NOTICE
ANSM - Last updated: 24/06/2014
Name of the medicinal product
ARNICALME, orodispersible tablet
Arnica montana 9 CH
framed
Read this leaflet carefully before you start taking 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 after 7 days, 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 ARNICAL, ORODISPERSIBLE AND IN WHAT CASES IS IT USED?
2. WHAT ARE THE INFORMATION TO BE KNOWN BEFORE TAKING ARNICALME, Orodispersible Tablet?
3. HOW TO TAKE ARNICALME, orodispersible tablet?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE ARNICALME, orodispersible tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS ARNICAL, ORODISPERSIBLE AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
Not applicable.
Therapeutic indications
ARNICALME, orodispersible tablet is a homeopathic medicine traditionally used in the treatment of hematomas (bruises), bruising (bruising), bruising, and muscle fatigue.
2. WHAT ARE THE INFORMATION TO BE KNOWN BEFORE TAKING ARNICALME, Orodispersible Tablet?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Children under 18 months.
Precautions for use; special warnings
Take special care with ARNICALME, orodispersible tablet:
· The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
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
Food and drinks
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine.
In the absence of experimental and clinical data, and as a precautionary measure, use of this medication should be avoided during pregnancy and lactation.
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 ARNICALME, orodispersible tablet
This medicine contains lactose.
3. HOW TO TAKE ARNICALME, orodispersible tablet?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
In adults: 2 tablets 3 times a day. Allow the tablets to melt under the tongue.
In children from 18 months: 1 tablet 3 times a day, to dissolve in a little water.
Method and route of administration
Sublingual pathway.
In children aged 18 months to 6 years: dissolve the tablet in a little water before taking because of the risk of false route. As soon as age permits, allow the tablets to melt under the tongue.
Duration of treatment
Spacer the catches as soon as improvement and stop the catches as soon as the symptoms disappear.
Maximum treatment of 7 days.
Symptoms and Instructions for Overdose
If you take more ARNICALME, orodispersible tablet than you should:
Consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take ARNICALME, orodispersible tablet:
Do not take a double dose to make up for a missed dose.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, ARNICALME, orodispersible tablet is likely to have undesirable effects, although not everyone is subject to it.
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 ARNICALME, orodispersible tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use ARNICALME, an orodispersible tablet after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
Storage conditions
Store at a temperature not exceeding 30 ° 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 ARNICALME contain, orodispersible tablets?
The active substance is:
Arnica montana 9 CH .............................................. .................................................. 2.5 mg
For a 250 mg orodispersible tablet.
The other components are:
Lactose, Croscarmellose sodium, Magnesium stearate.
Pharmaceutical form and content
What is ARNICALME, orodispersible tablets and contents of the pack?
This medication is in the form of orodispersible tablets. It is packaged in a box containing 40 tablets.
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
Boiron
2 WEST AVENUE LYONNAIS
69510 MESSIMY
exploiting
Boiron
2 WEST AVENUE LYONNAIS
69510 MESSIMY
Maker
Boiron
2 WEST AVENUE LYONNAIS
69510 MESSIMY
LA FRANCE
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.