SKINOREN 20% Cream

Зміст інструкції

1. Skinoren 20% cream
   1. What is Skinoren and what is it used for
   2. What you need to know before using Skinoren
   3. How to use Skinoren
   4. Possible side effects
   5. How to store Skinoren
   6. Package contents and other information

Skinoren 20% cream

Azelaic acid

Read this leaflet carefully before you start using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet, or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your condition does not improve or gets worse after a short period of treatment.

Contents of this leaflet:

• 1. What Skinoren is and what it is used for
• 2. What you need to know before you use Skinoren
• 3. How to use Skinoren
• 4. Possible side effects
• 5. How to store Skinoren
• 6. Contents of the pack and other information

1. What is Skinoren and what is it 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 characterized by the
presence of comedones (blackheads), papules, pustules (pimples), small nodules.
See 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Skinoren.
The product is only for application to the skin.
Pay particular attention to the use of this medicine:

• during pregnancy or breastfeeding (see section “Pregnancy and breastfeeding”);
• if you suffer from asthma, as worsening of asthma symptoms has been rarely reported in some patients who have been treated with azelaic acid.

Avoid contact with eyes, mouth and mucous membranes. If accidental contact occurs, wash the affected areas with
plenty of water. If eye irritation persists, consult a doctor.
Wash your hands after each application of Skinoren.
Limit the concomitant use of cosmetic preparations and alcoholic or aggressive detergents, lotions,
astringent or abrasive substances or exfoliating agents that may worsen the acne picture. For the choice of
the right products, ask your doctor or pharmacist for advice.
If after a short period of treatment you do not notice appreciable results, see your doctor.
Also consult your doctor in cases where these disorders have occurred in the past.

Other medicines and Skinoren
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
No interactions and incompatibilities between Skinoren and other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with milk
ask your doctor or pharmacist for advice before using this medicine.
Pay attention to the use of this medicine during pregnancy and breastfeeding.
It is not known whether azelaic acid is excreted in breast milk in vivo.
Newborns should not come into contact with the skin or breast treated with the 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 following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Warning: do not exceed the indicated doses without your doctor's advice.
Skinoren must be applied to the areas of skin to be treated twice a day (morning and evening), gently rubbing to promote absorption, over the entire surface that presents pimples or blackheads (approximately 2.5 cm of cream is sufficient to treat the entire face).
Before applying Skinoren, wash the skin thoroughly with water and dry it. You can also use a mild skin cleanser.
It is important to use Skinoren regularly for the entire 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, a noticeable improvement is generally observed after approximately 4 weeks. To achieve optimal results, use Skinoren continuously for several months.
In case of skin irritation, reduce the amount of cream for each application, or reduce the frequency of Skinoren use to once a day until the irritant phenomenon disappears. If necessary, discontinue treatment for a few days.

Use in children and adolescents
No dosage adjustments are expected in adolescents aged between 12 and 18 years.
The safety and efficacy of Skinoren in children under 12 years of age has not been proven.

If you use more Skinoren than you should
Given the very low toxicity of azelaic acid, both locally and systemically, it is unlikely that poisoning will occur.
In case of ingestion/accidental intake of an excessive dose of Skinoren, immediately inform your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Skinoren cream can cause side effects, although not everybody gets them.
Mostly, burning at the application site, itching or erythema (redness) may occur. Usually, the
symptoms of irritation are mild and disappear during treatment.
The following side effects are based on the results of clinical studies and post-marketing surveillance with
Skinoren cream.
The side effects are listed according to the frequency with which they have been observed.

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 scaling) 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
• seborrhea (excessively oily skin),
• acne,
• skin depigmentation (discoloration),
• paresthesia at the application site (sensation of tingling, prickling, stinging, burning),
• dermatitis at the application site,
• discomfort at the application site,
• edema at the application site (swelling).

Rare: may affect up to 1 in 1,000 people

• hypersensitivity to the medicine (which may occur with angioedema, contact dermatitis, eye swelling, facial swelling),
• worsening of asthma,
• urticaria,
• cheilitis (inflammation of the lips),
• rash,
• feeling of warmth at the application site,
• vesicles at the application site (small blisters filled with fluid),
• eczema at the application site,
• ulcer at the application site.

These side effects have been reported in patients using Skinoren cream after it has been
marketed.
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through 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 which is stated on the packaging. The expiry date refers to the last day of that month. The expiry date refers to the product in intact packaging, correctly stored.
The validity after first opening of the container is 6 months.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water 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 ingredient is azelaic acid. 1 g of Skinoren cream contains 200 mg of azelaic acid.
• The other ingredients are: benzoic acid (E210), cetearyl octanoate, glycerol 85%, glyceryl stearate + cetearyl alcohol + cetyl palmitate + cocoglycerides (CUTINA CBS), propylene glycol, purified water, stearoyl macrogolglycerides.

Description of Skinoren's appearance and package contents
Skinoren is presented as an opaque white cream.
The package is a tube containing 30 g.

Marketing authorisation 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.
Distributor in Italy:
LEO Pharma S.p.A.
Via Elio Vittorini 129
00144 Rome