1. WHAT IS HELICIDINE 10 PERCENT SUGAR-FREE, syrup sweetened with saccharin sodium and liquid maltitol AND WHEN IS IT USED?
Pharmacotherapeutic class
ANTITUSSIVE of peripheral action.
(R. Respiratory system)
Therapeutic indications
This medicine is recommended for the relief of dry coughs and coughs of irritation.
2. WHAT YOU SHOULD KNOW BEFORE TAKING HELICIDINE 10 PER CENT SUGAR-FREE, syrup sweetened with saccharin sodium and liquid maltitol
List of information needed before taking the medicine
If your doctor has informed you of an intolerance to certain sugars, contact him or her before taking this medicine.
Contraindications
Never use HELICIDINE 10 PER CENT SUGAR-FREE, syrup sweetened with saccharin sodium and liquid maltitol in the following cases:
-incase of known allergy to any of the constituents (especially to sodium methyl propyl parahydroxybenzoate and other parabens);
ininfants (under 2 years) because of the risk of aggravating bronchial congestion.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK THE ADVICE OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Take special care with HELICIDINE 10 PER CENT SUGAR-FREE, syrup sweetened with saccharin sodium and liquid maltitol:
Special Warnings
Do not use this medicine to treat a wet cough. In this case, coughing is a natural defence to clear bronchial secretions.
If the cough becomes oily, is accompanied by congestion, sputum, fever, ask your doctor for advice.
In case of chronic (long-term) bronchial or lung disease accompanied by coughing and spitting, medical advice is essential.
The treatment should not be continued if the 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 medicine.
The use of this medicine is not recommended in patients with fructose intolerance (a rare hereditary disease).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use
In case of diabetes or low sugar diet, take into account the intake of 3.4 g of sucrose per teaspoon and 10.3 g per tablespoon.
This medicine contains methyl parahydroxybenzoate (E218), it may cause allergic reactions.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
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, talk to your doctor or pharmacist.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
This medicine should be used with caution during pregnancy and breastfeeding.
Ask your doctor or pharmacist for advice before taking any medication.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect:
Methyl parahydroxybenzoate
Liquid maltitol
3. HOW TO TAKE HELICIDINE 10 PER CENT SUGAR-FREE, syrup sweetened with saccharin sodium and liquid maltitol
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
In the absence of efficacy, do not increase the dose beyond that recommended, do not take another cough suppressant at the same time, but consult a doctor.
The usual dosage is:
Adults: 2 tablespoons 3 times a day.
Children: 2 ml/kg/day divided into 3 doses:
Childrenfrom 25 to 50 kg (about 8 to 15 years): 3 to 5 tablespoons per day
Childrenfrom 15 to 25 kg (about 4 to 8 years): 1 tablespoon 3 times a day
childrenfrom 12 to 15 kg (about 30 months to 4 years): 2 teaspoons 3 times a day
Under 8 years: follow your doctor's advice.
Method of administration
Take by mouth.
Duration of treatment
Do not exceed 5 to 6 days of treatment without medical advice.
Symptoms and instructions in case of overdose
If you have used more than HELICIDINE 10 PERCENT SUGAR-FREE, syrup sweetened with saccharin sodium and liquid maltitol:
No specific signs have been observed when describing cases of overdose. If you think you have taken or given your child more HELICIDINE 10 PERCENT SWEETENED SYRUP with sodium saccharin and liquid maltitol than you should have and if you notice any side effects not listed in this leaflet, please contact your doctor immediately.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, HELICIDINE 10 PER CENT SUGAR-FREE, syrup sweetened with saccharin sodium and liquid maltitol is likely to have undesirable effects, although not everyone is subject to them:
Risk of worsening of bronchial congestion especially in infants and in some patients unable to cough up effectively.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE HELICIDINE 10 PERCENT SUGAR-FREE, syrup sweetened with saccharin sodium and liquid maltitol
Keep out of the reach and sight of children.
Expiry date
Do not use HELICIDINE 10 PER CENT SUGAR-FREE, syrup sweetened with sodium saccharin and liquid maltitol after the expiry date stated on the outer packaging.
Storage conditions
Before opening: No special storage precautions.
After the first opening of the bottle, the medicine should be stored for a maximum of 6 months at a temperature not exceeding 25°C.
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewage system or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does HELICIDINE 10 PER CENT SUGAR-FREE, syrup sweetened with saccharin sodium and liquid maltitol contain?
The active substance is:
Helicidin ........................................................................................................................................... 10 ml
For 100 ml of syrup.
The other components are:
Xanthan gum, sodium saccharinate, liquid maltitol, raspberry flavour, methyl parahydroxybenzoate, potassium sorbate, purified water
Pharmaceutical form and content
What is HELICIDINE 10 PER CENT SUGAR-FREE, syrup sweetened with saccharin sodium and liquid maltitol and what does it contain?
This medicine is in the form of a syrup. Bottle of 125 ml, 200 ml or 250 ml.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
THERABEL LUCIEN PHARMA
19 RUE ALPHONSE DE NEUVILLE
75017 PARIS
Operator
THERABEL LUCIEN PHARMA
123, RUE JULES GUESDE
92903 LEVALLOIS-PERRET CEDEX
FRANCE
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