NOTICE
ANSM - Last updated: 28/04/2016
Name of the medicinal product
ACTHÉANE, tablet
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take 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 of the 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 experience no improvement or feel less well after 3 months.
Review summary
What this leaflet contains:
1. What is ACTHÉANE, tablet and in which cases it is used?
2. What should I know before taking ACTHÉANE tablet ?
3. How to take ACTHÉANE, tablet ?
4. What are the possible side effects?
5. How to store ACTHÉANE tablet ?
6. Additional information.
1. WHAT ACTHÉANE is AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Not applicable.
Therapeutic indications
ACTHÉANE, tablet is a homeopathic medicine traditionally used in hot flushes and functional disorders of menopause.
2. BEFORE YOU TAKE ACTHENE, 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
Not applicable.
Precautions for use; special warnings
Warnings and Precautions
· Talk to your doctor or pharmacist before taking ACTHENE, tablet .
· The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
· 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
Not applicable.
Interactions with food and beverages
ACTHÉANE, tablet with food and drink.
This medication is taken at a distance from meals.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
ACTHÉANE, tablet is indicated in postmenopausal women.
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
ACTHÉANE, tablet contains sucrose and lactose.
3. HOW TO TAKE ACTHÉANE, tablet?
Instructions for proper use
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
1 tablet to be sucked 2 to 4 times per 24 hours, to be divided according to the intensity of the symptoms. This medication can also be taken at night if needed.
Decrease the number of daily intake with improvement and discontinue symptom withdrawal.
If there is no rapid improvement, consult your doctor.
Administration mode
Sublingual pathway.
Duration of treatment
The duration of the treatment is three months renewable.
Symptoms and Instructions for Overdose
If you take more ACTHENE tablets than you should:
Immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take ACTHÉANE, tablet:
Do not take a double dose to make up for the tablet you have forgotten to take.
Risk of withdrawal syndrome
Not applicable.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
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 ACTHÉANE, tablet?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.
Storage conditions
No special precautions for storage.
If necessary, warnings against visible signs of deterioration
Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What ACTHÉANE contains, tablet:
The active substances are:
Actaea racemosa 4 CH .............................................. .................................................. ... 0.5 mg
Arnica montana 4 CH .............................................. .................................................. ...... 0.5 mg
Glonoinum 4 CH ............................................... .................................................. 0.5 mg
Lachesis mutus 5 CH .............................................. .................................................. ...... 0.5 mg
Sanguinaria canadensis 4 CH .............................................. ............................................ 0.5 mg
The other components are:
Sucrose, Lactose and Magnesium Stearate.
Pharmaceutical form and content
What is ACTHÉANE, tablet and contents of the pack?
This medication is in the form of tablets. It is packaged in a box containing 60, 120, 240 or 360 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
LA FRANCE
exploiting
Boiron
2 WEST AVENUE LYONNAIS
69510 MESSIMY
LA FRANCE
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 notice was revised is {MM / YYYY}> <{month YYYY}.>
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.