The name of your medicine is APO-Isotretinoin. It contains the active ingredient isotretinoin.
It is used to treat severe acne, where other treatments have not worked.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
Isotretinoin 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 (i.e. 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 is used for more serious cases.
Do not give isotretinoin to children.
There is not enough information to recommend the use of this medicine in children.
This medicine should not be used in children.
Do not take this medicine if:
Before you start taking this medicine, tell your doctor if:
1. You have allergies to:
2. You are allergic to peanuts.
If you have a peanut allergy you should consult your doctor to discuss the risks and benefits of taking this product.
3. You have or have had any medical conditions, especially the following:
4. You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.
5. You are currently breast-feeding or you plan to breast-feed. Do not take this medicine whilst breast-feeding until you and your doctor have discussed the risks and benefits involved.
6. You drink large amounts of alcohol, or you smoke
7. You are taking or are planning to take any other medicines, This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
Some medicines may interact with isotretinoin. These include:
If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with isotretinoin.
Follow carefully all directions given to you by your doctor or pharmacist. Their instructions may be different to the information in this leaflet.
Your doctor or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
Swallow the capsules whole with a glass of water or milk.
Do not open the capsules and do not take any capsules that are damaged.
Isotretinoin may be taken once or twice a day and must always be taken with food.
If you are female, you should wait until the 2nd or 3rd day of the next normal menstrual period before starting isotretinoin therapy.
This helps ensure that you aren't pregnant before you start taking isotretinoin.
Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
Continue taking your medicine for as long as your doctor tells you.
Acne treatment with isotretinoin will usually last around four months, and in some cases a second course lasting four months may be needed, usually with a gap of two months between courses.
In the first few weeks of treatment your acne will probably get a little worse, but this will usually stop getting worse within seven to ten days. Do not worry about this, it is a sign that isotretinoin is working.
At the end of the course your acne should have cleared up significantly. Most patients notice their skin condition continues to improve even after isotretinoin treatment is finished.
Please note that isotretinoin cannot improve scars or pitting that were present before treatment started, but it will help prevent such skin damage in the future.
Make sure you have enough to last over weekends and holidays.
If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise take it as soon as you remember and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you become pregnant while taking isotretinoin, stop taking it and tell your doctor immediately.
Isotretinoin causes birth defects in females taking isotretinoin.
You must use strict birth control starting at least 1 month before you begin taking isotretinoin, for the whole time you are taking isotretinoin and for one month after you finish taking isotretinoin.
There is no known risk to males who wish to father children (except after overdosing; see above).
Tell your doctor that you are taking this medicine if:
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Be careful when driving or operating machinery until you know how this medicine affects you.
Normally isotretinoin 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. Some people may also feel drowsy or dizzy. Make sure you know how you react to isotretinoin before you drive a car, operate machinery or do anything else that may be dangerous if you are affected by isotretinoin.
During the first three weeks of taking isotretinoin, your skin may become irritated. Also, your acne may seem to get worse before it gets better. Check with your doctor if your skin condition does not improve within one to two months of starting this medicine or at any time your skin irritation becomes severe. Full improvement continues after you stop taking isotretinoin and may take up to six months. Your health care professional can help you choose the right skin products to reduce skin dryness and irritation.
If you develop any new skin rash (e.g. redness, hives, spots, blisters or flaking skin) during isotretinoin treatment, contact your doctor immediately.
There have been reports of skin rash associated with this medicine. Some of these rashes may be serious and can cause severe illness. These serious rashes may be accompanied or preceded by flu-like symptoms.
Isotretinoin may cause hearing problems in one or both ears (ringing in the ears, unable to hear certain sounds, deafness). This may occur during or after finishing a course of isotretinoin. No more isotretinoin should be taken and medical attention sought immediately.
Isotretinoin may cause bowel problems, so if you have severe stomach pains or bleeding from the rectum, or bloody diarrhoea, see your doctor right away.
Isotretinoin may cause dryness of the mouth and nose. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than two weeks, check with your doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
Isotretinoin may cause mood or behaviour problems, including having thoughts about self-harm or suicide; check with you doctor right away if unusual mood or behaviour problems occur.
Isotretinoin may cause bone or muscle problems, including joint pain, muscle pain or stiffness, or difficulty moving. Check with your doctor if these problems are bothersome.
Your doctor will monitor you for signs of raised lipid (fat) levels in your blood. You may be able to manage these with diet, weight loss, restricting alcohol intake and stopping smoking. However if you have severe pains in your upper abdomen (which may be due to raised lipid levels) see your doctor straight away.
For diabetic patients:
This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.
Wearing contact lenses during treatment with isotretinoin may cause discomfort.
You may temporarily need to wear your lenses for shorter periods or wear glasses instead.
Isotretinoin may cause dry eyes. An eye lubricant or artificial tears, available from your pharmacist, should relieve this problem. Make sure your doctor or eye specialist know if you have dry eyes, so they can monitor you.
Eye infections, inflammation and hazy vision may also occur and should be monitored closely by your doctor and eye specialist.
Avoid excessive exposure to the sun (or UV, sunlamp or solarium), wind or cold weather. Your skin will be more prone to sunburn, dryness, or irritation, especially during the first two or three weeks of treatment.
Use sunscreen or sun blocking lotions with a sun protection factor (SPF) of at least 15. Also, wear protective clothing and hats. Also use a skin moisturiser and a lip balm to prevent the skin and lips becoming dry.
Avoid waxing, dermabrasion and laser treatment while taking isotretinoin and for five to six months after stopping isotretinoin.
Your skin may be more sensitive while on isotretinoin. Waxing may cause dermatitis and dermabrasion may lift the skin's surface and cause scarring during and for several months after isotretinoin therapy.
Avoid using facial peels, electrolysis and some hair treatments.
Your skin and hair may be more delicate during treatment and for a while after taking isotretinoin. You may use mild creams and ointments to help with this. Your doctor or pharmacist can advise you.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking isotretinoin or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor or pharmacist if you notice any of the following and they worry you.
This list includes the more common side effects. Mostly, these are mild:
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects. You may need medical attention. Most of these side effects are rare.
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
If any of the following happen, stop taking your medicine and either tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
Some types of severe skin rash may cause serious illness, and may be life-threatening. For example, severe skin reactions which start with painful red areas, then large blisters and ends with peeling of layers of skin. These may be accompanied by fever and chills, aching muscles and generally feeling unwell. Such rashes may be called Erythema Multiforme, Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis.
Symptoms of depression may include:
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to isotretinoin, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C. Protect this medicine from light and moisture.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor or pharmacist tells you to stop taking this medicine or they have passed their expiry date, your pharmacist can dispose of the remaining medicine safely.
10 mg capsules*:
Red-orange, size 3, oval, soft gelatin capsules marked P10.
20 mg capsules*:
Red-orange, size 6, oval, soft gelatin capsules marked P20.
Available in blister strips of 60 capsules.
* Not all strengths, pack types and/or pack sizes may be available.
Each capsule contains 10 mg or 20 mg of isotretinoin as the active ingredient.
It also contains the following inactive ingredients:
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.
APO-Isotretinoin 10 mg capsule (blister pack): AUST R 190940.
APO-Isotretinoin 20 mg capsule (blister pack): AUST R 190941.