Consumer medicine information

Stieva-A Cream

Tretinoin

BRAND INFORMATION

Brand name

Stieva-A

Active ingredient

Tretinoin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Stieva-A Cream.

SUMMARY CMI

STIEVA-A

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 STIEVA-A?

STIEVA-A contains the active ingredient tretinoin. STIEVA-A is a cream used to treat acne.

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

2. What should I know before I use STIEVA-A?

Do not use if you have ever had an allergic reaction to tretinoin or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. Do not use this medicine if you are pregnant. This medicine should only be used by adolescents and adults, it should not be used in children.

For more information, see Section 2. What should I know before I use STIEVA-A? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with STIEVA-A and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use STIEVA-A?

  • Use STIEVA-A once daily at night all over the affected area.
  • Only use STIEVA-A on the skin, do not ingest or swallow it.

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

5. What should I know while using STIEVA-A?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using STIEVA-A.
Things you should not do
  • Do not stop using this medicine or change the dosage without first checking with your doctor.
  • Do not use this medicine if you are pregnant.
  • Do not use the cream on your mouth, lips, eyes or inside your nose.
  • Do not use this cream on skin that is irritated or damaged such as cuts, grazes, abrasions and sunburn.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how STIEVA-A affects you.
Looking after your medicine
  • Store this medicine below 30°C. Do not freeze STIEVA-A.

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

6. Are there any side effects?

Side effects which have been reported include redness of your skin, skin flaking, skin pain, itching, skin irritation, skin tenderness, burning feeling on the skin (especially when first applied), stinging and dry skin.

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

STIEVA-A

Active ingredient(s): tretinoin

Consumer Medicine Information (CMI)

This leaflet provides important information about using STIEVA-A. 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 STIEVA-A.

Where to find information in this leaflet:

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

1. Why am I using STIEVA-A?

STIEVA-A contains the active ingredient tretinoin.

STIEVA-A belongs to a group of medicines called retinoids.

STIEVA-A is used to treat acne (spots).

STIEVA-A can help 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.
  • lower the number of red, inflamed acne spots.

2. What should I know before I use STIEVA-A?

Warnings

Do not use STIEVA-A if:

  • you are allergic to tretinoin, or any of the ingredients listed at the end of this leaflet.

Always check the ingredients to make sure you can use this medicine.

  • you are pregnant or intend to become pregnant or are breastfeeding.
  • you or anyone in your close family have had skin cancer.
  • you are under the age of 12 (STIEVA-A is only for use in adolescents and adults).

Check with your doctor if you:

  • have any other medical conditions.
  • are allergic to foods, dyes, preservatives or any other medicines.
  • have 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).
  • take any medicines for any other condition.
  • take any other medicines for your acne.

You might need to use the two products at different times of the day (eg. One in the morning and the other at bedtime).

  • cannot tolerate or have skin reactions in sunlight.

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

Tell your doctor immediately if you are pregnant or intend to become pregnant.

You should not use STIEVA-A if you are pregnant.

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

You must use a reliable method of contraception whilst using STIEVA-A.

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.

Some medicines may interfere with STIEVA-A and affect how it works. This includes medicines containing benzoyl peroxide which are also used to treat acne.

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

4. How do I use STIEVA-A?

How to use STIEVA-A

  • Use STIEVA-A once daily at night time over the whole of the affected area.
  • Follow the instructions provided by your doctor or pharmacist and use STIEVA-A until your doctor tells you to stop.
  • It can take 6 to 8 weeks before you see the full benefit of applying STIEVA-A to the affected area.

How to apply STIEVA-A

STIEVA-A is only for application to the skin. Do not swallow.

  1. Wash your hands.
  2. Completely remove any makeup if you are wearing it.
  3. Wash the affected area with a mild soap and warm water and gently dry.
  4. Put a thin film of cream on the affected skin using your fingers to smooth it in.
  5. Apply to all areas of your skin where there is acne not just to the individual spots.

Take care not to apply too much STIEVA-A, 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 STIEVA-A or applying it too frequently will not help your acne clear up faster and it may cause redness, peeling and discomfort.

If this happens, you may need to use a non-pore-clogging moisturiser (non-comedogenic), use STIEVA-A less often or stop using it for a few days and then start again.

  1. Wash your hands after using STIEVA-A.

If you forget to use STIEVA-A

STIEVA-A should be used regularly at the same time each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much STIEVA-A

If you think that you have used too much STIEVA-A, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

The ingredients of STIEVA-A are not expected to be harmful if swallowed in the small amounts applied to the face. If you do accidentally get STIEVA-A in your mouth, rinse at once with plenty of water. Seek medical advice if you swallow a large amount.

5. What should I know while using STIEVA-A?

Things you should do

Tell your doctor straight away if you:

  • have not used STIEVA-A as directed
  • think you may be or are pregnant and stop using STIEVA-A immediately
  • are breastfeeding

Remind any doctor, dentist or pharmacist you visit that you are using STIEVA-A.

Things you should not do

  • Do not stop using this medicine or change how much you use without first checking with your doctor.
  • Do not use the cream on your mouth, lips, eyes or inside your nose.
  • Do not give this medicine to anyone else even if their symptoms seem similar to yours.
  • Do not use STIEVA-A to treat any other complaints unless your doctor tells you to.
  • Do not use this cream on skin that is irritated or damaged such as cuts, grazes, abrasions and sunburn.
  • Do not use 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 on sensitive skin such as the neck or allow it to accumulate in the folds of your skin including between the nose and lips.
  • Avoid skin products that contain alcohol, spices or lime.

These products may irritate your skin more if used together with STIEVA-A.

Things to be careful of

  • STIEVA-A can cause increased sensitivity to sunlight.

Avoid using sunlamps and spending a long time in the sun.

Use sunscreen and protective clothing to prevent sunburn.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how STIEVA-A affects you.

Looking after your medicine

  • Keep the cream in the tube until it is time to use it.
  • Do not put STIEVA-A in the freezer.

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

Store it in a cool dry place (below 30°C) away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effectsWhat to do
Skin related
  • redness of your skin
  • skin flaking
  • skin pain
  • itching
  • skin irritation
  • skin tenderness
  • burning feeling on the skin, especially when first applied
  • stinging
  • dry skin

These effects are normal. If they cause you a problem, try using STIEVA-A less often or stop using it for a few days and then start it again.

  • sensitivity to sunlight
  • darkening of fair skin
  • lightening of dark skin
  • rash at the site of application
  • swelling at the site of application
  • skin thinning
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
Allergic reaction
  • signs include wheezing, difficulty in breathing, swelling of the lips, mouth or tongue, hay fever, a lumpy rash (hives) on the skin, fainting
Skin related
  • severe burning, peeling or itching of your skin
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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 STIEVA-A contains

Active ingredient
(main ingredient)		tretinoin
Other ingredients
(inactive ingredients)		butylated hydroxyanisole
butylated hydroxytoluene
disodium edetate
isopropyl palmitate
methyl hydroxybenzoate
PEG-40 stearate
propyl hydroxybenzoate
propylene glycol
purified water
stearic acid
stearyl alcohol
white soft paraffin
Potential allergensmethyl hydroxybenzoate
propyl hydroxybenzoate

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

What STIEVA-A looks like

STIEVA-A is a white to light yellow cream.

0.025% - AUST R 39837 available in a 3 g or 25 g tube.

0.05% - AUST R 39839 available in a 25 g tube.

Who distributes STIEVA-A

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford VIC 3067
Australia

Trade marks are owned by or licensed to the GSK group of companies.

© 2022 GSK group of companies or its licensor.

This leaflet was prepared in October 2022.

Version 11.0

Published by MIMS March 2023

BRAND INFORMATION

Brand name

Stieva-A

Active ingredient

Tretinoin

Schedule

S4

 

1 Name of Medicine

Tretinoin.

2 Qualitative and Quantitative Composition

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.

Excipients with known effect.

Contains methyl hydroxybenzoate and propyl hydroxybenzoate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Cream.

4 Clinical Particulars

4.1 Therapeutic Indications

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.

4.2 Dose and Method of Administration

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.

4.3 Contraindications

Pregnancy.
Women planning a pregnancy.
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.

4.4 Special Warnings and Precautions for Use

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 folds.
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.
Stieva-A cream contains paraffin. Instruct patients not to smoke or go near naked flames due to the risk of severe burns. Fabric (clothing, bedding, dressings etc.) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

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.

Use in pregnancy.

Stieva-A is contraindicated (see Section 4.3 Contraindications) in pregnancy or in women of childbearing potential not using an effective method of contraception properly.
If this product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.

Use in 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 Section 5.2 Pharmacokinetic Properties).

Use in 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 Section 5.2 Pharmacokinetic Properties).

Use in the elderly.

There are no specific recommendations for use in the elderly.

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.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

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 (e.g. one in the morning and the other in the evening).

4.6 Fertility, Pregnancy and Lactation

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.
(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 0.5 mg/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. Foetal weight was reduced in rats with topical dermal administration at 5 mg/kg/day.
Stieva-A is contraindicated (see Section 4.3 Contraindications) in pregnancy or in women of childbearing potential not using an effective method of contraception properly.
If this product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.
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.
 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 breastfeeding or to discontinue/ abstain from tretinoin therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The following convention is used for the classification of the frequency of an adverse reaction and is based on the CIOMS guidelines:
Very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1000 to < 1/100; rare: ≥ 1/10,000 to < 1/1000; very rare: < 1/10,000; 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.

Postmarketing data.

Skin and subcutaneous tissue disorders.

Rare: skin hyperpigmentation, skin hypopigmentation, photosensitivity reaction, application site rash, application site oedema/ swelling, allergic reaction, skin atrophy.

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.

4.9 Overdose

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.

Treatment.

Appropriate symptomatic measures should be taken to provide relief from irritation due to excessive topical application.
Accidental ingestion should be managed clinically.
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.

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 intercellular 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.
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.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Metabolism.

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.

Excretion.

Metabolites are excreted as glucuronide conjugates in urine and bile.

5.3 Preclinical Safety Data

Genotoxicity.

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.

Carcinogenicity.

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 (also see Section 4.4, Sensitivity to sunlight).

6 Pharmaceutical Particulars

6.1 List of Excipients

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, white soft paraffin (see Section 4.4 Special Warnings and Precautions for Use), purified water, titanium dioxide*.
*Please note titanium dioxide is present in Stieva-A 0.1% cream formulation only.

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

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°C.

6.5 Nature and Contents of Container

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.

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 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.
Molecular formula: C20H28O2. Molecular weight: 300.4.

Chemical structure.


CAS number.

302-79-4.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes