ACTISOUFRE 4 mg/50 mg per 10 ml Oral/nasal suspension 30Ampoule/10ml

Sodium monosulfide nonahydrate ............................................................................................. 4,0 mg

Saccharomyces cerevisiae* .......................................................................................................... 50,0 mg

For one ampoule of 10 ml.

*Yeast

Used in chronic inflammatory conditions of the upper respiratory tract such as chronic rhinitis and rhinopharyngitis.

For special handling precautions, see section Disposal and handling.

By nasal route:

Dosage :

Two nasal irrigations per day.

Method of administration:

• Shake the ampoule before opening it.
• Remove the cap and the tip of the dropper bottle
• Fill the bottle with the contents of one ampoule.
• Stand in front of a sink, tilt the head slightly backward and choose one of the following administration methods:
  • Let ACTISOUFRE run into one nostril by pressing the dropper bottle. Breathe through the mouth while repeatedly pronouncing the syllable "ké". Keep the head slightly tilted back for a few moments (about 30 seconds) to allow the product to contact the secretions. Then straighten the head and swallow the secretions.
  Or
  • If you wish to swallow the minimum amount of secretions, you may proceed as follows:
• block one nostril, let ACTISOUFRE run into the other nostril by pressing the dropper bottle and perform 3 to 4 back-and-forth breathing movements through the nostril containing the liquid, then straighten the head and expel the solution by exhaling through that same nostril.
• Repeat the same procedure for the other nostril.
• Repeat until the contents of the dropper bottle have been fully used.
• After each use, rinse the dropper bottle and tip thoroughly under running water and dry them carefully.

By oral route:

Dosage :

• Children under 5 years: one ampoule per day.
• Adults and children over 5 years: one ampoule twice a day.

Method of administration:

• Children under 5 years:

Dilute the contents of one ampoule in a glass containing 10 ml of water, i.e. the volume of one dessert spoon, to be taken during a meal once a day.

• Adults and children over 5 years:

Dilute the contents of one ampoule in a glass containing 10 ml of water, i.e. the volume of one dessert spoon, to be taken during a meal twice a day.

Hypersensitivity to the active substances and in particular to sulfur or to any of the excipients listed in the section Composition.

By oral route:

This medicine contains 37 mg of sodium per ampoule, which is equivalent to 1,85 % of the maximum recommended daily dietary intake of 2 g of sodium per adult set by the WHO.

In the absence of data on pregnancy and breastfeeding, taking the medicine during pregnancy and breastfeeding is not recommended.

The effects of ACTISOUFRE on the ability to drive vehicles and use machines have not been studied.

By oral route: Possibility of digestive disorders of the gastralgia type.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website:www.signalement-sante.gouv.fr.

Pharmacotherapeutic class: Other cold remedies, ATC code: R05X

Mechanism of action

Sulfur supply from sodium sulfide and trace elements and vitamins from yeast Saccharomyces cerevisiae.

3 years.

Store in the original outer packaging.

• Shake the ampoule before opening it.
• Any residual aggregate that may remain is not active. It is formed of yeast cell walls which have previously released their soluble components (yeast extract rich in vitamins, trace elements, ...) into the ampoule. This residual aggregate therefore does not alter the activity of the product.

To empty a self-breaking ampoule into a container (the dropper bottle or a glass), proceed as follows: take one tip between the thumb and index finger and, with a firm movement, snap it open. Hold the ampoule open above the container and break the other tip in the same way.

• When the ampoule is opened, the smell reveals the mixture of sulfur and orange blossom essence.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.