NOTICE
ANSM - Updated on: 04/15/2021
Name of the drug
HEC, ointment for cutaneous and nasal application
Phenazone
Tannic acid
Witch hazel fluid extract
Boxed
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as directed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You may need to read it again.
· Contact your pharmacist for any advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
· You should contact your doctor if you do not feel any improvement or if you feel worse after finishing treatment.
What does this leaflet contain?
1. What is HEC, ointment for cutaneous and nasal application and what is it used for?
2. What information should you know before using HEC, ointment for cutaneous and nasal application?
3. How to use HEC, ointment for cutaneous and nasal application?
4. What are the possible side effects?
5. How to store HEC, ointment for cutaneous and nasal application?
6. Package contents and other information.
1. WHAT IS HEC, ointment for cutaneous and nasal application AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: Other nasal preparations (R: Respiratory system) - ATC code: R01AX30
Dermatology:
Local adjunctive treatment of minor superficial burns.
Rhinology:
Local adjunctive treatment in case of nosebleeds.
You should contact your doctor if you do not feel any improvement or if you feel worse after finishing treatment.
2. WHAT INFORMATION DO YOU NEED TO KNOW BEFORE USING HEC, ointment for cutaneous and nasal application?
Never use HEC, ointment for cutaneous and nasal application:
· if you are allergic to phenazone, tannic acid, witch hazel fluid extract or any of the other ingredients of this medicine listed in section 6, including pyrazoles, Peruvian balsam, wool fat (lanolin),
· if you are on oxygen therapy due to the risk of burns linked to the presence of fatty substances in the ointment,
· if you have infected lesions.
Warnings and Precautions
Talk to your doctor or pharmacist before using HEC, ointment for cutaneous and nasal application.
It is important to inform your doctor if you (or a member of your family) have Glucose-6-Phosphate Dehydrogenase deficiency because there is a risk of hemolysis (destruction of red blood cells) with topical phenazone.
Children
There is no relevant use of HEC, ointment for cutaneous and nasal application in the pediatric population.
Other medicines and HEC, ointment for cutaneous and nasal application
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
HEC, ointment for cutaneous and nasal application with food and beverages
Not applicable.
Pregnancy, breastfeeding and fertility
There are no human data. HEC, ointment for cutaneous and nasal application is not recommended during pregnancy. It should not be used during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and operating machinery
Not applicable.
HEC, ointment for cutaneous and nasal application contains Peruvian balsam and wool fat (lanolin).
This medicine contains Peruvian balsam and may cause skin reactions.
This medicine contains wool fat (lanolin) and may cause local skin reactions (e.g. contact dermatitis).
3. HOW TO USE HEC, ointment for cutaneous and nasal application?
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
Dosage
Dermatology: The recommended dose is 1 or 2 applications per day.
Rhinology: By impregnation of nasal wicks.
Mode of administration
Cutaneous and nasal route.
If you use more HEC Ointment for Cutaneous and Nasal Application than you should:
Rinse thoroughly with water.
Consult your doctor or pharmacist immediately.
If you forget to use HEC, ointment for cutaneous and nasal application:
Do not take a double dose to make up for a forgotten dose.
If you stop using HEC, ointment for cutaneous and nasal application:
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local irritation reactions such as burning sensation, sneezing, runny or stuffy nose, as well as general skin and allergic reactions that may be serious (itching, swelling of the face or throat, difficulty breathing) have been reported during post-marketing surveillance.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr .
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE HEC, ointment for cutaneous and nasal application?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What HEC contains, ointment for cutaneous and nasal application
· The active substances are:
Phenazone.............................................................................................................................. 0.75 g
Tannic acid................................................................................................................. 12.50 g
Witch hazel fluid extract................................................................................................. 0.75 g
For 100 g of ointment.
· Other ingredients are: Peruvian Balsam, Pectin, Purified Water, Wool Fat (Lanolin), Glycerol Dibehenate, Medium Chain Triglycerides (Labrafac CC).
What is HEC, ointment for cutaneous and nasal application and contents of the outer packaging?
This medicine comes in the form of an ointment for cutaneous and nasal application, 25g tube.
Marketing Authorisation Holder
CHAUVIN LABORATORY
416, RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
Marketing Authorization Operator
CHAUVIN LABORATORY
416, RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
Manufacturer
CHAUVIN LABORATORY
RIPOTIER INDUSTRIAL ZONE
50 AVENUE JEAN MONNET
07200 AUBENAS
OR
BAUSCH + LOMB IRELAND LIMITED
3013 LAKE DRIVE
CITYWEST
BUSINESS CAMPUS
DUBLIN 24, D24 PPT3
IRELAND
Names of the medicine in the member states of the European Economic Area
Not applicable.
The last date this notice was revised is:
[to be completed later by the holder]
{month YYYY}.
