国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone acetate
The Boots Company Plc
D07AA02
Hydrocortisone acetate
10mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000; GTIN: 5045094627288
INFORMATION FOR THE USER Bite & Sting Relief Hydrocortisone Cream READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription to treat minor conditions. However, you still need to use it carefully to get the best results from it. Keep this leaflet, you may need to read it again Ask your pharmacist if you need more information or advice WHAT THIS MEDICINE IS FOR This medicine contains Hydrocortisone Acetate, which belongs to a group of medicines called corticosteroids, which act to relieve pain and swelling. It can be used to relieve the swelling, itching and irritation caused by insect bites and stings. BEFORE YOU USE THIS MEDICINE This medicine can be used by adults and children aged 10 years and over. However, some people should not use this medicine or should seek the advice of their pharmacist or doctor first. X DO NOT USE: IF YOU ARE UNDER 10 YEARS OF AGE IF YOU ARE PREGNANT, unless advised by a doctor IF YOU HAVE BROKEN OR INFECTED SKIN – this includes impetigo, cold sores, acne, athlete’s foot, scabies or an infected bite or sting ON THE FACE OR EYES ON THE ANAL OR GENITAL AREAS ON BITES AND STINGS THAT ARE NOT caused by insects ON OTHER SKIN CONDITIONS such as eczema or dermatitis IF YOU TAKE OTHER MEDICINES This cream is not expected to cause problems with any other medicine you use. HOW TO USE THIS MEDICINE Check the cap seal is not broken before first use. If it is, do not use the cream. Pierce tube seal with end of cap. Apply only to the skin. AGE HOW MUCH TO USE HOW OFTEN TO USE IT Adults and children of 10 years and over A very small amount on the affected area Once or twice a day for 2 to 3 days Do not use on children under 10 years. Do not use more than the amount recommended above. If your symptoms get worse talk to a pharmacist or doctor. If your symptoms do not go away within 3 day, talk to a pharmacist or doctor. ! IF YOU USE TOO MUCH: It is unlikely to cause any harm to you. ! 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Boots Bite and Sting Relief Hydrocortisone Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrocortisone Acetate BP 1.0% w/w 3 PHARMACEUTICAL FORM A smooth, white cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Insect bite and sting reactions 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical administration Apply sparingly to a small area, once or twice a day, for a maximum of 2-3 days. Do not use in pregnancy without medical advice or in children under 10. 4.3 CONTRAINDICATIONS The product should not be used on the eyes or face, the ano-genital area or on broken or infected skin including impetigo, cold sores, acne, athlete’s foot, scabies or infected bites or stings. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The product labelling shall include the following statements: If the condition does not improve consult your doctor. Do not use on the eyes or face, anal or genital areas or on broken skin or infected skin, e.g. impetigo, cold sores, acne, athlete’s foot, scabies or infected bites or stings. Do not use for other bites or stings or for other skin conditions. Visual impairment: Visual impairment may be reported with systemic and topical use of corticosteroids. If patients develop symptoms such as blurred vision or other visual disturbances, consideration should be given to referring the patient to an ophthalmologist to establish the possible cause which may include cataract, glaucoma or rare conditions such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION This product should not be used in pregnancy without medical advice. There is no information about effects on lactation. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS Treatment with hydrocortisone is usually well tolerated but treatment should be sto 阅读完整的文件