FINACEA 150 mg/g GEL

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

FINACEA 150 mg/g gel

Azelaic acid

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.

Contents of the pack and other information:

1. What is Finacea gel and what is it used for
2. What you need to know before you use Finacea gel
3. How to use Finacea gel
4. Possible side effects
5. Storage of Finacea gel
6. Contents of the pack and further information

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

Finacea gel contains the active substance azelaic acid and belongs to the group of anti-acne preparations for external use (on the skin). Finacea gel is for the relief of papulopustular acne, mild to moderate, of the facial area and for 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 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 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 your eyes, mouth, and/or affected 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 cleansers, tinctures, and astringents, abrasives, and peeling agents when using Finacea gel for the treatment of rosacea.

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 medicines and Finacea gel

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

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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 whether you can use Finacea gel.

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

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

Driving and using machines

Finacea gel has no influence on the ability to drive or use machines.

Finacea gel contains benzoic acid and propylene glycol:

This medicine contains 1 mg of benzoic acid in each gram.

Benzoic acid may cause local irritation.

This medicine contains 120 mg of propylene glycol in each gram.

3. How to use Finacea gel

Follow exactly the instructions of administration of this medicine given 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).

Method of application

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

Do not use airtight or watertight (occlusive) dressings or bandages and wash your hands after applying the gel.

Posology and method of administration

Apply Finacea gel to the affected skin areas, twice a day (morning and evening), gently rubbing into the skin. Approximately 0.5 grams - 2.5 cm (1 inch) of gel is sufficient for the entire face.

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

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

Use in children and adolescents

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

Duration of treatment

The duration of treatment 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 effect of the treatment. In general, you can see a clear improvement after 4 weeks of treatment.

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

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

If there is no improvement after 2 months or if the rosacea worsens, you should stop 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 to cause any harm (poisoning).

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

If you forget to use Finacea gel

Do not use a double dose to make up for a forgotten dose. Continue as your doctor has prescribed.

If you stop using Finacea gel

If you stop treatment, your skin disease may worsen. Please consult your doctor before stopping the use of Finacea gel.

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

4. Possible side effects

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

There may be skin irritation (e.g., burning or itching). In most cases, the symptoms of irritation are mild or moderate and their frequency decreases 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 of 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):rash, sensation of 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 redness of the skin (erythema), scaling, heat, skin discoloration at the application site.

Rare (may affect up to 1 in 1,000 patients):

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

These 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):sensation of tingling or numbness (paresthesia), dry skin, rash, 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 redness of the skin (erythema), irritating rash (urticaria), discomfort at the application site.

Rare (may affect up to 1 in 1,000 patients):

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

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

Children and adolescents

Treatment of acne vulgaris in adolescents from 12 to 18 years of age.

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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Finacea gel

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

Do not use this medicine after the expiry date which is stated on the packaging and on the tube after "EXP". The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines 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 protect the environment.

6. Contents of the pack and further information

Composition of Finacea gel

• The active substance is azelaic acid (each gram of Finacea gel contains 150 mg of azelaic acid).
• The other ingredients are: benzoic acid (E210), carbomers, disodium edetate, lecithin, polysorbate 80, propylene glycol, purified water, sodium hydroxide, and medium-chain triglycerides.

Appearance of the product and pack size

Finacea gel is a white to yellowish-white opaque gel.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Manufacturer:

LEO Pharma Manufacturing Italy S.r.l

Via E. Schering 21

20054 Segrate (Milan) – Italy

This medicine is authorized in the Member States of the European Economic Area under the following names:

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

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

Date of last revision of this leaflet: April 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/