Bexon

Package leaflet: Information for the patient

Bexon, 50 mg/mL + 50 mg/mL + 0.5 mg/mL, solution for injection
Thiamini hydrochloridum + Pyridoxini hydrochloridum + Cyanocobalaminum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

Bexon is a vitamin preparation containing three B-group vitamins: vitamin B₁ (thiamine),
vitamin B₆ (pyridoxine), and vitamin B₁₂ (cyanocobalamin).
Bexon is used in the treatment of nervous system disorders associated with confirmed
deficiency of vitamins B₁, B₆, and B₁₂, which cannot be corrected by dietary changes:

Supportive treatment of nervous system disorders of various etiologies:

• neuropathic pain of various causes (e.g., postherpetic neuralgia);
• radicular syndromes;
• lumbosacral syndrome;
• sciatica;
• polyneuropathy (e.g., diabetic or alcoholic);
• optic neuritis;
• facial nerve palsy;
• carpal tunnel syndrome.

Treatment of clinical and subclinical deficiencies of B-complex vitamins, including:

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

2. Important information before using Bexon

When not to use Bexon:

• if the patient is allergic to thiamine hydrochloride (vitamin B₁), pyridoxine hydrochloride (vitamin B₆), cyanocobalamin (vitamin B₁₂), or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe conduction disorders of the heart (i.e. when electrical impulses stimulating the heart spread abnormally);
• if the patient suffers from acute congestive heart failure;
• during pregnancy or breastfeeding;
• in children under 12 years of age, because the medicine contains benzyl alcohol and high doses of vitamins.

Warnings and precautions
Before starting treatment with Bexon, discuss it with your doctor or pharmacist.
Bexon must be administered only by intramuscular injection. It must not be used intravenously. If Bexon is accidentally administered intravenously, the patient's condition must be closely monitored by a doctor.
If this medicine is used for longer than 6 months, nerve damage (neuropathy) may occur. Symptoms of neuropathy include: tingling, numbness, or burning sensations in the feet and hands. Inform your doctor if any of these symptoms occur.
Elderly patients
No special precautions are required for elderly patients.
Bexon with other medicines
Inform 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 particularly important to inform your doctor about the use of the following medicines:

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

Pregnancy and breastfeeding
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.
Due to the amount of active substances contained, this medicine may be used during pregnancy and breastfeeding only if deficiency of vitamins B₁ and B₆ is confirmed. Bexon should not be used during pregnancy or breastfeeding unless the doctor considers it absolutely necessary.
Driving and operating machinery
Bexon has no effect or has a negligible effect on the ability to drive and operate machinery.
Bexon contains benzyl alcohol, sodium, and potassium.
Benzyl alcohol
The medicine contains 40 mg of benzyl alcohol in each dose (2 mL).
Benzyl alcohol may cause allergic reactions.
Patients with liver or kidney disease should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).
Sodium
The medicine contains 11.41 mg of sodium in each dose (2 mL).
The medicine contains less than 1 mmol (23 mg) of sodium per dose (2 mL), meaning the medicine is considered "sodium-free".
Potassium
The medicine contains 0.07 mg of potassium in each dose (2 mL).
The medicine contains less than 1 mmol (39 mg) of potassium per dose (2 mL), meaning the medicine is considered "potassium-free".

3. How to use Bexon

This medicine should always be used as directed by the physician. In case of doubt, consult your doctor.

Recommended dose:

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

Method of administration
Bexon solution for injection is administered by deep intramuscular injection. This medicine must not be used in any other way! (see also: "Warnings and precautions").

Duration of treatment
The duration of treatment will be determined by the physician based on weekly assessment of the patient's condition.
As soon as possible, the physician will recommend switching from Bexon to oral vitamin B complex supplements.

Overdose of Bexon
If the patient has accidentally received an excessive dose of Bexon and feels unwell, seek immediate medical advice from a doctor.

Discontinuation of Bexon treatment
Do not discontinue treatment without first consulting your doctor. If the patient stops using Bexon too early, symptoms may recur.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, treatment with Bexon must be discontinued and you should contact your doctor immediately. Rapid treatment may be necessary.

Rare (may occur in less than 1 in 1,000 people):

• severe reactions of an allergic type (anaphylactoid reactions) caused by benzyl alcohol.

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

• allergic reactions such as rash, shortness of breath, shock, swelling of hands, feet or ankles, face, lips, tongue and (or) throat with difficulty swallowing or breathing (angioedema),
• skin reactions including itching and urticaria,
• acne,
• dizziness,
• drowsiness,
• slow heartbeat (bradycardia), fast heartbeat (tachycardia), irregular heartbeat (arrhythmia),
• vomiting,
• sweating,
• convulsions,
• burning sensation at the injection site,
• if this medicine has been accidentally injected into a blood vessel or an excessive dose has been administered, the following adverse reactions may occur: dizziness, vomiting, slow or irregular heartbeat, drowsiness, convulsions.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Bexon

Keep the medicine out of the sight and reach of children.
Store and transport in a refrigerated condition (2°C - 8°C).
Store in the original packaging 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Bexon contains

• The active substances in this medicine are thiamine hydrochloride, pyridoxine hydrochloride and cyanocobalamin.

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

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

What Bexon looks like and contents of the pack
Bexon is a red, clear liquid with a characteristic odour.
Bexon is available in packs containing 5 ampoules in a blister.
Each ampoule contains 2 mL of injection solution.

Marketing Authorisation Holder and Importer
Marketing Authorisation 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.
ul. Chełmżyńska 249
04-458 Warszawa

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Poland: Bexon

Additional information:
Vitamin B_ regulates carbohydrate breakdown, which is particularly important for nerve fibre metabolism.
Vitamin B_ regulates the metabolism of proteins, fats and carbohydrates.
Vitamin B_ is essential for cellular metabolism, normal blood formation and nervous system function. It regulates the production of nucleic acids in the body, and thus the development of new cell nuclei.