SUMMARY CMI

DIPROSONE^®

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 DIPROSONE?

DIPROSONE contains the active ingredient betamethasone dipropionate. DIPROSONE is used on the skin to relieve the redness, swelling, itching and discomfort of many skin problems such as psoriasis, eczema and other types of dermatitis.

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

2. What should I know before I use DIPROSONE?

Do not use if you have ever had an allergic reaction to betamethasone dipropionate 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 DIPROSONE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DIPROSONE and affect how it works.

More information can be found in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use DIPROSONE?

• Apply a thin film of DIPROSONE Cream or Ointment or a few drops of DIPROSONE Lotion to the affected skin or scalp twice daily. Massage gently until it disappears. For some patients, once daily application may be enough for maintenance therapy

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

5. What should I know while using DIPROSONE?

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

6. Are there any side effects?

Local, skin-related side effects such as burning, itching, irritation, infection or dryness, acne, skin thinning and discolouration have been reported with the use of topical corticosteroids, especially under occlusive dressings. 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

DIPROSONE^®

Active ingredient(s): betamethasone dipropionate

Consumer Medicine Information (CMI)

This leaflet provides important information about using DIPROSONE. 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 DIPROSONE.

Where to find information in this leaflet:

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

1. Why am I using DIPROSONE?

DIPROSONE contains the active ingredient betamethasone dipropionate. DIPROSONE is a type of cortisone and belongs to the group of medicines called corticosteroids. DIPROSONE is classified as a high potency topical corticosteroid.

There are three forms of DIPROSONE: cream, ointment and lotion.

DIPROSONE 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

DIPROSONE Lotion is also used on the scalp and hairy parts of the body.

2. What should I know before I use DIPROSONE?

Warnings

Do not use DIPROSONE if:

• you have had an allergic reaction, such as wheezing, rash or hives, to DIPROSONE, any other corticosteroid, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.

Unless your doctor tells you, do not use DIPROSONE 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

Tell your doctor or pharmacist if you have allergies to:

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

Check with your doctor if you:

• have any other medical conditions, especially if you have an infection
• take any medicines for any other condition

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 if you are breastfeeding or intend to breastfeed.

Your doctor will tell you if you can use DIPROSONE during pregnancy or while you are breast feeding.

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 other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

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

4. How do I use DIPROSONE?

How much to take / use

• Apply a thin film of DIPROSONE Cream or Ointment or a few drops of DIPROSONE Lotion to the affected skin or scalp twice daily. Massage gently until it disappears.
• For some patients, once daily application may be enough for maintenance therapy.

How to use DIPROSONE

• It is important to use DIPROSONE 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.
• Do not use DIPROSONE just before having a bath, shower or going swimming. If you do, you may reduce the effectiveness of DIPROSONE.

If you forget to use DIPROSONE

If you forget to use DIPROSONE, use it as soon as you remember and then go back to your normal time for applying DIPROSONE.

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

If you swallow DIPROSONE

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 DIPROSONE?

Things you should do

Tell your doctor if you feel that DIPROSONE 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 DIPROSONE exactly as prescribed.

Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

If you become pregnant while using DIPROSONE, tell your doctor.

Things you should not do

• Do not use DIPROSONE under dressings or on large areas of skin unless your doctor tells you.
• Do not use plastic pants or tight fitting nappies if DIPROSONE is to be used on the nappy area of young children.
• Do not use DIPROSONE in or near the eyes.
• Do not give DIPROSONE to anyone else even if their symptoms seem similar to yours.
• Do not use DIPROSONE to treat other conditions unless your doctor tells you.
• Your doctor has prescribed DIPROSONE specially for you and your condition. If you use it for another condition, it may not work or make the condition worse.
• Do not use DIPROSONE for more than four weeks at a time unless your doctor tells you.

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 increases.
• Only use DIPROSONE on skin areas that rub together such as under the arm or in the groin area if your doctor tells you.
• Only use DIPROSONE on the face if your doctor tells you. If improvement does not occur within one week, tell your doctor.
• 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.

Looking after your medicine

• Keep DIPROSONE in a cool dry place where the temperature stays below 25°C.
• DIPROSONE Lotion should be protected from light.

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.

Do not use DIPROSONE if the packaging shows signs of tampering.

Keep it where young children cannot reach it. Keep the medicine away from pets.

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

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

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 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 DIPROSONE contains

DIPROSONE Cream

DIPROSONE Ointment

DIPROSONE Lotion

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

What DIPROSONE looks like

DIPROSONE Cream is a white to off-white cream. It is packed in 15 g and 50 g tubes.(Aust R 18818).

DIPROSONE Ointment is a white to off-white ointment. It is packed in 15 g and 50 g tubes. (Aust R 144098).

DIPROSONE Lotion is a colourless to light yellow lotion. It is packed in 30 mL bottles.(Aust R 18829).

Who distributes DIPROSONE

Organon Pharma Pty Limited
Building A, 26 Talavera Road,
Macquarie Park, NSW 2113
AUSTRALIA

This leaflet was prepared in March 2022.

RCN: 100001001-AU

Published by MIMS August 2024

1 Name of Medicine

Betamethasone dipropionate.

2 Qualitative and Quantitative Composition

Betamethasone dipropionate equivalent to betamethasone 0.5 mg/g (0.05% w/w).

Diprosone cream (0.05% w/w).

Diprosone ointment (0.05% w/w).

Diprosone lotion (0.05% w/w).

3 Pharmaceutical Form

Diprosone is supplied as cream, ointment, lotion 0.05% w/w.

4 Clinical Particulars

4.1 Therapeutic Indications

Diprosone is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. These include atopic eczema, infantile eczema, nummular eczema, contact dermatitis, neurodermatitis, anogenital and senile pruritus, lichen planus, intertrigo and psoriasis.
Diprosone Lotion is indicated wherever hair impedes access to the skin in the treatment of corticosteroid-responsive dermatoses particularly on the scalp, chest and underarms, etc. It is also indicated in the treatment of seborrhoea and psoriasis of the scalp.

4.2 Dose and Method of Administration

Diprosone cream, ointment.

Diprosone lotion.

Children.

4.3 Contraindications

Hypersensitivity to betamethasone dipropionate, other corticosteroids or any components in Diprosone. Like other topical corticosteroids, Diprosone preparations are contraindicated in most viral infections of the skin, such as vaccinia, varicella, Herpes simplex, and also tuberculosis and acne rosacea.

4.4 Special Warnings and Precautions for Use

Diprosone preparations should not be used in or near the eyes.
If irritation or sensitisation develops, treatment should be discontinued and appropriate therapy instituted.
In the presence of an infection, an appropriate antifungal or antibacterial agent should be administered. If a favourable response does not occur promptly, Diprosone should be discontinued until the infection has been controlled adequately.
Corticosteroids are known to be absorbed percutaneously, therefore, in patients under prolonged and extensive topical treatment, the possibility of systemic effects should be kept in mind. This applies particularly when using the occlusive dressing technique.
Systemic absorption of topical corticosteroids will be increased if extensive body surface areas are treated or if the occlusive technique is used. Suitable precautions should be taken under these conditions or when long-term use is anticipated, particularly in infants and children.
Any of the side effects that are reported following systemic use of corticosteroids, including adrenal suppression, may also occur with topical corticosteroids, especially in infants and children.
Patients applying large doses of potent topical corticosteroids over large body surface areas should be evaluated periodically for evidence of HPA axis suppression. Manifestations of Cushing's syndrome also can be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying doses of Diprosone in excess of 15 g per day should be carefully monitored.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroid therapy.
Suitable precautions should be taken when using topical corticosteroids in patients with stasis dermatitis and other skin diseases with impaired circulation.
Topical corticosteroid preparations may produce striae or atrophy of the skin or subcutaneous tissue. If this occurs, treatment should be discontinued.
In most cases, 4 weeks continuous treatment should be considered the maximum.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The following adverse reactions have been reported with the use of topical corticosteroids: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae and miliaria.
Rarely reported adverse effects include tingling, prickly skin/ tightening or cracking of skin, warm feeling, laminar scaling and perilesional scaling, follicular rash, skin atrophy, erythema and telangiectasia.
Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Diprosone cream (0.05% w/w).

Diprosone ointment (0.05% w/w).

Diprosone lotion (0.05% w/w).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

The expiry date can be found on the packaging. In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG).

6.4 Special Precautions for Storage

Diprosone Cream, Ointment, Lotion: Store below 25°C.

6.5 Nature and Contents of Container

Diprosone Cream 0.05% w/w (0.5 mg/g): 2 g, 5 g, 15 g and 50 g tubes.
Diprosone Ointment 0.05% w/w (0.5 mg/g): 5 g, 15 g and 50 g tubes.
Diprosone Lotion 0.05% w/w (0.47 mg/mL): 30 mL and 100 mL bottles.
Not all pack sizes may be available.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Betamethasone dipropionate is a white or almost white, crystalline powder, practically insoluble in water, freely soluble in acetone and in methylene chloride, sparingly soluble in ethanol (96 per cent). The chemical name is 9-fluoro-11β-hydroxy- 16β-methyl-3,20-dioxopregna- 1,4-diene-17,21-diyl dipropanoate. The empirical formula is C₂₈H₃₇FO₇. Molecular Weight = 504.6.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes