Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Fluconazole 150mg; Clotrimazole 10 mg/g
Bayer New Zealand Limited
Fluconazole 150 mg
150mg & 10mg/g
Combination
Active: Fluconazole 150mg Excipient: Colloidal silicon dioxide Gelatin Lactose monohydrate Magnesium stearate Maize starch Opacode black S-1-17823 Sodium laurilsulfate Titanium dioxide Water Active: Clotrimazole 10 mg/g Excipient: Benzyl alcohol Cetostearyl alcohol Cetyl palmitate Octyldodecanol Polysorbate 60 Purified water Sorbitan stearate
Restricted
Mylan Laboratories Limited
Vaginal candidiasis. Cream can be used for relief of external itching/irritation and the management of candida vulvovaginitis or infection of the peri-anal area.
Package - Contents - Shelf Life: Blister pack, white opaque PVC/PVdC-aluminium - 1 capsules - 0 days Not applicable - Combination pack, 1 tube plus one capsule - 1 dose units - 36 months from date of manufacture stored at or below 25°C 3 months opened stored at or below 25°C. cream - Tube, aluminium, PE screw cap with spike - 10 g - 0 months Not applicable
2014-11-28
_Canesoral Duo CMI _ _13 July 2015_ Consumer Medicine Information 1 CANESORAL FLUCONAZOLE CAPSULE & CLOTRIMAZOLE CREAM DUO FLUCONAZOLE ORAL CAPSULE 150 MG & CLOTRIMAZOLE CREAM 10 MG/G WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Canesoral Fluconazole Capsule & Clotrimazole Cream Duo (referred to in the rest of this leaflet as Canesoral Duo). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you using Canesoral Duo against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CANESORAL DUO IS USED FOR Canesoral Duo is used to treat a type of fungal infection called vaginal thrush. Canesoral Duo contains two components: Canesoral Fluconazole Capsule is an oral capsule which contains the active ingredient fluconazole; Canesten cream contains the active ingredient clotrimazole. Both of these ingredients belong to a group of medicines called azole antifungals. Canesoral Fluconazole Capsule is taken by mouth and works from the inside to prevent the growth of the fungi causing your infection. Canesten cream is applied to the irritated area and provides soothing relief from external itching and irritation. _WHAT IS VAGINAL THRUSH? _ Vaginal thrush is a common name for vaginal candidiasis, an infection caused by a yeast-like fungus called _Candida_. _Candida_ is one of many organisms that live in the vagina. Your body’s natural balance (immune system) normally keeps _Candida_ under control, but when this natural balance is upset _Candida_ can multiply and can cause thrush symptoms. Common symptoms of vaginal thrush include: itching, burning or soreness around the vagina cottage cheese-like discharge _Canesoral Duo CMI _ _13 July 2015_ Consumer Medicine Information 2 swelling or irritati Read the complete document
_ _ _Canesoral Duo Data Sheet _ _1 May 2023_ NEW ZEALAND DATA SHEET Page 1 of 17 CANESORAL ® DUO FLUCONAZOLE ORAL CAPSULE 150 MG CLOTRIMAZOLE TOPICAL CREAM 10 MG/G 1. NAME OF THE MEDICINAL PRODUCT Canesoral Duo A powder-filled capsule containing 150 mg fluconazole and a topical cream containing 10 mg/g clotrimazole. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 150 mg fluconazole. Each gram of cream contains 10 mg clotrimazole (10 mg/g, 1% w/w). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard gelatine capsule, powder-filled and topical cream in a vanishing cream base. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Canesoral Duo is indicated for vaginal candidiasis. The cream can also be used for relief of external itching/irritation and the management of Candida vulvovaginitis or infection of the peri-anal area. 4.2 DOSE AND METHOD OF ADMINISTRATION The fluconazole capsule must be used as a single dose treatment only. The clotrimazole cream should be used in conjunction with the fluconazole capsule for relief of external itching/irritation and the management of Candida vulvovaginitis or infection of the peri-anal area. _ADULTS _ One fluconazole 150 mg capsule, swallowed whole, in a single dose. Consult a healthcare professional if over 60 years of age. Apply the cream thinly to the affected areas and rub in gently, two or three times daily. _Canesoral Duo Data Sheet _ _1 May 2023_ Page 2 of 17 _PAEDIATRIC POPULATION _ Canesoral Duo should not be taken by children under 18 years of age unless directed by their physician. _PATIENTS WITH IMPAIRED RENAL FUNCTION _ There is no separate dosage schedule in patients with renal impairment for the single dose fluconazole treatment. _ _ 4.3 CONTRAINDICATIONS Canesoral Duo should not be used in patients with known sensitivity to fluconazole; clotrimazole; to related azole compounds; or to any of the excipients listed in section 6.1. Coadministration of other medicines known to prolong the QT interval and which are metabol Read the complete document