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.

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 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 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 (spots).

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 are pregnant
  • you are planning a pregnancy
  • 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 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 medicines.
  • 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).

How do I use STIEVA-A Cream?

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-up.
  • 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 patients

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 Cream

  • Don't apply a double dose to make up for forgotten doses.
  • Apply the next dose at the usual time.

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 poisoning.

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 think you are or you could be pregnant and stop using STIEVA-A immediately. You should also consult with your doctor if you are planning to have a baby. 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 skin.

Do not use the cream on skin that has had cosmetic treatment such as depilation, chemical hair treatment, chemical peel, dermabrasion or laser resurfacing recently.

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 effects?

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
  • 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 Cream less often, or stop using it for a few days and then start again.

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 reaction.
  • 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 cupboard.

STIEVA-A Cream 0.025% and 0.05% should be stored below 30°C.

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 like

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.

Ingredients

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, white soft paraffin (see Section Things you must not do) and titanium dioxide. Please note titanium dioxide is present in STIEVA-A 0.1% cream formulation only.

Sponsor

STIEVA-A Cream is supplied in Australia by:

GlaxoSmithKline Australia Pty Ltd
Level 4
436 Johnston Street
Abbotsford Victoria 3067
Australia

Where to go for further information

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 18 August 2020.

The information provided applies only to: STIEVA-A.

STIEVA-A Cream 0.025%: AUST R 39837

STIEVA-A Cream 0.05%: AUST R 39839

STIEVA

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

© 2020 GSK group of companies or its licensor.

Version 10.0

Published by MIMS December 2020

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