Benadon 300 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Benadon 300 mg film-coated tablets

Pyridoxine hydrochloride (Vitamin B6)

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the instructions for administration provided in this leaflet or those given by your doctor or pharmacist.

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

Contents of the 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 adverse effects
5. How to store Benadon 300 mg tablets
6. Contents of the pack and other information

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

It contains pyridoxine as the active substance, which is vitamin B6, a water-soluble vitamin involved in many processes of human metabolism.

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

Benadon 300 mg tablets are indicated in 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 to any of the other ingredients of this medicine (listed in section 6)
• If you are being treated with levodopa (a medicine used in Parkinson's disease)
• If you are pregnant or breastfeeding
• Children under 14 years of age
• If you have any kidney or liver disease (renal and/or hepatic insufficiency)

Warnings and precautions

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

You must not take a higher dose than indicated or for a longer period than recommended. The duration of treatment should not exceed two weeks. If your doctor has prescribed Benadon tablets, follow the dosage and duration as directed by your doctor. Prolonged administration and high doses of pyridoxine (vitamin B6), as well as use of vitamin B6 not in accordance with instructions, may lead to significant neurological adverse effects (tingling sensations, reduced sensitivity, disturbances in gait, etc.) (see section 4).

Cases of dependence and withdrawal have been reported after taking vitamin B6 for one month, even at doses lower (e.g., 200 mg) than that contained in this medicine.

You should avoid exposure to sunlight during treatment with this medicine, as pyridoxine may cause photosensitivity (see section 4).

Interference with laboratory tests

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

Children and adolescents

Due to the dose it contains, this medicine should not be administered to children and adolescents under 14 years of age.

Other medicines and Benadon tablets

Inform 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 the effects of these medicines may be altered by Benadon tablets:

• Altretamine (a medicine used to treat certain types of cancer)
• Levodopa (a medicine for treating Parkinson's disease)
• Phenobarbital, phenytoin (medicines for epilepsy)
• Amiodarone (for heart conditions) (may increase the risk of photosensitivity)

Several medicines interfere with pyridoxine and may reduce vitamin B6 levels or increase vitamin B6 requirements, including:

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

Theophylline (for preventing and treating wheezing)

Taking Benadon tablets with alcohol

Excessive alcohol intake reduces the absorption of vitamins.

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 taking this medicine.

Benadon tablets are contraindicated during pregnancy and breastfeeding.

Women of childbearing potential must use an effective method of contraception during treatment.

Driving and using machines

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

However, this medicine may cause drowsiness in some patients, who should therefore not drive and/or operate machinery during treatment.

3. How to take Benadon 300 mg tablets

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult 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) daily.

At the physician's discretion, a dose of one tablet (300 mg of pyridoxine) daily may be prescribed.

Patients with renal or hepatic impairment:

Benadon tablets are contraindicated in patients with renal or hepatic impairment.

Oral use.

The tablet may be divided in half and administered in equal doses.

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

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

If symptoms worsen or do not improve after 7 days of treatment, consult your 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 than prescribed over a prolonged period, 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, other possible effects include nausea, vomiting, photosensitivity (increased sensitivity to sunlight) with skin lesions such as redness and blisters, headache, drowsiness, lethargy, and breathing difficulties.

In children, accidental ingestion of very high doses may additionally cause profound sedation and weakness.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone number 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 a missed dose.

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.

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 (paraesthesias), disturbances in gait, numbness in feet and hands, etc.; generally, these symptoms disappear when treatment is discontinued. It may occur that doses of 200 mg of pyridoxine per day for approximately 30 days may 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; skin-related adverse effects such as photosensitivity, with lesions including vesicles, blisters, rash, urticaria, redness, or itching; very rarely, a condition characterized by nodules and pustules on the face and neck (rosacea); nervous system-related adverse effects such as lethargy, drowsiness (in sensitive individuals), insomnia, and very rarely, with high doses, memory impairment.

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 via the Spanish Pharmacovigilance System for Human Medicines: https://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 tablets

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 unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Benadon 300 mg tablets

• The active substance 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 medicine and contents of the pack

This medicine is presented as film-coated, round, white tablets with a breakline. The tablet can be divided into two equal parts.

Each pack contains 20 film-coated tablets (in PVC-aluminium blisters).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

TEOFARMA S.r.l.

Via F.lli Cervi, 8

27010 Valle Salimbeme (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 most recent revision of this leaflet: August 2016.

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/