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Revised Sections: Contra-indications, Warnings, Interactions, Side Effects and Special Precautions, Overdose Date: 29/02/2012 __________________________________________________________________________________________ PACKAGE INSERT SCHEDULING STATUS Schedule 1 PROPRIETARY NAME AND DOSAGE FORM ® GYNO-PEVARYL 150 Ovule ® GYNO-PEVARYL DEPOT Ovule COMPOSITION GYNO-PEVARYL ovules contain as active ingredient 150 mg econazole nitrate. GYNO-PEVARYL DEPOT ovule contains 150 mg micronised econazole nitrate. PHARMACOLOGICAL CLASSIFICATION A 18.6 Vaginal preparations PHARMACOLOGICAL ACTION Pharmacodynamics Econazole is a broad spectrum antimycotic with fungicidal properties. The active substance of GYNO-PEVARYL DEPOT spreads over the vaginal epithelium where it forms a gel layer serving as an econazole depot. The antimycotic effect is thus ensured for several days. A broad spectrum of antimycotic activity has been demonstrated against dermatophytes, yeasts and moulds. Econazole nitrate acts by damaging cell membranes. The permeability of the fungal cell is increased. Sub-cellular membranes in the cytoplasm are damaged. The site of action is most probably the unsaturated fatty acid acyl moiety of membrane phospholipids. Pharmacokinetics Econazole is poorly absorbed after vaginal or topical administration in humans. Maximal concentrations of econazole and/or its metabolites in plasma or serum were observed 1 – 2 days following administration and were approximately 65 ng/ml for the 150 ovule. The percentage of applied econazole dose absorbed was found to be approximately 5 % for the 150 mg ovule. CCDS: May 2011 Safety Update Page 1 of 6 Amendment Type: CCDS May 2011 Safety Update Date: 20/02/2012 __________________________________________________________________________________________ Econazole and/or its metabolites in the systemic circulation are extensively bound (> 98 %) to serum proteins. Econazole is extensively metabolized by oxidation, deamination and/or O-dealkylation with the metabolites being eliminated by renal and fecal pathways. INDICATIONS For the relief of vaginal itching, burning and discharge associated with recurrent vaginal yeast infections. (Vaginal candidiasis). CONTRA-INDICATIONS GYNO-PEVARYL OVULE is contra-indicated in individuals who have shown hypersensitivity to any of its ingredients. WARNINGS Do not use in girls under 12 years of age. If skin rash or new irritation occurs, discontinue use. For intravaginal use only. GYNO-PEVARYL OVULE is not for ophthalmic or oral use. INTERACTIONS Econazole is a known inhibitor of CYP3A4/2C9 . Due to the limited systemic availability after vaginal application, clinically relevant interactions are unlikely to occur, but have been reported with oral anticoagulants. In patients taking oral anticoagulants, such as warfarin or acenocoumarol, caution should be exercised and the anticoagulant effect should be monitored. PREGNANCY AND LACTATION Safety in pregnancy and lactation has not been established. The use of this product should be avoided during the first trimester of pregnancy, since the safety in this regard has not been established. The possibility of absorption of econazole when administered vaginally cannot be excluded. DOSAGE AND DIRECTIONS FOR USE GYNO-PEVARYL 150: Introduce one GYNO-PEVARYL 150 ovule deep into the vagina preferably while in a reclining position, just before Page 2 of 6 Amendment Type: CCDS May 2011 Safety Update Date: 20/02/2012 __________________________________________________________________________________________ retiring at night. The ovules are to be introduced on three consecutive nights even during menstruation and even if symptoms disappear. GYNO-PEVARYL DEPOT: Introduce one GYNO-PEVARYL Depot Ovule deep into the vagina, preferably while in a reclining position, just before retiring at night. SIDE-EFFECTS AND SPECIAL PRECAUTIONS Clinical trial data The safety of GYNO-PEVARYL OVULE was evaluated in 3 630 patients who participated in 32 clinical trials. Adverse drug reactions (ADRs) reported for ≥ 1 % of patients treated with GYNO-PEVARYL OVULE in these studies are shown in Table 1. Table 1: Adverse drug reactions reported by ≥ 1 % of patients treated with GYNO-PEVARYL OVULE in 32 clinical trials. System Organ Class GYNO-PEVARYL OVULE % Adverse drug reaction (N=3 630) Skin and Subcutaneous Tissue Disorders Skin burning sensation 1,2 Pruritis 1,2 Adverse drug reactions that occurred in <1% of patients treated with GYNO-PEVARYL OVULE in the 32 clinical trials are listed in Table 2. Table 2: Adverse Drug Reactions reported by < 1 % of patients treated with GYNO-PEVARYL OVULE in 32 clinical trials. System organ class Adverse drug reaction Page 3 of 6 Amendment Type: CCDS May 2011 Safety Update Date: 20/02/2012 __________________________________________________________________________________________ Skin and subcutaneous tissue disorders Rash Reproductive system and breast disorders Vulvovaginal burning sensation Post marketing experience Adverse drug reactions first identified during post-marketing experience with GYNO-PEVARYL OVULE are included in Table 3. Table 3: Adverse Drug Reactions identified during post-marketing experience with GYNO-PEVARYL OVULE Immune system disorders Hypersensitivity Skin and subcutaneous tissue disorders Angioedema, urticaria, contact dermatitis, skin exfoliation, erythema General disorders and administration site conditions Application site pain, application site irritation, application site swelling KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT Accidental ingestion can lead to nausea and vomiting which should be treated symptomatically. Adverse events associated with overdose or misuse of GYNO-PEVARYL OVULE are expected to be consistent with adverse drug reactions listed in “Side-Effects and Special Precautions”. GYNO-PEVARYL OVULE is for vaginal insertion only. In the event of accidental ingestion, treat symptomatically. If the product is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist. IDENTIFICATION GYNO-PEVARYL 150: Yellowish to creamy-white ovule with a fat-like odour. GYNO-PEVARYL DEPOT: A yellowish to creamy-white ovule. Page 4 of 6 Amendment Type: CCDS May 2011 Safety Update Date: 20/02/2012 __________________________________________________________________________________________ PRESENTATION GYNO-PEVARYL 150: Carton boxes containing 3 ovules of 150 mg each. GYNO-PEVARYL DEPOT: Carton box containing one or two GYNO-PEVARYL Depot 150 mg ovules in a strip pack. STORAGE INSTRUCTIONS Store below 25 °C in a dry place. KEEP OUT OF REACH OF CHILDREN. REGISTRATION NUMBERS GYNO-PEVARYL 150: J/18.6/176 GYNO-PEVARYL DEPOT: R/18.6/179 NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION JANSSEN PHARMACEUTICA (Pty) Ltd (Reg no. 1980/011122/07) Building 6, Country Club Estate, 21 Woodlands Drive, Woodmead, 2191 Tel: +27 (11) 518 7000 www.janssen.co.za Nam. Reg. No’s.: Gyno Pevaryl Ovules: 90/18.6/00617 Gyno Pevaryl Depot Ovules: 90/18.6/00620 NS 1 Botswana Reg. No’s.: Gyno Pevaryl Ovules: B9303780 Gyno Pevaryl Depot Ovules : B9303775 Page 5 of 6 Amendment Type: CCDS May 2011 Safety Update Date: 20/02/2012 __________________________________________________________________________________________ S2 DATE OF PUBLICATION OF THE PACKAGE INSERT February 2012 Page 6 of 6