FLUISEDAL syrup 125ml
MEGLUMINE BENZOATE 130 mg/5 ml + POLYSORBATE  15 mg/5 ml + PROMETHAZINE HYDROCHLORIDE 2.5 mg/5 ml syrup (FLUISEDAL)
Alleviation of unproductive and irritative cough in adults and children aged more than 2 years.
The drug is recommended for the treatment of non-productive cough and irritating cough in adults and children from 2 years of age, especially when the cough develops in the evening and at night.
Do not take Fluicedal syrup in the following cases (contraindications)
– Infants (under 2 years of age) due to the risk of accumulation of bronchial secretions.
– Allergy to any component of the drug, in particular antihistamines.
– Previously detected or ongoing agranulocytosis (a sharp decrease in the number of leukocytes in the blood)
– Difficulty urinating caused by impaired function of the present gland or other etiology.
– Certain forms of glaucoma (increased intraocular pressure).
The use of this drug is not allowed during pregnancy or in combination with sultopride, unless the doctor advises you to do so.
For more information or advice, ask your doctor or pharmacist.
Special precautions when using Fluicedal syrup (special warning)
In case of cough in babies, it is necessary to consult a doctor.
Do not use this medicine to treat productive cough. In this case, coughing is a natural defense mechanism that is needed to release bronchial secretions.
If the cough becomes productive, accompanied by sputum accumulation and fever, consult a doctor.
In case of chronic (prolonged) disease of the bronchi or lungs, which is accompanied by cough and accumulation of sputum, it is necessary to consult a doctor.
Do not use this drug together with drugs that liquefy bronchial secretions (expectorants, mucolytics).
Treatment should not be continued if symptoms worsen. In this case, consult a doctor to review the treatment.
The use of the drug is not recommended for patients with fructose intolerance, glucose-galactose malabsorption syndrome, as well as sucrose-isomaltase deficiency (rare metabolic diseases).
This medicine contains sulfites that may cause or aggravate allergic reactions.
Safety measures during use
The use of this drug is not recommended for children under 2 years of age.
In case of long-term liver or kidney diseases, consult your doctor for dose selection.
When using this drug, you need to consult a doctor in the following cases:
– Severe heart disease or epilepsy
– Children with asthma or gastroesophageal reflux
– Elderly patients: who have a tendency to constipation, dizziness, drowsiness, disorders of the pituitary gland, it is necessary to inform the doctor before taking antihistamine.
Alcoholic drinks and drugs containing alcohol cannot be taken during the treatment.
It is recommended to avoid exposure to direct sunlight during treatment.
Care should be taken when using the drug due to the risk of sedative effect. Combination with other sedative drugs is not recommended (see paragraph “Taking and using other drugs”).
For diabetics or those on a low-sugar diet, consider the sugar content of this preparation in the daily ration: 3.6 g per 5 ml measuring spoon and 10.8 g per dinner spoon. If you have doubts about the correctness of taking the drug, consult a doctor or pharmacist.
Taking and using other drugs
In order to avoid drug interactions and in particular interactions with sultopride, inform your doctor or pharmacist about the current treatment
This drug contains the antihistamine promethazine and meglumine benzoate. Other medicines also contain these drugs. Do not mix drugs to avoid exceeding the recommended maximum dose (see Dosage).
It is not recommended to use together with other sedatives, due to the risk of enhancing the sedative effect of this drug.
The use of the drug is not recommended during pregnancy, unless the doctor gives permission. If you find out that you are pregnant during the treatment, consult your doctor immediately. Only your doctor can adapt the treatment to your condition. Ask your doctor or pharmacist for advice before taking any medicine.
Due to the fact that this drug is excreted in breast milk, do not take the drug during lactation. Ask your doctor or pharmacist for advice before taking any medicine.
Influence on the driving of the car and other mechanisms
Attention should be paid especially by drivers and machinery users who have a tendency to drowsiness when using this drug, especially at the initial stage of treatment.
The phenomenon of drowsiness is further aggravated by taking alcoholic beverages or drugs containing alcohol.
List of excipients with known effect: sodium metabisulphite (E223), sucrose (3.6 g per 5 ml measuring spoon and 10.8 g per dinner spoon), propylene glycol.
How to take Fluisedal syrup
Dosage: Only adults and children from 2 years of age.
Adults: 3-4 tablespoons per day.
For children, use a 5 ml measuring spoon full of syrup and follow the doctor’s instructions.
According to the indications:
– Children up to 12-15 years old: 6-9 measuring spoons (one measuring spoon is 5 ml) per day,
– Children up to 6-12 years old: 4-6 measuring spoons (one measuring spoon is 5 ml) per day,
– Children from 24 months to 6 years: 3-4 measuring spoons (one measuring spoon is 5 ml) per day.
In case of development of cough in infants, it is necessary to consult a doctor.
This drug is prescribed for you personally in specific situations:
– It may not be suitable for other occasions,
– Do not advise others to use it.
Method of use: oral
Duration of treatment: treatment should be done for a short time (several days) and be limited to the periods of time when the patient starts to cough.
If you take more Fluicedal syrup than you should: In case of overdose or accidental overdose, contact your doctor immediately.
- Possible side effects
Like all medicines, Fluicedal syrup can cause side effects, although not everybody gets them.
– Risk of accumulation of bronchial secretions, especially in infants and those patients who have difficulty in removing sputum.
Some effects require immediate discontinuation of treatment and notification of the physician.
– Allergic reactions:
o Skin rash (erythema, eczema, purpura, urticaria),
o Asthma attack,
o Angioedema (urticaria with sudden swelling of the face and throat, which may cause difficulty breathing),
o anaphylactic shock,
o Skin irritation due to exposure to the sun,
– a significant decrease in leukocytes, which may cause or increase fever with or without signs of infection,
– Decrease in the number of platelets in the blood, which may cause bleeding from the nose and gums.
Other effects are more common:
– Drowsiness, impaired concentration, which is especially evident at the initial stage of treatment,
– memory or concentration disorders, dizziness (more often in the elderly),
– Violation of coordination, tremors,
– Confusion (disorientation), hallucinations
– Dry mouth, visual disturbances, urinary retention, constipation, rapid heart rate, drop in blood pressure.
Less often, signs of irritation: agitation, neurosis and insomnia may develop.
Adverse event reporting
In case of developing any kind of side effects, the patient should contact the attending physician or pharmacist. This also applies to side effects that may not be listed in this instruction. Adverse events can also be reported through the pharmacosafety system on the website: www.ansm.sante.fr. By reporting side effects, each patient can participate in gathering additional information about the safety of this drug.
- How to store Fluicedal syrup
Keep out of reach of children and protected from sunlight. Do not use Fluicedal syrup after the expiration date indicated on the bottle. Do not store above 300C. Do not dispose of the drug in waste water or household waste. Ask your doctor how to dispose of the medicine you no longer need. These measures will help to protect the environment.
- Additional information
Active substances: meglumine benzoate (expressed as anhydrous salt): 2.600 g, polysorbate 20: 0.300 g, promethazine hydrochloride: 0.050 g in 100 ml of syrup.
1 measuring spoon (5 ml) contains 130 mg of meglumine benzoate, 15 mg of polysorbate 20, 2.5 mg of promethazine hydrochloride and 3.6 g of sucrose.
1 tablespoon (15 ml) contains 390 mg of meglumine benzoate, 45 mg of polysorbate 20, 7.5 mg of promethazine hydrochloride and 10.8 g of sucrose.
Other ingredients: ascorbic acid, sodium metabisulfite (E 223), caramel color (E 150) (caramel is obtained by heating sucrose or other dietary sugars), caramel flavoring (vanilla solution, piperonal, gamma-nonalactone, maltol and acetylmethylcarbinol in propylene glycol), sucrose, purified water.
The drug is a syrup. In 125-ml or 250-ml bottles
Owner/Operator/Manufacturer: LABORATORIES ELETRE
181-183 Andre Carmen Street 93300 Aubervillers – Tel: +33 (0) 1 48 34 75 03
The fact sheet was approved on October 18, 2010
More information about the drug is available on the ANSM website (France).