NOTICE
ANSM - Last updated: 20/04/2017
Name of the medicinal product
PRORHINEL RHEUME, nasal solution
Polysorbate 80 / Benzododecinium Bromide
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
If you have any further questions, ask your doctor or pharmacist.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist.
· If symptoms worsen or persist, consult a physician.
· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.
What is in this leaflet?
1. What is PRORHINEL RHEUME, nasal solution and in which cases is it used?
2. What should I know before using PRORHINEL RHUME, a nasal solution?
3. How to use PRORHINEL RHEUME, nasal solution?
4. What are the possible side effects?
5. How to keep PRORHINEL RHUME, nasal solution?
6. Package contents and other information.
1. WHAT IS PRORHINEL RUM, nasal solution AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic group - NASAL PREPARATION FOR LOCAL USE.
ATC code: (R: respiratory system).
2. BEFORE YOU USE PRORHINEL RHUME, nasal solution?
Never use PRORHINEL RHUME, nasal solution in the following cases:
· Allergy to antiseptics of the quaternary ammonium class during previous use.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Take special care with PRORHINEL RHUME, nasal solution:
Special warnings
As soon as the packaging is opened, and a fortiori the first use of a preparation for nasal use, microbial contamination is possible.
Glass ampoules, pipette bottles or spray bottles should not be stored more than 8 days after first use. Note the open date on the bulb or bottle.
Plastic bulbs should not be stored after use.
Precautions for use
In case of fever, severe headache, ear pain or other symptoms, consult your doctor.
IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Other medicines and PRORHINEL RHUME, nasal solution
Taking or using other medicines:
Do not combine several nasal medications containing an antiseptic.
TO AVOID POSSIBLE INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, IT MUST BE INFORMED SYSTEMATICALLY OF ANY OTHER TREATMENT IN PROGRESS AT YOUR DOCTOR OR YOUR PHARMACIST.
PRORHINEL COLD, nasal solution with food and beverages and alcohol
Not applicable.
Pregnancy, breastfeeding and fertility
This medication under normal conditions of use can be used during pregnancy and lactation.
In general, you should seek advice from your doctor or pharmacist before taking any medication.
Driving and using machines
No effects on the ability to drive and use machines have been observed.
PRORHINEL RUM, nasal solution contains:
Sodium chloride, 90 ° ethyl alcohol, glycerol, purified water.
3. HOW TO USE PRORHINEL COLD, nasal solution?
Dosage
In sprays:
Adult (with adult spray bottle): 2 sprays in each nostril 3 times a day.
Child (with child spray bottle): 2 sprays in each nostril 2 to 3 times a day.
In washing:
with the plastic ampoules forms of 5 ml or 10 ml or the pipette bottle.
Adult: 1 to 3 washes per day with ½ to 1 ampoule of 10 ml or 5 ml per nostril.
Child: 1 to 2 washes per day with ½ to 1 ampoule of 5 ml per nostril.
Infant: 1 wash per day with ½ to 1 ampoule of 5 ml per nostril.
In instillations:
with the plastic ampoules forms of 5 ml or 10 ml or the pipette bottle. Instillation is recommended when a small amount of solution is sufficient. Administer a few drops by applying gentle pressure to the ampoule or vial.
Adult: 2 to 3 instillations per day
Child and infant: 1 to 3 instillations per day.
Do not bleed violently within 10 minutes after administration of this product.
Administration mode
NASAL WAY. Do not inject.
Glass bulb: The contents of one or more ampoules can be placed in the pipette bottle or in the spray bottle. Close the bottle between each use.
Plastic ampoules: break the tip by simple twisting.
Duration of treatment
The treatment should not exceed a few days.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Notably allergic to sneezing, runny nose or skin reaction.
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 PRORHINEL RHEUME, nasal solution?
Keep this medicine out of the reach and sight of children.
Do not use PRORHINEL RHUME, nasal solution after the expiry date which is stated on the outer packaging.
Glass ampoules, pipette bottles or spray bottles should not be stored more than 8 days after first use. Note the open date on the bulb or bottle.
Plastic bulbs should not be stored after use.
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. PACKAGE CONTENTS AND OTHER INFORMATION
What PRORHINEL RHUME contains, nasal solution
· The active substance is:
Polysorbate 80 ................................................ .................................................. .................. 0.200 g,
Benzododecinium bromide monohydrate
expressed as anhydrous benzododecinium bromide ............................................ .................... 0.004 g.
per 100 ml of nasal solution
· The other components are:
Sodium chloride, 90 ° ethyl alcohol, glycerol, purified water.
What is PRORHINEL RHUME, nasal solution and contents of the pack
This medication is in the form of a nasal solution; box of 2, 4, 10, 12, 15, 18 or 20 ampoules of 5 ml or 10 ml.
Marketing Authorization Holder
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100, route de Versailles
CS 80001
78164 MARLY LE ROI Cedex
LA FRANCE
Marketing Authorization Operator
GLAXOSMITHKLINE HEALTH GRAND PUBLIC
100, route de Versailles
CS 80001
78164 MARLY LE ROI Cedex
LA FRANCE
Maker
UNITHER LABORATORY
ZI LONGPRE
10 RUE ANDRE DUROUCHEZ
80084 AMIENS CEDEX 2
or
EXCELVISION
RUE DE LA LOMBARDIERE
bp131
07100 ANNONAY
or
SOPHARTEX LABORATORY
21 RUE DU PRESSOIR
28500 VERNOUILLET
or
RENAUDIN LABORATORY
ZA ERROBI
64250 ITXASSOU
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:
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Other
Not applicable.