NOTICE
ANSM - Last updated: 31/07/2017
Name of the medicinal product
RHINOTROPHYL, nasal spray solution
Ethanolamine Tenoate
framed
Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor, pharmacist or nurse.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you do not feel any improvement.
What is in this leaflet?
1. What is RHINOTROPHYL solution for nasal spraying and in which cases is it used?
2. What should be known before taking RHINOTROPHYL solution for nasal spraying?
3. How to take RHINOTROPHYL solution for nasal spraying?
4. What are the possible side effects?
5. How to store nasal spray solution?
6. Package contents and other information.
1. WHAT IS RHINOTROPHYL Nasal spray solution AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group: ANTISEPTICALLY SCREENED NASAL PREPARATION (R: respiratory system) - ATC code: R01AX10
You should contact your doctor if you do not feel any improvement.
2. BEFORE YOU TAKE RHINOTROPHYL solution for nasal spraying?
Never take RHINOTROPHYL solution for nasal spray:
· if you are allergic to any of the constituents, especially parabens.
Warnings and Precautions
Ask your doctor or pharmacist or nurse before taking RHINOTROPHYL nasal spray solution.
This medicine contains sodium propyl parahydroxybenzoate and sodium methyl parahydroxybenzoate and may cause allergic reactions with urticaria and respiratory discomfort.
As soon as the packaging is opened, and a fortiori the first use of a preparation for nasal use, microbial contamination is possible. Do not keep too much preparation for nasal use.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Special warnings
In case of fever, severe headache, ear pain or other symptoms, consult your doctor.
Children and Youth
Not applicable
Other medicines and RHINOTROPHYL nasal spray solution
Inform your doctor or pharmacist if you are taking or have taken any other medicines.
RHINOTROPHYL solution for nasal spraying with food and beverages and alcohol
Not applicable
Pregnancy and breast feeding
It is best not to use this medication during pregnancy. If you discover that you are pregnant during treatment, consult your doctor, as he alone can judge the need to continue this treatment
The use of this medication should be avoided during breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine
Driving and using machines
Not applicable
RHINOTROPHYL spray solution contains:
List of excipients with known effect: soda propyl parahydroxybenzoate (E216), sodium methyl parahydroxybenzoate (E218)
3. HOW TO TAKE RHINOTROPHYL Nasal Spray Solution?
Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Adult : 1 spray into each nostril 4 to 6 times a day.
Use in children
Child over 30 months : 1 spray in each nostril 3 to 4 times a day.
Infant : 1 spray in each nostril twice a day.
Nasal sprays are done with the head slightly leaning back and the bottle in a vertical position
Duration of treatment
The treatment should not exceed a few days.
If you take more RHINOTROPHYL solution for nasal spray than you should have
Not applicable
If you forget to take RHINOTROPHYL solution for nasal spraying
Do not take a double dose to make up for a missed dose.
If you stop taking RHINOTROPHYL solution for nasal spraying
Not applicable
If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
· Possible nasal irritation
· Hypersensitivity reactions such as edema, erythema or urticaria
Declaration of side effects
If you experience any side effects, talk to your doctor, pharmacist or nurse. 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 RHINOTROPHYL Nasal Spraying Solution?
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 vial.
Do not throw any medicines into drains or rubbish. 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 RHINOTROPHYL contains nasal spray solution
· The active substance is:
Ethanolamine Tenoate: 3 g per 100 ml of nasal spray solution
· The other excipients are: sodium hydrogen phosphate dodecahydrate, sodium hydrogen phosphate dihydrate, sodium methyl parahydroxybenzoate, soda propyl paraben, purified water.
What is RHINOTROPHYL nasal spray solution and contents of the pack
This medication is in the form of a nasal spray solution. Box of 1 bottle of 12 ml or 20 ml
Marketing Authorization Holder
JOLLY-JATEL LABORATORIES
28 avenue Carnot
78100 - SAINT-GERMAIN-EN-LAYE
LA FRANCE
Marketing Authorization Operator
JOLLY-JATEL LABORATORIES
28 avenue Carnot
78100 - SAINT-GERMAIN-EN-LAYE
LA FRANCE
Maker
JOLLY-JATEL LABORATORIES
28 avenue Carnot
78100 - SAINT-GERMAIN-EN-LAYE
la France
Or
PHARMA DEVELOPMENT
Chemin de Marcy
58800 - CORBIGNY
LA FRANCE
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.