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Fusizone® contains, 2 different types of medicine: one medicine is called fusidic acid. It is a type of antibiotic. The other medicine is called betamethasone valerate. It is a type of corticosteroid (steroid). These 2 medicines work at the same time in different ways.Fusizone® works by: The antibiotic killing germs (bacteria) that cause infections.The corticosteroid reducing any swelling, redness or itchiness of your skin.
Fusizone® is used to treat: Conditions where the skin is inflamed (eczema or dermatitis) and also infected by germs (bacteria).
Do not use Fusizone® and tell your doctor or pharmacist if you have:
- If you are allergic (hypersensitive) to fusidic acid or betamethasone valerate or any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.
- To treat a skin condition caused by a fungus, such as athlete’s foot.
- To treat a skin condition caused by a virus, such as cold sores or chickenpox.
- To treat skin conditions caused only by bacteria, such as boils or spots.
- To treat skin conditions caused by tuberculosis (TB) or syphilis.
- To treat a skin condition called perioral dermatitis. This is a red spotty rash around your mouth or chin.
- To treat a skin condition called rosacea. This is redness and inflammation over your nose and cheeks. Ask your doctor if you are unsure.
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before using Fusizone:
- Do not use the cream on yourself or a child for more than 2 weeks; this is to avoid bacteria becoming resistant to the antibiotic and to avoid the steroid causing you side effects.
- Take special care if you are going to use this medicine near your eyes or the eyes of a child. If the cream gets into the eye, this may lead to glaucoma.
- If you use the cream over a long time or in large amounts it may make the chance of getting any side effects or infections higher. Also your skin may get more sensitive to this medicine.
- You must not use the medicine for a long time on your face.
- Unless your doctor has told you to, you must not use Fusizone® on open wounds or sensitive areas such as the nostrils, ears, lips or genitals.
- Unless your doctor has told you to, you must not use Fusizoneveins or acne.
- Adrenal suppression may occur. Signs are tiredness, depression and anxiety. This can be reversed by stopping Fusizone®.Using other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any medicines which you have bought without a prescription.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
- If you are pregnant or think you might be pregnant: Fusizone® should not be used during pregnancy, unless you are told to do so by your doctor.
- If you are breast-feeding: Fusizone® may be used by women who are breast-feeding, but the cream should not be applied to the breasts to avoid accidental ingestion by the infant.Tell your doctor if you become pregnant while using this medicine.
Driving and using machines
This medicine should not have any effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.
Fusizone® contains
Cetostearyl alcohol. This may give you an itchy rash and inflammation on your skin where your medicine is used.Please ask your doctor if you are worried about any of the ingredients in this medicine.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How to apply Fusizone®
This medicine is only for use on your skin or the skin of a child. Do not swallow it. Do not put it inside your body. Remove the cap. Check the seal is not broken before you first use the cream. Then push the spike in the cap through the seal on the tube. Always wash your hands before using Fusizone®. Rub the medicine gently on the skin. If you use it on your face be careful to avoid your eyes. Unless you are using the cream to treat your hands, always wash your hands after using Fusizone®. If you accidentally get any medicine in your eye, wash it out with cold water straight away. Then bathe your eye with eyewash if possible. Your eye may sting. If you start to have any problems with your sight or your eye is sore, contact your doctor immediately.
How much Fusizone® to use ®
- Your doctor will tell you how much Fusizone to use.
- The usual treatment time is up to 2 weeks. Ask your doctor before using this medicine for any longer.
- You should notice your skin improve after just a few days of using the cream. If there is no improvement after 7 days you should stop using the cream and go back to your doctor.
- Usually you should use this medicine twice each day. Use it in the morning and evening. To remind you to use the medicine, it may help to use it when you do another regular action, such as brushing your teeth.
- If you have been told to cover the skin with any dressings or bandages you may not need to use the medicine so often. A nappy on a baby may act as a dressing. Follow the advice of your doctor.Adults and children:
Your doctor should tell you the dose that is right for you or the child. If your doctor has told you the amount of cream to use then keep to this advice. If not, the following guide will help you to use the correct amount.You can use your first (index) finger to measure how much Fusizone® to use. Squeeze the cream along your finger from the tip to the first joint as shown in the diagram. This is called a fingertip unit.
The usual number of fingertip units you need to cover different parts of the body is shown in the diagrams. If you need to use a little more or a little less do not worry. If you are using the cream on a child still use an adult finger to measure out the fingertip unit.
If you use more Fusizone® than you should Tell your doctor straight away if have used more Fusizone® than you should. You may need to stop using this medicine.
If you forget to use Fusizone®
If you forget to use the cream at the right time, use it as soon as you remember. Then use this medicine again at the usual time.
Do not use a double dose to make up for a forgotten dose.
If you have any further questions about using this medicine, please ask your doctor or pharmacist.
Like all medicines, Fusizone® can cause side effects, although not everybody gets them.
Important side effects to look out for:
Tell your doctor or nurse immediately if any of the following happen. You may need to stop your treatment:
- You have difficulty breathing- Your face or throat swell
- Your skin develops a severe rash.
The following less serious side effects have also been reported. If any of them last a long time or cause problems, you should tell your doctor or nurse as soon as possible:
Any of the problems listed below are more likely if the medicine is used for a long time, in large amounts or on skin folds (such as armpits or under breasts).
These problems are more likely in babies and children. They are also more likely if the skin is covered with a dressing, bandage or nappy.
Uncommon (may affect up to 1 in 100 people) Itchy rash and skin inflammation in the area where the medicine is used, Worsening of your eczema, Burning feeling, Itching, Dry skin, Application site pain, Application site irritation.
Rare (may affect up to 1 in 1,000 people)Skin redness, Hives, Skin rash, Application site swelling
- Application site blisters.Some side effects are®known to be caused by betamethasone valerate (steroid), one of the ingredients in Fusizone you should tell your doctor if any of the side effects occur:
Adrenal glands may stop working properly. signs are tiredness, depression and anxiety, glaucoma, thinning of the skin, red spotty rash around the mouth or chin, stretch marks, small veins near the surface of the skin become visible , changes in growth of your body hair, excessive sweating, lightening of your skin colour, redness and pimples around the mouth, redness of the skin, nose or mouth, formation of cataracts.
Reporting of side effectsIf you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
- Keep this medicine out of the sight and reach of children.
- Do not use Fusizone® after the expiry date on the tube or carton. The expiry date is the last day of that month.
- Do not store the medicine above 30 ºC.
- Do not use the tube for more than 12 months after you first open it.
- Do not throw away any medicines via wastewater or household waste. Ask you pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
The active substance is Fusidic acid 20 mg.Betamethasone (as valerate) 1mg.
The other ingredients are: Cetyl Alcohol, Liquid Paraffin, Glyceryl monostearate, Cremophor A6, Cermophor A25, Propylene glycol, Methyl paraben, Propyl paraben, Glycerol and Purified water.
BATTERJEE PHARMA
Street No.: 401, Road No.: 403,
Industrial Area-Phase-IV,
P.O. Box: 10667,
Jeddah-21443,
Kingdom of Saudi Arabia
حمض فیوسیدیك ۲۰ملجم على ھیئة فالیرات یحتوي كل جرام فیوسیزون®كریم على۱ ملجم. یستعمل فیوسیزون® في علاج الإلتھابات الجلدیة في وجود أو غیاب العدوى البكتیریة. إن الإلتھابات الجلدیة تشمل التھاب الجلد بالتلامس، التھاب الجلد الإستشرائي ، الإكزیما القرصیة ، إكزیما الركود، الحزاز المسطح، الحساس البسیط المزمن، الصدفیة، الإلتھابات الجلد الزھامي، حكة عقیدیة، ذئبقة إحمراریة قرصیة، وتفاعلات لدغ الحشرات
قبل استعمال فیوسیزون®كریم۲لاتستعمل فیوسیزون®كریم وأخبر طبیبك أو الصیدلي إذا كنت تعاني من:
- إذا كنت تعاني من حساسیة من حمض الفوسیدیك أو أي من المكونات الأخرى في الدواء یمكنك العثور على قائمة من ھذه المكونات في المادة ٦ من ھذه النشرة.
- لعلاج مرض جلدي یسببھ نوع من الفطریات، مثل القدم الریاضي.
- لعلاج مرض جلدي یسببھ فیروس، مثل القروح الباردة أو الجدري المائي.
- لعلاج أمراض الجلد الناجمة فقط عن طریق البكتیریا، مثل الدمامل أو الزھري لعلاج الأمراض الجلدیة الناجمة عن مرض السل (TB).
- لعلاج مرض جلدي یسمى التھاب الجلد حول الفم وھو طفح جلدي أحمر متقطع حول الفم أو الذقن.
- لعلاج مرض جلدي یسمى الوردیة وھو احمرار والتھاب على الأنف والوجنتین اسأل طبیبك إذا كنت غیر متأكد
مدة العلاج المعتادة تصل الى اسبوعین .إسأل طبیبك قبل استخدام ھذا الدواء لفترة أطول. وینبغي علیك ملاحظة بشرتك تتحسن بعد أیام قلیلة من استخدام الكریم. إذا لم یكن ھناك أي تحسن بعد ۷ أیام فیجب التوقف عن استخدام الكریم والعودة إلى الطبیب. یجب استخدام ھذا الدواء مرتین كل یوم صباحا ومساء. إذا كان لدیك حاجة لتغطیة الجلد مع أي الضمادات أو ضمادات قد لا تحتاج إلى استخدام ھذا الدواء في كثیر من الأحیان. یمكنك استخدام إصبعك لقیاس مقدار استخدام فیوسیزون® كریم البالغین والأطفال:اضغط على كریم على طول إصبعك من طرف كما ھو مبین في الرسم البیاني. یظھر العدد المعتاد من وحدات الإصبع تحتاج إلى تغطیة أجزاء مختلفة من الجسم في الرسوم البیانیة.إذا كنت بحاجة إلى استخدام أكثر قلیلا أو أقل قلیلا لا تقلق. إذا كنت تستخدم كریم على الطفل لا یزال استخدام الاصبع الكبار لقیاس من وحدة الإصبع
لاینصح باستعمال فیوسیزون® كریم لفترة طویلة ، خصوصا في الأطفال.
التحذیرات والاحتیاطات:
- تحدث إلى طبیبك أو الصیدلي أو الممرضة قبل استخدام فیوسیزون® كریم.
- عدم استخدام الكریم على نفسك أو الأطفال لأكثر من اسبوعین وھذا لتجنب البكتیریا المقاومة للمضادات الحیویة وتجنب الستیروید الذي یسبب لك آثار جانبیة.
- إذا كنت تنوي استخدام ھذا الدواء بالقرب من عینیك أو عیني طفل یجب اتباع عنایة خاصة. إذا دخل الكریم داخل العین، قد یؤدي ھذا إلى الماء الأزرق في العین.
- إذا كنت تستخدم كریم على مدى فترة زمنیة طویلة أو بكمیات كبیرة قد یؤدي ذلك لآثار جانبیة أو التھابات أیضا أو قد یصبح جلدك أكثر حساسیة من ھذا الدواء.
- یجب عدم استخدام ھذا الدواء لفترة طویلة على الوجھ .
- عدم استخدام فیوسیزون® كریم على الجروح المفتوحة أوالحساسة ، وأیضا على الأنف والأذنین والشفتین أو الأعضاء التناسلیة.
- عدم استخدام فیوسیزون® كریم على جلد رقیق، وتقرحات الجلد، وعروق الكسر أو حب الشباب.
- قد تحدث أعراض الاكتئاب والقلق.
الحمل والرضاعة الطبیعیة
یجب أخذ الحیطة عند إستعمال فیوسیزون®كریم و الكورتیكوستیرویدات الأخرى في حالات الحمل و الرضاعة ، حیث یمكن إستعمال الدواء فقط عند الضرورة القصوي.
إستخدام أدویة أخرى
لا یوجد أى تداخل معروف لإستخدام فیوسیزون® كریم مع أى أدویة اخرى.
القیادة وإستخدام الألیات :
لایوجد أي تأثیر
- لا تستخدم ففیوسیزون®كریم بعد تاریخ انتھاء الصلاحیة المذكور على العلبة والشریط بعد كلمة EXP.
- یحفظ في درجة حرارة لا تزید عن ۳۰درجة مئویة.
- وینبغي أن لا یتم التخلص من الأدویة عن طریق میاه الصرف الصحي أو النفایات المنزلیة.
- مدة الاستخدام: ٦ ۱۲ شھر بعد الفتح في درجة حرارة ۲٥ درجة مئویة.
- اسأل الصیدلي حول كیفیة التخلص من الأدویة التي لم تعد مطلوبة .وستساعد ھذه التدابیر على حمایة البیئة
المادة الفعالة ھي: حمض فیوسیدیك. كل جرام یحتوي علي ۲۰ ملجم ھیئة فالیراتفیوسیدیك على ھیئة فالیرات.
المكونات الأخرى ھي: كحول سیتوستیریل، برافین أبیض لین، اوكسیل متعدد٤۰ , ستیرات، برافین سائل، ایزوبروبیل میرستات، جلیسرول، میثیل باربین، بروبیل باربین.
فیوسیزون® كریم ھو كریم ابیض ناعم یوجد فیوسیزون®كریم فى علبة كرتون تحتوي على أنبوبة ألومنیوم ۱٥جرام ونشرة داخلیة
بترجي فارما
الشارع رقم ٤۰۱ ،شارع رقم ٤۰۳ ،
منطقة المرحلة الرابعة الصناعیة،
ص. مربع: ۱۰٦٦۷ ،
جدة ۲۱٤٤۳ ،
المملكة العربیة السعودیة
Fusizone® is indicated in inflammatory dermatoses where bacterial infection is present or likely to occur.
Inflammatory dermatoses include contact dermatitis, atopic dermatitis nummular eczema, stasis eczema, lichen planus, lichen simplex chronicus, psoriasis, seborrheic, dermatitis, prurigo, discoid lupus erythematosus and insect bite reactions.
A small quantity should be applied to the affected area twice daily until a satisfactory response is obtained. A single treatment course should not normally exceed 2 weeks. In the more resistant lesions the effect of Fusizone® cream can be enhanced by occlusion with polythene film. Overnight occlusion is usually adequate.
Long term continuous topical therapy should be avoided, particularly in infants and children. Adrenal suppression can occur even without occlusion. Atrophic changes may occur on the face and to a lesser degree in other parts of the body, after prolonged treatment with potent topical steroids. Caution should be exercised if Fusizone® cream is used near the eye. Glaucoma might result if the preparation enters the eye. Systemic chemotherapy is required if bacterial infection persists. Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent application may increase the risk of developing antibiotic resistance. Steroidantibiotic combinations should not be continued for more than 7 days in the absence of any clinical improvement since in this situation occult extension of the infection may occur due to the masking of the steroid. Similarly, steroids may also mask hypersensitivity reactions. Fusizone® Cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
None known.
Fusizone® should be used with caution in pregnancy and lactation; the drug may be used only if the potential benefit justifies the potential risk.
None Known
Immune system disorders
Not known
Allergic reaction
Skin and subcutaneous tissue disorders
Uncommon
Skin irritation
Skin burning sensation
Pruritus
Eczema aggravated
Skin stinging sensation
Erythema
Rare
Urticaria
Dry skin
Not known
Contact Dermatitis
Rash
Telangiectasia
Class effect
Undesirable effects observed for corticosteroids include: Skin atrophy, telangiectasia, and skin striae, especially during prolonged application, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation, glaucoma and adrenocortical suppression.
National Pharmaco-vigilance and Drug Safety Centre info:
Fax: +966-11-205-7662
Toll-free number: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc
Excessive prolonged use of topical corticosteroids may suppress the pituitary adrenal functions resulting in secondary adrenal insufficiency which is usually reversible. In such cases symptomatic treatment is indicated.
Fusizone® combines the potent topical antibacterial action of Fusidic acid with the anti-inflammatory and antipruritic effects of Betamethasone. Betamethasone valerate is a topical steroid with rapid effect in inflammatory dermatoses. Fusidic acid inhibits bacterial protein synthesis, it is effective against Staphylococci, Streptococci, corynebacteria, Neisseria and certain Clostridia and Bacteroids . The antibacterial activity of Fusidic acid is not diminished in the presence of Betamethasone.
The degree of penetration of fusidic acid depends on factors such as the duration of exposure to fusidic acid and the condition of the skin. Fusidic acid is excreted mainly in the bile with little excreted in the urine. Betamethasone is absorbed following topical administration. The degree of absorption is dependent on various factors including skin condition and site of application. Betamethasone is metabolised largely in the liver but also to a limited extent in the kidneys, and the inactive metabolites are excreted with the urine.
No data available.
Cetostearyl Alcohol, White soft Paraffin, Polyoxyl 40 stearate, Liquid Paraffin, Isopropyl myristate, Methyl paraben, Propyl paraben, Glycerol and Purified water.
Not applicable.
Do not store above 30 ºC.
Carton box containing Aluminum tube of containing 15 gm along with a leaflet.
None
