NOTICE
ANSM - Updated: 03/08/2012
Name of the drug
PHYTOTUX syrup
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 after 6 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 PHYTOTUX, syrup AND WHAT IT IS USED FOR
2. WHAT INFORMATION DO YOU KNOW BEFORE TAKING PHYTOTUX, syrup?
3. HOW TO TAKE PHYTOTUX, syrup?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE PHYTOTUX, syrup?
6. ADDITIONAL INFORMATION
1. WHAT PHYTOTUX, syrup AND WHAT IT IS USED FOR
Pharmacotherapeutic class
ANTI-SUSTAINED PLANT-BASED MEDICINE
(R. Respiratory system)
Therapeutic indications
This medication is an adjunct to acute benign bronchial conditions in adults and children over 6 years of age .
2. WHAT INFORMATION DO YOU KNOW BEFORE TAKING PHYTOTUX, syrup?
List of information needed before taking the medication
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Do not take PHYTOTUX syrup in the following cases:
· in case of allergy to one of the constituents.
· in children under 6, due to alcohol content.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Be careful with PHYTOTUX, syrup:
Special warnings
WARNING THIS MEDICINAL PRODUCT CONTAINS ALCOHOL: the alcoholic strength of this medication is 2%, ie 0.09 g alcohol per teaspoon and 0.27 g alcohol per tablespoon. |
· The use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase (rare hereditary diseases) deficiency.
Medical advice is needed:
· in case of fever, fatty or purulent sputum,
· if you have chronic (long-term) bronchial and lung disease.
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, sucrose
3. HOW TO TAKE PHYTOTUX, syrup?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS OLD.
For information :
· children
from 20 to 30 kg (about 6 to 10 years): 2 to 3 teaspoons a day
from 30 to 50 kg (10 to 15 years): 3 to 4 teaspoons a day
· adults
1 to 4 tablespoons a day.
THIS MEDICINE HAS BEEN PERSONALLY DELIVERED TO YOU IN AN ACCURATE SITUATION:
· IT MAY NOT BE ADAPTED TO ANOTHER CASE.
· DO NOT ADVISE IT TO ANY OTHER PERSON.
Administration mode
ORAL WAY.
Duration of the treatment
Do not exceed 5 to 6 days of treatment 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, PHYTOTUX syrup 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 PHYTOTUX, syrup?
Keep out of the reach and sight of children.
Expiration date
Do not use PHYTOTUX syrup after the expiry date which is stated on the bottle.
Storage conditions
No special storage conditions.
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 PHYTOTUX contain, syrup?
The active substances are:
Extract concentrated at 1/10 th for syrup of tolu balm ..................................... .............................. 5.72 g
Extract concentrated in 1/10 th for syrup of ipecacuanha compound ..................................... .................... 5.25 g
For 100 ml of syrup.
The other components are:
Liquid sorbitol, purified water, sucrose solution, 96 percent ethanol, orange blossom flavored water, potassium sorbate, hydroxyethylcellulose, citric acid monohydrate
One teaspoon (5 ml) contains 0.09 g of ethanol.
One tablespoon (15 ml) contains 0.27 g of ethanol.
Voluminal alcoholic strength of the syrup: 2% (V / V).
Pharmaceutical form and content
What is PHYTOTUX, syrup and contents of the pack?
This medicine is in the form of syrup. Bottle of 250 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 ANSM website (France).
Information reserved for health professionals
Not applicable.
Other
Not applicable.