Isotretinoin belongs to a group of medicines called retinoids that are similar to Vitamin A. Isotretinoin works by cutting down the amount of oily substances made by the glands in your skin. Your doctor may prescribe Isotretinoin to treat abnormal cystic acne.
There are many different types of medicines used to treat acne. Isotretinoin is used for more severe cases that are resistant to other treatments.
Your doctor, however, may have prescribed Isotretinoin for another purpose.
Ask your doctor if you have any questions about why Isotretinoin has been prescribed for you.
Before you take Isotretinoin
When you must not take it:
- If you are pregnant, or you intend to become pregnant. If you become pregnant while on Isotretinoin, 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 Isotretinoin treatment, during and up to at least one month after treatment completion.
- If you are breastfeeding. You must not breastfeed while taking Isotretinoin.
- Do not take Isotretinoin 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 Isotretinoin therapy
- you plan to undertake vigorous types of exercise while on Isotretinoin treatment.
How to take Isotretinoin
It is important that you take your medicine exactly as your doctor tells you.
Your doctor will determine exactly how many Isotretinoin 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 Isotretinoin.
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 Isotretinoin is working for you. Your treatment with Isotretinoin will usually last 16 to 24 weeks. Sometimes a second course of treatment may be necessary.
Always take Isotretinoin 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 Isotretinoin therapy. This helps ensure that you aren't pregnant before you start taking Isotretinoin.
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 Isotretinoin 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 Isotretinoin to other members of your family or friends, even if their condition seems similar to yours. It has been prescribed for you personally.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Isotretinoin.
Isotretinoin 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.
Taking other medications
Some medicines and Isotretinoin 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 Isotretinoin works.
If you take too much (overdose)
If you or another person have taken more than the recommended dose of Isotretinoin, immediately telephone your doctor 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.
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 25°C (77°F).
Do not store medicines in the bathroom, on windowsills or in the glove box of your car.
Do not refrigerate, or freeze Isotretinoin capsules.
Protect your capsules from light.
Do not use this medicine after the expiry date shown on the outer pack.
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