NOTICE
ANSM - Updated: 09/03/2017
Name of the drug
SAMBUCUS LICENSE PASTE, sucking dough
Sambucus nigra mother tincture
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 better or if you feel worse.
Do not let this medicine within the reach of children.
What does this booklet contain ?
1. What is SAMBUCUS LICENSE PASTE, what is it used for?
2. What information do you need to know before taking SAMBUCUS LICENSE PASTE, sucking dough?
3. How to take SAMBUCUS LICENSE PASTE, paste to suck?
4. What are the possible side effects?
5. How to store SAMBUCUS LICENSE PASTE, paste to suck?
6. Contents of the package and other information.
1. WHAT IS SAMBUCUS LICENSE PASTE, SUCKING PASTE AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: homeopathic medicine.
Homeopathic medicine traditionally used in the symptomatic treatment of hoarse cough and hoarseness.
2. WHAT YOU SHOULD KNOW BEFORE TAKING SAMBUCUS LICENSE PASTES, sucking dough?
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Never take SAMBUCUS LICENSE PASTE, sucking paste:
· Children under 6 years old.
· If you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine, mentioned in section 6.
· This medication is contraindicated in people with hypertension due to the presence of glycyrrhizinic acid in licorice juice.
· This medication is contraindicated during pregnancy and lactation.
Warnings and precautions
· The use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency (rare hereditary diseases).
· The use of this drug is not recommended in patients with intolerance to glycyrrhizinic acid.
Other medicines and SAMBUCUS LICENSE PASTE, sucking dough
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
SAMBUCUS LICENSE PASTE, sucking dough with food and drinks
Not applicable.
Pregnancy and breast feeding
In the absence of experimental and clinical data, and as a precaution, the use of this drug is contraindicated during pregnancy and lactation.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Driving and using machines
Not applicable.
SAMBUCUS LICENSE PASTE, sucking paste contains sucrose, liquid glucose and sorbitol.
3. HOW TO TAKE SAMBUCUS LICENSE PASTES, dough to suck?
Dosage
Reserved for adults and children from 6 years old.
Adults: 5 pasta to suck each day.
Children from 6 years: 3 pasta to suck each day.
Administration mode
Oral way
Duration of treatment
The duration of treatment should not exceed one week.
If you have taken more SAMBUCUS LICENSE PASTES than you should have:
Immediately consult your doctor or pharmacist.
If you forget to take SAMBUCUS LICENSE PASTE, to suck:
Do not take a double dose to make up for the dose you forgot to take .
If you stop taking SAMBUCUS LICENSE PASTE, sucking dough:
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE 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 - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO PRESERVE SAMBUCUS LICENSE PASTE, sucking dough?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of this month.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What's in SAMBUCUS LICENSE PASTE, sucking dough
· The active substance is:
Sambucus nigra mother tincture
· The other components are:
Licorice juice, gum arabic, sucrose, liquid glucose, sorbitol, paraffin oil
What SAMBUCUS LICENSE PASTE, Pastry and contents of the pack
This medicine is in the form of a paste to suck. Box of about 70 g.
Marketing Authorization Holder
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
LA FRANCE
Operator of the marketing authorization
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
LA FRANCE
Maker
Boiron
3 RUE DES TONNARDERIES
41400 MONTRICHARD
LA FRANCE
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
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Other
Detailed information on this medicine is available on the ANSM website (France).