Melanin-related hyperpigmentation (brown skin spots), e.g. melasma (chloasma), brown skin spots after an inflammation

Posology

Unless prescribed otherwise, apply PIGMANORM Cream sparingly once daily to the affected skin areas

The average duration of treatment is seven weeks

If no lightening of the skin has occurred after 3 months at the latest, the treatment should be stopped

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. PIGMANORM Cream must not be used in the case of vitiligo (piebaldism, white-spot disease), melanoma or suspected melanoma, acute inflammation of the skin or eczema, perioral dermatitis (inflammation of the skin on the chin and lateral parts of the mouth), rosacea, and in all cases for which restrictions on the use of cortisone preparations apply, such as chickenpox, vaccine reactions, bacterial or fungal skin infections and specific skin processes (syphilis, tuberculosis). The ingredient hydroquinone can be absorbed to a small extent through the skin. Because of the potential risks associated with this substance, PIGMANORM Cream should not be applied to extensive areas of skin, and should not be used by patients with renal disease, pregnant women, and children under 12. Avoid any contact of PIGMANORM Cream with the mucous membranes of the eyes, nose, and mouth. Tretinoin must not be used during pregnancy (see section “Reproductive toxicology”

Based on animal studies in which hydroquinone was administered orally, this substance is suspected of having a mutagenic and weak carcinogenic effect. Even if topical application results only in limited absorption, the period of application in humans should depend on the treatment outcome and be kept as short as possible

Avoid any contact with eyes and mucous membranes.

In order to avoid any additional skin pigmentation and to prevent skin irritation, the treated skin areas should be protected from intensive sunlight and UV radiation. In special cases, it is recommended to cover the treated areas with an appropriate sun protection product

The possibility of increased absorption of other topically applied products should be taken into account if the skin is treated with a vitamin-A product

Pregnancy

PIGMANORM Cream must not be used during pregnancy, since the risk of a malformation in the child cannot be excluded during treatment with tretinoin

Breastfeeding

During the breast-feeding period, use of PIGMANORM Cream should be limited to cases in which it appears to be absolutely necessary. If it is used, the product must not be applied to the breast area to prevent the breast-fed child from coming into contact with the product

PIGMANORM Cream has no or negligible influence on the ability to drive and use machines

During treatment, skin reactions may, in rare cases (≥ 1/10,000 until <1/1,000), appear in the form of reddening, irritation, itching, peeling off, and burning. In the case of application over a very long period of time, local side effects may appear such as thinning of the skin, dilated blood vessels, appearance of striae and acne-like manifestations. PIGMANORM Cream should be stopped if pale spots appear around the treated area or on other parts of the body, or if no lightening of the skin has occurred after 3 months

To report any side effects

- National Pharmacovigilance and Drug Safety Center (NPC)

o Fax: +966-11-205-7662

o To call the executive management of vigilance and crisis management: +966-11-2038222 ext.: 2353– 2356 – 2317 – 2354 – 2334 – 2340

o Toll-free: 8002490000

o E-mail: npc.drug@sfda.gov.sa

o Website: www.sfda.gov.sa/npc

No cases of overdose have been reported
There is no risk of overdose if the product is applied to the skin in the recommended dose

Pharmacotherapeutic group: Corticosteroids, dermatological Preparations - Corticosteroids, weak, other combinations

ATC code: D07XA01

 

Vitamin A acid stimulates mitotic activity of the epidermis and at the same time causes thinning and densification of the stratum corneum. Increased cell proliferation in the epidermis leads to a certain bleaching of the skin, while thinning of the stratum corneum facilitates penetration of other topically applied active substances

 

Topically applied hydroquinone causes depigmentation of pathological hyperpigmentation of the skin by inhibiting enzymatic oxidation of tyrosine to 3,4-dihydroxyphenylalanine (DOPA) and suppressing additional metabolic processes in melanocytes

 

As a corticosteroid with few adverse effects and a weak anti-inflammatory effect, hydrocortisone has a certain temporary blanching effect, occasionally leads to hypopigmentation and at the same time has a marked anti-irritant effect. During prolonged used, local adverse effects (e.g. atrophy) are possibly only to be expected in the area of the eyelid. For use on a small surface area, any systemic effect after percutaneous absorption is negligible

Ultimately, hydroquinone has properties similar to those of phenol. Since it is therefore a potential irritant, it should not be applied to wounds, damaged skin, or mucous membranes Hydroquinone induces dosedependent gene, genome and chromosome mutations in cell cultures and in animal studies. Mild carcinogenic effects after oral administration were observed in a long-term animal study (mice). There are no known data to suggest that these findings cannot be extrapolated to humans

 

After percutaneous absorption, hydrocortisone (cortisol) causes only very minor suppression of the endogenous plasma concentration

Usual, local side effects of corticosteroids, such as striae distensae, folliculitis, hypertrichosis, steroid acne and perioral dermatitis rarely occur clinically, and atrophy is only very rarely observed. The substance has a slight teratogenic action in animal studies, but not in humans. It is not mutagenic or carcinogenic

 

After systemic administration, vitamin A acid is teratogenic and may cause hypervitaminosis A effects; this information is derived from pharmacological and toxicological studies. When vitamin A acid is applied topically, hypervitaminosis A may be excluded because of low percutaneous absorption. The amount absorbed percutaneously in humans is about 6% in non inflamed skin. If a maximum percutaneously absorbed quantity of 33% of the applied dose (e.g. 10 g cream with 0.1% vitamin A acid on about 3000 cm2) on very inflamed skin is assumed as an extreme value, this results in a maximum of 0.047 mg/kg

 

Only doses greater than 30 mg/kg lead to teratogenic damage in Rhesus monkeys. In rats, the teratogenic “no effect level” is 2.7 mg/kg. It is not expected that frequent application of the cream would lead to a cumulative effect because vitamin A acid is eliminated rapidly

In Wistar rats, tretinoin administered topically is not teratogenic, even at doses that are 1000 times greater than the topical dose administered to humans (assuming systemic availability of 0.0005 mg tretinoin/kg BW; this is equivalent to e.g. 500 mg of a 0.05% cream for a person weighing 50 kg). At these doses there were changes that are considered normal variants, e.g. delayed ossification of some bones or a dose-dependent increase in extra ribs

 

In rats, tretinoin administered orally is teratogenic and fetotoxic if it is administered in quantities 500 and 1000 times greater than the doses applied topically in humans

 

There are isolated reports of birth defects in children whose mothers received topical treatment with tretinoin during pregnancy and for whom the possibility of a causal link is discussed, but no

conclusive assessment is possible at the present time

 

A cohort study in more than 200 children whose mothers were exposed to topical tretinoin treatment during the first trimester of pregnancy did not indicate any increased incidence in birth defects compared with the children from a group of women who had not had this exposure. The teratogenic blood level of tretinoin in humans is not known. Tretinoin should therefore not be used during pregnancy because the risk of a malformation in the child cannot be excluded

"Sodium Cetostearyl Sulfate "Lanette E
Isopropyl Myristate
Polyethylene Glycol 200
Liquid Paraffin
Hard Paraffin
Cetyl Alcohol
Glyceryl Monostearate 40-50
Kolliphor CS A
Dehydol LS 4
Ascorbic Acid
Water for Injection

Not applicable

2 years

Store below 25°C

 Aluminum tube with plastic screw cap

Store in the original pack to protect from light
Tubes of Pigmanorm Cream should be discarded 28 days after opening