In this manual :
1. WHAT IS SEDERMYL 0.75% cream AND WHAT IS IT USED FOR?
2. WHAT DO YOU 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 TO USE SEDERMYL 0.75% cream?
6. ADDITIONAL INFORMATION
1. WHAT IS SEDERMYL 0.75% Cream AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
This medicine is an antihistamine for topical use. It belongs to the class of dermatological medicines.
This medicine is recommended in cases of itching, particularly insect bites.
2. WHAT DO YOU NEED TO KNOW BEFORE USING SEDERMYL 0.75% cream?
List of information needed before taking the medicine
SEDERMYL 0.75% cream is not a sunscreen.
SEDERMYL 0.75% cream should not be used as a skin care cream on healthy skin.
Never use SEDERMYL 0.75% cream in the following cases:
- history of allergy to antihistamines,
- infected or irritated skin lesions
- oozing skin lesions.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Be careful with SEDERMYL 0.75%, cream:
Do not apply over a large area, under an occlusive dressing, on injured skin or in premature babies or infants because of the risk of the active ingredient passing into the bloodstream.
Do not apply to mucous membranes.
This medicinal product contains cetostearyl alcohol and cetyl alcohol and may cause local skin reactions (for example: eczema).
This medicine contains propylene glycol and may cause skin irritation.
Itching is only a symptom which may have multiple causes requiring the advice of your doctor, especially in the event of persistent or worsening disorders.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines
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 lactation
Pregnancy and lactation
This medicine should be used with caution during pregnancy and breastfeeding. In general, you should seek the advice of your doctor or pharmacist before taking any medicine.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
Important information about some of the ingredients of SEDERMYL 0.75% cream
Cetostearyl alcohol, cetyl alcohol, propylene glycol.
3. HOW TO USE SEDERMYL 0.75% cream
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
1 application 2 to 3 times daily.
Do not exceed 5 days of treatment.
For adults and children over 30 months of age only.
Mode and route of administration
Dermal route.
Duration of treatment
If the symptoms persist after 5 days of treatment, consult your doctor.
Symptoms and instructions in case of overdose
Not applicable.
Instructions in case of missed doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, SEDERMYL 0.75% cream may have side effects, although not everyone is susceptible:
- risk of allergy to isothipendyl or to any component of the cream.
- Very rare cases of photosensitisation (skin reaction to sunlight or UV light).
If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO STORE SEDERMYL 0.75% cream
Keep out of the reach and sight of children.
Do not use SEDERMYL 0.75% cream after the expiry date stated on the box or tube. The expiry date refers to the last day of the month.
No special storage precautions.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does SEDERMYL 0.75% cream contain?
The active substance is:
Isothipendyl hydrochloride ................................................................................................................. 0.75 g
Per 100 g of cream.
The other components are:
Sodium acetate, emulsifier cetostearyl alcohol (type A) (Lanette N), oleic acid decylester (Cetiol V), cetyl alcohol, propylene glycol, purified water.
Pharmaceutical form and content
What is SEDERMYL 0.75% cream and what does it contain?
This medicine is in the form of a cream.
Tubes of 35 g and 60 g.
Not all presentations may be marketed.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
Operator
COOPERATION PHARMACEUTIQUE FRANCAISE
PLACE LUCIEN-AUVERT
77020 MELUN CEDEX
Manufacturer
COOPERATION PHARMACEUTIQUE FRANCAISE
2 RUE DE LA SAUSSAIE
77310 SAINT FARGEAU PONTHIERRY
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
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 Afssaps website (France).
Information for health professionals only
Not applicable.
Not applicable.
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