PATIENT INFORMATION LEAFLET

FINACEA 150 mg/g gel

Azelaic Acid

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

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before using Finacea gel

3.How to use Finacea gel

4.Possible side effects

5.Storage of Finacea gel

6.Contents of the pack and additional information

Finacea gel contains the active ingredient azelaic acid and belongs to the group of external anti‑acne preparations (for use on the skin). Finacea gel is for the relief of mild to moderate papulopustular acne on the face and for the treatment of papulopustular rosacea. Acne and papulopustular rosacea are associated with inflamed papules and pustules.

No use Finacea gel

If you are allergic to azelaic acid or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Finacea gel.

Finacea gel is for external use (on the skin) only. Be careful to avoid contact with the eyes, mouth, and other mucous membranes. In case of accidental contact, rinse the affected eyes, mouth, and/or mucous membranes with plenty of water. You should consult your doctor if eye irritation persists.

Please wash your hands after each application of Finacea gel.

It is advisable to avoid the use of alcoholic cleaners, tinctures, and astringents, abrasives, and peeling agents when using Finacea gel for rosacea treatment.

Rarely, worsening of asthma symptoms has been reported in patients with asthma treated with azelaic acid.

Children and adolescents

The safety and efficacy in the treatment of acne have been studied in adolescents from 12 to 18 years (see section 3. How to use Finacea gel). Finacea gel is not recommended for the treatment of acne in children under 12 years due to a lack of safety and efficacy data.

Finacea gel is not recommended for the treatment of rosacea in children under 18 years due to a lack of safety and efficacy data.

Other medications and Finacea gel

It has not been studied whether Finacea gel affects, or is affected by, other medications. Do not apply other medications or treatments to the face at the same time as Finacea gel.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

There is limited experience with the use of Finacea gel during pregnancy. If you are pregnant or breastfeeding, your doctor will decide if you can use Finacea gel.

Infants should not come into contact with treated breasts or skin areas.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Finacea gel has no influence on the ability to drive or operate machinery.

Finacea gel contains benzoic acid and propylene glycol:

This medication contains 1 mg of benzoic acid per gram.

Benzoic acid may cause local irritation.

This medication contains 120 mg of propylene glycol per gram.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Finacea gel is only indicated for external use (on the skin).

Application Method

Before using Finacea gel, clean the skin thoroughly with water and dry it. You can use a mild skin cleanser.

Do not use occlusive air- or water-impermeable dressings and wash your hands after applying the gel.

Usual Dosage and Administration Frequency

Apply Finacea gel to the affected skin areas, twice a day (morning and night), gently rubbing the skin. Approximately0.5 grams?2.5 cm(1 inch) of gel are sufficient for the entire face.

To achieve optimal treatment effect, it is essential to use Finacea gel continuously throughout the treatment period.

In case of skin irritation (see section 4. Possible adverse effects), reduce the amount of gel per application or the frequency of Finacea gel use to once a day until the irritation subsides. If necessary, temporarily discontinue treatment for a few days.

Use in Children and Adolescents

No dosage adjustment is necessary for children between 12 and 18 years old treated for acne.

Treatment Duration

The treatment duration may vary from person to person and also depends on the severity of the skin disorder.

Your doctor will tell you for how long you should use Finacea gel.

Acne:You can use Finacea gel for several months, depending on the treatment effect. Generally, you can notice a clear improvement after 4 weeks of treatment.

If there is no improvement after 1 month or if the acne worsens, discontinue treatment with Finacea gel and consult your doctor.

Rosacea:You can use Finacea gel for several months, depending on the treatment effect. You can notice a clear improvement after 4 weeks of treatment.

If there is no improvement after 2 months or if rosacea worsens, discontinue treatment with Finacea gel and consult your doctor.

If You Use More Finacea Gel Than You Should

Even if you have accidentally used more Finacea gel than you should, it is unlikely that a harmful effect (intoxication) will occur.

Please continue as prescribed and ask your doctor if you are unsure.

If You Forget to Use Finacea Gel

Do not use a double dose to compensate for a missed dose. Continue as prescribed by your doctor.

If You Discontinue Treatment with Finacea Gel

If you discontinue treatment, your skin condition may worsen. Please consult your doctor before discontinuing the use of Finacea gel.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, Finacea gel may cause side effects, although not everyone will experience them.

Skin irritation (such as burning or itching) may occur. In most cases, symptoms of skin irritation are mild or moderate and decrease in frequency during treatment.

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

The following side effects may occur during treatment with Finacea gel. They only affect the skin in the application area.

Acne

Very common (may affect more than 1 in 10 patients):burning, pain, itching (pruritus) at the application site.

Common (may affect up to 1 in 10 patients):eruption, tingling or numbness (paresthesia), dry skin at the application site.

Uncommon (may affect up to 1 in 100 patients):skin reaction due to an external agent (contact dermatitis), abnormal skin redness (erythema), peeling, heat, skin discoloration at the application site.

Rare (may affect up to 1 in 1000 patients)1:

• Hypersensitivity, which may occur with one or more of the following adverse reactions: angioedema (rapid inflammation under the skin), eye inflammation, facial inflammation, dyspnea (difficulty breathing)
• Skin irritation
• Urticaria
• Worsening of asthma

1These side effects have been reported after marketing authorization in patients who have used azelaic acid.

Rosacea

Very common (may affect more than 1 in 10 patients):burning, pain, itching (pruritus) at the application site.

Common (may affect up to 1 in 10 patients): tingling or numbness (paresthesia), dry skin, eruption, swelling (edema) at the application site.

Uncommon (may affect up to 1 in 100 patients):acne, skin reaction due to an external agent (contact dermatitis), abnormal skin redness (erythema), irritating eruption (urticaria), discomfort at the application site.

Rare (may affect up to 1 in 1000 patients)1:

• Hypersensitivity, which may occur with one or more of the following adverse reactions: angioedema (rapid inflammation under the skin), eye inflammation, facial inflammation, dyspnea (difficulty breathing)
• Skin irritation
• Urticaria
• Worsening of asthma

1These side effects have been reported after marketing authorization in patients who have used azelaic acid.

Children and adolescents

Treatment of acne vulgaris in adolescents aged 12-18 years.

In clinical studies that included adolescents, the overall incidence of side effects with Finacea gel was similar to that of the entire patient population.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the tube after "CAD". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Finacea gel

-The active ingredient is azelaic acid (Each gram of Finacea gel contains 150 mg of azelaic acid).

-The other components are: benzoic acid (E210), carboxymers, disodium edetate, lecithin, polisorbate 80, propylene glycol, purified water, sodium hydroxide, and medium-chain triglycerides.

Appearance of the product and contents of the packaging

Finacea gel is an opaque white to yellowish white gel.

Finacea gel is available in packaging of 5, 30, 50 g of gel.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Responsible manufacturer:

LEO Pharma Manufacturing Italy S.r.l

Via E. Schering 21

20054 Segrate (Milan) – Italy

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Finacea: Denmark, France, Iceland, Italy, Norway, Spain, Sweden, United Kingdom.

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

Last review date of this leaflet: April 2021

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/