What Skinoren is and what it is used for
Skinoren cream contains azelaic acid, which occurs naturally in the human body and which prevents the growth of the bacteria that are active in the occurrence of acne. In addition, Skinoren normalizes the formation of the top skin layer in such a way that blackheads do not form.
Skinoren is used for the treatment of mild to moderate acne.
Azelaic acid contained in Skinoren cream may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Skinoren
Do not use Skinoren
- if you are allergic to azelaic acid or any other ingredient (especially propylene glycol) of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Skinoren.
- If you have asthma. Exacerbation of asthma in patients treated with azelaic acid has been reported rarely.
- Skinoren cream should only be used externally.
- The cream should not come into contact with the eyes, mouth, or mucous membranes.
- If the preparation accidentally comes into contact with the eyes, mouth, or mucous membranes, rinse with plenty of water. If eye irritation persists, contact a doctor.
- In case of fragile, thin, or damaged skin, Skinoren cream should be used with caution.
- Hands must be washed after each treatment with Skinoren cream.
Children
Skinoren cream is not recommended for children under 12 years of age because there is no data on efficacy and safety for them.
Other medicines and Skinoren
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
There is no information on whether Skinoren affects the effect or safety of other medicines given at the same time or whether Skinoren is affected by other medicines.
Pregnancy and breastfeeding
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.
There is limited experience with the use of the active substance azelaic acid during pregnancy and breastfeeding.
Children should not come into contact with treated skin.
Driving ability and use of machinery
Skinoren does not affect the ability to drive or use machines.
Skinoren contains benzoic acid and propylene glycol
Skinoren cream contains 2 mg of benzoic acid per gram. Benzoic acid can cause local irritation.
Skinoren cream contains 125 mg of propylene glycol per gram.
How to use Skinoren
Always use this medicine as directed by your doctor and the directions on the pharmacy label. Ask your doctor or pharmacist if you are unsure.
Adults
Skinoren should only be used externally.
Before using Skinoren, the skin must be thoroughly cleaned with water or a mild skin cleanser and dried.
Skinoren is spread on the skin areas to be treated according to the doctor’s prescription, usually 2 times a day (morning and evening). The cream should be gently massaged into the skin. About 2.5 cm of cream is enough for the whole face.
If skin irritation occurs (see section 4. Possible side effects ), you can use a smaller amount of Skinoren or you can just treat the skin once a day until the irritation stops. You may need to take a break from treatment for a few days.
It is important to use Skinoren cream regularly throughout the treatment period. This treatment time varies from person to person and also depends on how severe the skin problems are.
Normally an improvement is seen after about 4 weeks, but to achieve the best possible results, the treatment should be continued for several months depending on how you respond to the treatment.
Use for children and adolescents
Dose adjustment is not necessary when Skinoren cream is given to adolescents between 12 and 18 years of age.
If you have used too much Skinoren
If you have used too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
It is unlikely that too much Skinoren cream will lead to poisoning symptoms.
If you forget to use Skinoren
Do not take a double dose to make up for a missed dose. Continue the treatment as prescribed by your doctor.
If you stop using Skinoren
If you stop treatment, your skin problems may worsen. Consult your doctor before stopping treatment.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Local skin irritation (usually with a stinging/stinging sensation) occurs especially at the beginning of the treatment but usually decreases during the treatment.
Angioedema :
Stop taking Skinoren cream and contact your doctor immediately if you experience any of the following symptoms ( angioedema ):
swelling of the face, tongue, or throat; difficulty swallowing; hives, and difficulty breathing.
The following side effects are based on reports from clinical studies and from follow-up after the approval of Skinoren cream. Side effects are listed according to how often they are reported to occur.
Very common (may affect more than 1 in 10 users):
At the site of administration: Stinging/stinging sensation, itching, redness of the skin.
Common side effects (may affect up to 1 in 10 users):
At the site of administration: Scaling, pain, dry skin, skin discoloration, skin irritation.
Uncommon (may affect up to 1 in 100 people):
Seborrhea (increased sebum production, giving the skin an oily appearance), acne, and loss of skin pigment.
At the site of administration: Numbness, skin inflammation, discomfort, edema (abnormal accumulation of fluid in the body).
Rare (may affect up to 1 in 1,000 users):
Drug hypersensitivity (which may occur together with angioedema 1, contact eczema 1, eye swelling 1, facial swelling 1 ), aggravated asthma, hives 1, inflammation of the lips, skin rash 1.
At the site of administration: the feeling of warmth, blisters, eczema, ulcers.
1 These side effects have been reported in patients who used Skinoren cream after approval
How Skinoren should be stored
Keep this medicine out of the sight and reach of children. Store at a maximum of 30°C.
Use before the expiry date stated on the packaging after “Expiry Date”.
The expiration date is the last day of the specified month.
Opened packaging is stable for 6 months.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active ingredient is azelaic acid. 1 g of cream contains 200 mg of azelaic acid.
- Other ingredients are benzoic acid (E210), cetearyl octanoate + isopropyl myristate (PCL Liquid), glycerol (85%), glycerol stearate + cetearyl alcohol + cetyl palmitate + coconut oil glycerides (CUTINA CBS), propylene glycol, water, stearoyl macrogol glycerides.
Appearance and package sizes of the medicine
Skinoren is a white, opaque cream.
Ointment tube: 30 g and 50 g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark
Manufacturer :
LEO Pharma Manufacturing Italy Srl
Via E. Schering 21
I-20054 Segrate
Milano
Italy
Local representative:
LEO Pharma AB
Box 404
201 24 Malmö
Phone: 040-352200
Email: info.se@leo-pharma.com