Consumer medicine information

Hydrozole Cream


Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.


1. Why am I using Hydrozole Cream?

Hydrozole Cream contains the active ingredient hydrocortisone 1% and clotrimazole 1%. Hydrozole Cream is used on the skin to relieve the redness, swelling, itching and discomfort of many skin problems such as nappy rash, candidal infections (a yeast-like micro-organism) where there is also inflammation on the skin, fungal-infected dermatitis and tinea infections such as jock itch and athlete’s foot.

For more information, see Section 1. Why am I using Hydrozole Cream? in the full CMI.

2. What should I know before I use Hydrozole Cream?

Do not use if you have ever had an allergic reaction to hydrocortisone or clotrimazole or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Hydrozole Cream? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Hydrozole Cream and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Hydrozole Cream?

  • For external use only.
  • Follow all directions given to you by your doctor or pharmacist carefully. Do not exceed the recommended dosage.

More instructions can be found in Section 4. How do I use Hydrozole Cream? in the full CMI.

5. What should I know while using Hydrozole Cream?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Hydrozole Cream.
  • If you become pregnant while using Hydrozole Cream or are pregnant or intend to become pregnant, talk to your doctor or pharmacist.
  • Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
Things you should not do
  • Do not use Hydrozole Cream under airtight or waterproof dressings, in the eyes, for acne or on large areas of skin unless your doctor has told you to.
  • Do not use Hydrozole Cream for more than 7 days unless a doctor has told you to or in large amounts for a long time.
  • Do not use Hydrozole Cream on children under 2 years of age unless a doctor has told you to.
Drinking alcohol
  • Tell your doctor or pharmacist if you drink alcohol.
Looking after your medicine
  • Keep Hydrozole Cream in a cool dry place where the temperature stays below 25°C. Do not refrigerate Hydrozole Cream. Heat and dampness can destroy some medicines.
  • Keep it where young children cannot reach it.

For more information, see Section 5. What should I know while using Hydrozole Cream? in the full CMI.

6. Are there any side effects?

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Hydrozole Cream

Active ingredient(s): Hydrocortisone (microfine) 1% w/w and Clotrimazole 1% w/w


Consumer Medicine Information (CMI)

This leaflet provides important information about using Hydrozole Cream. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Hydrozole Cream.

Where to find information in this leaflet:

1. Why am I using Hydrozole Cream?
2. What should I know before I use Hydrozole Cream?
3. What if I am taking other medicines?
4. How do I use Hydrozole Cream?
5. What should I know while using Hydrozole Cream?
6. Are there any side effects?
7. Product details

1. Why am I using Hydrozole Cream?

Hydrozole Cream contains the active ingredient hydrocortisone (it belongs to a group of medicines called corticosteroids) and clotrimazole (it belongs to a group of medicines called antifungals).

Hydrozole Cream is used on the skin to relieve the redness, swelling, itching and discomfort of many skin problems such as: –

  • Nappy rash
  • Candidal infections (a yeast-like micro-organism) where there is also inflammation on the skin
  • Fungal-infected dermatitis
  • Tinea infections such as jock itch and athlete’s foot.

Hydrozole Cream should only be used on children under 2 years of age (for example nappy rash) if a doctor has told you to.

Your doctor or pharmacist may have recommended Hydrozole Cream for another purpose. Ask your doctor or pharmacist if you have any questions about why Hydrozole Cream has been recommended for you.

Hydrozole Cream is not addictive.

Hydrozole Cream is only available from your pharmacist.

2. What should I know before I use Hydrozole Cream?

Warnings

Do not use Hydrozole Cream if:

  • you have an allergy to any medicine containing hydrocortisone or clotrimazole, or any of the ingredients listed at the end of this leaflet, or any other similar medicines (such as medicines of the same class).
    Always check the ingredients to make sure you can use this medicine.
  • you have a viral skin infection (such as cold sores, shingles or chicken pox)
  • you have bacterial skin infection such as school sores
  • you have pruritus (itching skin) without any inflammation or redness
  • you have rosacea (skin condition of the face where the nose and cheeks are unusually red)
  • you have acne
  • you have problems with your circulation
  • you have any other serious infections of the skin.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Ask your doctor or pharmacist to be sure you do not have any of these conditions.

Do not use Hydrozole Cream after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

Do not use Hydrozole Cream just before having a bath, shower or going swimming. If you do, you may reduce the effectiveness of Hydrozole Cream.

If you are not sure whether you should start using Hydrozole Cream, contact your doctor or pharmacist.

Check with your doctor if you:

  • have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes
  • are taking any medication containing corticosteroids for other conditions (e.g. asthma, arthritis, organ transplants)
  • have a serious illness affecting your immune system
  • have had or have any other medical conditions, including receiving a transplanted organ or HIV.
  • are pregnant or intend to become pregnant.
  • are breastfeeding or intend to breastfeed.

If you have not told your doctor about any of the above, tell your doctor before you use Hydrozole Cream.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed. Your doctor will discuss the risks and benefits of using Hydrozole Cream when pregnant.

Check with your doctor or pharmacist if you are breastfeeding or intend to breastfeed. Your doctor will discuss the risks and benefits of using Hydrozole Cream when breastfeeding.

Do not apply Hydrozole Cream to the breasts before breastfeeding.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Hydrozole Cream may interfere with each other.

These include:

  • asthma medication
  • medication for arthritis
  • medication for a recent organ transplant you have received
  • medication for the treatment of HIV.

These medicines may be affected by Hydrozole Cream or affect how well Hydrozole Cream works. You may need to use different amounts of your medicine, or you may need to use different medicines. Your doctor or pharmacist will advise you.

Your doctor or pharmacist may have more information on medicines to be careful with or avoid while using Hydrozole Cream.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Hydrozole Cream.

4. How do I use Hydrozole Cream?

How much to use

  • Gently rub a small quantity of Hydrozole Cream into the affected area two times daily for up to 7 days.
  • Apply enough cream to disappear into the skin without leaving any on the skin.
  • Do not exceed the recommended dosage.
  • You should use Hydrozole Cream for as long as your doctor or pharmacist tells you to. The usual treatment is up to 7 days.
  • If you use Hydrozole Cream for longer than your doctor or pharmacist tells you, the chance of side effects may increase.
  • You should apply a cream containing a single anti-fungal agent for an extra two weeks after the inflammation has subsided.
  • You must do this otherwise there might be a chance of the condition returning.
  • If you are not sure of how long you need to use Hydrozole Cream, talk to your doctor or pharmacist.

When to use Hydrozole Cream

  • If you use it less often than you should, it may not work as well and your skin problem may not improve. Using it more often than you should may not improve your skin problem any faster and may cause or increase side effects.
  • Use Hydrozole Cream at the same time every day.

How to use Hydrozole Cream

  • Hydrozole Cream is for external use only.
  • Follow all directions given to you by your doctor or pharmacist carefully.
  • These directions may differ from the information contained in this leaflet.
  • If you do not understand the instructions on the box, tube or this leaflet, ask your doctor or pharmacist for help.
  • Gently rub a small quantity of Hydrozole Cream into the affected area two times daily for up to 7 days.
  • Apply enough cream to disappear into the skin without leaving any on the skin.
  • Wash your hands after use, unless you are treating the hands.
  • If the location of the skin condition is in an area normally covered with clothing, you should ensure that loose clothing is worn over the affected area to be treated.
  • Follow the instructions provided with the medicine.

If you forget to use Hydrozole Cream

  • If it is almost time for your next application of Hydrozole Cream, skip the application you missed and apply the cream when you are next meant to. Otherwise, use it as soon as you remember, and then go back to using your cream as you would normally.
  • Do not use a double dose to make up for the dose that you missed.
  • If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

If you use too much Hydrozole Cream

If you think that you have used too much Hydrozole Cream, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Hydrozole Cream?

Things you should do

  • Tell your doctor(s) or pharmacist(s) who is treating you that you are using Hydrozole Cream.
  • If you feel that Hydrozole Cream is not helping your condition, tell your doctor or pharmacist.
  • Tell your doctor or pharmacist if for any reason, you have not used Hydrozole Cream exactly as prescribed. Otherwise, your doctor or pharmacist may think that it was not effective and change your treatment unnecessarily.
  • If you become pregnant while using Hydrozole Cream, tell your doctor or pharmacist.

Call your doctor straight away if you:

  • become pregnant while using Hydrozole Cream
  • find the condition worsen

Remind any doctor, dentist or pharmacist you visit that you are using Hydrozole Cream.

Things you should not do

Do not use Hydrozole Cream: –

  • under airtight or waterproof dressings
  • or on large areas of skin unless your doctor has told you to
  • in the eyes
  • to treat other complaints unless your doctor or pharmacist tells you to
  • for acne
  • on children under 2 years of age unless a doctor has told you to
  • for more than 7 days unless a doctor has told you to
  • in large amounts for a long time.

If you use large amounts for a long time, the chance of absorption through the skin and the chance of side effects may increase. Ask your doctor if you are concerned about the length of time you have been using Hydrozole Cream.

  • on skin areas that rub together such as under the arm or in the groin area unless your doctor tells you to.

Do not wear tight fitting clothing in the area being treated with Hydrozole Cream.

Do not give Hydrozole Cream to anyone else, even if they have the same symptoms as yours.

Do not dilute Hydrozole Cream.

The ingredients in Hydrozole cream may affect the latex used in barrier contraceptives such as condoms and diaphragms.

You may need to use other methods of contraception while using this medicine and for at least 5 days after last using the cream.

If you experience blurred vision or other visual disturbances, speak to your doctor.

Take care when applying Hydrozole Cream to the eyelids to make sure it does not get into your eye.

  • If you accidentally get Hydrozole Cream in your eyes, wash them well with water.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Hydrozole Cream affects you.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

  • Keep Hydrozole Cream in a cool dry place where the temperature stays below 25°C.
  • Heat and dampness can destroy some medicines.
  • Do not refrigerate Hydrozole Cream.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

When to discard your medicine

If your doctor or pharmacist tells you to stop using Hydrozole Cream or it has passed its expiry date, ask your pharmacist what to do with any that is left over.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Hydrozole Cream helps most people with skin problems but it may have unwanted side effects in a few people.

Tell your doctor or pharmacist if you notice any of the following side effects near or on the area you apply Hydrozole Cream and they worry you.

Do not be alarmed by the list of side effects, which follows; you may not experience any of them.

Less serious side effects

Less serious side effects What to do
  • Drying, cracking, blistering, peeling, thinning, tightening or redness of the skin.
  • Burning or stinging feeling on the skin.
  • Bruising of the skin.
  • Acne-type lumps on the skin.
  • Itching or irritation of skin.
  • Changes to the colour of your skin.
  • Rash or blisters.
  • Skin condition getting worse.
  • Other obvious unexpected changes to the skin area treated.
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects What to do
  • if your skin condition gets worse or your skin becomes swollen during treatment, you may be allergic to the medicine, have an infection or need other treatment.
  • wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting. These could be a symptom of an allergic reaction.
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Very rare side effects that may show up in blood tests or when your doctor gives you a medical examination:

  • a decrease in the level of the hormone cortisol in your blood
  • increased levels of sugar in your blood or urine
  • high blood pressure
  • cloudy lens in the eye (cataract)
  • increased pressure in the eye (glaucoma)
  • weakening of the bones through gradual loss of mineral (osteoporosis) – additional tests may be needed after your medical examination to confirm if you have this condition.

Ask your doctor or pharmacist if you don’t understand anything in this list.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Hydrozole Cream contains

Active ingredient
(main ingredient)
  • hydrocortisone 1%
  • clotrimazole 1%
Other ingredients
(inactive ingredients)
  • cetomacrogol 1000
  • glycerol
  • cetostearyl alcohol
  • light liquid paraffin
  • white soft paraffin
  • propylene glycol
  • chlorocresol 0.2% (as a preservative)
  • purified water
  • sodium hydroxide
  • lactic acid
Potential allergens chlorocresol 0.2% (as a preservative)

Hydrozole Cream does not contain lanolin, paraben preservatives or fragrances and washes off with water.

Do not take this medicine if you are allergic to any of these ingredients.

What Hydrozole Cream looks like

Hydrozole Cream is a smooth, non-greasy white cream, which is available in a 50 gram tube in a carton. (AUST R 10319).

Who distributes Hydrozole Cream

Haleon
Sydney, NSW, Australia.
AU: 1800028533

This leaflet was prepared in March 2023.

Published by MIMS May 2023