NOTICE
ANSM - Last updated: 17/11/2008
Name of the medicinal product
ARNICAN 4 PER CENT, 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 ARNICAN 4 PER CENT, cream AND WHAT IT IS USED FOR?
2. WHAT TO DO ABOUT BEFORE USING ARNICAN 4 PERCENT, cream?
3. HOW TO USE ARNICAN 4 PER CENT, cream?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ARNICAN 4 PER CENT, cream?
6. ADDITIONAL INFORMATION
1. WHAT IS ARNICAN 4 PER CENT, cream AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Plant-based medication.
Therapeutic indications
Traditionally used in the symptomatic treatment of bruising.
2. WHAT TO DO ABOUT BEFORE USING ARNICAN 4 PERCENT, cream?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use ARNICAN 4 PERCENT, cream:
This medicinal product should NOT be used in the following cases:
· Do not apply on mucous membranes, eyes, wound, oozing lesion, or infected lesion.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
This medicinal product MUST NOT BE USED, because of the presence of terpene derivatives in the formula, 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 ARNICAN 4 PER CENT, cream:
Special warnings
This specialty contains terpenic derivatives which can lead to excessive neurological convulsions in infants and children.
Observe the instructions for use:
· never apply a dose higher than recommended ( see Dosage ),
· do not apply over an extended surface of the body,
· respect the recommended frequency and duration of treatment.
This medicine contains "Parahydroxybenzoate" and may cause allergic reactions.
Precautions for use
After use, it is necessary to wash your hands to avoid any involuntary contact of the product with the eyes and the mucous membranes.
In case of epilepsy old or recent, REQUEST ADVICE TO YOUR DOCTOR.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Interaction with other medicines
Taking or using 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 - Breastfeeding
In general, during pregnancy and breast-feeding you should always seek advice from your doctor or pharmacist before taking any medicine.
In case of breast-feeding, it is preferable not to use this medication and in no case should it be applied on the breasts.
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:
Sodium methylated parahydroxybenzoate.
3. HOW TO USE ARNICAN 4 PER CENT, cream?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Apply in light massages until complete penetration.
Repeat 2 to 3 times per 24 hours.
Wash hands after application.
Method and route of administration
DERMAL
Frequency of Administration
2 to 3 times a day.
Duration of treatment
No prolonged use without medical advice.
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, ARNICAN 4 PERCENT, cream is likely to have undesirable effects, although not everyone is subject to it: especially skin allergy necessitating discontinuation of treatment.
DO NOT HESITATE TO REQUEST THE OPINION OF YOUR PHYSICIAN OR YOUR PHARMACIST AND REPORTED ANY EFFECT NOT DESIRED AND GENERATED WHICH IS NOT MENTIONED IN THIS PACKAGE .
Due to the presence of terpene derivatives and in case of non-respect of the recommended doses:
· risk of convulsions in children and infants,
· possibility of agitation, confusion in the elderly.
5. HOW TO STORE ARNICAN 4 PER CENT, cream?
Keep out of the reach and sight of children.
Expiration date
Do not use ARNICAN 4 PERCENT, cream after the expiry date stated on the carton.
Storage conditions
Store at a temperature of 25 ° C or lower.
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 ARNICAN contain 4 percent, cream?
The active substance is:
Arnica (extract from) ............................................ .................................................. ................................ 4,000 g
For 100 g of cream.
Other ingredients are: Vulnerable alcoholate, Ionone, Levomenthol, Essential oil of the matrix, essential oil of geranium rosat, essential oil reconstituted of neroli, essential oil of lavender, parahydroxybenzoate of soda methyl, oleate of macrogol (Labrafil M 1944 CS), stearate of emulsifiable ethylene glycol (Monthybase), purified water.
Pharmaceutical form and content
What is ARNICAN 4 PERCENT, cream and contents of the pack?
Cream, 15 or 50 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
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
Maker
FRENCH PHARMACEUTICAL COOPERATION
2 RUE DE LA SAUSSAIE
77310 PONTHIERRY
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.