BENADON 300 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Benadon 300 mg Film-Coated Tablets

Pyridoxine Hydrochloride (Vitamin B6)

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Contents of the Package Leaflet

1. What Benadon 300 mg Tablets are and what they are used for
2. What you need to know before taking Benadon 300 mg Tablets
3. How to take Benadon 300 mg Tablets
4. Possible side effects
5. Storage of Benadon 300 mg Tablets
6. Package Contents and Additional Information

1. What Benadon 300 mg Tablets are and what they are used for

They contain pyridoxine as the active ingredient, which is vitamin B6, a water-soluble vitamin involved in many human metabolic processes.

It is indicated for: Treatment of vitamin B6 deficiency due to increased requirements, insufficient intake, and deficiency induced by certain medications.

Benadon 300 mg Tablets are indicated for adults and adolescents over 14 years of age.

2. What you need to know before taking Benadon 300 mg Tablets

Do not take Benadon Tablets

• 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).

• If you are pregnant or breastfeeding
• Children under 14 years of age
• If you have kidney or liver disease (renal and/or hepatic insufficiency).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Benadon Tablets.

Do not take a higher dose than indicated or for a longer period than indicated. The duration of treatment should not exceed two weeks. If your doctor has prescribed Benadon Tablets, the dosage and duration will be as prescribed by your doctor. With continuous administration and high doses of pyridoxine (vitamin B6) and when vitamin B6 is not taken as indicated, significant neurological side effects (tingling sensation, reduced sensitivity, gait disturbances, etc.) may occur (see section 4).

There have been cases of dependence and withdrawal when taking vitamin B6 for a month, even at doses lower (200 mg) than those contained in this medication.

You should avoid exposure to the sun while taking this medication, as pyridoxine can cause photosensitivity (see section 4).

Interference with Laboratory Tests

If you are going to have any diagnostic tests (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Children and Adolescents

Due to the dose it contains, do not administer this medication to children and adolescents under 14 years of age.

Other Medications and Benadon Tablets

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

If you are using any of the following medications, it may be necessary to modify the dose of one of them or interrupt treatment, as the effects of these medications may be altered by Benadon Tablets:

• Altretamine (a medication used to treat certain types of cancer)
• Levodopa (a medication for Parkinson's disease)
• Phenobarbital, phenytoin (medications for epilepsy)
• Amiodarone (for the heart) (may have a higher risk of photosensitivity)

Several medications interfere with pyridoxine and may reduce vitamin B6 levels or increase their needs, including:

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

Theophylline (to prevent and treat shortness of breath)

Taking Benadon Tablets with Alcohol

Excessive alcohol consumption decreases the absorption of vitamins.

Pregnancy, Breastfeeding, and Fertility

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

Benadon Tablets are contraindicated in pregnancy and breastfeeding

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

Driving and Using Machines

The influence of Benadon Tablets on the ability to drive and use machines is negligible or insignificant.

However, this medication may cause drowsiness in some patients, who should not drive and/or use machines during treatment.

3. How to Take Benadon 300 mg Tablets

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 14 years of age:

It is recommended to take half a tablet (150 mg of pyridoxine) per day.

At the doctor's discretion, they may indicate taking one tablet (300 mg of pyridoxine) per day.

Patient with renal or hepatic insufficiency:

Benadon Tablets are contraindicated in patients with renal or hepatic insufficiency.

Oral administration.

The tablet can be split in half and divided into equal doses.

The tablets should not be chewed and should be swallowed with sufficient water.

In general, treatment should not exceed two weeks, although the doctor may recommend administration for more than 15 days.

If symptoms worsen or do not improve after 7 days of treatment, you should consult a doctor.

Use in Children and Adolescents

Benadon Tablets are contraindicated in children and adolescents under 14 years of age.

If You Take More Benadon Tablets Than You Should

If you take more Benadon Tablets for a long time continuously, you may experience disorders of the nervous system, such as altered or reduced sensitivity, tingling, numbness in hands and feet, unsteady gait, etc. In case of overdose, among other effects, you may experience nausea, vomiting; also, increased sensitivity to sunlight (photosensitivity) with skin lesions such as redness, blisters; headache, drowsiness, lethargy, difficulty breathing.

In children, accidental ingestion of very high doses can also cause deep sedation and weakness.

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

If You Forget to Take Benadon Tablets

Do not take a double dose to make up for the forgotten dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Related side effects are based on spontaneous notifications.

A disorder characterized by reduced sensitivity, tingling sensation in arms and legs (paresthesia), gait disturbances, numbness in hands and feet, etc. may occur, especially with prolonged treatment and more frequently with high doses; these symptoms usually disappear when treatment is discontinued. It may occur that doses of 200 mg of pyridoxine per day for approximately 30 days can produce a pyridoxine dependence and withdrawal syndrome.

Gastrointestinal disorders, such as nausea, abdominal pain (with high doses), vomiting, and loss of appetite, may also occur; skin effects, such as photosensitivity, with lesions like blisters, hives, rash, redness, or itching; in very rare cases, a condition characterized by nodules and pus-filled grains on the face and neck (rosacea); nervous system effects, such as lethargy, drowsiness (in sensitive individuals), insomnia, and in very rare cases, with high doses, memory impairment may occur.

Reporting Side Effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Benadon 300 mg Tablets

Do not store above 30°C.

Keep this medication out of sight and reach of children.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE Point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Benadon 300 mg Tablets

• The active ingredient is Pyridoxine Hydrochloride (Vitamin B6). Each tablet contains 300 mg of pyridoxine hydrochloride.
• The other components (excipients) are: talc, magnesium stearate (vegetable), povidone K-90, macrogol 6000, methacrylic acid copolymer (1:1), sodium carboxymethylcellulose, and purified water.

Appearance of the Product and Package Contents

This medication is presented in the form of film-coated tablets, round, white, scored. The tablet can be divided into two equal halves.

Each package contains 20 film-coated tablets (in PVC-Aluminum blisters).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

TEOFARMA S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbene (Pavia) – Italy

Manufacturer

Delpharm Gaillard

Rue de l’Industrie 33

74240 Gaillard (France)

Or

DELPHARM EVREUX,

5 Rue du Guesclin,

27000 Evreux, France

Or

TEOFARMA S.r.l.

Viale Certosa, 8/A

27100 Pavia, Italy

Date of the Last Revision of this Package Leaflet: August 2016.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/