FINACEA Gel Ref.[8142] Active ingredients: Azelaic acid

For external use only.

Finacea Gel contains benzoic acid which is mildly irritant to the skin, eyes and mucous membranes and propylene glycol which may cause skin irritation. Care should be taken to avoid contact with the eyes, mouth and other mucous membranes, and patients should be instructed accordingly (see section 5.3 Preclinical safety data). In the event of accidental contact, the eyes, mouth and/or affected mucous membranes should be washed with large amounts of water. If eye irritation persists, patients should consult a physician. The hands should be washed after each application of Finacea Gel.

It is advisable to avoid the concomitant use of alcoholic cleansers, tinctures and astringents, abrasives and peeling agents in patients using Finacea Gel for treatment of rosacea.

Worsening of asthma in patients treated with azelaic acid has been reported rarely during post-marketing surveillance.

No interaction studies have been performed. The composition of Finacea Gel gives no indication of any undesired interactions of the single components that could adversely affect the safety of the product. No drug-specific interactions were noted during any of the controlled clinical trials.

Pregnancy

There are no adequate and well-controlled studies of topically administered azelaic acid in pregnant women.

Animal studies do indicate the potential for effects with respect to pregnancy, embryo-fetal development, parturition or postnatal development. However, the dose levels without observed adverse effects in animals ranged across studies from 3-32 times the maximum recommended human dose based on body surface area (see section 5.3 Preclinical safety data).

Caution should be exercised when prescribing azelaic acid to pregnant women.

Lactation

It is not known if azelaic acid is secreted into human milk in vivo. However an in vitro equilibrium dialysis experiment demonstrated that passage of drug into maternal milk may occur. But the distribution of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk.

Azelaic acid is not concentrated in milk and less than 4% of topically applied azelaic acid is systemically absorbed, not increasing endogenous azelaic acid exposure above physiological levels. However, caution should be exercised when Finacea Gel is administered to a nursing woman.

Infants must not come into contact with treated skin/breast.

Fertility

There are no data on the effect of Finacea gel on human fertility. Results from animal studies showed no effect on fertility in male or female rats (see section 5.3 Preclinical safety data).

Finacea Gel has no influence on the ability to drive and use machines.

From clinical studies and post-marketing surveillance, the most frequently observed side effects included application site pruritus, application site burning and application site pain.

Frequencies of side-effects observed in clinical studies and post-marketing surveillance and given in the table below are defined according to the MedDRA frequency 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),
Not known (cannot be estimated from the available data).

Immune system disorders

Rare¹: hypersensitivity (which may occur with one or more of the following adverse reactions: angioedema, eye swelling, swelling face, dyspnoea),, worsening of asthma (see section 4.4)

Skin and subcutaneous tissue disorders

Uncommon: contact dermatitis, acne*

Rare¹: Skin irritation, urticaria

General disorders and administration site conditions

Very common: application site burning, application site pain, application site pruritus

Common: application site rash, application site paraesthesia, application site dryness, application site oedema*

Uncommon: application site erythema, application site exfoliation**, application site warmth**, application site discolouration**, application site discomfort*, application site urticaria*

* for indication Rosacea
** for indication Acne
¹ These adverse reactions have been reported during post-approval use of Finacea gel.

Generally, local skin irritation regresses in the course of the treatment.

Pediatric population

Treatment of acne vulgaris in adolescents 12–18 years of age

In 4 clinical phase II and II/III studies involving adolescents 12-17 years of age (120/383; 31%), the overall incidence of adverse events for Finacea Gel was similar for the groups aged 12-17 years (40%), aged ≥18 years (37%) and for the entire patient population (38%). This similarity also applied to the group aged 12-20 years (40%).

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.

Not applicable.