NOTICE
ANSM - Last updated: 21/02/2011
Name of the medicinal product
CREME OF DALIBOUR COOPER, cream
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 IS CREAM OF DALIBOUR COOPER, cream AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE CREAM OF DALIBOUR COOPER, cream?
3. HOW TO USE CREAM OF DALIBOR COOPER, cream?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE CREAM OF DALIBOR COOPER, cream?
6. ADDITIONAL INFORMATION
1. WHAT IS CREAM OF DALIBOUR COOPER, cream AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
SKIN PROTECTOR.
(D. Dermatology).
Therapeutic indications
Additional treatment of skin irritations.
2. BEFORE YOU USE CREAM OF DALIBOUR COOPER, cream?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use DALIBOUR COOPER cream in the following cases:
· child under 30 months of age,
· allergy known to one of the constituents (wool fat or lanolin, etc.),
· infected lesions,
· oozing lesions.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Due to the presence of terpene derivatives, this medicinal product MUST NOT BE USED in the following cases:
· infants under 30 months of age,
· children with seizures due to fever or not.
Precautions for use; special warnings
Take special care with CREME DE DALIBOUR COOPER, cream:
This specialty contains terpenic derivatives which can lead to excessive doses of neurological convulsion-like symptoms in infants and children.
Observe the instructions for use:
· never apply a dose higher than recommended ( see How to use CREAM OF DALIBOR COOPER, cream ),
· do not apply over an extended surface of the body,
· respect the recommended frequency and duration of treatment.
In case of epilepsy old or recent, REQUEST ADVICE TO YOUR DOCTOR.
Interaction with other medicines
Taking other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or 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 breast-feeding, it is preferable not to use this medication and in no case should it be applied on the breasts.
ASK YOUR DOCTOR OR YOUR PHARMACIST BEFORE TAKING ALL MEDICINAL PRODUCTS.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Important information about some of the ingredients of CREME DE DALIBOUR COOPER, cream
List of excipients with a known effect: Wool grease.
3. HOW TO USE CREAM OF DALIBOR COOPER, cream?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
2 to 3 applications per day.
Method and route of administration
DERMAL.
Symptoms and Instructions for Overdose
If you used more CREAM OF DALIBOR COOPER, cream than you should:
In the event of overdose, there is a risk of neurological convulsions in infants and children, and agitation and confusion in the elderly.
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, CREME DE DALIBOUR COOPER, cream is likely to have undesirable effects, although not everyone is subject to it: especially risk of allergy to one of the constituents (wool fat or lanolin, ...).
Due to the presence of terpene derivatives and in case of non-respect of the recommended doses:
· risk of convulsions in infants and children,
· possibility of agitation, confusion in the elderly.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE CREAM OF DALIBOR COOPER, cream?
Keep out of the reach and sight of children.
Expiration date
Do not use CREME DE DALIBOUR COOPER, cream after the expiry date which is stated on the outer packaging.
Storage conditions
Store at a temperature below 25 ° C.
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 CREME DE DALIBOUR COOPER, cream?
The active substances are:
Copper sulfate ............................................... .................................................. ............................... 0.10 g
Sulphate of zinc ............................................... .................................................. .................................. 0.35 g
Zinc oxide ............................................... .................................................. ................................ 10.00 g
Racemic Camphor ................................................ .................................................. ......................... 0.10 g
For 100 g of cream.
The other components are:
Purified water, wool grease, Vaseline.
Pharmaceutical form and content
What is CREME DE DALIBOUR COOPER, cream and contents of the pack?
This medication is in the form of a cream, 20 g tube.
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
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
exploiting
LABORATORIES FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Maker
LIPHA LABORATORIES
115, AVENUE LACASSAGNE
69003 LYON
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.