CELESTONE M

Betamethasone valerate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Celestone M.

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 has weighed the risks of you using this medicine against the benefits it 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 Celestone M is used for

Celestone M contains the active ingredient called betamethasone valerate.

It is a type of cortisone and belongs to the group of medicines called corticosteroids. Celestone M is classified as a moderately strong topical corticosteroid.

Celestone M is used on the skin to relieve the redness, swelling, itching and discomfort of many skin problems such as:

• Psoriasis (a stubborn skin disorder with raised, rough reddened areas covered with dry, fine silvery scales)
• Eczema (an often itchy skin condition with redness, swelling, oozing of fluid, crusting which may lead to scaling)
• other types of dermatitis

Your doctor may have prescribed this medicine for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. This medicine is available only with a doctor's prescription.

Before you use Celestone M

When you must not use it

Do not use Celestone M if you have an allergy to:

• other medicines containing betamethasone valerate
• any other corticosteroid(s)
• any of the ingredients listed at the end of this leaflet

Some symptoms of an allergic reaction include wheezing, skin rash and hives.

Do not use Celestone M if you have:

• a viral skin infection (such as cold sores, shingles or chicken pox)
• a fungal skin infection (such as thrush, tinea or ringworm)
• tuberculosis of the skin
• acne rosacea
• inflammation around the mouth
• skin conditions with ulcers

unless your doctor tells you.

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

Do not use Celestone M just before having a bath, shower or going swimming. If you do you may reduce the effectiveness of this medicine.

Do not use Celestone M if the packaging is torn or shows signs of tampering.

Do not use Celestone M after the expiry date. A use-by date is shown on the tube and carton of Celestone M Cream. If you use this medicine after the expiry date has passed, it may not work as well.

Before you start to use it

Tell your doctor or pharmacist if :

1. you have allergies to:

• any other medicines
• any other substances, such as foods, dyes or preservatives.

1. you are pregnant or intend to become pregnant 
   Your doctor will discuss the risks and benefits of using this medicine when pregnant.
   During pregnancy, do not use this medicine over large areas of the body or for prolonged periods.
2. you are breast-feeding or intend to breast-feed. 
   Your doctor will discuss the risks and benefits of using this medicine when breast-feeding. Do not apply this medicine to the breasts before breast-feeding.
3. you have any other medical conditions, especially if you have an infection.

Using other medicines

Tell your doctor or pharmacist if you are using other creams, ointments or lotions or taking any other medicines. This includes any that you buy without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you what to do when using Celestone M with other medicines.

How to use Celestone M

How to use it

Apply a thin film of Celestone M Cream to the affected skin two to three times daily. Massage gently until it disappears.

It is important to use Celestone M exactly as your doctor has told you. 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.

Follow these instructions only if you have been asked to use Celestone M under an occlusive dressing:

• apply a thin layer of Celestone M on the affected area
• cover with a light gauze dressing followed by a water-resistant plastic wrap on top
• extend the plastic wrap over the edges of the treated area
• seal the edges to normal skin using adhesive tape
• leave the dressing undisturbed for 1 to 3 days
• apply new occlusive dressings 3 to 4 times during the treatment period as needed

How long to use it

Your doctor or pharmacist will tell you how long to use Celestone M.

Do not use Celestone M for longer than your doctor tells you.

If you are not sure how long to use this medicine, talk to your doctor or pharmacist.

If you forget to use it

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

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 Celestone M. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep the telephone numbers of these places handy.

While you are using Celestone M

Things you must do

Discontinue Celestone M immediately if it causes irritation or sensitisation.

Tell all doctors and pharmacists who are treating you that you are using Celestone M.

Tell your doctor if you feel that Celestone M is not helping your condition or if your skin condition worsens or seems infected.

Tell your doctor if, for any reason, you have not used Celestone M exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

If you become pregnant while using Celestone M, tell your doctor.

Things you must not do

Do not use Celestone M under dressings or on large areas of skin unless your doctor tells you. If your doctor has ordered an occlusive dressing (airtight covering) to be applied over Celestone M, make sure you know how to apply it.

Since occlusive dressings increase the amount of medicine absorbed through your skin and the possibility of side effects, use them only as directed. If you have any questions about this, check with your doctor.

Do not use plastic pants or tight fitting nappies if Celestone M is to be used on the nappy area of young children.

Do not use Celestone M in or near the eyes.

Do not use Celestone M on the face unless your doctor tells you to. Use only a small amount and stop when the condition has cleared.

Do not give Celestone M to anyone else even if their symptoms seem similar to yours.

Do not use Celestone M to treat other conditions unless your doctor tells you. Your doctor has prescribed Celestone M 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 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 increase.

Ask your doctor if you are concerned about the length of time you have been using Celestone M.

Only use Celestone M on skin areas that rub together such as under the arm or in the groin area if your doctor tells you.

Children and adolescents should be followed closely by the doctor, since this medicine is absorbed through the skin and can affect growth or cause other unwanted effects.

Side effects

Tell your doctor if you do not feel well while you are using Celestone M.

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

All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Tell your doctor if you notice any of the following and they worry you:

• burning
• itching
• irritation
• infection or dryness of skin
• irritation or redness of the face
• increased hair growth
• acne
• change in skin colour
• thinning of skin with easy bruising
• maceration of the skin
• stretch marks
• infection of the hair roots
• rash around mouth area
• contact dermatitis
• heat rash
• secondary infection
• dilated blood vessels near the surface of the skin
• tingling
• warm feeling
• scaling skin

Celestone M may cause other side effects.

Side effects that may happen with oral or injectables corticosteroids may also occur with corticosteroids used on the skin, especially in infants and children.

Other side effects not listed above also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.

Ask your doctor if you don't understand anything in this list.

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

After using Celestone M

Storage

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

Do not store Celestone M or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep Celestone M where children cannot reach it. Keep the medicine away from pets. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

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

Product description

What it looks like

Celestone M Cream is a white to off-white cream. It is packed in 100 g tubes.

Ingredients

Celestone M Cream contains:

• betamethasone as valerate 0.2 mg/g
• chlorocresol (preservative)
• cetomacrogol 1000
• cetostearyl alcohol
• liquid paraffin
• soft white paraffin
• sodium acid phosphate
• phosphoric acid
• purified water

Supplier

Merck Sharp & Dohme (Australia) Pty Limited
Level 1 Building A, 26 Talavera Road,
Macquarie Park NSW 2113
AUSTRALIA

Australian Registration Number

Cream - AUST R 18778

Date of Preparation

24 September 2015