Consumer medicine information

Retrieve Cream

Tretinoin

BRAND INFORMATION

Brand name

ReTrieve Cream

Active ingredient

Tretinoin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Retrieve Cream.

What is in this leaflet

Read this leaflet carefully before you start RETRIEVE treatment, even if you have used RETRIEVE before.

This leaflet answers some common questions about RETRIEVE. 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 using RETRIEVE against the benefits this medicine is expected to have for you.

If you have any concerns about using RETRIEVE, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Retrieve is used for

RETRIEVE is used for the treatment of dry, sun-damaged skin. It contains tretinoin which is the acid form of Vitamin A. It works by regulating the growth and regeneration of the outer layer of the skin. This medicine is only available with a doctor's prescription. Your doctor may have prescribed RETRIEVE for another reason. Ask your doctor if you have any questions why RETRIEVE has been prescribed for you.

Before you use Retrieve

When you must not use it

Do not use RETRIEVE if you have an allergy to:

  • any medicine containing tretinoin, isotretinoin or vitamin A.
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty in breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Do not use this medicine after the expiry date (EXP) printed on the pack.

Do not use this medicine if the packaging is torn or shows signs of tampering. If it is expired or is damaged, return it to your pharmacist for disposal.

Do not give this medicine to children.

Before you start to use it

Tell your doctor if:

  • you are pregnant or plan to become pregnant.
  • you are breast-feeding or wish to breast-feed.
  • you have sunburn. Delay the use of RETRIEVE until the skin is fully recovered.
  • you have other forms of skin disease such as eczema.
    Delay use of RETRIEVE until the eczema has cleared or use with caution. RETRIEVE can cause severe irritation on eczema.
  • you have sensitive skin.

If you have not told your doctor about any of the above, tell him/her before you start using RETRIEVE.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop, cosmetics or any other skin preparations.

In particular, tell your doctor or pharmacist if you are using any of the following:

  • Medicines and skin preparations used to treat acne.
  • Skin preparations containing peeling agents (e.g. resorcinol, sulphur, salicylic acid or benzoyl peroxide).
  • Skin preparations containing vitamin A.
  • Cosmetics, perfumes or astringents (e.g. aftershave, skin toner) especially those containing high concentration of alcohol, spices, lime, menthol.
  • Abrasive powders, scrubbing agents, soaps, shampoos or cleansers.

Your doctor or pharmacist can help you avoid products that may cause problems. If you have forgotten to discuss with your doctor or pharmacist about any of these things, tell them before you start using RETRIEVE treatment.

How to use Retrieve

When to use it

RETRIEVE is usually used once a day before going to bed.

How much to use

The usual dose is to apply a thin layer to the affected skin area(s).

How to use it

Carefully follow the exact instructions given to you by your doctor or pharmacist. These may differ from the information contained in this leaflet.

  • If you are using a new tube, unscrew the cap and check that the aluminium seal is intact. To break the seal, reverse the cap and pierce through.
  • Wash the affected areas with a mild soap free cleanser and lukewarm water. Pat dry.
  • Apply the cream to the affected skin. Massage in gently.
  • Wash hands thoroughly with water after each application.
  • Only use RETRIEVE on intact skin. Be careful to avoid contact with your eyes, mouth, lips, angles of the nose and open wounds. Do not swallow.

The treatment program is to be started slowly. The usual dosage regimen is as follows:

  • First night - Apply, leave on for 5 minutes, then wash off.
  • Second night - Apply, leave on for 10 minutes, then wash off.
  • Third night - Apply, leave on for 30 minutes, then wash off.
  • Fourth night - Apply, leave on for one hour, then wash off.
  • Fifth night - Apply, leave on for one and a half hours, then wash off.
  • Sixth night - Apply, leave on for two hours, then wash off.
  • If, after a two-hour application, no redness or irritation has developed on the skin the following day, then the application may be left on overnight and washed off next morning.
  • If there is redness or irritation, check with your doctor.

Your doctor will observe how your skin responds to treatment, and how well it can tolerate the medication. If excessive skin reactions occur, your doctor may adjust the application to alternate nights or temporarily discontinue treatment. Therefore contact your doctor or pharmacist immediately if you notice any unusual symptoms (such as a rash) during treatment.

How long to use it

At your next visit, your doctor will see how your skin is responding to treatment. Do not apply more often, or for a longer time than what your doctor has told you. Your doctor will decide on the best course of treatment according to your skin condition and response. This may change from time to time depending on your medical condition. Ask your doctor or pharmacist on how to apply RETRIEVE if you are not sure.

If you forget to use Retrieve

Apply the medicine when you remember, and then go back to using it as you would normally. If it is almost time for your next application, skip the dose you missed. Go on to apply the next dose as before. Do not apply double dose to make up for the one you missed. If you are not sure what to do, ask your doctor or pharmacist. If you have trouble remembering when to apply your medicine, ask your pharmacist for some guides.

If you have used too much (overdose)

If you have applied too much RETRIEVE, remove any excess applied. Let your doctor know in the next visit even if you have not had any signs of skin redness or discomfort.

If your skin develops severe skin irritation, stop the treatment and contact your doctor immediately.

If you have swallowed RETRIEVE

Do not take this medicine by mouth.

If you or someone else accidentally swallows some RETRIEVE, immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 in Australia) for advice, or go to Accident and Emergency at the nearest hospital. Do this even if there are no signs of discomfort or poisoning. The person who has swallowed RETRIEVE may need urgent medical attention.

While you are using Retrieve

Things you must do

Follow your doctor's instructions. Tell your doctor if, for any reason, you have not used your medicine exactly as directed. Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

Protect your skin when you are in the sun. If you are outdoors, wear protective clothing and apply a broad-spectrum 30+ SPF sunscreen. Reapply sunscreen regularly.

Tell your doctor if you become pregnant while you are using RETRIEVE. If you are about to start taking any new medicine, tell your doctor and pharmacist that you are using RETRIEVE. Tell any other doctors, dentists and pharmacists who treat you that you are using this medicine.

Things you must not do

Do not swallow this medicine.

Do not apply to the eyes, around eyelids, mouth, lips, mucosa or angles of the nose.

Do not apply other skin preparations on top of the nightly application of RETRIEVE. Suitable sunscreens and moisturisers may be used during the day.

Do not apply more often than or longer time than what your doctor told you.

Do not use RETRIEVE to treat any other complaint unless your doctor tells you to

Do not give your medicine to anyone else, even if they have the similar symptoms to yours.

Do not mix RETRIEVE with any other preparations. They may prevent RETRIEVE from working.

Things to be careful of

Sunlight/Solarium
Avoid exposure of the treated area to excessive sunlight or overuse of a sunlamp because your skin may be more prone to sunburn while you are having RETRIEVE treatment. Practice the slip/slop/slap program. If prolonged exposure to sunlight cannot be avoided while you are using RETRIEVE, use at least a 30+ SPF broad-spectrum sunscreen or wear protective clothing over the treated areas.

Strong Wind/Dry Air
Other weather extremes such as strong wind or cold dry air may cause skin discomfort. Apply moisturiser or emollient if this occurs. Check with your doctor or pharmacist about suitable wind protection if you notice any unusual rash or redness.

Skin Treatments
Do not use any skin treatments, such as skin peels or medicated dressing on the same affected areas unless your doctor has told you to.

Cosmetics
Check with your doctor or pharmacist which cosmetics or perfumed toiletries you can use. Wash off any cosmetics before you apply RETRIEVE.

Washing your face
Avoid using harsh soaps or exfoliants. Use a mild bland soap, or any suitable soap free cleansers.

Side effects

RETRIEVE is generally well tolerated. However, like other medicines, RETRIEVE can cause side effects. If they occur, they are most likely to be minor or temporary. However, sometimes they are serious and would need medical attention.

Ask your doctor or pharmacist if you have any problems while you are using RETRIEVE. You may need medical attention if you get some of the side effects.

Tell your doctor if you notice any of the following and they continue to worry you:

  • redness of skin
  • feeling of warmth on skin
  • peeling of skin
  • slight stinging
  • darkening or lightening of the treated areas

Tell your doctor immediately if you experience any of the following as you may need urgent medical care:

  • excessive irritation
  • severe burning
  • the skin becomes very sensitive to light

STOP using RETRIEVE and tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you have an allergic reaction.

Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice any other side effects from your medicine which is making you feel unwell.

This medicine does not affect your ability to drive or operate machinery.

After using Retrieve

Storage

Keep RETRIEVE in a cool dry place where the temperature is below 25°C. Do not leave this medicine on window sill or inside a freezer. Do not leave this medicine in the car on hot days. Keep this medicine where children cannot reach it.

Disposal

Return any unused or expired medicine to your pharmacist, or ask them how to dispose of it. Do not keep any outdated medicine, or medicine no longer needed. Keep any discarded medicine out of the reach of children or pets.

Product description

What it looks like

RETRIEVE CREAM is a smooth off-white to pale yellow cream contained in a metal tube with an outer carton and is available in the following pack sizes:

  • 5g tube
  • 50g tube

Ingredients

RETRIEVE contains 500 microgram per gram of tretinoin as the active ingredient. It also contains:

  • cetyl alcohol
  • isopropyl palmitate
  • glyceryl stearate
  • sorbitan stearate
  • polysorbate
  • disodium edetate
  • tocopheryl acetate
  • retinyl palmitate
  • methyl and propyl hydroxybenzoates
  • diazolidinylurea
  • propylene glycol and water.

Sponsor

iNova Pharmaceuticals (Australia) Pty Limited
ABN: 13 617 871 539
Level 10, 12 Help Street
Chatswood NSW 2067
Australia
Tel: 1800 630 056

®= Registered Trademark

AUST R 15553

The leaflet was prepared in January 1999 and revised November 2017.

BRAND INFORMATION

Brand name

ReTrieve Cream

Active ingredient

Tretinoin

Schedule

S4

 

1 Name of Medicine

Tretinoin.

6.7 Physicochemical Properties

Chemical structure.


CAS number.

302-79-4.

2 Qualitative and Quantitative Composition

Tretinoin is a yellow to light orange crystalline powder. It is practically insoluble in water, sparingly soluble in methylene chloride and slightly soluble in ethanol (96 per cent).
ReTrieve Cream contains tretinoin 0.05% w/w (0.5mg/g) in a smooth, off-white to pale yellow hydrophilic cream base of cetyl alcohol, diazolidinyl urea, disodium edetate, dl-alpha tocopheryl acetate, glyceryl monostearate, isopropyl palmitate, methyl hydroxybenzoate, polysorbate 60, propylene glycol, propyl hydroxybenzoate, retinol palmitate, sorbitan monostearate and purified water.
Excipient with known effect:
Hydroxybenzoates, diazolidinyl urea.

3 Pharmaceutical Form

Cream, topical.
Tretinoin (ReTrieve) 0.05% w/w cream - Smooth off-white to pale yellow.

5 Pharmacological Properties

Tretinoin, being a metabolite of retinol, is both pharmacologically and structurally related to vitamin A which regulates cell growth and differentiation. It has been postulated that it acts by enhancing epithelial proliferation and accelerating epithelial differentiation.

5.1 Pharmacodynamic Properties

Mechanism of action.

Tretinoin, an all trans retinoic acid, occurs in the body as a tissue metabolite of vitamin A. The precise mechanism of action of topical tretinoin has not been fully elucidated.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Topically applied tretinoin appears to be slightly absorbed from the skin.

Metabolism & excretion.

Unlike retinol and its esters, it does not accumulate in the body but metabolises rapidly and excretes in the form of inactive glucuronides or oxidation products. These metabolites are mainly excreted in the faeces and some oxidised metabolites are found in the urine.
In vitro studies in human skin showed that only a small percentage of the applied dose could be detected in urine.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Adjunctive treatment of dry photoaged skin and related conditions.

4.3 Contraindications

Pregnancy.
Women planning a pregnancy.
Hypersensitivity to tretinoin or any of the ingredients in the formulation.

4.4 Special Warnings and Precautions for Use

Concomitant application of other topical preparations including cosmetics should be avoided because of possible incompatibility and interaction with tretinoin.
Particular caution should be exercised in the use of keratolytic agents such as sulphur, salicylic acid, benzoyl peroxide or resorcinol and chemical abrasives. If the patient has been treated with such preparations, the effect of the peeling agents must subside before any commencement of topical ReTrieve therapy.
Some medicated cleansers and scrubbing solutions have a strong drying effect. They should not be used in patients receiving tretinoin topical therapy.
Exposure of the treated areas to sunlight including sunlamps should be minimised during the course of topical treatment with ReTrieve.
Patients receiving tretinoin treatment are more susceptible to the effect of UV irradiation especially at the start of the therapy. Animal studies suggest that tretinoin may accelerate the tumorigenic potential of ultraviolet radiation in hairless albino mice, especially at high concentrations of the drug. Although the significance to human is unknown, patients undergoing tretinoin treatment should exercise utmost caution.
Patients with sunburn should be advised to use ReTrieve only after the skin is fully recovered.
Exposure to ultraviolet irradiation increases the intensity of inflammatory reaction. Patients receiving ReTrieve therapy should avoid exposure to artificial sunlamps or solarium.
Patients should be counselled to routinely use high SPF sunscreens as well as protective clothing while undergoing ReTrieve topical treatment, especially those individuals at risk of chronic sun exposure or having a family history of light sensitivity.
Extreme weather conditions, such as strong wind or cold dry air may cause skin irritation to patients receiving tretinoin treatment.
Do not swallow and avoid contact with mucous membranes or open wounds.
ReTrieve should not be applied to the eyes, mouth, lips, mucosa, or angles of the nose.
Should any of these occur, rinse the affected areas thoroughly with water to avoid local irritation. Particular caution is indicated for patients with eczema, since tretinoin has been reported to cause severe irritation on eczematous skin. The hands should be washed thoroughly with water after each application.
Over enthusiastic use or too frequent application may cause redness, stinging and discomfort. If severe irritation occurs, especially in the early stage of therapy, patient should be advised to discontinue temporarily or reduce the frequency of application.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant use of other topical medications (especially those containing keratolytic agents such as resorcinol, sulphur, salicylic acid, benzoyl peroxide and abrasive chemicals etc.) should be avoided in patients undergoing treatment with ReTrieve because of possible interactions with tretinoin. The application of ReTrieve should only commence after the effect of the peeling agents has completely subsided (see Section 4.4 Special Warnings and Precautions for Use). Tretinoin is an unstable compound that is often incompatible with substances found in topical preparations.
Some topical products and certain cosmetics contain high concentrations of alcohol, spices, lime or menthol. They should be used with caution especially in the early phase of treatment due to stinging action of these chemicals.
ReTrieve Cream should not be administered if the patient is also taking medicines known to be photosensitisers (e.g. thiazides, tetracyclines, flluoroquinolones, phenothiazines, sulphonamides) because of the possibility of augmented phototoxicity.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category D)
There have been isolated reports of birth defects in babies born to women using topical tretinoin in pregnancy. To date, there have been no adequate and well controlled prospective studies in women using topical tretinoin in pregnancy. A retrospective cohort study of babies born to 215 women exposed to topical tretinoin during the first trimester of pregnancy found no more birth defects among these babies than those born to 430 women in the same cohort who were not similarly exposed.
Orally administered retinoids have been associated with congenital abnormalities. When used in accordance with the prescribing information, topically administered retinoids are generally assumed to result in low systemic exposure due to minimal dermal absorption. However, there could be individual factors (e.g. damaged skin barrier, excessive use) that contribute to an increased systemic exposure.
Oral tretinoin has been shown to be teratogenic in rats when given at doses of 5 mg/kg/day and fetotoxic in rats when given at doses of 2.5 mg/kg/day. Oral doses of tretinoin have caused limb defects in mice.
However, 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.
These latter changes may be considered variants of normal development and are usually corrected after weaning.
ReTrieve is contraindicated in pregnancy, or in women planning a pregnancy. If the product is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued.
Safe use during lactation has not been established. It is not known whether this drug is excreted in human milk. Therefore, use during lactation is not recommended.

4.8 Adverse Effects (Undesirable Effects)

ReTrieve is generally well tolerated after nightly application. Side effects have been limited to mild irritation, evidenced by peeling and erythema, especially in the early stage of treatment. Some patients may experience a transitory sensation of warmth or slight stinging after application of the drug.
If excessive reactions occur, the frequency of application may be reduced or treatment discontinued temporarily till the reactions subside. The dose and frequency may then be adjusted to a level which the patient can tolerate.
Temporary hyperpigmentation or hypopigmentation has occurred with repeated topical application of the drug.
Contact allergy has been reported in isolated instances.
Increased sensitivity to UV light may be experienced in patients undergoing treatment and appropriate measures should be taken (see Section 4.4 Special Warnings and Precautions for Use).
Reversible changes in liver function tests have been reported after administration of tretinoin topical therapy but do not appear to be of clinical significance. Elevated serum level of bilirubin, alkaline phosphatase, glutamic-pyruvic transaminase, glutamic oxaloacetic transaminase and increase in thymol turbidity and flocculation were observed but in all cases reported, the results reverted to normal on discontinuing treatment.

Reporting suspected adverse effects.

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

4.2 Dose and Method of Administration

ReTrieve should be applied sparingly to the affected areas once daily at bedtime. Treatment with tretinoin should be individualised according to tolerance and response. No other topical preparations should be applied over the nightly inunction, but suitable moisturisers may be used during the day.
Begin the treatment program slowly, as follows:
1. Wash the affected areas prior to any application with mild soap free cleansers and pat dry.
2. First night: apply, leave for five minutes, then wash off.
3. Second night: apply, leave for ten minutes, then wash off.
4. Third, fourth, fifth and sixth nights: increase the treatment time each night by 30 minutes until the application is left on for two hours.
5. If, after a two hour application, no redness or irritation has developed on the skin the following day, then the application may be left on overnight and washed off next morning.
6. If excessive skin reactions occur, adjust the schedule to alternate nights until the skin accommodates.
Certain types of skin could be too sensitive to use ReTrieve Cream. Patients with very sensitive skin should consult a dermatologist before commencing treatment.

4.7 Effects on Ability to Drive and Use Machines

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

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
No data are available on the consequences of overdosage from accidental ingestion of ReTrieve. Tretinoin is a normal metabolite of vitamin A and has similar toxicity profile. The LD50 of tretinoin in mice and rats has been found to be 4 g/kg and 2 g/kg respectively.
The concentration of tretinoin present in ReTrieve at 0.5 mg/g is unlikely to cause any symptomatic effects. Any acute toxicity arising from accidental ingestion of the preparation will be more related to the toxicity of the vehicle components.
Symptoms of acute toxicity would be of gastrointestinal disturbance. In such event, treatment such as gastric lavage, inducing emesis and/or forced fluids should be performed as soon as possible.
Overdosage from excessive dermal application may produce marked erythema and skin inflammatory reactions. Should this occur, discontinue use and if necessary, apply cold compresses and/or mild emollient.

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

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

Contained in a metal (aluminium) tube with an outer carton and is available in the following pack sizes: 5 g tube, 10 g tube*, 50 g tube.
* - not currently 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.

Summary Table of Changes