Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Miconazole nitrate
Janssen-Cilag Ltd
G01AF; G01AF04
Miconazole nitrate
1200 milligram(s)
Vaginal capsule
Product subject to prescription which may be renewed (B)
Imidazole derivatives; miconazole
Not marketed
1989-06-09
- 1 - PACKAGE LEAFLET: INFORMATION FOR THE USER GYNO-DAKTARIN ® 1200 MG VAGINAL CAPSULE Miconazole nitrate Gyno-Daktarin 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-Daktarin vaginal capsule is and what it is used for 2 What you need to know before you use Gyno-Daktarin vaginal capsule 3 How to use Gyno-Daktarin vaginal capsule 4 Possible side effects 5 How to store Gyno-Daktarin vaginal capsule 6 Contents of the pack and other information 1 WHAT GYNO-DAKTARIN VAGINAL CAPSULE IS AND WHAT IT IS USED FOR The name of your medicine is Gyno-Daktarin 1200 mg vaginal capsule. It is called ‘Gyno-Daktarin vaginal capsule’ or just ‘capsule’ in this leaflet. Gyno-Daktarin vaginal capsule is for use in adults. Gyno-Daktarin vaginal capsule is a white to off white, egg-shaped pessary. When inserted into the vagina it releases a medicine called miconazole nitrate. This belongs to a group of medicines called ‘antifungals’. Gyno-Daktarin vaginal capsule is used for infections of the vagina. Signs of these infections include itching, redness and white discharge. Gyno-Daktarin vaginal capsule works by destroying the fungus that causes the infection and some of the bacteria which may also be present. Your sexual partner may also need to be treated. Ask your doctor for advice. ABOUT VAGINAL THRUSH Vaginal thrush is a very common problem affecting women of all ages. It has nothing to do with poor hygiene. It is often caused by a fungus (_Candida _ _albicans_) that is Đọc toàn bộ tài liệu
Health Products Regulatory Authority 19 November 2018 CRN008LPD Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gyno-Daktarin 1200 mg vaginal capsule. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 1200 mg miconazole nitrate. Also contains ethyl parahydroxybenzoate (E215) and sodium propyl parahydroxybenzoate (E217) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal capsule, soft. White to off white egg shaped soft vaginal capsule containing a white to cream coloured hydrophobic mass. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adult females only. For the local treatment of vulvo-vaginal Candida infections, including those with superinfection due to susceptible gram positive bacteria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Gyno-Daktarin vaginal capsule is for vaginal administration. Adults (aged 18 years and older) One soft vaginal capsule inserted high into the vagina before retiring at night. This is best done in the reclining position. Paediatrics (aged under 18 years) The safety and efficacy of Gyno-Daktarin vaginal capsule in children and adolescents has not been studied. 4.3 CONTRAINDICATIONS Health Products Regulatory Authority 19 November 2018 CRN008LPD Page 2 of 8 Gyno-Daktarin vaginal capsule is contraindicated in individuals with a known hypersensitivity to miconazole/miconazole nitrate, other imidazole derivatives or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Gyno-Daktarin vaginal capsule and with other miconazole formulations (see section 4.8). If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued. Appropriate therapy is indicated when the sexual partner is also infected. The concurrent use of latex condoms or diaphragms with vaginal anti-infective preparations may decrease the effectiveness of latex co Đọc toàn bộ tài liệu