Azelaic acid - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS • Hypersensitivity: Hypersensitivity reactions, including cases of angioedema, eye swelling, facial swelling, dyspnea, urticaria, and adverse skin reactions, have been reported.

In case of known hypersensitivity to any component of the gel, avoid the use of azelaic acid gel.

If hypersensitivity develops, discontinue treatment and institute appropriate therapy. • Skin Reactions: Skin irritation (i.e. pruritus, burning or stinging) may occur, usually during the first few weeks of treatment.

If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy. • Hypopigmentation: Isolated cases of hypopigmentation occurred after azelaic acid use.

Monitor patients with dark complexion for early signs of hypopigmentation. • Eye and Mucous Membrane Irritation: Azelaic acid gel has been reported to cause irritation of the eyes.

Avoid contact with the eyes and mucous membranes. • Exacerbation of Asthma: Consult a physician if asthma is exacerbated with azelaic acid gel use.

5.1 Hypersensitivity Hypersensitivity reactions, including cases of angioedema, eye swelling, facial swelling, dyspnea, urticaria, and adverse skin reactions, have been reported during post marketing surveillance.

Avoid the use of azelaic acid gel in patients with known hypersensitivity to any component of the gel.

If hypersensitivity develops during treatment, discontinue azelaic acid gel and institute appropriate therapy.

5.2 Skin Reactions Skin irritation (i.e. pruritus, burning or stinging) may occur during use of azelaic acid gel, usually during the first few weeks of treatment.

If sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy.

There have been isolated reports of hypopigmentation after use of azelaic acid.

Since azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation 5.3 Eye and Mucous Membranes Irritation Azelaic acid gel has been reported to cause irritation of the eyes.

Avoid contact with the eyes, mouth and other mucous membranes.

If azelaic acid gel comes in contact with the eyes, wash the eyes with large amounts of water and consult a physician if eye irritation persists [see Adverse Reactions ] .

5.4 Exacerbation of Asthma Worsening of asthma has been reported in patients using azelaic acid formulations including azelaic acid gel.

Consult a physician if asthma is exacerbated with use of azelaic acid gel.