Țară: Africa de Sud
Limbă: engleză
Sursă: South African Health Products Regulatory Authority (SAHPRA)
Bayer (Pty) Ltd û Isando
See ingredients
COMBINATION OF DOSAGE FORMS
Referred to CLOTRIMAZOLE A
Registered
1998-06-08
Page 1 of 7 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S1 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM: CANESTEN ® DUOPAK Vaginal Tablet 500 mg and Cream 100 mg READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU CANESTEN ® DUOPAK is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless you still need to use CANESTEN ® DUOPAK carefully to get the best results from it. Keep this leaflet. You may need to read it again. Do not share CANESTEN ® DUOPAK with any other person. Ask your pharmacist if you need more information or advice. You must see a doctor if your symptoms worsen or do not improve after 7 days. WHAT CANESTEN ® DUOPAK CONTAINS: VAGINAL TABLET The active ingredient is: Clotrimazole 500 mg. The other ingredients are: Calcium lactate pentahydrate, cellulose microcrystalline, crospovidone, hypromellose 15 cP, lactic acid, lactose monohydrate, magnesium stearate, maize starch, silica colloidal anhydrous. CREAM The active ingredient is: Clotrimazole 10 mg/g The other ingredients are: Benzyl alcohol 2 %, cetostearyl alcohol, cetyl palmitate, octyldodecanol, polysorbate 60, sorbitan stearate, purified water. Page 2 of 7 WHAT CANESTEN ® DUOPAK IS USED FOR: Vaginal Tablet is used for the relief of vaginal itching, burning and discharge associated with vaginal yeast infections. Cream is used for candida infections of the labia and adjacent areas as well as inflammation of the glans and prepuce of the sexual partner. BEFORE YOU USE CANESTEN ® DUOPAK: DO NOT USE CANESTEN ® DUOPAK: If you are hypersensitive (allergic) to clotrimazole or any of the other ingredients of CANESTEN ® DUOPAK. If you are under 12 years of age. If you are having your menstrual period. TAKE SPECIAL CARE WITH CANESTEN ® DUOPAK: If you have a fever, lower abdominal pain, back pain, foul smelling vaginal discharge, nausea, vaginal bleeding and/or associated shoulder pain you should consult a doctor. Avoid vaginal intercou Citiți documentul complet
Page 1 of 7 _PROFESSIONAL INFORMATION _ _HUMAN MEDICINE _ _The under-mentioned information with regard to this medicine shall appear on the _ _package insert. The information shall be presented in the format stipulated, provided _ _that the Council may authorise any deviation from such information or such format _ _(refer to Regulation 9 of the Act). _ 1 Scheduling status 2 Proprietary Name and Dosage Form 3 Composition 4 Category and Class 5 Pharmacological Action Pharmacokinetic properties Pharmacodynamic properties 6 Indications 7 Contraindications 8 Warnings and Special Precautions 9 Interactions 10 Human Reproduction Pregnancy Lactation 11 Dosage and Directions for Use 12 Side effects 13 Known Symptoms of Over-dosage and Particulars of its Treatment 14 Identification 15 Presentation 16 Storage Instructions 17 Registration Number 18 Name and Business Address of the Holder of the Certificate of Registration 19 Date of publication of the Professional Information Page 2 of 7 SCHEDULING STATUS: PROPRIETARY NAME AND DOSAGE FORM: CANESTEN ® DUOPAK Vaginal Tablet and Cream COMPOSITION: VAGINAL TABLET CONTAINS: ACTIVE INGREDIENT: Clotrimazole 500 mg INACTIVE INGREDIENTS: Calcium lactate pentahydrate, cellulose microcrystalline, crospovidone, hypromellose 15 cP, lactic acid, lactose monohydrate, magnesium stearate, maize starch, silica colloidal anhydrous. 10 G CREAM CONTAINS: ACTIVE INGREDIENT: Clotrimazole 100 mg INACTIVE INGREDIENTS: Benzyl alcohol 2 % m/m (as preservative), cetostearyl alcohol, cetyl palmitate, octyldodecanol, polysorbate 60, sorbitan stearate, purified water. CATEGORY AND CLASS: A 20.2.2 Fungicides PHARMACOLOGICAL ACTION: PHARMACODYNAMICS PROPERTIES Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane. Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts and moulds. S1 Page 3 of 7 PHARMACOKINETIC P Citiți documentul complet