Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Finacea 15% Gel
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Azelaic acid may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Finacea 15 % Gel (Finacea) contains the active substance azelaic acid and belongs to the group of anti-acne preparations for external use (on the skin). Finacea is for the relief of mild to moderate papulopustular acne of the face and the treatment of papulopustular rosacea. Papulopustular acne and rosacea are associated with inflamed papules and pustules. 2.
What you need to know before you take it
e Finacea®
Do not use Finacea •
if you are allergic to azelaic acid or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions Talk to your doctor or pharmacist before using Finacea. Finacea is for external use on the skin only. Take care to avoid contact with the eyes, mouth and other mucous membranes (the thin skin around body openings). In the event of an accidental contact, wash the eyes, mouth and/or affected mucous membranes with large amounts of water. You should consult a doctor or pharmacist if an eye irritation persists. Please wash your hands after each application of Finacea. It is advisable to avoid alcoholic cleansers, tinctures and astringents, abrasives and peeling agents when using Finacea for treatment of rosacea. 1
Rarely, it has been reported that in some patients with asthma who were treated with azelaic acid worsening of asthma symptoms had occurred. Children and adolescents Safety and efficacy in the treatment of acne have been studied in 12-18 years old adolescents (see section 3. How to use Finacea). Finacea is not recommended for the treatment of acne in children below the age of 12 due to a lack of data on safety and efficacy. Finacea is not recommended for the treatment of rosacea in children below the age of 18 due to a lack of data on safety and efficacy. Other medicines and Finacea It has not been studied whether Finacea affects or is affected by other medicines. Do not apply other medicines or treatments to your face at the same time as Finacea. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding There is limited experience from use of azelaic acid during pregnancy. If you are pregnant or breast-feeding, your doctor will decide whether you can use Finacea. Infants must not come into contact with treated skin or breast. 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 has no influence on the ability to drive and use machines. Finacea Gel contains benzoic acid and propylene glycol Finacea Gel contains 1 mg benzoic acid in each g. Benzoic acid may cause local irritation. Finacea Gel contains 120 mg propylene glycol in each g. 3.
How to take it
Finacea®
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Finacea is intended for external use on the skin only. • Before you apply Finacea, clean the skin thoroughly with water and dry. You may use a mild skin-cleansing agent. • Do not use air- and water-tight (occlusive) dressings or wrappings, and wash your hands after applying the gel. • Apply Finacea to the affected skin areas twice a day (in the morning and in the evening) and rub it gently into the skin. Approximately 2.5 cm, which is equal to 0.5 g (1 inch) of gel, is sufficient for the entire face. Finacea works more effectively if used continuously over the entire period of treatment. 2
In the event of an irritation of the skin (see section 4. Possible side effects), reduce the amount of gel per application or the frequency of use of Finacea to once a day until the irritation ceases. If necessary, you should interrupt the treatment temporarily for a few days. Use in children and adolescents Dose adjustment in children aged 12-18 years treated for acne is not necessary. Duration of treatment How long Finacea has to be used can vary from person to person and also depends on the severity of the skin disorder. Your doctor will tell you how long you should use Finacea. Acne: You can use Finacea over several months depending on the effect of the treatment. In general, you may notice a distinct improvement after 4 weeks. In case of no improvement after 1 month or if the acne becomes worse, you should discontinue Finacea and consult your doctor. Rosacea: You can use Finacea over several months depending on the effect of the treatment. You may notice a distinct improvement after 4 weeks of the treatment. In case of no improvement after 2 months or if the rosacea becomes worse, you should discontinue Finacea and consult your doctor. If you use more Finacea than you should Even if you have accidentally used more Finacea than you should, a harmful effect (intoxication) is unlikely. Please continue as prescribed and ask your doctor if you are not sure. If you forget to use Finacea Do not use twice the amount to make up for a forgotten treatment. Continue as prescribed by your doctor. If you stop using Finacea If you stop using Finacea your skin disease can get worse. Please ask your doctor before you stop using Finacea. If you have any further questions on the use of Finacea, ask your doctor or pharmacist. 4.
Possible side effects
Like all medicines, Finacea can cause side effects, although not everybody gets them. You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction. This is rare and may affect up to 1 in 1,000 people:
- Angioedema (rapid swelling under the skin)
- Eye swelling
- Swelling face
- Dyspnoea (shortness of breath) Skin irritations (for example burning and itching) may occur. In the majority of cases, the irritation symptoms are mild or moderate and their frequency decreases during the course of therapy. The most frequently observed side effects included itching (pruritis), burning and pain at the application site. 3
The following side effects may occur during the treatment with Finacea Gel. They only concern the skin in the application area: Acne: Very common (may affect more than 1 in 10 people): Burning, pain, itching (pruritis) at the application site Common (may affect up to 1 in 10 people): Rash, feeling of tingling or numbness (paraesthesia), dry skin at the application site Uncommon (may affect up to 1 in 100 people): Skin reaction due to an external agent (contact dermatitis), abnormal redness of the skin (erythema); scaling, warmth, skin discolouration at the application site Rare (may affect up to 1 in 1,000 people) 1:
- Skin irritation
- Urticaria (hives)
- Worsening of asthma. 1 These side effects have been reported in patients using azelaic acid since marketing approval. Rosacea: Very common (may affect more than 1 in 10 people): Burning, pain, itching (pruritus) at the application site Common (may affect up to 1 in 10 people): Feeling of tingling or numbness (paraesthesia), dry skin, rash, swelling (oedema) at the application site Uncommon (may affect up to 1 in 100 people): Acne, skin reaction due to an external agent (contact dermatitis), abnormal redness of the skin (erythema); nettle rash (urticaria), discomfort at the application site Rare (may affect up to 1 in 1,000 people) 1:
- Skin irritation
- Urticaria (hives)
- Worsening of asthma. 1
These side effects have been reported in patients using azelaic acid since marketing approval.
Children and adolescents Treatment of acne vulgaris in adolescents 12-18 years of age: In clinical studies involving adolescents, the overall incidence of adverse events for Finacea was similar to that for the entire patient population. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 4
By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Finacea®
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 carton and tube after "EXP". The expiry date refers to the last day of that month. Finacea does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help protect the environment. 6.
Contents of the pack and other information
What Finacea contains • •
The active substance is azelaic acid (Each gram of Finacea 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 triglycerides medium chain.
What Finacea looks like and contents of the pack Finacea is a white to yellowish-white opaque gel. Finacea is available in pack sizes of 5, 30, 50 or 2 x 50 g of gel. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer LEO Laboratories Limited Maidenhead, Berkshire SL6 3UD, UK Manufactured by: LEO Pharma Manufacturing Italy S.r.l. Via E. Schering 21,20054 Segrate (Milan), Italy This medicinal product is authorised in the Member States of the EEA under the following names: Finacea: Denmark, France, Iceland, Italy, Norway, Spain, Sweden, United Kingdom. Skinoren : Austria, Finland, Germany, Greece, Ireland, Portugal
This leaflet was last revised in April 2023. 5
For information in large print, Braille or audio/CD, telephone +44 (0)1844 347333 Registered Trade Mark
®
6
Frequently asked questions about Finacea 15% Gel
How do I take Finacea 15% Gel?
Finacea 15% Gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Finacea 15% Gel?
The active substance in Finacea 15% Gel is azelaic acid.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Finacea 15% Gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Finacea 15% Gel without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: azelaic acid
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For the relief of mild to moderate papular-pustular acne of the facial area.
For the topical treatment of papulopustular rosacea.
4.2. Posology and method of administration
Finacea 15 % Gel is intended for cutaneous use only.
Posology
Finacea Gel should be applied to the affected skin areas twice a day (in the morning and in the evening) and rubbed in gently. Approximately 0.5 g = 2.5 cm (1 inch) of gel is sufficient for the entire facial area.
Pediatric population
Use in adolescents (12-18 years of age) for the treatment of acne vulgaris. Dose adjustment is not required when Finacea Gel is administered to adolescents aged 12- 18 years.
The safety and efficacy of Finacea Gel for the treatment of acne vulgaris in children below the age of 12 years have not been established.
The safety and efficacy of Finacea Gel for the treatment of papulopustular rosacea in children below the age of 18 years have not been established.
Geriatric patients
No targeted studies have been performed in patients aged 65 and over.
Patients with hepatic impairment
No targeted studies have been performed in patients with hepatic impairment.
Patients with renal impairment
No targeted studies have been performed in patients with renal impairment.
Method of administration
Before Finacea Gel is applied, the skin should be thoroughly cleaned with plain water and dried. A mild skin-cleansing agent may be used.
Occlusive dressing or wrappings should not be used, and hands should be washed after applying the gel.
In the event of skin irritation (see section 4.8 Undesirable effects), the amount of gel per application should be reduced or the frequency of use of Finacea Gel should be reduced to once a day until the irritation ceases. If required, the treatment should be temporarily interrupted for a few days.
It is important to use Finacea Gel continuously over the entire period of treatment. The duration of use of Finacea Gel can vary from person to person and also depends on the severity of the skin disorder.
Acne: In general, a distinct improvement becomes apparent after 4 weeks. To obtain optimum results, Finacea Gel can be used over several months in accordance with the clinical outcome. In case of no improvement after 1 month or exacerbation of acne, Finacea Gel should be discontinued and other therapeutic options should be considered.
Rosacea: In general, a distinct improvement becomes apparent after 4 weeks of treatment. To obtain optimum results, Finacea Gel can be used over several months in accordance with the clinical outcome. In case of no improvement after 2 month or exacerbation of rosacea, Finacea Gel should be discontinued and other therapeutic options should be considered.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
For external use only.
Care should be taken when using Finacea Gel to avoid contact with the eyes, mouth and other mucous membranes, and patients should be instructed accordingly (see section 5.3 Preclinical safety data). In the event of accidental contact, the eyes, mouth and/or affected mucous membranes should be washed with large amounts of water. If eye irritation persists, patients should consult a physician. The hands should be washed after each application of Finacea Gel.
Finacea Gel contains 1 mg benzoic acid in each g. Benzoic acid may cause local irritation.
Finacea Gel contains 120 mg propylene glycol in each g.
Due to the highly sensitive facial skin in rosacea, the use of other topical drugs and skin care products that could cause local irritation, including soaps, alcoholic cleansers, tinctures, astringents, abrasives and peeling agents, should be avoided during treatment with Finacea Gel.
Worsening of asthma in patients treated with azelaic acid has been reported rarely during post-marketing surveillance.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. The composition of Finacea Gel gives no indication of any undesired interactions of the single components that could adversely affect the safety of the product. No drug-specific interactions were noted during any of the controlled clinical trials.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate and well-controlled studies of topically administered azelaic acid in pregnant women.
Animal studies do indicate the potential for effects with respect to pregnancy, embryo-fetal development, parturition or postnatal development. However, the dose levels without observed adverse effects in animals ranged across studies from 3-32 times the maximum recommended human dose based on body surface area (see section 5.3 Preclinical safety data).
Caution should be exercised when prescribing azelaic acid to pregnant women.
Lactation
It is not known if azelaic acid is secreted into human milk in vivo. However an in vitro equilibrium dialysis experiment demonstrated that passage of drug into maternal milk may occur. But the distribution of azelaic acid into maternal milk is not expected to cause a significant change from baseline azelaic acid levels in the milk.
Azelaic acid is not concentrated in milk and less than 4% of topically applied azelaic acid is systemically absorbed, not increasing endogenous azelaic acid exposure above physiological levels. However, caution should be exercised when Finacea Gel is administered to a nursing woman.
Infants must not come into contact with treated skin/breast.
Fertility
There are no data on the effect of Finacea gel on human fertility. Results from animal studies showed no effect on fertility in male or female rats (see section 5.3 Preclinical safety data).
4.7. Effects on ability to drive and use machines
Finacea Gel has no influence on the ability to drive and use machines.
4.8. Undesirable effects
From clinical studies and post-marketing surveillance, the most frequently observed side effects included application site pruritus, application site burning and application site pain.
Frequencies of side-effects observed in clinical studies and post-marketing surveillance and given in the table below are defined according to the MedDRA frequency convention:
Very common (≥1/10),
Common (≥1/100, <1/10),
Uncommon (≥1/1,000; <1/100),
Rare (≥1/10,000, <1/1,000),
Very rare (<1/10,000),
Not known (cannot be estimated from the available data).
System Organ Class
Very common
Common
Uncommon
Rare1
Immune system disorders
hypersensitivity (which may occur with one or more of the following adverse reactions:
angioedema, eye swelling, swelling face, dyspnoea),, worsening of asthma (see section 4.4)
Skin and subcutaneous tissue disorders
contact dermatitis, acne*
Skin irritation, urticaria
General disorders and administration site conditions
application site burning, application site pain, application site pruritus
application site rash, application site paraesthesia, application site dryness, application site oedema*
application site erythema, application site exfoliation**, application site warmth**, application site discolouration**, application site discomfort*, application site urticaria*
* for indication Rosacea
** for indication Acne
1 These adverse reactions have been reported during post-approval use of Finacea gel.
Generally, local skin irritation regresses in the course of the treatment.
Pediatric population
Treatment of acne vulgaris in adolescents 12–18 years of age:
In 4 clinical phase II and II/III studies involving adolescents 12-17 years of age (120/383; 31%), the overall incidence of adverse events for Finacea Gel was similar for the groups aged 12-17 years (40%), aged ≥18 years (37%) and for the entire patient population (38%). This similarity also applied to the group aged 12-20 years (40%).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Due to the very low local and systemic toxicity of azelaic acid intoxication is unlikely.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- SKINOREN 150 mg/g prescriptionACIDUM AZELAICUM · skin / topical
- SKINOREN 200 mg/g prescriptionACIDUM AZELAICUM · skin / topical
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- SkinorenAcidum azelaicum
- Skinoren RosaceaAcidum azelaicum
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Finacea 15% Gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.