NOTICE
ANSM - Updated: 19/10/2009
Name of the drug
BERBERIS COMPLEX No. 83, oral drops solution
framed
Read this leaflet carefully before using 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, 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 BERBERIS COMPLEX No. 83, oral solution in drops and in which case is it used?
2. What information do you need to know before using BERBERIS COMPLEX No. 83, oral drops solution ?
3. How to use BERBERIS COMPLEX No. 83, oral drops solution ?
4. What are the possible side effects?
5. How to store BERBERIS COMPLEX No. 83, oral drops solution ?
6. Additional information.
1. WHAT IS BERBERIS COMPLEX No. 83, oral drops solution AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
Homeopathic medicine traditionally used in the symptomatic treatment of common low back pain.
2. BEFORE YOU USE BERBERIS COMPLEX No. 83, oral solution in drops?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take BERBERIS COMPLEXE N ° 83, oral solution in drops:
· if you are hypersensitive to any of the components.
Precautions for use; special warnings
Take care with BERBERIS COMPLEX No. 83, oral drops solution:
· This medicine contains 48% ethanol V / V ethanol (alcohol), that is to say up to 189 mg per dose (20 drops), which is equivalent to 4.7 ml of beer, 1.7 ml of wine per dose.
· 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.
· Given the presence of the strain PULSATILLA in the formula, this drug should not be used in cases of otitis or sinusitis without medical advice.
Interactions with other drugs
Use of other medicines:
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist
Interactions with food and drinks
Food and drinks :
This medicine is to be taken away from meals.
Interactions with herbal products 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.
Due to the presence of alcohol, this medication is not recommended 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 BERBERIS COMPLEX No. 83, oral drops solution:
This medicine contains ethanol.
3. HOW TO USE BERBERIS COMPLEX No. 83, oral solution drops?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage:
Medicine reserved for adults.
20 drops 3 times a day.
Administration mode
Sublingual route.
To take in a little water, away from meals.
Keep the medicine under the tongue before swallowing.
Space the catches as soon as possible and stop the catches as soon as the symptoms disappear.
Hold the bottle vertically
Duration of treatment
Without medical advice, the duration of treatment is limited to 15 days.
Symptoms and instructions in case of overdose
Not applicable.
Instructions for omitting one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, BERBERIS COMPLEXE No. 83, oral drops solution is likely to have side effects, although not everyone is subject to 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 BERBERIS COMPLEX NO. 83, oral solution in drops?
Keep out of the reach and sight of children.
Expiration date
Do not use BERBERIS COMPLEX No. 83, oral drops solution after the expiry date which is stated on the carton or on the label.
Storage conditions
Keep the bottle tightly closed.
Store at a temperature not exceeding 25 ° 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 BERBERIS COMPLEXE No. 83, oral solution in drops contain?
The active substances are :
Berberis vulgaris ................................................ .............................. 2DH
Oxalicum acidum ................................................ ............................. 8DH
Autumnal Colchicum ................................................ ....................... 3DH
Colocynthis ................................................. .................................... 3DH
Betula ................................................. ............................................ 1DH
Kalium carbonicum ................................................ .......................... 2DH
Natrum sulfuricum ................................................ ............................. 2DH
Gnaphalium polycephalum ................................................ ................ 2DH
Pulsatilla ................................................. ......................................... 4DH
Terebinthina ................................................. .................................... 3DH
The other components are :
Ethanol 48% v / v.
Pharmaceutical form and content
What is BERBERIS COMPLEX No. 83, oral drops solution and contents of the pack?
BERBERIS COMPLEX No. 38, oral drops solution is an oral solution packaged in 30 ml yellow glass bottle with dropper under a cardboard case.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Holder
lehning laboratories
3 rue du petit marsh
57640 holy beard
LA FRANCE
exploiting
lehning laboratories
3 rue du petit marsh
57640 holy beard
LA FRANCE
Maker
lehning laboratories
3 rue du petit marsh
57640 holy beard
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.