GLYCEROL/VASELINE/PARAFFINE ZYDUS 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 (E216).

Adjunctive treatment of dry skin conditions in certain dermatoses such as atopic dermatitis, ichthyotic conditions, psoriasis.

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.

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/PARAFFIN ZYDUS may be used during pregnancy.

Breast-feeding

Given the nature of the active ingredients, no risk is expected. It is only recommended not to apply GLYCEROL/VASELINE/PARAFFIN ZYDUS to the breast during breastfeeding.

Fertility

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

GLYCEROL/VASELINE/PARAFFIN ZYDUS has no effect or a negligible effect on the ability to drive vehicles and use machines.

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

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 determinable (cannot be estimated from the available data).

* 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.

Pharmacotherapeutic class: EMOLLIENT and SKIN PROTECTANT, ATC code: D02AC.

Emollient and moisturising cream.

The mechanisms of action of this medicine are as follows:

• Reduction of insensible water loss: petrolatum and paraffin form a lipid layer that limits water loss from the stratum corneum and allows water-soluble and hygroscopic substances to be retained within it.

• 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 glycerol/petrolatum/paraffin, involving the restoration of corneodesmosomal junction homeostasis.

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

All of these properties were demonstrated in clinical studies representative of a state of dry skin in children:

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

• Glycerol/petrolatum/paraffin significantly improves the symptomatology assessed by the SRRC (Scaling, Roughness, Redness, Cracks fissures) score: 65 % of responders under this medication, versus 50 % under vehicle, the response being defined by a decrease in the SRRC score of at least 50 %.

• The decrease in the SRRC score was significantly greater (p < 0,05) on days 14 and 28 in patients treated with glycerol/petrolatum/paraffin 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 glycerol/petrolatum/paraffin.

• Atopic dermatitis in children: double-blind study versus placebo for 28 days followed by an open-label period for 2 months with reintroduction of glycerol/petrolatum/paraffin in patients who relapse by day 56.

• Glycerol/petrolatum/paraffin significantly improves skin dryness in patients presenting with moderate to severe xerosis (glycerol/petrolatum/paraffin 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 in xerosis increases over time from day 7 to day 28.

• When glycerol/petrolatum/paraffin is applied to xerotic skin, the hydration index measured with the corneometer reaches normal hydration values by day 28 (> 40 corneometer units).

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

The results of these clinical studies highlight the benefit of long-term treatment with glycerol/petrolatum/paraffin:

• In responder patients, discontinuation of treatment leads to a worsening of xerosis and dermatosis.

• Resumption of treatment leads to an improvement in xerosis and dermatosis.

Pre-clinical data show good skin tolerance of this medicinal product, which is otherwise confirmed in humans. The cream proves non-irritating to the eyes. Devoid of phototoxic potential, it shows, in animals, a low sensitising and photosensitising potential, but the risk is considered negligible in humans due to the absence of 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.

• Ichthyosis
• Atopic dermatitis