Citrosil - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Undesirable effects Shelf life and storage Other information

Active ingredients: Benzalkonium chloride

CITROSIL 0.175% SKIN SOLUTION

Citrosil package inserts are available for pack sizes:
  • CITROSIL 0.175% SKIN SOLUTION
  • CITROSIL 0.175% SKIN SPRAY, SOLUTION
  • CITROSIL 3.5% SKIN SOLUTION

Why is Citrosil used? What is it for?

WHAT IS IT

Benzalkonium chloride is an antiseptic and disinfectant that is part of a "wide range of substances known as quaternary ammonium compounds with bactericidal actions. Its action is exerted on Gram-positive and Gram-negative bacteria. It is also shown to be active on a large number. of fungal species.

WHY IT IS USED

Citrosil is used for the disinfection and cleaning of even damaged skin (wounds, grazes, abrasions, burns).

Contraindications When Citrosil should not be used

Hypersensitivity to the active substance or to any of the excipients.

Precautions for use What you need to know before taking Citrosil

Avoid contact with the eyes, brain, meninges and middle ear.

Accidental ingestion can have serious, sometimes fatal consequences. In case of accidental ingestion of the product, consult a doctor immediately.

Avoid exposure to ultraviolet rays (sun or artificial sources) after application.

Keep this medicine out of the reach of children.

Interactions Which drugs or foods can modify the effect of Citrosil

Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.

Avoid the simultaneous use of other antiseptics and detergents.

Warnings It is important to know that:

The product is for external use only.

Do not use for prolonged treatments; after a short period of treatment without appreciable results, consult your doctor. The use, especially prolonged, of products for topical use, can give rise to sensitization phenomena; in this case, stop the treatment and consult your doctor.

Do not use for the disinfection of mucous membranes.

WHAT TO DO DURING PREGNANCY AND BREASTFEEDING

Ask your doctor or pharmacist for advice before taking any medicine.

During pregnancy use only in case of real need.

EFFECTS ON THE ABILITY TO DRIVE VEHICLES AND ON THE USE OF MACHINERY

Citrosil does not affect the ability to drive or use machines.

Dose, Method and Time of Administration How to use Citrosil: Posology

Ready-to-use solution. Must be used pure.

Intact skin: rub the affected area with gauze soaked in the solution.

Superficial lesions: apply the product with a sterile gauze pack. Use two to three times a day.

Do not exceed the recommended dose.

Side Effects What are the side effects of Citrosil

Like all medicines, Citrosil can cause side effects, although not everybody gets them.

In some cases, intolerance (burning or irritation) may occur, however without consequences, which does not require modification of the treatment.

Compliance with the instructions on the package reduces the risk of unwanted effects.

If any of the side effects gets serious, or if you notice any side effects not listed on the pack, please tell your doctor or pharmacist.

Expiry and Retention

Expiry: see the expiry date printed on the package.

The expiry date refers to the product in intact packaging, correctly stored.

Warning: do not use the medicine after the expiry date shown on the package.

Store in the original package to protect the medicine from light and heat.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

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

Deadline "> Other information

COMPOSITION:

100 ml of solution contain:

ACTIVE INGREDIENT: benzalkonium chloride 0.175 g.

EXCIPIENTS: lemon essence; thyme essence; ethyl alcohol ; nonoxynol 30; tetrasodium edetate; quinoline yellow (E 104); patent blue (E 131); purified water.

PHARMACEUTICAL FORM AND CONTENT:

Cutaneous solution, bottle of 200 ml.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Citrosil can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

CITROSIL SKIN SOLUTION / SKIN SPRAY, SOLUTION

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

100 ml of cutaneous solution contain:

ACTIVE INGREDIENT: benzalkonium chloride 0.175 g.

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM -

Skin solution.

Skin spray, solution.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Disinfection and cleaning of even injured skin (wounds, grazes, abrasions, burns).

04.2 Posology and method of administration -

Method of administration

Solution

Ready to use solution.

It must be used pure.

Intact skin: rub the affected area with gauze soaked in the solution.

Superficial lesions: apply the product with a sterile gauze pack.

Apply two - three times a day.

Spray

Spray on the area to be treated two - three times a day.

DO NOT EXCEED THE RECOMMENDED DOSE.

04.3 Contraindications -

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Do not administer to children under the age of 1 year.

04.4 Special warnings and appropriate precautions for use -

The product is for external use only. Avoid contact with the eyes, brain, meninges and middle ear.

Do not use for prolonged treatments. After a short period of treatment without noticeable results, consult your doctor. Do not use for the disinfection of mucous membranes.

The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena; in this case, stop the treatment and consult your doctor. The accidental ingestion or inhalation of some disinfectants can have serious, sometimes fatal consequences. Avoid exposure to ultraviolet rays (sun or artificial sources) after applying the product.

04.5 Interactions with other medicinal products and other forms of interaction -

Avoid the simultaneous use of other antiseptics and detergents.

Pediatric population

Interaction studies have only been performed in adults.

04.6 Pregnancy and breastfeeding -

Pregnancy

The product should be used only in cases of real need.

During the period of breastfeeding, avoid applying the product on the breast to avoid ingestion of the product by the infant.

04.7 Effects on ability to drive and use machines -

Citrosil does not affect the ability to drive or use machines.

04.8 Undesirable effects -

The following adverse reactions have been identified after the authorization of the use of benzalkonium chloride.

Since these reactions arise from spontaneous reports, it is not always possible to define their frequency.

It is possible, in some cases, the occurrence of intolerance (burning or irritation), however without consequences, which does not require modification of treatment.

Pediatric population

The same frequency, type and severity of undesirable effects are expected in the pediatric population as in the adult population.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous 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. "address: www.agenziafarmaco.gov.it/it/responsabili.

04.9 Overdose -

No damage from overdose has been reported under normal conditions of use. Accidental ingestion may cause nausea and vomiting. Symptoms of intoxication resulting from the ingestion of significant quantities of quaternary ammonium compounds include dyspnoea, cyanosis, asphyxia, resulting from paralysis of the respiratory muscles, CNS depression, hypotension and coma. In humans, the lethal dose is approximately 1-3g. . The treatment of poisoning is symptomatic: administer soothing if necessary. Avoid emesis and gastric lavage.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

Pharmacotherapeutic group: antiseptics and disinfectants.

ATC code: D08AJ01.

Mechanism of action

Citrosil, thanks to the action of benzalkonium chloride, acts at the microorganism level by altering the cell membrane with consequent loss of cytoplasmic material and cell lysis.

This mechanism of action is therefore of the bactericidal type.

Antibacterial "activity

Citrosil exerts a bactericidal activity on gram-positive and gram-negative bacterial species, including: Staphylococcus aureus, Streptococcus faecalis, Neisseria species, Salmonella species, Proteus species, Klebsiella species, Citrobacter species, Pseudomonas aeruginosa.

The contact time required for Citrosil to lysate the bacterial cultures is about two minutes; against Pseudomonas aeruginosa, Citrosil is able to reduce its bacterial load to 99.99% within this period; similar results are obtained with respect to other bacterial species. It is active only on vegetative forms.

It is not active on Micobacterium tubercolosis.

"Antifungal" activity

Citrosil is shown to be active on a large number of fungal species, including Candida, Saccaromyces, Cryptococcus, Nocardia, Aspergillus, Coccidioides, Tricophyton.

05.2 "Pharmacokinetic properties -

Not relevant.

05.3 Preclinical safety data -

Not relevant.

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

Lemon essence, thyme essence, ethyl alcohol, polysorbate 20, edetate tetrasodium, quinoline yellow (E 104), patent blue (E 131), hydrochloric acid, purified water.

06.2 Incompatibility "-

Incompatibility with soaps, anionic surfactants, hydrogen peroxide, iodides.

06.3 Period of validity "-

5 years.

After first opening: 2 months.

06.4 Special precautions for storage -

Store in the original package to protect the medicine from light and heat.

For storage conditions after first opening see section 6.3.6.5

06.5 Nature of the immediate packaging and contents of the package -

High density polyethylene bottle.

Mechanical spray nebulizer in polyethylene can.

CITROSIL 0.175% cutaneous solution - bottle of 30 ml

CITROSIL 0.175% cutaneous solution - 60 ml bottle

CITROSIL 0.175% cutaneous solution - bottle of 100 ml

CITROSIL 0.175% cutaneous solution - 200 ml bottle

CITROSIL 0.175% cutaneous solution - 1000ml bottle

CITROSIL 0.175% cutaneous spray, solution - 100ml bottle

Not all pack sizes may be marketed.

06.6 Instructions for use and handling -

No special instructions.

Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

Italo Britannica Company L. MANETTI - H. ROBERTS & C. for Shares - Florence.

08.0 MARKETING AUTHORIZATION NUMBER -

CITROSIL 0.175% cutaneous solution - 30 ml bottle n ° 032781066

CITROSIL 0.175% cutaneous solution - 60 ml bottle n ° 032781078

CITROSIL 0.175% cutaneous solution - 100 ml bottle n ° 032781080

CITROSIL 0.175% cutaneous solution - 200 ml bottle n ° 032781092

CITROSIL 0.175% cutaneous solution - 1000 ml bottle n ° 032781104

CITROSIL 0.175% cutaneous spray, solution - 100 ml bottle n ° 032781116

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

Date of first authorization: 14 May 1996

Date of most recent renewal: November 30, 2012

10.0 DATE OF REVISION OF THE TEXT -

17/10/2016

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

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