NOTICE
ANSM - Updated: 24/06/2014
Name of the drug
HOMEOGENE 46, orodispersible tablet
framed
Read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have further questions, if you are not sure, ask your doctor or pharmacist for more information.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, talk to your pharmacist.
· If symptoms worsen or persist after treatment, seek medical attention.
· If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Summary notice
In this notice :
1. WHAT IS HOMEOGENE 46, orodispersible tablet AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE HOMEOGENE 46, orodispersible tablet?
3. HOW TO TAKE HOMEOGENE 46, orodispersible tablet?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE HOMEOGENE 46, orodispersible tablet?
6. ADDITIONAL INFORMATION
1. WHAT IS HOMEOGENE 46, orodispersible tablet AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
HOMEOGENE 46, orodispersible tablet is a homeopathic medicine traditionally used in mild sleep disorders.
2. BEFORE YOU TAKE HOMEOGENE 46, orodispersible tablet?
List of information needed before taking the medication
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Do not take HOMEOGENE 46, orodispersible tablet in the following case:
Children under 1 year old.
Precautions for use; special warnings
Be careful with HOMEOGENE 46, orodispersible tablet:
· The use of this drug is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
Interactions with other drugs
Not applicable.
Interactions with food and drinks
Food and drinks
This medication is best taken away from meals.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
In the absence of experimental and clinical data, and as a precautionary measure, the use of this drug should be avoided during pregnancy and lactation.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
Not applicable.
List of excipients with known effect
Important information about some of the ingredients of HOMEOGENE 46, orodispersible tablet:
This medicine contains lactose.
3. HOW TO TAKE HOMEOGENE 46, orodispersible tablet?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
Reserved for adults and children over one year old.
On medical advice in children under 30 months.
In adults: 2 tablets 3 times a day.
In children: 1 tablet 3 times a day. Dissolve the tablet in a little water to avoid the risk of false route.
Method and route of administration
Sublingual route.
Frequency of administration
Space the catches as soon as possible and stop the catches as soon as the symptoms disappear.
Duration of treatment
The duration of treatment should not exceed 2 weeks in adults and 10 days in children.
Symptoms and instructions in case of overdose
If you take more HOMEOGENE 46, orodispersible tablet than you should:
Consult your doctor or pharmacist.
Instructions for omitting one or more doses
If you forget to take HOMEOGENE 46, orodispersible tablet:
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, HOMEOGENE 46, orodispersible tablets can cause side effects, although not everyone gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE HOMEOGENE 46, orodispersible tablet?
Keep out of the reach and sight of children.
Expiration date
Do not use HOMEOGENE 46, orodispersible tablet after the expiry date which is stated on the carton.
Storage conditions
Store at a temperature not exceeding 30 ° C.
If necessary, warn against some visible signs of deterioration
Medications should not be thrown away to the sewer or garbage. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does HOMEOGENE 46, orodispersible tablet contain?
The active substances are :
Hyoscyamus niger 5CH ............................................... .................................................. ................ 0.625 mg
Nux moschata 4CH ............................................... .................................................. ...................... 0.625 mg
Passiflora incarnata 3DH ............................................... .................................................. ............... 0.625 mg
Stramonium 5CH ................................................ .................................................. ......................... 0.625 mg
For an orodispersible tablet of 250 mg.
The other components are :
Lactose, croscarmellose sodium, magnesium stearate.
Pharmaceutical form and content
What is HOMEOGENE 46, orodispersible tablet and contents of the pack?
This medicine is in the form of orodispersible tablets. Box of 60 tablets.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
exploiting
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
Maker
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
LA FRANCE
Names of the drug in the member states of the European Economic Area
Not applicable.
Date of approval of the notice
The last date this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the Afssaps (France) website.
Information reserved for health professionals
Not applicable.
Other
Not applicable.