SUMMARY CMI

Retrieve^® Cream

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 Retrieve?

Retrieve contains the active ingredient tretinoin. Retrieve is used for the treatment of dry, sun-damaged skin.

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

2. What should I know before I use Retrieve?

Do not use if you have ever had an allergic reaction to Retrieve 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.

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

3. What if I am taking other medicines?

Some medicines may interfere with Retrieve 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 Retrieve?

• The usual dose is to apply a thin layer to the affected skin area(s).
• Apply once a day before going to bed.
• Carefully follow the exact instructions given to you by your doctor or pharmacist.

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

5. What should I know while using Retrieve?

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

6. Are there any side effects?

Common and less-serious side effects include redness of skin, feeling of warmth on skin, peeling of skin, slight stinging and darkening or lightening of the treated areas.

Serious side effects include excessive irritation, severe burning and the skin becomes very sensitive to light.

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

Retrieve^® Cream

Active ingredient: Tretinoin 0.5 mg/g

Consumer Medicine Information (CMI)

This leaflet provides important information about using Retrieve. 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 Retrieve.

Where to find information in this leaflet:

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

1. Why am I using Retrieve?

Retrieve contains the active ingredient Tretinoin.

Tretinoin is the acid form of Vitamin A.

Retrieve is used for the treatment of dry, sun-damaged skin.

Retrieve works by regulating the growth and regeneration of the outer layer of the skin.

Your doctor may have prescribed Retrieve for another reason. Ask your doctor if you have any questions why Retrieve has been prescribed for you.

2. What should I know before I use Retrieve?

Warnings

Do not use Retrieve if:

• You are allergic to tretinoin, isotretinoin, vitamin A, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.

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
• The packaging is torn or shows signs of tampering

Check with your doctor if you have:

• any other medical conditions including:
  - sunburn. Delay the use of Retrieve until the skin is fully recovered.
  - 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.
  - sensitive skin.
• take any medicines for any other condition.

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

• Do not use Retrieve if you pregnant or planning a pregnancy.
• Stop using Retrieve immediately if you fall pregnant and see your doctor.
• Tell your doctor if you are breastfeeding or wish to breastfeed. It is not known whether Retrieve passes into breastmilk.

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 Retrieve and affect how it works.

These include:

• Medicines and skin preparations used to treat acne.
• Skin preparations containing peeling agents (e.g., resorcinol, sulfur, salicylic acid, or benzoyl peroxide).
• Skin preparations containing vitamin A.
• Medicines which can increase sun sensitivity including some antibiotics, diuretics, and antipsychotic medicines
• Cosmetics, perfumes, or astringents (e.g., aftershave, skin toner) especially those containing high concentration of alcohol, spices, lime, or menthol.
• Abrasive powders, scrubbing agents, soaps, shampoos, or cleansers.

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

4. How do I use Retrieve?

How much to use

• Apply a thin layer to the affected skin area(s).
• Follow the instructions provided below and use Retrieve until your doctor tells you to stop.

When to use Retrieve

• Retrieve should be used once a day before going to bed.

How to use Retrieve

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

• 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 assess how your skin responds to treatment, and how well it tolerates the medication. If excessive skin reactions occur, your doctor may adjust the application to alternate nights or temporarily discontinue treatment.

At your next visit, your doctor will review how your skin is responding to treatment. 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

Use Retrieve regularly at the same time each day. If you miss your dose at the usual time, 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 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 Retrieve

If you think that you have applied too much Retrieve, remove any excess cream.

Do not take this medicine by mouth. If you or someone else accidentally swallows some Retrieve, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre by calling 13 11 26 in Australia, 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.

5. What should I know while using Retrieve?

Things you should do

• Contact your doctor or pharmacist immediately if you notice any unusual symptoms (such as a rash) during treatment.
• Tell your doctor if, for any reason, you have not used your medicine exactly as directed.
• Protect your skin when you are in the sun. If you are outdoors, wear protective clothing and apply a broad-spectrum SPF 30+ or higher sunscreen. Reapply sunscreen regularly.

Call your doctor straight away if you:

• Become pregnant while you are using Retrieve.
• Notice any excessive skin reaction and unusual symptoms (such as a rash).

Remind any doctor, dentist or pharmacist you visit that you are using Retrieve.

Things you should not do

• 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 has 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 use any skin treatments, such as skin peels or medicated dressing on the same affected areas unless your doctor has told you to.
• Do not mix Retrieve with any other preparations. They may prevent Retrieve from working.
• Do not swallow this medicine.

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 whilst using Retrieve. When exposed to sunlight use at least a 30+ SPF broad-spectrum sunscreen and wear protective clothing over the treated areas.
• Strong Wind/Dry Air - These 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.
• Cosmetics - Check with your doctor or pharmacist which cosmetics or perfumed toiletries you can use. Wash any cosmetics off any affected areas before you apply Retrieve.
• Washing your face - Avoid using harsh soaps or exfoliants. Use a mild bland soap, or any suitable soap free cleansers.

Looking after your medicine

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

Store it in a cool dry place where the temperature is below 25°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

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 affects 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 Retrieve contains

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

What Retrieve looks like

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

• 5g tube
• 50g tube

(AUST R 15553).

Who distributes Retrieve

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

This leaflet was prepared in June 2023.

Published by MIMS August 2023

1 Name of Medicine

Tretinoin.

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.

4 Clinical Particulars

4.1 Therapeutic Indications

Adjunctive treatment of dry photoaged skin and related conditions.

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.

4.3 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.

Paediatric use.

Effects on laboratory tests.

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.

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)

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.

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.

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.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Metabolism & excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

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.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes