ACTISOUFRE Spray Nasal or oral spray (throat) in a 100 ml spray or in a box of 30 vials is used in chronic inflammatory conditions of the upper respiratory tract such as chronic rhinitis and nasopharyngitis .
For warnings, precautions for use and contraindications, please consult the instructions for use of this non-prescription medication.
This very gentle cleansing solution helps reduce inflammation of the nasal mucosa and promotes the elimination of cumbersome secretions , especially during chronic or recurrent upper respiratory tract conditions.
The vocation of actisoufre is twofold: assimilated to a gesture of hygiene, its spraying by microdiffusion moistens and cleans the nasal mucosa. It also promotes the reduction of inflammatory states of the upper airways .
Equipped with a non-invasive tip, Rhinotherm facilitates the elimination of nasal secretions in children who do not yet know how to blow their nose. Rich in sulphur, this nasal solution aims to reduce inflammation of the ENT sphere.
The ancestral properties of sulfur have never wavered over the years, particularly in improving breathing, which thus optimizes the oxygenation of the body.
This non-prescription drug Actisoufre is indicated in chronic inflammatory conditions of the upper respiratory tract such as rhinitis and chronic nasopharyngitis . This sulfur drug composed of a source of vitamins and trace elements , as well as sulfur associated with a yeast extract, will relieve congested nasal and/or oral passages.
Adults and children
infants
Don't :
Nasally:
Two nasal irrigations per day. Orally:
Children under 5 years old: half to one ampoule per day.
Adults and children over 5 years old: 2 ampoules per day.
This drug provides sulfur and yeasts in the form of sodium monosulfide nonahydrate and Saccharomyces cerevisie.
The composition of this sulfur-enriched Actisoufre nasal spray will help drain the nose and protect the respiratory mucous membranes. Indeed, the nasal mucosa filters thousands of liters of air per day. Directly in contact with the environment, it constitutes the first protective barrier of the respiratory system against external agents.
Active substances: Sodium monosulphide (sulphur compound)
Quantity corresponding to sodium sulphide 13.00 mg; Saccharomyces cerevisiae type D* 500.00 mg For a 100 ml bottle.
Other substances: Sodium saccharin, polysorbate 80, sodium methyl parahydroxybenzoate (E219), 20% chlorhexidine digluconate solution, sodium chloride, essence composed of Neroli A ( essential oils of petitgrain bitter orange and sweet orange, geraniol, terpineol , linalool, methyl anthranylate, phenylethyl alcohol, geranyl acetate), purified water.
Excipients with known effect: Sodium (in the form of chloride and saccharin), Sodium methyl parahydroxybenzoate (E219)
The active substances are: Sodium monosulphide nonahydrate 4 mg, Saccharomyces cerevisiae * 50 mg, for one 10 ml ampoule
* yeasts.
The other ingredients are: Sodium saccharin, polysorbate 80, essence composed of Neroli *, sodium chloride, purified water.
* Composition of the essence composed of Neroli: essential oils of bitter orange petitgrain and sweet orange, geraniol, terpineol, linalool, methyl anthranylate, phenylethyl alcohol, geranyl acetate.
Contraindication
Hypersensitivity to one of the constituents of the product and in particular to sulphur.
Pregnancy and breast feeding
In the absence of data on pregnancy and lactation, taking the drug during pregnancy and lactation is not recommended.
Caution
By oral route and in the event of a low-sodium diet, take into account the sodium intake which is 4.2 mg of sodium per spray (i.e. 0.18 mmol of sodium/spray).
100 ml of solution (i.e. 90 sprays of 2 to 3 seconds each) provide 378 mg of sodium (i.e. 16.4 mmol of sodium/100 ml).
The presence of sodium methyl parahydroxybenzoate is likely to cause an allergic reaction such as delayed hypersensitivity reactions in subjects sensitive to preservatives of the parahydroxybenzoate family (and their derivatives).
Side effects
By oral route: possibility of digestive disorders such as gastralgia.
Medicinal product not subject to medical prescription. Each bottle of Actisoufre spray contains 100 ml, i.e. 90 sprays (2 to 3 seconds each).
ACTISOUFRE is also available in boxes of 30 vials of 10 ml.
Chronic nasopharyngitis in infants, the best remedy: You
His family circle, the nanny, the children in the crèche or the nursery, everything is conducive to contaminating him, even if he is in excellent health. A toddler can suffer from nasopharyngitis up to 10 times a year! Also, you might as well take the right steps to soothe it at the first symptoms.
Attention, before ordering check the incompatibilities with your current treatments. If you need advice contact us. Do not leave medicines within the reach of children. If the symptoms persist, if they worsen or if new symptoms appear, contact our pharmacists.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated on : 13/10/2020
Product name
ACTISOUFRE, nasal/oral spray solution in pressurized bottle
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as it is described in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any of the unwanted effects, tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is ACTISOUFRE nasal/oral spray solution in pressurized bottle and what is it used for?
2. What do I need to know before using ACTISOUFRE nasal/oral spray solution in a pressurized bottle?
3. How do I use ACTISOUFRE, nasal/oral spray solution in a pressurized bottle?
4. What are the possible side effects?
5. How should ACTISOUFRE nasal/oral spray solution be stored?
6. Package contents and other information.
1. WHAT IS ACTISOUFRE, nasal/oral spray solution in pressurized bottle AND WHAT IS IT USED FOR?
Pharmacotherapeutic class Other cold medications. ATC code: R05X
This drug is recommended for chronic inflammatory conditions of the upper respiratory tract, such as chronic rhinitis and rhinopharyngitis.
2. WHAT DO I HAVE TO KNOW BEFORE USING ACTISOUFRE, nasal/oral spray solution in pressurized bottle?
Never use ACTISOUFRE, nasal/oral spray solution in a pressurized bottle:
- if you are allergic (hypersensitive) to any of the active ingredients, particularly sulfur, or to any of the other ingredients listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using ACTISOUFRE, nasal/oral spray solution in pressurized bottle.
Other medicines and ACTISOUFRE, nasal/oral spray solution in pressurized bottle:
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
ACTISOUFRE, nasal/oral spray solution in pressurized bottle with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
Do not use this product during pregnancy or while breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
ACTISOUFRE, nasal/oral spray solution in pressurized bottle contains sodium methyl parahydroxybenzoate (E219).
This drug contains less than 1 mmol (23 mg) of sodium per oral spray, i.e. it is essentially "sodium-free".
The presence of sodium methyl parahydroxybenzoate may lead to allergic reactions of the delayed hypersensitivity type in subjects sensitive to preservatives of the parahydroxybenzoate family (and their derivatives).
3. HOW TO USE ACTISOUFRE, nasal/oral spray solution in pressurized bottle?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
By nasal route:
Adults and children
The recommended dose is one prolonged spray* in each nostril 3 times a day, with the head tilted back.
Use in infants
One spray in each nostril 2 times a day.
Method of administration
Adults and children
Fit nasal spray tip (short nozzle) (see diagram). Insert the nozzle into the nostril and apply pressure to deliver a dose of product.
*The duration of a prolonged spray is estimated at 2 to 3 seconds for each nostril.
During each spray, please hold the bottle either upside down or sideways to avoid excessive consumption of propellant.
Use in infants
In order to avoid laryngospasm, the nasal spray should be administered with the infant in a side-lying position, or with the head tilted to one side in a sitting position for sitting infants.
Insert nasal cannula into nostril and spray firmly.
Repeat the operation for the other nostril, tilting the head to the other side.
Do not use:
Never carry out a nasal spray when the infant's head is backwards, to prevent the liquid from going down the throat.
By mouth:
One prolonged spray, 3 times a day, directly into the oral cavity, then swallow.
The duration of a prolonged spray is estimated at 2 to 3 seconds.
Method of administration
Do not use mouthpiece before 3 years.
Before the age of 3, use the nasal spray regardless of the route of administration.
From 3 years of age:
Insert mouthpiece (long, right-angled tip) (see diagram).
Insert the mouthpiece into the oral cavity, then apply pressure to deliver a dose of product.
When spraying, make sure you hold the bottle either upside down or sideways, to avoid excessive consumption of propellant.
For hygienic reasons, clean the nasal or mouthpiece after each use.
Do not use the bottle horizontally:
If you have used moreACTISOUFRE , nasal/oral spray solution in pressurized bottle than you should have:
Consult your doctor or pharmacist immediately.
If you forget to use ACTISOUFRE, nasal/oral spray solution in pressurized bottle:
Do not take a double dose to make up for the one you forgot to take.
If you stop using ACTISOUFRE, nasal/oral spray solution in pressurized bottle :
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Stomach upset may occur orally.
Reporting side effects
If you experience any side effects, please tell 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE ACTISOUFRE, nasal/oral spray solution in pressurized bottle?
Keep out of sight and reach of children.
Store at temperatures not exceeding 30°C.
Pressurized container:
The container contains a pressurized liquid. Do not expose to temperatures exceeding 50°C. Do not puncture container.
Do not use this medicine after the expiration date indicated on the packaging after EXP. The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What ACTISOUFRE nasal/oral spray solution in pressurized bottle contains
- The active ingredients are :
Sodium monosulfide
Quantity corresponding to sodium sulfide...................................................................... 13.00 mg
Yeast extract Saccharomyces cerevisiae type D...500.00 mg
Per 100 ml bottle
- Other components are :
Saccharin sodium, polysorbate 80, sodium methyl parahydroxybenzoate (E219), 20% chlorhexidine digluconate solution, sodium chloride, Neroli* flavor, purified water.
Neroli* aroma composition: petitgrain bigaradier and sweet orange essential oils, geraniol, terpineol, linalool, methyl anthranylate, phenylethyl alcohol, geranyl acetate.
What ACTISOUFRE nasal/oral spray solution in pressurized bottle is and what it contains
This medicine comes in the form of a nasal/oral spray solution in a 100 ml pressurized bottle with two nozzles: one for the nose and one for the mouth. Box of 1 bottle.
Marketing authorization holder
LABORATOIRES GRIMBERG SA
44 AVENUE GEORGES POMPIDOU
92300 LEVALLOIS-PERRET
FRANCE
Marketing authorization holder
LABORATOIRES GRIMBERG SA
ZA DES BOUTRIES, RUE VERMONT
78704 CONFLANS SAINTE HONORINE CEDEX
FRANCE
Manufacturer
LABORATOIRES GRIMBERG SA
ZA DES BOUTRIES
RUE VERMONT
78704 CONFLANS SAINTE HONORINE CEDEX
FRANCE
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
< {MM/YYYY}>< {month/YYYY}.>
Other
Not applicable.
Detailed information on this drug is available on the ANSM (France) website.
Médicament soufré
soufre, levure
.Présentations. Composition.Indications.Contre-indications.Grossesse et allaitement.Mode d'emploi et posologie. Conseils.Effets indésirables.Lexique
ACTISOUFRE : solution pour pulvérisation buccale ou nasale ; flacon pressurisé de 100 ml (90 doses) avec embouts buccal et nasal.
Non remboursé - Prix libre -
ACTISOUFRE : suspension buvable ou nasale ; boîte de 30 ampoules de 10 ml et flacon compte-gouttes.
Non remboursé - Prix libre -
Laboratoire Grimberg
| p 100 ml | p amp | |
| Sulfure de sodium (soufre) | 13 mg | 4 mg |
| Levure Saccharomyces cerevisiae | 500 mg | 50 mg |
| Sodium | 378 mg |
Posologie usuelle:
Par voie orale :
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