Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Antroquoril.

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 Antroquoril 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 Antroquoril is used for

Antroquoril contains the active ingredient called betamethasone valerate.

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

Antroquoril 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 Antroquoril for another reason.

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

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

Before you use Antroquoril

When you must not use it

Do not use Antroquoril 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 Antroquoril 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 Antroquoril just before having a bath, shower or going swimming.

If you do you may reduce the effectiveness of this medicine.

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

Do not use Antroquoril after the expiry date. A use-by date is shown on the tube and carton of Antroquoril 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.

2. you are pregnant or intend to become pregnant

Your doctor will discuss the risks and benefits of using this medicine when pregnant.

3. 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.

4. 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 Antroquoril with other medicines.

How to use Antroquoril

How to use it

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

It is important to use Antroquoril 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 Antroquoril under an occlusive dressing:

• apply a thin layer of Antroquoril 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 Antroquoril.

Do not use Antroquoril 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 Antroquoril. 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 Antroquoril

Things you must do

Discontinue Antroquoril immediately if it causes irritation or sensitisation.

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

Tell your doctor if you feel that Antroquoril 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 Antroquoril exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

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

Things you must not do

Do not use Antroquoril 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 Antroquoril, 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 Antroquoril is to be used on the nappy area of young children.

Do not use Antroquoril in or near the eyes.

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

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

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

Antroquoril 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
• visual disturbances or blurred vision

Antroquoril 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 Antroquoril

Storage

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

Do not store Antroquoril 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 Antroquoril 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 Antroquoril 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

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

Ingredients

Antroquoril Cream contains:

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

Supplier

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

Australian Registration Number

Cream - AUST R 70406

Date of Preparation

21 July 2022

RCN: 100001005AU

Published by MIMS September 2022

1 Name of Medicine

Betamethasone valerate.

2 Qualitative and Quantitative Composition

Antroquoril Cream contains betamethasone valerate equivalent to betamethasone 0.2 mg/g.

Excipients with known effect.

3 Pharmaceutical Form

Cream.

4 Clinical Particulars

4.1 Therapeutic Indications

Antroquoril is indicated for maintenance therapy for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses such as atopic eczema, infantile eczema, nummular eczema, anogenital and senile pruritus, contact dermatitis, seborrhoeic dermatitis, neurodermatitis, solar dermatitis, stasis dermatitis and psoriasis.

4.2 Dose and Method of Administration

Apply a small amount to the affected area two or three times daily.
Refractory lesions of psoriasis and other deep seated dermatoses, such as chronic lichen simplex, hypertrophic lichen planus, atopic dermatitis, chronic eczematous and lichenified hand eruptions, recalcitrant pustular eruptions of the palms and soles, respond better if occlusive dressings are used.

Occlusive dressings.

4.3 Contraindications

Hypersensitivity to betamethasone valerate, other corticosteroids or any components in Antroquoril. Like other topical corticosteroids, Antroquoril is contraindicated in most viral infections of the skin, such as vaccinia, varicella and herpes simplex, also tuberculosis and acne rosacea.

4.4 Special Warnings and Precautions for Use

Antroquoril should not be used in or near the eyes.
If irritation or sensitisation develops with the use of Antroquoril, 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, Antroquoril should be discontinued until the infection has been controlled adequately.
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.
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.
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.

Paediatric use.

Use in the elderly.

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 local adverse reactions have been reported with the use of topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, 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

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, liquid paraffin, monobasic sodium phosphate dihydrate, phosphoric acid, purified water, white soft paraffin.

6.2 Incompatibilities

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

6.3 Shelf Life

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

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Antroquoril Cream, 0.02% (0.2 mg/g): 100 g, Aluminium Tube.

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

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes