Important Safety Information - Azelaic Acid

Written by HeyDoctor Medical Team

Important safety information and consumer warnings you should know about azelaic acid.

Overview

The risk information provided here is not comprehensive. To learn more, talk about any new medicine with your healthcare provider and pharmacist. The full FDA-approved product labeling can be found at https://www.fda.gov/ or 1-800-555-DRUG. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Azelaic Acid (Finacea, Azelex)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  1. What Azelaic Acid is and what it is used for
  2. What you need to know before you use Azelaic Acid
  3. How to use Azelaic Acid
  4. Possible side effects
  5. How to store Azelaic Acid
  6. Contents of the pack and other information

1. What Azelaic Acid is and what it is used for

Azelaic Acid contains the active substance azelaic acid and belongs to the group of anti-acne preparation for external use (on the skin). Azelaic Acid is for the relief of mild to moderate papulopustular acne of the face and the treatment of papulopustular rosacea. Papulopustular acne and rosacea are associated with inflamed papules and pustules.

2. What you need to know before you use Azelaic Acid

Do not use Azelaic Acid

  • if you are allergic to azelaic acid or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Azelaic Acid. Azelaic Acid is for external use on the skin only. Take care to avoid contact with the eyes, mouth and other mucous membranes (the thin skin around body openings). In the event of accidental contact, wash the eyes, mouth and/or affected mucous membranes with large amounts of water. You should consult a doctor or pharmacist if an eye irritation persists.

Please wash your hands after each application of Azelaic Acid.

It is advisable to avoid alcoholic cleansers, tinctures and astringents, abrasives and peeling agents when using Azelaic Acid for treatment of rosacea.

Rarely, it has been reported that in some patients with asthma who were treated with azelaic acid worsening of asthma symptoms had occurred.

Children and adolescents

Safety and efficacy in the treatment of acne have been studied in 12-18 years old adolescents (see section 3. How to use Azelaic Acid). Azelaic Acid is not recommended for the treatment of acne in children below the age of 12 due to a lack of data on safety and efficacy. Azelaic Acid is not recommended for the treatment of rosacea in children below the age of 18 due to a lack of data on safety and efficacy.

Other medicines and Azelaic Acid

It has not been studied whether Azelaic Acid affects or is affected by other medicines. Do not apply other medicines or treatments to your face at the same time as Azelaic Acid. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.

Pregnancy and breast-feeding

There is limited experience from use of azelaic acid during pregnancy. If you are pregnant or breast-feeding, your doctor will decide whether you can use Azelaic Acid.

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

  • Azelaic Acid has no influence on the ability to drive and use machines.
  • Azelaic Acid contains benzoic acid and propylene glycol
  • Benzoic acid is mildly irritating to the skin, eyes and mucous membranes.
  • Propylene glycol may cause skin irritation.

3. How to use Azelaic Acid

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Azelaic Acid is intended for external use on the skin only.

  • Before you apply Azelaic Acid, clean the skin thoroughly with water and dry. You may use a mild skin-cleansing agent.
  • Do not use air- and water-tight (occlusive) dressings or wrappings, and wash your hands after applying the gel.
  • Apply Azelaic Acid to the affected skin areas twice a day (in the morning and in the evening) and rub it gently into the skin. Approximately 2.5 cm, which is equal to 0.5 g (1 inch) of gel, is sufficient for the entire face.

Azelaic Acid works more effectively if used continuously over the entire period of treatment.

In the event of an irritation of the skin (see section 4. Possible side effects), reduce the amount of gel per application or the frequency of use of Azelaic Acid to once a day until the irritation ceases. If necessary, you should interrupt the treatment temporarily for a few days.

Use in children and adolescents

Dose adjustment in children aged 12-18 years treated for acne is not necessary.

Duration of treatment

How long Azelaic Acid has to be used can vary from person to person and also depends on the severity of the skin disorder.

Your doctor will tell you how long you should use Azelaic Acid.

Acne: You can use Azelaic Acid over several months depending on the effect of the treatment. In general, you may notice a distinct improvement after 4 weeks.

  • In case of no improvement after 1 month or if the acne becomes worse, you should discontinue Azelaic Acid and consult your doctor.

Rosacea: You can use Azelaic Acid over several months depending on the effect of the treatment. You may notice a distinct improvement after 4 weeks of the treatment.

  • In case of no improvement after 2 months or if the rosacea becomes worse, you should discontinue Azelaic Acid and consult your doctor.

If you use more Azelaic Acid than you should

Even if you have accidentally used more Azelaic Acid than you should, a harmful effect (intoxication) is unlikely.

Please continue as prescribed and ask your doctor if you are not sure.

If you forget to use Azelaic Acid

Do not use twice the amount to make up for a forgotten treatment. Continue as prescribed by your doctor.

If you stop using Azelaic Acid

If you stop using Azelaic Acid your skin disease can get worse. Please ask your doctor before you stop using Azelaic Acid.

If you have any further questions on the use of Azelaic Acid, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Azelaic Acid can cause side effects, although not everybody gets them. Skin irritations (for example burning and itching) may occur.

In the majority of cases, the irritation symptoms are mild or moderate and their frequency decreases during the course of therapy.

The most frequently observed side effects include itching (pruritus), burning and pain at the application site.

The following side effects may occur during treatment with Azelaic Acid Gel. They only concern the skin in the application area:

Acne:

Very common (may affect more than 1 in 10 people):

  • Burning, pain, itching (pruritus) at the application site

Common (may affect up to 1 in 10 people):

  • Rash, feeling of tingling or numbness (paraesthesia), dry skin at the application site

Uncommon (may affect up to 1 in 100 people):

  • Skin reaction due to an external agent (contact dermatitis)
  • abnormal redness of the skin (erythema)
  • scaling
  • warmth
  • skin discolouration at the application site

Rare (may affect up to 1 in 1,000 people) [1]:

  • Hypersensitivity, which may occur with one or more of the following adverse reactions:
  • Angioedema (rapid swelling under the skin)

    • Eye swelling
    • Swelling face
    • Dyspnoea (shortness of breath)
  • Skin irritation
  • Urticaria (hives)
  • Worsening of asthma

[1] These side effects have been reported in patients using azelaic acid since marketing approval.

Rosacea:

Very common (may affect more than 1 in 10 people):

  • Burning
  • pain
  • itching (pruritus) at the application site

Common (may affect up to 1 in 10 people):

  • Feeling of tingling or numbness (paraesthesia)
  • dry skin
  • rash
  • swelling (oedema) at the application site

Uncommon (may affect up to 1 in 100 people):

  • Acne
  • skin reaction due to an external agent (contact dermatitis)
  • abnormal redness of the skin (erythema)
  • nettle rash (urticaria)
  • discomfort at the application site

Rare (may affect up to 1 in 1,000 people) [1}:

  • Hypersensitivity, which may occur with one or more of the following adverse reactions:

    • Angioedema (rapid swelling under the skin)
    • Eye swelling
    • Swelling face
    • Dyspnoea (shortness of breath)
  • Skin irritation
  • Urticaria (hives)
  • Worsening of asthma

[1] These side effects have been reported in patients using azelaic acid since marketing approval.

Children and adolescents

Treatment of acne vulgaris in adolescents 12-18 years of age:

  • In clinical studies involving adolescents, the overall incidence of adverse events for Azelaic Acid was similar to that for the entire patient population.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Azelaic Acid

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and tube after “EXP”. The expiry date refers to the last day of that month.

Azelaic Acid does not require any special storage conditions.

Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to dispose away medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Azelaic Acid contains

Active Ingredient: azelaic acid (each gram of Azelaic Acid contains 150 mg of azelaic acid). Other Ingredients:

  • Benzoic Acid(E210)
  • Carbomers
  • Disodium Edetate
  • Lecithin
  • Polysorbate 80
  • Propylene glycol
  • Purified water
  • Sodium hydroxide
  • Triglycerides medium chain

What Azelaic Acid looks like and contents of the pack

Azelaic Acid is a white to yellowish-white opaque gel.

Azelaic Acid is available in pack sizes of 5, 30, 50 or 2 x 50 g of gel. Not all pack sizes may be marketed.

The views expressed in this article intend to highlight alternative studies and induce conversation. They are the views of the author and do not necessarily represent the views of HeyDoctor, and are for informational purposes only, even if and to the extent that this article features the advice of physicians and medical practitioners. This article is not, nor is it intended to be, a substitute for professional medical advice, diagnosis, or treatment, and should never be relied upon for specific medical advice.

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