SUMMARY CMI

ORATANE

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 ORATANE?

ORATANE contains the active ingredient isotretinoin. ORATANE is used to treat acne. For more information, see Section 1. Why am I using ORATANE? in the full CMI.

2. What should I know before I use ORATANE?

Do not use if you have ever had an allergic reaction to ORATANE 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 ORATANE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ORATANE 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 ORATANE?

• Your doctor will tell you how many ORATANE capsules to take each day, take them exactly as your doctor has prescribed.
• ORATANE capsules should be swallowed whole with a glass of water or milk and must always be taken with food.

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

5. What should I know while using ORATANE?

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

6. Are there any side effects?

ORATANE helps most people with acne but it may have unwanted side effects in a few people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. When you are using ORATANE, you can have some serious side effects. Serious side effects may include nausea, vomiting, persistent headache, blurred vision or visual disturbances, changes in your hearing or ringing in your ears, severe upper stomach pain, unexpected muscle pain, tenderness or weakness, blood in stools or severe diarrhoea, severe bruising, sudden red or itchy spots, painful red areas, fever and chills, aching muscles, feeling depressed with or without suicidal thoughts and thinking, seeing or hearing things that are not real.

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

ORATANE (orr·a·tayn)

Active ingredient(s): isotretinoin

Consumer Medicine Information (CMI)

This leaflet provides important information about using ORATANE. 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 ORATANE.

Where to find information in this leaflet:

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

1. Why am I using ORATANE?

ORATANE contains the active ingredient isotretinoin. ORATANE belongs to a group of medicines called retinoids, which are similar to vitamin A.

Retinoids work by reducing the amount of the oily substance (i.e. sebum) made by glands in your skin, reducing bacteria and inflammation and opening clogged pores.

ORATANE is used to treat acne. There are many different types of medicines used to treat acne. ORATANE is used for more severe cases.

Your doctor, however, may have prescribed ORATANE for another purpose.

Ask your doctor if you have any questions about why ORATANE has been prescribed for you.

This medicine is available only with a doctor's prescription. ORATANE is not addictive.

2. What should I know before I use ORATANE?

Warnings

Do not use ORATANE if:

• you are allergic to isotretinoin, have had an allergic reaction to ORATANE, vitamin A, other retinoids 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 for at least one month before you plan to fall pregnant. If you fall pregnant while taking ORATANE there is an extremely high risk of having a baby that is severely deformed. You must use effective contraception for one month before, during and one month after treatment.
• you are breastfeeding. You must stop breastfeeding before treatment begins. Do not breastfeed while taking ORATANE.
• you are taking tetracycline antibiotics such as doxycycline
• you have severe liver disease
• you have very high fat levels (cholesterol, triglycerides) in your blood
• you have hypervitaminosis A. This is a condition caused by an excessive amount of vitamin A in the diet.
• the packaging is torn or shows signs of tampering
• the expiry date (EXP) printed on the pack has passed. If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure if you should start taking ORATANE, contact your doctor.

Do not give ORATANE to children.

ORATANE may be associated with slowing of growth when used in children before puberty. The use of ORATANE in children less than 12 years of age is not recommended.

Check with your doctor if you:

• you drink large amounts of alcohol
• you have any allergies to any other medicines, foods, preservatives or dyes. ORATANE capsules contain soya oil, which may contain traces of arachidic acid (a component of peanut oil).
• you have or have had any other health problems or issues including:
  - diabetes, or a history of diabetes in your family
  - depression
  - liver disease
  - kidney disease
  - lipid (cholesterol or triglyceride) disorder
  - hormone disorder
  - eye disorders
  - stomach or bowel disease

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

If you become pregnant while taking ORATANE, stop taking it and tell your doctor immediately.

ORATANE can cause birth defects (damage to unborn babies). You must use strict birth control, starting at least 1 month before you begin taking ORATANE, for the whole time you are taking ORATANE and for 1 month after you finish taking ORATANE.

There is no known risk to males who wish to father children.

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

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 ORATANE and affect how it works. These include:

• tetracycline antibiotics such as Doxycycline
• vitamin A, or preparations containing vitamin A (including vitamin supplements)
• other medicines you are using to treat your acne
• the "mini-pill", a progestogen-only oral contraceptive pill

These medicines may be affected by ORATANE or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

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

4. How do I use ORATANE?

How much to take

• Follow all directions given to you by your doctor or pharmacist carefully.
• They may differ from the information contained in this leaflet.
• Take ORATANE exactly as your doctor has prescribed.
• Your doctor will tell you how many ORATANE capsules to take each day.
• The dose will be calculated to suit your individual needs and your body weight. This dose may be adjusted during treatment when your doctor knows how you respond to ORATANE.

When to take ORATANE

• ORATANE may be taken once or twice a day and must always be taken with food.
• Female patients should wait until the 2nd or 3rd day of the next normal menstrual period before starting ORATANE treatment. This helps ensure that you aren't pregnant before you start taking ORATANE.

How to take ORATANE

• Capsules should be swallowed whole with a glass of water or milk.
• Do not open the capsules and do not take any capsules that are damaged.

How long to take ORATANE

• Continue taking ORATANE for as long as your doctor prescribes.
• Acne treatment with ORATANE will usually last 4 to 8 months. In the first few weeks of treatment your acne may get a little worse before it gets better. This is a sign that ORATANE is working.
• At the end of this time your acne should have cleared up significantly. Most patients notice their skin condition continues to improve even after ORATANE treatment is finished.
• Please note that ORATANE cannot improve scars or pitting that were present before treatment started, but it will help prevent such skin damage in the future.

If you forget to use ORATANE

ORATANE 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.

• This may increase the chance of getting an unwanted side effect.
• If you have missed several doses, please inform your doctor and follow the advice given to you.

If you take too much ORATANE (overdose)

If you think that you have used too much ORATANE, 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.

You may need urgent medical attention.

Signs of overdose include transient headache; vomiting; facial flushing; reddened, cracked lips; stomach pain; headache; dizziness and unsteady walking.

5. What should I know while using ORATANE?

Call your doctor straight away if you become pregnant while taking ORATANE, stop taking it and tell your doctor immediately.

Things you should do

• Remind any doctor, dentist or pharmacist you visit that you are using ORATANE.
• Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
• Tell your doctor if you feel ORATANE capsules are not helping your condition.
• Be sure to keep all of your appointments with your doctor so that your progress can be checked. Your doctor may ask you to have regular blood tests to monitor your liver function, blood sugar levels and blood cholesterol levels.
• If you are intending to do a lot of heavy lifting or exercise, tell your doctor. Your muscles and joints may be more prone to tenderness or stiffness if you do a lot of heavy exercise while taking ORATANE.
• If you experience dryness of the lips, mouth, nose or skin, you can use a moisturiser or petroleum jelly to soften the areas not affected by the acne.
• Talk to your doctor if you experience persistent pain in your lower back or buttocks during treatment with ORATANE. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may discontinue treatment with ORATANE and refer you to a specialist for treatment of inflammatory back pain. Further evaluation may be needed including imaging modalities such as MRI.

Things you should not do

• Do not stop taking ORATANE suddenly or change the dose without first checking with your doctor.
• Do not let yourself run out of medicine over the weekend or on holidays.
• Do not give ORATANE to anyone else even if their symptoms seem similar to yours.
• Do not use ORATANE to treat other complaints unless your doctor says to.
• Do not donate blood during treatment with ORATANE or for at least 1 month after stopping treatment.

Things to be careful of

• Wearing contact lenses during treatment with ORATANE may cause discomfort. ORATANE may cause dry eyes. An eye lubricant or artificial tears, available from your pharmacist, should relieve this problem. Otherwise, you may temporarily need to wear your lenses for shorter periods or wear glasses instead.
• Avoid excessive sun exposure and solariums and apply sunscreen whilst taking ORATANE. Your skin may be more prone to sunburn while on ORATANE.
• Avoid waxing and dermabrasion whilst taking ORATANE and for 5 to 6 months after stopping ORATANE treatment. Your skin may be more sensitive while on ORATANE. Waxing may cause dermatitis and dermabrasion may cause scarring during and for several months after ORATANE treatment.
• Avoid using facial peels, electrolysis and some hair treatments. Your skin and hair may be more delicate during treatment and for a while after ORATANE treatment.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how ORATANE affects you.

Normally ORATANE would not affect your ability to drive a car or operate machinery. However, altered night vision and other visual disturbances may occur when taking ORATANE. Make sure you know how you react to ORATANE before you drive a car, operate machinery or do anything else that may be dangerous if your vision is affected.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

• Keep your capsules in the blister pack until it is time to take them. If you take the capsules out of the packaging, they will not keep as well.
• Store it in a cool dry place where the temperature stays below 25°C for Oratane 5mg, 10mg, 30mg & 40mg, and below 30°C for Oratane 20mg, 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 windowsills.

Keep ORATANE where young children cannot reach it.

When to discard your medicine

If your doctor tells you to stop taking ORATANE, or the capsules have passed their expiry date, ask your pharmacist what to do with any capsules that are left over.

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 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 an authorised doctor's prescription.

What ORATANE contains

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

ORATANE is available as a 20 mg capsule in a pack of 60 capsules.

What ORATANE looks like:

ORATANE 5 mg capsules are soft, oval, faint pinkish/cream to cream in colour containing a yellow/orange liquid. Available in blister packs of 60 capsules. ARTG 127499

ORATANE 10 mg capsules are soft, oval, opaque light violet in colour containing a yellow/orange liquid. Available in blister packs of 60 capsules. ARTG 75034

ORATANE 20 mg capsules are soft, oval, opaque maroon, red in colour containing a yellow/orange liquid. Available in blister packs of 60 capsules. ARTG 69868

ORATANE 30 mg capsules are pink coloured soft gelatin capsules containing a yellow/ orange liquid. Available in blister pack of 60 capsules. ARTG 303071

ORATANE 40 mg capsules are soft, oval, opaque orange in colour containing a yellow/orange liquid. Available in blister packs of 30 capsules. ARTG 117206

Sponsor:

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne Victoria 3121
www.arrotex.com.au

This leaflet was prepared in November 2024

Published by MIMS January 2025

1 Name of Medicine

Isotretinoin.

2 Qualitative and Quantitative Composition

Oratane capsules contain either 5 mg, 10 mg, 20 mg, 30 mg, or 40 mg of isotretinoin.
Isotretinoin is related to both retinoic acid and retinol (vitamin A). Isotretinoin is a yellow orange to orange crystalline powder that is practically insoluble in water, soluble in methylene chloride, sparingly soluble in ether and slightly soluble in alcohol. It is sensitive to air, heat and light, especially in solution.

Excipients with known effect.

3 Pharmaceutical Form

Oratane 5 mg capsules are soft, oval, faint pinkish/cream to cream in colour containing a yellow/orange liquid.
Oratane 10 mg capsules are light violet coloured soft capsules containing a yellow/orange viscous liquid.
Oratane 20 mg capsules are maroon coloured soft capsules containing a yellow/orange viscous liquid.
Oratane 30 mg capsules are pink coloured soft capsules containing a yellow/orange viscous liquid.
Oratane 40 mg capsules are orange coloured soft capsules containing a yellow/orange viscous liquid.

4 Clinical Particulars

4.1 Therapeutic Indications

Oratane is indicated for the treatment of severe cystic acne and a single course of therapy has been shown to result in complete and prolonged remission of disease in many patients. If a second course of therapy is needed, it should not be initiated until at least eight weeks after completion of the first course, since experience has shown that patients may continue to improve while off the drug. Because of significant adverse effects associated with its use, isotretinoin should be reserved for patients with severe cystic acne who are unresponsive to conventional therapy, including systemic antibiotics.

4.2 Dose and Method of Administration

The therapeutic response to isotretinoin is dose related and varies between patients. This necessitates individual adjustment of dosage according to the response of the condition and the patient's tolerance of the drug. In most cases complete or near complete suppression of acne is achieved with a 16 week course of treatment.
All patients should initially receive doses up to 0.5 mg/kg bodyweight daily for a period of two to four weeks, when their responsiveness to the drug will usually be apparent. It should be noted that the transient exacerbation of acne is occasionally seen during this initial period. Satisfactory initial responses have been reported from 0.05 mg/kg/day. Relapse rates on the lower doses are higher (a second course may be required in about two-thirds of patients on 0.1 mg/kg/day for 16 weeks), but there is decreased incidence and severity of adverse effects at lower doses.
The daily dosage should be taken with food in the nearest number of whole capsules, either as a single dose or in two divided doses during the day, whichever is more convenient.
Doses up to 1 mg/kg/day may be used in patient's refractory to initial treatment at lower doses.
The above daily dosages of isotretinoin should be continued for 16 weeks to complete the course of treatment.
After a period of two months off therapy, and if warranted by persistent severe cystic acne, a second course of therapy may be initiated.

4.3 Contraindications

Use in pregnancy (Category X).

4.4 Special Warnings and Precautions for Use

Women of childbearing potential should be warned that the drug causes birth defects. They should be instructed that they must not be pregnant when isotretinoin therapy is initiated, and that they should use an effective form of contraception while taking isotretinoin and for one month after isotretinoin has been stopped (see Section 4.3 Contraindications).
Because of the relationship of isotretinoin to vitamin A, patients should be advised against taking vitamin supplements containing vitamin A to avoid additive toxic effects.
Oratane contains soya oil, therefore, caution should be taken with patients allergic to peanut or soya.
Donation of blood by patients during and within one month of cessation of isotretinoin treatment to women of childbearing potential should be avoided.

Skin and subcutaneous tissue disorders.

Benign intracranial hypertension.

Eye disorders.

Hearing impairment.

Biochemical abnormalities.

Musculoskeletal and connective tissue disorders.

Psychiatric disorders.

Gastrointestinal disorders.

Allergic reactions.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

As a rule concomitant therapy is not indicated but nonirritant topical preparations may be used if required. Concurrent administration of isotretinoin with topical keratolytic or exfoliative antiacne agents should be avoided as local irritation may increase.
Concurrent treatment with vitamin A must be avoided, as symptoms of hypervitaminosis A may be intensified (see Section 4.8 Adverse Effects (Undesirable Effects)).
Cases of pseudotumour cerebri and/or papilloedema have been reported in association with the use of isotretinoin. Four out of ten of these patients had retinal haemorrhages. Symptoms appeared after 21 days to 6 months therapy with 40 to 120 mg daily. Concomitant tetracycline or minocycline was administered in 5 out of 10 cases; both of these drugs have been implicated in causing intracranial hypertension. Concomitant therapy with tetracyclines is contraindicated (see Section 4.3 Contraindications).
Since acne is an androgen dependent disease, contraceptives containing an androgen progestational substance, such as one derived from 19-nortestosterone (norsteroid), particularly in the presence of gynaecoendocrinological problems, should be avoided.
The effect of microdosed progesterone preparations may be diminished by interaction with isotretinoin. Therefore, microdosed progesterone preparations or "minipills" should not be used.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Decreased night vision has occurred during isotretinoin therapy and in rare instances has persisted after discontinuation of therapy. As the onset in some patients was sudden, patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night.

4.8 Adverse Effects (Undesirable Effects)

Most adverse effects appear to be dose related with the more pronounced effects occurring at doses above 1 mg/kg/day. The adverse effects may recede during continued therapy and the mucocutaneous effects were reversible with dosage reduction or discontinuation of therapy. Exacerbation of the cystic acne may occur during the initial stages of therapy.
Many of the adverse effects seen in patients receiving isotretinoin are similar to those described in patients taking very high doses of vitamin A.

Postmarketing experience.

Symptoms associated with hypervitaminosis A.

Skin and appendages disorders.

Musculoskeletal system disorders.

Renal and urinary disorders.

Psychiatric and central nervous system disorders.

Sensory disorders.

Gastrointestinal system disorders.

Liver and biliary system disorders.

Respiratory system disorders.

Reproductive system and breast disorders.

Disorders of the blood.

Laboratory findings.

Resistance mechanism disorders.

Miscellaneous reactions.

Reporting suspected adverse effects.

4.9 Overdose

Signs of hypervitaminosis A could appear in cases of overdose. Clinically, overdose has been associated with transient headache, vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness and ataxia. All symptoms quickly resolved without apparent residual effects.
Treatment of overdose should consist of general supportive measures.
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.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Tissue distribution in animals.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Oratane capsules contain isotretinoin, beeswax - yellow, disodium edetate, butylated hydroxyanisole, dl-alpha-tocopherol, soya oil - partially hydrogenated, soya oil, vegetable oil - hydrogenated (5 mg, 10 mg and 20 mg only), soya oil - hydrogenated (30 mg and 40 mg only).
The capsule shell contains sorbitol solution (70% non-crystallising), glycerol, gelatin, titanium dioxide, water - purified, brilliant scarlet 4R CI16255 (10 mg and 20 mg only), sunset yellow FCF CI15985 (40 mg only), indigo carmine CI73015 (20 mg only), iron oxide black CI177499 (10 mg only), iron oxide red (30 mg 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

Store below 30°C in the closed carton to protect from light and moisture:
Oratane 20 mg capsules AUST R 69868.
Store below 25°C in the closed carton to protect from light and moisture:
Oratane 5 mg capsules AUST R 127499;
Oratane 10 mg capsules AUST R 75034;
Oratane 30 mg capsules AUST R 303071;
Oratane 40 mg capsules AUST R 117206.

6.5 Nature and Contents of Container

Oratane 5 mg capsules are available in PVC/PVDC/Al blister packs of 15 (sample pack)*, 30*, 60 and 90* capsules.
Oratane 10 mg capsules are available in PVC/PVDC/Al blister packs of 15 (sample pack)*, 30*, 60 and 90* capsules.
Oratane 20 mg capsules are available in PVC/PVDC/Al blister packs of 15 (sample pack)*, 30*, 60 and 90* capsules.
Oratane 30 mg capsules are available in PVC/PVDC/Al blister packs of 15 (sample pack)*, 30*, 60 and 90* capsules.
Oratane 40 mg capsules are available in PVC/PVDC/Al or PVC/PCTFE/Al blister packs of 15 (sample pack)*, 30, 60* and 90* capsules.
*Currently not marketed.

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)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes