NOTICE
ANSM - Last updated: 27/03/2014
Name of the medicinal product
CARBOCISTEIN RATIOPHARM TIP 2 PER CENT FOR CHILDREN, syrup
framed
Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult your doctor.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
Review summary
In this notice :
1. WHAT CARBOCISTEINE RATIOPHARM TIPS 2 PER CENT FOR CHILDREN, SYRUP AND WHAT IT IS USED FOR?
2. WHAT ARE THE INFORMATION TO BE KNOWN BEFORE TAKING CARBOCISTEIN RATIOPHARM TIP 2 PER CENT FOR CHILDREN, SYRUP?
3. HOW TO TAKE CARBOCISTEIN RATIOPHARM TIP 2 PERCENT CHILDREN, SYRUP?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE CARBOCISTEIN RATIOPHARM TIP 2 PER CENT FOR CHILDREN, SYRUP?
6. ADDITIONAL INFORMATION
1. WHAT CARBOCISTEINE RATIOPHARM TIPS 2 PER CENT FOR CHILDREN, SYRUP AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
MUCOLYTIC.
(R: Respiratory System).
Therapeutic indications
This medication is a fluidizer of bronchial secretions and thus facilitates their evacuation by coughing.
It is recommended in the states of congestion of the bronchi especially in acute bronchitis.
2. WHAT ARE THE INFORMATION TO BE KNOWN BEFORE TAKING CARBOCISTEIN RATIOPHARM TIP 2 PER CENT FOR CHILDREN, SYRUP?
List of information needed before taking the medication
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Never use CARBOCISTEINE RATIOPHARM TIP 2 PER CENT FOR CHILDREN, syrup:
· in case of known allergy to any of the constituents (including methyl parahydroxybenzoate and other parabens);
· (less than 2 years) due to the risk of worsening bronchial congestion.
If in doubt, it is essential to seek the advice of your doctor or pharmacist.
Precautions for use; special warnings
Take special care with CARBOCISTEINE RATIOPHARM TIP 2 PER CENT FOR CHILDREN, syrup:
Special warnings
Medical advice is required:
· in case of fatty or purulent expectoration,
· if you have chronic (long-term) bronchial and lung disease.
It is advisable not to take a cough medication or bronchial drying medication during the treatment period with this medication.
Treatment should not be continued if symptoms worsen. In this case, consult your doctor for a re-evaluation of your treatment.
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
Precautions for use
In case of stomach or duodenal ulcer, PREVENT YOUR DOCTOR.
This medicine contains sodium. This medicine contains 13 mg of sodium per 5 ml of syrup. To be taken into account in patients controlling their sodium dietary intake.
This medicine contains methyl parahydroxybenzoate (E218) and may cause allergic reactions.
In case of doubt do not hesitate to ask the advice of your doctor or pharmacist.
Interaction 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 beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication will only be used during pregnancy if necessary.
Precautions should be taken when administering this medication during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
List of excipients with known effect: Sodium, sucrose (2,9 g per measuring spoon), methyl parahydroxybenzoate (E218).
3. HOW TO TAKE CARBOCISTEIN RATIOPHARM TIP 2 PERCENT CHILDREN, SYRUP?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Child 2 to 5 years: 100 mg twice a day, that is 1 measuring spoon 2 times a day.
Children over 5 years: 100 mg 3 times a day, that is 1 measuring spoon 3 times a day.
THIS MEDICINE HAS BEEN PERSONALLY ISSUED IN A SPECIFIC SITUATION:
· IT MAY NOT BE ADAPTED TO ANOTHER CASE,
· DO NOT ADVISE IT TO ANOTHER PERSON.
Method and route of administration
Oral use.
Duration of treatment
Do not exceed 8 to 10 days of treatment without medical advice.
Symptoms and Instructions for Overdose
Not applicable.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, CARBOCISTEIN RATIOPHARM TIP 2 PERCENT CHILDREN, syrup is likely to have undesirable effects, although not everyone is subject to it:
· Risk of aggravation of bronchial congestion in infants.
· Allergic skin reactions such as itching, rash, urticaria and swelling of the face.
· Possible digestive disorders: nausea, diarrhea, vomiting, upset stomach.
It is advisable in this case to reduce the dosage.
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE CARBOCISTEIN RATIOPHARM TIP 2 PER CENT FOR CHILDREN, SYRUP?
Keep out of the reach and sight of children.
Expiration date
Do not use CARBOCISTEIN RATIOPHARM TIP 2 PERCENT CHILDREN, syrup after the expiry date stated on the vial.
Storage conditions
Store at a temperature below 25 ° C.
If necessary, warnings against visible signs of deterioration
Not applicable.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What is CARBOCISTEIN RATIOPHARM TIP 2 PER CENT FOR CHILDREN, syrup?
The active substance is:
Carbocistein ................................................. .................................................. ...................................... 2 g
For 100 ml of syrup.
The other components are:
Methyl parahydroxybenzoate (E218), sucrose solution, sodium hydroxide, banana flavor, purified water.
A measuring spoon (5 ml of syrup) contains 100 mg of carbocisteine and 2.9 g of sucrose.
Pharmaceutical form and content
What is CARBOCISTEINE RATIOPHARM TIP 2 PER CENT FOR CHILDREN, syrup and contents of the pack?
This medication is in the form of a syrup. 125 ml bottle.
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
TEVA HEALTH
100-110 Esplanade of the General de Gaulle
92931 PARIS LA DEFENSE CEDEX
exploiting
TEVA HEALTH
100-110 Esplanade of the General de Gaulle
92931 PARIS LA DEFENSE CEDEX
Maker
H2 PHARMA
21 RUE JACQUES TATI
ZAC LA CROIX BONNET
78390 BOIS D'ARCY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.