Țară: Africa de Sud
Limbă: engleză
Sursă: South African Health Products Regulatory Authority (SAHPRA)
Bayer (Pty) Ltd û Isando
See ingredients
CREAM
EACH 5 g VAGINAL CREAM CONTAINS CLOTRIMAZOLE 0,5 g
Registered
1987-04-11
Page 1 of 6 SCHEDULING STATUS S1 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU CANESTEN ® 1 VC is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use CANESTEN ® 1 VC carefully to get the best results from it. Keep this leaflet. You may need to read it again. Do not share CANESTEN ® 1 VC 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 ® 1 VC CONTAINS The active substance is Clotrimazole 500 mg/5 g The other ingredients are benzyl alcohol 1 % (as a preservative), cetostearyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, sorbitan monostearate and purified water. WHAT CANESTEN ® 1 VC IS USED FOR For the relief of vaginal itching, burning, discharge and possibly pain associated with vaginal yeast infections (vaginal thrush). BEFORE USING CANESTEN ® 1 VC DO NOT USE CANESTEN ® 1 VC: If you are allergic to clotrimazole or to any of the ingredients in CANESTEN ® 1 VC If you are under 12 years of age If you are having your menstrual period. CANESTEN ® 1 VC Vaginal Cream 10 % Page 2 of 6 TAKE SPECIAL CARE WITH CANESTEN ® 1 VC: 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 your doctor. Avoid vaginal intercourse while using CANESTEN ® 1 VC as it may result in vaginal infection and your partner could become infected. If symptoms persist for more than 7 days you may have a condition that requires medical treatment. You should consult your doctor. You should not use tampons, intravaginal douches, spermicides or other vaginal preparations while using CANESTEN ® 1 VC. CANESTEN ® 1 VC may reduce the effectiveness and safety of latex (rubber) products such a Citiți documentul complet
Page 1 of 6 SCHEDULING STATUS: PROPRIETARY NAME AND DOSAGE FORM: CANESTEN ® 1 VC Vaginal Cream COMPOSITION: ACTIVE INGREDIENT: Clotrimazole 500 mg/5 g INACTIVE INGREDIENTS: Benzyl alcohol 1 % (as preservative), cetostearyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, sorbitan monostearate and 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 functional impairment of the fungal cytoplasmic membrane. Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeast and moulds. PHARMACOKINETIC PROPERTIES A pharmacokinetic investigation after vaginal application reported that 3 – 10 % of clotrimazole is absorbed. INDICATIONS: Infections of the genital region (vaginitis) caused by Candida. S1 Page 2 of 6 CONTRAINDICATIONS: Hypersensitivity to clotrimazole or to any of the excipients of CANESTEN ® 1 VC (Vaginal Cream). WARNINGS AND SPECIAL PRECAUTIONS: If symptoms persist for more than 7 days, the patient should be evaluated by a medical practitioner. Recurrent infections may indicate an underlying medical cause. Patients should seek medical advice if symptoms return within 2 months. Treatment during the menstrual period should not be performed. The treatment should be completed before the onset of menstruation. Tampons, intravaginal douches, spermicides or other vaginal products should not be used while using CANESTEN ® 1 VC. Avoidance of vaginal intercourse is recommended in case of vaginal infection and while using CANESTEN ® 1 VC as the partner could become infected. CANESTEN ® 1 VC is intended for use by adults and children 12 years of age and older only. CANESTEN ® 1 VC MAY REDUCE THE EFFECTIVENESS AND SAFETY OF LATEX PRODUCTS SUCH AS CONDOMS AND DIAPHRAGMS WHEN APPLIED ON THE GENITAL AREA (WOMEN: INTRAVAGINALLY, LABIA AND ADJACENT AREA OF THE VULVA; MEN: PR Citiți documentul complet