ACTISOUFRE nasal or oral spray 100ml

ACTISOUFRE nasal or oral spray 100ml View larger

3400935167156

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

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ACTISOUFRE nasal or oral spray 100ml

Description of nasal or oral spray 100ml

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

Application advice and advice on nasal or buccal spray 100ml

Nasally

Adults and children

* Extended spray in each nostril 3 times a day, his head tilted back.

Infants

A spray in each nostril two times per day.

The administration must be performed while lying on your side or sitting position, when the infant is old enough to sit, the head tilted to the side to prevent laryngospasm.

Insert the tip Nasal (short end) into the nostril and perform a free spray. Repeat this process for the other nostril, tilting his head to the other side.

Don'ts:

Never perform a nasal spray when the infant's head is back to prevent the liquid down into the throat.

The spraying time is estimated at 2 to 3 seconds for each nostril.

Orally

1 spray 3 times a day, directly into the mouth and then swallowed.

* The spraying time is estimated at 2 to 3 seconds for each nostril.

Insert the mouthpiece (along a right angle end) into the oral cavity and exert a pressure to deliver a dose of product.

Each bottle contains 100 ml or 90 sprays (2 to 3 seconds each).

Sure during each spray head handle well the bottle top to prevent excessive consumption of propellant.

Composition nasal or buccal spray 100ml

Sodium saccharin (E954)
Polysorbate 80 (E433)
Sodium methyl paraben (E219)
Sodium chloride
Chlorhexidine
Purified water
A gas composed of Neroli:
Petitgrain
Bigaradier
Orange
Geraniol
Terpineol
Linalool
Methyl anthranilate
Phenylethyl alcohol
Geranyl acetate
Propellant:
Nitrogen (E941)
Presence of:
Sodium

Precaution for use with actisoufre pulv nasal / buccal 100ml

Indication against

Hypersensitivity to any component of the product including sulfur.

Pregnancy and Breastfeeding

In the absence of data on pregnancy and lactation, the medication during pregnancy and lactation is not recommended.

Caution

Orally and in case of low salt diet, consider sodium intake is 4.2 mg sodium spray (0.18 mmol sodium / spray).

100 ml of solution (90 sprays every 2 to 3 seconds) provide 378 mg sodium (16.4 mmol sodium/100 ml).

The presence of methyl paraben sodium is likely to cause an allergic type delayed in susceptible individuals Conservatives family parabens (and their derivatives) hypersensitivity reaction.

Adverse effects

Oral: possibility of digestive disorders such gastralgie.

Presentation of nasal or buccal spray 100ml

Medicinal product not subject to medical prescription. Each bottle contains 100 ml or 90 applications (2 to 3 seconds each).

Our expert advice pharmacy

Be careful before ordering check incompatibilities with your current medications. If need advice please contact us. Do not leave medicines out of reach of children. If symptoms persist, get worse or if new symptoms occur, contact our pharmacists.

Warnings on drugs

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Attention to incompatibilities on products in your.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find record of the drug at the site of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related adverse event (s) (s) (s) the use of a drug


VIDAL OF THE FAMILY

ACTISOUFRE

Sulfur medication

Sulfur yeast

. Presentations . Composition . Indications . Contraindications . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

ACTISOUFRE: solution for oral or nasal spraying; 100 ml (90 doses) pressurized bottle with mouthpiece and nosepiece.
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ACTISOUFRE: oral or nasal suspension; box of 30 vials of 10 ml and dropper bottle.
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Laboratory Grimberg

COMPOSITION (summary)
p 100 ml p amp
Sulfur of sodium (sulfur) 13 mg 4 mg
Saccharomyces cerevisiae yeast 500 mg 50 mg
Sodium 378 mg

INDICATIONS (summary)
It combines sulfur and a yeast extract, a source of vitamins and trace elements.
It is used in the adjunctive treatment of chronic rhinitis and nasopharyngitis .
CONTRAINDICATIONS (summary)
This medication should not be used in cases of sulfur intolerance .
PREGNANCY AND BREAST-FEEDING (summary)
The effect of this medication during pregnancy or lactation is not well known. As a precaution, it should not be used in pregnant women or nursing mothers.
DIRECTIONS FOR USE AND DOSAGE (summary)
Pressurized vial: The solution should be sprayed, after careful flushing, into each nostril for 2 or 3 seconds. It can also be sprayed directly into the mouth and then swallowed.
Bulb: shake well before use. The persistence of an insoluble deposit in the ampoule is normal. The contents of the ampoule can be diluted in a glass of water and swallowed during meals. It can also be used in nasal irrigation after introduction into the dropper bottle.

Usual dosage:

Orally:
  • Adult and child over 5 years: 2 ampoules per day or 1 spray 3 times a day.
  • Children under 5 years: ½ to 1 ampoule per day or 1 spray 3 times a day.
Nasally:
  • Adult and child: 1 ampoule in each nostril twice a day or 1 prolonged spray in each nostril 3 times a day, with the head leaning back.
  • Infant: 1 spray in each nostril twice a day, lying down or in a sitting position with the head inclined to the side.
TIPS (summary)
For greater comfort, it is best to warm the solution before using it in irrigation.
Rinse the dropper bottle thoroughly with running water after use; let it dry head down.
POSSIBLE ADVERSE EFFECTS (summary)
Stomach pains when administered orally.


GLOSSARY (summary)


intolerance
Undesirable effect, most often digestive, when taking a drug. The irritation of the stomach due to aspirin is intolerance and not an allergy.


nasal irrigation
Technique for the use of certain drugs which allows close and prolonged contact with the nasal cavities: reverse the head back and slowly pour the solution into a nostril. At the same time, repeatedly and rapidly pronounce the syllable "ké" to prevent the solution from sinking into the mouth. Leave the medication in contact with the secretions for a few moments, then evacuate it by tilting the head forward.


rhinitis
Inflammation or infection of the nose and nasal cavities. Rhinitis can have an infectious origin (bacteria or virus) or an allergic origin. Allergic rhinitis includes seasonal rhinitis (hay fever) and perennial rhinitis, which are often persistent during the year (eg due to mites, animal hair or chemical agents) .


nasopharyngitis
Inflammation of the upper part of the pharynx, situated behind the nose and above the veil of the palate. Its origin can be viral or bacterial.


treatment
Treatment that complements the action of a specific treatment, but generally does not achieve healing on its own.


way
  • Pathway (route of administration) used to administer drugs: oral, sublingual, subcutaneous, intramuscular, intravenous, intradermal, transdermal.
  • Set of hollow organs allowing the passage of air (airways), food (digestive tract), urine (urinary tract), bile (bile ducts), etc.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 04/04/2017

Name of the medicinal product

ACTISOUFRE, solution for nasal / buccal spraying in a pressurized bottle

Sodium monosulphide, yeast extract Saccharomyces cerevisiae

framed

Please read this leaflet carefully before you start using this medicine because it contains important information for you.

You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.

· Keep this leaflet. You might need to read it again.

· Ask your pharmacist for advice or information.

· If you experience any of the side effects, talk to your doctor, or your pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.

· You should talk to your doctor if you do not feel better or feel less well.

Do not use this medication for children.

What is in this leaflet?

1. What is ACTISOUFRE, solution for nasal / buccal spraying in a pressurized vial and when is it used?

2. What should I know before using ACTISOUFRE, solution for nasal / buccal spraying in a pressurized vial?

3. How to use ACTISOUFRE, a nasal / buccal spray solution in a pressurized vial?

4. What are the possible side effects?

5. How to store ACTISOUFRE, solution for nasal / buccal spraying in a pressurized bottle?

6. Package contents and other information.

1. WHAT IS ACTISOUFRE, a nasal / buccal spray solution in a pressurized vial AND WHAT IT IS USED FOR?

Pharmacotherapeutic group OTHER DRUG MEDICINES. ATC code: R05X

(R: respiratory system).

This medication is recommended in chronic inflammatory states of upper respiratory tract such as chronic rhinitis and rhinopharyngitis.

2. BEFORE YOU USE ACTISOUFRE, solution for nasal / buccal spraying in a pressurized vial?

Never take ACTISOUFRE, nasal / buccal spray solution in a pressurized vial:

· if you are allergic (hypersensitive) to active substances and in particular to sulfur or any of the other ingredients of this medicinal product mentioned in section 6.

Warnings and Precautions

Take special care with ACTISOUFRE, nasal / buccal spray solution in pressurized vial in the following cases:

Orally and in the case of a low sodium diet, take into account the sodium intake of 4.2 mg sodium per spray (0.18 mmol sodium / spray).

100 ml of solution give 378 mg of sodium (ie 16.4 mmol of sodium / 100 ml).

The presence of sodium methyl parahydroxybenzoate is likely to result in an allergic reaction to the type of delayed hypersensitivity reactions in preservative subjects of the parahydroxybenzoate family (and their derivatives)

Other medicines and Actisulfur, solution for nasal / buccal spraying in pressurized vial:

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

Actisulfur, solution for nasal / buccal spraying in a pressurized bottle with foods for drinks and alcohol

Not applicable.

Pregnancy and lactation and fertility

Taking the medication during pregnancy and lactation is not recommended.

If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor for advice or pharmacist before taking this medication.

Sport

Not applicable.

Driving and using machines

Not applicable.

ACTISOUFRE, nasal / buccal spray solution in pressurized vial contains: sodium (as chloride (900 mg) and saccharin (35 mg)) and sodium methyl parahydroxybenzoate (E219) (100 mg).

3. HOW TO USE ACTISOUFRE, solution for nasal / buccal spraying in a pressurized bottle?

Dosage :

Nasally :

Adults and children

The recommended dose is a prolonged spray in each nostril 3 times a day, with the head leaning back.

Use in Infants

Spray into each nostril twice a day.

* The time of a spray is evaluated to 2 or 3 seconds for each nostril.

Administration should be done in a lying position on the side or in a sitting position when the infant is old enough to sit with the head inclined to the side to avoid laryngospasm.

Insert the tip into the nostril and spray.

Repeat the procedure for the other nostril by tilting the head on the other side.

Not to do :

Never perform a nasal spray when the infant's head is back to prevent the liquid from descending into the throat.

Orally :

A spray, 3 times a day, directly into the oral cavity and then swallow.

Sodium: 4.2 mg sodium by spraying (ie 0.18 mmol sodium / spray).

For hygienic reasons, clean the nose or mouthpiece after each use.

Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.

Method of administration :

Place the nosepiece (short tip) or mouthpiece (long tip at right angles) according to the route of administration used (see diagram).

Insert either the nosepiece into the nostril or the mouthpiece into the oral cavity, and then apply pressure to deliver a dose of product.

During each spraying, please ensure that the bottle is held either head up or head down to avoid excessive consumption of the propellant.

Pictogram indicating that the bottle should not be held horizontally

If you used more ACTISOUFRE, a nasal / buccal spray solution in a pressurized vial you should:

Immediately consult your doctor or pharmacist.

If you forget to use ACTISOUFRE, solution for nasal / buccal spraying in pressurized vial:

Do not take a double dose to make up for a missed dose.

If you stop using ACTISOUFRE, nasal / buccal spray solution in a pressurized vial:

Not applicable.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

Possibilities of gastralgia for the solution administered orally.

Declaration of side effects

If you experience any side effects, talk to 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: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr

By reporting adverse reactions, you are helping to provide more information about the safety of the drug.

5. HOW TO STORE ACTISOUFRE, solution for nasal / buccal spraying in a pressurized bottle?

Keep this medicine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.

Store at a temperature not exceeding 30 ° C.

Pressurized container :

The container contains a pressurized liquid. Do not expose to temperatures above 50 ° C. Do not pierce the container.

Do not throw any medication into sewer. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What ACTISOUFRE contains, solution for nasal / buccal spraying in a pressurized bottle

· The active substances are:

Sodium monosulphide

Amount corresponding to sodium sulphide ............................................ ............................. 13.00 mg

Saccharomyces cerevisiae type D * ............................................................ ............ .500.00 mg

For a bottle of 100 ml

*Yeast extract

· The other components are:

Saccharin sodium, polysorbate 80, sodium methyl parahydroxybenzoate (E219), solution of 20% chlorhexidine digluconate, sodium chloride, Neroli * flavoring, purified water.

* Composition of the aroma Neroli : essential oils of petitgrain orange and sweet orange, geraniol, terpineol, linalol, methyl anthranylate, phenylethyl alcohol, geranyl acetate.

What is ACTISOUFRE, nasal / buccal spray solution in pressurized vial and contents of the pack

This medication is in the form of a nasal / buccal spray solution in a 100 ml pressurized bottle with two tips: a nosepiece and a mouthpiece.

Marketing Authorization Holder

LABORATOIRES GRIMBERG SA

19 RUE POLIVEAU

75005 PARIS

Marketing Authorization Operator

LABORATOIRES GRIMBERG SA

ZA DES BOUTRIES, STREET VERMONT

78704 CONFLANS SAINTE HONORINE CEDEX

Maker

LABORATOIRES GRIMBERG SA

ZA DES BOUTRIES

RUE VERMONT

78704 CONFLANS SAINTE HONORINE CEDEX

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

The last date on which this leaflet was revised is:

[to be completed later by the holder]

<{MM / YYYY}> <{YYYY month}.>

Other

Not applicable.

Detailed information on this medicine is available on the ANSM website (France).

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