NOTICE
ANSM - Updated: 16/03/2010
Name of the drug
SOMNIDORON, oral drops solution
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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 15 days, consult your doctor.
· 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 SOMNIDORON, oral drops solution AND WHAT IT IS USED FOR
2. WHAT INFORMATION IS NECESSARY BEFORE TAKING SOMNIDORON, oral solution in drops?
3. HOW TO TAKE SOMNIDORON, oral solution in drops?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE SOMNIDORON, oral solution in drops?
6. ADDITIONAL INFORMATION
1. WHAT SOMNIDORON, oral drops solution AND WHAT IT IS USED FOR
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
SOMNIDORON oral drops solution is a homeopathic medicine traditionally used in the treatment of minor sleep disorders, especially in case of difficulty falling asleep.
2. WHAT INFORMATION IS NECESSARY BEFORE TAKING SOMNIDORON, oral solution in drops?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take SOMNIDORON oral drops in case of allergy to any of the components of this medicine ( see What SOMNIDORON contains, oral drops solution ).
Precautions for use; special warnings
Take special care with SOMNIDORON, oral drops solution:
This medicine contains 30% ethanol (alcohol), i.e. up to 360 mg per dose (30 drops).
The use of this drug is dangerous in alcoholic subjects and should be taken into account in pregnant or breastfeeding women, children and high-risk groups such as hepatic insufficiency or epileptics.
Interactions with other drugs
Taking or using other medicines
SOMNIDORON oral drops may change or increase the effect of another medicine.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Interactions with food and drinks
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Due to the presence of alcohol, this medication is not recommended during pregnancy and during breastfeeding. 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
List of excipients with known effect: alcohol.
3. HOW TO TAKE SOMNIDORON, oral solution in drops?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Medicine reserved for adults and children over 12 years old.
Take 30 drops at bedtime.
When using for the first time, unscrew the cap completely so as to break the tamper-proof ring. This remains attached to the neck of the bottle.
The vial should be spilled, dropper down. From then on, the air enters through the pierced hole in the dropper. This allows the drops to be released one by one until the desired dosage is obtained.
The duration of treatment should not exceed 15 days. Beyond that medical advice is necessary.
If you have the impression that the effect of SOMNIDORON oral drops solution is too strong or too weak, consult your doctor or pharmacist.
Oral way. To dilute in a little water, to keep a few moments in mouth before swallowing.
Symptoms and instructions in case of overdose
Not applicable.
Instructions for omitting one or more doses
If you forget to take SOMNIDORON, oral drops solution: 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, SOMNIDORON oral drops solution can cause side effects, although not everybody 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 SOMNIDORON, oral solution in drops?
Keep out of the reach and sight of children.
Expiration date
Do not use SOMNIDORON oral drops solution after the expiry date which is stated on the carton.
Storage conditions
No special precautions of conservation.
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 SOMNIDORON contain, oral drops solution?
The active substances are:
Coffea tosta 20DH ............................................... .................................................. .............................. 10 ml
Stramonium 12DH ................................................ .................................................. ............................. 10 ml
Valeriana officinalis 3DH ............................................... .................................................. ..................... 10 ml
For 30 ml.
The other component is: 30% ethanol.
Alcoholic volume of the solution: 30% V / V
Pharmaceutical form and content
What SOMNIDORON oral drops solution and contents of the pack?
This medicine is in the form of oral solution drops.
Bottle of 30 ml equipped with a dropper.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
WELEDA LABORATORY
9, EUGENE JUNG STREET
BP 152
68331 HUNINGUE CEDEX
exploiting
WELEDA LABORATORY
9 EUGENE JUNG STREET
BP 152
68331 HUNINGUE CEDEX
Maker
WELEDA LABORATORY
9 EUGENE JUNG STREET
BP 152
68331 HUNINGUE CEDEX
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.