NOTICE
ANSM - Last updated: 23/02/2016
Name of the medicinal product
DESOMEDINE 0.1 PER CENT, solution for nasal sprays in vial
hexamidine
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
· Keep this leaflet. You might need to read it again.
· If you have any further questions, ask your doctor or pharmacist.
· This medicine has been prescribed for you. Do not give this to anyone else. It could be harmful to them, even if the signs of their illness are the same as yours.
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
Review summary
In this notice :
1. WHAT IS DESOMEDINE 0.1 PER CENT, nasal spray solution in a vial AND WHAT IT IS USED FOR?
2. BEFORE YOU USE DESOMEDINE 0.1 PER CENT, nasal spray solution in a vial?
3. HOW TO USE DESOMEDINE 0.1 PER CENT, nasal sprays in a vial?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE DISOMEDINE 0,1 PER CENT, solution for nasal sprays in a bottle?
6. ADDITIONAL INFORMATION
1. WHAT IS DESOMEDINE 0.1 PER CENT, nasal spray solution in a vial AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Antiseptic
Therapeutic indications
This medication is an antiseptic solution for instillation in the nose.
It is recommended in the treatment of infections of the nose.
2. BEFORE YOU USE DESOMEDINE 0.1 PER CENT, nasal spray solution in a vial?
List of information needed before taking the medication
Not applicable.
Cons-indications
Never use DESOMEDINE 0.1 PER CENT, nasal spray solution in the following cases:
· Allergy to one of the constituents.
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 DESOMEDINE 0.1 PER CENT, solution for nasal sprays in vial:
· Close the bottle carefully after use.
· Do not use certain medications containing antiseptic at the same time.
· Prolonged use (more than 10 days) of this medication is undesirable as it is likely to alter the natural microbial balance of the nose.
Interaction with other medicines
Taking or using other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.
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, you should seek advice from your doctor or pharmacist before taking any medication.
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 DESOMEDINE 0.1 PER CENT, nasal sprays in a vial?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
4 to 6 instillations per day in each nostril.
IN ALL CASES CONFORM TO THE ORDER OF YOUR DOCTOR STRICTLY.
Symptoms and Instructions for Overdose
If you used more than 0.1% DESOMEDINE, nasal flask solution you should:
In case of overdose (repeated excessive use), symptoms may include tingling, irritation or nasal burns. Nasal irrigation with physiological saline is recommended.
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, DESOMEDINE 0,1 PER CENT, solution for nasal sprays in vial is likely to have undesirable effects, although not everyone is subject to it.
· Transient irritation and possibility of allergic reactions.
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 drug safety
5. HOW TO STORE DISOMEDINE 0,1 PER CENT, solution for nasal sprays in a bottle?
Keep out of the reach and sight of children.
Expiration date
Do not use this medicine after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of that month.
Storage conditions
Store at a temperature not exceeding 25 ° C.
This medicine should not be stored more than 30 days after opening the bottle.
Note the opening date in plain text on the packaging.
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 contains DESOMEDINE 0.1 PER CENT, solution for nasal sprays in a vial?
The active substance is :
Hexamidine di-isethionate ............................................ .................................................. .............. 100.0 mg
For 100 ml of solution.
The other components are :
Sodium chloride, boric acid, borax, water for injections.
Pharmaceutical form and content
What is DESOMEDINE 0.1 PER CENT, nasal spray solution in bottle and contents of the pack?
This medicine is available as a nasal spray solution - 10 ml vial.
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
CHAUVIN LABORATORY
416, RUE SAMUEL MORSE
CS99535
34961 MONTPELLIER CEDEX 2
exploiting
CHAUVIN LABORATORY
416, RUE SAMUEL MORSE
CS99535
34961 MONTPELLIER CEDEX 2
Maker
LABORATOIRE CHAUVIN SA
INDUSTRIAL ZONE RIPOTIER HIGH
07200 AUBENAS
or
DR GERHARD MANN CHEM. PHARM. FABRIK GMBH
BRUNSBÜTTELER DAMM, 165/173
13581 BERLIN
GERMANY
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 Afssaps website (France).
Information for health professionals only
Not applicable.
Other
Not applicable.