NOTICE
ANSM - Updated on : 24/08/2023
Product name
ARTENSIUM, cream
Sidebar
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any 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.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is ARTENSIUM cream and what is it used for?
2. What do I need to know before using ARTENSIUM cream?
3. How do I use ARTENSIUM, cream?
4. What are the possible side effects?
5. How should ARTENSIUM cream be stored?
6. Package contents and other information.
1. WHAT IS ARTENSIUM, cream AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: Homeopathic medicine.
Homeopathic medicine traditionally used in the symptomatic local treatment of
- pain caused by minor trauma: sprain, contusion.
- pain of muscular and tendino-ligamentary origin.
- painful flare-ups of arthrosis, after at least one medical opinion.
2. WHAT DO I HAVE TO KNOW BEFORE USING ARTENSIUM cream?
Never use ARTENSIUM, cream
- If you are allergic to the active ingredients or any of the excipients listed in section 6.
- Do not use on mucous membranes, eyes, oozing dermatitis, infected lesions or injured skin, or under occlusive dressings.
Warnings and precautions
Talk to your doctor or pharmacist before using ARTENSIUM cream.
This medicine contains 151 mg alcohol (ethanol) in an estimated application of 4 g, equivalent to 37.8 mg/g (3.78% w/w). This may cause a burning sensation on damaged skin.
Children
Not applicable.
Other medicinal products and ARTENSIUM cream
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
ARTENSIUM, cream with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
ARTENSIUM, cream may be used during pregnancy and lactation.
Driving and use of machinery
Not applicable.
ARTENSIUM, cream contains ethanol.
3. HOW DO I USE ARTENSIUM cream?
Dosage
Pain in cases of minor trauma: for adults and children aged 10 and over only.
Apply a thin layer to the painful area, massaging gently until completely absorbed, 3 times a day.
Maximum duration of treatment 4 days. On medical advice, the maximum duration of treatment is 7 days.
Pain of muscular and tendino-ligamentary origin: for adults and children aged 10 and over.
Apply a thin layer to the painful area, massaging gently until completely absorbed, 3 times a day.
Maximum duration of treatment 7 days. On medical advice, the maximum duration of treatment is 14 days.
Painful flare-ups of arthrosis: for adults only.
Only after at least one medical opinion.
Apply a thin layer to the painful area, massaging gently until completely absorbed, 3 times a day for 7 days. Treatment can be continued, if necessary, for up to 14 days. If pain persists beyond this period, a doctor should be consulted.
Discontinue treatment as soon as symptoms disappear.
Method of administration
Dermal route.
Pump bottle:
1) Remove safety clip
2) Rotate pump to ON position
3) Hold bottle upright, pump facing upwards
4) Prime pump with pressure before first use and dispense cream.
If you have used more ARTENSIUM, cream than you should have, contact your doctor or pharmacist.
Consult your doctor or pharmacist.
If you forget to use ARTENSIUM, cream
Do not take a double dose to make up for the one you forgot to take.
If you stop using ARTENSIUM, cream
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
An allergic reaction to arnica is possible, requiring discontinuation of treatment.
Like all medicines, this product may cause undesirable effects, but they are not systematically observed in everyone.
Reporting side effects
It is important to report suspected side effects after the drug has been authorized. It enables ongoing monitoring of the drug's risk/benefit ratio. Healthcare professionals report any suspected adverse reaction via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr.
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO USE ARTENSIUM cream?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box. The expiration date refers to the last day of the month.
Store at temperatures not exceeding 25°C. Use within 6 months of first use.
Keep tube tightly closed.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What ARTENSIUM cream contains
- The active substance is :
Arnica montana mother tincture ................................................................................................... 7.0 g
Harpagophytum mother tincture........... ....................................................................................... 3.0 g
For 100 g of cream.
- The other ingredients are :
Purified water, virgin sweet almond oil, glycerine, SEPINEO P600 (copolymer of acrylamide and sodium acryloyldimethyltaurate, isohexadecane, polysorbate 80, sorbitan oleate), chlorhexidine digluconate (20% solution).
What ARTENSIUM cream is and what it contains
This medicine comes in the form of a cream: 70 g tube or 120 g multi-dose bottle with pump.
Marketing authorization holder
BOIRON
2 AVENUE DE LOUEST LYONNAIS
69510 MESSIMY
FRANCE
Marketing authorization holder
BOIRON
2 AVENUE DE LOUEST LYONNAIS
69510 MESSIMY
FRANCE
Manufacturer
BOIRON
2 AVENUE DE LOUEST LYONNAIS
69510 MESSIMY
FRANCE
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
HEALTH EDUCATION ADVICE
Warning : whatever the indication for which you are using this medicine, if you are unable to use the limb which is causing you pain, in the event of a large haematoma ("bruise"), or violent pain, you should consult your doctor immediately.
Pain in case of minor trauma: sprain, contusion
In the event of a sprain, apply ice as soon as possible.
You should consult your doctor, who will assess the need for an X-ray and orthopaedic treatment:
- If you are unable to use the limb that hurts
- or if a hematoma (bruise) appears within 24 to 48 hours,
- or if there is severe deformity or swelling.
Do not resume sports or strenuous exercise until the pain has completely disappeared.
Painful flare-up of arthrosis
Arthrosis must be diagnosed by a doctor, who alone can distinguish it from other diseases.