Benadon 300 mg solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Benadon 300 mg injection solution

Pyridoxine hydrochloride (Vitamin B6)

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• 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 only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Benadon 300 mg injection solution is and what it is used for
2. What you need to know before using Benadon 300 mg injection solution
3. How to use Benadon 300 mg injection solution
4. Possible side effects
5. How to store Benadon 300 mg injection solution
6. Contents of the pack and other information

1. What Benadon 300 mg injectable solution is and what it is used for

It contains Pyridoxine, vitamin B6, a water-soluble vitamin involved in many processes of human metabolism.

Benadon injectable solution is indicated for:

• Drug-induced vitamin B6 deficiency.
• Treatment of vitamin B6 deficiency states, such as those due to increased requirements or inadequate intake.

Benadon injectable solution is indicated in adults over 14 years of age.

2. What you need to know before using Benadon 300 mg injection solution

Do not use Benadon injection solution

• if you are allergic to pyridoxine or to any of the other ingredients of this medicine (listed in section 6).
• if you are being treated with levodopa (a medicine used for Parkinson's disease).

Due to its high dose, Benadon must not be used:

• if you are pregnant or breastfeeding
• in children under 14 years of age
• if you have any kidney or liver disease (renal and/or hepatic impairment).

Warnings and precautions

Talk to your doctor or pharmacist before using Benadon injection solution.

• Do not take a higher dose than recommended or for longer than indicated. Serious neurological adverse effects (such as tingling sensations, reduced sensitivity, etc.) may occur with prolonged administration and high doses of pyridoxine (see section 3, “If you use more Benadon than you should”).
• Cases of dependence and withdrawal have been reported after taking daily doses of vitamin B6 for one month, even at doses lower than that contained in this medicine.
• Avoid exposure to sunlight, as pyridoxine may cause photosensitivity, with skin symptoms such as rash or blisters.
• Whenever possible, the preferred route of administration for the indications of this medicine is oral (using an oral formulation). Otherwise, intramuscular administration should be used, given by a qualified healthcare professional as slowly as possible.

Interference with laboratory tests

If you are due to have any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), inform your doctor that you are being treated with this medicine, as it may alter test results.

Children

This medicine is contraindicated in children under 14 years of age.

Using Benadon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are taking any of the following medicines, it may be necessary to adjust the dose or discontinue treatment, as their effects may be altered by Benadon injection:

• Altretamine (used to treat cancer)
• Levodopa (for Parkinson's disease)
• Phenobarbital, phenytoin (for epilepsy)
• Amiodarone (for heart conditions)

Several medicines interfere with pyridoxine (vitamin B6) and may reduce levels of this vitamin, including:

• Antibiotics for tuberculosis: (isoniazid, cycloserine, ethionamide, pyrazinamide)
• Hydralazine (for hypertension)
• Penicillamine (for rheumatic diseases)
• Oral contraceptives
• Immunosuppressants, such as corticosteroids
• Alcohol

Using Benadon injection solution with alcohol

Excessive alcohol intake reduces vitamin absorption.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine is contraindicated during pregnancy and breastfeeding (see “Do not use Benadon injection solution” in section 2).

Women of childbearing age must use an effective contraceptive method during treatment.

Driving and using machines

The effect of Benadon injection on the ability to drive and operate machinery is none or negligible.

However, this medicine may cause drowsiness in some patients, who should therefore avoid driving and/or operating machinery during treatment.

Benadon 300 mg injection solution contains:

This medicine contains less than 23 mg (1 mmol) of sodium per 2 ml vial and is therefore considered essentially "sodium-free".

3. How to use Benadon 300 mg injection solution

Follow exactly the instructions for the administration of this medicine as given by your doctor. If in doubt, consult your doctor again.

The recommended dose is:

Intramuscular route.

Adults and patients over 14 years of age

When absorption is clearly impaired or in the case of treatment for severe vitamin B6 deficiency, the usual daily dose is 1 vial per day (corresponding to 2 ml of injection solution containing 300 mg of Vitamin B6) administered by intramuscular route.

In cases of drug-induced deficiency, administration of one vial (300 mg) every two days for 3 weeks is recommended.

As maintenance dose, your doctor will prescribe a lower dose using another medicine taken orally.

Treatment with Benadon should generally not exceed two weeks, although at the physician’s discretion, depending on the indication, it may be prolonged for a longer period.

The solution must be administered by a qualified healthcare professional as slowly as possible.

Patients with renal or hepatic impairment

Benadon injection solution is contraindicated in patients with renal or hepatic impairment due to the high dose of vitamin B6 it contains.

Use in children

Benadon injection solution is contraindicated in children under 14 years of age (see “Do not use Benadon injection solution” in section 2).

If you use more Benadon injection solution than you should

If you use more than the recommended dose, you may experience nervous system disorders such as altered or reduced sensitivity, tingling, numbness in feet and hands, etc. In case of overdose, depending on the dose, you may also experience nausea, vomiting, increased sensitivity to sunlight (photosensitivity) with skin lesions such as redness, blisters, headache, drowsiness, lethargy, and breathing difficulties.

In children, accidental administration of very high doses may additionally cause deep sedation and weakness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested (or go to a medical center).

If you forget to use Benadon injection solution

Do not use a double dose to make up for a missed dose.

If you stop treatment with Benadon injection solution

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

The reported adverse effects are based on spontaneous reports, making it impossible to estimate their frequency.

With prolonged treatment, and more frequently with high doses, a disorder may occur characterized, among other symptoms, by reduced sensitivity, tingling sensations in arms and legs (paresthesias), disturbances in gait, numbness in feet and hands, etc.; generally, these symptoms disappear when treatment is discontinued. It may also occur that doses of 200 mg of pyridoxine per day for approximately 30 days lead to a pyridoxine dependence and withdrawal syndrome.

Gastrointestinal disturbances may also occur, such as nausea, abdominal pain (with high doses), vomiting, and loss of appetite.

In the skin, photosensitivity may appear, with lesions such as vesicles, blisters, rash, urticaria, redness, or itching; very rarely, a condition characterized by nodules and pustules on the face and neck.

Nervous system adverse effects such as lethargy, drowsiness (in sensitive individuals), and insomnia may occur; memory impairment (with high doses) could also appear.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish System of Pharmacovigilance for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Benadon 300 mg injectable solution

Do not store at temperatures above 30°C.

Keep this 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 indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

Administration of the medicine and handling of needles must be carried out with caution.

6. Contents of the pack and other information

Composition of Benadon 300 mg injectable solution

• The active substance is Pyridoxine hydrochloride (Vitamin B6). Each ml of injectable solution contains 150 mg of pyridoxine hydrochloride. Each 2 ml ampoule contains 300 mg of pyridoxine hydrochloride.
• The other components (excipients) are: edetate disodium, sodium metabisulfite, sodium hydroxide, water for injections, and low-oxygen nitrogen.

Appearance of the medicinal product and contents of the pack

This medicine is presented as a clear, colourless to slightly yellowish injectable solution in 2 ml glass vials.

Each pack contains 6 vials.

• Other presentations:

Benadon 300 mg film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

TEOFARMA S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbeme (Pavia) – Italy

Manufacturer

CENEXI SAS

Rue Marcel and Jacques Gaucher, 52.

F-94120 Fontenay Sous Bois (France)

Date of the most recent revision of this leaflet: September 2014.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/