Consumer Medicine Information

What is in this leaflet?
This leaflet answers some common questions about SIGMACORT.

It does not contain all the available information. It does not take place of talking to your doctor or pharmacist.

All medicines have risks and benefits.

Your doctor has weighed the risks of using SIGMACORT against the benefits this medicine is expected to have for you.

If you have any concerns about this medicine, ask your doctor or pharmacist.

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

What is SIGMACORT?
The name of your medicine is SIGMACORT.

It contains the active ingredient called hydrocortisone acetate.

It is available as a cream and an ointment.

SIGMACORT is a type of cortisone and belongs to the group of medicines called corticosteroids.

What SIGMACORT is used for?
Indications
SIGMACORT is a topical corticosteroid therapy for non-infective inflammatory conditions of the skin eg. eczema, dermatitis.

That is SIGMACORT is used to relieve the redness, swelling, itching and other discomforts of the skin.

Your doctor however, may have prescribed SIGMACORT for another purpose.

Ask your doctor (or pharmacist) if you have any questions about why SIGMACORT has been prescribed for you.

A doctor's prescription is required for the 50 gram tube of SIGMACORT cream or ointment.

The 30 gram tube of SIGMACORT cream or ointment can be purchased without a doctor's prescription.

Before you use SIGMACORT
When you must not use it
Do not use SIGMACORT if you have ever had an allergic reaction to:

SIGMACORT or hydrocortisone acetate.
Any of the ingredients in SIGMACORT listed at the end of this leaflet.
Do not use SIGMACORT if you have:

A viral skin infection (such as herpes simplex, cold sores, shingles or chicken pox)
A fungal skin infection (such as thrush, tinea or ringworm)
Tuberculous condition of the skin
Vaccinia (cowpox: a viral disease passed from cattle)
Varicella (a rare form of chicken pox)
Unless your doctor tells you to use it.

SIGMACORT should not be used if you 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 SIGMACORT if the packaging shows sign of tampering or the seal on the tube is broken, or if the product does not look quite right.

Before you start to use it
You must tell your doctor if:

You are allergic to any other medicines, foods, dyes or preservatives.
You have any other health problems
You are pregnant or breast-feeding.
Do not apply SIGMACORT to the breast before breast feeding.

Using 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 about any of the above, tell them before you start using SIGMACORT.

Use in Children
Do not use in children unless your doctor tells you to do so.

How to use SIGMACORT?
How to use it
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 it
If you forget to use SIGMACORT, use it as soon as you remember and then go back to your normal times for applying SIGMACORT.

Do not try to make up for the amount you missed by using more than you normally use.

If you swallow it
Telephone your doctor or Poisons Information Centre (phone 13 11 26) or go to the accident and emergency centre at your nearest hospital immediately if anyone swallows SIGMACORT.

Keep the telephone numbers of these places handy.

While you are using SIGMACORT
Things you must 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 must not do
Do not use SIGMACORT under dressings or on large areas of skin unless your doctor tells you.

Do not use SIGMACORT 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 SIGMACORT.

Only use SIGMACORT under the arm or in the groin if your doctor tells you.

Side Effects
Tell your doctor or pharmacist if you do not feel well while you are using SIGMACORT. SIGMACORT helps most people with skin problems but it may have some unwanted side effects in a few people.

Side effects reported by some people using SIGMACORT include:

itching
burning
dryness
acne-form eruptions
In addition to the above side effects prolonged or over-use of this product may cause the following side effects in some people:

high blood pressure
elevated cholesterol and triglyceride levels in the blood
cataracts
glaucoma
SIGMACORT may cause other side effects. If you have any other side effects, check with your doctor.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using SIGMACORT
Storage
Keep SIGMACORT 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.

Keep SIGMACORT in a cool dry place where the temperature stays below 25 °C.

Do not leave SIGMACORT in the car or on windowsills. Heat can destroy some medicines.

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

Further Information
This is not all the information that is available on SIGMACORT. If you need more information, ask a doctor or pharmacist.

Product Description
What it looks like
SIGMACORT cream is a soft white cream with faint odour of chlorocresol.

SIGMACORT ointment is a yellowish-white ointment with a faint odour of paraffin and lanolin.

Both SIGMACORT cream and ointment are packed in 30 g and 50 g tubes.

Ingredients
Hydrocortisone acetate (microfined) 1% or 10 mg/g is the active ingredient in both SIGMACORT cream and ointment.

List of inactive ingredients

Sigmacort Cream
Paraffin - soft white,
Paraffin - liquid,
Cetomacrogol 1000,
Cetostearyl alcohol and
Chlorocresol (preservative).
Sigmacort Ointment
Paraffin - soft white,
Paraffin - hard,
Paraffin - liquid and
Wool fat.
Sigmacort ointment is preservative free.
The Australian Product Registration numbers are:

SIGMACORT cream AUST R 19778 and SIGMACORT ointment AUST R 19779.

Manufacturer
Sigma Pharmaceuticals Pty Ltd.
(A.C.N. 004 118 594)
1408 Centre Road
Clayton Victoria 3168
Australia.

Phone: (03) 9839 2800

This leaflet was prepared in February 1996. Last amendment August 2000.