Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Isotretinoin Lupin. 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 taking Isotretinoin Lupin against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Isotretinoin Lupin is used for

Isotretinoin Lupin contains the active ingredient isotretinoin.

Isotretinoin Lupin is used to treat acne.

Isotretinoin Lupin belongs to a group of medicines called retinoids, which are similar to vitamin A.

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

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

Your doctor, however, may have prescribed Isotretinoin Lupin for another purpose.

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

This medicine is available only with a doctor's prescription.

Isotretinoin Lupin is not addictive.

Before you take Isotretinoin Lupin

When you must not take it

Do not take Isotretinoin Lupin if:

3. you have had an allergic reaction to Isotretinoin Lupin, vitamin A, other retinoids or any other ingredients of Isotretinoin Lupin (listed at the end of this leaflet).
4. you are taking tetracycline antibiotics (such as Akamin, Vibramycin, doxycycline hydrochloride (Doryx), Frakas, Minomycin).
5. you have severe liver disease.
6. you have very high fat levels (cholesterol, triglycerides) in your blood.
7. you have hypervitaminosis A. This is a condition caused by an excessive amount of vitamin A in the diet.
8. the packaging is torn or shows signs of tampering.
9. 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 Isotretinoin Lupin, contact your doctor.

Do not give Isotretinoin Lupin to children. There is limited information on the use of Isotretinoin Lupin in children before puberty.

Before you start to take it

Tell your doctor if:

1. you have any allergies to any other medicines, foods, preservatives or dyes. Isotretinoin Lupin capsules contain soya oil, which may contain traces of arachidic acid (a component of peanut oil).
2. 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;
• stomach or bowel disease.

3. you drink large amounts of alcohol.

If you have not told your doctor about any of the above, tell them before you start taking Isotretinoin Lupin.

Taking other medicines

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

Some medicines may interfere with Isotretinoin Lupin. These include:

• tetracycline antibiotics (such as Akamin, doxycycline hydrochloride (Doryx), Frakas, Vibramycin, Minomycin);
• 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 Isotretinoin Lupin, 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.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Isotretinoin Lupin.

Ask your doctor or pharmacist if you are not sure about this list of medicines.

How to take Isotretinoin Lupin

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 Isotretinoin Lupin exactly as your doctor has prescribed. Your doctor will tell you how many Isotretinoin Lupin capsules to take each day.

This dose will be calculated to suit your individual needs and your body weight. This dose may be adjusted during treatment when the doctor knows how you respond to Isotretinoin Lupin.

How to take it

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.

When to take it

Isotretinoin Lupin may be taken once or twice a day and must always be taken with meals.

Female patients should wait until the 2nd or 3rd day of their next normal menstrual period before starting Isotretinoin Lupin treatment. This helps ensure that you aren't pregnant before you start taking Isotretinoin Lupin.

How long to take it

Continue taking Isotretinoin Lupin for as long as your doctor prescribes.

Acne treatment with Isotretinoin Lupin will usually last 4 to 8 months. In the first few weeks of treatment your acne will probably get a little worse before it gets better.

Do not worry about this, it is a sign that Isotretinoin Lupin 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 Isotretinoin Lupin treatment is finished.

Please note that Isotretinoin Lupin 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 take it

Do not try to make up for missed doses by taking an extra dose. This may increase the chance of getting an unwanted side effect.

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

If you have missed several doses, please inform your doctor and follow the advice given to you.

If you take too much (overdose)

Immediately telephone your doctor, or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much Isotretinoin Lupin.

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.

Keep telephone numbers for these places handy.

While you are taking Isotretinoin Lupin

Things you must do

If you become pregnant while taking Isotretinoin Lupin, stop taking it and tell your doctor immediately. Isotretinoin Lupin can cause birth defects (damage to unborn babies). You must use strict birth control, starting at least 1 month before you begin taking Isotretinoin Lupin, for the whole time you are taking Isotretinoin Lupin and for 1 month after you finish taking Isotretinoin Lupin.

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

Tell all doctors, dentists and pharmacists who are treating you that you are taking Isotretinoin Lupin.

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 Isotretinoin Lupin 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 Isotretinoin Lupin.

Things you must not do

Do not stop taking Isotretinoin Lupin 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 Isotretinoin Lupin to anyone else even if their symptoms seem similar to yours.

Do not use Isotretinoin Lupin to treat other complaints unless your doctor says to.

Do not donate blood during treatment with Isotretinoin Lupin or for at least 1 month after stopping treatment.

Things to be careful of

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

Wearing contact lenses during treatment with Isotretinoin Lupin may cause discomfort. Isotretinoin Lupin 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 a sunscreen while taking Isotretinoin Lupin. Your skin may be more prone to sunburn while on Isotretinoin Lupin.

Avoid waxing and dermabrasion while taking Isotretinoin Lupin and for 5 to 6 months after stopping Isotretinoin Lupin treatment. Your skin may be more sensitive while on Isotretinoin Lupin. Waxing may cause dermatitis and dermabrasion may cause scarring during and for several months after Isotretinoin Lupin 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 Isotretinoin Lupin treatment.

Side effects

Isotretinoin Lupin helps most people with acne but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

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

• dryness of the lips, mouth, nose and skin. A moisturiser or petroleum jelly can be used to soften the lining of the nose, lips and the skin areas not affected by the acne;
• fragile skin;
• change in colour of the skin;
• peeling palms of the hands and soles of the feet;
• itchy skin rash;
• an increased susceptibility to sunburn;
• sweating;
• changes to the nails;
• eye problems such as dry, sore, swollen or itchy eyes, discharge or trouble seeing at night;
• nosebleeds;
• tenderness or stiffness in your bones, joints or muscles;
• tiredness;
• headache;
• hair loss (sometimes occurs and is usually temporary but in rare cases, has persisted);
• excessive hairiness;
• hoarseness
• sexual changes or changes in breast tissue.

These side effects are usually mild and dose related. Most of them disappear completely in a few days to a few weeks after the dose of Isotretinoin Lupin is lowered or stopped.

Tell your doctor immediately if you experience any of the following:

• nausea;
• vomiting;
• persistent headache;
• blurred vision or visual disturbances;
• changes in your hearing or ringing in your ears;
• severe upper stomach pain;
• blood in stools or severe diarrhoea;
• severe bruising;
• sudden red, often itchy spots, similar to the rash of measles starting on the face, hands or feet. The spots may blister or change to flat round raised, red, pale-centred marks. Also, you may have fever, sore throat, headache and/or diarrhoea;
• painful red areas, that change to large blisters and end with peeling of layers of skin, that may occur on lips, mouth, eyes, nose and genitals. Those affected may have fever and chills, aching muscles and generally feel unwell;
• thinking, seeing or hearing things that are not real;
• feeling depressed, with or without suicidal thoughts.

Symptoms of depression may include:

• feeling sad or having crying spells;
• losing interest in activities you once enjoyed;
• sleeping too much or having trouble sleeping;
• changes in your appetite or body weight;
• having trouble concentrating;
• withdrawing from your friends or family;
• feeling like you have no energy;
• feelings of worthlessness or inappropriate guilt.

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

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.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you don't understand anything in this list.

After taking Isotretinoin Lupin

Storage

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 well.

Keep the blister pack in a cool dry place where the temperature stays below 25°C.

Do not store Isotretinoin Lupin, or any other medicine, in a bathroom or near a sink.

Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep Isotretinoin Lupin where young children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Protect Isotretinoin Lupin from light.

Disposal

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

Product description

Availability

Isotretinoin Lupin capsules come in two strengths, 10 mg and 20 mg.

Isotretinoin Lupin 10 mg and 20 mg capsules are available in packs of 60 capsules.

What it looks like

Isotretinoin Lupin 10 mg – red-orange, size 3, oval, soft gelatin capsules marked P10.

Isotretinoin Lupin 20 mg – red-orange, size 6, oval, soft gelatin capsules marked P20.

Ingredients

Active ingredient

• Each 10 mg capsule contains 10 mg isotretinoin.
• Each 20 mg capsule contains 20 mg isotretinoin.

Inactive ingredients

The capsules also contain:

• soya oil;
• yellow beeswax;
• hydrogenated soya oil; and
• partially hydrogenated soya oil.

The capsule shell contains:

• gelatin;
• glycerol;
• titanium dioxide;
• ferrous oxide red and yellow.

The printing uses Videojet Inksource 16-9000 ink, which contains Brilliant Blue FCF and shellac.

Australian Registration Numbers

Isotretinoin Lupin 10 mg: AUST R 324225

Isotretinoin Lupin 20 mg: AUST R 324226

Distributor

Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia

Email: ghinfo@generichealth.com.au
Telephone: +61 3 9809 7900
Website: www.generichealth.com.au

This leaflet was prepared in December 2020.

Published by MIMS February 2021

Notes

Distributed by Generic Health Pty Ltd

1 Name of Medicine

Isotretinoin.

2 Qualitative and Quantitative Composition

Isotretinoin Lupin 10 mg capsules contain 10 mg isotretinoin.
Isotretinoin Lupin 20 mg capsules contain 20 mg isotretinoin.

List of excipients with known effect.

3 Pharmaceutical Form

Isotretinoin Lupin 10 mg capsules are soft gelatin, oval, red-orange, size 3 capsules marked P10.
Isotretinoin Lupin 20 mg capsules are soft gelatin, oval, red-orange, size 6 capsules marked P20.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of severe cystic acne.

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 Isotretinoin Lupin at doses up to 0.5 mg/kg/day 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 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 reactions 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 patients refractory to initial treatment at lower doses.
The above daily dosages of Isotretinoin Lupin 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

Severely impaired liver function and in patients with chronic abnormally elevated blood lipid values.
Hypersensitivity to the drug or other ingredients in isotretinoin capsules or to other retinoids.
Pre-existing hypervitaminosis A.
Rare cases of benign intracranial hypertension have been reported after isotretinoin and after tetracyclines. Concomitant treatment with tetracyclines is, therefore, contraindicated (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Use in pregnancy (Category X).

Use in lactation.

4.4 Special Warnings and Precautions for Use

Information for patients.

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 non-irritant 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 six months therapy with 40 mg to 120 mg daily.
Concomitant tetracycline or minocycline was administered in five out of ten 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.

Post-marketing experience.

Symptoms associated with hypervitaminosis A.

Skin and appendages disorders.

Musculoskeletal system disorder.

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.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Soya oil, yellow beeswax, hydrogenated soya oil and partially hydrogenated soya oil. The capsule shell contains gelatin, glycerol, titanium dioxide, iron oxide red and iron oxide yellow. The printing ink used is Proprietary Ingredient Number 4632, which is Videojet Inksource 16-9000 ink and contains Brilliant Blue FCF and shellac.

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 in the original packaging. Protect from light and moisture.

6.5 Nature and Contents of Container

Isotretinoin Lupin 10 mg capsules are supplied in PVC/PE/PVDC/Al blister packs of 60 capsules.
Isotretinoin Lupin 20 mg capsules are supplied in PVC/PE/PVDC/Al blister packs of 60 capsules.

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

Isotretinoin is related to both retinoic acid and retinol (vitamin A). Isotretinoin is a yellow-orange to orange crystalline powder, 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.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

(S4) Prescription Only Medicine.

Summary Table of Changes