Bexon

Package Leaflet: Information for the Patient

Bexon, 50 mg/mL + 50 mg/mL + 0.5 mg/mL, Solution for Injection

Thiamine Hydrochloride + Pyridoxine Hydrochloride + Cyanocobalamin

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Bexon and what is it used for

Bexon is a vitamin medicine containing three B vitamins: vitamin B1 (thiamine), vitamin B6 (pyridoxine), and vitamin B12 (cyanocobalamin). Bexon is used to treat nervous system disorders with confirmed vitamin B1, B6, and B12 deficiencies that cannot be corrected by dietary changes:

• Supportive treatment of nervous system disorders of various etiologies:
• neuropathic pain of various etiologies (e.g., postherpetic neuralgia);
• radiculitis;
• lumbar syndrome;
• sciatica;
• polyneuropathy (e.g., diabetic or alcoholic);
• optic neuritis;
• facial nerve paralysis;
• carpal tunnel syndrome.

Treatment of clinical and subclinical vitamin B deficiencies, including:

• beriberi;
• anemias resulting from vitamin B12 deficiency;
• other diseases resulting from vitamin B1, B6, and B12 deficiencies.

2. Important information before using Bexon

When not to use Bexon:

• during pregnancy or breastfeeding;
• in children under 12 years of age, as the medicine contains benzyl alcohol and high doses of vitamins.

Warnings and precautions

Before starting treatment with Bexon, the patient should discuss it with their doctor or pharmacist. Bexon should only be administered intramuscularly. It must not be administered intravenously. If Bexon is accidentally administered intravenously, the patient's condition must be closely monitored by a doctor. If this medicine is used for more than 6 months, nerve damage (neuropathy) may occur. Symptoms of neuropathy include tingling, numbness, or burning sensation in the feet and hands. The patient should inform their doctor if any of these symptoms occur.

Elderly patients

No special precautions are required for elderly patients.

Bexon and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. It is particularly important to inform the doctor about the use of the following medicines:

• medicines used to treat tuberculosis (cycloserine, isoniazid);
• D-penicillamine (a medicine used to treat rheumatoid arthritis);
• hydralazine (a medicine used to lower blood pressure);
• adrenaline (a medicine used to treat life-threatening allergic reactions and to restore heart function after cardiac arrest);
• noradrenaline (a medicine used to increase blood pressure to normal values);
• antibiotics belonging to the sulfonamide group, e.g., sulfasalazine, sulfamethoxazole;
• levodopa (a medicine used to treat Parkinson's disease);
• 5-fluorouracil (a medicine used to treat cancer);
• prolonged use of oral contraceptives containing estrogens;
• other vitamins;
• medicines containing sulfites. If the patient is unsure whether a medicine contains sulfites, they should consult their doctor or pharmacist.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Due to the amount of active substances, this medicine can be used during pregnancy and breastfeeding only if vitamin B1 and B12 deficiencies are confirmed. Bexon should not be used during pregnancy or breastfeeding unless the doctor considers it absolutely necessary.

Driving and using machines

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

Bexon contains benzyl alcohol, sodium, and potassium.

Benzyl alcohol

The medicine contains 40 mg of benzyl alcohol per dose (2 mL). Benzyl alcohol may cause allergic reactions. Patients with liver or kidney disease should contact their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

Sodium

The medicine contains 11.41 mg of sodium per dose (2 mL). The medicine contains less than 1 mmol (23 mg) of sodium per dose (2 mL), which means it is considered "sodium-free".

Potassium

The medicine contains 0.07 mg of potassium per dose (2 mL). The medicine contains less than 1 mmol (39 mg) of potassium per dose (2 mL), which means it is considered "potassium-free".

3. How to use Bexon

This medicine should always be used exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor.

Recommended dose:

• In severe cases with acute pain, the recommended dose is one injection (2 mL) once a day;
• After alleviation of pain symptoms or in less severe cases, the recommended dose is one injection (2 mL) administered 2 to 3 times a week.

Method of administration

Bexon solution for injection is administered deep intramuscularly. This medicine must not be used in any other way! (see also "Warnings and precautions").

Duration of treatment

The doctor will decide how long the treatment should last based on the patient's weekly assessment. As soon as possible, the doctor will recommend switching to oral vitamin B supplements.

Using more than the recommended dose of Bexon

If the patient has been given too much Bexon by mistake and feels unwell, they should contact their doctor immediately.

Stopping treatment with Bexon

The patient should not stop treatment without consulting their doctor. If the patient stops using Bexon too early, symptoms may recur. In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bexon can cause side effects, although not everybody gets them. If the patient experiences any of the following side effects, they should stoptreatment with Bexon and consult their doctor. Immediate treatment may be necessary. Rare (may affect up to 1 in 1,000 people):

• severe allergic reactions (anaphylactoid reactions) caused by benzyl alcohol may occur.

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

• allergic reactions, e.g., rash, dyspnea, shock, swelling of hands, feet, or ankles, face, lips, tongue, and/or throat with difficulty swallowing or breathing (angioedema),
• skin reactions, including itching and hives,
• acne,
• dizziness,
• drowsiness,
• slow heart rate (bradycardia), fast heart rate (tachycardia), irregular heart rate (arrhythmia),
• nausea and vomiting,
• sweating,
• cramps,
• burning sensation at the injection site,

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +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, more information can be gathered on the safety of the medicine.

5. How to store Bexon

The medicine should be stored out of sight and reach of children. Store and transport at a refrigerated temperature (2°C - 8°C). Store in the original package to protect from light. Do not freeze. Do not use this medicine after the expiry date stated on the label and carton after: EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bexon contains

• The active substances of Bexon are thiamine hydrochloride, pyridoxine hydrochloride, and cyanocobalamin.

1 mL of the solution for injection contains:thiamine hydrochloride 50 mg, equivalent to 39.35 mg of thiamine (vitamin B1), pyridoxine hydrochloride 50 mg, equivalent to 41.15 mg of pyridoxine (vitamin B6), and cyanocobalamin 0.5 mg, equivalent to 0.49 mg of cobalamin (vitamin B12). 2 mL of the solution for injection contains:thiamine hydrochloride 100 mg, equivalent to 78.7 mg of thiamine (vitamin B1), pyridoxine hydrochloride 100 mg, equivalent to 82.3 mg of pyridoxine (vitamin B6), and cyanocobalamin 1 mg, equivalent to 0.98 mg of cobalamin (vitamin B12).

• The other ingredients are benzyl alcohol, lidocaine hydrochloride, sodium hydroxide (for pH adjustment), sodium polyphosphate, potassium hexacyanoferrate(III), and water for injections.

What Bexon looks like and contents of the pack

Bexon is a red, clear liquid with a characteristic odor. Bexon is available in packs containing 5 ampoules in a blister pack. One ampoule contains 2 mL of the solution for injection.

Marketing authorization holder and importer

Marketing authorization holder Aflofarm Farmacja Polska Sp. z o.o., ul. Partyzancka 133/151, 95-200 Pabianice, tel. (42) 22-53-100. Importer Farmak International Sp. z o.o., al. Piłsudskiego 141, 92-318 Łódź, Poland.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland: Bexon Date of last revision of the leaflet:19.02.2024 ------------------------------------------------------------------------------------------------------------------------

Additional information:

Vitamin B1regulates carbohydrate metabolism, which is particularly important for the metabolism of nerve fibers. Vitamin B6regulates the breakdown of proteins, fats, and carbohydrates. Vitamin B12is essential for cell metabolism, blood formation, and the functioning of the nervous system. It regulates the production of nucleic acids in the body, and thus the development of new cell nuclei.