Package leaflet: Information for the patient

Xanturenasi 300 mg tablets

Pyridoxine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Xanturenasi is and what it is used for
What you need to know before taking Xanturenasi
How to take Xanturenasi
Possible side effects
How to store Xanturenasi
Contents of the pack and other information

1. What Xanturenasi is and what it is used for

Xanturenasi is a medicine containing the active substance pyridoxine hydrochloride (Vitamin B6).
Xanturenasi is indicated for the treatment and prevention of disorders/diseases related to deficiency or insufficient levels of Vitamin B6.

2. What you need to know before taking Xanturenasi

Do not take Xanturenasi:
If you are allergic to pyridoxine hydrochloride or to any of the other ingredients of this
medicinal product (listed in section 6).
If you are taking medicines containing L-dopa (medicines used for the treatment of Parkinson's disease).

Warnings and precautions
Talk to your doctor or pharmacist before taking Xanturenasi.
Xanturenasi contains lactose:
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking
this medicinal product.

Other medicines and Xanturenasi
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take
any other medicines. The use of Xanturenasi must be avoided in patients being treated with L-dopa
(pharmacological substance used for the treatment of Parkinson's disease).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicinal product.
The use of this medicinal product is not recommended during breastfeeding.

Driving and using machines
Xanturenasi does not affect the ability to drive or operate machinery.

3. How to take Xanturenasi

Take this medicine exactly as stated in this leaflet or according to the instructions given by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 tablets per day.
If you take more Xanturenasi than you should:
Cases of overdose (excessive dosage) have not been reported.
In case of accidental ingestion or intake of an excessive dose of Xanturenasi, contact your doctor immediately or go to the nearest hospital.
If you forget to take Xanturenasi:
Do not take a double dose to make up for the missed dose.
If you stop treatment with Xanturenasi:
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
No significant adverse effects have been observed in humans. Rarely, non-specific skin reactions may occur.
Following the instructions provided in this leaflet helps reduce the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide further information on the safety of this medicine.

5. How to store Xanturenasi

Keep this medicine out of the sight and reach of children.
No special storage precautions are required for Xanturenasi.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Xanturenasi contains
One tablet contains:
Active substance: pyridoxine hydrochloride 300 mg.
Other components: corn starch, lactose, povidone, stearic acid, talc.
Description of the appearance of Xanturenasi and pack contents
Xanturenasi is supplied in a pack containing 10 white tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
TEOFARMA S.r.l. - Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l. - Viale Certosa, 8/A - 27100 Pavia