NOTICE
ANSM - Updated on : 16/10/2023
Product name
CARBOCISTEINE BIOGARAN CONSEIL 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique
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 of the side effects listed above, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 5 days.
What does this leaflet contain?
1. What is CARBOCISTEINE BIOGARAN CONSEIL 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique and what is it used for?
2. What do I need to know before taking CARBOCISTEINE BIOGARAN CONSEIL 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique?
3. How to take CARBOCISTEINE BIOGARAN CONSEIL 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique?
4. What are the possible side effects?
5. How to store CARBOCISTEINE BIOGARAN CONSEIL 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique?
6. Package contents and other information.
1. WHAT IS CARBOCISTEINE BIOGARAN CONSEIL 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: MUCOLYTICS - ATC code: R05CB03.
This medicine liquefies secretions (mucus) in the bronchial tubes. It facilitates evacuation by coughing (expectoration).
This medicine is reserved for adults and adolescents over 15 years of age.
It is used in cases of recent cough with difficulty in expectoration.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING CARBOCISTEINE BIOGARAN CONSEIL 5 PER CENT SUGAR-FREE, oral solution in bottle sweetened with sodium saccharin?
Never take CARBOCISTEINE BIOGARAN CONSEIL 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique:
- if you are allergic to carbocisteine or to any of the other ingredients of this medicine (in particular methyl parahydroxybenzoate), as listed in section 6.
- if you have stomach or intestinal ulcers.
Warnings and precautions
You should not take medicines that prevent coughing (cough suppressants) or that 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.
Ask your doctor, pharmacist or nurse before taking CARBOCISTEINE BIOGARAN CONSEIL.
- if you have a fever or if your sputum is "greenish",
- if you have chronic bronchial or lung disease,
- if you have a history of digestive ulcers (stomach or intestine),
- in elderly subjects,
- if co-administered with drugs likely to cause stomach or intestinal bleeding.
Children and adolescents
Not applicable.
Other medicinal products and CARBOCISTEINE BIOGARAN CONSEIL 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique.
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicine.
This medicine contains carbocisteine. Other drugs contain carbocisteine. Do not combine them so as not to exceed the maximum recommended doses (see "HOW TO TAKE CARBOCISTEINE BIOGARAN CONSEIL 5 PER CENT SUGAR-FREE, oral solution in bottle sweetened with sodium saccharin").
CARBOCISTEINE BIOGARAN CONSEIL 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique with food, beverages and alcohol.
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. Carbocisteine 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 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique contains sodium, sodium methyl parahydroxybenzoate (E219), glucose, fructose, sucrose 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 59.6 mg fructose per 15 ml measuring cup.
This medicine contains "parahydroxybenzoate" (E219) and may cause allergic reactions (possibly delayed).
This medicine contains less than 1 mmol (23 mg) of sodium per 15 ml measuring cup, i.e. it is essentially "sodium-free".
This product contains 90 mg of alcohol (ethanol) per 15-ml measuring cup. The amount per dose of this medicine is equivalent to 3 ml beer or 1 ml wine.
The small amount of alcohol contained in this medicine is unlikely to have any noticeable effect.
3. HOW TO TAKE CARBOCISTEINE BIOGARAN CONSEIL 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique?
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.
Dosage
The usual dose is 1 measuring cup (15 ml) 3 times a day (morning, noon and evening), between meals.
Once filled, the 15 ml measuring cup contains 750 mg carbocisteine.
If you are following a sugar-free or low-sugar diet, this medicine is suitable for your diet.
Method of administration
- Use the measuring cup to measure the amount of oral solution for one dose (15 ml). You can also use a tablespoon (1 15 ml measuring cup is equivalent to 1 tablespoon).
- Rinse the measuring cup well after each use.
- Close the bottle tightly after use.
Duration of treatment
Do not exceed 5 days' treatment. Consult your doctor if symptoms worsen or persist after 5 days' treatment.
If you have taken more CARBOCISTEINE BIOGARAN CONSEIL 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique than you should have
Consult your doctor or pharmacist immediately.
If you forget to take CARBOCISTEINE BIOGARAN CONSEIL 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique
Do not take a double dose to make up for the one you forgot to take.
If you stop taking CARBOCISTEINE BIOGARAN CONSEIL 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique
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 product may cause undesirable effects, but they do not occur systematically in everyone.
- Digestive disorders such as stomach pains, nausea, vomiting and diarrhoea. It is advisable to reduce dosage.
- Bleeding from the stomach or intestine. Treatment should be discontinued.
- Allergic skin rash and anaphylactic reactions such as hives, itching, rash of patches or pimples on the skin, 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 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging and 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 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique contains
- The active substance is :
Carbocisteine............................................................................................................................. 5 g
per 100 ml drinking solution.
- The other components are :
Hydroxyethylcellulose, sodium saccharin, sodium parahydroxybenzoate, caramel/vanilla* flavoring (contains sucrose, fructose, glucose and ethanol), 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, ethanol.
What is CARBOCISTEINE BIOGARAN CONSEIL 5 POUR CENT SANS SUCRE, solution buvable en flacon édulcorée à la saccharine sodique and what does it contain?
This medicine is available as an oral solution in a bottle.
125 ml, 150 ml, 200 ml or 300 ml bottle with measuring cup.
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 D'ARCY
or
LABORATOIRES BIOPHELIA
RUE MICHAEL FARADAY
BP 442
ZAC DE LA VRILLONNERIE
37174 CHAMBRAY LES TOURS CEDEX
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.