Consumer medicine information

Zatamil

Mometasone furoate

BRAND INFORMATION

Brand name

Zatamil

Active ingredient

Mometasone furoate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Zatamil.

What is in this leaflet

This leaflet answers some common questions about Zatamil.

It does not contain all the available information.

It does not take the place of talking to your pharmacist or doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you using Zatamil against the benefits he expects it will 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 is Zatamil used for?

The name of this medicine is Zatamil. It contains the active ingredient called mometasone furoate.

Zatamil is a type of 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 other hairy parts of the body.

Zatamil 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, however, may have prescribed Zatamil for another purpose. Ask your doctor if you have any questions about why Zatamil has been prescribed for you.

Zatamil is available only with a doctor's prescription.

Zatamil is not addictive.

Before you use Zatamil

When you must not use Zatamil

  1. Do not use Zatamil if you have had an allergic reaction to :
  • mometasone furoate
  • any other corticosteroids
  • any of the ingredients in Zatamil listed at the end of this leaflet
  1. Do not use Zatamil:
  • if you have a viral skin infection (such as cold sores, shingles or chicken pox)
  • if you have a fungal skin infection (such as thrush, tinea or ringworm)
  • on acne
  • for inflammation around the mouth
  • for skin conditions with ulcers
  • for tuberculosis of the skin

Check with your doctor that you do not have any of these conditions.

Before you start to use Zatamil

Tell your pharmacist or doctor :

  • If you have any allergies to any other medicines
  • If you have allergies to any other substances, such as foods, preservatives or dyes.

Tell your doctor:

  • if you are pregnant, intend to become pregnant or are breast feeding
    Your doctor will tell you if you can use Zatamil during pregnancy or while you are breast feeding.
    Do not apply Zatamil to the breasts before breast feeding.

Using other medicines

Tell your pharmacist or doctor if you are using other creams, ointments or lotions or taking any medicine. This includes any medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

How to use Zatamil

How to 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.

If you do not understand the instructions on the box/bottle, ask your pharmacist or doctor for help.

It is important to use Zatamil 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.

How long to use Zatamil

Do not use Zatamil for more than four weeks unless your doctor has told you to use it longer. If you are not sure how long to use Zatamil, talk to your doctor. If you use Zatamil for longer than you have been told, the chance of side effects may increase.

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.

However, 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 - Immediately telephone your doctor or Poisons Information Centre (telephone: 13 11 26 Australia), or go to Casualty at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep these telephone numbers handy.

While you are using Zatamil

Things you must 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 the Zatamil was not effective and change your treatment unnecessarily.

  • If your skin condition worsens or becomes infected, tell your doctor.
  • If you become pregnant while using Zatamil, tell your doctor.

Things you must 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 pharmacist or doctor 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.

Side effects

Zatamil helps most people with skin problems but it may have unwanted side effects in a few people.

If they occur, most side effects are likely to be minor and temporary. However, some may be serious and need medical attention.

Zatamil is generally well tolerated.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • itching
  • burning
  • tingling/stinging
  • thinning of the skin
  • appearance of small blood vessels on the surface of the skin
  • stretch marks or streaks on the skin
  • acne/pimples/lumps on the skin/blisters containing pus
  • redness
  • boils/abscesses
  • dermatitis
  • increased size of affected area / worsening of disease
  • numbness
  • dry skin
  • inflamed hair roots.
  • Blurred vision or other vision disturbances

Tell your doctor if you notice anything else that is making you feel unwell while using Zatamil, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Ask your pharmacist or 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 Zatamil

Storage

Zatamil Hydrogel

  • Keep Zatamil Hydrogel in a dry place where the temperature stays below 25°C.

Zatamil Ointment

  • Keep Zatamil Ointment in a dry place where the temperature stays below 25°C.

Zatamil Lotion

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

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.

Disposal

If your doctor tells you to stop using Zatamil or it has passed its expiry date, ask your pharmacist what to do with any product that is left over.

Product description

What Zatamil looks like:

Zatamil Hydrogel:
A clear colourless soft gel packed in a 5g,15g, and 45g tube.

Zatamil Ointment:
White to off-white ointment packed in a 5g, 15g, and 45g tube.

Zatamil Lotion:
A light clear lotion packed in a 30mL dropper bottle.

Ingredients:

Zatamil Hydrogel contains:

  • Mometasone furoate
  • Hexylene Glycol
  • Purified Water
  • Hypromellose
  • Citric acid

Zatamil Lotion contains:

  • Mometasone furoate
  • Industrial methylated spirits
  • Propylene glycol
  • Purified water
  • Hypromellose
  • Citric acid (anhydrous)

Zatamil Ointment contains:

  • Mometasone furoate
  • Soft white paraffin
  • Light liquid paraffin
  • Hexylene glycol
  • Polyethylene
  • Cetostearyl alcohol
  • Purified water
  • Silica (colloidal anhydrous)
  • Citric acid (anhydrous)

Manufacturer / Distributor / Supplier

Manufactured and distributed in Australia by:

Ego Pharmaceuticals Pty Ltd
21-31 Malcolm Road, Braeside 3195

© Ego Pharmaceuticals

Australian Registration Numbers

Zatamil Hydrogel AUST R 195415

Zatamil Ointment AUST R 195416

Zatamil Lotion AUST R 195414

Date of Approval of leaflet:
10/05/2012

Date of Revision:
28/09/2018.

Published by MIMS December 2018

BRAND INFORMATION

Brand name

Zatamil

Active ingredient

Mometasone furoate

Schedule

S4

 

1 Name of Medicine

Mometasone furoate.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

83919-23-7.

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.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Mometasone furoate is a synthetic 16α-methyl analogue of beclomethasone for topical use exhibiting anti-inflammatory, antipruritic and vasoconstrictor properties.
In laboratory animals, mometasone furoate exhibits potent topical anti-inflammatory activity but approximately half of the suppressive effect on the hypothalamic pituitary adrenal (HPA) axis when compared with equivalent doses of betamethasone valerate. The topical to systemic potency ratio of mometasone furoate is approximately three to ten times that of betamethasone valerate in animal studies.
Mometasone has high lipophilicity and displays greater in vitro affinity for glucocorticoid receptors in rat epidermis than betamethasone dipropionate. In humans, using inhibition of UV-B induced erythema as an indicator of anti-inflammatory effect, 0.1% mometasone was found to be equipotent with methylprednisolone aceponate 0.1%ii and 2 to 4-fold better than betamethasone valerate 0.1% and betamethasone dipropionate 0.05%iii in preventing inflammation.

Clinical trials.

The Administrative Appeals Tribunal decision provided that equivalence could be established on the satisfactory completion of vasoconstriction assays conducted in accordance with the U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry, Guidance Topical Dermatologic Corticosteroids: in vivo bioequivalence, Issue Date: 2 June 1995.
The sponsor submitted satisfactory vasoconstriction assays in compliance with the U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry, Guidance Topical Dermatologic Corticosteroids: in vivo bioequivalence, Issue Date: 2 June 1995.

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 studyiv, 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 studyv 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.

No data available.

Carcinogenicity.

No data available.

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.

4.3 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.

Clinical studies in adults have typically included elderly patients. No overall differences in safety or effectiveness were observed between these subjects and younger subjects and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of older individuals cannot be ruled out.

Paediatric use.

The use of mometasone furoate 0.1% once daily has been documented in a number of studies in children from 7 months to 12 years of age, with moderate to severe dermatitis involving at least 15% of the body surface area. Duration of treatment was usually only for 3 weeks, with up to 6 weeks in one study. No skin thinning was observed in any of these studies or change in plasma cortisol levels, where this was monitored. In general, mometasone furoate was well tolerated. Local reactions were minor, e.g. stinging, and occurred in few patients. However, although mometasone appears to be safe in young children and may have less effect on the HPA axis than other corticosteroids of similar strength, caution is advised when prescribing mometasone or any other corticosteroid for prolonged use in children. Care should be taken that application sites in infants and young children are not occluded with tightly fitting napkins or plastic pants.

Effects on laboratory tests.

No data available.

Visual disturbance.

Visual disturbance may be reported with systemic and topical 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 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.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B3)
Category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals have shown evidence of an increased occurrence of foetal damage, the significance of which is considered uncertain in humans.
As with corticosteroids in general, studies with mometasone furoate in animals have shown teratogenic effects when administered systemically at relatively low dosage levels. There are no adequate and well controlled studies of the teratogenic effects of corticosteroids in pregnant women. Topical corticosteroids should be used with caution during pregnancy and only if the potential benefit to the patient outweighs the potential risk to the foetus.
Drugs of this class should not be used on pregnant patients in large amounts or for prolonged periods of time.
Systemically administered corticosteroids are secreted into breast milk but the quantities are too low to have a deleterious effect on the infant. It is not known if topically applied mometasone furoate will be absorbed in sufficient quantity to produce detectable levels in breast milk. Therefore, topical mometasone furoate should be used with caution during breastfeeding and only if the potential benefits to the mother outweigh the potential risks to the infant. Temporary cessation of breastfeeding during treatment may also be considered.

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.

Mild to moderate stinging, itching, burning, mild skin atrophy and acneform reactions have been reported in less than 5% of patients.
Other less common reactions reported in less than 1% of patients include erythema, furunculosis, dermatitis, abscess, aggravated allergy, disease exacerbation, paraesthesia, dry skin, pimples, folliculitis and papular and pustular formation.
Infrequent local reactions reported with other topical corticosteroids: irritation, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae and miliaria.

Systemic adverse reactions.

Similarly to other topical corticosteroids, mometasone furoate has the potential to suppress the HPA axis. However, in clinical studies of up to 6 weeks duration, the application of mometasone 0.1% once daily, without occlusion, did not affect plasma cortisol.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

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.

4.7 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.

4.9 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).

7 Medicine Schedule (Poisons Standard)

S4.

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.

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.

Summary Table of Changes