NOTICE
ANSM - Last updated: 10/02/2017
Name of the medicinal product
DERMOFENAC DEMANGEAISONS 0.5%, cream
hydrocortisone
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as described in this leaflet.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should contact your doctor if you experience no improvement or feel less well after 3 days.
Do not use this medication for children.
What is in this leaflet?
1. What is DERMOFENAC DEMANGEAISONS 0.5%, cream and in which cases is it used?
2. What should I know before using DERMOFENAC DEMANGEAISONS 0.5%, cream?
3. How to use DERMOFENAC DEMANGEAISONS 0.5%, cream?
4. What are the possible side effects?
5. How to store DERMOFENAC DEMANGEAISONS 0.5%, cream?
6. Package contents and other information.
1. WHAT DERMOFENAC DISMANTAGES 0.5%, cream AND IN WHAT CASES IS IT USED?
This medicine contains a corticosteroid.
This medication is indicated for adults and children over 6 years of age in the following cases:
· stings of nettles,
· Insect bites,
· localized sunburns.
2. BEFORE YOU USE DERMOFENAC REMOVALS 0.5%, cream?
Do not use DERMOFENAC 0.5% DEMANGEAISONS, cream:
· if you are allergic (hypersensitive) to hydrocortisone or to any of the other ingredients of this medication mentioned in section 6, in particular because of the presence of wool fat (lanolin), stearyl alcohol and cetyl alcohol,
· on wounds,
· on an acne,
· on rosacea, on infected skin, whether the origin is bacterial (eg impetigo ...), viral (herpes, shingles, varicella), mycotic (due to microscopic fungi) or parasitic.
Warnings and Precautions
Special warnings
DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
If blistering occurs after sunburn, consult your doctor before applying the product.
Precautions for use
This medication contains a corticosteroid, follow the directions for use. An increase in the amount applied and / or in the number of applications would not improve either the activity or the speed of action of the product but could cause undesirable effects:
· do not deal with large areas,
· do not cover with a closed dressing (occlusive dressing), as this may cause some of the active ingredient to pass through the blood,
· do not apply other dermatological products to the treated surface,
· do not use more than twice a day, do not exceed the recommended duration of use (3 days).
If symptoms persist beyond 3 days of treatment, take the advice of your doctor.
In case :
· of local intolerance,
· irritation, superinfection of the skin, stop treatment and consult your doctor.
This medication contains lanolin, cetyl alcohol and stearyl alcohol, and may cause local skin reactions (eg, eczema).
If you have any doubts, ask your doctor or pharmacist before using DERMOFENAC DEMANGEAISONS 0.5%, cream .
Children and Youth
Not applicable.
Other medicines and DERMOFENAC DEMANGEAISONS 0.5%, cream
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.
DERMOFENAC DEMANGEAISONS 0.5%, cream with food, drinks or alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before using this medicine.
If needed, this medication may be used during pregnancy.
feeding
Breast-feeding is possible when treated with this medication.
Do not apply on the breasts during breastfeeding, because of the risk of ingestion of the product by the newborn.
Sport
Not applicable.
Driving and using machines
Not applicable.
DERMOFENAC DEMANGEAISONS 0.5%, cream contains
Lanolin (wool fat), cetyl alcohol and stearyl alcohol.
3. HOW TO USE DERMOFENAC DEMANGEAISONS 0.5%, cream?
Always use this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.
Apply cream 2 times a day, morning and evening.
Apply the product in a thin layer, then spread it by massaging lightly until it is completely absorbed.
Wash your hands after application.
The duration of use is limited to 3 days |
Persistence of symptoms beyond 3 days requires medical advice.
Use in children and adolescents
Not applicable.
If you used more than 0.5% DERMOFENAC SPRAY, cream you should:
Not applicable.
If you forget to use DERMOFENAC 0.5% DEMANGEAISONS, cream:
Not applicable.
If you stop using DERMOFENAC 0.5% DEMANGEAISONS, cream:
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medication can cause side effects, although not everybody gets them.
· Risk of thinning of the skin, dilation of small blood vessels, stretch marks, acne outbreak, redness and irritation around the mouth,
· Cases of exaggerated development of the hair system, skin discolouration disorder, secondary infection especially during prolonged treatment, under occlusive dressing or in folds, have been reported,
· Due to the presence of wool fat, risk of eczema,
· If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
Additional Adverse Events in Children and Adolescents
Not applicable.
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 DERMOFENAC DEMANGEAISONS 0.5%, cream?
Keep this medicine out of the reach and sight of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
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 DERMOFENAC DEMANGEAISONS contains 0,5%, cream
· The active substance is:
Hydrocortisone ................................................. .................................................. 0.50 g per 100 g.
· The other components are:
stearyl alcohol, cetyl alcohol, isopropyl alcohol, wool fat (lanolin), macrogol 1000 palmitostearate, macrogol 4000 palmitostearate, macrogol 6000 palmitostearate, purified water.
What is DERMOFENAC DEMANGEAISONS 0.5%, cream and contents of the pack
This medication is in the form of a cream, in a 15 g tube.
Marketing Authorization Holder
PFIZER FAMILY HEALTH
23-25 AVENUE OF DOCTOR LANNELONGUE
75014 PARIS
Marketing Authorization Operator
PFIZER FAMILY HEALTH
23-25 AVENUE OF DOCTOR LANNELONGUE
75014 PARIS
Maker
CHEMINEAU LABORATORIES
93 ROAD OF THE MONEY
37210 VOUVRAY
la France
or
DOPPEL FARMACEUTICI SRL
VIA MARTIRI DELLE FOIBE, 1
29016 CORTEMAGGIORE (PC)
ITALY
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].
Other
Not applicable.