NOTICE
ANSM - Updated on : 17/02/2023
Product name
CARBOCISTEINE BIOGARAN CONSEIL 2% CHILDREN SUGAR-FREE drinkable solution sweetened with saccharin sodium
Carbocisteine
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or nurse.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
- Contact your doctor if you do not feel better or feel worse after 10 days.
Keep out of the reach of children.
What does this leaflet contain?
1. What is CARBOCISTEINE BIOGARAN CONSEIL, 2% CHILDREN SWEETEN DRINKING SOLUTION sweetened with saccharin sodium and what is it used for?
2. What do I need to know before taking CARBOCISTEINE BIOGARAN CONSEIL, 2 % ENFANTS SANS SUCRE solution buvable édulcorée à la saccharine sodique?
3. How to take CARBOCISTEINE BIOGARAN CONSEIL, 2 % ENFANTS SANS SUCRE solution buvable édulcorée à la saccharine sodique?
4. What are the possible side effects?
5. How to store CARBOCISTEINE BIOGARAN CONSEIL, 2% CHILDREN SUGAR-FREE oral solution sweetened with sodium saccharin?
6. Package contents and other information.
1. WHAT IS CARBOCISTEINE BIOGARAN CONSEIL 2% CHILDREN SUGAR-FREE oral solution sweetened with saccharin sodium AND WHAT IS IT USED FOR?
Pharmacotherapeutic class - ATC code: R05CB03.
This medicine liquefies secretions (mucus) present in the bronchial tubes. It facilitates evacuation through coughing (expectoration).
It is used in cases of recent cough with difficulty in expectoration.
You should consult your doctor if you do not feel any improvement or if you feel less well after 10 days.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING CARBOCISTEINE BIOGARAN CONSEIL 2% children's sugar-free drinkable solution sweetened with sodium saccharin?
Never take CARBOCISTEINE BIOGARAN CONSEIL 2% CHILDREN SUGAR-FREE drinkable solution sweetened with saccharin sodium.
- if you (or your child) are allergic to carbocisteine, methyl parahydroxybenzoate or any of the other components of this medicine (see section 6),
- if you (or your child) have a stomach or intestinal ulcer,
- if your child is under 2 years of age, due to the risk of worsening bronchial congestion.
Warnings and precautions
Ask your doctor, pharmacist or nurse before taking CARBOCISTEINE BIOGARAN CONSEIL.
You (or your child) must not use medicines which prevent coughing (cough suppressants) or which dry up bronchial secretions when taking CARBOCISTEINE BIOGARAN CONSEIL. CARBOCISTEINE BIOGARAN CONSEIL liquefies secretions, making them easier to cough up. Coughing is useful for expectoration.
- if you (or your child) have a fever or if your sputum is "greenish",
- if you (or your child) suffer from chronic (long-term) bronchial or lung disease,
- if you (or your child) have a history of digestive ulcer (stomach or intestine),
- in elderly subjects,
- if co-administered with drugs likely to cause stomach or intestinal bleeding.
If stomach or intestinal bleeding occurs, treatment should be discontinued.
Children and adolescents
Not applicable.
Other medicines and CARBOCISTEINE BIOGARAN CONSEIL 2% CHILDREN SWEETEN DRINKING SOLUTION sweetened with sodium saccharin
Tell your doctor or pharmacist if you (or your child) are taking, have recently taken or may take any other medicines.
CARBOCISTEINE BIOGARAN CONSEIL 2% CHILDREN SUGAR-FREE drinkable solution sweetened with saccharin sodium with food and drink.
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
No data are available on the use of carbocisteine in pregnant women.
If you are pregnant, the use of carbocisteine is not recommended.
This medicine should only be used during pregnancy on the advice of your doctor.
If you discover that you are pregnant during treatment, consult your doctor, who is the only person who can judge whether it is necessary to continue treatment.
Breast-feeding
No data are available on the presence of carbocisteine in breast milk.
It is not advisable to breast-feed your child while taking this medicine.
Driving and use of machinery
Not applicable.
CARBOCISTEINE BIOGARAN CONSEIL 2% ENFANTS SANS SUCRE solution buvable édulcorée à la saccharine sodique contains sodium, glucose, fructose, saccharose, sodium methyl parahydroxybenzoate (E219) and ethanol.
This medicine contains sucrose and glucose. If your doctor has informed you that you are intolerant to certain sugars, contact him/her before taking this medicine.
Sucrose, fructose, glucose
This medicine contains less than 20 mg fructose per 5 ml measuring spoon.
This medicine contains "parahydroxybenzoate" (E219) and may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol (23 mg) sodium per 5 ml measuring spoon, i.e. it is essentially "sodium-free".
This medicine contains 30 mg of alcohol (ethanol) per 5 ml measuring spoon. The amount per measuring spoon is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol contained in this medicine is unlikely to have any noticeable effect.
3. HOW DO I TAKE CARBOCISTEINE BIOGARAN CONSEIL 2% CHILDREN SUGAR-FREE DRINKING SOLUTION sweetened with saccharin sodium?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
The box contains one 5 ml measuring spoon. You may also use a teaspoon.
Use in children and adolescents
Dosage for children aged 2 to 5 years
The recommended dose is 1 teaspoonful 2 times a day.
Dosage for children over 5 years of age
The recommended dose is 1 measuring spoon, 3 times a day.
Method of administration
Take orally.
Use the measuring spoon provided to measure the amount of syrup for one dose (5 ml).
Rinse measuring spoon well after each use.
Close bottle tightly after use.
Duration of treatment
Do not exceed 8-10 days' treatment. Consult your doctor if symptoms worsen or persist after 10 days' treatment.
If you have taken more CARBOCISTEINE BIOGARAN CONSEIL 2% CHILDREN SWEETEN DRINKING SOLUTION sweetened with saccharin sodium than you should have done
Consult your doctor or pharmacist immediately.
If you forget to take CARBOCISTEINE BIOGARAN CONSEIL 2% children's sugar-free oral solution sweetened with sodium saccharin
Do not take a double dose to make up for the one you forgot to take.
If you stop taking CARBOCISTEINE BIOGARAN CONSEIL 2% CHILDREN SUGAR-FREE oral solution sweetened with saccharin sodium
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
- Risk of worsening bronchial congestion in infants.
- Digestive disorders such as stomach pains, nausea, vomiting and diarrhea. Dosage reduction is recommended.
- Bleeding from the stomach or intestine may occur. Treatment should be discontinued.
- Allergic skin rash and anaphylactic reactions such as itching, rash of patches or pimples on the skin, urticaria, swelling of the face and/or neck which may cause difficulty in breathing and endanger the patient (angioedema). In this case, discontinue treatment and consult your doctor immediately.
- A rash of brown or purplish patches which may leave a discoloration on the skin (erythema pigmentum fixata). In this case, consult your doctor immediately.
- Rash of pimples, sometimes with bubbles on the skin, which may also affect the mouth (erythema multiforme), rash of bubbles with detachment of the skin, which may spread to the whole body and endanger the patient (Stevens-Johnson syndrome).
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https: //signalement.social-sante.gouv.fr/
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO USE CARBOCISTEINE BIOGARAN CONSEIL 2% children's sugar-free oral solution sweetened with sodium saccharin?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the bottle. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What CARBOCISTEINE BIOGARAN CONSEIL 2% children's sugar-free oral solution sweetened with sodium saccharin contains
- The active substance is :
Carbocisteine............................................................................................................................. 2 g
per 100 ml drinking solution.
- The other components are :
Hydroxyethylcellulose, sodium saccharin, sodium parahydroxybenzoate, caramel/vanilla* flavoring (contains sucrose, fructose and glucose), sodium hydroxide, purified water.
*Compositionof caramel/vanilla flavoring: cocoa alcoholate and alcoholature, grape alcoholate and alcoholature, vanilla extract, vanillin, coffee extract, anisic aldehyde, propylene glycol, ethyl alcohol.
What CARBOCISTEINE BIOGARAN CONSEIL 2% children's sugar-free drinkable solution sweetened with saccharin sodium is and what it contains
This medicine comes in the form of a 125 ml bottle of drinking solution and a 5 ml measuring spoon.
Marketing authorization holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Marketing authorization holder
BIOGARAN
15, BOULEVARD CHARLES DE GAULLE
92700 COLOMBES
Manufacturer
H2 PHARMA
21 RUE JACQUES TATI
ZAC LA CROIX BONNET
78390 BOIS DARCY
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.