NOTICE
ANSM - Last updated: 27/10/2011
Name of the medicinal product
FLUISEDAL WITHOUT PROMETHAZINE, syrup
Meglumine Benzoate / Polysorbate 20
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 a physician.
· 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 FLUISEDAL WITHOUT PROMETHAZINE, syrup AND WHAT IT IS USED FOR?
2. BEFORE YOU TAKE FLUISEDAL WITHOUT PROMETHAZINE, SYRUP?
3. HOW TO TAKE FLUISEDAL WITHOUT PROMETHAZINE, syrup?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE FLUISEDAL WITHOUT PROMETHAZINE, syrup?
6. ADDITIONAL INFORMATION
1. WHAT FLUISEDAL WITHOUT PROMETHAZINE, syrup AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
MUCOLYTIC
(R. Respiratory system)
Therapeutic indications
Supplemental treatment of disorders of bronchial secretion.
2. BEFORE YOU TAKE FLUISEDAL WITHOUT PROMETHAZINE, 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
Do not take FLUISEDAL WITHOUT PROMETHAZINE, syrup in the following cases:
· in case of known allergy to one of the constituents;
· (less than 2 years) due to the risk of worsening bronchial congestion.
This medication is GENERALLY NOT RECOMMENDED during pregnancy ( see Pregnancy and Lactation ).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use; special warnings
Special warnings
Do not take an antitussive medication or bronchial drying medication during the treatment period with this medication.
Consult your doctor:
· in case of purulent expectoration, fever,
· in case of chronic bronchial or lung disease.
Treatment should not be continued if symptoms worsen. In this case, consult your doctor for a re-evaluation of your treatment.
If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.
The use of this medication is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Precautions for use
In case of diabetes or low-sugar diet, consider sugar intake:
· 3.6 g per teaspoon
· 10.8 g per tablespoon.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR 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 - Breastfeeding
The use of this medication is not recommended during pregnancy.
As a precaution, it is preferable not to use this medication while breastfeeding.
GENERALLY, DURING PREGNANCY AND BREASTFEEDING, ALWAYS REQUEST NOTICE TO YOUR DOCTOR OR YOUR PHARMACIST BEFORE TAKING A MEDICINE.
Sport
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
No effects on the ability to drive and use machines have been reported.
List of excipients with known effect
List of excipients with known effect: sucrose
3. HOW TO TAKE FLUISEDAL WITHOUT PROMETHAZINE, syrup?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
The usual dosage is:
In adults and children from 12 years : 2 to 4 tablespoons per day.
In children from 6 to 12 years : 4 to 8 teaspoons per day.
In children from 30 months to 6 years : 3 to 4 teaspoons per day.
In children from 24 to 30 months : 1 to 3 teaspoons per day.
In all cases, follow the prescription of your doctor.
Method and route of administration
Oral use.
Duration of treatment
Do not exceed 8 days of treatment without medical advice.
Symptoms and Instructions for Overdose
If you took more FLUISEDAL WITHOUT PROMETHAZINE, syrup you did not need:
Overdosage may worsen bronchial overcrowding ( see What side effects may occur? ).
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, FLUISEDAL SANS PROMETHAZINE, syrup is likely to have side effects, although not everyone should, please inform your doctor or pharmacist.
Risk of aggravation of the bronchial congestion in particular in the infant and in some patients incapable of effective expectoration.
If you notice any side effects not listed in this leaflet, or if certain side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE FLUISEDAL WITHOUT PROMETHAZINE, syrup?
Keep out of the reach and sight of children.
Expiration date
Do not use FLUISEDAL WITHOUT PROMETHAZINE, syrup after the expiry date stated on the outer packaging.
Storage conditions
Store at a temperature below 25 ° C and away from light.
If necessary, warnings against visible signs of deterioration
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 does FLUISEDAL WITHOUT PROMETHAZINE, syrup contain?
The active substances are:
Meglumine Benzoate
Quantity corresponding to anhydrous product at ............................................ .............................................. 2.6 g
Polysorbate 20 ................................................ .................................................. .................................. 0.3 g
For 100 ml of syrup.
1 teaspoon contains 3.6 g of sucrose
1 tablespoon contains 10.8 g of sucrose
The other components are:
C olorant glucosic E150 *, sucrose, caramel flavor **, purified water.
* Composition of the glucose dye: glucose, ammonia
** Composition of caramel flavor: vanillin, piperonal, gamma nonalactone, maltol, acetylmethylcarbinol, propylene glycol
Pharmaceutical form and content
What is FLUISEDAL WITHOUT PROMETHAZINE, syrup and contents of the package
This medicine is in the form of syrup- 125 and 250 ml flasks.
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
LABORATORY OF ELERT THERAPEUTIC ACHIEVEMENTS
181-183 STREET ANDRE KARMAN
93303 AUBERVILLIERS CEDEX
exploiting
ELERT LABORATORIES
181 - 183, ANDRE KARMAN STREET
93303 AUBERVILLIERS CEDEX
Maker
LABORATORY OF ELERT THERAPEUTIC ACHIEVEMENTS
181-183 STREET ANDRE KARMAN
93300 AUBERVILLIERS
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.