Country: Միացյալ Թագավորություն
language: անգլերեն
source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Azelaic acid
Mawdsley-Brooks & Company Ltd
D10AX03
Azelaic acid
200mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13060100
IIT001-01 - Page 1 + 2 - 165 x 300 mm – DRA_90036 IIT001-01 - 28/01/2019 - OMA: Updated for CI project (CAPA 173674) Insert, 50 g 165 x 300 mm IIT001-01 09/08/2018 JUG 28/01/2019 OMA 100% All products Used for: Segrate keyline DRA_90036 Comments: Approval: Date: Production site approval: Graphic approval: Revision info: WHAT IS IN 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 SKINOREN ® IS AND WHAT IT IS USED FOR • Skinoren is a skin cream used to treat COMMON ACNE (ACNE VULGARIS). • Skinoren Cream should only be used to treat acne. You should not use this medicine for any other skin condition. • Skinoren attacks the bacterium called Propionibacterium acnes, which plays an essential part in causing acne. Skinoren also reduces growth of the harder outermost skin cells that block the pores of the skin to cause blackheads and whiteheads. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE 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. Skinoren is for external use on the skin only. You should not allow Skinoren to come into contact with your eyes, mouth or other mucous membranes. If it does, wash the eyes, mouth or other mucous membranes immediately with large amounts of cool water. Rarely, it has been reported that in some patients with asthma who were treated with azelaic acid worsening of asthma symptoms had occurred. Skinoren is not recommended for use in children below the age of 12 due to a lack of data on safety and efficacy. OTHER MEDICINES AND SKINOREN Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. PREGNANCY AND BREAST-FEEDING There is limited experience with use of the active substance read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Skinoren 20% Cream. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Skinoren Cream contains 200 mg (20% w/w) azelaic acid. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. White, opaque cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of acne vulgaris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION Cutaneous use DOSAGE REGIMEN Skinoren Cream should be applied to the affected areas of skin twice daily (mornings and evenings), and rubbed in gently. As a guide 2.5 cm (approx. 0.5 g) of cream is sufficient for the entire facial area. If other areas of acne, in addition to the face require treatment, for example the chest and back, the amount of cream should be adjusted accordingly. Patients with sensitive skin should be advised to use Skinoren only once a day (in the evening) for the first week of treatment and then proceed to twice daily applications. Before Skinoren Cream is applied, the skin should be thoroughly cleaned with plain water and dried. A mild skin-cleansing agent may be used. The duration of use of Skinoren Cream can vary from patient to patient and also depends on the severity of the acne. In general, a distinct improvement becomes apparent after about 4 weeks. To obtain the best results, Skinoren Cream should be used continuously over a period of several months (see Section 5.1 Pharmacodynamic properties). It is important to continue to use Skinoren Cream regularly over the entire period of treatment. However, in the event of intolerable skin irritation (see Section 4.8 Undesirable effects), the amount of cream per application should be reduced or the frequency of use of Skinoren Cream should be reduced to once a day until the irritation ceases. If required, treatment might have to be temporarily interrupted for a few days. ADDITIONAL INFORMATION ON SPECIAL POPULATIONS PEDIATRIC PATIENTS Use in adolescents (12 - 18 years of age): dose adjustment is not requ read_full_document