Neiraxin® B

Package Leaflet: Information for the User

Neiraxin B, (100 mg/100 mg/1 mg/20 mg)/2 ml, Solution for Injection

Pyridoxine hydrochloride, Thiamine hydrochloride, Cyanocobalamin, Lidocaine hydrochloride

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• 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 those not listed in this package leaflet, tell your doctor or nurse. See section 4.

Package Leaflet Contents

• 1. What is Neiraxin B and what is it used for
• 2. Important information before using Neiraxin B
• 3. How to use Neiraxin B
• 4. Possible side effects
• 5. How to store Neiraxin B
• 6. Package contents and other information

1. What is Neiraxin B and what is it used for

The active substances of Neiraxin B are: pyridoxine hydrochloride (vitamin B6), thiamine hydrochloride (vitamin B1), cyanocobalamin (vitamin B12), lidocaine hydrochloride. Neiraxin B is used to treat hematological and neurological symptoms resulting from chronic deficiency of vitamins B6, B1, and B12 in adults and children over 12 years of age.

2. Important information before using Neiraxin B

When not to use Neiraxin B:

• if you are allergic to pyridoxine hydrochloride (vitamin B6), thiamine hydrochloride (vitamin B1), cyanocobalamin (vitamin B12), lidocaine hydrochloride, or any of the other ingredients of this medicine (listed in section 6);
• if you have severe heart conduction disorders and acute uncontrolled heart failure;
• during pregnancy and breastfeeding.

Due to the presence of benzyl alcohol, the medicine should not be administered to newborns, especially premature infants. The daily dose of benzyl alcohol should not exceed 90 mg: in children under 3 years of age, poisoning and anaphylactoid reactions may occur.

Warnings and precautions

The medicine should only be administered intramuscularly (i.m.), not intravenously (i.v.). In case of accidental intravenous administration, the patient will be monitored or hospitalized, depending on the severity of the symptoms.

Neiraxin B and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. The following medicines are particularly important:

• solutions containing sulfites (vitamin B1 decomposes in sulfite-containing solutions with acid. Other vitamins may be inactivated in the presence of vitamin B1 degradation products);
• isoniazid, cycloserine - used to treat tuberculosis;
• D-penicillamine - used to treat rheumatoid arthritis;
• epinephrine - used to treat severe allergies (anaphylactic reactions);
• norepinephrine - used to treat shock and low blood pressure;
• sulfonamides - antibiotics also used to treat inflammatory bowel diseases;
• levodopa - used to treat Parkinson's disease.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or nurse for advice before using this medicine. The safe daily dose of vitamin B6 during pregnancy and breastfeeding is 25 mg. Since the medicine contains 100 mg of vitamin B6 in one 2 ml ampoule, it should not be used during pregnancy and breastfeeding.

Driving and using machines

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

Neiraxin B contains benzyl alcohol, sodium, and potassium

Benzyl alcohol:

• The medicine contains 40 mg of benzyl alcohol in each ampoule, which corresponds to 20 mg/ml. Benzyl alcohol may cause allergic reactions.
• Do not administer to premature infants or newborns.
• The medicine may cause poisoning and allergic reactions in infants and children under 3 years of age.
• Ask your doctor or pharmacist for advice if you are pregnant, breastfeeding, or if you have liver or kidney disease, as a large amount of benzyl alcohol may accumulate in the body and cause side effects (metabolic acidosis). Sodium:
• The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free". Potassium:
• The medicine contains less than 1 mmol (39 mg) of potassium per dose, which means the medicine is considered "potassium-free".

3. How to use Neiraxin B

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor. The medicine should only be administered intramuscularly (i.m.), not intravenously (i.v.). In case of accidental intravenous administration, the patient will be monitored or hospitalized, depending on the severity of the symptoms. Your doctor will determine the correct dose for you and how often to administer it. Use in adults and children over 12 years of ageIn case of severe and acute symptoms, usually one injection (2 ml) is administered once a day to achieve high concentrations of the active substances in the blood. If the acute phase has passed, and in case of milder symptoms, one injection is administered 2-3 times a week. Elderly patientsNo dose adjustment is necessary. Children and adolescentsNeiraxin B solution for injection should not be used in children under 12 years of age. Instructions for opening the ampoule:

• 1) Turn the ampoule so that the colored dot is at the top. If some solution remains in the top part, gently tap with your fingers so that the solution flows to the bottom part of the ampoule.
• 2) To open the ampoule, use both hands; holding the lower part of the ampoule, break the upper part of the ampoule with the other hand, pressing in the opposite direction of the colored dot (see the diagram below).

Overdose of Neiraxin B

This medicine is administered under medical supervision, so it is unlikely that the dose of Neiraxin B will be too high or too low. If you think that the effect of Neiraxin B is too strong or too weak, talk to your doctor or nurse.

4. Possible side effects

Like all medicines, Neiraxin B can cause side effects, although not everybody gets them. The frequency of side effects is as follows: Rare(may affect up to 1 in 1,000 people)

• Allergic reactions (e.g., skin rash, respiratory arrest, anaphylaxis, angioedema) Benzyl alcohol: allergic reactions

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

• Rapid heartbeat (tachycardia)
• Excessive sweating, acne, skin reactions with itching and urticaria

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

• Dizziness, impaired consciousness
• Slow heartbeat (bradycardia), heart rhythm disorders
• Vomiting
• Seizures
• Systemic reactions, including stimulation and/or depression of the central nervous system (balance disorders, irritation, feeling of threat, euphoria, confusion, dizziness, impaired consciousness, tinnitus, blurred or double vision, vomiting, feeling of cold or heat, feeling of numbness) - may occur as a result of rapid administration (accidental intravenous injection, injection into well-perfused tissues), or as a result of overdose.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 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, you can help provide more information on the safety of this medicine.

5. How to store Neiraxin B

Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original package to protect from light. Keep the medicine out of the sight and reach of children. After opening, the contents of the package should be used immediately. Do not use this medicine after the expiry date stated on the carton after: expiry date (EXP). The expiry date refers to the last day of the month stated.

6. Package contents and other information

What Neiraxin B contains

• The active substances are pyridoxine hydrochloride (vitamin B6), thiamine hydrochloride (vitamin B1), cyanocobalamin (vitamin B12), lidocaine hydrochloride.

1 ml of solution for injection contains: 50 mg of pyridoxine hydrochloride, 50 mg of thiamine hydrochloride, 0.5 mg of cyanocobalamin, 10 mg of lidocaine hydrochloride. One ampoule (2 ml) contains: 100 mg of pyridoxine hydrochloride, 100 mg of thiamine hydrochloride, 1 mg of cyanocobalamin, 20 mg of lidocaine hydrochloride.

• The other ingredients are: benzyl alcohol, pentasodium triphosphate, sodium hydroxide (for pH adjustment), potassium hexacyanoferrate(III), water for injections.

What Neiraxin B looks like and contents of the package

Clear, red solution for injection (injection). Neiraxin B is packaged in brown glass ampoules with a capacity of 2 ml. 5 ampoules are packaged in a PVC insert. 1, 2, or 5 inserts are packaged in a cardboard box. Package sizes: 5, 10, or 25 ampoules. Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

AS KALCEKS Krustpils iela 71E 1057 Rīga Latvia Tel.: +371 67083320 E-mail: kalceks@kalceks.lv

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

Estonia Neiratax Latvia Neiratax 100 mg/100 mg/1 mg/20 mg/2 ml šķīdums injekcijām Lithuania Neiratax 100 mg/100 mg/1 mg/20 mg/2 ml injekcinis tirpalas Czech Republic Neiraxin Hungary Neiratax 100 mg/100 mg/1 mg/20 mg/2 ml oldatos injekció Bulgaria Neiraxin B 100 mg/100 mg/1 mg/20 mg/2 ml инжекционен разтвор Poland Neiraxin B Slovakia Neiraxin Romania Neiraxin soluţie injectabilă Netherlands Neiraxin 100 mg/100 mg/1 mg/20 mg/2 ml oplossing voor injectie

Date of last revision of the package leaflet: 05/05/2022