GYNOXIN 200 MG VAGINAL CAPSULES - patient leaflet, side effects, dosage

Patient leaflet - GYNOXIN 200 MG VAGINAL CAPSULES

= GYNOXIN 200mg and 600mg VAGINAL CAPSULES =

------- (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. What Gynoxin vaginal capsules are and what they are used for

2. Before you use Gynoxin vaginal capsules

3. How to use Gynoxin vaginal capsules

4. Possible side effects

5. How to store Gynoxin vaginal capsules

6. Further information

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. 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 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 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.

1815 A

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.

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

Manufacturer

Catalent Italy SpA – via Nettunense Km. 20 – 04011 Aprilia (LT) – Italy

REOORDM1