Consumer Medicine Information

MONISTAT^® 1

Soft Gel Vaginal Ovule and External Cream
miconazole nitrate

What is in this leaflet

This leaflet answers some common questions about MONISTAT^® 1. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you using MONISTAT^® 1 against the benefits this medicine is expected to have for you.

If you have any concerns about using MONISTAT^® 1 ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What MONISTAT^® 1 is used for

MONISTAT^® 1 consists of one MONISTAT^® soft gel vaginal ovule and MONISTAT^® external cream used to treat candidal (thrush) infections of the vagina. Candida is an overgrowth of the yeast fungus resulting in an imbalance of the natural microorganisms present in the vagina.

Both MONISTAT^® soft gel vaginal ovule and external cream are antifungals and work by treating the Candida that causes thrush.

There are many signs and symptoms of a vaginal yeast infection which include:

• Vaginal itching.
• A thick, white and clumpy vaginal discharge.
• Vaginal soreness, irritation or burning.
• Rash or redness on the skin outside the vagina.

Conditions which may increase a woman's susceptibility to yeast infection include diabetes, obesity, illness, changes in hormone levels during pregnancy and taking some oral contraceptive pills.

Ask your doctor or pharmacist if you have any questions about why this medicine has been recommended for you.

Before you use MONISTAT^® 1

When you must not use it

Do not use MONISTAT^® 1 if:

• You have an allergy to miconazole or other imidazole antifungals, or any of the other ingredients. See Product Description at the end of this leaflet for a list of ingredients.

Do not use MONISTAT^® 1 if packaging is torn or shows signs of tampering, or if the blister and tube in the pack are not covered by foil seals. Do not use MONISTAT^® 1 beyond the expiry date (month and year) printed on the pack.

Before you start to use it

You must tell your doctor or pharmacist if:

• This is the first time you have had these symptoms.
• You are pregnant or think you might be.
• You are breast feeding or wish to breastfeed.
• You suffer from diabetes.
• You are taking warfarin or other anticoagulants, medicines used to prevent blood clots, because bleeding or bruising may occur.

If you have not told your doctor or pharmacist about any of the above, tell them before you start using MONISTAT^® 1.

• Your doctor or pharmacist will advise you whether or not to use MONISTAT^® 1 or if you need to adapt your treatment.

Using MONISTAT^® 1

You need to insert the MONISTAT^® soft gel vaginal ovule into the vagina once at bedtime.

You may apply the MONISTAT^® cream twice a day to the outside of the vagina until symptoms disappear.

How to use MONISTAT^® 1:

To use the MONISTAT^® soft gel vaginal ovule:

1. Separate the paper backing from the blister pack of the vaginal ovule, by peeling back the cover from the corner. Keep contents dry before use.
2. Place the vaginal ovule firmly into the top of the applicator so it will not fall out.
3. Gently insert the applicator into the vagina as far as it will comfortably go. This can be done while lying on your back with your knees bent (fig. 1). You can also do this while standing with your feet spread a few inches apart and your knees bent.
4. Push in the plunger to place the vaginal ovule as far back in the vagina as possible (fig. 2).
5. Remove the applicator and discard it.

fig. 1	fig. 2

To use the MONISTAT^® cream:

Apply the cream onto the skin outside the vagina to treat any itching and irritation. To open the tube, unscrew the cap. Press the sharp point of the cap into the sealed end of the tube. Push down firmly until the seal is broken. Squeeze a small amount of the cream onto your fingertips and gently apply twice daily until symptoms disappear.

If you do not understand the instructions provided with this medicine, ask your doctor or pharmacist for help.

If you forget to use it

For MONISTAT^® 1:

• The cream should be applied twice daily until symptoms disappear. If you forget to apply the cream on one day, apply as soon as you remember. If it is almost time to apply the cream, skip the missed dose and apply your next dose.

If you forget, or are not sure what to do, check with your doctor or pharmacist.

If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.

In case of swallowing

Immediately telephone your doctor or the Poisons Information Centre for advice, or go to Accident and Emergency at your nearest hospital.

Poisons Information Centre telephone numbers:

• Australia: 13 11 26
• New Zealand: 0800 764 766

Keep this telephone number handy.

While you are using MONISTAT^® 1

Things you must do

• Always follow your doctor's and pharmacist's instructions carefully.
• If you are sexually active, ask your doctor or pharmacist about whether your partner should also be treated.
• Tell your doctor if your symptoms do not improve after 3 days treatment with MONISTAT^® 1. Your doctor may wish to carry out further tests or give you another treatment.
• MONISTAT^® 1 can be used during your menstrual period. If you get your period whilst using MONISTAT^® 1, continue to finish the course of treatment.
• Wear cotton underwear and loose-fitting clothes to keep the area cool and dry as yeast grow well in warm moist areas.

Things you must be careful of

These products may damage the rubber of condoms and diaphragms and cause them to fail. You should not rely on condoms or diaphragms to prevent sexually transmitted diseases or pregnancy while using MONISTAT^® 1.

Things you must not do

• Do not use MONISTAT^® 1 to treat any other complaint unless your doctor or pharmacist says so.
• Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Side Effects

Treatment with MONISTAT^® 1 is generally well tolerated.

Tell your doctor or pharmacist if you experience any of the following:

• Skin reactions such as burning, itching or irritation

These side effects can commonly occur.

Stop using MONISTAT^® 1 and consult your doctor if you experience any of the following:

• abdominal pain
• hives
• skin rash
• headaches
• severe vaginal irritation

Other side effects not listed above may also occur in some people. Tell your doctor or pharmacist if you notice any other effects.

After using MONISTAT^® 1

Storage

Keep MONISTAT^® 1 in a cool dry place where the temperature is below 25°C.

Keep your medicines where children cannot reach them. A locked cupboard at least one-and-a-half metres (1.5 m) above the ground is a good place to store medicines.

Do not store MONISTAT^® 1, or any other medicine, in the bathroom or near a sink. Do not leave medicines in the car or on window sills. Heat and dampness can destroy some medicines.

Product Description

What it looks like

MONISTAT^® 1 contains one MONISTAT^® soft gel vaginal ovule with a disposable applicator and a 9 g tube of white odourless MONISTAT^® cream.

Ingredients

The active ingredient of MONISTAT^® 1 is miconazole nitrate.

The vaginal ovule in MONISTAT^® 1 contains 1200 milligrams of miconazole nitrate. It also contains gelatin, glycerol, lecithin, liquid paraffin, titanium dioxide and soft white paraffin.

The topical cream in MONISTAT^® 1 contains 20 milligrams of miconazole nitrate in each gram. It also contains isopropyl myristate, polysorbate 60, stearyl alcohol, cetyl alcohol, propylene glycol, potassium hydroxide, benzoic acid and purified water.

Sponsor

Johnson & Johnson Pacific Pty Ltd
Level 3, 1 Bay Street, Broadway NSW 2007
Australia
Telephone: 131 565

Johnson & Johnson Pacific (New Zealand) Ltd
105 Carlton Gore Road
Newmarket, Auckland
Telephone: 0800 446 147

This leaflet was prepared in June 2005.

® Trade mark Johnson & Johnson