Download S2 GYNO-PEVARYL® 50, 150 Ovule

Revised Sections:
Contra-indications, Warnings, Interactions, Side Effects and Special Precautions, Overdose
Date: 29/02/2012
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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
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Amendment Type: CCDS May 2011 Safety Update
Date: 20/02/2012
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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
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Amendment Type: CCDS May 2011 Safety Update
Date: 20/02/2012
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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
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Amendment Type: CCDS May 2011 Safety Update
Date: 20/02/2012
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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.
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Amendment Type: CCDS May 2011 Safety Update
Date: 20/02/2012
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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
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Amendment Type: CCDS May 2011 Safety Update
Date: 20/02/2012
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S2
DATE OF PUBLICATION OF THE PACKAGE INSERT
February 2012
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