NOTICE
ANSM - Updated: 11/07/2016
Name of the drug
DROSETUX syrup
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse after 3 days.
Summary notice
What does this booklet contain :
1. What is DROSETUX, syrup and in what cases is it used?
2. What information do you need to know before taking DROSETUX, syrup?
3. How to take DROSETUX, syrup?
4. What are the possible side effects?
5. How to store DROSETUX, syrup?
6. Additional information.
1. WHAT DROSETUX, syrup AND WHAT IT IS USED FOR
Pharmacotherapeutic class
Not applicable.
Therapeutic indications
This homeopathic medicine is traditionally used in the treatment of dry coughs, irritation and in troublesome nonproductive coughs.
2. WHAT INFORMATION IS NECESSARY BEFORE TAKING DROESETUX, syrup?
List of information needed before taking the medication
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Cons-indications
Never take DROSETUX, syrup:
· If you are allergic (hypersensitive) to the active substances or to any of the ingredients of this medicine, listed in section 6.
Precautions for use; special warnings
Warnings and precautions for use:
The use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase (rare hereditary diseases) deficiency.
This medicine contains:
· 2.1 g of sucrose for a dose of 2.5 ml,
· 4.2 g of sucrose for a dose of 5 ml,
· 12.6 g of sucrose for a dose of 15 ml,
which must be taken into account in the daily ration in case of a diet low in sugar or diabetes.
Interactions with other drugs
Other medicines and DROSETUX, syrup:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Interactions with food and drinks
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
Given the available data, the use of DROSETUX syrup is possible in pregnant or breastfeeding women.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice or pharmacist before taking this medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
DROSETUX, syrup contains the sucrose.
3. HOW TO TAKE DROPS, syrup?
Instructions for a good use
Not applicable.
Dosage, Mode and / or Route (s) of Administration, Frequency of Administration and Duration of Treatment
Oral way.
This medication should not be used in children under 30 months of age without medical advice.
Dosage
From the onset of the first symptoms of dry cough irritation and non-productive cough annoying:
Adult: take a dose of 15 ml using the measuring cup 2 to 3 times a day.
Children from 5 years: take 1 dose of 5 ml with the measuring cup 3 to 5 times a day.
Children under 5 years old: Take 1 dose of 2.5 ml using the measuring cup 3 to 4 times a day.
Frequency of administration
The catches must be distributed during the day, preferably outside meals.
Space the shots as soon as you improve.
Stop taking as soon as the symptoms disappear.
Duration of treatment
The duration of treatment is 5 days. If there is no improvement after 3 days, consult a doctor.
Symptoms and instructions in case of overdose
If you take more DROPS, syrup than you should:
Immediately consult your doctor or pharmacist.
Instructions for omitting one or more doses
If you forget to take DROSETUX, syrup:
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr .
By reporting side effects, you can help provide more information about the safety of the medicine.
5. HOW TO STORE DROSETUX, syrup?
Keep this medicine out of the reach and sight of children.
Expiration date
Do not take DROPS, syrup after the expiry date stated on the box.
The expiry date refers to the last day of the month.
Storage conditions
No special storage conditions.
Do not store beyond 1 year after opening.
If necessary, warn against some visible signs of deterioration
Do not dispose of any medication at the sewer or with household waste. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What DROSETUX contains, syrup
The active substances are :
Arnica montana 4 CH .............................................. .................................................. ............................ 0.1 g
Belladonna 4 CH ............................................... .................................................. ................................. 0,1 g
Cina 4 CH ............................................... .................................................. .......................................... 0,1 g
Coccus cacti 5 CH .............................................. .................................................. ................................ 0.1 g
Corallium rubrum 4 CH .............................................. .................................................. .......................... 0,1 g
Cuprum metallicum 5 CH .............................................. .................................................. ....................... 0.1 g
Drosera 4 CH ............................................... .................................................. ...................................... 0,1 g
Ferrum phosphoricum 5 CH .............................................. .................................................. .................. 0,1 g
Ipeca 4 CH ............................................... .................................................. .......................................... 0,1 g
Solidago virga aurea 3 DH ............................................. .................................................. ...................... 0,1 g
For 100 g of syrup
The other components are :
Sucrose solution, sodium benzoate (E211), citric acid monohydrate (E330), purified water.
Pharmaceutical form and content
Appearance of DROSETUX, syrup and contents of the pack:
This medicine is in the form of syrup.
One can contains a 150 ml bottle and a measuring cup (15 ml) graduated to 2.5 ml, 5 ml and 15 ml.
Name and address of the marketing authorization holder and the production authorization holder responsible for batch release, if different
Marketing Authorization Holder and Manufacturer
Holder
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
LA FRANCE
exploiting
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
LA FRANCE
Maker
Boiron
2 AVENUE OF WESTERN LYONNAIS
69510 MESSIMY
LA FRANCE
Names of the drug in the member states of the European Economic Area
Not applicable.
Date of approval of the notice
The last date this leaflet was last revised is {date}.
AMM under exceptional circumstances
Not applicable.
Internet information
Detailed information on this medicine is available on the ANSM website (France).
Information reserved for health professionals
Not applicable.
Other
Not applicable.