NOTICE
ANSM - Updated on : 29/09/2021
Product name
SEDERMYL 0.75%, cream
Isothipendyl hydrochloride
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as it is described in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any 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 do not feel any improvement or if you feel less well after 5 days.
What does this leaflet contain?
1. What is SEDERMYL 0.75% cream and what is it used for?
2. What do I need to know before using SEDERMYL 0.75% cream?
3. How do I use SEDERMYL 0.75% cream?
4. What are the possible side effects?
5. How should SEDERMYL 0.75% cream be stored?
6. Package contents and other information.
1. WHAT IS SEDERMYL 0.75% cream AND WHERE IS IT USED?
Pharmacotherapeutic class - ATC code: D04AA22
ANTIPRURITIC AGENTS, INCLUDING ANTIHISTAMINES, ANESTHETICS, ETC. - ANTIHISTAMINES FOR TOPICAL USE
This medicine contains a neuroleptic with antihistaminic properties, disothipendyl hydrochloride.
This medicine is an antihistamine for topical use.
It is indicated in cases of itching, particularly insect bites.
2. WHAT DO I HAVE TO KNOW BEFORE USING SEDERMYL 0.75% cream?
Never use SEDERMYL 0.75%, cream
- if you are allergic to the active substance or to any of the other ingredients listed in section 6,
- if you have infected or irritated skin lesions,
- if you have oozing skin lesions
- if you suffer from eczema.
Warnings and precautions
Talk to your doctor or pharmacist before using SEDERMYL 0.75% cream.
Itching is only a symptom and may have multiple causes. Consult your doctor if symptoms persist or worsen.
Due to the presence of disothipendyl hydrochloride, there is a risk of skin sensitization and photosensitization. In the event of proven cutaneous sensitization to the disothipendyl hydrochloride contained in the cream, cross-sensitization may occur after systemic administration of phenothiazines.
Also, persistent or worsening pruritus may be linked to an allergy to disothipendyl hydrochloride or to any of the components of this drug.
The development of an allergy to disothipendyl hydrochloride may contraindicate future use of certain systemically-applied drugs (some local anesthetics, some antihistamines).
Do not apply to large surfaces, occlusive dressings, damaged skin or infants, as the active ingredient may pass into the bloodstream.
Do not apply to mucous membranes.
In view of the photosensitizing effect of phenothiazines, it is preferable to avoid exposure to sunlight or UV-A during treatment.
To avoid the risk of photosensitization, it is advisable to protect treated areas by wearing clothing throughout the treatment.
Do not apply to large areas of the body.
SEDERMYL 0.75% cream is not a sunscreen.
SEDERMYL 0.75% cream should not be used as a skin care cream on healthy skin.
Children
The safety and efficacy of SEDERMYL 0.75% cream in children under 2 years of age have not been established.
Other drugs and SEDERMYL 0.75%, cream
Tell your doctor or pharmacist if you are using, have recently used or may use any other medicines.
SEDERMYL 0.75% cream with food, drink and alcohol
Not applicable.
Pregnancy and breast-feeding
This medicine should be used with caution during pregnancy and while breast-feeding.
If you are pregnant or breastfeeding, think you might be pregnant or are planning to become pregnant, ask your doctor or pharmacistfor advicebefore using this product.
Driving and using machines
Not applicable.
SEDERMYL 0.75% cream contains cetostearyl alcohol and cetyl alcohol and may cause local skin reactions (e.g. eczema).
This medicine contains propylene glycol and may cause skin irritation.
This medicine contains propylene glycol and may cause skin irritation. This medicine contains 100 mg propylene glycol per dose, equivalent to 100 mg/g.
3. HOW TO USE SEDERMYL 0.75% cream?
Always use this medicine exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
For adults and children over 2 years of age.
1 application 2 to 3 times a day.
Method and route of administration
Cutaneous route.
Apply only to the insect bite, not to healthy skin.
Wash hands after use.
Duration of treatment
Do not use for more than 5 days without medical advice.
Use in children
The safety and efficacy of SEDERMYL 0.75% cream in children under 2 years of age have not been established.
If you have used more SEDERMYL 0.75% cream than you should have
Signs of overdosage with disothipendyl hydrochloride: convulsions (especially in children), disturbances of consciousness, coma;
Symptomatic treatment should be instituted in a specialized facility.
What if you forget to use SEDERMYL 0.75% cream?
Not applicable.
If you stop using SEDERMYL 0.75% cream ?
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
As with all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Risk of allergy to isothipendyl hydrochloride or to a component of the cream, with cutaneous reactions localized to the application site.
Very rare cases of photosensitization (cutaneous reaction on exposure to sunlight or UV rays).
Very rare cases of generalized hypersensitivity reactions (generalized allergic reactions affecting the whole body).
Reporting side effects
If you experience any side effects, please tell 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: www.signalement-sante.gouv.fr
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE SEDERMYL 0.75% cream?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the tube and outer packaging. The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What SEDERMYL 0.75% cream contains
The active substance is:
Isothipendyl hydrochloride .................................................................................................. 0.750 g
Per 100 g of cream
Other ingredients are:
Sodium acetate, cetostearyl alcohol emulsifier (type A) (Lanette N), oleic acid decylester (Cétiol V), cetyl alcohol, propylene glycol, purified water.
What SEDERMYL 0.75% cream is and what it contains
This medicine comes in the form of a cream.
Tubes of 35 g and 60 g.
Not all presentations may be marketed.
Marketing authorization holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
Marketing authorization holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
Manufacturer
COOPERATION PHARMACEUTIQUE FRANCAISE
2 RUE DE LA SAUSSAIE
77310 SAINT FARGEAU PONTHIERRY
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Not applicable.
Detailed information on this drug is available on the ANSM (France) website.