NOTICE
ANSM - Updated on: 01/07/2015
Name of the medicinal product
BISEPTINESPRAID, solution for skin application
Chlorhexidine Gluconate, Benzalkonium Chloride, Benzyl Alcohol
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
· This medication can be used in self-medication, ie used without consultation or prescription from a doctor.
· If symptoms persist beyond 5 days, if they become worse or if new symptoms appear, seek the advice of your pharmacist or doctor.
· This leaflet is designed to help you use this medicine. Keep there, you might need to reread it.
Do not use this medication for children.
Review summary
In this notice :
1. WHAT IS BISEPTINESPRAID, a dermal application solution AND IN WHAT CASES IS IT USED?
2. BEFORE YOU USE BISEPTINESPRAID, solution for skin application?
3. HOW TO USE BISEPTINESPRAID, solution for skin application?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE BISEPTINESPRAID, solution for skin application?
6. ADDITIONAL INFORMATION
1. WHAT IS BISEPTINESPRAID, a dermal application solution AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group
Not applicable.
Therapeutic indications
Antisepsis of small superficial wounds.
2. BEFORE YOU USE BISEPTINESPRAID, solution for skin application?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use BISEPTINESPRAID, solution for skin application in the following cases:
· if you are allergic to the active substance or to any of the other ingredients of this medication mentioned in section 6
· do not apply in the eyes, ears, on the mucous membranes in particular genital.
· do not use for disinfection of medical-surgical equipment.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Precautions for use; special warnings
Take special care with BISEPTINESPRAID, solution for skin application:
Special warnings
This medicinal product is for external use only. Do not swallow
There is a risk of the active substance passing into the general circulation when used on a large surface, under occlusive dressing, on damaged (especially burned) skin, premature skin or infant skin.
Use with caution in newborns, especially premature infants. BISEPTINESPRAID may cause skin burns.
Precautions for use
Use cleanly and do not keep for too long an opened bottle because microbial contamination is possible as soon as the bottle is opened.
Interaction with other medicines
Taking or using other medicines
This medicine should not be used together with other local antiseptics (risk of incompatibility or ineffectiveness). Prior use of soap should be followed by a thorough rinse before using this medicine.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
This medication should be used with caution during pregnancy and lactation.
In general, during pregnancy and breast-feeding you should always seek advice from your doctor or pharmacist before taking any medicine.
Sport
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE BISEPTINESPRAID, solution for skin application?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Do not swallow.
1 to 2 applications per day. It is not necessary to rinse after application.
Dermal
External use
The duration of use is limited to 5 days. |
Symptoms and Instructions for Overdose
If you take more BISEPTINESPRAID, a skin application solution you should:
In case of massive oral ingestion, perform a gastric lavage. Acute oral toxicity of chlorexidine is low (almost negligible digestive absorption).
Contact a poison control center.
Instructions for omission of one or more doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· allergic eczema in contact with the product
· rarely, general allergic accident
· chemical burns in newborns (unknown frequency).
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 BISEPTINESPRAID, solution for skin application?
Keep out of the reach and sight of children.
Expiration date
Do not use BISEPTINESPRAID, a dermal application solution after the expiry date which is stated on the outer packaging.
Storage conditions
For polyethylene bottles: Store at a temperature not exceeding 30 ° C.
For polyethylene spray bottles: Store at a temperature not exceeding 25 ° C.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does BISEPTINESPRAID, solution for skin application?
The active substances are:
Chlorhexidine Gluconate ............................................... .................................................. .............. 0.250 g
Benzalkonium chloride ............................................... .................................................. ................ 0.025 g
Benzyl alcohol ................................................ .................................................. ......................... 4,000 ml
For 100 ml.
The other component is:
Purified water.
Pharmaceutical form and content
What is BISEPTINESPRAID, solution for skin application and contents of the outer packaging?
This medication is in the form of a solution for skin application.
Bottle of 50, 100, 125, 150, 200 or 250 ml.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
BAYER HEALTHCARE SAS
220 AVENUE OF RESEARCH
59120 LOOS
exploiting
BAYER HEALTHCARE SAS
33 STREET OF INDUSTRY
74240 GAILLARD
Maker
KVP PHARMA + VETERINAR PRODUKTE GMBH
Projensdorfer Strasse 324
24106 KIEL
GERMANY
or
FAMAR NEDERLAND BV
INDUSTRIEWEG 1
5531 AD BLADEL
NETHERLANDS
or
CHEMINEAU LABORATORIES
93, ROAD OF CURRENCY
37210 VOUVRAY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the ANSM website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.