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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.
• Keep this leaflet. You may need to
read it again.
• If you have any further questions, ask

your doctor or pharmacist.
• This medicine has been prescribed

for you. Do not pass it on to others.
It may harm them even if their
symptoms are the same as yours.
• 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.
In this leaflet:
1.What Neotigason is and what it is
used for
2. Before you take Neotigason
3. Important Information 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 maybe scaly. These skin problems
include psoriasis, ichthyosis and keratosis
follicularis (Darier’s disease). It works by
making your skin grow more normally.
Neotigason is normally used while under
the care of a specialist dermatologist (skin
doctor).

2. Before you take Neotigason
Do not take Neotigason if you are allergic
(hypersensitive) to:
•  citretin or any of the other ingredients
A
of Neotigason (listed in Section 7: Further
Information).

•  ther ‘retinoid’ medicines. These include
O
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:
•  ou are pregnant or think you may be
Y
pregnant or you are breast-feeding
(see Section 3: Important information for
women).
•  ou might get pregnant while taking
Y
Neotigason or within 2 years of
stopping it (see Section 3: Important
information for women).
•  ou have liver or kidney problems.
Y
•  ou have very high levels of fat in your
Y
blood (also known as ‘hyperlipidaemia’)
•  ou are taking an antibiotic called
Y
tetracycline (for an infection) or a
medicine called methotrexate (for skin
problems, arthritis or cancer). See the
section on ‘Taking other medicines’.
•  ou are taking other retinoid medicines or
Y
medicines, vitamins supplements or foods
that contain 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
Take special care with Neotigason
Check with your doctor or pharmacist before
taking Neotigason if:
•  ou have diabetes. You will need to check
Y
your blood sugar levels more often when
you start taking Neotigason.
•  ou have high levels of fat in your blood
Y
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 in 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.

AAAF6319

PAGE 1

Acitretin (Neotigason) 10mg and 25mg capsules PIL - UK
item no:

AAAF6319

dimensions: 125x210 (4 pages)

print proof no:

5

pharmacode:

origination date: 15.07.13

min pt size: 7.5pt

1. PMS 281
2.
3.
4.
5.
6.

originated by:
approved for print/date

colours/plates:

DR

revision date:

07.04.15

Technical Approval

revised by:

DR

date sent: 15.07.13

supplier:

Cenexi

technically app. date: 23.12.13

Non Printing Colours
1. profile
2.
3.

A serious condition which causes the
small blood vessels (capillaries) to leak has
been reported very rarely (Capillary Leak
Syndrome/Retinoic Acid Syndrome). This
can lead to severe hypotension (low blood
pressure), oedema (build up of fluid leading
to swelling) and shock (collapse).
A serious skin reaction with symptoms such
as rash, blistering or peeling of the skin
(Exfoliative dermatitis) has been reported
very rarely.
If any of the above apply to you, or if you
are not sure, talk your doctor or pharmacist
before you take Neotigason.
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.
Do not take Neotigason, and tell your doctor
or pharmacist, if you are taking any of the
following medicines:
•  n antibiotic called tetracycline (for an
A
infection).
•  medicine called methotrexate (for skin
A
problems, arthritis or cancer).
•  ther retinold medicines, such as
O
isotretinoin or tazarotene.
•  edicines or vitamin supplements that
M
contain Vitamin A.
•  ow dose progesterone only
L
contraceptives (‘minipills’)
Tell you doctor or pharmacist if you are
taking the following medicine:
•  henytoin (used to treat epilepsy).
P
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.
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.
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
Neotigason will damage an unborn baby.
The following instructions must be strictly
followed, even if you have fertility problems:
Pregnancy and breast-feeding
Do not take Neotigason if:
•  ou are pregnant or think that 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:
• You must use an effective method
or 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.
• Your doctor will want you to have a
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
S
negative pregnancy test, on the second
or third day of your next period.
•  hile you are taking Neotigason, and
W
for 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.
•  ake Neotigason at a meal time or with a
T
drink of milk.
•  wallow each capsule whole.
S
The dose varies from one patient to another.
Your doctor will work out the right dose for
you.

PAGE 2

Acitretin (Neotigason) 10mg and 25mg capsules PIL - UK
item no:

AAAF6319

dimensions: 125x210 (4 pages)

print proof no:

5

pharmacode:

origination date: 15.07.13

min pt size: 7.5pt

1. PMS 281
2.
3.
4.
5.
6.

originated by:
approved for print/date

colours/plates:

DR

revision date:

07.04.15

Technical Approval

revised by:

DR

date sent: 15.07.13

supplier:

Cenexi

technically app. date: 23.12.13

Non Printing Colours
1. profile
2.
3.

Adults and elderly people
•  he usual starting dose for adults and
T
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.
•  he maximum dose is 75mg a day.
T
•  ost people take Neotigason for up to 3
M
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
• f you forget to take a dose, take it as soon
I
as you remember. However, if it is nearly
time for the next dose, skip the missed
dose.
•  o not take a double dose (two doses at
D
the same time) to make up for a forgotten
dose.
If someone else takes your Neotigason
capsules 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 experience the
following side effects:
• mmediate allergic reaction with
I
symptoms such as skin rash, swelling or
itching of the skin, swelling of the face,
lips, throat or tongue, red and swollen
eyes, severe nasal congestion, asthma or
wheezing. The reaction can be minor to
life-threatening.
•  severe headache.
A
•  eeling or being sick.
F
•  roblems with your eye sight.
P
•  ou feel any aches and pains in your
Y
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):
• 
dry, irritated or swollen eyes, which may
lead to intolerance of contact lenses
• 
dry, irritated or runny nose, nose bleeding
•  mouth, thirst
dry
• 
dryness or inflammation of the lips, which
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
• 
changes in how the liver is working
(shown by blood test)
• 
increased levels of fats in your blood
(shown by blood test)
Common (affects 1 to 10 users in 100):
• headache
• 
inflammation of the mucous tissue of the
mouth, abdominal pain, diarrhoea, feeling
sick, being sick
• 
fragile skin, sticky feeling on the skin or
a rash, skin inflammation, changes to
the texture of the hair, brittle nails, skin
infection around a nail, redness of the skin
• 
joint pain, muscle pain
• 
swelling of hands, ankles and feet
Uncommon (affects 1 to 10 users in 1,000):
• dizziness
• blurred vision
• 
inflammation of the gums
• 
inflammation of the liver
• 
fissures, cracks or fine linear scars in the
skin e.g. around the mouth (rhagades),
blisters and inflammation of the skin
(dermatitis bullous), skin being more
sensitive to the sun (photosensitivity
reaction)

PAGE 3

Acitretin (Neotigason) 10mg and 25mg capsules PIL - UK
item no:

AAAF6319

dimensions: 125x210 (4 pages)

print proof no:

5

pharmacode:

origination date: 15.07.13

min pt size: 7.5pt

1. PMS 281
2.
3.
4.
5.
6.

originated by:
approved for print/date

colours/plates:

DR

revision date:

07.04.15

Technical Approval

revised by:

DR

date sent: 15.07.13

supplier:

Cenexi

technically app. date: 23.12.13

Non Printing Colours
1. profile
2.
3.

Rare (affects 1 to 10 users in 10,000):
• 
damage to the peripheral nervous 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):
• 
increased blood pressure in the skull
• 
night blindness, inflammation of the
cornea in the eye (ulcerative keratitis)
• 
yellowing of the skin or the whites of the
eyes (jaundice)
• 
bone pain, changes in bone growth
Side effects with unknown frequency:
• 
infection of the vagina (also known as
candida or thrush)
• 
impaired hearing, ringing in the ear
(tinnitus)
•  serious condition which causes the small
a
blood vessels (capillaries) to leak (Capillary
Leak Syndrome/Retinoic Acid Syndrome).
This can lead to severe hypotension (low
blood pressure), oedema (build up of fluid
leading to swelling) and shock (collapse).
• 
flushing; sweating, skin redness on the
face
• 
changes in the way things taste; bleeding
in the rectum
•  serious skin reaction with symptoms
a
such as rash, blistering or peeling of the
skin (Exfoliative dermatitis)
• 
small, reddish bumps or nodules on the
skin that may bleed easily (pyogenic
granuloma), scaling or thinning of the skin
• 
cracks or scaring at the corners of the
mouth
• 
loss of eyelashes or eyebrows (madarosis)
• 
improve or worsen glucose tolerance in
diabetic patients
• 
general unwell feeling, drowsiness
• 
swelling of the face, lips, throat or tongue
(angioedema)
• 
severe itchy skin rash with pale or red
irregular raised patches (hives)
An initial worsening of psoriasis symptoms
is sometimes seen at the beginning of the
treatment period.
Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.

6. How to store Neotigason
•  eep Neotigason capsules in their
K
originally packaging to protect them from
moisture.
•  o not store Neotigason capsules above
D
25˚C.
•  eep out of the reach and sight of
K
children.
•  o not use Neotigason capsules after the
D
expiry date printed on the pack.
•  o not throw away any left over capsules,
D
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 Informationn
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, gelatine, 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 look like and contents
of the pack
Neotigason 10mg capsules are brown and
white marked (Actavis logo) on the brown
half and ‘10’ on the white half.
Neotigason 25mg capsules are brown and
yellow marked (Actavis logo) 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,
Reykjavikurvegi 76-78
220 Harfnarfjordur, Iceland
Manufacturer
Cenexi,
52 Rue Marcel et Jacques Gaucher,
94120 Fontenay – Sous-Bois, France
This leaflet was last revised in April 2015.

By reporting side effects you can help
provide more information on the safety of
this medicine.
AAAF6319

PAGE 4

Acitretin (Neotigason) 10mg and 25mg capsules PIL - UK
item no:

AAAF6319

dimensions: 125x210 (4 pages)

print proof no:

5

pharmacode:

origination date: 15.07.13

min pt size: 7.5pt

1. PMS 281
2.
3.
4.
5.
6.

originated by:
approved for print/date

colours/plates:

DR

revision date:

07.04.15

Technical Approval

revised by:

DR

date sent: 15.07.13

supplier:

Cenexi

technically app. date: 23.12.13

Non Printing Colours
1. profile
2.
3.

Expand view ⇕

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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