Package Insert: Information for the User

Benadon 300 mg Injectable Solution

Piridoxine Hydrochloride (Vitamin B6)

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contains Pyridoxine, vitamin B6, a water-soluble vitamin that is involved in many human metabolism processes.

Benadon injectable solution is indicated for:

- Medication-induced vitamin B6 deficiency.

- Treatment of vitamin B6 deficiency states, such as those due to increased requirements or insufficient intake.

Benadon injectable solution is indicated for adults 14 years of age and older.

Do not use Benadon injectable solution

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

Due to the high dose it contains, Benadon should not be used:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Benadon injectable solution.

- Do not take a higher dose than recommended or for a longer period than indicated. Continuous administration and high doses of pyridoxine may cause significant neurological side effects (tingling sensation, reduced sensitivity, etc.) (see““If you take more Benadon than you should””in section 3).

- Cases of dependence and withdrawal have been reported when taking daily doses of vitamin B6, even lower than the dose contained in this medication, for a month.

- You should avoid exposure to the sun, as pyridoxine may cause photosensitivity, with skin symptoms such as rashes or blisters.

- Whenever possible, the preferred route of administration for this medication will be oral (with another oral medication). Otherwise, intramuscular, administered by a qualified healthcare professional as slowly as possible.

Interference with diagnostic tests

If you are to undergo any diagnostic test (including blood, urine, skin tests that use allergens, etc. …), inform your doctor that you are being treated with this medication, as it may alter the results.

Children

This medication is contraindicated in children under 14 years old.

Use of Benadon with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

If you are using any of the following medications, you may need to modify the dose of one of them or interrupt treatment, as their effects may be modified by Benadon injectable:

• Altretamine (used to treat cancer)
• Levodopa (for Parkinson's disease)
• Fenobarbital, phenytoin (for epilepsy)
• Amiodarone (for the heart).

Several medications interfere with pyridoxine (vitamin B6) and may reduce its levels, including:

• Tuberculosis antibiotics: (isoniazid, cycloserine, ethionamide, pyrazinamide)
• Hidralazine (for hypertension)
• Penicillamine (for rheumatic diseases)
• Oral contraceptives
• Immunosuppressants, such as corticosteroids.
• Alcohol

Use of Benadon injectable solution with alcohol

Excessive alcohol consumption reduces the absorption of vitamins.

Pregnancy, breastfeeding, and fertility

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

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

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

Driving and operating machinery

The influence of Benadon injectable solution on the ability to drive and operate machinery is negligible or insignificant.

However, this medication may cause drowsiness in a few patients, who should not drive and/or operate machinery during treatment.

Benadon 300 mg injectable solution contains:

This medication contains less than 23 mg (1 mmol) of sodium per 2 ml vial, making it essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

The recommended dose is:

Intramuscular route.

Adults and patients over 14 years old

When absorption is clearly impaired or in the case of severe B6 vitamin deficiency treatment, thedaily dose is 1 vial per day(which corresponds to 2 ml of injectable solution containing 300 mg of Vitamin B6)given intramuscularly.

In the case of medication-induced deficiency, it is recommended to administer 1 vial (300 mg) every 2 days for 3 weeks.

As a maintenance dose, your doctor will indicate a lower dose with another medication given orally.

TheBenadon treatment in general should not exceed two weeks, although at the doctor's discretion,depending on the indication, it could be prolonged for a longer period.

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

Patients with renal or hepatic insufficiency

Benadoninjectable solution is contraindicated in patients with renal or hepatic insufficiencydue to the high dose of vitamin B6 it contains.

Use in children

Benadoninjectable solution is contraindicated in children under 14years old(see“Do not use Benadon injectable solution”, in the section 2).

Using more Benadon injectable solution than you should

Using more than the recommended dose may cause nervous system disorders such as alterations or reduction of sensitivity, tingling, numbness in feet and hands, etc. In case of overdose, depending on the dose, among other effects, you may experience nausea, vomiting; also, photosensitivity with skin lesions such as redness, blisters; headache, drowsiness, lethargy, respiratory difficulty.

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

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

Missing a dose of Benadon injectable solution

Do not use a double dose to compensate for the missed dose.

Stopping treatment with Benadon injectable solution

If you have any other questions about the use of thismedication, ask your doctor or pharmacist.

Like all medications,thismedication may produceadverse effects, although not all people will experience them.

Adverse effects reported are based on spontaneous notifications, and it is not possible to estimate their frequency.

Prolonged treatment and higher doses may cause a disorder characterized by, among other symptoms, reduced sensitivity,tingling sensation in arms and legs (paresthesias), changes in gait, numbness in feet and hands, etc.; these symptoms generally disappear when treatment is discontinued. Doses of 200 mg of pyridoxine per day for approximately 30 days may cause a dependence and withdrawal syndrome from pyridoxine.

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

Skin may exhibit photosensitivity, with lesions such as vesicles, blisters, rash, urticaria, redness, or itching; in very rare cases, a condition characterized by nodules and pus-filled pimples on the face and neck may occur.

Adverse effects on the nervous system, such as drowsiness, somnolence (in sensitive individuals), insomnia; memory impairment (with high doses) may also occur.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication

Do not store at a temperature above 30°C.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.Ask your pharmacist how to dispose ofthe packaging and medications you no longerneed.By doing so, you will help protect the environment.

The administration of the medication and the handling of needles should be done with caution.

Composition of Benadon 300 mg injectable solution

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

Appearance of the product and contents of the packaging

This medication is presented in the form of an injectable solution, transparent, colorless to slightly yellowish, in glass vials of 2 ml.

Each package contains 6 vials.

- Other presentations:

Benadon 300 mg film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

TEOFARMA S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbeme (Pavia) – Italy

Responsible for manufacturing

CENEXI SAS

Rue Marcel and Jacques Gaucher, 52.

F-94120 Fontenay Sous Bois (France)

Last review date of this leaflet:September 2014.

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/