Finacea 150 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
FINACEA 150 mg/g gel
Azelaic acid
Read the entire 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 and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Finacea gel is and what it is used for
- What you need to know before using Finacea gel
- How to use Finacea gel
- Possible side effects
- How to store Finacea gel
- Contents of the pack and other information
1. What Finacea gel is and what it is used for
Finacea gel contains the active substance azelaic acid and belongs to the group of topical anti-acne preparations (for use on the skin). Finacea gel is indicated for the relief of mild to moderate papulopustular acne on the facial area and for the treatment of papulopustular rosacea. Papulopustular acne and rosacea are characterized by inflamed papules and pustules.
2. What you need to know before using Finacea gel
Do not use Finacea gel
If you are allergic to azelaic acid or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Finacea gel.
Finacea gel is for external use (on the skin) only. Take care to avoid contact with the eyes, mouth, and other mucous membranes. In case of accidental contact, wash the eyes, mouth, and/or affected mucous membranes thoroughly with plenty of water. 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, toners and astringents, abrasive products, and exfoliating agents (peelings) while 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 for the treatment of acne have been studied in adolescents aged 12 to 18 years (see section 3. How to use Finacea gel). The use of Finacea gel for the treatment of acne is not recommended in children under 12 years of age due to lack of safety and efficacy data.
The use of Finacea gel for the treatment of rosacea is not recommended in children under 18 years of age due to 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 medications 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 need to use any other medicines.
Pregnancy and breastfeeding
There is limited experience regarding the use of Finacea gel during pregnancy. If you are pregnant or breastfeeding, your doctor will decide whether you can use Finacea gel.
Infants must not come into contact with treated breasts or skin areas.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Finacea gel has no influence on the ability to drive or operate machinery.
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 for use of this medicine provided by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.
Finacea gel is intended for topical use only (on the skin).
Method of application
Before using Finacea gel, thoroughly clean the skin with water and dry it. You may use a mild skin cleansing agent.
Do not use occlusive dressings or wraps (airtight or waterproof). Wash your hands after applying the gel.
Usual dose and frequency of administration
Apply Finacea gel to the affected areas of skin twice daily (in the morning and evening), gently rubbing it into the skin. Approximately 0.5 grams – 2.5 cm (1 inch) of gel is sufficient for the entire face.
To achieve optimal treatment effect, it is important to use Finacea gel continuously throughout the treatment period.
If skin irritation occurs (see section 4. Possible side effects), reduce the amount of gel applied or decrease the frequency of use to once daily until the irritation subsides. If necessary, temporarily interrupt treatment for a few days.
Use in children and adolescents
Dosage adjustment is not required for children aged 12 to 18 years being treated for acne.
Treatment duration
The duration of treatment may vary from person to person and also depends on the severity of the skin disorder.
Your doctor will advise you on how long you should use Finacea gel.
Acne: Finacea gel may be used for several months, depending on treatment response. Generally, you may notice a clear improvement after 4 weeks of treatment.
If there is no improvement after 1 month, or if acne worsens, you should discontinue treatment with Finacea gel and consult your doctor.
Rosacea: Finacea gel may be used for several months, depending on treatment response. You may notice a clear improvement after 4 weeks of treatment.
If there is no improvement after 2 months, or if rosacea worsens, you should 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 recommended, it is unlikely that harmful effects (poisoning) will occur.
Please continue as prescribed and ask your doctor if you are unsure.
If you forget to use Finacea gel
Do not apply a double amount to make up for a missed dose. Continue as prescribed by your doctor.
If you stop using Finacea gel
If you stop treatment, your skin condition may worsen. Please consult your doctor before stopping the use of Finacea gel.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Finacea gel may cause adverse effects, although not everyone experiences them.
Skin irritation (for example, burning or itching) may occur. In most cases, 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 adverse effects may occur during treatment with Finacea gel. They affect only the skin at the application site.
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, tingling or numbness sensation (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), peeling, warmth, skin discoloration at the application site.
Rare (may affect up to 1 in 1,000 patients)1:
- Hypersensitivity, which may occur with one or more of the following adverse reactions: angioedema (rapid swelling under the skin), eye inflammation, facial swelling, dyspnea (difficulty breathing)
- Skin irritation
- Urticaria
- Worsening of asthma
1These side effects have been reported after marketing authorization in patients using 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 sensation (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), irritant rash (urticaria), discomfort at the application site.
Rare (may affect up to 1 in 1,000 patients)1:
- Hypersensitivity, which may occur with one or more of the following adverse reactions: angioedema (rapid swelling under the skin), eye inflammation, facial swelling, dyspnea (difficulty breathing)
- Skin irritation
- Urticaria
- Worsening of asthma
1These side effects have been reported after marketing authorization in patients using 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 adverse effects with Finacea gel was similar to that in the entire patient population.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse 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 refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Finacea gel
- The active substance is azelaic acid (each gram of Finacea gel contains 150 mg of azelaic acid).
- The other components 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 contents of the pack
Finacea gel is an opaque white to yellowish-white gel.
Finacea gel is available in pack sizes of 5, 30 and 50 g of gel.
Only certain 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 medicinal product is authorized in the European Economic Area member states under the following names:
Finacea: Denmark, France, Iceland, Italy, Norway, Spain, Sweden, United Kingdom.
Skinoren: Austria, Finland, Germany, Greece, Ireland, Portugal.
Date of the most recent review of this leaflet: April 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/