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
using 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 risk
against the benefits they expect it will have for
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 for one
need to read it again.
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 our • 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 Taking other medicines
• swelling of the face, tongue, lips, or other
parts of the body Tell your doctor if you are taking any other
medicines, including medicines that you buy
Do not take ORATANE if you are taking without a prescription from your pharmacy,
tetracycline antibiotics, such as doxycycline, supermarket or health food shop.
minocycline.
Some medicines may interfere with ORATANE.
Do not take ORATANE if you have kidney or liver These include:
disease. • Tetracycline antibiotics
• Vitamin A or formulations containing
Do not take ORATANE if you have very high
vitamin A
levels of fat (triglycerides, cholesterol) in your
• Other medicines for acne
blood.
• The mini-pill, a progesterone-only oral
contraceptive pill
Do not take ORATANE if you have an excessive
amount of Vitamin A in your diet
These medicines may be affected by ORATANE,
(hypervitaminosis A).
or may affect how well it works. You may need to
take different amounts of your medicine, or you
Do not give ORATANE capsules to children under
may need to take either different medicines or
13 years.
use an additional contraceptive method.
Do not take it after the expiry date (EXP) printed
Talk to your doctor or pharmacist if you are not
on the back. If you take it after the expiry date
sure about this list of medicines. Your doctor or
has passed, it may not work as well.
pharmacist has more information on medicines
to be careful with or avoid while taking
Do not take it if the packaging is torn or shows
ORATANE.
signs of tempering, or if the capsules do not look
quite right.
How to take ORATANE
If you are not sure whether you should start
taking ORATANE capsules, talk to your doctor.
How much to take
Before you start to use it
Always take ORATANE exactly as your doctor or
Tell your doctor if you: pharmacist tells you to. The directions given may
• have allergies to other substances, such as differ from information contained in this leaflet.
foods, preservatives or dyes
Your doctor will determine exactly how much
• are feeling depressed, or have history of
ORATANE you need for your condition.
depression
This will be matched especially to your needs and
• have thoughts about harming yourself, or
your bodyweight and may be adjusted by your
have had them in the past
doctor when it is known how you respond to
• drink large amounts of alcohol
ORATANE capsules.
• have any other health problems, including
diabetes
How to take it
If you have not told your doctor about any of
the above, tell them before you start taking Swallow ORATANE capsules whole with a glass
ORATANE. of water. Do not open ORATANE capsules or take
damaged capsules.

ORATANE must be taken with meals.

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When to take it ORATANE capsules can cause birth defects. This
means that you must use strict birth control for
Take ORATANE at about the same time each day. at least 1 month before you start ORATANE, the
Taking it at the same time each day will have the whole time you are using ORATANE capsules
best effect. It will also help you remember when and for at least 1 month after you finish taking
to take it. ORATANE capsules.

Female patients should wait until the 2nd or 3rd No specific contraceptive precautions are
day of their menstrual period before starting necessary for men. Although isotretinoin and its
ORATANE. This helps to ensure that you are not metabolites are present in very low levels in your
pregnant before you start to take ORATANE. semen, these levels are considered too low to
harm the unborn baby of your female partner.
How long to take it
Isotretinoin treatment does not appear to
damage sperm.
Continue taking ORATANE capsules for as long
as your doctor prescribes. Tell all doctors, dentists and pharmacists who
are treating you that you are on ORATANE
Your treatment with ORATANE will usually last 16 capsules.
to 24 weeks. Sometimes a second course of
treatment may be necessary. Keep all of your doctor’s appointments so that
Skin condition continues to improve even after your progress can be checked.
ORATANE treatment has finished. You may require regular tests to check your liver,
blood sugar levels and blood cholesterol levels.
In the first few weeks your acne may get worse Your doctor may decide to monitor your bone
before it gets better. Do not worry as this is a growth and bone structure, particularly if you are
sign the ORATANE capsules are working. a child or young person.

Although ORATANE cannot improve scars or Tell your doctor if you feel ORATANE is not
pitting that existed before commencement of helping your condition.
treatment, it will help prevent further scarring.
If you have not taken your medicine exactly as
If you forget to take it prescribed, you must inform your doctor. Your
doctor may think ORATANE was not effective and
Do not take a double dose to make up for the change your treatment unnecessarily.
dose that you missed. This may increase the
chance of unwanted side effects. If you are intending to do a lot of heavy lifting or
exercise, tell your doctor. Your muscles and
Continue with the next dose when it is due. If you joints may become stiff or tender while taking
are unsure what to do, ask your doctor or ORATANE.
pharmacist.
If you have missed several doses please inform Things you must not do
your doctor and follow the advice given to you.
Do not give ORATANE capsules to anyone else,
While you are taking ORATANE even if their symptoms seem similar to yours.

Do not donate blood while taking ORATANE or

Things you must do for at least four weeks after stopping treatment.

If you become pregnant while taking ORATANE Do not stop taking ORATANE or change the dose
capsules, stop taking it and inform your doctor without first checking with your doctor.
immediately.
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Do not let yourself run out of ORATANE capsules emergency at your nearest hospital, if you think
over the weekend or on holidays. that you or anyone else may have taken too
much ORATANE.
Do not use ORATANE capsules to treat other Do this even if there are no signs of discomfort
complaints unless told to by your doctor. or poisoning. You may need urgent medical
attention.
Do not take any other medicines without first
telling your doctor or pharmacist. Signs of overdose include transient headache,
vomiting, facial flushing, reddened lips, stomach
Things to be careful of pain, headache, dizziness and unsteady walking.

Be careful driving or operating machinery until Side effects

you know how ORATANE affects you.
Normally ORATANE capsules would not affect
your ability to drive a car or operate machinery. Tell your doctor or pharmacist as soon as
However altered night vision and other visual possible if you do not feel well while taking
disturbances may occur while taking ORATANE ORATANE. In addition to the beneficial effects of
capsules. Make sure you know how you react to ORATANE for acne, it is possible that unwanted
ORATANE capsules before you drive a car, effects will occur during treatment, even when it
operate machinery or do anything else that might is used as directed.
be dangerous if your vision is altered.
All medicines can have side effects. Sometimes
Wearing contact lenses during treatment with they are serious, most of the time they are not.
ORATANE capsules may cause discomfort. You may need medical treatment if you get some
ORATANE may cause dry eyes so an artificial tears of the side effects.
or lubricant may be necessary. Otherwise you
may choose to wear your contact lenses for Ask your doctor or pharmacist to answer any
shorter periods or wear glasses. questions you may have.

Avoid waxing, dermatological abrasions, facial Tell your doctor if you notice any of the
peels, electrolysis and some while taking following and they worry you:
ORATANE and for six months after ORATANE • Dryness of the lips, mouth, nose, eyes and
treatment has stopped. Your skin may be more skin
sensitive while on ORATANE. • Peeling of skin on palms of hands and
soles of feet
Avoid using hair colouring, perming products. • Skin redness, rash, itching, inflammation
Your skin and hair will be more delicate while • Tenderness, stiffness in bones, joints or
taking ORATANE. muscles
• Headache
Avoid excessive sun exposure, and always apply • Nosebleeds
sunscreen while taking ORATANE. Your skin may • Increased sensitivity to sunlight
be more prone to sunburn. • Temporary hair loss (in some rare cases
hair loss has persisted)
• Problems getting or maintaining an
In case of overdose erection
• Lower libido
If you take too much (overdose)
These side effects are usually mild and dose
Immediately telephone your doctor or the related. After the dose of ORATANE capsules is
National Poisons Centre (telephone 0800 reduced or stopped most of these side effects
POISON or 0800 764 766), or go to accident and should disappear within a few days or weeks.

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Stop taking ORATANE capsules and contact your Keep ORATANE 5 mg, ORATANE 10 mg, ORATANE
doctor immediately if you experience any of the 30 mg, ORATANE 40 mg capsules in a cool dry
following: place where the temperature stays below 25°C.
• Bloody diarrhoea, blood in urine Protect from light.
• Nausea, vomiting, stomach pain or fever
• Persistent headache, severe headache or Keep ORATANE 20 mg capsules in a cool dry place
seizure where the temperature stays below 30°C. Protect
• Blurred vision or visual disturbances from light.
• 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
aggressive than usual (e.g. temper Keep ORATANE capsules where children cannot
outbursts, thoughts of violence) reach it. A locked cupboard at least one-and-a-
• Change in appetite or body weight half metres above the ground is a good place to
• Have trouble concentrating store medicines.
• Withdraw from family or friends
• Feel like you have no energy Disposal
• Have feelings of worthlessness or
inappropriate guilt Return any unused medicine to your pharmacist.
• Start having thoughts about hurting If your doctor tells you to stop taking this
yourself or taking your own life (suicidal medicine or they have passed their expiry date,
thoughts). ask your pharmacist what to do with any unused
medicine.
These may be serious side effects and may
require urgent medical attention.
Product description
This is not a complete list of all possible side
effects. Others may occur in some people and
there may be some unknown side effects.
What it looks like

You should tell your doctor about unwanted ORATANE 5 mg capsules are soft, oval, opaque
effects that occur during treatment. In some white in colour containing a yellow/orange liquid.
cases you doctor may want to reduce your dose
or stop treatment. ORATANE 10 mg capsules are soft, oval, opaque
light violet in colour containing a yellow/orange
Do not be alarmed by this list of possible side liquid.
effects. You may not experience any of them.
ORATANE 20 mg capsules are soft, oval, opaque
maroon-red in colour containing a yellow/orange
After taking ORATANE liquid.

Oratane 30 mg capsules are soft, oval opaque

Storage
pink in colour, containing a yellow/orange liquid.

Keep your capsules in the blister pack until it is ORATANE 40 mg capsules are soft, oval, opaque
time to take them. If you take the capsules out of light orange in colour containing a yellow/orange
the packaging they will not keep as well. liquid.

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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).

Sponsor details

ORATANE is supplied in New Zealand by:

Douglas Pharmaceuticals Ltd
P O Box 45 027
Auckland 0651
New Zealand
Phone: (09) 835 0660

Date of preparation

5 April 2018
(based on data sheet dated 27 March 2018)

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