NOTICE
ANSM - Updated: 12/12/1997
Name of the drug
BIOCARDE, oral solution
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, 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 BIOCARDE is, oral solution AND WHAT IT IS USED FOR
2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE BIOCARDE, oral solution?
3. HOW TO TAKE BIOCARDE, oral solution?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE BIOCARDE, oral solution?
6. ADDITIONAL INFORMATION
1. WHAT BIOCARDE is, oral solution AND WHAT IT IS USED FOR
Pharmacotherapeutic class
Herbal medicine and mineral elements for sedative purposes.
Therapeutic indications
This medicine is a mild sedative.
It is recommended:
· In adults, to reduce nervousness in cases of exaggerated perception of heartbeat (palpitations) after any heart disease has been ruled out.
· In adults and children in mild sleep disorders.
2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE BIOCARDE, oral solution?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not take BIOCARDE, oral solution if you are allergic to any of the ingredients .
IF IN DOUBT, DO NOT HESITATE TO ASK FOR THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Be careful with BIOCARDE, oral solution:
Special warnings
In children, a sleep disorder requires consultation with your doctor. |
WARNING: THE ALCOHOLIC TITLE OF THIS MEDICINAL PRODUCT IS 63% (V / V) OR 210 mg ALCOHOL FOR 15 DROPS AND 84 mg FOR 6 DROPS. |
Precautions for use
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other drugs
Taking or using 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
Not applicable.
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.
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 BIOCARDE, oral solution?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
In adults :
In case of palpitations: 15 drops, 3 times a day.
Minor sleep disorders: 15 drops in the evening at dinner and 15 drops at bedtime.
In children over 6 years old :
Minor sleep disorders: 6 drops in the evening at dinner and 6 drops at bedtime.
Administration mode
ORAL WAY.
Duration of the treatment
Treatment should not be prolonged without medical advice.
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, BIOCARDE oral 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 BIOCARDE, oral solution?
Keep out of the reach and sight of children.
Expiration date
Do not use BIOCARDE, oral solution after the expiry date which is stated on the bottle.
Storage conditions
Store at a temperature below 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 BIOCARDE, oral solution contain?
The active substances are:
Hawthorn (fluid hydroalcoholic extract of flowering tops and fruits) ...................................... .......... 40 ml
Passionflower (tincture of aerial parts) ........................................... .................................................. 10 ml
Valerian (root tincture) ............................................ .................................................. ............... 15 ml
Oats (fluid hydroalcoholic extract of aerial flower parts) ........................................ ................. 10 ml
Melissa (fluid hydroalcoholic extract of flowering aerial parts) ........................................ ............... 10 ml
Motherwort (tincture of aerial parts) ........................................... .................................................. 15 ml
For 100 ml of oral solution.
Pharmaceutical form and content
What is BIOCARDE oral solution and contents of the pack?
This medicine is in the form of an oral solution. Bottle of 30 ml.
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 Marais
57640 Saint Beard
exploiting
LEHNING Laboratories
3, rue du Petit Marais
57640 Saint Beard
Maker
LEHNING Laboratories
3, rue du Petit Marais
57640 Saint Beard
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.