This patient product information is only a guide on how to use Oratane capsules. Your doctor and pharmacist will have more detailed and complete product information.
Always talk to your doctor if you have any questions or difficulty before, during or after taking your medicine.
The active ingredient in Oratane 20mg capsules is isotretinoin, a substance very similar to vitamin A.
The other ingredients in Oratane 20mg capsules are soya oil - hydrogenated, DL-alpha-tocopherol, disodium edetate, butylated hydroxyanisole, soya oil-(partly) hydrogenated, beeswax - yellow and vegetable oil - hydrogenated. The capsule shell contains gelatin, glycerol, sorbitol solution 70% (non-crystallising), indigo carmine CI73015, brilliant scarlet 4R CI16255, titanium dioxide, water-purified.
Oratane 20mg capsules are soft, oval, opaque maroon-red in colour containing a yellow/orange liquid.
Oratane 20mg capsules are used to treat abnormal cystic acne. Oratane works by cutting down the amount of oily substances made by glands in your skin.
Oratane CAUSES BIRTH DEFECTS and must absolutely not be used by pregnant women or by women who intend to become pregnant. So, if you are pregnant or think you are pregnant or even if you are planning to be pregnant, you must tell your doctor. It is very important that pregnancy is ruled out before you start to take Oratane. This means that you must use strict birth control for at least 1 month before you start Oratane and for the whole time you are taking Oratane and for at least 1 month after you finish taking Oratane.
You should wait until the 2nd or 3rd day of your next normal menstrual period before you start taking your course of Oratane. If you discover that you have become pregnant while you are taking Oratane, stop taking it immediately and tell your doctor.
Make sure your doctor knows if you:
This is extremely IMPORTANT, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines.
Therefore you should not take Oratane with other drugs or use other creams or ointments for acne unless you have informed your doctor and obtained permission to do so.
When you are taking Oratane, you should avoid taking vitamin supplements that contain greater then 2500 IU of vitamin A. If you are not sure, check with your doctor or pharmacist.
Your skin may be more sensitive to the effects of the sun (you have a higher chance of developing sunburn) while you are taking Oratane. Avoid excessive sun exposure and apply a sunscreen while taking Oratane.
Do not donate blood until at least 2 weeks after stopping treatment.
If you experience unwanted effects such as headache, nausea, vomiting or visual difficulties while you are taking Oratane, you should stop taking Oratane and see your doctor as soon as possible.
Normally your ability to drive cars or operate machinery will not be affected by Oratane, however disturbed night vision and other visual disturbances may occur. Make sure that you are aware whether Oratane affects you before you operate machinery or drive a car.
Oratane must absolutely not be taken during pregnancy or while you are breast-feeding. You must tell your doctor if you are pregnant, if you think you are pregnant or if you intend to become pregnant. You must not take Oratane in this case, as Oratane may cause harm to your unborn baby.
Always take Oratane exactly as your doctor tells you to.
Your doctor will determine exactly how much Oratane you need for your condition. This will be matched especially to your needs and your bodyweight and may be adjusted by your doctor when it is known how you respond to Oratane. 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 Oratane is working for you.
Your treatment with Oratane will usually last 16 to 20 weeks. Sometimes a second course of treatment may be necessary. Always take Oratane with meals. The capsules should be swallowed un-chewed together with water or another non-alcoholic drink. Do not open the capsules. If you forget to take one dose, you should not make up for the missing dose by doubling the dose at the next dosing time. Instead you should simply continue with the next dose when it is due.
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 Oratane cannot improve scars or pitting that were present before treatment started, but it will help prevent such skin damage in the future.
Do not give Oratane to other members of your family or friends, even if their condition seems similar to yours. It has been prescribed for you personally.
You should return any capsules remaining at the end of treatment to your dermatologist or pharmacist.
If you or another person have taken an overdose of Oratane, you must contact your doctor, or the nearest hospital immediately.
Treatment with Oratane usually lasts for 16 to 20 weeks. 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. If your acne returns, you can take another course of Oratane at a later date if your doctor prescribes it again.
In addition to the beneficial effects of Oratane it is possible that unwanted effects will occur during treatment, even when it is used as directed.
The most common side effects are related to dryness of the lips, mouth, 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.
You may also get tenderness or stiffness in your bones or muscles, peeling palms and soles, skin infections, tiredness, headache, an increased susceptibility to sunburn and eye problems. As Oratane can cause dry eyes, wearing contact lenses during treatment with Oratane may cause discomfort and you may temporarily need to wear glasses instead. Moisturising eye drops may help with any discomfort caused by dry eyes.
In some patients, hair thinning sometimes occurs (and in rare cases, has persisted).
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 Oratane is lowered or stopped.
Rare unwanted effects reported in association with Oratane include sore or bleeding gums, weight loss, abnormal menstrual cycle, numbness or tingling feeling, dizziness, blurred vision and depression.
If you have diabetes or your doctor thinks you might be a diabetic, you will need to have blood sugar checks a few times while you are taking Oratane.
You should tell your doctor about unwanted effects which occur during treatment. In some cases your doctor may want to reduce your dose or stop treatment.
If you are concerned about these or any other unexpected effect(s), please talk to your doctor.
Always keep this medicine in the closed original pack and out of the sight and reach of children. In a cool, dry place, where the temperature is less than 30°C.
Do not store medicines in the bathroom, on window sills or in the glove box of your car. Do not refrigerate, or freeze Oratane capsules.
Do not use this medicine after the expiry date (EXP) shown on the outer pack.
Oratane has been prescribed for you personally, and you must not under any circumstances give it to anyone else.
Oratane 20mg capsules are available in blister packs of 60 capsules.
If you have any questions about Oratane capsules, please ask your doctor or pharmacist. Further information may also be obtained from Douglas Pharmaceuticals Ltd, in New Zealand. Oratane capsules are only available on your doctor’s prescription.
In New Zealand
Douglas Pharmaceuticals Ltd
PO Box 45027