Actisoufre Rhinitis Rhinopharyngitis is used in chronic inflammatory conditions of the upper respiratory tract, such as chronic rhinitis and rhinopharyngitis. It can be used as a nasal or oral spray.
For information on warnings, precautions for use and contraindications, please consult the package insert for this non-prescription medication.
This gentle cleansing solution helps reduce inflammation of the nasal mucosa, and helps eliminate congested secretions, particularly in the case of chronic or recurrent upper respiratory tract infections.
Thanks to its hypertonic concentration enriched with sulfur, this spray decongests the nose and facilitates the evacuation of nasal secretions. It is recommended for adults and children aged 6 and over to help prevent and relieve the symptoms of allergic rhinitis:
To gently and effectively relieve the symptoms of colds and nasopharyngitis in your children, discover our recommendation with Pediakid Nose and Throat Spray, a precious ally in the pharmacy.
actisoufre has a dual purpose: as a hygienic gesture, its microdiffusion spray moistens and cleanses the nasal mucosa. It also helps reduce inflammation of the upper airways.
Equipped with a non-invasive nozzle, Rhinotherm facilitates the elimination of nasal secretions in children who cannot yet blow their nose. Rich in sulfur, this nasal solution is designed to reduce inflammation of the ENT sphere.
The ancestral properties of sulfur have never wavered over the years, notably in improving breathing, which optimizes oxygenation of the body.
Actisoufre is indicated for chronic inflammatory conditions of the upper respiratory tract, such as chronic rhinitis and rhinopharyngitis. This sulfur-containing medicine, composed of a source of vitamins andtrace elements, as well as sulfur combined with yeast extract, will relieve blocked nasal and/or oral passages.
In the event of a blocked nose, essential oils can also be inhaled.
How to use Actisoufre spray
Adults and children
Infants
Do not :
Give your opinion on the advice for use and dosage of Actisoufre Spray nasal or throat for Rhinitis with our partner Verified opinions after your purchase. Method and route of administration :
This medicine contains sulfur and yeast in the form of sodium monosulfide nonahydrate and Saccharomyces cerevisie.
The composition of Actisoufre nasal spray, enriched with sulfur, helps to drain the nose and protect the respiratory mucosa.The nasal mucosa filters thousands of liters of air a day. Directly in contact with the environment, it constitutes the respiratory system's first protective barrier against external agents.
Active ingredients: Sodium monosulfide (sulfur compound)
Quantity corresponding to sodium sulfide 13.00 mg; Saccharomyces cerevisiae type D* 500.00 mg For a 100 ml bottle.
Other ingredients: Saccharin sodium, polysorbate 80, sodium methyl parahydroxybenzoate (E219), 20% chlorhexidine digluconate solution, sodium chloride, Neroli A compound oil(essential oils of petitgrain bigaradier and sweet orange, geraniol, terpineol, linalool, methyl anthranylate, phenylethyl alcohol, geranyl acetate), purified water.
Notable excipients: Sodium (as chloride and saccharin), sodium methyl parahydroxybenzoate (E219).
Contraindication
Hypersensitivity to any of the product's constituents, particularly sulfur.
Pregnancy and breast-feeding
In the absence of data concerning pregnancy and breast-feeding, use of this product during pregnancy and breast-feeding is not recommended.
Warnings
For oral use and in case of low-sodium diet, take into account the sodium intake of 4.2 mg of sodium per spray (i.e. 0.18 mmol of sodium/spray).
100 ml solution (i.e. 90 sprays of 2 to 3 seconds each) provides 378 mg sodium (i.e. 16.4 mmol sodium/100 ml).
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).
Undesirable effects
Oral: possible gastralgia-type digestive disorders.
Not subject to medical prescription. Each bottle of Actisoufre spray contains 100 ml, or 90 sprays (2 to 3 seconds each).
Actisoufre is also available in boxes of 30 x 10 ml ampoules.
The best remedy for chronic nasopharyngitis in infants: You
Your baby's family, nanny, children at nursery or day-care center can all contaminate him, even if he's in excellent health. A toddler can suffer from rhinopharyngitis up to 10 times a year! So it's a good idea to take steps to soothe him at the very first symptoms.
Before ordering, please check for incompatibilities with your current treatments. If you need advice, please contact us. Keep medicines out of the reach of children. If symptoms persist or 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.
Ce médicament associe du soufre et un extrait de levures, source de vitamines et d'oligoéléments.
Il est utilisé dans le traitement d'appoint des rhinites et des rhinopharyngites chroniques.
Les prix mentionnés ne tiennent pas compte des « honoraires de dispensation » du pharmacien.
| p 100 ml | p amp | |
| Sulfure de sodium (soufre) | 13 mg | 4 mg |
| Levure Saccharomyces cerevisiae | 500 mg | 50 mg |
| Sodium | 378 mg |
Ce médicament ne doit pas être utilisé en cas d'intolérance au soufre.
L'effet de ce médicament pendant la grossesse ou l'allaitement est mal connu. Par prudence, son usage est déconseillé chez la femme enceinte ou chez celle qui allaite.
Flacon pressurisé : la solution doit être pulvérisée, après un mouchage soigneux, dans chaque narine, pendant 2 ou 3 secondes. Elle peut aussi être pulvérisée directement dans la bouche, puis avalée.
Ampoule : bien agiter avant l'emploi. La persistance d'un dépôt non soluble dans l'ampoule est normale. Le contenu de l'ampoule peut être dilué dans un verre d'eau et avalé au cours des repas. Il peut aussi être utilisé en irrigation nasale après introduction dans le flacon compte-gouttes.
Par voie nasale :
Pour plus de confort, il est préférable de faire tiédir la solution avant de l'utiliser en irrigation.
Rincez soigneusement le flacon compte-gouttes à l'eau courante après usage ; laissez-le sécher tête en bas.
Douleurs d'estomac lors de l'administration par voie orale.
Effet indésirable, le plus souvent digestif, lors de la prise d'un médicament. L'irritation de l'estomac due à l'aspirine est une intolérance et non une allergie.
Technique d'utilisation de certains médicaments qui permet un contact étroit et prolongé avec les fosses nasales : renverser la tête en arrière et faire couler lentement la solution dans une narine. Dans le même temps, prononcer de façon répétée et rapide la syllabe « ké » pour empêcher la solution de couler dans la bouche. Laisser pendant quelques instants le médicament en contact avec les sécrétions, puis l'évacuer en penchant la tête en avant.
Champignon microscopique.
Enfant de un à 30 mois. Un enfant de moins de un mois est un nouveau-né.
Inflammation ou infection du nez et des fosses nasales. La rhinite peut avoir une origine infectieuse (bactérie ou virus) ou une origine allergique. Les rhinites allergiques regroupent les rhinites saisonnières (rhume des foins) et les rhinites appelées perannuelles, c'est-à-dire souvent persistantes en cours d'année (dues par exemple aux acariens, aux poils d'animaux ou à des agents chimiques).
Consultez l'article : Rhume (rhinite)
Inflammation de la partie haute du pharynx, située en arrière du nez et au-dessus du voile du palais. Son origine peut être virale ou bactérienne.
Consultez l'article : Rhinopharyngite de l’enfant.
Substance minérale qui peut former des sels, notamment avec le chlore (chlorure de sodium, ou sel de table).
Substance indispensable à la croissance et au bon fonctionnement de l'organisme. Les besoins en vitamines sont normalement couverts par une alimentation variée. Dans les pays développés, seule la carence en vitamine D, chez le jeune enfant ou le vieillard peu exposés au soleil, justifie une supplémentation systématique. Un apport supérieur aux besoins, par des médicaments notamment, peut être à l'origine d'un surdosage et de troubles divers (vitamines A et D essentiellement).
Consultez l'article : Les vitamines.
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