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
Acitretin
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 get serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1 What Acitretin is and what it is used for
2 Before you take Acitretin
3 How to take Acitretin
4 Possible side effects
5 How to store Acitretin
6 Further information

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
rest of this leaflet.
Acitretin belongs to a group of medicines
known as retinoids. Retinoids are derived from
vitamin A.






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.



Acitretin is used to treat




• 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 should only be prescribed by doctors,
preferably skin specialists, who have
experience in treatment with systemic retinoids
and correctly assess the risk of acitretin in case
of pregnancy.

2 Before you take Acitretin
Do not take Acitretin
• if you are a girl or woman of
childbearing age and could therefore be
or have 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 “Instructions for girls and
women of child-bearing age” in section
"Pregnancy and breast-feeding").
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 are taking other retinoid medicines
or medicines, vitamin supplements or foods
that contain high levels of vitamin A (more
than 5000 IU per day). (See ‘Taking other
medicines’.)
if you are using the antibiotic tetracycline.
if you are being treated with 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). The contraceptive
effect of the mini-pill may be reduced by
Acitretin, whereby reliable contraceptive
protection is no longer guaranteed (see
“Taking Acitretin with other medicines”).
if you are allergic (hypersensitive) to the
active substances or to other “retinoid”
medicines or to any of the other ingredients.
Hypersensitivity usually manifests itself in
the form of skin reactions, such as a rash,
hives and/or itching.

Take special care with Acitretin
• if you are a girl or woman of childbearing
age and the doctor decides to use this
medicine, you must strictly follow a number
of instructions (see “Instructions for girls
and women of childbearing age” in section
“Pregnancy and breast-feeding”).
• 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 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 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.

Tests before starting treatment:
• Your doctor should have your blood
tested before the start of treatment to
check your liver function. The 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, at
least every 3 months. If your liver function
seems to be abnormal, this must be
monitored every week. If this abnormal
liver function results in premature
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
the blood (diabetes) or if you have high
levels of fats such as triglycerides or
cholesterol 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 tested for fats and cholesterol.
• 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 bone changes (see “4. Possible
side effects”). 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.

Instructions for girls and women of
childbearing age
Acitretin is highly teratogenic. That means
it is likely that your unborn baby would be
severely damaged.
The malformations that are typical for
acitretin include, for example, damage to the
central nervous system, the heart and the
large blood vessels, the skull and face, the
skeleton and the thymus gland.
The percentage of malformations is high,
even if the medicine was taken only for a
short period during pregnancy or if you get
pregnant within 2 years following the end of
treatment.

If you are a girl or woman of
childbearing age, you can only take
Acitretin:
• if you suffer from a very severe or disabling
skin disease that has not shown any
improvement on other treatment.
• if you strictly observe the following
precautions to prevent a pregnancy while
you are taking Acitretin and for 2 years after
stopping it:
– your doctor has explained the
teratogenic risk of Acitretin and you
understand why you must not get
pregnant and how to prevent pregnancy.
– you must use an effective method of
birth control (contraception) for at least
1 month before you start taking the
medicine, and for 2 years after you stop

taking it. Speak to your doctor about how
you take effective contraceptive
precautions.
– you have undergone a medically
supervised pregnancy test in the 2
weeks before you start taking Acitretin to
make sure you are not pregnant.
– you start taking Acitretin after the negative
pregnancy test, on the second or third
day of your next period.
– you understand and accept the need for
monthly follow up visits and maybe
further pregnancy tests, as decided by
your doctor.
– you strictly follow these precautions again
during a repeat treatment with Acitretin.
• if you do 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 may ask you (or your guardian) to
sign a declaration in which you confirm that
you have been informed about the risks of
treatment with Acitretin and that you accept
the necessary precautionary measures.
If you become pregnant during treatment
with Acitretin or during the two years after
treatment has stopped, immediately stop
taking the medicine and contact your
doctor.

Taking Acitretin with other medicines
Please tell your doctor or pharmacist if you are
taking/using or have recently taken/used 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.

Taking Acitretin with food and drink
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
“Instructions for girls and women of
childbearing age”).

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 or may get pregnant at any time
during treatment and for 2 years after
treatment has stopped.

p l e a s e t ur n o v e r

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C o n t i n ue d : B e f o r e y o u t a k e A c i t r e t i n

Acitretin, the active substance of this medicine,
is likely to cause malformations in the unborn
child. If you do get pregnant during treatment
with this medicine in spite of the described
precautions (see “Instructions for girls and
women of childbearing age”) or in the two
years following treatment, there is a high risk of
severe malformations of the unborn baby.

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.

If you take more Acitretin than you
should

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

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.

Driving and using machines

If you forget to take Acitretin

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 “Take special care with 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.

Breast-feeding

3 How to take Acitretin
Always take Acitretin exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
• Take Acitretin 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.
For individual treatment, Acitretin capsules are
available with a content of 10 or 25 mg of
acitretin.

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

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, Acitretin can cause side
effects, although not everyone will get 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
associated with taste disturbances
• 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
during treatment with Acitretin (see “Take
special care with”).

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 “Take special care with”).
• 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.
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.

6 Further information
What Acitretin contains
The active substance is acitretin.
Acitretin 10 mg capsule: Each hard capsule,
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
− Sodium laurilsulfate
− Titanium dioxide (E171)
− Iron oxide yellow (E172)
− Iron oxide black (E172)
− Iron oxide red (E172)
− Shellac

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 Genus Pharmaceuticals
10 and 25 mg capsules

UK Acitretin 10 and 25 mg capsules
This leaflet was last approved in
February 2011

What Acitretin looks like and contents
of the pack

Keep out of the reach and sight of children.

Acitretin 10 mg consists 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.

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.

Acitretin 25 mg consists 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.

Do not store above 30°C. Store in the original
package, in order to protect from moisture.

The capsules are packaged in PVC/PVDC
aluminium blister packs.

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.

Pack sizes: 30 and 60 hard capsules.

5 How to store Acitretin

Not all pack sizes may be marketed.
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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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