Actisoufre – 30 Ampoules

Chronic rhinitis and rhinopharyngitis – Nasal or oral use – From 30 months

Who is it for: Children · Adolescents · Adults
Pregnancy / Breastfeeding: Ask a doctor
Form: Drinkable solution in breakable ampoules

Description

Actisoufre is a medication that provides sulfur and Saccharomyces cerevisiae yeast.
It is used to help relieve chronic rhinitis, chronic rhinopharyngitis, and other persistent inflammatory conditions of the upper respiratory tract.

Each 10 ml ampoule contains:

• Sulfur: Sodium monosulfide nonahydrate (4 mg)

• Yeasts: Saccharomyces cerevisiae (50 mg)

• Other ingredients: sodium saccharin, polysorbate 80, neroli compound essence (essential oils of petitgrain bigarade and sweet orange: geraniol, terpineol, linalool, methyl anthranilate, phenylethyl alcohol, geranyl acetate), sodium chloride, purified water.

How to Use

Nasal route:

• 2 nasal irrigations per day.

• Fill the provided bottle with one ampoule.

• Lean your head back over a sink and pour the solution into one nostril while breathing through your mouth and repeating “keh”.

• Use the full bottle and rinse it after each use.

• Shake the ampoule well before breaking to mix all components.

Oral route:

• Swallow with water during a meal.

• Dosage:

  • Children under 5 years: ½ to 1 ampoule per day

  • From 5 years and adults: 2 ampoules per day

The duration of treatment is determined by your doctor.

Precautions

• Do not use if you are allergic to sulfur.

• Ask a doctor if pregnant or breastfeeding.

• If you follow a low-sodium diet, note that each ampoule contains 37 mg of sodium.

Packaging

Box of 30 breakable ampoules.

Please read the following full disclosure before taking or using this product.

SUMMARY OF PRODUCT CHARACTERISTICS

ANSM – Last updated: 07/09/2020

1. NAME OF THE MEDICINAL PRODUCT

ACTISOUFRE, 4 mg/50 mg per 10 ml, oral or nasal suspension

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium monosulfide nonahydrate ............................................................. 4.0 mg
Saccharomyces cerevisiae yeast ............................................................. 50.0 mg

Per 10 ml ampoule.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension or nasal instillation suspension.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

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

4.2 Posology and method of administration

For special handling precautions, see section 6.6.

Nasal route

Posology:
Two nasal irrigations per day.

Method of administration:

• Shake the ampoule before opening it.

• Remove the cap and dropper-bottle tip.

• 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 methods:

Method 1:

• Let ACTISOUFRE run into one nostril by squeezing the dropper bottle.

• Breathe through the mouth while repeatedly pronouncing the syllable “keh”.

• Keep the head slightly back for a few moments (about 30 seconds) to allow the product to remain in contact with secretions.

• Then straighten the head and swallow the secretions.

Method 2 (if you wish to swallow as little of the secretions as possible):

• Block one nostril, let ACTISOUFRE run into the other nostril by squeezing the bottle, and perform 3–4 back-and-forth breathing movements through that nostril containing the liquid.

• Then straighten the head and expel the solution by exhaling through that same nostril.

• Repeat on the other side.

• Continue until the dropper bottle is completely used.

• After each use, thoroughly rinse the bottle and tip with running water and allow them to dry carefully.

Oral route

Posology:

• Children under 5 years: one ampoule per day.

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

Method of administration:

• Children under 5 years:
  Dilute the contents of one ampoule in a glass containing 10 ml of water (the volume of a dessert spoon). Take once daily with a meal.

• Adults and children over 5 years:
  Dilute the contents of one ampoule in a glass containing 10 ml of water (the volume of a dessert spoon). Take twice daily with meals.

4.3 Contraindications

Hypersensitivity to the active substances, particularly sulfur, or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Oral route:
This medicine contains 37 mg of sodium per ampoule, equivalent to 1.85% of the WHO’s recommended maximum daily sodium intake of 2 g for an adult.

4.5 Interaction with other medicinal products and other forms of interaction

Not applicable.

4.6 Fertility, pregnancy and lactation

Due to the absence of data regarding pregnancy and breastfeeding, use during pregnancy or breastfeeding is not recommended.

4.7 Effects on ability to drive and use machines

The effects of ACTISOUFRE on the ability to drive or use machinery have not been studied.

4.8 Undesirable effects

Oral route:
Possible digestive disorders such as stomach pain.

Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continuous monitoring of the benefit/risk ratio. Healthcare professionals should report any suspected adverse reaction through the national reporting system:
ANSM and the network of Regional Pharmacovigilance Centres – Website: www.signalement-sante.gouv.fr.

4.9 Overdose

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic class: Other cold preparations
ATC code: R05X

Mechanism of action:
Provides sulfur via sodium sulfide and trace elements and vitamins via Saccharomyces cerevisiae yeast.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium saccharin, polysorbate 80, Neroli flavor (essential oils of petitgrain bigarade and sweet orange: geraniol, terpineol, linalool, methyl anthranilate, phenylethyl alcohol, geranyl acetate), sodium chloride, purified water.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store in the original outer packaging.

6.5 Nature and contents of container

10 ml suspension in a brown glass ampoule, with a dropper bottle.

6.6 Special precautions for disposal and handling

• Shake the ampoule before opening it.

• Any residual aggregate is inactive. It consists of yeast cell walls that have released their soluble components (yeast extract rich in vitamins, trace elements, etc.). This residual aggregate does not alter the product’s activity.

• To empty a breakable ampoule into a container (dropper bottle or glass): hold one tip between thumb and index finger and break it off with a sharp movement. Hold the opened ampoule over the container and break the second tip the same way.

• When the ampoule is opened, the odor reflects the mixture of sulfur and orange blossom essence.

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

7. MARKETING AUTHORISATION HOLDER

LABORATOIRES GRIMBERG SA
44, Avenue Georges Pompidou
92300 Levallois-Perret
France

8. MARKETING AUTHORISATION NUMBER(S)

• 34009 364 681 4 6: 10 ml ampoule (brown glass): box of 18

• 34009 324 701 4 3: 10 ml ampoule (brown glass): box of 24

• 34009 328 164 3 9: 10 ml ampoule (brown glass): box of 30

• 34009 356 150 3 9: 10 ml ampoule (brown glass): box of 60

Not all presentations may be marketed.

9. DATE OF FIRST AUTHORISATION / RENEWAL

First authorisation: 29 January 1992
Renewal: 29 January 2012

10. DATE OF REVISION OF THE TEXT

[To be completed later by the marketing authorisation holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

PRESCRIPTION AND DISPENSING CONDITIONS

Medicine not subject to medical prescription.