Consumer Medicine Information

ORATANE® Ask your doctor if you have any questions about

why ORATANE has been prescribed for you.
Isotretinoin
5 mg, 10 mg, 20 mg, 30 mg and 40 mg Capsules This medicine is available only with a doctor's
prescription.
What is in this leaflet
ORATANE capsules are not addictive.
Please read this leaflet carefully before you start
taking ORATANE.
Before you take ORATANE
This leaflet answers some common questions
about ORATANE. It does not contain all the When you must not take it
available information. It does not take the place
of talking to your doctor or pharmacist.
Do not take ORATANE if you are pregnant or for
at least one month before you intend to become
All medicines have risks and benefits. Your doctor
pregnant. If you fall pregnant while taking
has weighed the risks of you taking ORATANE
ORATANE capsules, there is an extremely high
against the benefits they expect it will have for
risk of having a baby that is severely deformed.
you.
Pregnancy testing should be performed before,
If you have any concerns about taking this
during (every month is strongly recommended)
medicine, ask your doctor or pharmacist.
and for a month after treatment has finished.
Keep this leaflet with the medicine. You may
You must use effective contraception (birth
need to read it again.
control) for one month before, during and at
least one month after treatment with ORATANE.
What ORATANE is used for It is recommended that two complementary
forms of contraception including a barrier
method should be used. Progesterone only
The active ingredient in ORATANE capsules is contraceptive tablets (minipills) alone are an
isotretinoin, a substance very similar to vitamin A. inadequate method of contraception while you
ORATANE belongs to a group of medicines called are on isotretinoin.
retinoids.
Do not breastfeed while taking ORATANE
ORATANE capsules are used to treat acne. Of the capsules. Breast-feeding must stop before
many acne medicines, ORATANE is used for more ORATANE treatment can start.
severe cases.
Do not take ORATANE if you have an allergy to:
• any medicine containing isotretinoin
ORATANE capsules work by cutting down the • other retinoids, including vitamin A
amount of oily substances (sebum) made by your • any of the ingredients listed at the end of
glands in your skin. ORATANE capsules will also this leaflet
help to reduce the bacteria, inflammation and
open clogged pores. Some of the symptoms of an allergic reaction
may include:
Your doctor may have prescribed ORATANE for • difficulty in breathing or wheezing
another reason. • shortness of breath
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 • hives on the skin, rash, or itching Tell your doctor if you drink large amounts of
• swelling of the face, tongue, lips, or other alcohol.
parts of the body
If you have not told your doctor about any of
Do not take ORATANE if you are taking the above, tell them before you start taking
tetracycline antibiotics, such as doxycycline, ORATANE.
minocycline.
Taking other medicines
Do not take ORATANE if you have kidney or liver
disease.
Tell your doctor if you are taking any other
Do not take ORATANE if you have very high medicines, including medicines that you buy
levels of fat (triglycerides, cholesterol) in your without a prescription from your pharmacy,
blood. supermarket or health food shop.

Do not take ORATANE if you have very high Some medicines may interfere with ORATANE.
levels of vitamin A in your body These include:
(hypervitaminosis). It is a condition caused by an • Tetracycline antibiotics
excessive amount of Vitamin A in the diet. • Vitamin A or formulations containing
vitamin A
Do not give ORATANE capsules to children under • Other medicines for acne. Avoid the use
13 years. of topical keratolytic or exfoliative anti-
acne agents while you are on ORATANE.
Do not take it after the expiry date (EXP) printed • The mini-pill, a progesterone-only oral
on the back. If you take it after the expiry date contraceptive pill
has passed, it may not work as well.
These medicines may be affected by ORATANE or
Do not take it if the packaging is torn or shows may affect how well it works. You may need to
signs of tempering, or if the capsules do not look take different amounts of your medicine, or you
quite right. may need to take different medicines.

If you are not sure whether you should start Talk to your doctor or pharmacist if you are not
taking ORATANE capsules, talk to your doctor. sure about this list of medicines. Your doctor or
pharmacist has more information on medicines
to be careful with or avoid while taking
Before you start to use it
ORATANE.

Tell your doctor if you have:

How to take ORATANE
1. allergies to other substances, such as foods,
preservatives or dyes. Oratane capsules
contain soya oil.
How much to take
2. ever had any mental illness (including
depression and suicidal behaviour). Always take ORATANE exactly as your doctor or
3. liver disease pharmacist tells you to. The directions given may
4. kidney disease differ from information contained in this leaflet.
5. lipid (cholesterol or triglyceride) disorder
6. eye disorders Your doctor will determine exactly how much
7. hearing impairment ORATANE you need for your condition. This will
8. bowel disease be matched especially to your needs and your
9. diabetes (high blood sugars) bodyweight and may be adjusted by your doctor
when it is known how you respond to ORATANE
capsules.
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How to take it
While you are taking ORATANE

Swallow ORATANE capsules whole with a glass Things you must do

of water. Do not open ORATANE capsules or take
damaged capsules. If you become pregnant while taking ORATANE
capsules, stop taking it and inform your doctor
ORATANE must be taken with meals. immediately.

When to take it ORATANE capsules can cause birth defects. This

means that you must use strict birth control for
at least 1 month before you start ORATANE, the
Take ORATANE at about the same time each day.
whole time you are using ORATANE capsules
Taking it at the same time each day will have the
and for at least 1 month after you finish taking
best effect. It will also help you remember when
ORATANE capsules.
to take it.
No specific contraceptive precautions are
Female patients should wait until the 2nd or 3rd
necessary for men. Although isotretinoin and its
day of their menstrual period before starting
metabolites are present in very low levels in your
ORATANE. This helps to ensure that you are not
semen, these levels are considered too low to
pregnant before you start to take ORATANE.
harm the unborn baby of your female partner.
However, you must never share your medication
How long to take it
with anyone.

Continue taking ORATANE capsules for as long Tell all doctors, dentists and pharmacists who
as your doctor prescribes. are treating you that you are on ORATANE
capsules.
Your treatment with ORATANE will usually last 16
to 24 weeks. Most patients only need one course. Keep all of your doctor’s appointments so that
Your acne may continue to improve for up to 8 your progress can be checked.
weeks after treatment. Therefore, you will not You may require regular tests to check your liver,
usually start another course until then. blood sugar levels and blood cholesterol levels.
Your doctor may decide to monitor your bone
In the first few weeks your acne may get worse growth and bone structure, particularly if you are
before it gets better. It usually improves as a child or young person.
treatment goes on.
Tell your doctor if you feel ORATANE is not
Although ORATANE cannot improve scars or helping your condition.
pitting that existed before commencement of
treatment, it will help prevent further scarring. If you have not taken your medicine exactly as
prescribed, you must inform your doctor. Your
If you forget to take it doctor may think ORATANE was not effective and
change your treatment unnecessarily.
Do not take a double dose to make up for the
dose that you missed. This may increase the If you are intending to do a lot of heavy lifting or
chance of unwanted side effects. intensive exercise, tell your doctor. Your muscles
and joints may become stiff or tender while
Continue with the next dose when it is due. If you taking ORATANE.
are unsure what to do, ask your doctor or
pharmacist. If you have missed several doses, Things you must not do
please inform your doctor and follow the advice
given to you.
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Do not give ORATANE capsules to anyone else, Avoid using hair colouring, perming products.
even if their symptoms seem similar to yours. Your skin and hair will be more delicate while
taking ORATANE.
Do not donate blood while taking ORATANE or
for at least four weeks after stopping treatment Avoid excessive sun exposure, and always apply
because an unborn baby could be harmed if a sunscreen while taking ORATANE. Your skin may
pregnant patient receives your blood. be more prone to sunburn.

Do not stop taking ORATANE or change the dose

without first checking with your doctor. In case of overdose
Do not let yourself run out of ORATANE capsules If you take too much (overdose)
over the weekend or on holidays.
Immediately telephone your doctor or the
Do not use ORATANE capsules to treat other
National Poisons Centre (telephone 0800
complaints unless told to by your doctor.
POISON or 0800 764 766) or go to accident and
emergency at your nearest hospital, if you think
Do not take any other medicines without first
that you or anyone else may have taken too
telling your doctor or pharmacist.
much ORATANE.
Do this even if there are no signs of discomfort
Things to be careful of or poisoning. You may need urgent medical
attention.
Be careful driving or operating machinery until
you know how ORATANE affects you. Signs of overdose include transient headache,
Normally ORATANE capsules would not affect vomiting, facial flushing, reddened lips, stomach
your ability to drive a car or operate machinery. pain, headache, dizziness and unsteady walking.
However altered night vision and other visual
disturbances may occur while taking ORATANE
capsules. Make sure you know how you react to Side effects
ORATANE capsules before you drive a car,
operate machinery or do anything else that might Tell your doctor or pharmacist as soon as
be dangerous if your vision is altered. possible if you do not feel well while taking
ORATANE. In addition to the beneficial effects of
ORATANE may cause dry eyes, intolerance to ORATANE for acne, it is possible that unwanted
contact lenses and visual difficulties including effects will occur during treatment, even when it
decreased night vision. Tell your doctor if you is used as directed.
have any of these symptoms. Your doctor may
ask you to use lubricating eye ointment or All medicines can have side effects. Sometimes
artificial tears. If you use contact lenses and you they are serious, most of the time they are not.
have developed intolerance to contact lenses, You may need medical treatment if you get some
you may be advised to wear glasses during the of the side effects.
treatment. Your doctor may refer you to a
specialist for advice if you develop visual Ask your doctor or pharmacist to answer any
difficulties and you may be asked to stop taking questions you may have.
ORATANE.
Tell your doctor if you notice any of the
Avoid waxing, dermatological abrasions, facial following and they worry you:
peels, electrolysis while taking ORATANE and for • Dryness of the lips, mouth, nose, eyes and
six months after ORATANE treatment has skin
stopped. Your skin may be more sensitive while • Peeling of skin on palms of hands and
on ORATANE. soles of feet

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 • Skin redness, rash, itching, inflammation • Feel like you have no energy
• Tenderness, stiffness in bones, joints or • Have feelings of worthlessness or
muscles inappropriate guilt
• Headache • Start having thoughts about hurting
• Nosebleeds yourself or taking your own life (suicidal
• Increased sensitivity to sunlight thoughts).
• Temporary hair loss (in some rare cases
hair loss has persisted) These may be serious side effects and may
• Problems getting or maintaining an require urgent medical attention.
erection
• Lower libido This is not a complete list of all possible side
effects. Others may occur in some people and
These side effects are usually mild and dose there may be some unknown side effects.
related. After the dose of ORATANE capsules is
reduced or stopped most of these side effects You should tell your doctor about unwanted
should disappear within a few days or weeks. effects that occur during treatment. In some
Stop taking ORATANE capsules and contact your cases you doctor may want to reduce your dose
doctor immediately if you experience any of the or stop treatment.
following:
• Bloody diarrhoea, blood in urine Do not be alarmed by this list of possible side
• Nausea, vomiting, stomach pain or fever effects. You may not experience any of them.
• Persistent headache, severe headache, or
seizure
• Blurred vision or visual disturbances After taking ORATANE
• changes in your hearing or ringing in your
ears. Storage
• Unexpected muscle pain or weakness
• Severe bruising
• sudden red, often itchy spots, similar to Keep your capsules in the blister pack until it is
the rash of measles starting on the face, time to take them. If you take the capsules out of
hands or feet. The spots may blister or the packaging they will not keep as well.
change to flat round raised, red, pale- Keep ORATANE 5 mg, ORATANE 10 mg, ORATANE
centred marks. You may also have a fever, 30 mg, ORATANE 40 mg capsules in a cool dry
sore throat, headache and/ or diarrhoea place where the temperature stays below 25°C.
• painful red areas, that change to large Protect from light.
blisters and end with peeling of layers of
skin, that may occur on lips, mouth, eyes, Keep ORATANE 20 mg capsules in a cool dry place
nose and genitals. Those affected may where the temperature stays below 30°C. Protect
have fever and chills, aching muscles and from light.
generally feel unwell.
• Feeling depressed with or without suicidal
thoughts Do not store ORATANE in the bathroom or near
• Start to feel sad or have crying spells a sink. Do not leave it in the car or on a
• Lose interest in activities you once windowsill. Heat and dampness can destroy
enjoyed some medicines.
• Sleep too much or have trouble sleeping
• Become more irritable, angry or Keep ORATANE capsules where children cannot
aggressive than usual (e.g., temper reach it. A locked cupboard at least one-and-a
outbursts, thoughts of violence) half metres above the ground is a good place to
• Change in appetite or body weight store medicines.
• Have trouble concentrating
• Withdraw from family or friends
Disposal
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Return any unused medicine to your pharmacist.
Sponsor details
If your doctor tells you to stop taking this
medicine or they have passed their expiry date, ORATANE is supplied in New Zealand by:
ask your pharmacist what to do with any unused Douglas Pharmaceuticals Ltd
medicine.
P O Box 45 027
Auckland 0651
Product description New Zealand
Phone: (09) 835 0660
What it looks like

ORATANE 5 mg capsules are soft, oval, opaque

Date of preparation
white in colour containing a yellow/orange liquid.
29 October 2019
ORATANE 10 mg capsules are soft, oval, opaque (based on data sheet dated 29 October 2019)
light violet in colour containing a yellow/orange
liquid.

ORATANE 20 mg capsules are soft, oval, opaque

maroon-red in colour containing a yellow/orange
liquid.

Oratane 30 mg capsules are soft, oval opaque

pink in colour, containing a yellow/orange liquid.

ORATANE 40 mg capsules are soft, oval, opaque

light orange in colour containing a yellow/orange
liquid.

Ingredients
Active ingredient(s):
Isotretinoin

Inactive ingredients:
Soya oil, tocopherol, disodium edetate, butylated
hydroxyanisole, yellow beeswax, hydrogenated
soya oil.

The capsule shells contain:

Gelatin, glycerol, sorbitol solution 70% (non-
crystallising), titanium dioxide and water
(purified).

10 mg capsules only: Iron oxide black (CI 77499)

and Ponceau Red (CI 16255).
20 mg capsules only: Indigo carmine (CI 73015)
and Ponceau Red (CI 16255).
30 mg capsules only: Iron oxide red
40 mg capsules only: Sunset yellow (CI 15985).

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