Consumer medicine information

Diprosone OV

Betamethasone dipropionate

BRAND INFORMATION

Brand name

Diprosone OV

Active ingredient

Betamethasone dipropionate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Diprosone OV.

What is in this leaflet

This leaflet answers some common questions about DIPROSONE OV Cream and Ointment.

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 DIPROSONE OV against the benefits they expect it will have for you.

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

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

What DIPROSONE OV is used for

DIPROSONE OV contains the active ingredient betamethasone dipropionate.

Betamethasone dipropionate is a very strong corticosteroid used to decrease inflammation, redness, itchiness and discomfort of some skin conditions.

DIPROSONE OV Cream and Ointment are used to treat persistent or severe:

  • dermatitis
  • eczema (an often itchy skin condition with redness, swelling, oozing of fluid, crusting which may lead to scaling)
  • acute or chronic psoriasis (a stubborn skin disorder with raised, rough, reddened areas covered with dry, fine silvery scales)

Your doctor may have prescribed DIPROSONE OV for another reason.

Ask your doctor if you have any questions about why DIPROSONE OV has been prescribed for you.

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

Before you use DIPROSONE OV

When you must not use it

Do not use DIPROSONE OV if you have had an allergic reaction to:

  • other medicines containing betamethasone dipropionate
  • 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 DIPROSONE OV if you have:

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

Do not use DIPROSONE OV in children under 12 years of age unless your doctor tells you to. Long-term use may affect their growth and development.

Do not use DIPROSONE OV just before having a bath, shower or a swim. If you do, you may reduce the effectiveness of DIPROSONE OV.

Do not use DIPROSONE OV if the expiry date (EXP) printed on the pack has passed. If you use DIPROSONE OV after the expiry date has passed, it may not work as well.

Do not use DIPROSONE OV if the packaging is torn or shows signs of tampering.

Before you start to use it

Tell your doctor or pharmacist if you have allergies to:

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

Tell your doctor if:

  • you are pregnant or breast-feeding.
    Your doctor will tell you if you can use DIPROSONE OV during pregnancy or while you are breast-feeding.
  • 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 or ointments or taking any other medicines. This includes medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

How to use DIPROSONE OV

How to use it

Apply a thin layer of DIPROSONE OV Cream or Ointment to completely cover the affected area once or twice daily.

It is important to use DIPROSONE OV 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 condition may not improve.

Using it more often than you should may not improve your skin condition faster and may cause or increase side effects.

How long to use it

Your doctor will advise you how long to use DIPROSONE OV. Duration of treatment might take from a few days to a longer period of time.

Do not use DIPROSONE OV for more than 4 weeks without seeing your doctor.

Do not use DIPROSONE OV once the skin condition has cleared.

If you forget to use it

If you forget to use DIPROSONE OV, use it as soon as you remember and then use again at the normal time. Do not apply twice the amount to make up for the application that you missed.

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 you think that you or anyone may have swallowed DIPROSONE OV. Do this even if there are no signs of discomfort or poisoning.

Keep the telephone numbers of these places handy.

While you are using DIPROSONE OV

Things you must do

If you are about to start taking any new medicine, tell your doctor, dentist and pharmacist who are treating you that you are using DIPROSONE OV.

Tell your doctor if you feel that DIPROSONE OV is not helping your skin problem or if your skin problem worsens or seems infected.

Go to your doctor regularly for a check-up if you are on long-term DIPROSONE OV therapy.

Tell your doctor if you become pregnant while using DIPROSONE OV.

Things you must not do

Do not use DIPROSONE OV in or near the eyes.

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

Do not use DIPROSONE OV under an air-tight dressing such as a plastic wrap or a tight nappy.

Do not use more than 45g of DIPROSONE OV Cream or Ointment per week (one and a half tubes).

Do not give DIPROSONE OV to anyone else, even if they have similar symptoms as you.

Do not use DIPROSONE OV to treat any other complaint(s) unless your doctor tells you to.

Things to be careful of

Do not use large amounts for a long time. DIPROSONE OV is absorbed through the skin and side effects may increase with extended use.

Do not continue to use DIPROSONE OV if skin begins to thin or stretch marks appear.

Do not use DIPROSONE OV between skin folds or between fingers or toes for a long period without seeing your doctor.

DIPROSONE OV does not take the place of antibiotics if there is an infection.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using DIPROSONE OV.

DIPROSONE OV is generally welltolerated but may have unwanted side effects in a few people. These side effects mainly involve the skin and include:

  • burning
  • stinging sensation
  • itchiness
  • irritation
  • dry skin, softening of the skin
  • acne
  • lightening in skin colour
  • contact dermatitis
  • dermatitis around the mouth
  • inflamed follicles
  • increased hair growth
  • skin infection
  • stretch marks

Other less common side effects include:

  • tingling, prickly skin
  • tightening or cracking of skin
  • scaling of skin
  • thinning of the skin
  • sensation of warmth
  • rash
  • redness
  • hives
  • visual disturbances or blurred vision

Long-term use over large areas may suppress cortisol production in the body or cause side effects similar to those from oral corticosteroids, especially in infants and children.

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

Ask your doctor or pharmacist 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 DIPROSONE OV

Storage

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

Do not store DIPROSONE OV or any other medicines in the bathroom or near the sink. Do not leave it in the car or on the window sill. Heat and dampness can destroy some medicines.

Keep DIPROSONE OV where children cannot reach it. 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 DIPROSONE OV, 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

DIPROSONE OV Cream is a smooth white cream. It is packed in 30g tubes.

DIPROSONE OV Ointment is a smooth white ointment. It is packed in 30g tubes.

Ingredients

DIPROSONE OV Cream contains:

  • betamethasone as dipropionate 0.5 mg/g
  • carbomer 980
  • propylene glycol
  • sodium hydroxide
  • titanium dioxide
  • purified water

DIPROSONE OV Ointment contains:

  • betamethasone as dipropionate 0.5 mg/g
  • propylene glycol
  • white beeswax
  • propylene glycol monostearate
  • white soft paraffin

DIPROSONE OV Cream and Ointment do not contain preservatives, parabens or lanolin.

Supplier

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

Australian Registration Numbers

Cream - AUST R 18825

Ointment - AUST R 18823

Date of Preparation

23 March 2022

RCN: 100001002-AU

Published by MIMS May 2022

BRAND INFORMATION

Brand name

Diprosone OV

Active ingredient

Betamethasone dipropionate

Schedule

S4

 

1 Name of Medicine

Betamethasone dipropionate.

2 Qualitative and Quantitative Composition

Diprosone OV cream (0.05%). Each g contains 0.64 mg betamethasone dipropionate, equivalent to betamethasone 0.5 mg.
Diprosone OV ointment (0.05%). Each g contains 0.64 mg betamethasone dipropionate, equivalent to betamethasone 0.5 mg.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Diprosone OV 0.5 mg/g is supplied as cream and ointment.

4 Clinical Particulars

4.9 Overdose

Symptoms. Excessive prolonged use of topical corticosteroids can suppress pituitary-adrenal function resulting in secondary adrenal insufficiency and produce manifestations of hypercorticism, including Cushing's disease.
Treatment. Appropriate symptomatic treatment is indicated. Acute hypercorticoid symptoms are virtually reversible. Treat electrolyte imbalance, if necessary. In cases of chronic toxicity, slow withdrawal of corticosteroids is advised.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

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 percent).
Chemically betamethasone dipropionate is a synthetic corticosteroid which has the chemical name: 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.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSBETADI.gif CAS number. 5593-20-4.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/DIPROVST.gif