In this manual :
1. WHAT IS DESOMEDINE 0.1 PER CENT, nasal spray solution in a bottle AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE USING DESOMEDINE 0.1 PER CENT Nasal Spray Solution?
3. HOW DO I USE DESOMEDINE 0.1 PER CENT, nasal spray solution in a bottle?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW DO I USE DESOMEDINE 0.1 PER CENT Nasal Spray Solution?
6. ADDITIONAL INFORMATION
1. WHAT IS DESOMEDINE 0.1 PER CENT, nasal spray solution in a bottle AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Antiseptic
This medicine is an antiseptic solution for instillation in the nose.
It is recommended for the treatment of infections of the nose.
2. WHAT YOU SHOULD KNOW BEFORE USING DESOMEDINE 0.1 PER CENT, nasal spray solution in a bottle
List of information needed before taking the medicine
Not applicable.
Never use DESOMEDINE 0.1 PER CENT Nasal Spray in a bottle if you are
- Allergy to any of the components.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take care with DESOMEDINE 0.1 PER CENT, nasal spray solution in a bottle:
- Close the bottle tightly after use.
- Do not use certain medicines containing antiseptics at the same time.
- Prolonged use (more than 10 days) of this medicine is not desirable as it may alter the natural microbial balance of the nose.
Interactions with other medicines
Taking or using other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medication, even if it is obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
This medicine should be used with caution during pregnancy and breastfeeding.
In general, you should seek advice from your doctor or pharmacist before taking any medicine.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Not applicable.
3. HOW TO USE DESOMEDINE 0.1 PERCENT nasal spray solution in a bottle
Instructions for proper use
Not applicable.
Dosage, Method 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, STRICTLY ADHERE TO YOUR DOCTOR'S PRESCRIPTION.
Symptoms and instructions in case of overdose
If you have used more DESOMEDINE 0.1 PER CENT Nasal Spray Solution in a bottle than you should have, contact your doctor:
In case of overdose (repeated excessive use), symptoms may include nasal stinging, irritation or burning. Nasal irrigation with saline solution is recommended.
Instructions in case of missed dose(s)
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, DESOMEDINE 0.1 PERCENT Nasal Spray is susceptible to adverse reactions, although not everyone is susceptible:
- Transient irritation and possible allergic reactions.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE DESOMEDINE 0.1 PER CENT, nasal spray solution in a bottle
Keep out of the reach and sight of children.
Do not use DESOMEDINE 0.1 PER CENT Nasal Spray Solution after the expiry date stated on the outer packaging. The expiry date refers to the last day of the month.
Store at a temperature not exceeding 25°C.
This medicine must not be stored for more than 30 days after opening the bottle.
Note the date of opening in plain text on the packaging.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does DESOMEDINE 0.1 PER CENT nasal spray solution in bottle contain?
The active substance is:
Hexamidine di-isethionate ............................................................................................................ 100.0 mg
Per 100 ml of solution.
The other components are:
Sodium chloride, boric acid, borax, water for injection.
Pharmaceutical form and content
What is DESOMEDINE 0.1 PER CENT, nasal spray solution in a bottle and what does it contain?
This medicine is presented as a solution for nasal sprays - 10 ml bottle.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
LABORATOIRE CHAUVIN
416, RUE SAMUEL MORSE
CS99535
34961 MONTPELLIER CEDEX 2
Operator
LABORATOIRE CHAUVIN
416, RUE SAMUEL MORSE
CS99535
34961 MONTPELLIER CEDEX 2
Manufacturer
LABORATOIRE CHAUVIN S.A.
ZONE INDUSTRIELLE RIPOTIER HAUT
07200 AUBENAS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
Not applicable.
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