NOTICE
ANSM - Updated: 17/01/2017
Name of the drug
CALAMINE THERICA GEL, gel for local application
Zinc oxide / Calamine
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have further questions, if you are not sure, ask your doctor or pharmacist for more information.
Keep this leaflet, you may need to read it again.
If you need more information and advice, talk to your pharmacist.
If the symptoms get worse or persist, consult a doctor.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Summary record
In this notice :
1. WHAT CALAMINE THERICA GEL, gel for topical application AND WHAT IT IS USED FOR
2. WHAT YOU SHOULD KNOW BEFORE USING CALAMINE THERICA GEL, gel for topical application?
3. HOW TO USE CALAMINE THERICA GEL, gel for local application?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE CALAMINE THERICA GEL, gel for local application?
6. ADDITIONAL INFORMATION
1. WHAT CALAMINE THERICA GEL, gel for topical application AND WHAT IT IS USED FOR
Pharmacotherapeutic class
SKIN PROTECTOR
(D. Dermatology)
Therapeutic indications
Adjunctive treatment of skin irritations.
2. WHAT YOU SHOULD KNOW BEFORE USING CALAMINE THERICA GEL, gel for topical application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use CALAMINE THERICA GEL, gel for topical application in the following cases:
· Allergy known to one of the constituents of the product, in particular allergy to quaternary ammoniums.
· Infected lesions.
· Oozing lesions.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST
Precautions for use; special warnings
Take special care with CALAMINE THERICA GEL, gel for local application:
Due to the presence of benzalkonium chloride, this drug may cause skin reactions.
IF IN DOUBT DO NOT HESITATE TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST
Interactions with other drugs
Taking or using other medicines:
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINES, YOU MUST SIGNALLY REPORT ANY OTHER TREATMENT IN PROGRESS TO YOUR DOCTOR OR PHARMACIST.
Interactions with food and drinks
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication should be used with caution during pregnancy and lactation.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with known effect : benzalkonium chloride.
3. HOW TO USE CALAMINE THERICA GEL, gel for local application?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
Apply 2 to 3 times a day in a thin layer on the surface to be treated. Let dry.
Method and route of administration
DERMAL
Symptoms and instructions in case of overdose
If you have used more CALAMINE THERICA GEL, a local application gel than you should have:
In case of overdose: rinse thoroughly with water.
Instructions for omitting one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, CALAMINE THERICA GEL, local application gel is likely to have side effects, although not everybody gets them:
In case of intolerance to one of the components of the gel, allergic reactions and eczema of contact are possible.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CALAMINE THERICA GEL, gel for local application?
Keep out of the reach and sight of children.
Expiration date
Do not use CALAMINE THERICA GEL, gel for local application after the expiry date which is stated on the outer carton.
Storage conditions
No special storage conditions.
If necessary, warn against some visible signs of deterioration
Medicines should not be thrown away with sewage or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does CALAMINE THERICA GEL contain, gel for local application?
Active substances are :
Zinc oxide ............................................... .................................................. ................................ 8,000 g
Calamine ................................................. .................................................. ...................................... 8,000 g
For 100 ml of gel for local application.
The other components are :
Benzalkonium chloride, sodium hydroxyethylcellulose, glycerol, purified water.
Pharmaceutical form and content
What is CALAMINE THERICA GEL, gel for topical application and contents of the pack?
This medicine is in gel form for local application; tube of 50 ml.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
LABORATORIES BAILLEUL SA
10-12 AVENUE PASTEUR
2310 Luxembourg
LUXEMBOURG
exploiting
BAILLEUL LABORATORIES
264, RUE DU FAUBOURG SAINT-HONOR É
75008 PARIS
Maker
THERICA LABORATORIES
15, AVENUE HENRY DUNANT
27400 LOUVIERS
Names of the medicine in the member states of the European Economic Area
Not applicable.
Date of approval of the notice
The last date this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps (France) website.
Information reserved for health professionals
Not applicable.
Other
Not applicable.