15% gel. Azelaic acid 

1. What Finacea gel is and what it is used for

Finacea contains the active substance azelaic acid and is an anti-acne medicine for topical treatment. Finacea is used for the relief of mild to moderate acne on the face (with papules and pustules ), and for the treatment of papulopustular rosacea. Acne with papules and pustules and papulopustular rosacea are conditions with inflamed blisters with or without var.

2. What you need to know before using Finacea gel

Do not use Finacea gel

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

Warnings and cautions

Talk to your doctor or pharmacist before using Finacea gel.

  • Finacea gel should only be used topically.
  • Gel one should not come in contact with eyes, mouth,h, or mucous membranes.
  • If the preparation accidentally comes into contact with the eyes, mouth, or mucous membranes, rinse with plenty of water. If eye irritation persists, consult a physician or pharmacist.
  • Hands should be washed after each Finacea gel treatment. Skin cleansers, solutions, and toner containing alcohol as well as abrasive and exfoliating products should be avoided when Finacea gel is used as a treatment for rosacea.
  • In rare cases, worsening asthma symptoms have been reported in some patients with asthma and concomitantly treated with azelaic acid.

Children and young people

Safety and efficacy in the treatment of acne have been studied in adolescents between 12 and 18 years of age. (see section 3 How to use Finacea gel ). Finacea gel can not be recommended for children under 12 years of age in the treatment of acne data on efficacy and safety are not available for them. 
Finacea gel is not recommended for children under 18 years of age when treating rosacea as data on efficacy and safety are not available for them.

Other medicines and Finacea gel

No studies on the effects of Finacea gel on or on other medicines have been performed. Do not use other medicines or other treatments on your face while using Finacea gel.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, your doctor will decide if you can use Finacea gel. 
There is limited experience with the use of the active substance azelaic acid during pregnancy.

Children should not come into contact with treated skin.

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

Finacea gel does not affect the ability to drive or use machines.

Finacea gel contains benzoic acid and propylene glycol

Benzoic acid can cause mild irritation to the skin, eyes, and mucous membranes. 
Propylene glycol can cause skin irritation.

3. How to use Finacea gel

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Finacea gel should only be used topically.

Method of administration

Before using Finacea gel, the skin should be thoroughly cleansed with water and dried. You can use a mild skin cleanser. Do not use airtight or waterproof dressings or covers. You must wash your hands after applying the gel.

Dosage and how often you should use Finacea gel 
Apply Finaceagelon to the skin areas to be treated twice a day (morning and evening) and gently apply it to the skin. About 2.5 cm (0.5 grams) of gel is enough for the whole face.

To achieve the best effect, Finacea gel must be used regularly throughout the treatment period. 
If skin irritation occurs (see section 4 Possible side effects ) you can use a small amount of Finacea gel or you can just treat the skin once a day until the irritation stops. You may need to take a break from treatment for a few days.

Use for children and adolescents

Dose adjustment is not necessary when Finacea gel is given to children between 12 and 18 years of age.

How long to use Finacea gel The treatment time varies from person to person and also depends on how severe the skin problems are. Your doctor will tell you how long to use Finacea gel.

Acne: You can use Finacea gel for several months depending on the effect of your treatment. Normally a clear improvement is seen after 4 weeks. If you do not notice improvement within 1 month or if the acne worsens, stop the treatment and contact your doctor.

Rosacea: You can use Finacea gel for several months depending on the effect of your treatment. A clear effect can be seen after 4-8 weeks of treatment. If you do not notice an improvement within 2 months, or if your rosacea worsens, stop treatment and contact your doctor.

If you use more Finacea gel then you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

It is unlikely that too much Finacea gel would lead to poisoning symptoms.

If you forget to use Finacea gel

Do not take a double dose to make up for a forgotten dose. Continue treatment as prescribed by your doctor.

If you stop using Finacea gel

If you stop treatment, your skin disease may get worse. Consult your doctor before stopping treatment.

If you have any further questions on the use of Finacea gel, please contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Finacea gel can cause side effects, although not everybody gets them.

Skin irritation (eg burning and itching ) may occur.

The symptoms are in most cases mild or moderate and they usually decrease during treatment. The most commonly reported side effect is included itching ( pruritus ), stinging, and pain at the site of application.

The following side effects may occur during treatment with Finacea gel. They occur only on the skin at the application site.

Acne:

Very common (may affect more than 1 user in 10): Burning, pain, itching ( pruritus ) at the application site. 
Common (may affect up to 1 in 10 people): Rash, stinging/tingling sensation or numbness ( paresthesia ), dry skin at the application site. 
Uncommon (may affect up to 1 in 100 people ): Skin reaction due to skin contact with a foreign substance (contact dermatitis), abnormal skin redness ( erythema ), dandruff, feeling hot, discoloration of the skin at the application site. 
Rare (may affect up to 1 in 1,000 people) 1 :

  • Hypersensitivity that may occur with one or more of the following side effects: Angioedema (rapid swelling under the skin), eye swelling, facial swelling, dyspnoea (shortness of breath)
  • Skin irritation
  • Urticaria ( hives )
  • Exacerbated asthma1  These side effects are reported in patients using azelaic acid for approval.

Rosacea: 
Very common (may affect more than 1 user in 10): Burning, pain, itching ( pruritus ) at the application site. 
Common (may affect up to 1 in 10 people ): Stinging/tingling sensation or numbness ( paresthesia ), dry skin, rash, swelling ( edema ) at the application site. 
Uncommon (may affect up to 1 in 100 people): Acne skin reaction due to skin contact with a foreign substance (contact dermatitis), abnormal redness of the skin ( erythema ), hives ( urticaria ), feeling of discomfort at the application site.
Rare (may affect up to 1 in 1,000 people) :

  • Hypersensitivity that may occur with one or more of the following side effects: Angioedema (rapid swelling under the skin), eye swelling, facial swelling, dyspnoea (shortness of breath)
  • Skin irritation
  • Urticaria ( hives )
  • Exacerbated asthma1  These side effects are reported in patients using azelaic acid for approval.

Children and adolescents 
Treatment of acne in adolescents between 12 and 18 years of age: 
In clinical trials, the mean frequency of side effects of Finacea gel was similar for adolescents and adult patients.

5. How to store Finacea gel

Keep out of sight and reach of children. 
Do not use this medicine after the expiry date which is stated on the carton and tube. The expiration date is the last day of the specified month.

Finacea gel has no special storage instructions.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is azelaic acid. (1 gram Finacea gel contains 150 mg azelaic acid)
  • The other ingredients are benzoic acid (E210), carbomer, disodium edetate, lecithin, polysorbate 80, propylene glycol, purified water, sodium hydroxide, triglycerides (medium fatty acids).

What the medicine looks like and the contents of the pack

Finacea gel is a white to yellowish opaque gel. 
Finacea is available in pack sizes of 5, 30, 50, and 2 x 50 g gel. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LEO Pharma A / S

Industrial Park 55

DK-2750 Ballerup

Denmark

Manufacturer:

LEO Pharma Manufacturing Italy Srl 
Via E. Schering 21 
I-20090 Segrate 
Milano 
Italy

Local representative:

LEO Pharma AB

Box 404

201 24 Malmö

Tel: 040-352200

Email: info.se@leo-pharma.com

This medicine is authorized in the European Economic Area under the names: 
Finacea: Denmark, France, Iceland, Italy, Norway, Spain, United Kingdom.

Skinoren: Austria, Finland, Germany, Greece, Ireland, Portugal.

Muhammad Nadeem

Leave a Reply