Consumer Medicine Information

MONISTAT^® 7 Day Cream

20 mg/g Vaginal Cream Tube (45g) with 7 Disposable Applicators
miconazole nitrate

What is in this leaflet

This leaflet answers some common questions about MONISTAT^® 7 Day Cream. 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^® 7 Day Cream against the benefits this medicine is expected to have for you.

If you have any concerns about using MONISTAT^® 7 Day Cream ask your doctor or pharmacist.

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

What MONISTAT^® 7 Day Cream is used for

MONISTAT^® 7 Day Cream is 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.

MONISTAT^® cream is an antifungal and works 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^® 7 Day Cream

When you must not use it

Do not use MONISTAT^® 7 Day Cream 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^® 7 Day Cream if packaging is torn or shows signs of tampering, or if the tube in the pack is not covered by the foil seal. Do not use MONISTAT^® 7 Day Cream 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, a medicine 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^® 7 Day Cream.

• Your doctor or pharmacist will advise you whether or not to use MONISTAT^® 7 Day Cream or if you need to adapt your treatment.

Using MONISTAT^® 7 Day Cream

You should use MONISTAT^® 7 Day Cream at bedtime for 7 days in a row in order to achieve the best results.

How to use MONISTAT^® 7 Day Cream:

1. 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.
2. Attach the applicator to the tube of cream by screwing the applicator to the tube (fig. 1).
3. Gently squeeze the cream into the applicator, continue squeezing until applicator is full.
4. Unscrew the applicator from the tube (fig. 2). Replace the cap on the tube of cream.
5. 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. 3).
6. Press the plunger to apply the entire content of cream (fig. 4).
7. Remove the applicator and discard it.

Apply before bedtime for the next six days, using a new applicator each time.

For external vaginal itch or irritation : squeeze a small amount of cream onto finger and apply twice daily to the skin outside of the vagina until symptoms disappear.

fig. 1	fig. 2
fig. 3	fig. 4

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^® 7 Day Cream:

If you forget to use one dose of MONISTAT^® 7 Day Cream, do so as soon as you remember.

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to until the course of treatment is finished.

If you have missed more than one dose, 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.

It is important that you complete the entire treatment course as advised even though the symptoms may disappear before completion.

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^® 7 Day Cream

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 7 days treatment with MONISTAT^® cream. Your doctor may wish to carry out further tests or give you another treatment.
• MONISTAT^® 7 Day Cream can be used during your menstrual period. If you get your period whilst using MONISTAT^® 7 Day Cream, continue to finish the course of treatment.
• Whilst using MONISTAT^® 7 Day Cream, use sanitary napkins rather than tampons.
• 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^® 7 Day Cream.

Things you must not do

• Do not use MONISTAT^® 7 Day Cream 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^® 7 Day Cream 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^® 7 Day Cream 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^® 7 Day Cream

Storage

Keep MONISTAT^® 7 Day Cream 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^® 7 Day Cream, 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^® 7 Day Cream contains a 45g tube of white odourless MONISTAT^® cream and 7 disposable plastic applicators.

Ingredients

The active ingredient of MONISTAT^® 7 Day Cream is miconazole nitrate.

The vaginal cream in MONISTAT^® 7 Day Cream 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