Isotane Consumer Medicine Information

10 mg and 20 mg Capsules

Isotretinoin

What is in this leaflet

This leaflet answers some common questions about ISOTANE. 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 ISOTANE 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 is Isotane used for

Your medicine is in the form of a capsule. Isotretinoin belongs to a group of medicines called retinoids that are similar to Vitamin A. ISOTANE works by cutting down the amount of oily substances made by the glands in your skin. Your doctor may prescribe ISOTANE to treat abnormal cystic acne.

There are many different types of medicines used to treat acne. ISOTANE is used for more severe cases that are resistant to other treatments.

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

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

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

Before you take ISOTANE

When you must not take it:

  • If you are pregnant, or you intend to become pregnant. If you become pregnant while on ISOTANE, there is a high risk that the baby you have may be severely deformed. Adequate birth control must be used one month prior to starting ISOTANE treatment, during and up to at least one month after treatment completion.
  • If you are breastfeeding. You must not breastfeed while taking ISOTANE.
  • Do not take ISOTANE if you think you are allergic to Vitamin A, other retinoids or any of the ingredients listed at the end of this leaflet.
  • If you have liver disease.
  • If you have hypervitaminosis A (excessive amounts of Vitamin A obtained from the diet or supplements).
  • If you have very high fat levels (cholesterol, triglycerides) in your blood.
  • If you are taking tetracycline antibiotics.
  • If the product has passed its expiry date printed on the label.
  • If the package is not intact or if the packaging shows any sign of tampering.
  • If there is a noticeable change to the appearance of the product.

Before you start to take it

You must tell your doctor or pharmacist if:

  • you are depressed (have feelings of deep sadness and unworthiness or feel "down"), or have felt this way in the past
  • you have abnormal thoughts or behaviour or a mental illness, or have had them in the past
  • you have thoughts of harming yourself (suicidal thoughts or tendencies), or you have had them in the past.
  • you have any other health problems or issues including:
    • you are considerably overweight
    • diabetes, or a history of diabetes in your family
    • a history of pancreatitis (inflamed pancreas)
    • kidney disease
    • very high fat levels (cholesterol, triglycerides) in your blood
  • you drink large amounts of alcohol
  • you have allergies to any other substance, such as foods, preservatives or dyes
  • you are on the "mini-pill", a progestogen only oral contraceptive pill; this type of contraception has been found to be inadequate while on ISOTANE therapy
  • you plan to undertake vigorous types of exercise while on ISOTANE treatment.

Taking other medications

Some medicines and ISOTANE may interfere with each other. These include any tetracycline antibiotics, vitamin A, or preparations containing vitamin A and other medicines you are using to treat your acne.

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may affect how well ISOTANE works.

How to take ISOTANE

It is important that you take your medicine exactly as your doctor tells you.

Your doctor will determine exactly how many ISOTANE capsules you need for your condition. This will be matched especially to your needs and your body weight, and may be adjusted by your doctor when it is known how you respond to ISOTANE.

In the first few weeks of treatment your acne may get a little worse before it gets better. Do not worry about this as this is a sign that ISOTANE is working for you. Your treatment with ISOTANE will usually last 16 to 24 weeks. Sometimes a second course of treatment may be necessary.

Always take ISOTANE with meals. The capsules should be swallowed unchewed together with water or another non-alcoholic drink. Do not open the capsules.

Female patients should wait until the 2nd or 3rd day of the next normal menstrual period after having used effective birth control for at least one month before starting ISOTANE therapy. This helps ensure that you aren't pregnant before you start taking ISOTANE.

Do not change the prescribed dose yourself. If you think the effect of your medicine is too weak or too strong, talk to your doctor. Please note that ISOTANE 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:

If you forget to take a dose take it as soon as you remember unless it is nearly time for your next dose. Never take two doses at the same time.

Do not give ISOTANE to other members of your family or friends, even if their condition seems similar to yours. It has been prescribed for you personally.

While you are taking ISOTANE

Things you must do

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

ISOTANE causes severe birth defects in babies if the mother is taking ISOTANE. You must use strict birth control starting at least 1 month before you begin taking ISOTANE, for the whole time you are taking ISOTANE and for 1 month after you finish taking ISOTANE. Even if you are infertile or not sexually active effective birth control is recommended.

If you take further courses of ISOTANE after completing the initial treatment you must ensure that each time you take ISOTANE you use strict birth control at least one month before, for the whole time during and for 1 month after you have finished taking ISOTANE.

If you do become pregnant while taking ISOTANE, you should discuss with your doctor whether to continue with the pregnancy or have it terminated.

Tell your doctor if you notice any changes in your mood or behaviour (such as feelings of deep sadness and unworthiness or feeling "down"), or if you start to have suicidal thoughts or tendencies.

Tell your doctor if you notice any changes in your vision or if your eyes start to feel dry.

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

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 the 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 fat levels.

Your doctor may decide to monitor your bone growth and make-up, particularly if you are a child or young person.

If you are intending to do a lot of heavy 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 ISOTANE.

Things you must not do

Do not stop taking ISOTANE 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 use ISOTANE to treat other complaints unless your doctor says to.

Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting with a pharmacist.

Do not donate blood during treatment with ISOTANE or for at least 4 weeks after stopping treatment.

Do not give ISOTANE to anyone else even if their symptoms seem similar to yours.

Things to be careful of

Be careful driving or operating machinery until you know how ISOTANE affects you.
Normally ISOTANE would not affect your ability to drive a car or operate machinery. However altered night vision and other visual disturbances may occur when taking ISOTANE. Make sure you know how you react to ISOTANE 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 ISOTANE may cause discomfort.
ISOTANE 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 contact lenses for shorter periods or wear glasses instead.

AVOID EXCESSIVE SUN EXPOSURE AND SOLARIUMS. Apply a sunscreen while taking ISOTANE. Your skin may be more prone to sunburn while on ISOTANE.

Avoid hair removal using waxing and also dermabrasion (medical removal of layers of skin) while taking ISOTANE and for at least 6 months after stopping ISOTANE.
Your skin may be more sensitive while on ISOTANE. Waxing may cause scarring or dermatitis and dermabrasion may cause scarring during and for at least 6 months after ISOTANE 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 ISOTANE.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ISOTANE.

ISOTANE helps most people with acne but it may have unwanted side effects.

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.

Your doctor or pharmacist want to help so ask any questions you may have.

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

  • dryness of the lips, mouth, throat, nose, eyes 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
  • skin eruptions, rashes and itching, inflammation, redness, sweating or colouration
  • nail inflammation, infection or altered appearance
  • nosebleeds
  • tenderness or stiffness in your bones, joints or muscles
  • headache
  • an increased susceptibility to sunburn
  • hair loss or increased growth.

Your doctor can help you with these side effects.

Tell your doctor immediately or go to your nearest Accident or Emergency Centre if you notice any of the following:

  • nausea, vomiting, stomach pain
  • you feel depressed (have feelings of deep sadness and unworthiness or feel "down")
  • changes in your normal behaviour
  • persistent headache, severe headache or seizure
  • blurred vision or visual disturbances, including decreased vision at night
  • severe stomach pain which passes straight through to your back (infected pancreas)
  • blood in your urine
  • difficulty in breathing
  • tiredness, signs of bruising or bleeding more easily
  • signs of infection such as swelling, tenderness, redness and increased temperature
  • sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing.

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.

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

If you take too much (overdose)

If you or another person have taken more than the recommended dose of ISOTANE, immediately telephone your doctor, or the National Poisons Information Centre (0800 POISON or 0800 764 766) for advice, or go to your nearest Accident and Emergency Centre. 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 lips, stomach pain, dizziness and unsteady walking.

Keep telephone numbers for these places handy.

Storage Conditions

Always keep this medicine in the closed original pack and out of sight and reach of children. Store in a cool, dry place, where the temperature is less than 25C.

Do not store medicines in the bathroom, on windowsills or in the glove box of your car.

Do not refrigerate, or freeze ISOTANE capsules. Protect your capsules from light.

Do not use this medicine after the expiry date shown on the outer pack. ISOTANE has been prescribed for you personally, and you must not under any circumstances give it to anyone else.

Disposal

Return any unused capsules to your pharmacist for disposal.

Product Description

Availability

ISOTANE capsules come in two strengths, 10 mg and 20 mg.

What ISOTANE looks like

10 mg Capsule: Oval capsule with a yellow paste fill and a reddish brown opaque gelatin shell bearing the logo "I10" in black ink.

20 mg Capsule: Oval capsule with a yellow paste fill and a bicoloured reddish brown/cream opaque gelatin shell bearing the logo "I20" in black ink

Active ingredient: isotretinoin

  • Each 10 mg capsule contains 10 mg isotretinoin.

  • Each 20 mg capsule contains 20 mg isotretinoin.

Inactive ingredients:

The 10 mg and 20 mg capsules also contain: Soybean Oil, Yellow Beeswax, Hydrogenated Vegetable Oil, Gelatin, Glycerol, Red Iron Oxide Paste (E172), Yellow Iron Oxide Paste (E172), Titanium Dioxide (E171), and black printing ink.

ISOTANE does not contain sucrose or gluten.

Where to go for further information

Should you have any questions regarding this product, please contact your doctor or pharmacist.

Date of information

10th November 2003.