NEOTIGASON CAPSULES 10MG

Active substance: ACITRETIN

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Patient Information Leaflet UK

Neotigason 10mg and 25mg Capsules
Acitretin
Please read all of this leaflet carefully
before you start taking this medicine.
•  eep this leaflet. You may need to
K
read it again.
•  f you have any further questions, ask
I
your doctor or pharmacist.
•  his medicine has been prescribed
T
for you. Do not pass it on to others.
It may harm them even if their
symptoms are the same as yours.
•  f any of the side effects become
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serious or troublesome, or if you
notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Neotigason is and what it is
used for
2. Before you take Neotigason
3.  mportant information
I
for women
4. How to take Neotigason
5. Possible side effects
6. How to store Neotigason
7. Further information
1. What Neotigason is and what
it is used for
Neotigason contains a medicine called
acitretin. This belongs to a group of
medicines called ‘retinoids’.
Neotigason is used to treat severe skin
problems where the skin has become thick
and may be scaly. These skin problems
include psoriasis, ichthyosis and keratosis
follicularis (Darier’s disease). It works by
making your skin grow more normally.

2. Before you take Neotigason
Do not take Neotigason if you are allergic
(hypersensitive) to:
• Acitretin or any of the other ingredients
of Neotigason (listed in Section 7:
Further information).
• Other ‘retinoid’ medicines. These
include isotretinoin and tazarotene.
Do not take Neotigason if any of the above
apply to you. If you are not sure, talk to
your doctor or pharmacist before taking
Neotigason.
Do not take Neotigason if:
• You are pregnant or think you may
be pregnant or you are breast-feeding
(see Section 3: Important information
for women).
• You might get pregnant while taking
Neotigason or within 2 years of
stopping it (see Section 3: Important
information for women).
• You have liver or kidney problems.
• You have very high levels of fat in your
blood (also known as ‘hyperlipidaemia’).
• You are taking an antibiotic called
tetracycline (for an infection) or a
medicine called methotrexate (for skin
problems, arthritis or cancer). See the
section on ‘Taking other medicines’.
• You are taking other retinoid medicines
or medicines, vitamin supplements or
foods that contain high levels of
Vitamin A. See the section on ‘Taking other
medicines’.
Do not take Neotigason if any of the above
apply to you. If you are not sure, talk to
your doctor or pharmacist before taking
Neotigason.

Neotigason is normally used while under
the care of a specialist dermatologist
(skin doctor).

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28031453

Take special care with Neotigason
Check with your doctor or pharmacist
before taking Neotigason if:
• You have diabetes. You will need to
check your blood sugar levels more
often when you start taking
Neotigason.
•  ou have high levels of fat in your blood
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or you are obese or drink a lot of
alcohol. Your doctor may need to
do blood tests while you are taking
Neotigason to check the amount of fat
in your blood.
• You are going out into strong sunlight
or you are going to use a sun bed.
Neotigason can make the effects of UV
light on the skin stronger. Before going
out into strong sunlight apply a
sunblock to exposed skin.
If any of the above apply to you, or if you are
not sure, talk to your doctor or pharmacist
before you take Neotigason.

Driving and using machines
Your vision may be affected, particularly at
night time, while you are taking Neotigason.
Be careful if you are driving or using any
tools or machines.

Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines that
you buy without a prescription and herbal
medicines. This is because Neotigason can
affect the way some other medicines work.
Also some other medicines can affect the
way Neotigason works.

Neotigason will damage an unborn baby.
The following instructions must be strictly
followed, even if you have fertility problems:

Do not take Neotigason, and tell your doctor
or pharmacist, if you are taking any of the
following medicines:
• An antibiotic called tetracycline (for an
infection).
• A medicine called methotrexate (for
skin problems, arthritis or cancer).
• Other retinoid medicines, such as
isotretinoin or tazarotene.
• Medicines or vitamin supplements that
contain high levels of Vitamin A (more
than 5000 IU per day).
•  ow dose progesterone only
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contraceptives (‘minipills’).
Tell your doctor or pharmacist if you are
taking the following medicine:
• Phenytoin (used to treat epilepsy).
Taking Neotigason with food and drink
Women of childbearing potential should
not consume alcohol (in drinks, food
or medicines) during treatment with
Neotigason and for 2 months after
cessation of therapy. Concurrent ingestion
of Neotigason and alcohol may result in
formation of a compound (etretinate), which
may be harmful to an unborn child, and if
formed takes some time for it to be totally
removed from the body.

Important information for blood donors
You must not give blood while you are taking
Neotigason or for 2 years after you stop
taking it.
Important information about some of the
ingredients of Neotigason
This medicine contains glucose, which is a
type of sugar. If you have been told by your
doctor that you cannot tolerate or digest
some sugars (have an intolerance to some
sugars), talk to your doctor before taking this
medicine.

3. Important information for women

Pregnancy and breast-feeding
Do not take Neotigason if:
•  ou are pregnant or think you may be
Y
pregnant or you are breast-feeding.
•  ou might get pregnant while taking this
Y
medicine or within 2 years of stopping it.
Birth control (contraception) and
pregnancy tests
If you are a female patient at an age where
you could get pregnant:
•  ou must use an effective method of
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birth control (contraception) for at least 1
month before you start taking Neotigason,
while you are taking it, and for 2 years
after you stop taking it.
•  our doctor will want you to have a
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pregnancy test about 2 weeks before
starting treatment, which must be
negative. You may also be asked to have
regular pregnancy tests while you are
taking Neotigason.
•  tart taking Neotigason after the negative
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pregnancy test, on the second or third
day of your next period.
•  hile you are taking Neotigason, and for
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2 years after stopping it, contact your
doctor straight away if you get pregnant
or think you may be pregnant.
If you have any questions about these
instructions, talk to your doctor or
pharmacist before taking Neotigason.

4. How to take Neotigason
Always take Neotigason exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
sure.
• Take Neotigason at a meal time or with
a drink of milk.
• Swallow each capsule whole.
The dose varies from one patient to another.
Your doctor will work out the right dose for
you.
Adults and elderly people
• The usual starting dose for adults and
elderly people is 25mg or 30mg
once a day.
•  fter 2 to 4 weeks, your doctor may
A
increase or decrease your dose. This will
depend on how well it works and how it
affects you.
• The maximum dose is 75mg a day.
•  ost people take Neotigason for up
M
to 3 months. However, your doctor may
decide that you need to take it for longer.
You must not take Neotigason for more
than 6 months at a time.
Children
Neotigason is not normally given to children.
If it is given to a child, the doctor will decide
the correct dose. This is based on the child’s
weight.
If you take more Neotigason than you
should
If you take more Neotigason than you
should, talk to a doctor or go to a hospital
straight away. Take the medicine pack with
you. The following effects may happen: a
bad headache, dizziness, feeling or being
sick, being sleepy or irritable or having itchy
skin.
If you forget to take Neotigason
• If you forget to take a dose, take it as
soon as you remember. However, if it
is nearly time for the next dose, skip
the missed dose.
• Do not take a double dose (two doses
at the same time) to make up for a
forgotten dose.
If someone else takes your Neotigason
tablets by mistake, they should talk to a
doctor or go to a hospital straight away.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

5. Possible side effects
Like all medicines, Neotigason can cause side
effects, although not everyone will get them.
You will probably have some side effects
during treatment with Neotigason, even
before you see your skin starting to get
better. These effects often wear off as your
treatment continues. Your doctor can help
you to deal with them.
Stop taking Neotigason and see a doctor
straight away if you get the following side
effects at the same time:
• A severe headache.
• Feeling or being sick.
• Problems with your eye sight.
See a doctor straight away if:
• You feel any aches and pains in your
muscles, bones or joints. This may
mean you have extra growth on the
surface of your bones. This can happen
if you take Neotigason for a long time.
Your doctor may want to check you regularly
to find out if this is happening. These checks
are particularly important if a child is taking
Neotigason.
Other possible side effects:
Very common (affects more than 1 user
in 10):
d
•  ry, irritated or swollen eyes, which may
lead to intolerance of contact lenses
d
•  ry, irritated or runny nose, nose bleeding
•  ry mouth, thirst
d
•  ryness or inflammation of the lips, which
d
may be alleviated by application of a fatty
ointment. Itching, hair loss, peeling of the
skin from the palms of hands or the soles
of the feet or even rest of the body
•  hanges in how the liver is working
c
(shown by blood test)
• ncreased levels of fats in your blood
i
(shown by blood test)
Common (affects 1 to 10 users in 100):
•  eadache
h
• nflammation of the mucous tissue of the
i
mouth, abdominal pain, diarrhoea, feeling
sick, being sick
•  ragile skin, sticky feeling on the skin or
f
a rash, skin inflammation, changes to
the texture of the hair, brittle nails, skin
infection around a nail, redness of the skin
•  oint pain, muscle pain
j
•  welling of hands, ankles and feet
s

Uncommon (affects 1 to 10 users in
1,000):
•  izziness
d
•  lurred vision
b
• nflammation of the gums
i
• nflammation of the liver
i
•  issures, cracks or fine linear scars in the
f
skin e.g. around the mouth (rhagades),
blisters and inflammation of the skin
(dermatitis bullous), skin being more
sensitive to the sun (photosensitivity
reaction)
Rare (affects 1 to 10 users in 10,000):
•  amage to the peripheral nervous
d
system, which may include symptoms
like muscle weakness, numbness and
tingling in the feet and hands or burning,
stabbing or shooting pain
Very rare (affects less than 1 user in
10,000):
• ncreased blood pressure in the skull
i
•  ight blindness, inflammation of the
n
cornea in the eye (ulcerative keratitis);
•  ellowing of the skin or the whites of the
y
eyes (jaundice)
•  one pain, changes in bone growth
b
Side effects with unknown frequency:
• nfection of the vagina (also known as
i
candida or thrush)
• mpaired hearing, ringing in the ear
i
(tinnitus)
•  lushing; sweating, skin redness on the
f
face
•  hanges in the way things taste; bleeding
c
in the rectum
s
•  mall, reddish bumps or nodules on the
skin that may bleed easily (pyogenic
granuloma), scaling or thinning of the
skin
•  racks or scaring at the corners of the
c
mouth
• mprove or worsen glucose tolerance in
i
diabetic patients.
•  eneral unwell feeling, drowsiness
g
An initial worsening of psoriasis symptoms
is sometimes seen at the beginning of the
treatment period.
If any of the side effects become serious or
troublesome, or if you notice any side effects
not listed in this leaflet, please tell your
doctor or pharmacist.

6. How to store Neotigason















Keep Neotigason capsules in their
original packaging to protect them
from moisture.
Do not store Neotigason capsules
above 25°C.
Keep out of the reach and sight of
children.
Do not use Neotigason capsules after
the expiry date printed on the pack.
Do not throw away any left over
capsules. Instead, return them to your
pharmacist so that they can be
disposed of carefully. Only keep them if
your doctor tells you to.

7. Further information
What Neotigason contains
The active substance in Neotigason capsules
is acitretin. There are two different strengths
of capsules: Neotigason 10mg Capsules
(each capsule contains 10mg acitretin) and
Neotigason 25mg Capsules (each capsule
contains 25mg acitretin).
The other ingredients (in both strengths of
capsule) are glucose (liquid, spray dried),
sodium ascorbate, gelatin, purified water,
microcrystalline cellulose, iron oxide black
(E172), iron oxide yellow (E172), iron oxide
red (E172) and titanium dioxide (E171),
shellac, n-butyl alcohol, isopropyl alcohol,
propylene glycol and ammonium hydroxide.
What Neotigason looks like and contents
of the pack
Neotigason 10mg capsules are brown and
white marked
on the brown half and
‘10’ on the white half.
Neotigason 25mg capsules are brown and
yellow marked
on the brown half
and ‘25’ on the yellow half.
The capsules are supplied in blister packs
of 56 or 60 capsules or brown glass bottles
with metal screw caps containing 30 or 100
capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf,
Reykjavíkurvegi 76-78
220 Hafnarfjordur, Iceland.
Manufacturer
Cenexi,
52, Rue Marcel et Jacques Gaucher,
94120 Fontenay-Sous-Bois, France
This leaflet was last
revised in
June 2011

L20220CEN-30
28031453

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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