NOTICE
ANSM - Updated on: 16/02/2015
Name of the medicinal product
LUMBALGINE cream
Glycol Salicylate, Racemic Camphor, Benzyl Nicotinate, Levomenthol
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 your doctor.
· 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 LUMBALGINE, cream AND WHAT IT IS USED FOR?
2. WHAT TO DO ABOUT BEFORE USING LUMBALGINE, cream?
3. HOW TO USE LUMBALGINE, cream?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE LUMBALGINE, cream?
6. ADDITIONAL INFORMATION
1. WHAT IS LUMBALGINE, cream AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
With analgesic aim
(M. LOCOMOTEUR SYSTEM)
Therapeutic indications
Local topical treatment of muscle and tendon-ligament pain in adults.
2. WHAT TO DO ABOUT BEFORE USING LUMBALGINE, cream?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use LUMBALGINE, cream in the following cases:
· Allergy to salicylates, a related drug (NSAIDs, aspirin) or other components.
· Do not apply to mucous membranes, eyes, wounds, oozing lesions, infected lesions or occlusive dressings.
· History of epilepsy
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 LUMBALGINE, cream:
Special warnings
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 LUMBALGINE, cream ),
· do not apply over an extended surface of the body,
· respect the recommended frequency and duration of treatment.
This medicine contains castor oil and can cause skin reactions (eg eczema)
Precautions for use
This medication is for adults only.
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
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY 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 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 to the breasts.
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 a well-known effect: Castor oil.
3. HOW TO USE LUMBALGINE, cream?
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
Apply the cream on the painful area one or more times a day.
Wash hands after application.
Method and route of administration
CUTTING VOTE.
Massage gently until complete penetration.
Duration of treatment
Do not use for prolonged periods without medical advice.
Symptoms and Instructions for Overdose
If you take more LUMBALGINE, cream than you should:
In case of overdose: rinse thoroughly with water.
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, LUMBALGINE, cream is likely to have unwanted effects, although not everyone is subject to it.
Risk of allergic reaction to any of the components, necessitating discontinuation of therapy.
Possibility of normal erythematous skin reaction at the point of application.
In the case of non-compliance with recommended doses, agitation, confusion and somnolence may occur in elderly patients
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 LUMBALGINE, cream?
Keep out of the reach and sight of children.
Expiration date
Do not use LUMBALGINE, cream after the expiry date which is stated on the outer packaging.
Storage conditions
Store at a temperature not exceeding 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 LUMBALGINE contain, cream?
The active substances are:
Glycol Salicylate ............................................... .................................................. ......................... 10.00 g
Racemic Camphor ................................................ .................................................. ......................... 3.50 g
Benzyl Nicotinate ............................................... .................................................. ........................ 1.00 g
Levomenthol ................................................. .................................................. ................................... 1,00 g
For 100 g of cream.
The other components are:
Anionic emulsifying wax with sodium cetostearylsulfate and polyoxyethylenated castor oil 40, Octyldodecanol, Turpentine essential oil, Purified water.
Pharmaceutical form and content
What is LUMBALGINE, cream and contents of the pack?
This medication is in the form of a cream.
Tube of 50 or 90 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
FRENCH PHARMACEUTICAL COOPERATION
Place Lucien Auvert
77020 MELUN CEDEX
exploiting
Laboratories COOPERATION PHARMACEUTIQUE FRANCAISE
Place Lucien Auvert
77020 MELUN CEDEX
Maker
PHARMACEUTICAL CO ENGL AISE
2, rue de la Saussaie
77310 SAINT-FARGEAU-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 Ansm website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.