
In newborns and infants, profound sedation (lethargy, drowsiness, very deep sleep), significant drop in blood pressure, or respiratory disturbances may occur.
Missed dose of Benfonerv
Do not take a double dose to make up for a missed dose. Continue taking the medicine as recommended.
Discontinuation of Benfonerv
Discontinuing treatment with Benfonerv may result in treatment failure.
If adverse effects occur, consult a doctor for advice on continuing treatment.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions reported during the use of Benfonerv:

Rare (may occur in up to 1 in 1,000 patients):

• allergic reactions (urticaria, rash, anaphylactic shock)

Very rare (may occur in up to 1 in 10,000 patients):

• gastrointestinal disorders such as nausea and other gastrointestinal complaints, which have been documented as single cases in clinical trials with benfotiamine.
• acneiform and bullous rash (red rash and skin blisters).

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
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 Benfonerv

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the package following EXP.
The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the original packaging to protect from light.
Medicines must 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. Package contents and other information

What Benfonerv contains

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

What Benfonerv looks like and contents of the pack
Pink, oval, coated tablets, sized 15 mm x 7 mm.
Benfonerv coated tablets are packed in PVC/PVDC/Aluminium blisters, placed in a cardboard box. The pack contains 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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. Władysława Reymonta 2
05-092 Dziekanów Leśny