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EFFEDERM 0,05 % Cream Tube/30g

Bailleul France

EFFEDERM 0,05 % Cream Tube/30g

CIP / EAN code: 3400931762775

Product information from VIDAL.

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Product information

Find indications, dosage and precautions in the sections below.

Automatic English translation of the French VIDAL document. Original numerical values and units are retained, including decimal commas.

VIDAL
Medicines
Update of 23/09/2024

EFFEDERM®
tretinoin


Forms and presentations

0,05 % Cream:  Tube of 30 g.
Solution for cutaneous application:  Bottle of 50 ml (0,14 ml/dose), with metering valve.


Composition

Cream: per tube
Tretinoin 
15 mg
Excipients: macrogol 2000 stearate, polysorbate 60, mixture of mono- and diglycerides of saturated fatty acids, partially oxyethylenated cetostearyl alcohol, peanut oil, ethanol 96 °, propylene glycol, chlorhexidine acetate, butylhydroxytoluene, potassium sorbate, purified water.

Excipients with known effect: partially oxyethylenated cetostearyl alcohol, peanut oil, propylene glycol, butylhydroxytoluene, ethanol, polysorbate 60.

Solution for cutaneous application: per vial
Tretinoin 
25 mg
Excipients: DL alpha-tocopherol, ethanol at 95 %, propylene glycol.

Excipients with known effect: propylene glycol.


Indications

  • Moderate severity acne, particularly indicated in retention acne.
  • Keratinization disorders resistant to emollients.
  • Flat warts.

Dosage and administration

Dosage
Acne:
The starting dosage is one application, in the evening. The frequency of applications will be adjusted according to the reactions obtained.
In case of significant primary irritation, switch to one application every other day.
In the absence of any local reaction, the frequency of applications may be increased to 2 per day. From the end of the second week until the end of the initial treatment (12e at 14e week), the rhythm of applications is on average once a day or less in case of persistent irritation.
The application frequency must be prescribed such that it avoids unpleasant irritation reactions; only mild erythema, moderate desquamation, or even a slight burning sensation are acceptable.
Stronger reactions must be anticipated in subjects with thin skin and blond or red hair, and the most suitable dosage must be chosen.
To obtain the best result, the patient must be warned of the normal reactions that mark the start of treatment: primary irritation and transient efflorescence; he must be reviewed regularly to adjust the dosage and minimize primary irritation.
He must be warned of the delayed nature of the improvement, of the value of continuing therapy until the third month to obtain an optimum result, and of the need for treatment.
Improvement is clearly visible by week 6e of treatment, it continues to achieve the best possible result by week 12e or week 14e week.
At this date, or earlier if all acne lesions have disappeared, maintenance treatment with 2 or 3 applications per week may be started.
Keratinization disorders, flat warts:
The frequency of applications will depend on the nature of the condition. It is on average 1 to 2 applications per day.

Method of administration:

Cutaneous use.

Cream:
After washing and thoroughly drying the skin, apply a thin layer of cream to the lesions with light massage, avoiding the eyes, eyelids, lips, and nostrils.
Wash hands after using the product.
Solution for cutaneous application:
After washing and thoroughly drying the skin, apply the solution with a cotton make-up pad to the areas to be treated, avoiding the eyes, eyelids, lips, and nostrils.
Discard the cotton make-up pad after use.

Contraindications

Cream and solution for cutaneous application:
  • Hypersensitivity to the active substance or to any of the excipients listed in section Composition.
  • Pregnancy (see Fertility/Pregnancy/Breastfeeding).
  • Women planning a pregnancy.
Cream:
Due to the presence of peanut oil, this medicine is contraindicated in cases of allergy to peanut or soy.

Warnings and precautions

Cream and solution for cutaneous application:
  • Because of possible intolerance phenomena such as edema and eczematization of a transient nature, a repeated test on a reduced skin surface (test patch) is advisable during the first applications.
  • If a hypersensitivity-type reaction or severe irritation appears, treatment must be temporarily or even permanently discontinued.
  • In case of accidental application to mucous membranes, eyes, mouth, nostrils, or an open wound, rinse thoroughly with lukewarm water.
  • Due to the irritant nature of the treatment, concomitant use of astringent cleansing cosmetic products and drying or irritating agents (such as perfumed or alcohol-containing products) should be avoided.
  • Exposure to the sun and ultraviolet lamps, which causes additional irritation, should be avoided.
    Treatment may nevertheless be continued if sun exposure is reduced to a minimum (protection by wearing a hat and use of a sunscreen cream) and the rhythm of applications is adjusted.
    In case of exceptional sun exposure (a day at the seaside for example), do not apply the day before, the same day, or the day after.
    If prior exposure has caused sunburn, wait for complete recovery before starting treatment.
Cream:
  • This medicine contains cetostearyl alcohol and may cause local skin reactions (for example: contact dermatitis).
  • This medicine contains 20 mg of propylene glycol per g of cream and may cause skin irritation.
  • This medicine contains butylhydroxytoluene and may cause local skin reactions (for example: contact dermatitis) or irritation of the eyes and mucous membranes.
  • This medicine contains 70 mg of alcohol (ethanol at 96 °) per 1 g of cream, equivalent to 70 mg/g. This may cause a burning sensation on damaged skin.
  • This medicine contains 11 mg of polysorbate (polysorbate 60) per 1 g of cream, equivalent to 11 mg/g. Polysorbates may cause allergic reactions. Inform your doctor if you have already had / your child has already had an allergy.
Solution for cutaneous application:
  • Propylene glycol may cause skin irritation.
  • Do not use this medicine in babies under 4 weeks old who have open wounds or large areas of damaged or injured skin (burns) without first informing your doctor or pharmacist.

Interactions

Due to the irritating nature of this preparation, it is preferable to avoid any product that may cause local irritation (alcohol-based solutions in particular).


Fertility, pregnancy and breastfeeding

Oral retinoids are associated with congenital abnormalities. When used in accordance with the prescribing information, topical retinoids are generally considered to result in low systemic exposure due to minimal dermal absorption. However, individual factors (for example: skin lesion, excessive use) may contribute to increased systemic exposure.

Pregnancy:
  • In animals: tretinoin has been shown to be teratogenic when given orally; when applied topically at high doses, it induces minor skeletal malformations.
  • In humans: Effederm is contraindicated (see Contraindications) in pregnant women or women planning a pregnancy.
    If used in a pregnant patient, or if a patient treated with this medicine becomes pregnant, treatment must be discontinued.

Breastfeeding:

It is not known whether tretinoin is secreted into breast milk after administration of Effederm, but it is known that retinoids administered orally and their metabolites are secreted into breast milk. Therefore, Effederm must not be used in breastfeeding women.


Driving and using machines

Effederm has no or negligible effect on the ability to drive vehicles and use machines.

Adverse effects

Cream and solution for cutaneous application:
  • Reversible skin irritation may occur, disappearing when treatment is interrupted or applications are spaced out. A feeling of warmth or slight tingling may occur after application.
  • Due to the presence of propylene glycol, risk of contact eczema.
  • Due to the presence of alcohol, frequent applications to the skin may cause irritation and dryness of the skin.
Cream:
  • Due to the presence of sorbic acid, risk of urticaria.
  • Due to the presence of butylhydroxytoluene, risk of contact eczema, irritation of the skin, eyes and mucous membranes.
  • Due to the presence of peanut oil, risk of hypersensitivity reactions (anaphylactic shock, urticaria).
Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: https://signalement.social-sante.gouv.fr.


Pharmacodynamics

Pharmacotherapeutic class: Topical anti-acne retinoids (ATC code: D10AD01).

The activity of tretinoin is based on a mechanism of action that corresponds point by point to the pathogenesis of acne:

  • tretinoin counteracts and prevents the formation of acne lesions: by stimulating the follicular epithelium, the increased proliferation of non-cohesive keratinized cells is intensified. These free horny cells are expelled with the sebum to the skin surface. The horny plug cannot form and the formation of new lesions is thus prevented;
  • tretinoin causes the expulsion of retention elements (open comedones, microcysts). In addition to superficial desquamation of the epidermis, tretinoin exerts a deep action on the follicular epithelium: it stimulates the proliferation of free horny cells which, combined with the reduced cohesion of the horny plug, leads to the expulsion of the microcyst or comedone;
  • tretinoin accelerates the evolution of inflammatory elements (papules, pustules).

Applied at the start of the inflammatory phase, tretinoin increases the permeability of the follicular wall to irritant agents responsible for inflammatory phenomena (keratin fragments, free fatty acids...) and accelerates in the same measure the evolution and elimination of papules and pustules. It thus prevents the transformation of these lesions into cystic nodules.


Pharmacokinetics

The percutaneous absorption rates of tretinoin or retinoic acid, in preparations for topical use, although variable (dosage form, site, treated surface area, duration of treatment...), remain low at therapeutic doses. Retinoic acid is rapidly metabolised (48 h).


Preclinical safety

In repeated-dose toxicity studies conducted mainly by the oral route and in a few cases by the parenteral or dermal route in mice and rats, but also in a few studies in rabbits and dogs, tretinoin exerted marked toxicity at high doses, mainly causing fractures of the long bones as a sign of disturbed bone mineralisation, and testicular atrophy with impaired spermatogenesis. Dermal administration of approximately 0,5 mg/kg body weight in rats and rabbits as a 1 % formulation did not cause systemic signs of toxicity, but induced transient local erythema.

Tretinoin was not mutagenic in the Ames test in bacteria in vitro, but induced sister chromatid exchanges in human fibroblasts in vitro. The specific photo-carcinogenicity study showed an increase in skin tumours caused by ultraviolet light during treatment with tretinoin.

No effect of tretinoin on female fertility was reported, but toxic doses resulted in impaired spermatogenesis in males. Tretinoin was highly embryotoxic and teratogenic in mice, rats, rabbits and monkeys, inducing a high incidence of cleft palate and other malformations. The NOAEL following oral administration was determined to be 0,5 to 1,0 mg/kg body weight in the rat, and the NOAEL following subcutaneous administration was determined to be 1,0 mg/kg body weight in the rabbit. In studies on embryo-foetal development effects following cutaneous application, although no systemic level of tretinoin after topical application was detected in the rat, skeletal or cardiac malformations were described. These abnormalities are consistent with the effects of retinoids and occur at 16 times the recommended clinical dose, assuming 100 % absorption, based on comparison of body surface area. In a peri- and postnatal toxicity study in rats, tretinoin exerted toxic effects at doses above 2 mg/kg body weight following oral administration.

Topical application of tretinoin to the skin may cause reversible skin irritation with erythema, oedema, epithelial proliferation, acanthosis, hyperkeratosis and exfoliation of the superficial layer.


Storage conditions

Shelf life of the cream:
18 months.
Shelf life of the solution for cutaneous application:
3 years.

Cream: Store at a temperature not exceeding 25 °C.

Solution for cutaneous application: No special precautions for storage.


HANDLING/DISPOSAL INSTRUCTIONS

No special requirements.


Prescription, supply and reimbursement

LIST I
Marketing authorisation (AMM) 3400931762775 (1974/97, SmPC rev 01.08.2024) cream.
3400932270699 (1979, SmPC rev 30.08.2018) solution for cutaneous application.
   
Price: 2,37 euros (cream).
3,72 euros (solution for cutaneous application).
Social security reimbursement at 30 %.
Cream: Collection.


BAILLEUL Laboratories
264, rue du Faubourg-Saint-Honoré. 75008 Paris
Tel: 01 56 33 11 11
https://www.bailleul.com

Source: VIDAL · Updated on 10/11/2026. This information does not replace advice from a healthcare professional.