Nebiotin

Package leaflet: Information for the patient

NEBIOTIN

5 mg tablets
Biotin
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you notice worsening of symptoms after a few days.

Contents of this leaflet:

1. What NEBIOTIN is and what it is used for
2. What you need to know before taking NEBIOTIN
3. How to take NEBIOTIN
4. Possible side effects
5. How to store NEBIOTIN
6. Contents of the pack and other information

1. What NEBIOTIN is and what it is used for

NEBIOTIN contains the active substance biotin, a vitamin essential for the body as it is involved in the development and growth of the organism and in the metabolism of fats, sugars, and amino acids.
This medicinal product is indicated for the treatment of conditions associated with biotin deficiency (deficiency states).
If any of the side effects worsen or you do not feel better, consult your doctor.

2. What you need to know before taking NEBIOTIN

Do not take NEBIOTIN

• if you are allergic to biotin, to similar substances (chemically related) or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Consult your doctor or pharmacist before taking NEBIOTIN. Other medicines and NEBIOTIN Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. NEBIOTIN and food Do not consume raw eggs during treatment with this medicine, because raw egg white contains avidin, a substance that renders biotin ineffective.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding
with breast milk, consult your doctor or pharmacist before taking this
medicine.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to take NEBIOTIN

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take 3-4 tablets daily, swallowing them with water.

If you take more NEBIOTIN than you should
Cases of overdose are not known.
In case of accidental ingestion/overdose of NEBIOTIN, contact your doctor immediately or go to the nearest hospital.

If you forget to take NEBIOTIN
Do not take a double dose to make up for the missed tablet.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions may occur:
Very rare (may affect up to 1 in 10,000 people):

• allergic reactions such as skin irritations (erythematous or urticarial skin manifestations).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at the following website:
www.agenziafarmaco.gov.it/it/responsabili .
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store NEBIOTIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container following "Exp.".
The expiry date refers to the last day of that month.
Store below 25°C.
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 NEBIOTIN contains

• The active substance is biotin. Each tablet contains 5 mg of biotin.
• The other components are: sodium stearate, rice starch. Description of the appearance of NEBIOTIN and contents of the pack Carton pack containing 30 tablets.

Marketing Authorization Holder
DIFA COOPER S.P.A.
Via Milano, 160 – 21042 Caronno Pertusella - Varese (VA)
Manufacturer
LA.FA.RE. S.r.l. – Via Sac. Benedetto Cozzolino, 77 – 80056 Ercolano (NA) – Italy