SUMMARY CMI

Zatamil*

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 Zatamil?

Zatamil contains the active ingredient mometasone furoate. Zatamil is used on the skin to relive 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 Zatamil? in the full CMI.

2. What should I know before I use Zatamil?

Do not use if you have ever had an allergic reaction to mometasone furoate or any of the ingredients listed in Section 7. Product details.

Do not use if you have a viral skin condition, a fungal skin condition, on acne, inflammation around the mouth, a skin condition with ulcers, or your have tuberculosis of the skin.

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 Zatamil? in the full CMI.

3. What if I am taking other medicines?

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

Refer to Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Zatamil?

• Apply a light film of Zatamil Hydrogel or Ointment or a few drops of Zatamil Lotion to the affected area once a day and rub in lightly.

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

5. What should I know while using Zatamil?

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

6. Are there any side effects?

Most side effects are likely to be minor and temporary. Consult your doctor immediately if you have blurred vision, or other vision disturbances.

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

Zatamil*

Active ingredient(s): mometasone furoate 0.1% w/w

Consumer Medicine Information (CMI)

This leaflet provides important information about using Zatamil. 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 Zatamil.

Where to find information in this leaflet:

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

1. Why am I using Zatamil?

Zatamil contains the active ingredient mometasone furoate. Zatamil is a cortisone and belongs to the group of medicines called corticosteroids.

There are three dosage forms of Zatamil: gel, ointment and lotion.

Zatamil Lotion is formulated for easier application to the scalp and hairy parts of the body.

Zatamil is used on the skin to relieve 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, however, may have prescribed Zatamil for another purpose. Ask your doctor if you have any questions about why Zatamil has been prescribed for you.

A doctor's prescription is required for the 45g tube of Zatamil Hydrogel and Ointment, as well as Zatamil Lotion.

The 15g tube of Zatamil Hydrogel and Ointment can be purchased without a doctor's prescription.

Zatamil is not addictive.

2. What should I know before I use Zatamil?

Warnings

Do not use Zatamil if:

1. You are allergic to mometasone furoate, any other corticosteroids, or any of the ingredients listed in Section 7. Product details
2. Always check the ingredients to make sure you can use this medicine.
3. You have a viral skin infection (such as cold sores, shingles or chicken pox)
4. You have a fungal skin infection (such as thrush, tinea or ringworm)
5. You have acne
6. You have inflammation around the mouth
7. You have a skin condition with ulcers
8. You have tuberculosis of the skin

Check with your doctor if you:

• Have any other medical conditions, particularly the skin conditions listed above.
• Have allergies to any other medicines.
• If you have allergies to any other substances, such as foods, preservatives or dyes.

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.

Do not apply Zatamil to the breasts before breastfeeding.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are 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 Zatamil.

4. How do I use Zatamil?

How much to use

• Apply a light film of Zatamil Hydrogel or Ointment or a few drops of Zatamil Lotion
• Follow the instructions provided and use Zatamil until your doctor tells you to stop.
• If you do not understand the instructions on the pack, ask your pharmacist or doctor for help.

When to use Zatamil

• Zatamil should be used once a day, as prescribed by your doctor.

If you forget to use Zatamil

If you forget to apply Zatamil, use it as soon as you remember, and then continue using it at the usual time each day.

If it is almost time for your next application, skip the one you missed and continue with your regular schedule at the usual time.

Apply the same amount of Zatamil as usual. Do not apply more Zatamil to make up for the amount you missed.

If you swallow Zatamil

Zatamil must not be swallowed or taken internally. It is for use on the skin only.

If anyone accidentally swallows Zatamil 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 Zatamil?

Things you should do

• Tell all doctors and pharmacists who are treating you that you are using Zatamil.
• If your condition does not improve after one week of using Zatamil daily, tell your pharmacist or doctor.
• Tell your pharmacist or doctor if, for any reason, you have not used the medicine exactly as prescribed. Otherwise, your pharmacist or doctor may think that Zatamil was not effective and change your medicine unnecessarily.
• If your skin condition worsens or becomes infected, tell your doctor.

Things you should not do

• Do not use Zatamil under dressings or on large areas of skin, particularly in infants and children, unless your doctor tells you.
• Do not use Zatamil under a nappy or under plastic pants, in the case of infants or young children, unless the doctor tells you.
• Do not use Zatamil in or around the eyes.
• Do not use Zatamil on anyone else, even if they appear to have the same symptoms as yours.
• Do not use Zatamil to treat other complaints, unless your doctor tells you to.
• Do not use Zatamil just before having a bath, shower or going swimming. If you do, you may reduce the effectiveness of Zatamil.
• Do not use Zatamil if the packaging is torn or shows signs of tampering.
• Do not use Zatamil if the expiry date (EXP) printed on the pack has passed. If you use this medicine after the expiry date has passed, it may not work as well.

Things to be careful of

• Do not use large amounts of Zatamil 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 or pharmacist if you are concerned about the length of time you have been using Zatamil.
• Do not use Zatamil on skin areas that rub together, such as under the arm or in the groin area, unless your doctor has told you to apply it there.
• Do not use Zatamil on your face unless your doctor has told you to.

Looking after your medicine

• Keep Zatamil Hydrogel in a dry place where the temperature stays below 25°C
• Keep Zatamil Ointment in a dry place where the temperature stays below 25°C
• Keep Zatamil Lotion in a cool dry place where the temperature stays below 25°C. Do not refrigerate.

Follow the instructions in the carton on how to take care of your medicine properly.

Do not store Zatamil in the car or on window sills, where it can get very hot, as this may destroy the medicine.

Keep Zatamil where young 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.

When to discard your medicine (as relevant)

Discard Zatamil if your doctor tells you to stop using it, or the product has passed its expiry date.

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.

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

Serious side effects

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

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 Zatamil Hydrogel contains

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

What Zatamil Lotion contains

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

What Zatamil Ointment contains

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

What Zatamil looks like

Zatamil Hydrogel (AUST R 195415) is a clear colourless soft gel packed in a tube.

Zatamil Lotion (AUST R 329568) is a light clear lotion packed in a dropper bottle.

Zatamil Ointment (AUST R 195416) is a white to off-white ointment packed in a tube.

Who distributes Zatamil

Manufactured and distributed in Australia by:
Ego Pharmaceuticals Pty Ltd
13-31 Malcolm Road, Braeside 3195

This leaflet was prepared in October 2020.

Published by MIMS December 2020

1 Name of Medicine

Mometasone furoate.

2 Qualitative and Quantitative Composition

Mometasone furoate 0.1% (1 mg/g).
Mometasone furoate is a white to off-white powder which is practically insoluble in water, soluble in acetone and in methylene chloride, slightly soluble in ethanol (96 per cent).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Zatamil Hydrogel is a clear, colourless to straw-coloured gel.
Zatamil Ointment is an opaque white to off-white ointment.
Zatamil Lotion is a clear, colourless to straw-coloured lotion.

4 Clinical Particulars

4.1 Therapeutic Indications

Short-term (up to four continuous weeks) relief of inflammation and pruritic manifestations of corticosteroid responsive dermatoses, such as psoriasis and atopic dermatitis.
Zatamil Lotion is suitable for use in scalp psoriasis and applications to other areas of the body.

4.2 Dose and Method of Administration

Apply a thin film of the ointment or gel to the affected skin once daily. For Zatamil Lotion a few drops should be applied to the affected skin areas including scalp sites once daily; massage gently and thoroughly until the medication disappears.

4.3 Contraindications

Hypersensitivity to mometasone furoate or to other corticosteroids.
As with other corticosteroids, Zatamil is contraindicated in most viral infections of the skin, tuberculosis, acne rosacea, perioral dermatitis, fungal skin infections and ulcerative conditions.

4.4 Special Warnings and Precautions for Use

For external use only. Avoid contact with eyes.
If irritation or sensitisation develops, treatment should be discontinued and appropriate therapy instituted.
In the presence of an infection, an antibacterial or antifungal agent, as appropriate should be added to the treatment regimen. If the infection does not resolve promptly, corticosteroid therapy should be discontinued until the infection is controlled.
As with all topical corticosteroids in general, systemic absorption will be increased if the product/s is/are applied to large areas of the body, under occlusion, where the epidermal barrier is compromised and where the treatment is long-term. These considerations are especially important in infants and children due to the larger skin surface to bodyweight ratio and the possibility of occlusive napkins and plastic pants being used. Use of corticosteroids in children should be limited to the least amount required for therapeutic effect.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

Visual disturbance.

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)

See Table 1.
In general, mometasone furoate 0.1%, applied once daily, without occlusion, appears to be well tolerated.

Local adverse reactions.

Systemic adverse reactions.

Reporting suspected adverse effects.

4.9 Overdose

Prolonged use over large areas of the body can suppress pituitary adrenal function resulting in secondary adrenal insufficiency. Infants and young children are likely to be particularly susceptible to HPA axis suppression, Cushing's syndrome and growth suppression under these conditionsⁱ. 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.
If a large amount of Zatamil is accidentally ingested, particularly by a child, contact the Poisons Information Centre. For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Following topical application of radiolabelled mometasone furoate in animals, systemic absorption was minimal in all species studied, ranging from approximately 2% in dogs to 11% in rabbits over a five to seven day period.
In a human study^iv, only 0.7% of [H³]mometasone was absorbed into the systemic circulation, after an 8-hour contact time, from an ointment base applied to intact skin, without occlusive dressing. However, only 1.6% of the dose had diffused into the skin while 94% remained on the skin surface. In a similar study, 0.4% was absorbed systemically from a 0.1% mometasone cream.
Another study^v in healthy volunteers found that after repeated application of 10 g/day of 0.1% mometasone ointment, under occlusion, for 20 hours/day. For 5 days plasma levels of about 100 picogram/mL of mometasone furoate were achieved. No metabolites were detected in plasma. Only 0.00076% of the total topically administered dose was excreted in the urine as mometasone furoate, its 6β-hydroxy metabolite and mometasone itself. Cortisol levels were not affected. In this study, after a single application of 24 hours duration, plasma concentrations peaked at 130 picogram/mL after 12 hours and declined rapidly after removal of the ointment to 15 picogram/mL after 72 hours. These authors concluded that 0.1% mometasone furoate ointment had little possibility of causing systemic effects when used in the manner employed in this study.
However inflammation and/or other disease processes in the skin may increase percutaneous absorption. Over the longer-term, occlusive dressings substantially increase percutaneous absorption.
The low levels absorbed systemically after topical administration and the rapid elimination can be considered responsible for the low systemic activity and minimal effect on the hypothalamic pituitary adrenal (HPA) axis.^vi
In animal studies, 75% of a subcutaneously or peritoneally administered does was excreted in the faeces, after metabolism in the liver.^vi Due to the very low levels detected in plasma, metabolism in humans has not been studied.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each gram of Zatamil Hydrogel contains mometasone furoate 1 mg in a gel base of hexylene glycol, purified water, hypromellose and citric acid.
Each gram of Zatamil Ointment contains mometasone furoate 1 mg in an ointment base of soft white paraffin, light liquid paraffin, hexylene glycol, polyethylene, cetostearyl alcohol, purified water, colloidal anhydrous silica, citric acid.
Each gram of Zatamil Lotion contains mometasone furoate 1 mg in a lotion base of ethanol, propylene glycol, purified water, hypromellose and citric acid.

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

Zatamil Hydrogel: Store below 25°C.
Zatamil Ointment: Store below 25°C.
Zatamil Lotion: Store below 25°C. Do not refrigerate.

6.5 Nature and Contents of Container

Zatamil Hydrogel: 45 g, 15 g and 5 g* in laminate tube with a tamper evident seal packed into a carton.
Zatamil Ointment: 45 g, 15 g and 5 g* in laminate tube with a tamper evident seal packed into a carton.
Zatamil Lotion: 30 mL in plastic dropper bottle packed into a tamper evident carton.
*Not currently 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

Chemical structure.

CAS number.

References

i. Memorandum: Department of Health and Human Services. Public Health Service. Food and Drug Administration. Centre for Drug Evaluation and Research. September 26, 2003. Postmarketing Safety review PID D030565.
ii. Keckes A, Heger-Mahn D, Kleine Kuhlmann R and Langer L: Comparison of the local and systemic side effects of methylprednisolone aceponate and mometasone furoate applied as ointments with equal anti-inflammatory activity. Journal of the American Academy of Dermatology 29:576:58-580. 1993.
iii. Bjerring P: Comparison of the bioactivity of mometasone furoate 0.1% fatty cream, betamethasone dipropionate 0.05% cream and betamethasone valerate 0.1% cream in humans. Skin Pharmacology. 6:187-192, 1993.
iv. Samson C, Peets E, Winter-Sperry R and Wolkoff H: Mometasone furoate - Elocon - A medium potency topical corticosteroid with favourable efficacy/safety profile : In Topical Corticosteroids. Maibach HI and Surber C (eds). Basel, Karger. 1992. pp462-479.
v. Higashi N, Katagiri K: Percutaneous absorption of a 0.1% mometasone furoate ointment fate, excretion and adrenocortical suppression [in Japanese]. Skin Research 32(3):394-402. 1990.
vi. Degreef H and Dooms-Gooseens A: The new corticosteroids: Are they effective and safe. Dermatologic Clinics. 11(1):155-160.

7 Medicine Schedule (Poisons Standard)

Zatamil Hydrogel.

Zatamil Ointment.

Zatamil Lotion.

Summary Table of Changes