Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about APOHEALTH Hydrocortisone 1% Cream. 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 taking this medicine 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 is this medicine

The name of your medicine is APOHEALTH Hydrocortisone 1% Cream. It contains the active ingredient called hydrocortisone acetate. It is available as a cream.

APOHEALTH Hydrocortisone 1% Cream is a type of cortisone and belongs to the group of medicines called corticosteroids.

What this medicine is used for

APOHEALTH Hydrocortisone 1% Cream is a topical corticosteroid therapy for non-infected inflammatory conditions of the skin e.g. eczema, dermatitis.

APOHEALTH Hydrocortisone 1% Cream is used on the skin to relieve the redness, swelling, itching and discomfort of skin problems such as rashes due to eczema, dermatitis, soap, detergent, cosmetics, jewellery, insect bites, itching anal and genital areas not due to infection, and sunburn.

Your doctor or pharmacist however, may have recommended APOHEALTH Hydrocortisone 1% Cream for another purpose.

Ask your pharmacist or doctor if you have any questions about why APOHEALTH Hydrocortisone 1% Cream has been recommended or prescribed to you.

APOHEALTH Hydrocortisone 1% Cream is only available from your pharmacist.

Before you use this medicine

When you must not use it

Do not use this medicine if you have an allergy to:

• any medicine containing hydrocortisone acetate.
• any of the ingredients listed at the end of this leaflet.
• any other similar medicines.

Do not use this medicine on:

• Untreated bacterial infections
• Parasitic skin infections (such as scabies)
• Viral skin infection (such as herpes simplex, cold sores, shingles or chicken pox)
• Tuberculous conditions of the skin
• Vaccinia (cowpox: a viral disease passed from cattle)
• Varicella (a rare form of chicken pox)
• Acne or rosacea
• Cuts or open wounds.

Do not use APOHEALTH Hydrocortisone 1% Cream on psoriasis unless recommended by your doctor.

APOHEALTH Hydrocortisone 1% Cream should not be used if you suffer from poor circulation of blood in the skin region, as it may result in skin ulcers.

Do not use occlusive dressings or waterproof bandages unless a doctor has told you to.

Ask your doctor (or pharmacist) to be sure that you do not have any of these conditions.

Do not use APOHEALTH Hydrocortisone 1% Cream after the expiry date printed on the pack. It may have no effect at all, or worse, it may give an entirely unexpected effect if you use after the expiry date.

Do not use APOHEALTH Hydrocortisone 1% Cream if the packaging shows sign of tampering or the seal on the tube is broken, or if the product does not look quite right.

Before you start to use it

Tell your doctor or pharmacist if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor or pharmacist if you have or have had any of the following medical conditions:

• any other health problems such as diabetes or problems with your immune system
• serious eye conditions including cataract, glaucoma or central serous chorioretinopathy (CSCR).

Tell your doctor or pharmacist if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor can discuss with you the risks and benefits involved.

If APOHEALTH Hydrocortisone 1% Cream is to be applied to the breast, do not apply the cream to the breast before breast feeding. Ensure that the breast area is free of the cream before breastfeeding.

Using other medicines

Tell your doctor (or pharmacist) if you are using other creams, ointments or lotions or taking any medicine, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with APOHEALTH Hydrocortisone 1% Cream if it is used excessively or for prolonged periods. Some of these medicines include medicines to treat epilepsy, diuretics, oral contraceptive pills and immunosuppressants.

Your doctor or pharmacist has a list of medicines that may interfere with APOHEALTH Hydrocortisone 1% Cream.

If you have not told your doctor (or pharmacist) about any of the above, tell them before you start using APOHEALTH Hydrocortisone 1% Cream.

Use in Children

Do not use in children under 2 years unless your doctor tells you to do so.

How to use this medicine

How to use it

Apply a thin layer to affected areas two to four times a day or as directed. Rub in gently. Reduce the number of applications as the disorder subsides.

Do not apply this cream under occlusive dressings or waterproof bandages unless on the advice of a doctor.

It is important to use APOHEALTH Hydrocortisone 1% Cream exactly as your doctor (or pharmacist) has told you.

If you use it less 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.

Use APOHEALTH Hydrocortisone 1% Cream at the same time every day.

How long to use it

Do not use APOHEALTH Hydrocortisone 1% Cream for more than 7 days except on the advice of a doctor. If your condition persists, see your pharmacist or doctor.

Reduce the number of applications as the disorder subsides. If you use APOHEALTH Hydrocortisone 1% Cream for a long time, the chance of side effects increases.

If you forget to use it

If you forget to use APOHEALTH Hydrocortisone 1% Cream, use it as soon as you remember and then go back to your normal times for applying APOHEALTH Hydrocortisone 1% Cream.

Do not try to make up for the amount you missed by using more than you normally use.

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 APOHEALTH Hydrocortisone 1% Cream.

While you are using this medicine

Things you must do

Tell all your doctors and pharmacists who are treating you that you are using APOHEALTH Hydrocortisone 1% Cream.

Tell your doctor if you feel that APOHEALTH Hydrocortisone 1% Cream is not helping your condition.

Tell your doctor if you become pregnant while using APOHEALTH Hydrocortisone 1% Cream.

Things you must not do

Do not use APOHEALTH Hydrocortisone 1% Cream under dressings or on large areas of skin unless your doctor tells you.

Do not use APOHEALTH Hydrocortisone 1% Cream in or near the eyes.

Do not give APOHEALTH Hydrocortisone 1% Cream to anyone else even if their symptoms seem similar to yours.

Do not use APOHEALTH Hydrocortisone 1% Cream to treat other conditions unless your doctor tells you.

Your doctor or pharmacist has recommended APOHEALTH Hydrocortisone 1% Cream 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 of APOHEALTH Hydrocortisone 1% Cream for a long time. If you use large amounts for long time, the chance of systemic 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 APOHEALTH Hydrocortisone 1% Cream.

Only use APOHEALTH Hydrocortisone 1% Cream under the arm or in the groin if your doctor tells you.

Possible side effects

Tell your doctor or pharmacist if you do not feel well while you are using APOHEALTH Hydrocortisone 1% Cream.

APOHEALTH Hydrocortisone 1% Cream helps most people with skin problems but it may have some unwanted side effects in a few people.

Side effects reported by some people using APOHEALTH Hydrocortisone 1% Cream include:

• itching
• burning
• dryness
• acne-form eruptions
• thinning of the skin
• blurred vision

In addition to the above side effects prolonged or over-use of this product may cause the following side effects in some people:

• high blood pressure
• elevated cholesterol and triglyceride levels in the blood
• cataracts
• glaucoma
• central serous chorioretinopathy (CSCR)

APOHEALTH Hydrocortisone 1% Cream may cause other side effects. If you have any other side effects, check with your doctor.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Storage and disposal

Storage

Keep APOHEALTH Hydrocortisone 1% Cream where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Keep APOHEALTH Hydrocortisone 1% Cream in a cool dry place where the temperature stays below 25 °C.

Do not leave APOHEALTH Hydrocortisone 1% Cream in the car or on windowsills. Heat can destroy some medicines.

Disposal

If your doctor tells you to stop using APOHEALTH Hydrocortisone 1% Cream or it has passed its expiry date, ask your pharmacist what to do with any APOHEALTH Hydrocortisone 1% Cream left over.

Further information

This is not all the information that is available on APOHEALTH Hydrocortisone 1% Cream. If you need more information, ask a doctor or pharmacist.

Product description

What it looks like

APOHEALTH Hydrocortisone 1% Cream is a soft white cream.

APOHEALTH Hydrocortisone 1% Cream is packed in 30g tubes.

Ingredients

Hydrocortisone acetate 1% or 10 mg/g is the active ingredient in APOHEALTH Hydrocortisone 1% Cream.

It also contains the following inactive ingredients:

• soft white paraffin,
• liquid paraffin,
• cetomacrogol 1000,
• cetostearyl alcohol,
• chlorocresol (preservative),
• citric acid and
• sodium citrate dihydrate

Australian Registration Numbers

APOHEALTH Hydrocortisone 1% Cream

AUST R 295687

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

The APOTEX and APOHEALTH trademarks are used under licence.

This leaflet was last updated in:
June 2018.

Published by MIMS April 2019

1 Name of Medicine

Hydrocortisone acetate.

2 Qualitative and Quantitative Composition

1.0% w/w hydrocortisone acetate in a water miscible, lanolin free cetomacrogol base.

Excipients with known effect.

3 Pharmaceutical Form

APOHealth Hydrocortisone 1% Cream is a soft white cream with a faint odour of chlorocresol.

4 Clinical Particulars

4.1 Therapeutic Indications

Topical corticosteroid therapy for the temporary relief of symptoms of non-infective inflammatory conditions of the skin (e.g. minor skin irritations, itching and rashes due to eczema, dermatitis, contact dermatitis [such as rashes due to soap, detergent, cosmetics and jewellery], insect bites, itching anal and genital areas and sunburn).

4.2 Dose and Method of Administration

Adults and children from 2 years of age: apply a thin layer to affected areas 2 - 4 times daily. Reduce the number of applications as the disorder subsides.
The cream should not be used under occlusive dressings or waterproof bandages unless advised to by a doctor.
This preparation should not be used for more than 7 days except on the advice of a doctor.
Rub in gently.

4.3 Contraindications

Tuberculous and fungal conditions of the skin, acute Herpes simplex, vaccinia, varicella and all viral infections.
Untreated bacterial infections.
Parasitic infestations (e.g. scabies).
In patients with markedly impaired circulation since skin ulceration has occurred in these patients following the use of corticosteroids.
Hypersensitivity to any component of the cream.
Not to be used in the eyes.
Not to be used for acne or rosacea.
The cream should not be used under occlusive dressings or waterproof bandages unless advised to by a doctor.
Topical steroids should be used with caution and occlusive dressings should not be used in patients with primary skin infections.

4.4 Special Warnings and Precautions for Use

For external use only. Avoid contact with eyes.
This medicine should not be used in the eyes. Use of the cream near the eyes should be avoided. This is due to the risk of corticosteroid-induced open-angle glaucoma.
If irritation develops APOHealth Hydrocortisone 1% Cream should be discontinued and alternative therapy instituted. Prolonged and heavy doses of hydrocortisone may have an immunosuppressant effect and thus decrease resistance to infection as well as mask signs of it. If infection of the skin is present suitable antifungal or antibacterial agents should be used first. Any occlusive dressings should be discontinued. If the infection does not respond promptly to therapy, corticosteroid therapy should be discontinued until the infection has been controlled.
Where very large areas are treated for long periods (e.g. atopic dermatitis), the possibility of systemic absorption exists, particularly if an occlusive dressing is applied. Prolonged use of large quantities of topical corticosteroids may also result in atrophic striae or acne eruptions.
Due to the possible systemic absorption of topical steroids, there may be a need for periodic evaluation of hypothalamo-pituitary-adrenal (HPA)-axis suppression by using the urinary free cortisol test or the corticotrophin stimulation test. If the HPA-axis suppression is evident, withdrawal should be attempted and the frequency of application reduced.
Any corticosteroid therapy tends to elevate blood glucose levels in diabetic patients, and this should be monitored during treatment.
Corticosteroids should be used cautiously in patients with non-specific ulcerative colitis, diverticulitis, colon abscess or other pyogenic infection, colon obstruction, or extensive fistulas and sinus tracts, fresh intestinal anastomoses, active or latent peptic ulcers, renal insufficiency, hypertension, osteoporosis and myasthenia gravis.
Topical corticosteroids should be used with caution in the management of psoriasis, as exacerbation of the disease or pustular psoriasis may occur during or on withdrawal of topical corticosteroid therapy.
Topical corticosteroids should also be used with caution in patients with impaired T cell function or in those patients receiving other immunosuppressive therapy. The immunosuppressive effects of corticosteroids may be associated with impairment of the normal function of T cells and macrophages. The result of this impairment may be the activation of latent infection or exacerbation of intercurrent infections, including those caused by Candida, Mycobacterium, Toxoplasma, Strongyloides, Pneumocystis, Cryptococcus, Nocardia and Amoeba.
Patients on long term therapy, if there is a risk of immunosuppression, should not be given any live attenuated vaccines.
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.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There are many potential drug interactions with hydrocortisone, however most are quite unlikely with topical therapy, occurring mainly with prolonged or over-use.
Carbamazepine, phenytoin and rifampicin all induce hepatic enzymes and thus lead to increased metabolism of hydrocortisone.
Concomitant use of diuretics, which also deplete potassium ion concentration in the blood, may cause hypokalaemia.
All corticosteroids antagonise the effects of neuromuscular blocking agents, such as vecuronium.
Oral contraceptives have been shown to prolong the half-life of hydrocortisone and thus potentiate its anti-inflammatory effects.

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)

An itching or burning sensation may be experienced when using this medication.
Topical corticosteroids may cause adverse dermatological effects. Adverse dermatological effects are most likely to occur in intertriginous and facial areas. Local adverse corticosteroid effects occur most frequently with occlusive dressings, especially with prolonged therapy, and may require discontinuation of the dressings. Atrophy of the epidermis, subcutaneous tissue and dermal collagen; drying and cracking or tightening of the skin may occur. Epidermal thinning, telangiectasia, increased fragility of cutaneous blood vessels, purpura and atrophic striae are also reported.
Other adverse dermatologic effects of topical corticosteroids include acneform eruption, vesiculation, irritation, pruritus, hypertrichosis, rosacea-like eruptions on the face, erythema, hyperthesia, perioral dermatitis, burning or stinging sensation, folliculitis, and hypopigmentation.
Adverse dermatological effects usually improve when the drug is discontinued but may persist for long periods; atrophic striae may be permanent. In addition to the other adverse dermatological effects of topical corticosteroid therapy, maceration of the skin and miliaria may occur, especially when occlusive dressings are used. Topically applied steroids are generally nonsensitising, but allergic contact dermatitis may occur rarely.
Topical corticosteroids should be used with caution in the management of psoriasis (see Section 4.4 Special Warnings and Precautions for Use).
Topical corticosteroids should also be used with caution in patients with impaired T cell function or in those patients receiving other immunosuppressive therapy. The result of this impairment may be the activation of latent infection or exacerbation of intercurrent infections (see Section 4.4 Special Warnings and Precautions for Use).
Any cardiovascular adverse events are unlikely with topical hydrocortisone therapy, however, prolonged prolific use may result in a transient hypertension as a result of fluid retention.
Long term corticosteroid use has resulted in Benign Intracranial Hypertension, with most reports occurring in children.
Corticosteroids have documented effects on serum lipids, including increased total cholesterol, increased low density lipoproteins and increased triglyceride levels.
Topical and systemic corticosteroid therapy has been implicated in posterior subcapsular cataract formation, elevated intraocular pressure, optic nerve damage and papilloedema.
Cataracts, although primarily reported with systemic corticosteroid use, have been reported with use of topical preparations.
Hydrocortisone has least potential for causing glaucoma, but reports have demonstrated this complication in patients using topical preparations on the face.
Post-marketing reports include the following adverse effect:

Eye disorders.

Reporting suspected adverse effects.

4.9 Overdose

Acute ingestion or accidental poisoning, even in massive doses, is rarely a clinical problem. Treatment should be symptomatic and supportive. Excessive chronic exposure results in adverse systemic effects. In such cases the use of topical corticosteroid should be discontinued, with the consideration to tapering the dose. Emesis or activated charcoal is not usually indicated unless multiple ingestion is suspected. Support the patient as necessary and treat symptomatically.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Soft white paraffin, liquid paraffin, cetomacrogol 1000, cetostearyl alcohol, chlorocresol, citric acid, sodium citrate dihydrate, purified water.

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

30 g 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

Hydrocortisone acetate is an odourless, white or almost white, crystalline powder. Hydrocortisone acetate 112 mg is approximately equivalent to 100 mg of hydrocortisone.
Hydrocortisone is a corticosteroid and is chemically described as 17-hydroxycorticosterone or 11,17,21-Trihydroxypregn-4-ene-3,20-dione. Hydrocortisone acetate is chemically described as hydrocortisone 21-acetate.
Solubility: Practically insoluble in water and in ether, soluble in ethanol (1 in 230) and in chloroform (1 in 200).
Molecular formula: C₂₃H₃₂O₆.
Molecular weight: 404.5.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S3.

Summary Table of Changes