Package Insert: Information for the User

Benadon 300 mg Film-Coated Tablets

Piridoxine Hydrochloride (Vitamin B6)

Read this package insert carefully before taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those given by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to 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 not listed in this package insert.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

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

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

Benadon 300 mg tablets are indicated for adults and adolescents over 14 years old.

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 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 take Benadon tablets.

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

Cases of dependence and withdrawal have been reported when taking vitamin B6 for a month at doses even lower (with 200 mg) than that contained in this medication.

Avoid exposure to the sun while taking this medication, as pyridoxine may cause photosensitivity (see section 4).

Interference with diagnostic tests

Inform your doctor if you are to undergo any diagnostic tests (including blood, urine, etc.) as this medication may alter the results.

Children and adolescents

Due to the dose contained, do not administer this medication to children and adolescents under 14 years old.

Other medications and Benadon tablets

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, it may be necessary to modify the dosage of one of them or discontinue treatment, as the effects of these medications may be modified by Benadon tablets:

• Altretamine (a medication used to treat certain types of cancer)
• Levodopa (a medication for Parkinson's disease)
• Fenobarbital, 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 its needs, including:

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

Theophylline (to prevent and treat wheezing)

Benadon tablets and alcohol

Excessive alcohol consumption reduces the absorption of vitamins.

Pregnancy, breastfeeding, and fertility

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

Benadon tablets are contraindicated during pregnancy and breastfeeding.

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

Driving and operating machinery

The influence of Benadon tablets 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.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 14 years:

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

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

Patients 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.

Generally, 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 your doctor.

Use in children and adolescents

Benadon tablets are contraindicated in children and adolescents under 14 years.

If you take more Benadon tablets than you should

If you take more Benadon tablets for a long time, you may suffer from nervous system disorders such as alterations or reduction of sensitivity, tingling, numbness in feet and hands, unstable gait, etc. In case of overdose, 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 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 or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested (or go to a medical center).

If you forgot to take Benadon tablets

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

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

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

Adverse effects reported are based on spontaneous notifications.

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 pyridoxine dependence and withdrawal syndrome.

Other gastrointestinal discomforts such as nausea, abdominal pain (with high doses), vomiting, and loss of appetite may also occur; skin effects such as 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 (rosacea); nervous system effects such as drowsiness, somnolence (in sensitive individuals), insomnia, and in very rare cases, with high doses, memory impairment may 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 of Pharmacovigilance for Human Use Medications: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Do not store above 86°F (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.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

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 (vegetal), povidone K-90, macrogol 6000, copolymer of methacrylic acid (1:1), sodium carboxymethylcellulose, and purified water.

Appearance of the product and contents of the packaging

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).

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

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

Last review date of this leaflet: August 2016.

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