GLYCEROL/VASELINE/PARAFFINE SANDOZ 15 %/8 %/2 % Cr T/250g

Glycerol.......................................................................................................................................................15,000 g

Petroleum jelly........................................................................................................................................................8,000 g

Liquid paraffin...........................................................................................................................................2,000 g

For 100 g.

Excipient with known effect: propyl parahydroxybenzoate.

Adjunctive treatment of dry skin states associated with certain dermatoses such as atopic dermatitis, ichthyotic conditions, psoriasis in adults and children including infants.

Adjunctive treatment of superficial burns of small extent.

Dosage

In adults and children, including infants, apply the cream as a thin layer to the areas to be treated once or twice daily, or more if necessary.

Paediatric population

The safety and efficacy of GLYCEROL/VASELINE/PARAFFINE SANDOZ have not been established in premature infants.

Method of administration

Cutaneous use.

Hypersensitivity to the active substances or to any of the excipients listed in section Composition.

Do not swallow.

It is recommended not to apply to an infected lesion or under an occlusive dressing.

This medicine contains propyl parahydroxybenzoate and may cause allergic reactions (possibly delayed).

No interaction studies have been performed.

Pregnancy

No effect is expected on pregnancy because systemic exposure to glycerol, vaseline and paraffin is negligible. GLYCEROL/VASELINE/PARAFFINE SANDOZ can be used during pregnancy.

Breast-feeding

No effect on the breastfed newborn/infant is expected because systemic exposure of the breastfeeding mother to glycerol, vaseline and paraffin is negligible.

GLYCEROL/VASELINE/PARAFFINE SANDOZ can be used during breastfeeding. It is only recommended not to apply GLYCEROL/VASELINE/PARAFFINE SANDOZ to the breast during breastfeeding.

Fertility

No effect on fertility is expected because systemic exposure to glycerol, vaseline and paraffin is negligible.

GLYCEROL/VASELINE/PARAFFINE SANDOZ has no or negligible effect on the ability to drive vehicles and use machines.

Adverse effects are classified below according to the MedDRA database by System Organ Classes and by frequency, according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1000), very rare (<1/10 000), frequency not known (cannot be estimated from the available data).

The following adverse effects have been reported during clinical studies and since the marketing of this medicinal product:

* irritation, redness, pain or itching at the application site

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to 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 Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

No cases of overdose have been reported with GLYCEROL/VASELINE/PARAFFINE SANDOZ.

Pharmacotherapeutic class: OTHER EMOLLIENTS AND SKIN PROTECTANTS, ATC code: D02AX.

Emollient and moisturising cream.

The mechanisms of action of this medicine are as follows:

• Reduction of insensible water loss from the skin: vaseline and paraffin form a lipid layer limiting the water loss from the stratum corneum and allowing the retention within it of water-soluble and hygroscopic substances.

• Increase in hydration of the superficial layers of the skin due to the hygroscopic power of glycerol and its penetration into the epidermis.

The skin protective effect has also been demonstrated by tests ex vivo performed on delipidated tissue implants. These tests showed rapid restructuring of the lipid barrier with demonstration of the emollient activity of the GLYCEROL/VASELINE/PARAFFINE combination involving restoration of corneodesmosomal junction homeostasis. A study ex-vivo performed on isolated human stratum corneum showed an improvement in the ceramide content, lipid components of stratum corneum.

These properties, demonstrated in pharmaco-clinical studies on validated models, promote the restoration of skin hydration and barrier function, which is likely to reduce phenomena of irritation, pruritus and scratching.

Clinical studies representative of a state of cutaneous dryness such as ichthyosis or atopic dermatitis in children have confirmed these properties:

• Ichthyosis: double-blind study versus placebo for 28 days followed by an open-label period of 2 months.

The GLYCEROL/VASELINE/PARAFFIN combination significantly improves the symptoms assessed by the SRRC (Scaling, Roughness, Redness, Cracks fissures) score: 65 % of responders on this medicine, versus 50 % on vehicle, the response being defined as a decrease in the SRRC score of at least 50 %.

The decrease in the SRRC score and pruritus was significantly greater (p < 0,05) on days 14 and 28 in patients treated with the GLYCEROL/VASELINE/PARAFFIN combination compared with the placebo group (double-blind period). During the open-label period, a significant decrease (p < 0,01) in the SRRC score as well as in pruritus was observed up to day 84 in patients treated with the GLYCEROL/VASELINE/PARAFFIN combination.

• Atopic dermatitis in children: double-blind study versus placebo for 28 days followed by an open-label period for 2 months with re-introduction of the GLYCEROL/VASELINE/PARAFFIN combination in patients who relapse on day 56.

The GLYCEROL/VASELINE/PARAFFIN combination significantly improves skin dryness in patients presenting with moderate to severe xerosis (GLYCEROL/VASELINE/PARAFFIN combination 43 % versus placebo 29 %, p < 0,001) during the double-blind period (D1 to D28). The significant improvement in atopic dermatitis in patients presenting with moderate to severe xerosis is observed from day 7. The difference observed on xerosis increases over time from day 7 up to day 28.

When the GLYCEROL/VASELINE/PARAFFIN combination is applied to xerotic skin, the hydration index measured with a corneometer reaches normal hydration values on day 28 (> 40 corneometer units).

The results observed during the open-label period (D29 to D84) show that in responder patients, stopping the emollient leads to a relapse of xerosis, and in non-responder patients, introducing or continuing the emollient treatment after day 28 leads to an improvement of xerosis.

The results of these clinical studies highlight the benefit of long-term treatment with the GLYCEROL/VASELINE/PARAFFIN combination:

• in responder patients, discontinuation of treatment leads to worsening of xerosis and of the dermatosis.

• resuming treatment leads to an improvement of xerosis and dermatosis.

Pre-clinical data show good skin tolerance of this medicine, otherwise confirmed in humans. The cream proves non-irritating to the eyes. Devoid of photo-toxic potential, it presents, in animals, a low sensitising and photo-sensitising potential, but the risk is considered negligible in humans due to the absence of UV absorption beyond 290 nm.

21 months.

After first opening of the tube: 6 months

This medicine does not require any particular storage precautions.

No special requirements.

• Dry skin