In this manual :
1. WHAT IS HEC, ointment for cutaneous and nasal application AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE USING HEC, Ointment for cutaneous and nasal application
3. HOW DO I USE HEC Skin and Nose Ointment?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE HEC, skin and nasal ointment?
6. ADDITIONAL INFORMATION
1. WHAT IS HEC, ointment for cutaneous and nasal application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Other nasal preparations (R: Respiratory system).
Dermatology:
Local adjunctive treatment of superficial burns of small extent.
Rhinology:
Local adjunctive treatment of nosebleeds.
2. WHAT YOU SHOULD KNOW BEFORE USING HEC, ointment for cutaneous and nasal application
List of information needed before taking the medicine
Not applicable.
This medicine should NOT BE USED in the following cases:
- allergy to any of the components of the ointment, including pyrazoles, Peru balsam, wool grease or lanolin,
- infected lesions.
In case of doubt, it is essential to seek the advice of your doctor or pharmacist.
Precautions for use; special warnings
Be careful with HEC, ointment for cutaneous and nasal application:
It is important to tell your doctor if you (or a family member) have Glucose-6-Phosphate Dehydrogenase deficiency because a risk of hemolysis (destruction of red blood cells) exists with topical phenazone.
This medicine contains Peruvian balsam and lanolin (wool fat) and may cause skin reactions (e.g. eczema).
Interactions with other medicines
Use of other medications
Talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and breastfeeding
Pregnancy - Lactation
There are no data in humans.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Important information about some ingredients of HEC, ointment for cutaneous and nasal application:
Peru balsam, lanolin (wool fat).
3. HOW TO USE HEC, ointment for cutaneous and nasal application
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
Dermatology: 1 or 2 applications per day.
Rhinology: as an impregnation of nasal wicks
Method of administration
Dermal route.
Symptoms and instructions in case of overdose
If you have used more HEC, ointment for cutaneous and nasal application than you should have:
Rinse with plenty of water.
Consult your pharmacist or physician immediately.
Instructions in case of missed doses
If you forget to use HEC Skin and Nasal Ointment:
Do not take a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, HEC Skin and Nasal Ointment may have side effects, although not everyone is susceptible:
Local irritant reactions such as burning, sneezing, nasal discharge or congestion, and skin and allergic reactions have been reported during post-marketing surveillance.
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 HEC, skin and nasal ointment
Keep out of the reach and sight of children.
Do not exceed the expiry date on the outer packaging
Store at a temperature below 25°C.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household garbage. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
Phenazone ........................................................................................................................................ 0,75 g
Tannic acid ................................................................................................................................. 12,50 g
Witch hazel fluid extract ................................................................................................................... 0.75 g
For 100 g of ointment.
Peru balsam, pectin, purified water, wool fat (lanolin), glycerol dibehenate, medium chain triglycerides (Labrafac CC).
Pharmaceutical form and content
Ointment for cutaneous and nasal application, 25 g tube.
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
Laboratoires CHAUVIN
B.P.1174
34009 MONTPELLIER Cedex 1
Manufacturer
LABORATOIRE CHAUVIN
ZI Ripotier Haut
07200 AUBENAS
Names of the medicinal product in the member states of the European Economic Area
In accordance with the regulations in force.
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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