Patient leaflet - Gynoxin 600 mg vaginal capsules
1. What Gynoxin vaginal capsules are and what they are used for
Gynoxin 200mg and 600mg vaginal capsules contain fenticonazole nitrate as the active ingredient which is an anti-fungal agent.
Gynoxin prevents the growth of certain types of fungi. It is particularly effective against Candida albicans, which causes thrush.
Gynoxin vaginal capsules are for insertion into the vagina only.
2. What you need to know before you use Gynoxin vaginal capsules
Do not use Gynoxin vaginal capsules:
- If you are allergic to fenticonazole or any of the other ingredients of this medicine (listed in section 6).
- Gynoxin 600 mg vaginal capsules contain soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.
Warnings and precautions
Talk to your doctor or pharmacist if:
- You are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and fertility”).
- You are using a “barrier” method of contraception made of latex (see section “Other medicines and Gynoxin vaginal capsules”). Consequently, you should use alternative precautions while using this product.
- You are using spermicides, intravaginal douches or other vaginal products (see section “Other medicines and Gynoxin vaginal capsules”).
- You experience any irritation or sensitivity to the product.
- Your symptoms are not reduced within one week or in case of severe or recurrent symptoms.
- Your partner is also affected.
- You had more than two previous infections in the last 6 months.
- You or your partner have ever had a sexually transmitted disease.
- You have ever had hypersensitivity to imidazoles or other vaginal antifungal products.
- You are aged or over 60
You have any of the following symptoms:
- Abnormal or irregular vaginal bleeding
- Blood staining of a vaginal discharge
- Vulval or vaginal sores, ulcers or blisters
- Lower abdominal pain or dysuria
- Adverse effects such as redness, itching or rash associated with the treatment
Children and adolescents
Gynoxin vaginal capsules are not recommended for children under 16 years.
Other medicines and Gynoxin vaginal capsules
The fatty excipients and oils contained in the soft vaginal capsules may damage contraceptives made of latex, such as condoms and diaphragms (see “Warnings and precautions” section).
It is not recommended to use spermicides (substance inserted vaginally, that destroys sperm and are used as contraceptive alone or in combination with e.g. diaphragms). Any local vaginal treatment is likely to inactivate a local contraceptive spermicide.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding or think you may be pregnant, ask your doctor for advice before using this medicine. Gynoxin vaginal capsules should be used in pregnancy and breast-feeding periods under the supervision of a physician.
Driving and using machines
Gynoxin vaginal capsules have no influence on the ability to drive and use machines.
Gynoxin vaginal capsules contain:
- ethyl parahydroxybenzoate sodium and sodium propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
3. How to use Gynoxin vaginal capsules
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The use of Gynoxin in children is not recommended.
The recommended dose is either:
- one Gynoxin 200mg vaginal capsule every day for 3 days (your symptoms may disappear quickly but it is important that you continue using the capsules for 3 days) or
- one Gynoxin 600mg vaginal capsule for 1 day.
Insert the vaginal capsules at bedtime.
How to insert the Gynoxin vaginal capsule
- 1. Lie down, bring your knees up and open your legs.
- 2. Push the vaginal capsule as deeply into the vagina as is comfortable.
- 3. Always wash your hands with mild soap and warm water afterwards. Gynoxin is not greasy, does not soil and can easily be removed with water.
If there is no improvement, or the condition worsens, consult your doctor.
Use in children and adolescents
The dose recommendation for children aged 16 years or above is the same as for adults.
If you use more Gynoxin vaginal capsules than you should
In case the vaginal capsule is eaten or swallowed, contact a doctor immediately or go to the nearest hospital.
If you forget to use Gynoxin vaginal capsules
Do not use a double dose to make up for a missed dose.
If you stop using Gynoxin vaginal capsules
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A slight burning sensation may be experienced when the medicine is inserted into the vagina. This will quickly disappear. When used as recommended, Gynoxin is absorbed only slightly and no side effects involving the entire body (systemic effects) are reported.
The use of medicines for topical use, especially if prolonged, may cause sensitisation (see “Warnings and precautions” section).
The following side effects have been reported with Gynoxin:
Very rare (may affect up to 1 in 10,000 people):
- vulvovaginal burning sensation
- skin erythema, pruritus and rash
Frequency Not Known:
- Application site hypersensitivity
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Gynoxin vaginal capsules
Do not store above 30°C. Do not refrigerate or freeze. Store in the original package.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
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.
6. Contents of the pack and other information
Gynoxin 200 mg vaginal capsules
- The active substance is fenticonazole nitrate. 1 vaginal capsule contains 200 mg of fenticonazole nitrate.
- Other ingredients: medium chain triglycerides and silica, colloidal anhydrous (E551). The capsule shell contains: gelatin, glycerol (E422), titanium dioxide (E171), ethyl parahydroxybenzoate sodium (E215) and sodium propyl parahydroxybenzoate (E217).
Gynoxin 600 mg vaginal capsules
- The active substance is fenticonazole nitrate. 1 vaginal capsule contains 600 mg of fenticonazole nitrate.
Other ingredients: liquid paraffin, white soft paraffin and soya lecithin. The capsule shell contains:
gelatin, glycerol (E422), titanium dioxide (E171), ethyl parahydroxybenzoate sodium (E215) and sodium propyl parahydroxybenzoate (E217).
What Gynoxin vaginal capsules look like and contents of the pack
Gynoxin vaginal capsules are ivory white, opaque, soft gelatin capsules.
They are packaged in blister packs of aluminium foil and plastic.
Gynoxin 200 mg vaginal capsules – packs of three
Gynoxin 600 mg vaginal capsules – packs containing one capsule
Marketing Authorisation Holder
Recordati Industria Chimica e Farmaceutica SpA - via Matteo Civitali - 1-20148 Milan - Italy
Manufacturer
Catalent Italy SpA - via Nettunense Km. 20 - 04011 Aprilia (LT) - Italy
This leaflet was last revised in September 2020.