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GYNOXIN 2% VAGINAL CREAM

Active substance(s): FENTICONAZOLE NITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GYNOXIN 2% VAGINAL CREAM
(fenticonazole nitrate)
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:

1.
2.
3.
4.
5.
6.

What Gynoxin 2% vaginal cream is and what it is used for
Before you use Gynoxin 2% vaginal cream
How to use Gynoxin 2% vaginal cream
Possible side effects
How to store Gynoxin 2% vaginal cream
Further information

1. WHAT GYNOXIN 2% VAGINAL CREAM IS AND WHAT IT IS USED FOR
Gynoxin 2% vaginal cream contains 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.

2. BEFORE YOU USE GYNOXIN 2% VAGINAL CREAM
You MUST NOT use Gynoxin 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 Gynoxin.
• 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 prescription.
Interaction of the cream 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 cream should not be used by pregnant or breast-feeding women unless your doctor advises you.
Driving and using machines
Gynoxin has no effect on your ability to drive or use machines.
Important information about some of the ingredients of Gynoxin
The cream contains the following ingredients:
• Propylene glycol (E1520) which may cause skin irritation
• Lanolin (wool fat) and cetyl alcohol which may cause local skin reactions.

3. HOW TO USE GYNOXIN 2% VAGINAL CREAM
Always use Gynoxin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is one applicator full in the morning and one applicator full in the evening for 3 days. Your symptoms may disappear
quickly but it is important that you continue using the cream for 3 days.
If there is no improvement, or the condition worsens, consult your doctor.
The use of Gynoxin in children is not recommended.
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How to apply Gynoxin
Follow the instructions in the diagrams below:

1. Screw the applicator onto 2. Squeeze the tube gently at 3. Remove the applicator
the tube in place of the cap.
its lower end, so as to fill the from the tube, which should be
applicator. If there is a certain closed immediately with the
resistance in the piston, pull cap.
it delicately. Unless otherwise
prescribed by the physician, the
applicator must be completely
filled.

4. In a lying down position,
with knees raised and spread
apart, delicately insert the
applicator into the vagina as
deeply as possible. Push the
piston in completely, then pull
out the applicator without
touching the piston.

Take care to ensure that the applicator is always perfectly clean.
After each use, wash it carefully with warm water and soap. If your doctor advises sterilization of the applicator, for a particular reason,
follow his instructions. Do not use water which is hotter than 50°C, or solvents. Then dry the applicator and store in its container.
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 you use more Gynoxin than you should
If you or someone else has swallowed some Gynoxin by accident, seek medical advice immediately.
If you forget to use Gynoxin
If you forget to apply a dose, do so as soon as you remember and then go on as before. Do not apply 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 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 cream for prolonged periods of time, you may become allergic to it.
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 2% VAGINAL CREAM
Keep out of the reach and sight of children.
Do not store above 30°C. 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 2% vaginal cream contains
The active ingredient is fenticonazole nitrate. Each applicator full contains approximately 100mg fenticonazole nitrate.
The other ingredients are propylene glycol (E1520), wool fat, almond oil, polyglycolic ester of fatty acids, cetyl alcohol, glyceryl
monostearate, disodium edetate and purified water (see end of Section 2: Important information about some of the ingredients of
Gynoxin for further information).
What Gynoxin 2% vaginal cream looks like and contents of the pack
Gynoxin is a white cream. It is packaged in an aluminium tube with a plastic cap.
Each tube contains 30g. An applicator is provided; each applicator contains approximately 5g.
Marketing Authorisation Holder and Manufacturer
Recordati Industria Chimica e Farmaceutica SpA
via Matteo Civitali 1-20148 Milan - Italy
This leaflet was last approved in July 2010

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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.

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