GYNOXIN 600MG VAGINAL CAPSULES
Active substance(s): FENTICONAZOLE NITRATE / FENTICONAZOLE NITRATE / FENTICONAZOLE NITRATE
GYNOXIN 200mg and 600mg VAGINAL CAPSULES
Read all of this leaflet carefully before you start using this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
What Gynoxin vaginal capsules are and what they are used for
Before you use Gynoxin vaginal capsules
How to use Gynoxin vaginal capsules
Possible side effects
How to store Gynoxin vaginal capsules
1. WHAT GYNOXIN VAGINAL CAPSULES ARE AND WHAT THEY ARE
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. BEFORE YOU USE GYNOXIN VAGINAL CAPSULES
You MUST NOT use Gynoxin vaginal capsules if you are:
• allergic to fenticonazole nitrate, or other similar medicines known as imidazoles e.g. clotrimazole, or any
of the other ingredients (see Section 6, and end of Section 2)
Take special care
• if you are using a barrier method of contraception such as a condom or diaphragm, you should not use
• when you apply Gynoxin, you may feel a slight burning sensation, but this usually disappears very quickly.
• if you use Gynoxin for prolonged periods of time, you may become allergic to it.
Taking other medicines
Please tell your doctor if you are taking any other medicines, including those obtained without a
Interaction of the capsules with other medicines is unlikely.
Pregnancy and breast-feeding
You should tell your doctor if you are pregnant, if you think you are pregnant or if you are breast-feeding.
The capsules should not be used by pregnant or breast-feeding women unless your doctor advises you.
Driving and using machines
Gynoxin vaginal capsules have no effect on your ability to drive or use machines.
Important information about some of the ingredients of Gynoxin vaginal capsules
Ethyl parahydroxybenzoate sodium (E215) and sodium propyl parahydroxybenzoate (E217), which are
ingredients in this product, may cause allergic reactions (possibly delayed).
3. HOW TO USE GYNOXIN VAGINAL CAPSULES
Always use Gynoxin vaginal capsules exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The use of Gynoxin in children is not recommended.
The usual 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)
• 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.
What to do if a Gynoxin vaginal capsule is swallowed accidentally
If you or someone else has swallowed a Gynoxin vaginal capsule by accident, seek medical advice immediately.
If you forget to use Gynoxin vaginal capsules
If you forget to insert a capsule, do so as soon as you remember and then go on as before. Do not use a
double dose to make up for the forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like other medicines, Gynoxin vaginal capsules can cause side effects, although not everybody gets them.
You may suffer from mild and transient rash or burning sensations that generally disappear rapidly.
If you use Gynoxin vaginal capsules for prolonged periods of time you may become allergic to them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor.
5. HOW TO STORE GYNOXIN VAGINAL CAPSULES
Keep out of the reach and sight of children.
Do not store above 30°C. Do not refrigerate or freeze.
Store in the original container. Do not use after the expiry date shown on the outer packaging.
Medicines should not be disposed of via household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Gynoxin vaginal capsules contain
The active ingredient is fenticonazole nitrate
• Gynoxin 200mg vaginal capsules contain 200mg
• Gynoxin 600mg vaginal capsules contain 600mg fenticonazole nitrate.
The other ingredients are:
For Gynoxin 200mg vaginal capsules: medium chain triglycerides and silica, colloidal anhydrous (E551).
For Gynoxin 600mg vaginal capsules: liquid paraffin, white soft paraffin and soya lecithin.
The capsule shell for both strengths 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 200mg vaginal capsules - packs of three
Gynoxin 600mg vaginal capsules - packs containing one capsule
Marketing Authorisation Holder
Recordati Industria Chimica e Farmaceutica SpA - via Matteo Civitali - 1-20148 Milan - Italy
Catalent Italy SpA - via Nettunense Km. 20 - 04011 Aprilia (LT) - Italy
This leaflet was last approved in July 2010
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.