NOTICE
ANSM - Updated: 27/05/2016
Name of the drug
PASSIFLORA INCARNATA TINCTURE BOIRON, oral fluid
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel any improvement or if you feel worse after 1 month.
Do not let this medicine within the reach of children.
Summary notice
What does this booklet contain :
1. What is PASSIFLORA INCARNATA TINTING MOTHER Boiron, oral fluid and in what cases is it used?
2. What you need to know before taking PASSIFLORA INCARNATA TINCTURE BOIRON, oral fluid ?
3. How to take PASSIFLORA INCARNATA TINTING MOTHER Boiron, oral liquid ?
4. What are the possible side effects?
5. How to store PASSIFLORA INCARNATA TINTING MOTHER Boiron, oral liquid ?
6. Additional information.
1. WHAT PASSIFLORA INCARNATA DYE MOTHER Boiron, oral fluid AND WHAT IT IS USED FOR?
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
PASSIFLORA INCARNATA TEXTURE MOTHER BOIRON, oral liquid is a homeopathic medicine traditionally used in case of nervousness and sleep disorders (especially in case of difficulty of falling asleep) in adults.
2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE PASSIFLORA INCARNATA DYE MOTHER BOIRON, oral fluid?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use PASSIFLORA INCARNATA TINTING MOTHER Boiron, oral liquid:
· In the child.
· If you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine, mentioned in section 6.
Precautions for use; special warnings
Warnings and precautions
· This medicine contains 65% ethanol (alcohol), that is, 206 mg alcohol per unit dose (20 drops).
· The use of this drug is dangerous in alcoholic subjects and should be taken into account in high risk groups such as hepatic insufficiency or epileptics.
· The maximum duration of treatment should not exceed 6 months over a lifetime.
· Do not exceed the recommended dose.
Interactions with other drugs
Other medicines and PASSIFLORA INCARNATA TINTING MOTHER BOIRON, oral liquid:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
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
This medication should not be used during pregnancy and lactation.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
PASSIFLORA INCARNATA TEXTURE MOTHER BOIRON, oral liquid contains ethanol. (20 drops contain 206 mg of ethanol).
3. HOW TO TAKE PASSIFLORA INCARNATA TINTING MOTHER Boiron, oral fluid?
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.
Using the graduated syringe, take 20 drops 2 to 3 times a day, to dilute in a little water.
Space the catches as soon as possible and stop taking them as soon as the symptoms disappear.
Administration mode
Oral way.
Duration of treatment
The treatment should not exceed 1 month. Beyond that, consult a doctor.
Symptoms and instructions in case of overdose
If you take more than PASSIFLORA INCARNATA TINTING MOTHER Boiron, oral fluid than you should:
Immediately consult your doctor or pharmacist.
Instructions for omitting one or more doses
If you forget to take PASSIFLORA INCARNATA TINTING MOTHER Boiron, oral liquid :
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, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE PASSIFLORA INCARNATA DYE MOTHER Boiron, oral liquid?
Keep this medicine out of the sight and reach of children.
Expiration date
Do not take this medicine after the expiry date which is stated on the bottle.
Storage conditions
No special storage conditions.
This medicine should be used for a maximum of 1 month after first opening.
If necessary, warn against some visible signs of deterioration
Do not dispose of any medication at the sewer or with household waste. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What contains PASSIFLORA INCARNATA TINTING MOTHER BOIRON, oral liquid?
· The active substance is:
Passiflora incarnata, mother tincture.
for a 60 ml bottle.
· The other components are:
96% V / V ethanol, purified water.
Pharmaceutical form and content
What is PASSIFLORA INCARNATA TINTING MOTHER Boiron, oral liquid and contents of the pack?
PASSIFLORA INCARNATA TINTING MOTHER BOIRON is an oral liquid, packaged in a bottle of
60 ml, with a graduated syringe for oral administration.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Marketing Authorization Holder and Manufacturer
Holder
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
la France
exploiting
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
la France
Maker
Boiron
20 RELEASE STREET
69110 SAINTE-FOY-LES-LYON
LA FRANCE
or
Boiron
3 RUE DES TONNARDERIES
41400 MONTRICHARD
LA FRANCE
or
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 leaflet was revised is {MM / YYYY}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the ANSM website (France).
Information reserved for health professionals
Not applicable.
Other
Not applicable.