Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Gyno-Pevaryl Once 150mg vaginal pessary
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Econazole nitrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for The name of your medicine is Gyno-Pevaryl Once 150mg vaginal pessary. It is called 'Gyno-Pevaryl Once' in this leaflet. Gyno-Pevaryl Once is a solid, torpedo-shaped pessary (vaginal suppository). When inserted into the vagina it releases a medicine called econazole nitrate. This belongs to a group of medicines called 'antifungals'. Gyno-Pevaryl Once is used for infections of the vagina and the skin around the vagina. The infections are caused by fungi and yeasts such as thrush (Candida).
What you need to know before you take it
e Gyno-Pevaryl Once Do not use Gyno-Pevaryl Once if: You are allergic to econazole nitrate or any of the other ingredients of this medicine (listed in section 6) You are allergic to any other medicine used to treat thrush or other fungal infections You are under 16 years old Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Gyno-Pevaryl Once. Warnings and precautions Talk to your doctor or pharmacist before using Gyno-Pevaryl Once if: You are using any other treatment for your vagina.
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Talk to your doctor about using another type of contraception while you are using this medicine if: You are using a 'barrier' method of contraception. This includes condoms or diaphragms. This is because Gyno-Pevaryl Once can damage the rubber and stop them working properly You are using a spermicidal contraceptive Other medicines and Gyno-Pevaryl Once Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription or herbal medicines. In particular tell your doctor if you are taking: Medicines to thin the blood (anticoagulants) such as warfarin or acenocoumarol. Your doctor may check that the anticoagulant is working properly Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You may still be able to use Gyno-Pevaryl Once if your doctor thinks you need to. Driving and using machines This medicine is not likely to affect you being able to drive or use any tools or machines.
How to take it
Gyno-Pevaryl Once Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Using the pessary Always wash your hands thoroughly before using this medicine. This is particularly important if you are pregnant Use the pessary just before going to bed. This helps it to stay in place Do not swallow the pessary Inserting the pessary with the applicator Remove the pessary from the plastic packet using the easy open tab Pull the plunger of the applicator out until it sticks Gently push the pessary into the cup. Do not force it because it might stick Lie down with your knees bent and spread apart. Insert the applicator high into your vagina, pessary first Push the plunger to release the pessary Remove the applicator and dispose of it safely in your household waste
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If you swallow Gyno-Pevaryl Once If the pessary is eaten or swallowed talk to a doctor or go to the nearest hospital casualty department straight away. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using Gyno-Pevaryl Once and tell your doctor straight away if you notice the following. You may need urgent medical treatment. Sudden swelling of the face or throat. Hives (also known as nettle rash or urticaria), severe irritation, reddening or blistering of your skin. These may be signs of a severe allergic reaction (affects fewer than 1 in 10,000 people) Other side effects: Common side effects (affects more than 1 in 100 patients) Itchy skin Burning sensation (skin) Uncommon side effects (affects fewer than 1 in 100 patients) Rash Burning sensation (around or inside the vagina) Rare side effects (affects fewer than 1 in 1000 patients) Reddening of your skin Frequency unknown: Pain, swelling or irritation (around or inside the vagina) Inflammation of the skin (contact dermatitis) Peeling, flaky skin Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Gyno-Pevaryl Once Keep this medicine out of the sight and reach of children. Store in the original container. Do not store above 30°C. Keep away from heat and sunlight. Do not use Gyno-Pevaryl Once: After the expiry date which is stated on the label. The expiry date refers to the last day of that month If the plastic packet is broken or missing If the pessary is not light beige in colour
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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Gyno-Pevaryl Once contains The active substance is econazole nitrate. The pessary contains 150mg econazole nitrate. The other ingredients are polygel, colloidal silicon dioxide, Witepsol H 19, Wecobee FS, stearyl heptanoate. What Gyno-Pevaryl Once looks like and contents of the pack Gyno-Pevaryl Once comes in a plastic strip containing one pessary. It is torpedo-shaped and light beige in colour. Marketing Authorisation Holder: Karo Pharma AB, Box 16184, 103 24 Stockholm, SwedenManufacturer: Lusomedicamenta-Sociedade, Técnica Farmacêutica, S.A., Estrada Consiglieri Pedroso, 69-B, Queluz de Baixo, 2730-055 Barcarena, Portugal OR Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium This leaflet was last revised in May 2021.
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Frequently asked questions about Gyno-Pevaryl Once 150mg vaginal pessary
How do I take Gyno-Pevaryl Once 150mg vaginal pessary?
Gyno-Pevaryl Once 150mg vaginal pessary comes as pessary containing 150mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Gyno-Pevaryl Once 150mg vaginal pessary?
The active substance in Gyno-Pevaryl Once 150mg vaginal pessary is econazole nitrate.
Are there equivalent medicines to Gyno-Pevaryl Once 150mg vaginal pessary?
Medicines with the same active substance, strength and form include: Gyno-Pevaryl 150 mg Vaginal Pessaries. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Gyno-Pevaryl Once 150mg vaginal pessary, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Gyno-Pevaryl Once 150mg vaginal pessary without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: econazole nitrate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Vaginitis due to Candida Albicans and other yeasts
4.2. Posology and method of administration
For vaginal administration.
Adults:
Insert one pessary high into the vagina at night prior to retiring. Pregnant women should thoroughly wash their hands before self-administering Gyno-Pevaryl Once pessary.
Children:
Gyno-Pevaryl Once pessary is not indicated for use in children under the age of 16 years.
Elderly:
No specific dosage recommendations or precautions apply.
4.3. Contraindications
Hypersensitivity to any imidazole preparation, other vaginal antifungal products or to any ingredients of Gyno-Pevaryl Once vaginal pessary.
4.4. Special warnings and precautions for use
For intravaginal use only. This preparation is not for oral use.
Hypersensitivity has rarely been recorded; if it should occur administration should be discontinued.
Contact between contraceptive diaphragms or condoms and this product must be avoided since the rubber may be damaged by the preparation.
Patients using spermicidal contraceptives should consult their physician since any local vaginal treatment may inactivate the spermicidal contraceptive (see section 4.5).
Gyno-Pevaryl Once vaginal pessary should not be used in conjunction with other internal or external treatment of the genitalia.
4.5. Interaction with other medicinal products and other forms of interaction
Econazole is a known inhibitor of CYP3A4/2C9. Due to the limited systemic availability after vaginal application (see Section 5.2. Pharmacokinetic Properties), 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 more frequently.
Adjustment of the oral anticoagulant dosage may be necessary during and after the treatment with econazole.
Contact between latex products such as contraceptive diaphragms or condoms and this product must be avoided since the constituents of the product may damage the latex. Patients using spermicidal contraceptives should consult their physician since any local vaginal treatment may inactivate the spermicidal contraceptive (see section 4.4).
4.6. Fertility, pregnancy and lactation
Pregnancy
In animals, econazole nitrate has shown no teratogenic effects but is foetotoxic at high doses. The significance of this to man is unknown as there is no evidence of an increased risk when taken in human pregnancy. However, animal studies have shown reproductive toxicity (see section 5.3). Because there is vaginal absorption, as with other imidazoles, econazole should be used in pregnancy only if the practitioner considers it to be necessary.
Breast-feeding
Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups. It is not known whether econazole nitrate is excreted in human milk. Caution should be exercised when using Gyno-Pevaryl Once vaginal pessaries if the patient is breast-feeding.
Fertility
Results of econazole animal reproduction studies showed no effects on fertility.
4.7. Effects on ability to drive and use machines
None known
4.8. Undesirable effects
The safety of Gyno-Pevaryl Vaginal Cream and Vaginal Pessaries was evaluated in 3630 patients who participated in 32 clinical trials.
Based on pooled safety data from these clinical trials, the most commonly reported adverse reactions were (with % incidence) pruritus (1.2%) and skin burning sensation (1.2%).
Including the above mentioned adverse reactions, the following table displays adverse reactions that have been reported with the use of Gyno-Pevaryl Vaginal Cream and Vaginal Pessaries from either clinical trial or postmarketing experiences. The displayed frequency categories use the following convention:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available clinical trial data).
Adverse reactions
System Organ Class
Adverse Reactions
Frequency Category
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1,000 to <1/100)
Rare
(≥1/10,000 to <1/1,000)
Not known
Immune System Disorders
Hypersensitivity
Skin and Subcutaneous Tissue Disorders
Pruritus, Skin burning sensation
Rash
Erythema
Angioedema, Urticaria, Contact dermatitis, Skin exfoliation
Reproductive System and Breast Disorders
Vulvovaginal burning sensation
General Disorders and Administration Site Conditions
Application site pain, Application site irritation, Application site swelling
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Adverse events associated with overdose or misuse of Gyno-Pevaryl are expected to be consistent with adverse drug reactions already listed in Section 4.8. (Undesirable effects).
In the event of accidental ingestion, nausea, vomiting and diarrhoea may occur. If necessary treat symptomatically.
💬 Ask about this leaflet
Ask anything about Gyno-Pevaryl Once 150mg vaginal pessary. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.