NOTICE
ANSM - Last updated: 28/06/2017
Name of the medicinal product
ALGESAL SURACTIVE, cream
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· If symptoms persist, worsen or new symptoms appear, seek advice from your pharmacist or doctor.
What is in this leaflet?
1. What is ALGESAL SURACTIVE, cream and in which cases it is used?
2. What should I know before using ALGESAL SURACTIVE, cream?
3. How to take ALGESAL SURACTIVE, cream?
4. What are the possible side effects?
5. How to keep ALGESAL SURACTIVE, cream?
6. Package contents and other information.
1. WHAT IS ALGESAL SURACTIVE, cream AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group - ATC code: M02AX10 - For analgesic (M. LOCOMOTEUR SYSTEM).
Local topical treatment of pain of muscular origin and tendon-ligament.
2. BEFORE YOU USE ALGESAL SURACTIVE, CREAM?
Never use ALGESAL SURACTIVE, 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.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR PHYSICIAN OR YOUR PHARMACIST.
Warnings and Precautions
Observe the instructions for use:
- Do not use on mucous membranes, eyes, oozing dermatosis, eczema, infected lesion or wound, or under occlusive dressing,
- Never apply a dose higher than recommended (see DOSAGE),
- Do not apply over an extended area of the body,
- Do not apply if breast-feeding,
- Respect the recommended frequency and duration of treatment.
After use, it is necessary to wash your hands to avoid any involuntary contact of the product with the eyes and the mucous membranes.
This medication contains castor oil and may cause severe allergic reactions.
This medicine contains cetyl alcohol and may cause local skin reactions (eg, eczema).
This specialty contains terpenic derivatives which can lead to excessive neurological convulsions in infants and children.
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.
Other medicines and ALGESAL SURACTIVE, cream
IN ORDER TO AVOID INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, YOU MUST SIGNAL SYSTEMATICALLY ANY OTHER TREATMENT IN PROGRESS TO YOUR DOCTOR OR YOUR PHARMACIST.
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 on the breasts.
Driving and using machines
Not applicable.
ALGESAL SURACTIVE, cream contains castor oil and cetyl alcohol.
3. HOW TO USE ALGESAL SURACTIVE, cream?
Dosage
RESERVED FOR ADULTS AND CHILDREN OF MORE THAN 7 YEARS.
In local massages on the painful area, 2 to 3 times a day, until complete penetration.
Wash hands after use.
Administration mode
Dermal.
Duration of treatment
Do not use for prolonged periods without medical advice.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Possible local allergic reaction requiring discontinuation of treatment.
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 ALGESAL SURACTIVE, cream?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of that month .
Store at a temperature of 25 ° C or lower.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What ALGESAL SURACTIVE contains, cream
· The active substances are:
Salicylic acid ................................................ .................................................. ........... 6.54 g
Diethylamine ................................................. .................................................. 3,46 g
Myrtecaïne ................................................. .................................................. .................. 1.00 g
For 100 g of cream.
· The other components are:
Excipients : Ethylene glycol monostearate, Light liquid paraffin, Cetyl alcohol, Polyoxyethylene castor oil, Macrogol 300 stearate, Saturated polyglycosylated glycerides, Glycerol monostearate, Lavandin composition *, Hydrochloric acid, Purified water.
* Composition of lavandin composition : Essential oil of lavandin grosso, essential oil and fractions of essential oil of eucalyptus of China, linalol, acetate of linalyl, racemic camphor.
What is ALGESAL SURACTIVE, cream and contents of the pack
This medication is in the form of a cream, in 40, 50 and 100 g tubes.
Marketing Authorization Holder
PHARMA DEVELOPMENT
CHEMIN DE MARCY
INDUSTRIAL ZONE
58800 CORBIGNY
Marketing Authorization Operator
PHARMA DEVELOPMENT
CHEMIN DE MARCY
INDUSTRIAL ZONE
58800 CORBIGNY
Maker
PHARMA DEVELOPMENT
CHEMIN DE MARCY
INDUSTRIAL ZONE
58800 CORBIGNY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Not applicable.