NOTICE
ANSM - Last updated: 26/11/2015
Name of the medicinal product
NICOBION 500 mg film-coated tablet
nicotinamide
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS NICOBION 500 mg film-coated tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE NICOBION 500 mg film-coated tablet?
3. HOW TO TAKE NICOBION 500 mg film-coated tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE NICOBION 500 mg film-coated tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS NICOBION 500 mg film-coated tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
VITAMIN PP
(A: digestive system and metabolism)
Therapeutic indications
This medication is indicated for the treatment of vitamin PP deficiency: pellagra.
2. BEFORE YOU TAKE NICOBION 500 mg film-coated tablet?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Do not take NICOBION 500 mg film-coated tablets in the following cases:
· allergy to any of the components of the tablet.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with NICOBION 500 mg film-coated tablet:
Special warnings
Since nicotinamide is metabolised in the liver, if you have liver problems, please tell your doctor.
Precautions for use
The use of this medication is not recommended in patients with galactose intolerance, lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interaction with other medicines
Taking or using other medicines:
IN ORDER TO AVOID POSSIBLE PROHIBITIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
In case of deficiency confirmed by your doctor, this medication can be taken during pregnancy.
The use of this medication should be avoided during breastfeeding.
Generally, during pregnancy and breast-feeding, you should always seek advice from your doctor or pharmacist before taking any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Excipient with a known effect: lactose.
3. HOW TO TAKE NICOBION 500 mg film-coated tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS.
Swallow without chewing with a little water, 1 to 2 tablets per day.
Method and route of administration
Oral use.
Duration of treatment
Follow your doctor's advice.
Symptoms and Instructions for Overdose
If you take more NICOBION 500 mg film-coated tablets than you should:
At very high doses, acute reversible hepatitis has been reported.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, NICOBION 500 mg film-coated tablets are likely to have side effects, although not everybody gets them.
The following adverse reactions have been reported when nicotinamide is administered orally at high doses and parenterally:
Skin and subcutaneous tissue disorders : flush, facial erythema
Gastrointestinal disorders : stomach pain, nausea, vomiting, diarrhea
Nervous system disorders : headache, dizziness
Hepatobiliary disorders : hepatitis
Investigations : elevation of transaminases
If you notice any side effects not listed in this leaflet, or if certain side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE NICOBION 500 mg film-coated tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use NICOBION 500 mg film-coated tablets after the expiry date which is stated on the outer packaging.
Storage conditions
Store at a temperature below 25 ° C and away from light.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does NICOBION 500 mg contain, film-coated tablets?
The active substance is :
Nicotinamide (vitamin PP) ............................................. .................................................. 500 mg
For a film-coated tablet.
The other components are :
Lactose monohydrate, povidone, corn starch, magnesium stearate, microcrystalline cellulose, hypromellose, macrogol 6000, titanium dioxide.
Pharmaceutical form and content
What is NICOBION 500 mg film-coated tablets and contents of the pack?
This medication is in the form of a film-coated tablet, film-coated tablets (Polyamide / Aluminum / PVC-Aluminum).
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
TEOFARMA SRL
VIA FRATELLI CERVI, 8
27010 VALLE SALIMBENE (PV)
ITALY
exploiting
TEOFARMA SRL
VIALE CETOSA 8 / A
27100 PAVIA (PV)
ITALY
Maker
TEOFARMA SRL
VIALE CERTOSA 8 / A
27100 PAVIA
ITALY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.