NOTICE
ANSM - Updated: 14/09/2017
Name of the drug
HUMEXPHYTO SUGAR-FREE CLIMBING LIP, oral solution sweetened with liquid maltitol
Dry extract of climbing ivy leaf
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, pharmacist or nurse.
· 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 or nurse. 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 one week of treatment
What does this booklet contain ?
1. What is LIERRE GRIMPANT HUMEXPHYTO SUGAR FREE, oral solution sweetened with liquid maltitol and in which cases is it used?
2. What you need to know before taking LIERRE GRIMPANT HUMEXPHYTO SUGAR FREE, oral solution sweetened with liquid maltitol?
3. How to take YIELD CLIMPANT HUMEXPHYTO SUGAR FREE, oral solution sweetened with liquid maltitol?
4. What are the possible side effects?
5. How to store YELLOW CLIMPANT HUMEXPHYTO SUGAR FREE, oral solution sweetened with liquid maltitol?
6. Contents of the package and other information.
1. WHAT YELLOW SUGAR-FREE HUMEXPHYTO CLIMBER, oral solution sweetened with liquid maltitol AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: expectorants, ATC code: R05CA012
A plant-based drug used as an expectorant in case of productive cough.
You should talk to your doctor if you do not feel better or feel worse after one week of treatment.
2. BEFORE YOU TAKE LIERRE HUMEXPHYTO SUGAR-FREE INGREDIENT, oral solution sweetened with liquid maltitol?
Do not take YOUR HUMEXPHYTO CLIMPANT WITHOUT SUGAR:
· if you are allergic (hypersensitive) to climbing ivy, other plants of the family Araliaceae or any of the other ingredients of this medicine, listed in section 6.
· In children under 2 years of age due to a risk of worsening respiratory symptoms.
Warnings and precautions
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Talk to your doctor before taking LIERRE GRIMPANT HUMEXPHYTO SUGAR FREE .
· If you suffer from dyspnea (shortness of breath), fever or purulent expectoration
· If symptoms persist for more than a week
· If you are taking opioid cough suppressants such as codeine or dextromethorphan
· If you have gastritis or a gastric ulcer
The use of this drug is not recommended in patients with fructose intolerance (rare hereditary disease).
children
· Do not use in children under 2 years. See "Do not take YELLOW CLIMPANT HUMEXPHYTO WITHOUT SUGAR".
· If children 2-4 years old have persistent or recurrent coughs, a medical diagnosis should be made before starting treatment.
Other medicines and LIERRE CLIMPANT HUMEXPHYTO SUGAR-FREE
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
HUMEXPHYTO SUGAR-LIKE CLIMBER WITH FOOD, DRINKS AND DRINK
Not applicable.
Pregnancy and lactation and fertility
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 this medicine.
In the absence of sufficient safety data, the use of SUGAR-FREE HUMEXPHYTO YIELD LIERRE during pregnancy or lactation is not recommended.
Sport
Not applicable.
Driving and using machines
Not applicable.
HUMEXPHYTO SUGAR-FREE CLIMBER YARN contains liquid maltitol.
3. HOW TO TAKE YELLOW CLIMPANT HUMEXPHYTO SUGAR FREE, oral solution sweetened with liquid maltitol?
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Please measure the SUGAR-FREE HUMEXPHYTO CLIMBING LIERRE with the graduated measuring cup.
Teenagers, adults and seniors
Take a measuring cup of 7.5 ml twice a day.
Use in children
Children from 6 to 11 years
Take a measuring cup of 5 ml twice a day.
Children from 2 to 5 years
Take a measuring cup of 2.5 ml twice a day.
Persistent or recurrent cough in children aged 2 to 4 years requires a medical diagnosis before initiating treatment.
Children under 2 years
HUMEXPHYTO NON-SUGAR YIELD YIELD should not be used in children under 2 years of age because of a risk of worsening respiratory symptoms.
· 1 measuring cup of 7.5 ml corresponds to 52.5 mg of dry extract of climbing ivy leaf.
· 1 measuring cup of 5 ml corresponds to 35 mg of dry extract of climbing ivy leaf.
· 1 measuring cup of 2.5 ml corresponds to 17.5 mg of dry extract of climbing ivy leaf.
Administration mode
Oral way.
Duration of treatment
One week.
If symptoms persist after 1 week of treatment, consult a doctor or pharmacist.
If you take more SUGAR-FREE HUMEXPHYTO YIELD LIERRE than you should
Immediately consult your doctor or pharmacist.
If you forget to take LIERRE GRIMPANT HUMEXPHYTO WITHOUT SUGAR
Do not take a double dose to make up for the dose you forgot to take.
If you stop taking LIERRE GRIMPANT HUMEXPHYTO SUGAR FREE
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following undesirable effects have been observed (frequency not known):
· Gastrointestinal disorders such as nausea, vomiting or diarrhea
· Hypersensitivity r éactions (allergic reactions) such as hives, rash or shortness of breath were observed
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. 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 STORE YIELD CLIMPANT HUMEXPHYTO SUGAR FREE, oral solution sweetened with liquid maltitol?
Keep this medicine out of the sight and reach of children.
After the first opening of the vial, the oral solution must be used within 14 days.
Do not use this medicine after the expiry date which is stated on the label, carton, vial after "EXP". 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 LIERRE GRIMPANT HUMEXPHYTO WITHOUT SUGAR
· The active substance is:
Climbing Ivy ( Hedera helix L. ) (dry leaf extract) ................................... ............. 0.700 g
Extraction solvent: ethanol 30% V / V
Drug / extract ratio: 4-8: 1
For 100 ml of oral solution.
· The other components are:
Sodium benzoate, liquid maltitol, anhydrous citric acid, xanthan gum, honey flavor *, purified water.
* Composition of the honey aroma: flavoring substances of natural and unnatural origins, propylene glycol.
Adjuvant of the extract : maltodextrin
What LIERRE GRIMPANT HUMEXPHYTO SUGAR and contents of the pack
Oral solution in a glass bottle of 100 ml, 150 ml or 200 ml with measuring cup.
Not all presentations may be marketed
Marketing Authorization Holder
URGO HEALTHCARE LABORATORIES
42 LONGVIC STREET
21300 CHENOVE
Operator of the marketing authorization
The ABORATORIES URGO HEALTHCARE
42 LONGVIC STREET
21300 CHENOVE
Maker
H2 PHARMA
ZA The Cross Bonnet
21 rue Jacques Tati
78390 Bois d'Arcy
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
{MM / YYYY}
Other
Detailed information on this medicine is available on the ANSM website (France).