STIEVA-A 0.1% 1mg/g cream tube

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
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[Tretinoin 0.025% w/w, 0.05% w/w,0.1% w/w]

Consumer Medicine Information

What is in this leaflet?

Please read this leaflet carefully

before you use Stieva-A Cream.

This leaflet answers some common

questions about Stieva-A. It does not

contain all of the available


It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the expected benefits of you using

Stieva-A Cream against the risks this

medicine could have for you.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What is Stieva-A

Cream used for?

Stieva-A Cream is used to treat acne


Stieva-A belongs to a group of

medicines called retinoids.

Stieva-A Cream helps to:

Make your skin less oily

Loosen blackheads and

whiteheads so that they come out

more easily

Stop new blackheads, whiteheads

and spots from forming

Lowers the number of red,

inflamed acne spots.

Stieva-A Cream is for use by adults

and adolescents with acne.

It is not for use by children.

Your doctor may have prescribed

Stieva-A Cream for another reason.

Stieva-A Cream is not addictive.

Before you use Stieva-

A Cream

Do not use if:

You must not use Stieva-A Cream if:

you have ever had an allergic

reaction to tretinoin or any of the

ingredients listed toward the end

of this leaflet. (See "Ingredients")

if you or any of your close

family have had skin cancer

if you are pregnant or trying to

become pregnant

if you are breast-feeding

the expiry date (EXP) printed

on the pack has passed

the packaging is torn or shows

signs of tampering

Tell your doctor if:

You must tell your doctor if:

you are allergic to foods, dyes,

preservatives or any other


you are using any other

medicines for acne.

You may need to use the two

products at different times of the

day (eg. one in the morning and

the other at bedtime).

you are taking any other

medicines, including medicines

you buy without a prescription.

Stieva-A Cream can affect how

other medicines work, or cause

skin irritation with other

medicines. This includes

medicines containing benzoyl

peroxide (also used to treat acne).

you are breastfeeding, pregnant

or trying to become pregnant.

you cannot tolerate or have skin

reactions in sunlight or are

allergic (hypersensitive) to

tretinoin or any of the other

ingredients of Stieva-A Cream

you suffer from eczema,

redness of the skin, broken

blood vessels and tiny pimples

usually on the central area of

the face (rosacea), or redness

and soreness around the mouth

(perioral dermatitis).

Stieva-A Cream may further irritate

these conditions.

How do I use Stieva-A


How much to use

Use Stieva-A Cream as directed by

your doctor or pharmacist.

Use Stieva-A Cream once daily at

night time over the whole of the

affected area. Your doctor will

tell you how many times to use

the medicine.

You should keep using the

medicine until your doctor tells

you otherwise.

How to apply it

Stieva-A Cream is for application

to the skin only.

Wash your hands.



Completely remove any make-


Wash the affected area with a

mild soap and warm water, and

gently dry.

Put a thin film of cream on the

affected skin, using your

fingertips, and smooth in.

Apply to all of the area of your

skin which has acne, not just

each spot.

Take care not to apply too much

cream especially where it could

run into your eyes, the angles of

your nose, any skin folds, or other

areas of the skin that do not

require treatment.

Applying too much cream or

applying it more frequently will

not help your spots clear up more

quickly, and may cause redness,

peeling and discomfort. If this

does happen, you may need to use

a non-pore-clogging moisturiser

(non-comedogenic) use the cream

less often, or stop using it for a

few days and then start again.

Wash your hands after using

the cream.

How long to use it for

It can take 6 to 8 weeks before

you see the full benefit of Stieva-

A Cream.

Do not stop using Stieva-A Cream,

or change the dose without first

checking with your doctor.

Use in children and elderly


Stieva-A Cream is for use by adults

and adolescents with acne.

It is not for use by children.

If you forget to use Stieva-A


Don't apply a double dose to

make up for forgotten doses.

Apply the next dose at the usual


What do I do if I take

too much? (Overdose)

Immediately telephone your doctor

or Poisons Information Centre call

131126 if you think you or anyone

else may have used too much

Stieva-A Cream, even if there are

no signs of discomfort or


The ingredients of Stieva-A Cream

are not expected to be harmful if

swallowed in the small amounts

applied to the face. If you do

accidentally get Stieva-A Cream in

your mouth, rinse at once with plenty

of water. Seek medical advice if you

swallow a large amount.

If you are not sure what to do,

contact your doctor or pharmacist.

While you are using

Stieva-A Cream

Things you must do

Tell your doctor if, for any reason,

you have not used your medicine

exactly as directed.

Tell your doctor if you are

pregnant or planning to become


Use a reliable method of

contraception properly while you

are using Stieva-A Cream to

prevent pregnancy.

If you do become pregnant during

treatment with Stieva-A Cream,

tell your doctor.

Breast-feeding is not recommended

during treatment with Stieva-A

Cream. Discuss with your doctor

whether you choose to breast-feed

or to use Stieva-A Cream.

Only use the cream on your skin.

Keep it away from areas such as

your mouth, lips, and eyes or inside

your nose.

Things you must not do

Do not give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Do not use Stieva-A Cream to treat

any other complaints unless your

doctor says to.

Do not use the cream on any

irritated areas of the skin, such as

cuts, grazes, sunburn, or broken


Do not use the cream on skin that

has had cosmetic treatment such as

depilation, chemical hair

treatment, chemical peel,

dermabrasion or laser resurfacing


Do not use too much Stieva-A

Cream on sensitive skin such as the

neck, or allow it to accumulate in

folds of your skin, including those

between the nose and lips.

Avoid skin products that contain

alcohol, spices or lime. These

products may irritate your skin

more if used with Stieva-A Cream.

Stieva-A Cream can cause

increased sensitivity to sunlight.

Avoid using sunlamps and

spending a long time in the sun

while using Stieva-A Cream. Use a

sunscreen product and protective

clothing to prevent sunburn.

Things to be careful of

Be careful driving or operating

machinery until you know how

Stieva-A Cream affects you.

What are the side


Check with your doctor as soon as

possible if you think you are

experiencing any side effects or

allergic reactions due to using

Stieva-A Cream, even if the

problem is not listed below.

Like other medicines, Stieva-A

Cream can cause some side effects. If

they occur, they are most likely to be

minor and temporary. However,



some may be serious and need

medical attention.

The most commonly reported side-

effects are:

redness of your skin

skin flaking

skin pain


skin irritation

skin tenderness

burning feeling on the skin,

especially when first applied


dry skin

These effects are normal. If they

cause you a problem, try using

Stieva-A Cream less often, or stop

using it for a few days and then start


Other rare effects include:

sensitivity to sunlight

darkening of fair skin

lightening of darker skin

rash at the site of application

swelling at the site of application

allergic reaction

skin thinning

Tell your doctor or pharmacist if

any of the side effects become

severe or troublesome, or if you

notice any side effects not listed in

this leaflet.

Tell your doctor immediately if you

notice any of the following:

Wheezing, swelling of the lips/

mouth, difficulty in breathing,

hayfever, lumpy rash (hives) or

fainting. These could be a

symptom of an allergic


Severe burning, peeling, or

itching of your skin.

Stop using Stieva-A Cream.

This is not a complete list of all

possible side effects. Others may

occur in some people and there may

be some side effects not yet known.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

How do I store Stieva-

A Cream?

Keep this medicine where children

cannot reach it, such as in a locked


Stieva-A Cream 0.025% and

0.05% should be stored below


Do not freeze.

Stieva-A Cream 0.1% should be

stored below 25°C.

Do not leave in a car, on a window

sill or in a bathroom.

Return any unused or expired

medicine to your pharmacist.

Product description

What Stieva-A Cream looks


Stieva-A Cream comes in 25 g tubes

containing 0.025% w/w, 0.05% w/w

and 0.1% w/w tretinoin in a smooth

light yellow cream.


Stieva-A Cream contains the active

ingredient tretinoin.

Stieva-A Cream also contains

butylated hydroxytoluene, butylated

hydroxyanisole, disodium edetate,

isopropyl palmitate, methyl

hydroxybenzoate, PEG-40 stearate,

propyl hydroxybenzoate, propylene

glycol, purified water, stearic acid,

stearyl alcohol, soft, white paraffin

and titanium dioxide. Please note

titanium dioxide is present in

Stieva-A 0.1% cream formulation



Stieva-A Cream is supplied in

Australia by:

GlaxoSmithKline Australia Pty Ltd

Level 4

436 Johnston Street

Abbotsford Victoria 3067


Where to go for further


Pharmaceutical companies are not in

a position to give people an

individual diagnosis or medical

advice. Your doctor or pharmacist is

the best person to give you advice on

the treatment of your condition.

This leaflet was prepared on

2 September 2016.

The information provided applies

only to: Stieva-A.

Stieva-A Cream 0.025%: AUST R


Stieva-A Cream 0.05%: AUST R


Stieva-A Cream 0.1%: AUST R


Stieva-A is a registered trade mark of

Stiefel Laboratories, Inc.

Version 7.0



Read the complete document



Creams 0.025% w/w, 0.05% w/w and 0.1% w/w



Chemical names: 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexene-1-yl)-2,4,6,8-non-tetraenoic

acid; all-trans-retinoic acid; tretinoin

Chemical structure

Molecular formula: C

. Molecular weight: 300.4.

CAS Number: 302-79-4


Stieva-A Creams 0.025%, 0.05% and 0.1% contain the active ingredient Tretinoin USP at a

concentration of 0.25 mg/g, 0.5 mg/g and 1.0 mg/g respectively in a vanishing cream base.

Stieva-A Cream also includes the following excipients: butylated hydroxytoluene, butylated

hydroxyanisole, disodium edetate, isopropyl palmitate, methyl hydroxybenzoate, propyl

hydroxybenzoate, PEG-40 stearate, propylene glycol, stearic acid, stearyl alcohol, soft, white

paraffin, purified water, titanium dioxide*.

*Please note titanium dioxide is present in Stieva-A 0.1% cream formulation only.


Tretinoin is a known metabolite of vitamin A, which regulates epithelial cell growth and

differentiation. It is thought that topically applied tretinoin in acne acts by:

stimulating mitosis in the epidermis

reducing intercelluar cohesion in the stratum corneum

contesting the hyperkeratosis characteristic of acne vulgaris

aiding desquamation, preventing the formation of lesions

mediating an increased production of less cohesive epidermal sebaceous cells, which

appears to promote the initial expulsion of comedones and their subsequent prevention.

Tretinoin shows weak inhibition of leukotriene-B4-induced migration of polymorphonuclear

leukocytes which may contribute to its topical anti-inflammatory activity. More marked

inhibition of polymorphonuclear leukocyte migration is seen with isotretinoin. The weaker effect

of tretinoin compared to isotretinoin may account for the greater rebound effect seen with topical

tretinoin when compared with topical isotretinoin.

Pharmacodynamic effects

The pharmacological action of tretinoin remains to be fully elucidated. It has the following

actions when given systemically:

suppresses sebaceous gland activity

reduces sebum production

prevents or reduces comedogenesis

suppresses Propionibacterium acnes

reduces inflammation.



Tretinoin is metabolised rapidly in vivo, and involves isomerisation to 9-cis,11-cis and 13-cis-

retinoic acid (isotretinoin) and oxidation to 4-oxo and 4-hydroxy metabolites. Metabolites are

excreted as glucuronide conjugates in urine and bile.


Stieva-A is indicated for use in the treatment of acne vulgaris, in particular forms where

comedones, papules and pustules predominate. Stieva-A is not generally effective in most cases

of severe pustular or nodulocystic acne.


Patients with known hypersensitivity to any of the ingredients should not use Stieva-A.

Tretinoin preparations have been reported to cause severe irritation of eczematous skin and

should only be used with the utmost caution in patients with this condition.

Stieva-A should not be used in patients with a personal or family history of skin cancer.


Tretinoin should be used with caution in patients with a history of local tolerability reactions,

photoallergy, or local hypersensitivity.

Contact with the mouth, eyes, lips, other mucous membranes, or areas of broken skin should be

avoided. In case of accidental contact, rinse well with water.

Care should be taken not to let the medicine accumulate in skin fold areas and in the nasolabial


Due to the irritant nature of tretinoin, caution should be used when applying to sensitive areas of

skin, such as the neck, abraded or eczematous skin, or when treating patients with inflammatory

skin conditions that may coexist with acne e.g rosacea or perioral dermatitis.

Concomitant topical acne therapy should be used with caution because a cumulative irritant

effect may occur. If irritancy or dermatitis occur, reduce frequency of application or temporarily

interrupt treatment and resume once the irritation subsides. Treatment should be discontinued if

the irritation persists.

In patients whose skin has been subjected to procedures such as depilation, chemical hair

treatment, chemical peels, dermabrasion or laser resurfacing, the skin should be allowed to

recover before application is considered.

Cosmetics that have a strong drying effect, including products with high concentrations of

alcohol and/or astringents, or that have a potential irritating effect should be used with caution as

a cumulative irritant effect may occur.

Sensitivity to sunlight

As tretinoin may cause increased sensitivity to sunlight, sunlamps should not be used and

deliberate or prolonged exposure to sunlight should be avoided or minimised. When exposure to

strong sunlight cannot be avoided, patients should be advised to use a broad-spectrum sunscreen

product (protects against UVA and UVB rays) and wear protective clothing.

If a patient has sunburn, this should be resolved before using tretinoin.

Weather extremes, such as wind or cold, may be more irritating to patients using tretinoin-

containing products.

Studies have shown that in mice treated with tretinoin and exposed to UV light, tretinoin may

speed up the appearance of tumours induced by UV light (artificial sunlight); mice treated with

tretinoin but not exposed to the light did not develop tumours. The significance of these findings

as related to human beings is unknown. However, the exposure of the areas treated with Stieva-A

to sunlight should be avoided or minimised. The use of sunlamps should be avoided during

treatment. Patients who have considerable sunlight exposure, for reasons such as occupation,

should exercise particular caution. Use of sunscreen products and protective clothing may be

prudent when sunlight exposure cannot be avoided.

Effects on fertility

There are no data on the effect of topical tretinoin on fertility in humans, but isotretinoin, an

isomer of tretinoin, in oral therapeutic dosages does not affect the number, motility, and

morphology of sperm.

Effects on fertility have not been investigated in adequate studies in animals. Minimal to marked

testicular degeneration was observed in a 6-week toxicology study in dogs with oral treatment at

≥2 mg/kg/day.

Use in pregnancy

Pregnancy Category D.

Tretinoin has been shown to be teratogenic in rats following topical dermal administration of a

10 mg/kg dose given twice on a single day of gestation. Teratogenicity is also seen in mice and

rats at high oral doses. Topical tretinoin has not been shown to be teratogenic in rats and rabbits

when given at doses of 0.5mg/kg/day and 1.6 mg/kg/day, respectively. However, at these topical

doses, delayed ossification occurred in a number of bones in both species. These latter changes

may be considered variants of normal development and are usually corrected after weaning.

Fetal weight was reduced in rats with topical dermal administration at 5 mg/kg/day.

Topical tretinoin is not recommended during pregnancy or in women of childbearing potential

not using an effective method of contraception properly.

A number of observational studies of varying sample size involving a total of 1535 women

exposed to topical tretinoin in early pregnancy did not provide evidence of an increased risk of

congenital abnormalities, including retinoic acid embryopathy or major structural defects overall.

A small number of temporally associated congenital abnormalities have been reported during

clinical use of topical tretinoin. Although no definite pattern of teratogenicity and no causal

association have been established from these cases, they include reports of the rare birth defect

category, holoprosencephaly (defects associated with incomplete midline development of the

forebrain). The significance of these reports in terms of risk to the foetus is uncertain, since these

effects have not been reproduced.

Orally administered retinoids have been associated with congenital abnormalities. When used in

accordance with the prescribing information, there is low systemic absorption from topically

administered tretinoin. However, risk cannot be excluded since there may be other factors that

contribute to an increased systemic exposure such as: amount used; skin barrier integrity;

concurrent use with other products; dietary intake of or ingestion of supplements containing

vitamin A.

No specific contraceptive precautions are necessary for men using topical tretinoin.

Use in lactation

There is insufficient information on the excretion of topically applied tretinoin in human milk.

A risk to the newborns/infants cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue /abstain from

tretinoin therapy taking into account the benefit of breast-feeding for the child and the benefit of

therapy for the woman.

Paediatric use

The safety and efficacy of topical tretinoin in children prior to puberty have not been established,

therefore tretinoin is not recommended for use in this population.

Use in the elderly

There are no specific recommendations for use in the elderly.


Tretinoin was negative in assays for gene mutation in bacteria (Ames test) and mammalian cells

(Chinese hamster lung cells). A two-fold increase in sister chromatid exchange (SCE) frequency

was found in human diploid fibroblasts, but other chromosomal aberration assays (human

lymphocytes in vitro, mouse micronucleus test in vivo) did not show a clastogenic or

aneuplodogenic effect.


In a 91-week dermal study in mice, treatment at 0.5 and 1 mg/kg for three days per week was

associated with the development of squamous cell carcinomas and papillomas in females at the

site of application. These skin tumours occurred in the context of severe dermal irritation; the

relevance to humans is unclear. No carcinogenicity was observed at a dose of 0.025 mg/kg (less

than the maximum human dose, adjusted for body surface area).

The tumourigenic potential of UV irradiation was increased with concurrent dermal exposure to

tretinoin at a dose of 100 mg/kg in hairless albino mice. Although the relevance of this finding

to humans is unknown, patients should minimise exposure to sunlight or artificial UV sources

(see also Sensitivity to sunlight).

Renal impairment

No dosage adjustment is necessary.

Renal impairment is not expected to result in systemic exposure of clinical significance. This is

because negligible percutaneous absorption of tretinoin follows topical application (see


Hepatic impairment

No dosage adjustment is necessary.

Hepatic impairment is not expected to result in systemic exposure of clinical significance. This is

because negligible percutaneous absorption of tretinoin follows topical application (see



Concomitant application of oxidising agents, such as benzoyl peroxide, should be avoided since

they may reduce the efficacy of topical tretinoin. If combination therapy is required, the products

should be applied at different times of the day (eg, one in the morning and the other in the



The following convention is used for the classification of the frequency of an adverse reaction

and is based on the CIOMS guidelines:

Very common:



≥1/100 to <1/10


≥1/1000 to <1/100


≥1/10000 to <1/1000

Very rare:


Not known*:

(Cannot be estimated from the available data)

Clinical trial data

Skin and subcutaneous tissue disorders

Very common:

Application site erythema, skin exfoliation, pain of skin, application site

pruritus, skin irritation, skin tenderness, skin burning sensation,

application site stinging, dry skin

The above adverse events, seen more frequently with the higher strength 0.1% cream, are

generally moderate and usually subside with continued treatment.

Post-marketing data

Skin and subcutaneous tissue disorders


skin hyperpigmentation, skin hypopigmentation, photosensitivity reaction,

application site rash, application site oedema/swelling, allergic reaction,

skin atrophy


Adults and adolescents

Stieva-A is for topical use only.

Stieva-A should be applied once daily before retiring - to the whole area under treatment. The

skin should be thoroughly cleansed and dried before application of Stieva-A.

Therapeutic effects may not be seen until 6-8 weeks after the start of treatment. Treatment should

normally be continued for three months.

Patients being treated with Stieva-A may continue to use cosmetics.

Patients should be advised that excessive application will not improve efficacy, but may increase

the risk of skin irritation.

If undue irritation (redness, peeling or discomfort) occurs, patients may use a non-comedogenic

moisturiser as needed and should reduce frequency of application or temporarily interrupt

treatment. The normal frequency of application should be resumed once the irritation subsides.

Treatment should be discontinued if the irritation persists.

Formulation strength should be selected and adjusted according to the patient’s tolerance.


Symptoms and signs

Oral ingestion of a 30 g tube of topical tretinoin would result in less exposure than achieved with

the recommended dosage of oral tretinoin. Consequently, the theoretical occurrence of symptoms

of overdosage (e.g. hypervitaminosis A) is highly unlikely.


Appropriate symptomatic measures should be taken to provide relief from irritation due to

excessive topical application.

Accidental ingestion should be managed clinically or

contact the Poisons Information Centre

(telephone 13 11 26) for advice on overdose management.


Stieva-A Creams 0.025%, 0.05% and 0.1% are supplied in epoxy-lined aluminium tubes in pack

sizes of 3 g (physician’s sample for 0.025% and 0.1% only), 6 g (0.1% only) and 25 g.

Not all strengths or pack sizes may be distributed in Australia.

For Stieva-A Cream 0.025% and 0.05%:

Store below 30°C.

Do not freeze.

For Stieva-A Cream 0.1%:

Store below 25


GlaxoSmithKline Australia Pty Ltd

Level 4

436 Johnston Street

Abbotsford Victoria 3067


Prescription only medicine



15 May 1992


30 August 2016

Stieva-A is a registered trade mark of Stiefel Laboratories, Inc.

Version 10.0

Read the complete document

Public Summary

Summary for ARTG Entry:


STIEVA-A 0.1% tretinoin 1mg/g cream tube

ARTG entry for

Medicine Registered


GlaxoSmithKline Australia Pty Ltd

Postal Address

PO Box 18095,Melbourne, VIC, 8003


ARTG Start Date


Product category




Approval area

Drug Safety Evaluation Branch


Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.


1. STIEVA-A 0.1% 1mg/g cream tube

Product Type

Single Medicine Product

Effective date



See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Indicated for use in the treatment of acne vulgaris, in particular forms where comedones, papules and pustules predominate.

Additional Product information

Container information



Life Time





2 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine


1. Medicine Component

Dosage Form


Route of Administration


Visual Identification

Smooth, pale yellow cream, free from grittiness and visible contamination.

Active Ingredients


1 mg/g

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at

Public Summary

Page 1 of

Produced at 23.11.2017 at 07:01:35 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

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