Skinoren
Italy
Table of Contents
Package leaflet: Information for the user
Skinoren 20% cream
Azelaic acid
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
- Talk to your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of treatment.
Contents of this leaflet:
- What Skinoren is and what it is used for
- What you need to know before using Skinoren
- How to use Skinoren
- Possible side effects
- How to store Skinoren
- Contents of the pack and other information
1. What Skinoren is and what it is used for
Skinoren is an anti-acne preparation for topical use (on the skin).
Skinoren is used for the treatment of acne (acne vulgaris) in its various forms, characterised by the presence of comedones (blackheads), papules, pustules (pimples), and small nodules.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.
2. What you need to know before using Skinoren
Do not use Skinoren
- 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 using Skinoren.
This product is for topical use only.
Pay particular attention when using this medicine:
- during pregnancy or breastfeeding (see section “Pregnancy and breastfeeding”);
- if you suffer from asthma, as worsening of asthma symptoms has rarely been reported in some patients treated with azelaic acid.
Avoid contact with eyes, mouth, and mucous membranes. In case of accidental contact, wash the affected areas thoroughly with plenty of water. If eye irritation persists, consult your doctor.
Wash your hands after each application of Skinoren.
Minimize as much as possible the concomitant use of cosmetic preparations and alcohol-based or harsh cleansers, tinctures, astringent or abrasive substances, or exfoliating agents, as these may worsen acne. For advice on suitable products, consult your doctor or pharmacist.
If you do not notice any noticeable improvement after a short period of treatment, consult your doctor.
Also consult your doctor if such symptoms have occurred previously.
Other medicines and Skinoren
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions or incompatibilities between Skinoren and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Exercise caution when using this medicine during pregnancy and breastfeeding.
It is not known whether azelaic acid is excreted in human breast milk.
Newborns must not come into contact with skin or breasts treated with this product.
Skinoren contains benzoic acid and propylene glycol
This medicine contains benzoic acid, which may be moderately irritating to the skin, eyes, and mucous membranes, and propylene glycol, which may cause skin irritation.
3. How to use Skinoren
Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Warning: Do not exceed the recommended doses without medical advice.
Skinoren should be applied to the affected areas of the skin twice daily (morning and evening), gently rubbing it in to promote absorption, over the entire area affected by pimples or blackheads (approximately 2.5 cm of cream is sufficient to treat the whole face).
Before applying Skinoren, thoroughly wash the skin with water and dry it. You may also use a mild skin cleanser.
It is important to use Skinoren regularly throughout the duration of treatment. The duration of treatment with Skinoren may vary from patient to patient and depending on the severity of the condition.
In patients with acne, noticeable improvement is generally observed after approximately 4 weeks. For optimal results, use Skinoren continuously for several months.
If skin irritation occurs, reduce the amount of cream applied each time, or decrease the frequency of Skinoren use to once daily until the irritation resolves. If necessary, interrupt treatment for a few days.
Use in children and adolescents
No dosage adjustments are required in adolescents aged between 12 and 18 years.
The safety and efficacy of Skinoren in children under 12 years of age has not been established.
If you use more Skinoren than you should
Due to the very low local and systemic toxicity of azelaic acid, poisoning is unlikely.
In case of accidental ingestion/overdose of Skinoren, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, Skinoren cream can cause side effects, although not everyone experiences them.
Most commonly, burning at the application site, itching or erythema (redness) may occur. Usually, these irritation symptoms are mild and disappear during treatment.
The following side effects are based on results from clinical trials and post-marketing surveillance with Skinoren cream.
The side effects are listed according to their frequency of occurrence.
Very common: may affect more than 1 in 10 people
- burning at the application site,
- itching at the application site,
- erythema (redness) at the application site.
Common: may affect up to 1 in 10 people
- desquamation (peeling and flaking) at the application site,
- pain at the application site,
- dryness at the application site,
- discoloration at the application site,
- irritation at the application site.
Uncommon: may affect up to 1 in 100 people
- seborrhoea (excessively oily skin),
- acne,
- skin depigmentation (loss of skin colour),
- paraesthesia at the application site (tingling, tickling, pricking, stinging, burning sensations),
- dermatitis at the application site,
- discomfort at the application site,
- oedema at the application site (swelling).
Rare: may affect up to 1 in 1,000 people
- hypersensitivity to the medicine (which may present as angioedema, contact dermatitis, swelling of the eyes, swelling of the face),
- worsening of asthma,
- urticaria,
- cheilitis (inflammation of the lips),
- rash,
- sensation of warmth at the application site,
- vesicles at the application site (small fluid-filled blisters),
- eczema at the application site,
- ulceration at the application site.
These side effects have been reported in patients using Skinoren cream during the post-marketing phase.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Skinoren
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of
that month. The stated expiry date applies to the product in its original, unopened packaging, stored correctly.
The shelf life after first opening the container is 6 months.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Skinoren contains
- The active substance is azelaic acid. 1 g of Skinoren cream contains 200 mg of azelaic acid.
- The other components are: benzoic acid (E210), cetyl octanoate, glycerol 85%, glyceryl stearate + cetearyl alcohol + cetyl palmitate + coco-glycerides (CUTINA CBS), propylene glycol, purified water, stearoyl macrogol glycerides.
Description of the appearance of Skinoren and contents of the pack
Skinoren is a white, opaque cream.
The pack is a tube containing 30 g.
Marketing Authorization Holder and Manufacturer
LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup, Denmark
Manufacturer
LEO Pharma Manufacturing Italy S.r.l. - Via E. Schering, 21 - 20090 Segrate (MI), Italy.
Licensee in Italy:
LEO Pharma S.p.A.
Via Elio Vittorini 129
00144 Rome