Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Novatin. It does not contain all
the available information. It does not take the place of talking to your doctor or
All medicines have risks and benefits. Your doctor has weighed the risks of you using
this medicine 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 want to read it again.
What this medicine is used for
Novatin is used to treat psoriasis and keratinisation disorders. Acitretin, the active
ingredient of Novatin, belongs to a group of medicines called retinoids.
How it works
Novatin is very similar to Vitamin A, which is obtained from our diet and is vital
for the normal growth and development of the body, especially the skin. Novatin works
to return skin to normal when problems with the normal development of the skin are
present, as in the case of severe psoriasis and some other skin disorders.
Ask your doctor if you have any questions about why this medicine has been prescribed
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
This medicine is not addictive.
Novatin should only be taken by children where alternative therapy cannot be used.
Before you take this medicine
When you must not take it
Do not take this medicine if you have an allergy to:
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue, throat or other parts of the body
rash, itching or hives on the skin
Do not take this medicine if you have or have had any of the following medical conditions:
severe kidney or liver disease
abnormally high levels of fat in your blood
Do not take this medicine if you are pregnant or plan to become pregnant in the next
Any possibility that you may be pregnant must be ruled out by both yourself and your
doctor before you start taking Novatin capsules. The result of a pregnancy test must
be negative when performed within two weeks before beginning of Novatin treatment.
Novatin is highly teratogenic, meaning there is an extremely high risk of having a
baby that is severely deformed.
This means you must use effective contraception (preferably 2 complementary methods)
for one month before, during and 2 years after treatment with Novatin.
Tell your doctor immediately if you become pregnant in the 2 years following the end
Do not take this medicine if you are breastfeeding.
Breastfeeding must stop before Novatin treatment can start. Do not breastfeed while
Do not take this medicine if you are taking the following medicines:
tetracycline antibiotics (e.g. doxycycline, minocycline)
vitamin A or preparations containing vitamin A
Do not donate blood during and for two years after completing Novatin treatment.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Tell your doctor if you have or have had any of the following medical conditions:
family history of diabetes
high triglycerides or cholesterol levels in the blood
family history of high blood triglycerides or cholesterol levels
If you have not told your doctor about any of the above, tell them before you start
taking this medicine.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get
without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interact with Novatin. These include:
tetracycline antibiotics (e.g. doxycycline, minocycline)
medicines containing alcohol
the "mini-pill", a low-dose progestogen oral contraceptive
vitamin A, or formulations that contain vitamin A
These medicines may be affected by this medicine or may affect how well it works.
You may need different amounts of your medicines, or you may need to take different
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
How to take this medicine
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ to the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
How much to take
Your doctor will tell you how much of this medicine you should take. This will depend
on your condition and whether you are taking any other medicines. This may also consider
your bodyweight and whether you develop any side effects.
The starting dose is usually either one 25 mg capsule or 30 mg (3 x 10 mg capsules)
per day for 2 to 4 weeks.
Your dose may be adjusted by your doctor when it is known how you respond to Novatin
The initial signs of improvement may be seen in the first 1 to 3 weeks. It may take
2 to 3 months until the full effect is seen.
Affected skin areas will either peel off or steadily clear. Sometimes more redness
or itching may be present at first, but this will normally improve as treatment continues.
How to take it
These capsules should be swallowed whole with a glass of water or milk.
When to take it
Take this medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
Female patients should wait until the 2nd or 3rd day of their menstrual period before
This helps to ensure that you are not pregnant before you start to take Novatin.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
A temporary increase in psoriasis is sometimes seen when first starting treatment.
Make sure you have enough to last over weekends and holidays.
If you forget to take it
If it is almost time to take your next dose, skip the dose you missed and take your
next dose at the usual time.
Otherwise, take it as soon as you remember and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13
11 26) for advice or go to Accident and Emergency at your nearest hospital if you
think that you or anyone else may have taken too much of this medicine. Do this even
if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are taking this medicine
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking this medicine.
Tell any other doctors, dentists and pharmacists who are treating you that you take
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor’s appointments so your progress can be checked.
Your doctor may ask you to do some blood, liver function and other tests from time
to time to check your progress and pick up any unwanted side effects.
Things you must not do
Do not give this medicine to anyone else, even if they have the same condition as
Do not take your medicine to treat any other complaint unless your doctor tells you
Do not stop taking your medicine or change the dosage without first checking with
Things to be careful of
Be careful when driving or operating any vehicle at night.
Decreased night vision has been reported with acitretin therapy.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Novatin.
This medicine helps most people with skin disorders, but it may have unwanted side
effects in a few people. All medicines can have side effects. Sometimes they are serious,
most of the time they are not. You may need medical attention if you get some of the
Do not be alarmed by the following lists of side effects. You may not experience any
Ask your doctor or pharmacist to answer any questions you may have.
Common side effects can include:
Tell your doctor and pharmacist if you notice any of the following and they worry
dryness of the lips, mouth, nose, eyes and skin. Moisturiser or petroleum jelly can
be used to soften the lining of the nose, lips and the skin
drying and inflammation of mucous membranes
difficulty producing tears
intolerant of contact lenses
impaired night vision
itchiness, redness or rashes
thinning or peeling of the skin that was not previously affected
more prone to sun burn
nail fragility or conditions
strange hair texture or loss
abnormal liver tests
increase in blood cholesterol
muscle, joint or bone pain
noises or ringing in ears
changes in taste
hay fever like symptoms
swelling in limbs
The above list includes the more common side effects of your medicine.
Tell your doctor as soon as possible if you notice any of the following:
changes in mood including depression or aggression
male breast enlargement
changes in hearing
The above list includes serious side effects and you may need medical attention.
If you experience any of the following, stop taking your medicine and contact your
doctor immediately or go to the Accident and Emergency department at your nearest
headache, nausea and vomiting, and visual disturbances can be signs of papilloedema
and needs medical investigation
shortness of breath, wheezing or difficulty breathing; swelling of the face, lips,
tongue, throat or other parts of the body; rash, itching or hives on the skin (signs
of an allergic reaction)
itchy, yellowing skin, lighter coloured stool or darker urine (jaundice)
The above list includes very serious side effects and you may need urgent medical
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may occur in some patients.
Storage and disposal
Keep your medicine in the pack until it is time to take it.
If you take your medicine out of the pack it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store your medicine or any other medicine in the bathroom or near a sink. Do
not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine leftover.
What Novatin capsules look like
10 mg capsule: Hard gelatin capsule containing a yellow powder with a white to off-white
body and a brown cap printed in black with "A10" on the capsule body. AUST R 196006
25 mg capsule: Hard gelatin capsule containing a yellow powder with a yellow to light
yellow body and a brown cap printed in black with "A25" on the capsule body. AUST
Available in blister packs of 60 and 100 capsules.
* Not all strengths, pack types and/or pack sizes may be available.
Each capsule contains 10 or 25 mg of acitretin as the active ingredient.
It also contains the following:
sodium lauryl sulphate
black printing ink (shellac glaze, iron oxide black (E172), propylene glycol (E1520))
iron oxide red (E172) (colourant) iron oxide yellow (E172) (colourant)
This medicine does not contain gluten, lactose, sucrose, tartrazine or any other azo
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
This leaflet was prepared in December 2018.