Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Econazole nitrate
Karo Healthcare UK Ltd
D01AC03
Econazole nitrate
10mg/1gram
Vaginal cream
Vaginal
No Controlled Drug Status
Valid as a prescribable product
BNF: 07020200
- 1 - PACKAGE LEAFLET: INFORMATION FOR THE USER GYNO-PEVARYL ® CREAM Econazole nitrate Gyno-Pevaryl is a registered trademark READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again • If you have any further questions, ask your doctor or pharmacist • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours • If you get any side effects talk to your doctor or pharmacist This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET 1. What Gyno-Pevaryl is and what it is used for 2. What you need to know before you use Gyno-Pevaryl 3. How to use Gyno-Pevaryl 4. Possible side effects 5. How to store Gyno-Pevaryl 6. Contents of the pack and other information 1. WHAT GYNO-PEVARYL IS AND WHAT IT IS USED FOR The name of your medicine is Gyno-Pevaryl cream. It is called ‘Gyno-Pevaryl’ in this leaflet. Gyno-Pevaryl contains a medicine called econazole nitrate. This belongs to a group of medicines called ‘antifungals’. Gyno-Pevaryl is used for infections caused by fungi and yeasts such as thrush (_Candida_). • In women, it is used for infections of the vagina and the skin around the vagina • In men, it is used for infections of the penis and the skin around the penis Your sexual partner should also be treated. They may have the infection even if they have no symptoms. If they are not treated, they may give the infection back to you. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE GYNO-PEVARYL DO NOT USE GYNO-PEVARYL IF: • You are allergic to econazole nitrate or any of the other ingredients of this medicine (listed in section 6) • You are allergic to any other medicine used to treat thrush or other fungal infections • You are under 16 years old Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacis Prečítajte si celý dokument
OBJECT 1 GYNO-PEVARYL CREAM Summary of Product Characteristics Updated 09-Aug-2016 | Janssen-Cilag Ltd 1. Name of the medicinal product Gyno-Pevaryl Cream 2. Qualitative and quantitative composition Each 100 g of cream contains 1 g econazole nitrate (1% w/w). For a full list of excipients, see section 6.1. 3. Pharmaceutical form Vaginal cream. 4. Clinical particulars 4.1 Therapeutic indications For the treatment of mycotic vulvovaginitis and mycotic balanitis. 4.2 Posology and method of administration Route of Administration For vaginal/penile administration. Females: One applicator full (approximately 5 g) intravaginally once daily at night for not less than 14 days. The cream should also be applied to the vulva. The full 14 days treatment should be carried out even if the symptoms of vaginal itching or discharge have disappeared. In pregnant women, it is recommended that administration takes place without the use of an applicator, or is performed by a physician. Pregnant women should thoroughly wash their hands before self- administering Gyno-Pevaryl cream. Males: Apply the cream to the penis, including under the foreskin, once daily for not less than 14 days. The sexual partner should also be treated. 4.3 Contraindications Hypersensitivity to any imidazole preparation, other vaginal antifungal products or to any ingredients of Gyno-Pevaryl cream. 4.4 Special warnings and precautions for use Not for ophthalmic or oral use. Hypersensitivity has rarely been recorded; if it should occur administration should be discontinued. Contact between contraceptive diaphragms or condoms and this product must be avoided since the rubber may be damaged by the preparation. Patients using spermicidal contraceptives should consult their physician since any local vaginal treatment may inactivate the spermicidal contraceptive (see section 4.5). Gyno-Pevaryl Cream should not be used in conjunction with other internal or external treatment of the genitalia. Gyno-Pevaryl Cream is not indicated for use in children under the age of 16 y Prečítajte si celý dokument