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| نشرة الممارس الصحي | نشرة معلومات المريض بالعربية | نشرة معلومات المريض بالانجليزية | صور الدواء | بيانات الدواء |
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1. WHAT FUCIDIN® CREAM IS Fucidin® is an antibiotic with powerful antibacterial activity against a number of gram-positive organisms. Staphylococci, including the strains resistant to penicillin or to other antibiotics, are particularly susceptible to Fucidin®. Besides pronounced antibacterial activity against the majority of organisms responsible for skin infections, Fucidin® also possesses unique ability for penetration to the focus of infection, even when applied to intact skin.
2. WHAT IS FUCIDIN® CREAM USED FOR Fucidin® cream is indicated for treatment of skin infections caused by staphylococci, streptococci, Propionibacterium acnes, Corynebacterium minutissimum, and other organisms sensitive to fusidic acid. The most important indications being: Impetigo, Boils, Carbuncles Paronychia, Infected wounds, Sycosis barbae, Hidradenitis Erythrasma, Folliculitis Acne vulgaris For external use Fucidin® cream is an invisible, non-staining preparation, which is cosmetically acceptable for treatment of face and scalp infections
Avoid getting the cream in your eyes (e.g. accidentally from your hands) as it could damage them.
Fucidin® cream is applied to the affected area 2–3 times daily, generally for a period of 7 days, except of acne where therapy should be extended for a longer period according to the nature of this disease
Like all medicines, Fucidin® cream can cause side effects, although not everybody gets them. Important side effects to look out for: You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction: - You have difficulty breathing - Your face or throat swell - Your skin develops a severe rash Other possible side effects: Uncommon side effects (probably affect less than 1 in 100 people) - Irritation at site of application (including pain, burning, stinging and skin redness) - Itching - Rash If any of the side effects become serious or you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.
Shelf life: 3 years. Storage Conditions: Do not store above 25°C. See the expiry date printed on the carton.
Each gramme contains: Fusidic acid 20 mg in neutral cream base
LEO Pharma A/S
الفيوسيدين® مضاد حيوي قوي ذو فعالية ضد عدد من الجراثيم موجبة التفاعل مع اختبار جرام. المكورات العنقودية بما في ذلك السلالات المقاومة للبنسيلين أو المضادات الحيوية الأخرى سريعة التأثر فيوسيدين® خاصة.
بالإضافة للفعالية المتميزة للفيوسيدين® ضد غالبية الجراثيم المسئولة عن الأمراض الجلدية. يتمتع الفيوسيدين® أيضاً بمقدرة فريدة على النفاذ إلى بؤرة العدوى حتى من خلال الجلد السليم.
تجنب دخول كريم فيوسيدين® في منطقة العين (عن طريق الخطأ من يديك)، وهذا قد يسبب ضرراً للعين.
تدهن الأماكن المصابة بكريم الفيوسيدين® 2-3 مرات يومياً، لمدة 7 أيام ما عدا في حالات حب الشباب حيث تمتد فترة العلاج لمدة أطول تبعاً لطبيعة المرض.
تأثيرات جانبية غير مألوفة (قد تؤثر على أقل من شخص واحد من بين 100 شخص).
- تهيجات في مواقع استعمال ودهن الكريم (تشمل آلام، تحرق (شعوب بحرق)، شعور بلدغ (لسعة) واحمرار جلدي).
- حكة.
- طفح جلدي.
إذا أصبحت أي من التأثيرات الجانبية خطيرة، أو لاحظتم حدوث أي تأثيرات جانبية غير واردة في هذه النشرة الطبية، الرجاء إبلاغ الطبيب أو الصيدلي.
مدة الحفظ: 3 سنوات
شروط التخزين: يجب عدم تخزين وحفظ هذا الدواء فوق درجة حرارة 25 درجة مئوية.
انظر إلى تاريخ انتهاء الصلاحية المطبوع على العلبة الكرتونية.
كريم
حامض فيوسيديك 20 ملجرام / جرام في قاعدة مرهم متعادلة
أنبوب 30 جرام
منتجات مستحضرات ليو فارما ايه/اس
باليروب - الدنمارك
Skin infections caused by bacteria sensitive to fusidic acid.
Adults and children: Fucidin Cream should be applied 2 – 3 times daily.
Contains cetyl alcohol and potassium sorbate which may cause rash (for instance contact dermatitis). Contains furthermore butylhydroxyanisole (E320) which may cause rash (for instance contact dermatitis) and irritation of the eye and mucous membranes.
None.
Pregnancy:
Should only be used with caution during pregnancy. No clinical data are available regarding the use of fusidic acid in connection with pregnancy. Studies in animals do not report any direct or indirect harm to pregnancy, the development of the embryo/foetus, the delivery or the postnatal development.
Lactation:
Can be used during breast feeding.
No marking.
Fucidin Cream has no or negligible influence on the ability to drive or use ma-chines.
Based on the clinical data for Fucidin Cream and Ointment it is presumed that approximately 10 - 15% of the patients will experience undesirable effects.
The most frequently reported undesirable effects are various skin reactions, in particular on the application spot.
Immune system disorders Frequency unknown |
Allergic reaction. |
Dermatological disorders Not common (>1/1000 and <1/100) Frequency unknown
* Various types of rash reactions have been reported including erythematous, maculo-papular and pustular exanthema.
| Exanthema*, irritation of the skin, pruritis, burning or stinging sensation of the skin, erythema, dry skin. Contact dermatitis, eczema, urticaria, angioneurotic oedema, periorbal oedema
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Overdosing is not likely.
Fucidin exerts antibacterial effects by inhibiting the protein synthesis in bacteria. Resistance to fusidic acid is rare (1-2%) after 30 years of use. Bacteria resistant to penicillin and other antibiotics are often sensitive to fusidic acid.
Insignificant systemic absorption.
Apart from what is mentioned in other parts of this summary of product character- istics, there are no preclinical data relevant to the prescribing physician.
Cetyl alcohol
Glycerol (85 per cent) Polysorbate 60
White soft paraffin Potassium sorbate E 202 Butylhydroxyanisole E 320 Water, purified
Liquid paraffin
Hydrochloric acid, diluted
All-rac-α-tokoferol
Not relevant.
None.
Tube (aluminium).
None.
