NOTICE
ANSM - Last updated: 20/10/2016
Name of the medicinal product
SOLACY PEDIATRIQUE, tablet for oral suspension
L-Cystine, Coated Vitamin A Acetate, Precipitated Sulfur, Yeast Saccharomyces cerevisiae
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Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or feel less well.
Do not use this medication for children.
What is in this leaflet?
1. What is SOLACY PEDIATRIC, suspension tablet drinking and when is it used?
2. What should be known before taking SOLACY PEDIATRIC, tablet for suspension drinkable ?
3. How to take SOLACY PEDIATRIQUE, tablet for suspension drinkable ?
4. What are the possible side effects?
5. How to store SOLACY PEDIATRIQUE, tablet for suspension drinkable ?
6. Package contents and other information.
1. WHAT SOLACY PEDIATRICS, tablet for oral suspension AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group: Other common cold medications, ATC code: R05X (R. Respiratory system)
Additional symptomatic treatment of nasopharyngeal diseases of infants over 6 months of age and child.
2. BEFORE YOU TAKE SOLACY PEDIATRIC, tablet for oral suspension?
Never take SOLACY PEDIATRIC, tablet for oral suspension:
· if you are allergic (hypersensitive) to the active ingredients or any of the other ingredients of this medication mentioned in section 6
· if you take a dose of 10,000 IU / d or more of vitamin A from Solacy associated with a cyclin antibiotic.
· if you are taking a medicine containing retinoids (vitamin A derivatives)
Warnings and Precautions
A Make sure your doctor or pharmacist before taking Solacy pediatric tablets for oral suspension.
Avoid prolonged treatment in case of digestive intolerance.
This specialty containing vitamin A (retinol), take into account the doses administered when concurrently taking other specialty containing this vitamin. Each tablet contains 1000 IU of vitamin A (retinol), the recommended dosages should be observed in order not to exceed the recommended daily vitamin A nutrient intake listed below:
· infants <1 year = 1250 - 1330 IU
· children 1 to 3 years = 1330 IU
· children aged 4 to 12 = 2000 - 2700 IU
· adolescents = 2700 - 3300 IU
Due to the presence of sucrose, this drug should not be used in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency (rare metabolic diseases).
Other medications and Pediatric Solacy, tablet for oral suspension
Inform your doctor or pharmacist if you are taking, have recently taken or may be taking any other medicines.
You should not take Solacy pediatric if you are taking a medicine containing retinoids (vitamin A derivatives).
You should not take an antibiotic of the cyclin class associated with pediatric Solacy at a dose of 10,000 IU / day or more of vitamin A. This would be more than 3 times the normal Solacy pediatric dose in children from 5 years.
Pediatric Solacy, tablet for oral suspension with food, drinks and alcohol
Not applicable.
Pregnancy and breast feeding
Although the use of this medication is reserved for the child, the attitude to adopt during pregnancy and breastfeeding is mentioned for information purposes only.
In pregnant or nursing mothers, taking into account the daily dietary intake, it is recommended not to exceed a daily dose of 5000 IU vitamin A provided by medicines.
Therefore, do not exceed the dosage recommended by your doctor.
Sport
Not applicable.
Driving and using machines
Not applicable.
Pediatric Solacy, tablet for oral suspension contains sucrose , an excipient with a known effect
3. HOW TO TAKE SOLACY PEDIATRIC, tablet for oral suspension?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
The recommended dose is:
· 6 months to 30 months: 1 tablet per day, for 3 months
· 30 months to 5 years: 2 tablets per day, for 3 months
· from 5 years: 3 tablets per day, for 3 months
To be taken preferably during the meal.
RESERVES to infants over 6 months of age and to the child.
Duration of treatment: In cure of 3 months.
It is IMPERATIVE TO DELAY THE TABLET in a little water or any other cold liquid before taking this medication because the taking of tablet undefined in the child of less than 6 years can lead to a false road (risk of swallowing through and choking).
If you take more SOLACY PEDIATRIC, tablet for oral suspension than you should:
In the event of mistake of an excessively high dose, manifestations of vitamin A overdose may occur. Immediately consult your doctor or pharmacist.
If you forget to take SOLACY PEDIATRIQUE, tablet for oral suspension:
Do not take a double dose to make up for the missed dose.
If you stop taking SOLACY PEDIATRIQUE, tablet for oral suspension:
If you have any further questions on the use of this medication, ask your doctor or pharmacist.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Possibility of digestive disorders (stomach pain)
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE SOLACY PEDIATRIQUE, tablet for oral suspension?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 30 ° C
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What SOLACY PEDIATRIQUE contains, tablet for oral suspension
· The active substances are:
L-cystine ............................................... .................................................. .......................... 36.30 mg
Precipitated Sulfur ................................................ .................................................. ................ 11.00 mg
Coated Vitamin A Acetate *
corresponding quantity of retinol ................................................................................. 1000 IU
Yeast Saccharomyces cerevisiae ** ............................................. ....................................... 38.70 mg
For a tablet of 243 mg.
* Composition of coated vitamin A acetate: vitamin A acetate crystallized at 500,000 IU / g, gelatin, sucrose, corn starch, antioxidant (BHT).
** Yeast Saccharomyces cerevisiae : constituted by high fermentation of washed and dried Saccharomyces cerevisiae.
· The other ingredients are: Microcrystalline cellulose, magnesium stearate, anhydrous citric acid, sodium cyclamate, strawberry flavor ***
*** Composition of the aroma strawberry : maltodextrin, gum arabic, dextrose, gamma undecalactone, butyric acid, cinnamyl butyl isobutyrate butyryllactate, diacetyl, di-n-propyl ketone, ethyl isovaleranate, heliotropyl acetate, octine methyl carbonate, methyl salicylate, ethylvanillin, vanillin, maltol, ethylmaltol, heliotropin, betanaphthylethyl ether, benzoic aldehyde
What is SOLACY PEDIATRIQUE, tablet for oral suspension and contents of the pack
60 tablets for drinkable suspension in cardboard box
Marketing Authorization Holder
GRIMBERG LABORATORIES
19 RUE POLIVEAU
75005 PARIS
Marketing Authorization Operator
GRIMBERG LABORATORIES
19 RUE POLIVEAU
75005 PARIS
Maker
GRIMBERG LABORATORIES
ZA DES BOUTRIES
RUE VERMONT
78704 CONFLANS-SAINTE-HONORINE
Names of the medicinal product in the Member States of the European Economic Area
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