NOTICE
ANSM - Last updated: 07/01/2016
Name of the medicinal product
ELGYDIUM toothpaste
Calcium carbonate / chlorhexidine (digluconate)
framed
Read this leaflet carefully before you start using 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 ELGYDIUM, toothpaste and WHAT IT IS USED FOR?
2. BEFORE YOU USE ELGYDIUM, toothpaste?
3. HOW TO USE ELGYDIUM, toothpaste?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ELGYDIUM, toothpaste?
6. ADDITIONAL INFORMATION
1. WHAT ELGYDIUM, toothpaste and WHAT IT IS USED FOR?
Pharmacotherapeutic group
Not applicable.
Therapeutic indications
· gingivitis, periodontopathies
· prevention of caries by bactericidal action on plaque
2. BEFORE YOU USE ELGYDIUM, toothpaste?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use ELGYDIUM toothpaste if:
· allergy to chlorhexidine or any of the other ingredients.
IN CASE OF DOUBT IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DENTIST OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with ELGYDIUM, toothpaste :
Do not swallow.
This medicine contains parahydroxybenzoates and may cause allergic reactions.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE OPINION OF YOUR DENTIST OR YOUR PHARMACIST.
Interaction with other medicines
Taking or using other medicines
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMICALLY OF ANY OTHER TREATMENT IN PROGRESS TO YOUR DENTIST OR TO YOUR PHARMACIST.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy - breastfeeding
This medication, under normal conditions of use, may be used during pregnancy and lactation.
In general, you should seek advice from your dentist 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
Excipients with a known effect : methyl and propyl parahydroxybenzoates.
3. HOW TO USE ELGYDIUM, toothpaste?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Carry out daily after each meal a careful brushing of all dental surfaces, taking care to:
· brush all surfaces of all teeth preferably from the gum to the tip of the tooth,
· rinse thoroughly with water.
Careful brushing takes about 3 minutes ( see diagram at the end of the Notice ).
Symptoms and Instructions for Overdose
Not applicable.
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, this medicine may cause side effects, although not everybody gets them.
· due to the presence of parahydroxybenzoates, possibility of allergic reactions (see section "Take special care with ELGYDIUM, toothpaste").
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr . By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE ELGYDIUM, toothpaste?
Keep out of the reach and sight of children.
Expiration date
Do not use ELGYDIUM, toothpaste after the expiry date stated on the outer packaging.
Storage conditions
No special storage conditions.
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 ELGYDIUM contain toothpaste?
The active substances are :
Chlorhexidine Digluconate ............................................... .................................................. ........... 0.004 g
Calcium carbonate ............................................... .................................................. .......................... 25 g
For 100g of toothpaste
The other components are :
Pure sodium Lauryl sulfate, glycerol, colloidal silica, amorphous hydrated precipitated silica, carrageenate, sodium carboxymethyl cellulose, titanium oxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate, sodium saccharinate, artificial flavor, potable water.
Pharmaceutical form and content
What is ELGYDIUM, toothpaste and contents of the pack?
This medication is in the form of a toothpaste; 4 g, 8 g, 50 g, 100 g or 150 g.
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
Pierre FABRE MEDICAMENT
45, place Abel Gance
92100 Boulogne BILLANCOURT
exploiting
Laboratories PIERRE FABRE MEDICAMENT
45, Place Abel Gance
92100 Boulogne BILLANCOURT
Maker
To complete
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.