Consumer medicine information

Finacea

Azelaic acid

BRAND INFORMATION

Brand name

Finacea

Active ingredient

Azelaic acid

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Finacea.

What is in this leaflet

This leaflet answers some common questions about Finacea®.

It does not contain all the available information.

It does not take the place of talking to your doctor (or pharmacist).

All medicines have benefits and risks. Your doctor or pharmacist has weighed the risks of you using Finacea® against the benefits they expect it will have for you.

If you have any concerns about this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What Finacea® is used for

Finacea® is used to treat the following conditions:

  • Mild to moderate acne vulgaris, usually simply called acne
  • Rosacea, where the skin on the nose and cheeks has one or more of the following features: a redness that looks like a blush; pimples; small knobbly lumps on the nose and / or thin red lines due to enlarged blood vessels.

If using Finacea® for rosacea, you should contact a doctor for a correct diagnosis of your condition before commencing treatment.

When rubbed into the skin, the azelaic acid in Finacea® kills the bacteria that cause acne. In addition Finacea® stops the acne relevant (epidermal) skin cells from growing too strongly and thus blocking the pores of the skin to form pimples.

It is not known exactly how Finacea® works to treat rosacea.

Finacea® has been especially formulated for use in acne patients with greasy skin conditions.

There is no evidence that Finacea® is addictive.

Before you use Finacea®

When you must not use it

Do not use Finacea® if:

  • you have an allergy to Finacea® or any of the ingredients in Finacea® listed at the end of this leaflet, in particular propylene glycol.

Finacea® is for external use only.

You should be careful not to get Finacea® in your eyes when putting it onto your face.

The absorption of Finacea® into the blood stream is very limited.

Do not use Finacea® just before having a bath, shower or going swimming. If you do, you may reduce the effectiveness of Finacea®.

Using other medicines and skin treatments.

There is no information available on the use of Finacea® in conjunction with other skin disorder treatments, sunscreens or cosmetics.

Do not use Finacea® if the packaging is torn or shows signs of tampering.

Do not use Finacea® if the Expiry date (EXP) printed on the pack has passed. If you use this medicine after the expiry date has passed, it may not work (as well).

If you are not sure whether you should start using Finacea®, contact your doctor or pharmacist.

Before you start to use it

Tell your doctor or pharmacist if:

  1. if you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.
Pregnancy and breast-feeding:
  1. if you are pregnant or intend to become pregnant
Your doctor or pharmacist will discuss the risks and benefits of using Finacea® when pregnant.
  1. if you are breast-feeding or intend to breast-feed
Your doctor or pharmacist will discuss the risks and benefits of using Finacea® when breast-feeding.

If you have not told your doctor or pharmacist about any of the above, tell them before you use any Finacea®.

How to use Finacea®

How much to use

Finacea® should be applied to the affected areas of the skin morning and night, and should be used regularly over several months. This dosage may be modified by your doctor or pharmacist.

Use of Finacea® more than twice daily will not increase its effectiveness, and could cause irritation.

Finacea® should be massaged into the skin gently until it vanishes.

Finacea® should be applied sparingly (approximately 0.5g, equivalent to a 2.5cm strip of gel is sufficient for the entire facial area).

How to use it

Before Finacea® is applied, the skin should be thoroughly cleaned with water, or with a mild skin-cleansing agent.

Be careful not to get Finacea® in your eyes when putting it on your face. Finacea® is very irritating to the eyes. If Finacea® is accidentally rubbed into your eye, you should immediately rinse your eye with large amounts of water.

How long to use it

The length of time that Finacea® needs to be used will vary from person to person, and will also depend on the initial severity of your skin disorder. Improvement is usually noticed within 1-2 months of use, but to obtain the best results, Finacea® should be used regularly over several months. Whilst in most cases you will not need to use Finacea® for more than 6 months, it may be used for longer periods, and may also be reused after a period of stopping.

If intolerable irritation of the skin develops (see Side Effects), treatment should be stopped immediately. If irritation persists, please see your doctor or pharmacist. Once the irritation has ceased, your pharmacist or doctor may advise you to recommence treatment using a smaller amount of gel or using the gel only once a day until the skin can tolerate the treatment.

If your condition does not improve within 8 weeks you should consult your doctor or pharmacist.

If you forget to use it

If you forget to use Finacea®, use it as soon as you remember. Then go on as before. If you are not sure what to do, ask your doctor or pharmacist.

If you use too much (overdose) or if you swallow it

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), if you think that you or anyone else may have swallowed Finacea®. Do this even if there are no signs of discomfort or poisoning. Keep this telephone number handy.

While you are using Finacea®

Things you must do

Tell all doctors and pharmacists who are treating you that you are using Finacea®.

If you feel that Finacea® is not helping your condition, tell your doctor (or pharmacist).

Tell your doctor or pharmacist if, for any reason, you have not used Finacea® exactly as prescribed. Otherwise, your doctor or pharmacist may think that it was not effective and change your treatment unnecessarily.

If you become pregnant while using Finacea®, tell your doctor.

Things you must not do

Do not use Finacea® in or near the eyes.

Do not give Finacea® to anyone else, even if they have the same symptoms as yours.

Do not use Finacea® to treat other complaints unless your doctor or pharmacist tells you to.

Side effects

Tell your doctor or pharmacist if you do not feel well while you are using Finacea®. Like other medicines, Finacea® can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • burning
  • itching
  • stinging/tingling
  • redness
  • skin dryness
  • skin scaling

These are the more common side effects of Finacea® and can occur at the start of treatment. When treating acne, they usually disappear as treatment continues.

Skin disease, acne and hair infections are uncommon. If marked skin irritation persists, the treatment should be stopped until the irritation goes, and you should ask your doctor or pharmacist before recommencing.

Topical azelaic acid preparations may rarely cause temporary skin depigmentation or skin discolouration especially in people with darker skin.

In very rare cases allergic skin reaction (e.g. rash) may occur.

The occurrence of side effects was higher in rosacea patients compared to acne patients in the clinical trials, however this could be due to the more sensitive skin of rosacea patients.

Some people may get other side effects while using Finacea®.

Ask your doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using Finacea®

Storage

Keep Finacea® in a cool dry place where the temperature stays below 30°C.

Do not store Finacea® or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep Finacea® where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor or pharmacist tells you to stop using Finacea® or it has passed its expiry date, ask your pharmacist what to do with any Finacea® that is left over.

Product description

Finacea® is the brand name for a gel containing 15% azelaic acid. It also contains benzoic acid, propylene glycol, polysorbate 80, lecithin, polyacrylic acid, medium chain triglycerides, sodium hydroxide, disodium edetate and purified water.

Finacea® is available in 5g, 30g and 50g tubes. Not all pack sizes may be available.

Its AUST R number is 97747

® LEO, LEO/Lion device and Finacea® are registered trademarks of LEO Pharma A/S

Sponsor

LEO Pharma Pty Ltd
Brisbane, QLD
Australia
Toll Free No. 1800 991 778

Date of information

This leaflet was revised July 2019

86840529

Published by MIMS July 2020

BRAND INFORMATION

Brand name

Finacea

Active ingredient

Azelaic acid

Schedule

S2

 

Name of the medicine

Azelaic acid (micronised) in a gel base.

Excipients

Benzoic acid, propylene glycol, polysorbate 80, lecithin, polyacrylic acid, triglycerides (medium chain), sodium hydroxide, disodium edetate and purified water.

Description

Chemical name: 1,7-heptanedicarboxylic acid. Structural formula: HOOC-(CH2)7-COOH. Molecular formula: C9H16O4. MW: 188.22. Melting point: 105 to 110°C. Azelaic acid is a white crystalline powder. Azelaic acid is freely soluble in 96% v/v ethanol, methanol and boiling water.

Pharmacology

Pharmacodynamics.

Azelaic acid exerts an antibacterial effect on Propionibacterium acnes, which plays an important role in the pathogenesis of acne. Finacea significantly reduces both the population density of P. acnes and the amount of free fatty acids in the skin surface lipids.
Azelaic acid inhibits the proliferation of cultivated keratinocytes by inhibiting the DNA synthesis and accelerates the comedolysis of tetradecane induced comedones in the rabbit ear model. Electron microscopic and immunohistochemical examinations of skin biopsies following treatment with Finacea show ultrastructural changes, especially in the keratohyaline granules and in the filaggrin, which is an important factor in keratinisation.
The mechanism by which azelaic acid interferes with the pathogenic events in rosacea is unknown. Two in vitro and ex vivo investigations indicate that azelaic acid may exert an anti-inflammatory effect by reducing the formation of proinflammatory, reactive oxygen species but the clinical relevance of these findings is not clear.

Pharmacokinetics

Following topical application, azelaic acid penetrates into all layers of the human skin. The penetration into damaged skin is more rapid than into intact skin. 3.6% of the administered dose was absorbed following application of an azelaic acid (20%) cream formulation 5 g to the face, upper back and chest with peak serum levels occurring two to three hours after dermal application. The application of cream 5 g twice daily results in a systemic burden of 1 to 1.5 mg/kg bodyweight.
43% of azelaic acid is bound to plasma proteins, with 78% bound to albumin. 60% of the systemically available azelaic acid is excreted unchanged in the urine within 12 hours, the remainder is metabolised through β-oxidation into short chained dicarboxylic acids (C7, C5-carboxylic acids) which are also excreted via the urine. Due to the low percutaneous absorption the amount of azelaic acid eliminated via the breast milk is approximately 0.01%, with a milk/ plasma coefficient of 0.7. This corresponds to a dose to the infant of less than 200 microgram/day following twice daily administration of azelaic acid cream (20%) 5 g. The safety of this dose in infants is unknown.
Steady-state plasma levels of azelaic acid in rosacea patients after eight weeks twice daily treatment with Finacea were significantly higher than in patients treated with the vehicle control but were within the range also observed in volunteers and untreated acne patients on normal diets. This indicates that the extent of percutaneous absorption of azelaic acid following twice daily application of Finacea does not significantly alter the systemic burden of azelaic acid derived from dietary and endogenous sources.

Indications

Papulopustular rosacea.
Mild to moderate acne vulgaris.
Finacea has been especially formulated for use in acne patients with greasy skin conditions.

Contraindications

Hypersensitivity to any ingredient of Finacea, in particular propylene glycol.

Warnings

Finacea is for external use only. Avoid contact with the eyes. If it does, the eyes should immediately be rinsed with copious amounts of water.

Precautions

In animal investigations (rabbit, monkey) Fiancea caused eye irritation. As a precaution care should be taken to avoid contact with the eyes. Should contact with the eyes occur, the eyes must be immediately rinsed with copious amounts of water. No data on concomitant use with other skin disorder therapies, cosmetics or sunscreens are available.

Use in pregnancy.

(Category B1)
Reproductive studies with azelaic acid administered orally to rats, rabbits and monkeys (at doses up to 2.5, 0.5 and 0.05 mg/kg/day, respectively) produced no evidence of fetal malformations. Adverse fetal effects (embryotoxicity) were reported at the highest doses tested (doses at which maternotoxicity tended to occur). The effect on the human fetus is unknown.

Use in lactation.

The theoretical amount of azelaic acid received by an infant via the breast milk would be negligible and considering the low toxicity any risk resulting from use is not expected. The safety of Finacea in infants is not, however, known.

Adverse Effects

Local skin irritation (in descending order of frequency), e.g. burning, pruritus, stinging/ tingling, erythema, irritation, dry skin, scaling and rash can occur usually at the start of treatment. When treating acne this usually regresses during the course of treatment. If the irritation is severe or related to a hypersensitivity reaction, treatment should be ceased. In other cases where marked irritation persists the frequency of use should be reduced to one application per day until the irritation disappears or alternatively the treatment may be temporarily interrupted. Discolouration of the skin or temporary skin depigmentation, especially in people with darker skin, has also been observed. Skin dryness has been observed with the gel.
The spectrum of undesirable cutaneous effects related to Finacea is similar in acne and rosacea.
The incidence of adverse events was higher in rosacea patients, however this could be due to the more sensitive skin of rosacea patients.
Contact dermatitis, acne, skin disorder and folliculitis are uncommon with Finacea.
In very rare cases, allergic skin reactions (e.g. rash) may occur.

Dosage and Administration

Finacea should be applied sparingly to the affected areas of the skin twice a day (morning and night). Finacea should be massaged gently into the skin until vanishing. Approximately 0.5 g (= 2.5 cm strip of gel) is sufficient for the entire facial area.
Before Finacea is applied the skin should be thoroughly cleaned with water or, if applicable, with a mild skin cleansing agent.
In the event of intolerable irritation of the skin (see Adverse Reactions), treatment should be stopped immediately. Once the irritation has ceased, treatment can recommence but the amount of gel used should be reduced or frequency of treatment reduced to once a day until skin tolerance occurs. If required, the treatment might have to be temporarily interrupted for a few days.
The duration of use of Finacea varies with individual patients and the severity of the skin disorder. Improvement is usually detectable within one to two months of treatment. Optimum duration of therapy depends on the severity of the skin disorder. Although most reported experiences to date have been for treatment periods that did not exceed six months, Finacea has been used for up to a year or longer in appropriately selected cases for control of individual lesions, and repeat courses have been employed for recurrences. It is important that Finacea is used regularly throughout the treatment period.

Overdosage

Finacea is intended for external use only. Findings from animal experiments show that vomiting may occur after ingestion of large amounts. No organotoxic changes are likely, though no human data on overdosage are available. For further information, contact the Poisons Information Centre on 131 126.

Presentation

Gel, 15%: 5 g*, 30 g, 50 g*.
*Not currently available in Australia.

Poison Schedule

S2.