Actisoufre Oral or Nasal Ampoules is a medication indicated for chronic inflammatory conditions of the upper respiratory tract, such as rhinitis and nasopharyngitis. Its formula, based on sulfur and yeast, works at the source to relieve nasal and throat discomfort in both adults and children.
For warnings, precautions, and contraindications, please consult the package insert for this over-the-counter medication.
When the nose remains congested, the throat feels irritated, and episodes of rhinitis or nasopharyngitis tend to become persistent, the body is often signaling a chronic inflammatory condition of the upper respiratory tract. Actisoufre Ampoules is a medication specifically indicated for this condition, designed to address these persistent imbalances in the nose and throat. It is suitable for both adults and children, offering a gradual approach that is gentle on the mucous membranes.
Its formula is based on a simple principle: providing sulfur combined with yeast to support the mucous membranes’ natural defense mechanisms. This action can be compared to a gentle “restoration of balance”: rather than masking symptoms, the product helps the body better manageexcess secretions and inflammation, much like helping a clogged filter regain its flow.
Thanks to this action, Actisoufre helps soothe irritated mucous membranes and promote daily respiratory comfort. The nose becomes clearer, the throat less sensitive, and breathing gradually regains a sense of ease. This gentle approach is particularly beneficial when episodes recur or become chronic.
The addition of orange blossom aroma provides a subtle and pleasant scent, which makes it easier to take, especially for children. The distinctive scent reflects the blend of sulfur and this aroma, without affecting the medication’s effectiveness.
Because it acts both systemically and on the mucous membranes, Actisoufre can be incorporated into a comprehensive strategy aimed at supporting the balance of the respiratory tract and protecting the mucous membranes from repeated irritants (cold, pollution, dry air). In addition, using the Actisoufre Nasal Spray for the Common Cold, Rhinitis, and Nasopharyngitis allows for localized action on the nasal mucosa, creating a beneficial synergy between internal and local effects.
Directions for Use
Actisoufre Ampoules can be administered in two ways: orally or nasally.
For oral use, dilute the contents of the ampoule in a small glass of water (about one dessert spoon) and take it with a meal.
Children under 5 years of age: 1 ampoule per day.
Adults and children over 5 years of age: 1 ampoule twice daily.
For nasal administration, fill the dropper bottle with the contents of one ampoule, then perform two nasal irrigations per day, allowing the product to remain in contact with the mucous membranes for a few moments before lifting your head.
Share your feedback on the usage instructions and dosage of Actisoufre Oral or Nasal Ampoules with our partner Avis Vérifiés after your purchase.
Precautions
Ingredients
Sodium Monosulfide Nonahydrate, Saccharomyces Cerevisiae Yeast, Sodium Saccharin, Polysorbate 80, Neroli Flavoring*, Sodium Chloride, Purified Water.
*Composition of the Neroli Flavoring: petitgrain bigarade and sweet orange essential oils, geraniol, terpineol, linalool, methyl anthranilate, phenylethyl alcohol, geranyl acetate.
The active ingredients, s per 10-ml ampoule, are:
Sodium monosulfide nonahydrate ............................................................................................. 4.0 mg
Saccharomyces cerevisiae yeast ............................................................................................. 50.0 mg
Packaging
Box of 30 10-ml ampoules with 1 dropper bottle, available online at the best price, for improved overall well-being.
To optimize results, be sure to combine taking Actisoufre with good daily nasal hygiene (gentle rinsing with saline solution or seawater). A sufficiently humidified indoor environment and regular hydration also contribute to mucosal comfort and enhance the treatment’s effectiveness.
FAQ
Can Actisoufre be used over a long period of time?
It is used for chronic inflammatory conditions. The duration of use depends on medical or pharmaceutical advice. If in doubt, consult a healthcare professional.
Can Actisoufre be given to children?
Yes, even for very young children, with a dosage adjusted according to age.
Is the smell normal when opening the ampoule?
Yes, it is the result of the mixture of sulfur and orange blossom flavoring and does not affect the product’s effectiveness.
Pharmacovigilance Report an adverse drug reaction(s)
NOTICE
ANSM - Updated on : 07/09/2020
Product name
ACTISOUFRE 4 mg/50 mg per 10 ml, oral suspension or suspension for nasal instillation
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any of the side effects listed above, please 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 4 mg/50 mg per 10 ml, oral suspension or suspension for nasal instillation and what is it used for?
2. What do I need to know before taking ACTISOUFRE 4 mg/50 mg per 10 ml, oral suspension or suspension for nasal instillation?
3. How should I take ACTISOUFRE 4 mg/50 mg per 10 ml, oral suspension or nasal instillation?
4. What are the possible side effects?
5. How to store ACTISOUFRE 4 mg/50 mg per 10 ml, suspension for oral or nasal instillation?
6. Package contents and other information.
1. WHAT IS ACTISOUFRE 4 mg/50 mg per 10 ml, suspension for oral or nasal instillation AND WHAT IS IT USED FOR?
Pharmaco-therapeutic class: Other cold medications, ATC code: R05X
This medicine contains sulfur and yeast in the form of sodium monosulfide nonahydrate and saccharomyces cerevisiae.
This medicine is used in chronic inflammatory conditions of the upper respiratory tract, such as chronic rhinitis and rhinopharyngitis.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING ACTISOUFRE 4 mg/50 mg per 10 ml, oral suspension or suspension for nasal instillation?
Never take ACTISOUFRE 4 mg/50 mg per 10 ml, oral suspension or suspension for nasal instillation:
- if you are allergic to sulfur or to any of the other ingredients of this medicine, as listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before taking ACTISOUFRE 4 mg/50 mg per 10 ml, suspension for oral or nasal instillation.
This medicine contains 37 mg sodium (main component of table salt) per ampoule. This is equivalent to 1.85% of the recommended maximum daily dietary intake of sodium for an adult.
Other medicines and ACTISOUFRE 4 mg/50 mg per 10 ml, oral suspension or suspension for nasal instillation
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
ACTISOUFRE 4 mg/50 mg per 10 ml, suspension for oral or nasal instillation with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Driving and using machines
Not applicable.
ACTISOUFRE 4 mg/50 mg per 10 ml, oral suspension or suspension for nasal instillation contains sodium.
3. HOW DO I TAKE ACTISOUFRE 4 mg/50 mg per 10 ml, suspension for oral or nasal instillation?
Always take this medicine exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
If you feel that the effect of ACTISOUFRE 4 mg/50 mg per 10 ml, oral suspension or suspension for nasal instillation is too strong or too weak, consult your doctor or pharmacist.
- Shake ampoule before opening.
- Any aggregates that may remain are not active. It is formed by the walls of yeasts which have previously released their soluble components (yeast extract rich in vitamins, trace elements, etc.) into the ampoule. This residual aggregate does not alter the product's activity.
- To empty a self-closing ampoule into a container (dropper bottle or glass), proceed as follows: take a point between thumb and forefinger and, with a sharp movement, break open the ampoule. Hold the open ampoule over the container and break the other tip in the same way.
- When the ampoule is opened, the odour is indicative of the mixture of sulphur and orange blossom oil.
For nasal use:
Dosage
Two nasal irrigations per day.
Method of administration :
- Remove cap and tip of dropper bottle.
- Fill dropper bottle with contents of one ampoule.
- Stand in front of a washbasin, tilt head back slightly and choose one or other of the following administration methods:
o Press the dropper bottle to force ACTISOUFRE into one nostril. Breathe in through the mouth, repeating the syllable "ké". Keep your head slightly back for a few moments (approx. 30 seconds) to allow the product to come into contact with the secretions. Then straighten your head and swallow the secretions.
Or
o If you wish to swallow the minimum amount of secretions, you can proceed as follows: block one nostril, pour ACTISOUFRE into the other nostril by pressing on the dropper bottle and make 3 to 4 back-and-forth breathing movements through the nostril containing the solution, then straighten your head and expel the solution by breathing out of the same nostril.
- Repeat the same operation in the other nostril.
- Repeat in each nostril until the entire contents of the dropper bottle have been used.
- After each use, rinse dropper bottle and tip thoroughly under running water and dry thoroughly.
For oral use:
Dosage
- Children under 5: one ampoule per day.
- Adults and children over 5: one phial twice a day.
Method of administration:
- Children under 5:
Dilute the contents of one ampoule in a glass containing a little water (the equivalent of a dessert spoon), to be taken with a meal once a day.
- Adults and children over 5 years of age:
Dilute the contents of one ampoule in a glass containing a little water (the equivalent of a dessert spoon), to be taken with a meal twice a day.
Duration of treatment:
Always follow the dosage instructions given by your doctor. If in doubt, consult your doctor or pharmacist.
If you have taken more ACTISOUFRE 4 mg/50 mg per 10 ml, oral suspension or suspension for nasal instillation than you should have :
Consult your doctor or pharmacist immediately.
If you forget to take ACTISOUFRE 4 mg/50 mg per 10 ml, oral suspension or suspension for nasal instillation :
Do not take a double dose to make up for the one you forgot to take.
If you stop taking ACTISOUFRE 4 mg/50 mg per 10 ml, oral suspension or for nasal instillation :
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.
- May cause stomach upset when taken 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 - Website: www.signalement-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE ACTISOUFRE 4 mg/50 mg per 10 ml, oral suspension or suspension for nasal instillation?
Keep out of sight and reach of children.
Keep in original packaging.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
Do not dispose of any medicine in the garbage . Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What ACTISOUFRE 4 mg/50 mg per 10 ml oral suspension or suspension for nasal instillation contains
- The active ingredients are :
Sodium monosulfide nonahydrate...................................................................................... 4.0 mg
Saccharomyces cerevisiae yeast....................................................................................... 50.0 mg
per 10 ml ampoule
- The other components are :
Saccharin sodium, polysorbate 80, Neroli* flavoring, sodium chloride, purified water.
*Compositionof Neroli aroma: essential oils of petitgrain bigaradier and sweet orange, geraniol, terpineol, linalol, methyl anthranylate, phenylethyl alcohol, geranyl acetate.
What ACTISOUFRE 4 mg/50 mg per 10 ml, oral suspension or suspension for nasal instillation is and what it contains
This medicine comes in the form of an oral or nasal suspension in 10 ml ampoules. Boxes of 18, 24, 30 or 60 with 1 dropper bottle.
Not all presentations may be marketed.
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].
Other
Detailed information on this drug is available on the ANSM (France) website.
This medicine combines sulfur and yeast extract, a source of vitamins and trace elements.
It is used in the adjunctive treatment of chronic rhinitis and rhinopharyngitis.
Prices do not include dispensing fees.
| p 100 ml | p amp | |
| Sodium sulfide (sulfur) | 13 mg | 4 mg |
| Saccharomyces cerevisiae yeast | 500 mg | 50 mg |
| Sodium | 378 mg |
This product should not be used in cases of sulfur intolerance.
The effect of this drug during pregnancy and lactation is not well known. As a precaution, it is not recommended for use by pregnant or breast-feeding women.
Pressurized bottle: after carefully blowing your nose, spray the solution into each nostril for 2-3 seconds. It can also be sprayed directly into the mouth, then swallowed.
Ampoule: shake well before use. The persistence of a non-soluble deposit in the ampoule is normal. The contents of the ampoule can be diluted in a glass of water and swallowed with meals. It can also be used for nasal irrigation after introduction into the dropper bottle.
Nasal route:
For greater comfort, it's best to warm the solution before using it for irrigation.
Rinse the dropper bottle thoroughly under running water after use and leave to dry upside down.
Stomach pain when administered orally.
Undesirable effect, usually digestive, when taking a medicine. Stomach irritation caused by aspirin is an intolerance, not an allergy.
A technique for using certain medications that allows close, prolonged contact with the nasal cavity: tilt the head back and slowly drip the solution into one nostril. At the same time, pronounce the syllable "ké" repeatedly and rapidly to prevent the solution from flowing into the mouth. Leave the solution in contact with secretions for a few moments, then remove it by tilting the head forward.
Microscopic fungus.
Child aged between one and 30 months. A child less than one month old is a newborn.
Inflammation or infection of the nose and nasal cavity. Rhinitis can be infectious (bacterial or viral) or allergic in origin. Allergic rhinitis includes seasonal rhinitis (hay fever) and perennial rhinitis, which often persists throughout the year (due to dust mites, animal hair or chemical agents, for example).
See article: Colds (rhinitis)
Inflammation of the upper part of the pharynx, behind the nose and above the soft palate. It can be caused by viruses or bacteria.
See article: Rhinopharyngitis in children.
Mineral substance that can form salts, notably with chlorine (sodium chloride, or table salt).
A substance essential for growth and proper functioning of the body. Vitamin requirements are normally covered by a varied diet. In developed countries, only vitamin D deficiency in young children or elderly people with little exposure to sunlight justifies systematic supplementation. Intake in excess of requirements, particularly through medication, can lead to overdosage and various disorders (mainly vitamins A and D).
See article: Vitamins.
Once the cold has set in, your eyes are glistening, your speech is slurred, your sinuses and throat are clogged with mucus, your voice is nasally, your head feels like it weighs a ton and you've eaten your third pack of tissues, what can you do to relieve the discomfort and fatigue? There are a number of things you can…
Read the article on the blogCleansing the nose should be as much a part of our daily routine as any other act of bodily hygiene. But few of us actually do it. Too restrictive? A cultural barrier? Or a question of habit? Nasal hygiene, which is mainly practised by infants, is a simple gesture with numerous benefits. It prevents and relieves rhinitis, sinusitis and other…
Read the article on the blogTreating fever, flu and colds with homeopathy: natural solutions to boost your natural defences. Fever, flu and colds are common illnesses that affect our immune system. Fortunately, homeopathy can be an effective alternative for treating these symptoms. In our online pharmacy, we've put together a range of natural solutions to boost your immunity and relieve your troublesome symptoms. Fever, flu…
Read the article on the blog
