Land: Malta
Språk: engelsk
Kilde: Medicines Authority
MICONAZOLE NITRATE
Janssen-Cilag International NV Turnhoutsewes 30, B-2340 Beerse, Belgium
G01AF04
MICONAZOLE NITRATE 400 mg
VAGINAL CAPSULE
MICONAZOLE NITRATE 400 mg
POM
GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
Withdrawn
2006-12-29
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER GYNO-DAKTARIN 400MG 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 capsules 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 400mg vaginal capsules. 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 capsules 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 ‘anti-fungals’ Gyno-Daktarin vaginal capsules is used for infections of the vagina. Signs of these infections include itching, redness and white discharge. Gyno-Daktarin vaginal capsules 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 Page 2 of 6 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 (_Cand Les hele dokumentet
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Gyno-Daktarin 400 mg vaginal capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 400 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 super infectiondue 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) Once daily before bedtime, insert one vaginal capsule deeply into the vagina. This is best done in the reclining position. Repeat this procedure for 3 days. The treatment can be repeated if necessary. Complete the entire treatment even if symptoms (e.g., pruritus and leukorrhea) have disappeared or menstruation begins. In case of severe infections it may be advisable to prescribe a 6-day treatment course right from the start. 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 Gyno-Daktarin vaginal capsule is contraindicated in individuals with a known hypersensitivity to miconazole/miconazole nitrate, other imidazole derivatives or another ingredient of the soft vaginal capsule. 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 se Les hele dokumentet