Actisoufre for the Common Cold, Rhinitis, and Nasopharyngitis is used to treat chronic inflammatory conditions of the upper respiratory tract, such as chronic rhinitis and nasopharyngitis. It can be used as a nasal and oral spray.
For warnings, precautions, and contraindications, please refer to the package insert for this over-the-counter medication.
This very gentle cleansing solution helps reduce inflammation of the nasal mucosa and promotes the removal of thick secretions, particularly in cases of chronic or recurrent upper respiratory tract conditions.
This spraydecongests the nose and facilitates the drainage of nasal secretions thanks to its hypertonic solution enriched with sulfur. It is recommended for adults and children 6 years and older to help prevent and relieve the symptoms of allergic rhinitis:
To gently and effectively relieve cold and nasopharyngitis symptoms in your children, check out our recommendation: Pediakid Nose-Throat Spray, a valuable ally at the pharmacy.
Actisoufre serves a dual purpose: as part of a hygiene routine, its microdiffusion spraymoisturizes and cleanses the nasal mucosa. It also helps reduce inflammation in the upper respiratory tract.
Equipped with a non-invasive tip, Rhinotherm helps clear nasal secretions in children who haven’t yet learned to blow their noses. Rich in sulfur, this nasal solution is designed to reduce inflammation in the ENT area.
The time-honored properties of sulfur have remained consistent over the years, particularly in improving breathing, which in turn optimizes the body’s oxygenation.
This over-the-counter medication, Actisoufre, is indicated for chronic inflammatory conditions of the upper respiratory tract, such aschronic rhinitis and nasopharyngitis. Thissulfur-basedmedication,which containsvitaminsandtrace minerals as well as sulfur combined with yeast extract, will provide relief from congested nasal and/or oral passages.
For a stuffy nose, you can also use inhalations made with essential oils.
Instructions for Use of Actisoufre Spray
Adults and children
Infants
Do not:
Share your feedback on the usage instructions and dosage of Actisoufre Nasal or Throat Spray for Rhinitis with our partner “Verified Reviews” after your purchase. Method and route of administration :
This medication provides sulfur and yeast in the form of sodium monosulfide nonahydrate and Saccharomyces cerevisiae.
The composition of this sulfur-enriched Actisoufre nasal spray helps clear the nose and protect the respiratory mucous membranes. In fact, the nasal mucosa filters thousands of liters of air per day. In direct contact with the environment, it serves as the respiratory system’s first line of defense against external agents.
Active ingredients:Sodium monosulfide(sulfur compound)
Amount equivalent to 13.00 mg of sodium sulfide; Saccharomyces cerevisiae type D* 500.00 mg per 100-ml bottle.
Other ingredients: Sodium saccharin, polysorbate 80, sodium methyl parahydroxybenzoate (E219), 20% chlorhexidine digluconate solution, sodium chloride,Neroli A compound(essential oilsof petitgrain bigarade and sweet orange, geraniol, terpineol, linalool, methyl anthranilate, phenethyl alcohol, geranyl acetate), purified water.
Excipients with known effects: Sodium (in the form of chloride and saccharin), Sodium methyl parahydroxybenzoate (E219)
Contraindications
Hypersensitivity to any of the product’s ingredients, particularly sulfur.
Pregnancy and Breastfeeding
In the absence of data regarding pregnancy and breastfeeding, use of this medication during pregnancy and breastfeeding is not recommended.
Warning
When taken orally and in cases of a low-sodium diet, take into account the sodium content, which is 4.2 mg of sodium per spray (equivalent to 0.18 mmol of sodium per spray).
100 mL of solution (equivalent to 90 sprays of 2 to 3 seconds each) provides 378 mg of sodium (equivalent to 16.4 mmol of sodium per 100 mL).
The presence of sodium methyl parahydroxybenzoate may cause an allergic reaction, such as delayed hypersensitivity reactions, in individuals sensitive to preservatives in the parahydroxybenzoate family (and their derivatives).
Adverse Effects
When taken orally: digestive disturbances such as epigastric pain may occur.
Over-the-counter medication. Each bottle of Actisoufre spray contains 100 ml, equivalent to 90 sprays (2 to 3 seconds each).
Actisoufreis also available in a box of 30 ampoules, each containing 10 ml.
Chronic nasopharyngitis in infants: The best remedy is you
Family members, the nanny, and other children at daycare or preschool—all of these can easily spread the infection, even if your child is in excellent health. A toddler can suffer from nasopharyngitis up to 10 times a year! So, it’s best to take the right steps to soothe them as soon as the first symptoms appear.
Warning: Before ordering, check for any interactions with your current medications. If you need advice, contact us. Keep medications out of the reach of children. If symptoms persist, 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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