NOTICE
ANSM - Updated: 14/12/2015
Description of the Medicine
HELICIDINE 10 PERCENT WITHOUT SUGAR, sweetened syrup with saccharin sodium and liquid maltitol
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Please read this leaflet carefully before using this medication. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist for more information.
AT· Keep this leaflet, you may need to read it again.
AT· If you need more information and advice, ask your pharmacist.
AT· If symptoms worsen or persist, consult a physician.
AT· If you notice any side effects not listed in this leaflet, or if you notice any of the side effects listed as severe, please inform your doctor or pharmacist.
Review summary
In this notice :
1. WHAT IS HELICIDINE 10 PERCENT WITHOUT SUGAR, sweetened syrup with sodium saccharin and liquid maltitol AND WHAT IS IT?
2. BEFORE YOU TAKE HELICIDINE 10 PERCENT WITHOUT SUGAR, sweetened syrup with saccharin sodium and liquid maltitol?
3. HOW TO TAKE HELICIDINE 10 PERCENT WITHOUT SUGAR, sweetened syrup with saccharin sodium and liquid maltitol?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE HELICIDINE 10 PERCENT WITHOUT SUGAR, sweetened syrup with saccharin sodium and liquid maltitol?
6. ADDITIONAL INFORMATION
1. WHAT IS HELICIDINE 10 PERCENT WITHOUT SUGAR, sweetened syrup with sodium saccharin and liquid maltitol AND WHAT IS IT?
Pharmacotherapeutic group
ANTI-TEST OF PERIODIC ACTION.
(R. Respiratory system)
Therapeutic Indications
This medication is recommended to soothe dry coughs and irritating coughs.
2. BEFORE YOU TAKE HELICIDINE 10 PERCENT WITHOUT SUGAR, sweetened syrup with saccharin sodium and liquid maltitol?
List of information needed before taking the medication
If your doctor has informed you of an intolerance to certain sugars, contact him / her before taking this medication.
Cons-indications
Never use HELICIDINE 10 PERCENT WITHOUT SUGAR, sweetened syrup with saccharin sodium and liquid maltitol in the following cases:
AT· in the case of a known allergy to one of the constituents (notably methyl parahydroxybenzoate and sodium propyl parabens and other parabens);
AT· (less than 2 years) due to the risk of worsening bronchial congestion.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Employment Precautions; special warnings
Take special care with HELICIDINE 10% WITHOUT SUGAR, sweetened syrup with saccharin sodium and liquid maltitol:
Special warnings
Do not use a cough with this medication. In this case, coughing is a natural defensive means necessary for the escape of bronchial secretions.
If the cough becomes oily, is accompanied by clutter, sputum, fever, seek advice from your doctor.
In the case of chronic (long-term) bronchial or lung disease accompanied by coughs with sputum, a medical opinion is essential.
Treatment should not be continued if symptoms worsen. In this case, consult your doctor for a re-evaluation of your treatment.
If your doctor has informed you of an intolerance to certain sugars, contact him / her before taking this medication.
The use of this medication is disliked in patients with fructose intolerance (rare hereditary disease).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Employment Precautions
In case of diabetes or low-sugar diet, consider the intake of 3.4 g of sucrose per teaspoon and 10.3 g per tablespoon.
This medication contains methylated parahydroxybenzoate (E218), it can cause allergic reactions.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Interactions with other medicines
Taking or using other medicines:
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, speak to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with phytotherapeutic products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication should be used with caution during pregnancy and lactation.
Ask your doctor or pharmacist for advice before taking any medication.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with a well-known effect:
Methyl parahydroxybenzoate
Liquid maltitol
3. HOW TO TAKE HELICIDINE 10 PERCENT WITHOUT SUGAR, sweetened syrup with saccharin sodium and liquid maltitol?
Instructions for proper use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Administration Frequency and Duration of Treatment
Dosage
In the absence of efficacy, do not increase the doses beyond what is advised, do not jointly take another cough suppressant, but consult a physician.
The usual dosage is:
Adults: 2 tablespoons 3 times a day.
Children: 2 ml / kg / day divided into 3 doses:
AT· children from 25 to 50 kg (approximately 8 to 15 years): 3 to 5 tablespoons per day
AT· children from 15 to 25 kg (about 4 to 8 years): 1 tablespoon 3 times a day
AT· children from 12 to 15 kg (about 30 months to 4 years): 2 teaspoons 3 times a day
Below 8 years: comply with the advice of your doctor.
Administration mode
Oral use.
Duration of treatment
Do not exceed 5 to 6 days of treatment without medical advice.
Symptoms and Instructions for Overdose
If you used more than 10% HELICIDINE WITHOUT SUGAR, sweetened syrup with saccharin sodium and liquid maltitol:
No specific signs were observed when describing cases of overdoses. If you think you have taken or have given your child more HELICIDINE 10% WITHOUT SUGAR, sweetened syrups with sodium saccharin and liquid maltitol than you need and if you notice any undesirable effects mentioned in this leaflet, please contact your doctor immediately.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of undesirable effects
Like all medicines, HELICIDINE 10 PERCENT WITHOUT SUGAR, sweetened syrup with saccharin sodium and liquid maltitol is likely to have undesirable effects, although not everyone is subject to it:
AT· Risk of aggravation of the bronchial congestion in particular in the infant and in some patients incapable of effective expectoration.
If you notice any side effects not listed in this leaflet, or if certain undesirable effects become serious, please inform your doctor or pharmacist.
5. HOW TO STORE HELICIDINE 10 PERCENT WITHOUT SUGAR, sweetened syrup with saccharin sodium and liquid maltitol?
Keep out of the reach and sight of children.
Date of filing
Do not use HELICIDINE 10 PERCENT WITHOUT SUGAR, sweetened syrup with saccharin sodium and liquid maltitol after the expiration date stated on the outer packaging.
Storage conditions
Before opening: No special precautions for storage.
After first opening the bottle, the medicinal product should be kept for a maximum of 6 months at a temperature not exceeding 25 ° C.
If necessary, warnings against some visible signs of deterioration
Medicines should not be thrown away or washed away with household garbage. Ask your pharmacist what to do with unused medications. These measures will protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does HELICIDINE 10% CONTAIN WITHOUT SUGAR contain, sweetened syrup with saccharin sodium and liquid maltitol?
The active substance is :
Hemididine ............................................... .................................................. .......................................... 10 ml
For 100 ml of syrup.
The other components are :
Xanthan Gum, Sodium Saccharinate, Liquid Maltitol, Raspberry Arms, Methyl Parahydroxybenzoate, Potassium Sorbate, Purified Water
Pharmaceutical form and content
What is HELICIDINE 10 PERCENT WITHOUT SUGAR, sweetened syrup with saccharin sodium and liquid maltitol and contents of the outer packaging?
This medication is in the form of a syrup. Bottle of 125 ml, 200 ml or 250 ml.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
THERABEL LUCIEN PHARMA
19 RUE ALPHONSE DE NEUVILLE
75017 PARIS
exploiting
THERABEL LUCIEN PHARMA
19 rue Alphonse de Neuville
75017 PARIS
Maker
ZETA FARMACEUTICI SPA
VIA GALVANI, 10
36066 SANDRIGO (VI)
ITALY
OR
LABORATORIO REIG JOFRE SA
C / GRAN CAPITAN 10
08970 SAN JOAN DESPI - BARCELONA
SPAIN
Names of medicines in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last day this notice was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medication can be found on the website of the ANSM (France).
Information for Health Professionals
Not applicable.
Other
Not applicable.