ISOTREX Gel Ref.[6941] Active ingredients: Isotretinoin

Contact with the mouth, eyes and mucous membranes and with abraded skin should be avoided. Care should be taken not to let the medicine accumulate in skin fold areas and in the nasolabial folds.

Due to the irritant nature of Isotrex gel, caution should be used when applying to sensitive areas of skin, such as the neck, or in patients with concomitant rosacea or perioral dermatitis. Isotrex should also be used with caution in patients who have had a problem tolerating this or similar retinoid products in the past.

Due to the potential for severe irritation, application to eczematous skin should be avoided.

Isotrex gel should be used with caution in patients with a history of photoallergy.

As Isotrex gel may cause increased sensitivity to sunlight, sunlamps should not be used and deliberate or prolonged exposure to sunlight should be avoided or minimised. When exposure to strong sunlight cannot be avoided, patients should be advised to use a sunscreen product and wear protective clothing. Due to the potential for photosensitivity, resulting in greater risk for sunburn, Isotrex Gel should be used with caution in patients with a personal or family history of skin cancer.

If a patient has sunburn, this should be resolved before using Isotrex Gel.

Concomitant topical acne therapy should be used with caution because a cumulative irritant effect may occur. If irritancy or dermatitis occur, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if the irritation persists.

Butylated hydroxytoluene (BHT) may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

Concomitant application of oxidising agents, such as benzoyl peroxide, should be avoided since they may reduce the efficacy of topical isotretinoin. If combination therapy is required, the products should be applied at different times of the day (e.g., one in the morning and the other in the evening).

Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result into low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.

Pregnancy

Topical isotretinoin is contraindicated (see section 4.3) in pregnancy, or in women planning a pregnancy. If the product is being used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.

There are limited data available from the use of topical isotretinoin in pregnant women. However, studies totalling 1535 women exposed to topical tretinoin (an isomer of isotretinoin) in early pregnancy did not provide evidence of an increased risk of congenital abnormalities, including retinoic acid embryopathy or major structural defects.

In the clinical setting however, use of topical tretinoin in early pregnancy has been temporally associated with retinoic acid specific embryopathy. There are also a few reports of the rare birth defect category, holoprosencephaly (defects associated with incomplete midline development of the forebrain). The significance of these reports in terms of risk to the foetus is uncertain, since no causal association has been established from these cases and these effects have not been reproduced.

Breastfeeding

There is insufficient information on the excretion of topically applied isotretinoin in human milk.

A risk to the newborns/infants cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from isotretinoin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

There are no data on the effect of topical isotretinoin on fertility in humans, but isotretinoin in oral therapeutic dosages does not affect the number, motility, and morphology of sperm.

Not applicable; the product is a topical preparation which acts locally at the site of application.

The frequency of adverse reactions listed below is defined using the following convention: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Skin and subcutaneous tissue disorders

Very common: Application site erythema, skin exfoliation, skin pain, application site pruritus, skin irritation, skin tenderness, skin burning sensation, application site stinging, dry skin

Post-marketing data

The following adverse drug reactions are based on post-marketing reports. Since these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency, however in reality the following reactions are rarely seen.

Skin and subcutaneous tissue disorders

Not known: Skin hyperpigmentation, skin hypopigmentation, photosensitivity reaction

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 reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.