ACITRETIN 25 MG CAPSULES

Active substance: ACITRETIN

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Package Leaflet:
Information for the User

Acitretin 10 mg
capsules
Acitretin 25 mg
capsules

1 What Acitretin is and
what it is used for
The name of your medicine is “Acitretin 10 mg
Capsules” or “Acitretin 25 mg Capsules” but
will be referred to as “Acitretin” throughout the
leaflet.
Acitretin belongs to a group of medicines
known as retinoids. Retinoids are derived from
vitamin A.

Acitretin

The medicine is used to treat severe skin
problems where the skin has become thick and
may be scaly and which does not respond to
other conventional treatments satisfactorily.

Read all of this leaflet carefully before you
start taking this medicine.

• extensive and serious forms of various
skin disorders resulting from disturbances
of the outer layer of skin (the epidermis),
such as psoriasis, together with a dry,
scaling, waxy rash.
• specific skin disorders characterized by
dry scales as a result of marked
keratinization (ichthyosis, an organic
process by which keratin is deposited in
cells and the cells become horny like nails
and hair) and similar disorders in which a
skin rash (pityriasis) or small elevations of
skin and mucosa (lichen ruber) occur.



Acitretin is used to treat

- 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 get serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.






What is in this leaflet
1 What Acitretin is and what it is used for
2 What you need to know before you take
Acitretin
3 How to take Acitretin
4 Possible side effects
5 How to store Acitretin
6 Contents of the pack and other
information

2 What you need to know
before you take Acitretin
Do not take Acitretin

• if you are pregnant.
• if you are a girl or woman of childbearing
age and could therefore become pregnant
because this medicine can cause
malformations in the unborn baby. If you
have discussed the possible risks with the
doctor and nevertheless decide to use this
medicine, you must STRICTLY follow a
number of instructions (see “Only under
STRICT conditions can Acitretin be
prescribed to women who might become










pregnant, because of the risk for
congenital malformations (harmful
effects on the unborn baby”)).
if you are breast-feeding.
if your liver is not working properly.
if your kidneys are not working properly.
if you have very high levels of fat or
cholesterol in your blood (also known as
“hyperlipidaemia”).
if you use other retinoid medicines or
medicines, vitamin supplements or foods
that contain high levels of vitamin A (more
than 5000 IU per day) (See “Other
medicines and Acitretin”).
if you use an antibiotic tetracycline.
if you use a medicine called methotrexate
(a medicine that is used in the treatment of
cancer, psoriasis and rheumatic diseases).
if you use the so-called mini-pill (a
contraceptive pill with only a low
progesterone content).
if you are allergic (hypersensitive) to
acitretin or any of the other ingredients of
this medicine (listed in section 6) or to other
“retinoid” medicines. Hypersensitivity
usually shows itself in the form of skin
reactions, such as a rash, hives and/or
itching.
if you are a child.

If one or more of these warnings are
applicable for you, talk to your doctor before
taking Acitretin.

Warnings and precautions
• if you are a blood donor. You must not give
blood while you are taking Acitretin or for
1 year after you stop taking it.
• if you receive donor blood. You must not
receive donor blood from patients treated
with acitretin if you are a woman of
childbearing age.
• if you suffer from high levels of sugar in the
blood (diabetes). You will need to check
your blood sugar levels more often when
you start taking this medicine.
• if you drink alcohol (see “Pregnancy” and
“Possible side effects”). Talk to your doctor
about your alcohol use.

• if you notice that you have problems with
your vision, especially in the dark (see
“Driving and using machines”).
• if you wear contact lenses. Acitretin causes
dry eyes, therefore you have to wear glasses
throughout the period of treatment.
• if Acitretin is to be used in children. Growth
and bone development must be checked at
regular intervals. In long-term treatment of
children, the doctor must carefully weigh the
possible severe side effects against the
benefit of therapy with this medicine.
• if you are going out into strong sunlight or
you are going to use a sun bed, Acitretin
can make the effects of UV light on the skin
stronger. In this case avoid too much sun
and do not use a sun bed. Before going out
in the sun, you must make sure you have
adequate sun protection.
Talk to your doctor if any of the above warnings
apply to you or have applied to you in the past.

Tests before starting treatment:
• Your doctor should have your blood tested
to check your liver function before the
start of treatment. Your blood must also be
tested every week or every other week
during the first 1 to 2 months after the start
of treatment. After this, it should be tested
at least every 3 months. If your liver seems
to be working abnormally, this must be
monitored every week. If this abnormal liver
function results in early discontinuation of
treatment, the liver function must be
monitored for at least 3 months after
stopping Acitretin therapy.
• If you suffer from high levels of sugar in
your blood (diabetes), if you have high
levels of fats in your blood, if you are
overweight or if you drink a lot of alcohol
and are in long-term treatment, your blood
must be checked for the amount of fats.
• Before treatment with Acitretin and during
long-term therapy, your doctor will take xrays of certain bones at regular intervals
(e.g. once a year) because this medicine
may cause changes in your bones. If this
applies to you, the doctor will discuss with

you the advantages and disadvantages of
continuation of therapy.
Please inform your doctor if you notice the
following possible signs of bone changes:
pain in bones, joints or muscles, restricted
mobility.

Other medicines and Acitretin
Tell your doctor or pharmacist if you are
taking/using, have recently taken/used or might
take/use any other medicines, including
medicines obtained without a prescription.
The effect of phenytoin (a medicine for
epilepsy) may be increased by Acitretin. The
dosage of phenytoin may need to be adjusted.

Do not take Acitretin together with:
• the antibiotic tetracycline, because
increased pressure in the brain may occur.
• methotrexate (a medicine that is used in
the treatment of cancer, psoriasis and
rheumatic diseases), because this
combination can cause inflammation of the
liver.
• the so-called mini-pill (a contraceptive pill
with only a low progesterone content).
Acitretin may reduce the contraceptive
effect, therefore you must not use these pills
as a contraceptive together with Acitretin.
• medicines or vitamin A supplements that
contain high levels of vitamin A (more than
5000 IU per day).
• other retinoid medicines such as
isotretinoin.

Acitretin with food and alcohol
You should not drink alcohol during treatment
with Acitretin as the risk for side effects would
be increased.
Girls and women of childbearing age must not
drink alcohol at all during treatment with
Acitretin and 2 months after stopping it (see
“Only under STRICT conditions can Acitretin
be prescribed to women who might become
pregnant, because of the risk for congenital
malformations (harmful effects on the
unborn baby”)).

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine.

Pregnancy
You must NOT take Acitretin if you are
pregnant. If you do get pregnant during
treatment with this medicine in spite of the
described precautions (see “Only under
STRICT conditions can Acitretin be
prescribed to women who might become
pregnant, because of the risk for congenital
malformations (harmful effects on the
unborn baby”)) or in the 2 years following
treatment, there is a high risk of severe
malformations of the unborn baby. Therefore
you should NEVER use Acitretin during
pregnancy and you should not get pregnant
within 2 years following treatment.
Only under STRICT conditions can Acitretin
be prescribed to women who might become
pregnant, because of the risk for congenital
malformations (harmful effects on the
unborn baby).
These are the conditions:
– you must suffer from a severe disorder that
does not show any improvement with
other treatments.
– you must be able to understand the
instructions provided by your doctor and
adequately follow them.
– your doctor has explained the risks of
becoming pregnant during treatment and
for 2 years after stopping it. Also your
doctor must have explained the
precautionary measures and what the
consequences of pregnancy might be.

control for at least 1 month before you
start taking the medicine and for 2 years
after you stop taking it. You will be advised
to use a combination of 2 methods (a birth
control pill or intra-uterine device
combined with a condom or diaphragm).
– you must undergo a reliable pregnancy
test within 3 days before starting treatment
and this test must indicate that you are not
pregnant.
– you must start treatment on the second or
third day after your next normal period.
– you are strongly advised to undergo a
pregnancy test every month of treatment.
– you must undergo a pregnancy test within
3 days of your next prescription.
– you must undergo pregnancy tests every
1-3 months for a period of 2 years after
stopping Acitretin.
– you must not drink any alcohol while you
are taking Acitretin and for 2 months after
stopping it, because alcohol can increase
the risk of malformations.
– your doctor will check if you understand
everything, and if so to confirm that you
do and that you are prepared to follow all
measures.
– you must follow these precautions again
during any repeat treatment with Acitretin.
– You must also follow these precautions if
you never use birth control because you
are infertile. Only if your uterus has been
removed, would these precautions not
apply to you.
please turn over



– you must be able to adequately take
precautions to prevent a pregnancy.
– you must be able to understand what may
happen if you do not use an effective
method of birth control.
– you must use an effective method of birth
* Trademark

24980501

GEN/ACT/PIL/245_10
14/03/2014

Continued: Before you take Acitretin

Breast-feeding
You must not take Acitretin if you are breastfeeding, because acitretin passes into the milk
and may harm the baby.

Driving and using machines
Your night vision may get worse during
treatment. This can happen suddenly. In rare
cases, this has continued after the treatment
has stopped. Be careful if you are driving or
using any tools or machines at night or in a
tunnel (see "Warnings and precautions").

3 How to take Acitretin
Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
• Take Acitretin at a meal time, preferably 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 25 mg or 30 mg once a
day.
• After 2 to 4 weeks, your doctor may
increase or decrease your dose. This will
depend on how well it works and how it
affects you.
• The maximum dose is 75 mg a day.
• Most people take Acitretin for up to 3
months. However, your doctor may decide
that you need to take it for longer.

Use in children and adolescents
Acitretin 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.
You can use additional local treatments of the
skin, including skin care products, after
consultation with your doctor.

If you take more Acitretin than you
should
If you take more Acitretin than you should, you
may suffer from headache, nausea and/or
vomiting, drowsiness, irritability and itching.
Stop taking the medicine and consult your
doctor immediately.

If you forget to take Acitretin
Do not take a double dose of Acitretin to make
up for a forgotten dose. If you forget to take a
dose, take it as soon as you remember and
continue according to the dosing schedule.
However, if it is nearly time for the next dose,
skip the missed dose.

If you stop taking Acitretin
Your doctor can judge best if and how you
must stop taking Acitretin. Always contact your
doctor before you want to stop taking the
medicine.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
• The side effects of Acitretin are dose
related. The higher the daily dose, the
greater the risk of side effects.
• Most side effects occur at the start of
treatment when the dose still has to be
adjusted. Most side effects are reversible
after altering the dose or discontinuation of
treatment.
• Occasionally the symptoms of your skin may
get worse in the beginning of treatment.
• As Acitretin is a vitamin A derivative, most of
its side effects are similar to the symptoms
that occur if someone has used too much
vitamin A.

Very common side effects
(affecting more than 1 of 10 patients treated)
• over 80% of patients experienced:
– dry skin and mucous membranes, dry lips
and possibly inflamed lips.
• 40 – 80% of patients experienced:
– dry mucous membranes of the skin and
nose
– peeling of the skin, especially the palms
of the hands and soles of the feet
– inflammation of the nasal mucosa.
• 10 – 40% of patients experienced:
– nose bleed
– scaling and thinning of healthy skin with
increased sensitivity
– reddening of the skin
– itching
– sensation of “burning skin”
– sensation of “sticky skin”
– inflammatory skin changes
– hair loss
– swelling and pain in the area around your
nails
– fragile nails
– inflammation of the eye (conjunctivitis)
– feeling more thirsty than usual
– feeling cold.
Using moisturisers or “emollients” from the
start of treatment can help you to deal with dry
skin problems.
Side effects of the skin and mucous
membranes occur rather soon (a few days)
after start of treatment, hair loss cannot be
expected until several weeks into the
treatment.
These side effects are reversible after altering
the dose or discontinuation of treatment.
However, new growth of hair will take some
months, due to the hair growth cycle.

Common side effects
(affecting 1 to 10 of 100 patients treated)
• chapping
• inflammation of oral mucosa and gums
• blisters on skin

• changes in skin and hair colour
• change in the growth rate and texture of hair
• visual disturbances such as dry eye, blurred
vision, impaired night vision. Wearing of
contact lenses might become impossible.
For this reason you should wear glasses
before treatment with Acitretin (see
“Warnings and precautions”).

Uncommon side effects
(affecting 1 to 10 of 1,000 patients treated)
• muscle, joint and bone pain
After long-term treatment with Acitretin,
bone changes may occur (extra growth on
the surface of your bones, thinning of
bones, reduced bone density [osteoporosis],
premature stop of bone growth) and
calcifications in soft tissues (ligaments and
tendons) (see “Warnings and precautions”).
• increased retention of water in the body
(oedema)
• sensation of heat
• changed sense of taste
• headache.

Rare side effects
(affecting 1 to 10 of 10,000 patients treated)
• increased sensitivity of the skin to sunlight,
as a result of which sunburn can occur after
only a brief exposure to the sun
• inflammations or ulcers of the cornea
• gastro-intestinal troubles (e.g. nausea,
vomiting, abdominal pain, diarrhoea,
digestive disorders)
• inflammation of the liver (hepatitis) and
jaundice
• increased pressure in the brain
(pseudotumor cerebri).
Symptoms can include severe headache,
nausea, vomiting and blurred vision. If you
experience these symptoms immediately
stop taking the medicine and contact
your doctor.

Other side effects observed during
treatment with Acitretin
• increased occurrence of vaginal infection
(also know as Candida or thrush)

• increased levels of liver enzymes
• increased levels of fats and cholesterol in
the blood.
These changes are particularly seen in
patients with a disposition to increased fatty
acid levels, (diabetes, obesity, alcohol
misuse or disturbance of fat metabolism),
but they are not of a lasting nature and may
be treated by dietary means. However,
potential arterial stenosis (when the carotid
arteries become narrow or blocked) due to
the increased fatty acid and cholesterol
levels cannot be excluded.

Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme (Website: www.mhra.gov.uk/yellowcard).
By reporting side effects, you can help provide
more information on the safety of this
medicine.

5 How to store Acitretin
Keep out of the reach and sight of children.
Do not use the medicine after the expiry date
which is stated on the carton and blister label
after EXP. The expiry date refers to the last day
of that month.
Do not store above 30°C. Store in the original
package, in order to protect from moisture.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

contains 10 mg acitretin.
Acitretin 25 mg capsule: Each hard capsule,
contains 25 mg acitretin.
The other ingredients are:
Capsule filling:
− Maltodextrin
− Sodium ascorbate
− Microcrystalline cellulose
Capsule shell:
− Gelatin
− Propylene glycol
− Sodium laurilsulfate
− Titanium dioxide (E171)
− Iron oxide yellow (E172)
− Iron oxide black (E172)
− Iron oxide red (E172)
− Purified water
− Shellac

What Acitretin looks like and contents
of the pack

POM
PL 06831/0251 Acitretin 10 mg Capsules
PL 06831/0252 Acitretin 25 mg Capsules

Marketing Authorisation Holder and
Manufacturer
Genus Pharmaceuticals
Park View House, 65 London Road, Newbury,
Berkshire RG14 1JN, UK.
This medicinal product is authorised in the
Member States of the EEA under the
following names:
NL Acitretine CF

10 and 25 mg capsules

UK Acitretin

10 and 25 mg capsules

This leaflet was last revised in
March 2014

Acitretin 10 mg capsules consist of a white to
off-white body and a brown cap printed in
black with “A10” on the capsule body and filled
with a yellow powder.
Acitretin 25 mg capsules consist of a yellow to
light yellow body and a brown cap printed in
black with “A25” on the capsule body and filled
with a yellow powder.
The capsules are packaged in PVC/PVDC
aluminium blister packs.
Pack sizes: 30 and 60 hard capsules.
Not all pack sizes may be marketed.

6 Contents of the pack and
other information
What Acitretin contains
The active substance is acitretin.
Acitretin 10 mg capsule: Each hard capsule,

24980501

XXXXXX

* Trademark

GEN/ACT/PIL/245_10
14/03/2014

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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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