SUMMARY CMI

Antroquoril^®

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 Antroquoril?

Antroquoril contains the active ingredient betamethasone valerate. Antroquoril is used on the skin to relieve the redness, swelling, itching and discomfort of many skin problems.

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

2. What should I know before I use Antroquoril?

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

3. What if I am taking other medicines?

Some medicines may interfere with Antroquoril 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 Antroquoril?

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

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

5. What should I know while using Antroquoril?

For more information, see Section 5. What should I know while using Antroquoril? 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

Antroquoril^®

Active ingredient(s): betamethasone valerate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Antroquoril. 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 Antroquoril.

Where to find information in this leaflet:

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

1. Why am I using Antroquoril?

Antroquoril contains the active ingredient betamethasone valerate. Antroquoril 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) and other types of dermatitis.

2. What should I know before I use Antroquoril?

Warnings

Do not use Antroquoril:

• If you are allergic to betamethasone valerate, any other corticosteroid(s), or any of the ingredients listed at the end of this leaflet. Some symptoms of an allergic reaction include wheezing, skin rash and hives.
• Always check the ingredients to make sure you can use this medicine.

Unless your doctor tells you to, 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

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

Check with your doctor if you:

• have any other medical conditions especially if you have an infection
• take any medicines for any other condition
• have allergies to any other medicines or any other substances, such as foods, dyes or preservatives.

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.

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

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor will discuss the risks and benefits of using this medicine when pregnant or breast-feeding.

Do not apply this medicine to the breasts before 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.

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.

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

4. How do I use Antroquoril?

How much to use

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

How to use Antroquoril

• 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.
• Your doctor or pharmacist will tell you how long to use Antroquoril. Do not use Antroquoril for longer than your doctor tells you.
• Do not use Antroquoril just before having a bath, shower or going swimming. If you do you may reduce the effectiveness of this medicine.

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

If you forget to use Antroquoril

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 Antroquoril

If you or someone else has swallowed Antroquoril, you may need urgent medical attention.

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 Antroquoril?

Things you should do

Discontinue Antroquoril immediately if it causes irritation or sensitisation.

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.

Remind any doctor, dentist or pharmacist you visit that you are using Antroquoril.

Things you should 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 tightly 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 Antroquoril.
• 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.

Looking after your medicine

• Keep Antroquoril in a place where the temperature stays below 25°C

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 Antroquoril if the packaging is torn or shows signs of tampering.

Keep it where young children cannot reach it.

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 Antroquoril contains

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

What Antroquoril looks like

Antroquoril Cream is a white to off-white cream. It is packed in 100 g tubes. (Aust R 70406).

Who distributes Antroquoril

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

This leaflet was prepared in July 2022.

RCN: 100001004AU

Published by MIMS August 2024

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