SUMMARY CMI
Sigmacort
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 Sigmacort?
Sigmacort contains the active ingredient hydrocortisone acetate. Sigmacort is used to relieve the redness, swelling, itching and other discomforts of the skin.
For more information, see Section 1. Why am I using Sigmacort? in the full CMI.
2. What should I know before I use Sigmacort?
Do not use if you have ever had an allergic reaction to hydrocortisone acetate 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 Sigmacort? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Sigmacort 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 Sigmacort?
Apply a thin smear to affected areas two to four times a day or as directed.
More instructions can be found in Section 4. How do I use Sigmacort? in the full CMI.
5. What should I know while using Sigmacort?
Things you should do |
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Things you should not do |
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Things to be careful of |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using Sigmacort? in the full CMI.
6. Are there any side effects?
Common side effects include itching, burning, dryness and acne-form eruptions. Prolonged or over-use of this medicine may cause other side effects including high blood pressure.
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.
FULL CMI
Sigmacort
Active ingredient: hydrocortisone acetate
Consumer Medicine Information (CMI)
This leaflet provides important information about using Sigmacort 1%, abbreviated as Sigmacort in this document. 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 this medicine.
Where to find information in this leaflet:
1. Why am I using Sigmacort?
2. What should I know before I use Sigmacort?
3. What if I am taking other medicines?
4. How do I use Sigmacort?
5. What should I know while using Sigmacort?
6. Are there any side effects?
7. Product details
1. Why am I using Sigmacort?
Sigmacort contains the active ingredient hydrocortisone acetate. It is a type of cortisone and belongs to the group of medicines called corticosteroids.
It is available as a cream and an ointment.
Sigmacort is used for non-infective inflammatory skin conditions e.g. eczema, dermatitis and is used to relieve the redness, swelling, itching and other discomforts of the skin.
2. What should I know before I use Sigmacort?
Warnings
Do not use Sigmacort if you:
- are allergic to hydrocortisone acetate, or any of the ingredients listed at the end of this leaflet.
- have a viral skin infection (such as herpes simplex, cold sores, shingles or chicken pox)
- have a fungal skin infection (such as thrush, tinea or ringworm)
- have tuberculous condition of the skin
- have vaccinia (cowpox: a viral disease passed from cattle)
- have varicella (a rare form of chicken pox)
- suffer from poor circulation of blood in the skin region, as it may result in skin ulcers. Occlusive dressings should not be used if you have a skin infection.
Ask your doctor or pharmacist to be sure that you do not have any of these conditions.
Do not use SIGMACORT after the expiry date printed on the pack.
It may have no effect at all, or worse, it may give an entirely unexpected effect if you use after the expiry date.
Do not use it if the packaging shows sign of tampering or the seal on the tube is broken, or if the product does not look quite right.
Check with your doctor if you:
- are allergic to any other medicines, foods, dyes or preservatives.
- have any other health problems.
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.
Do not apply Sigmacort to the breast before breastfeeding.
Use in children
Do not use in children unless your doctor tells you to do so.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are using other creams, ointments or lotions or taking any medicine. This includes any that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with Sigmacort if it is used excessively or for prolonged periods.
Your doctor or pharmacist has a list of medicines that may interfere with Sigmacort.
If you have not told your doctor or pharmacist about any of the above, tell them before you start using Sigmacort.
4. How do I use Sigmacort?
How much to use
Apply a thin smear to affected areas two to four times a day or as directed.
Occlusive dressings are not necessary unless advised by your doctor.
It is important to use Sigmacort exactly as your doctor or pharmacist has told you.
If you use it less 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 Sigmacort at the same time every day.
How long to use it
Your doctor or pharmacist will tell you how long to use Sigmacort.
Reduce the number of applications as the disorder subsides.
If you use Sigmacort for a long time, the chance of side effects increases.
If you forget to use Sigmacort
If you forget to use Sigmacort, use it as soon as you remember and then go back to your normal times for application.
Do not try to make up for the amount you missed by using more than you normally use.
If you swallow it
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 Sigmacort?
Things you should do
Tell all your doctors and pharmacists who are treating you that you are using Sigmacort.
Tell your doctor if you feel that Sigmacort is not helping your condition.
Tell your doctor if, for any reason, you have not used Sigmacort exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Tell your doctor if you become pregnant while using Sigmacort.
Things you should not do
Do not use Sigmacort under dressings or on large areas of skin unless your doctor tells you.
Do not use it in or near the eyes.
Do not give Sigmacort to anyone else even if their symptoms seem similar to yours.
Do not use Sigmacort to treat other conditions unless your doctor tells you.
Your doctor has prescribed Sigmacort especially for you and your condition. If you use it for another condition, it may not work or make the condition worse.
Things to be careful of
Do not use large amounts of Sigmacort for a long time. If you use large amounts for long time, the chance of systemic absorption through the skin and the chance of side effects increase.
Ask your doctor or pharmacist if you are concerned about the length of time you have been using this medicine.
Only use Sigmacort under the arm or in the groin if your doctor tells you.
Looking after your medicine
Keep it where young children cannot reach it.
Keep this medicine in a cool dry place where the temperature stays below 25°C.
Do not leave it in the car or on windowsills.
Heat can destroy some medicines.
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.
Less serious side effects
Less serious side effects | What to do |
| Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
Prolonged or over-use of this product may cause the following side effects in some people:
| Check with your doctor. |
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
Sigmacort cream and ointment are available in two sizes; 30 g and 50 g tubes. A doctor's prescription is required for the larger 50 g tube of Sigmacort cream or ointment. However, the 30 g tube can be purchased at a pharmacy without a doctor's prescription.
What Sigmacort cream contains
Active ingredient (main ingredient) | hydrocortisone acetate (microfine): 10 mg/g or (1% w/w) |
Other ingredients (inactive ingredients) |
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What Sigmacort ointment contains
Active ingredient (main ingredient) | hydrocortisone acetate (microfine): 10 mg/g or (1% w/w) |
Other ingredients (inactive ingredients) |
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Do not take this medicine if you are allergic to any of these ingredients.
What Sigmacort looks like
Sigmacort cream is a soft white cream with a faint odour of chlorocresol. The Australian Product Registration number is AUST R 19778.
Sigmacort ointment is a soft yellowish-white ointment with a faint odour of paraffin and lanolin. The Australian Product Registration number is AUST R 19779.
Who distributes Sigmacort
Aspen Pharmacare Australia Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia
Made in Australia.
This leaflet was prepared in May 2024.
Published by MIMS July 2024