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ISOTRETINOIN 5 MG CAPSULES

Active substance(s): ISOTRETINOIN

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Do not take vitamin A supplements
or tetracyclines (a type of antibiotic)
during therapy with Isotretinoin 5 mg
because the risk of getting side
effects may increase.
Do not use any skin treatments for
acne during treatment with
Isotretinoin 5 mg because local
irritation may increase.

Pregnancy and breast-feeding
Pregnancy

The foetal deformities associated
with exposure to isotretinoin include
central nervous system abnormalities
(hydrocephalus, cerebellar
malformation/abnormalities,
microcephaly), facial dysmorphia,
cleft palate, external ear abnormalities
(absence of external ear, small or
absent external auditory canals),
eye abnormalities (microphthalmia),
cardiovascular abnormalities
(conotruncal malformations such
as tetralogy of Fallot, transposition
of great vessels, septal defects),
thymus gland abnormality and
parathyroid gland abnormalities.
There is also an increased incidence
of spontaneous abortion.

Your night vision may get worse
during your treatment. This can
happen suddenly. In rare cases this
has continued after the treatment has
stopped. You should therefore be
cautious when driving or operating
machines.

Driving and using machines

You should not take Isotretinoin
5 mg if you are breast-feeding,
because isotretinoin is likely to pass
into the milk and may harm the baby.

Lactation

If pregnancy occurs or might be
likely in a woman treated with
isotretinoin, treatment must be
stopped immediately and the
patient should contact her doctor
without delay.

2. BEFORE YOU TAKE
ISOTRETINOIN 5 MG
(continued... )

use a sun-lamp or sun-bed. Your
skin may become more sensitive
to sunlight during Isotretinoin 5 mg
therapy. Before going out in the
sun apply a sun-protection product
with a high protection factor of at
least SPF 15.
• Cosmetic procedures
such as
dermabrasion or laser treatments
(removing horny skin or scars) and
wax epilation should be avoided
during and for at least 6 months
after treatment; Isotretinoin 5 mg
may make your skin more fragile
and this could cause scarring or
irritation of the skin.
• Reduce intensive physical
activity during Isotretinoin 5 mg
therapy, because muscle and joint
pain have been observed during
Isotretinoin 5 mg treatment.
• Do not donate blood either during
or for one month after Isotretinoin
5 mg treatment. If someone who is
pregnant receives your donated
blood, her baby may be born with
serious birth defects.

Isotretinoin 5 mg must not be
taken during pregnancy, as
Isotretinoin the active compound
of Isotretinoin 5 mg is highly
teratogenic. If pregnancy does
occur in spite of the described
precautions (Pregnancy
prevention
program) during treatment or in the
month following, there is a great
risk of very severe and serious
damage to the unborn baby.

Drowsiness, dizziness and visual
disturbances have been reported
very rarely. If you experience any of
these effects, you should not drive,
operate machinery or take part in
any other activities where these
symptoms could put either yourself
or others at risk.

What to avoid when taking
Isotretinoin 5 mg
• Avoid too much sun and do not

The usual starting dose is 0.5 mg per
kilogram body weight per day (0.5
mg/kg/day). After a few weeks your
doctor may adjust your dose.
This
will depend on how you are getting
on with your medicine. For most
patients the dose will be between 0.5
and 1.0 mg/kg/day.

Adults including adolescents
and the elderly

c individual doses might
be better matched by other available
strengths.
etc.

Your doctor will prescribe an
individual dose in accordance with
your body weight and other clinical
ciency,

Dosage

Occasionally your acne may get
rst weeks of
worse
treatment. It should improve with
continued treatment.
not chew or suck them.

• Swallow the capsules whole, do

Always take Isotretinoin 5 mg exactly
as your doctor has told you. You
should check with your doctor or
pharmacist if you are not sure.
• The capsules should be taken
with food once or twice daily.

3. HOW TO TAKE
ISOTRETINOIN 5 MG

If you take more Isotretinoin 5
mg than you should

Only a doctor can prescribe it for
you. Never give it to others. It may
harm them even if their symptoms
appear similar to yours.

Remember this medicine is for
you

A course of treatment usually
lasts for 16 to 24 weeks.
Your
acne may continue to improve for
up to 8 weeks after the treatment
nishes. Therefore, a further course
of treatment should not be started
until at least this period has elapsed.
Most patients only need a single
course of treatment.

Duration of treatment

If you cannot tolerate the
recommended dose, your doctor may
continue your treatment at a lower
dose with the consequence of a
longer therapy duration and a higher
risk of relapse.

Patients with intolerance

Isotretinoin is not recommended
for use in children less than 12
cient
cacy and safety. Use in
children over 12 only after puberty.

Children

the levels of fats such as
triglycerides or cholesterol
in your blood. Your doctor will
do some blood tests in or der to
monitor these levels before, during
and at the end of your Isotretinoin
5 mg treatment. Tell your doctor
if you already have high levels of
these substances in your blood
or if you have diabetes, are
overweight, or are an alcoholic,
as you may need to have blood
tests more frequently.
• Isotretinoin 5 mg may increase
your liver enzyme levels.
Your
doctor will do some blood tests
before, during and at the end of
your Isotretinoin 5 mg treatment to
check your liver values. In cases
where liver enzyme values remain
high your doctor may reduce your
dose or stop your Isotretinoin 5 mg
therapy.

reaction (skin redness, itching) or
a serious anaphylactic reaction.
• If you experience a persistent
headache, nausea, vomiting and
blurred vision . Isotretinoin 5 mg
has been very rarely associated
with a condition called benign
intracranial hypertension.
• If you experience severe
haemorrhagic diarrhoea (e.g.
blood in your stool). Isotretinoin
5 mg has on very rare occasions
ammatory
bowel disease.

Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines, including
medicines obtained without a
prescription.

Important information about
some of the ingredients of
Isotretinoin 5 mg

Other precautions
• Isotretinoin 5 mg may increase

The following symptoms are possible:
severe headache, nausea or vomiting,
somnolence, irritability and itching.
If you take too many capsules or
someone else accidentally takes
your medicine, contact your doctor,
pharmacist or nearest hospital
immediately.

Treatment with Isotretinoin 5 mg
does not appear to damage sperm.
Isotretinoin and its metabolites are
present in very low levels in your
semen. These levels are considered
too low to harm the unborn baby of
your female partner.

problems, or, if you think you have
signs of depression while taking
Isotretinoin 5 mg such as feeling
very sad for no reason, crying
culty concentrating or
you become withdrawn from your
friends or family. Your doctor may
refer you for appropriate treatment
if necessary. Stopping therapy with
Isotretinoin 5 mg may not be
enough and you may require
further psychiatric or psychological
help. Rare cases of depression,
worsening depression, anxiety,
mood changes, psychotic
symptoms and very rarely suicidal
thoughts, suicide attempts and
suicide have been reported.
• If you suffer from kidney failure.
In this case therapy has to begin
with a lower dose.
• Isotretinoin 5 mg therapy may
affect your night vision.
You may
develop dry eyes or sight problems
during Isotretinoin 5 mg therapy
which normally returns to normal
once treatment is stopped.
Always be cautious when driving
or operating machinery at night
because these sight changes can
happen quite suddenly. If you wear
contact lenses and experience
dry eyes you may need to wear
glasses for the duration of
Isotretinoin 5 mg treatment. If you
experience any problems with
your sight, please inform your
doctor immediately , as your
Isotretinoin 5 mg may need to be
stopped and your sight monitored.

Taking other medicines

If you have the impression that the
effect of Isotretinoin 5 mg is too
strong or too weak, talk to your
doctor or pharmacist.

Rare (may affect up to 1 in every 1000
people )
• Allergic skin reaction (symptoms
include reddening of the skin, rash,
itching)
• Severe allergic response
(anaphylactic reactions), which
may cause shock (symptoms
culty in breathing
or swallowing, sudden swelling
of the throat, face, lips and
tongue, reddening of the skin and
dizziness)
• Hypersensitivity (symptoms
include reddening of the skin, rash,
itching)
and stop taking Isotretinoin 5mg
if any of the following side effects
occur.

Go to a doctor straight away

Some of the side effects associated
with the use of isotretinoin are
dose-related. The side effects are
generally reversible after altering the
dose or discontinuation of treatment;
however some may persist after
treatment has stopped.
Like all medicines, Isotretinoin 5 mg
can cause side effects, although not
everybody gets them.

4. POSSIBLE SIDE
EFFECTS
If you have any further questions
on the use of this product, ask your
doctor or pharmacist.

After this you must see your
doctor at regular 28 days intervals.
As a rule further medically supervised
pregnancy tests must be carried out
monthly on the day of the prescribing
visit or in the 3 days before the visit
throughout the course of treatment.

You must remember not to share your
medication with anyone, particularly
not females.

Contact your doctor
• If you have any kind of mental

Stop treatment immediately
and contact your doctor as
soon as possible
• If you experience an allergic

Isotretinoin 5 mg contains soya oil.
If you are allergic to peanut or soya,
do not use this medicinal product.

Severe forms of rash may progress
to widespread peeling of the skin
which can be life threatening.
These serious skin rashes are often
preceded by headache, fever,
u-like symptoms). If
you develop a rash or these skin
symptoms stop taking Isotretinoin
5mg and contact your doctor
immediately .
Additional symptoms such as
infection of the eye (conjunctivitis) or
ulcers of the mouth, throat or nose
may occur.
Unknown frequency
Serious skin rashes (erythema
multiforme, Stevens- Johnson
syndrome, and toxic epidermal
necrolysis), which are potentially lifethreatening and require immediate
medical attention. These appear
initially as circular patches often with
central blisters usually on arms and
hands or legs and feet, more severe
rashes may include blistering of the
chest and back.
ammatory bowel disease and
nausea.
ammation
• Benign intracranial hypertension
• Oedema of the optic disc
(papilloedema, as sign of benign
intracranial hypertension)
• Blurred vision
• Clouding of the surface of the eye
(cataract)
• Colour blindness (colour vision
ciencies)
• Decreased night vision
ammation
• Visual disturbances

Very common (may affect more than 1
in every 10 people)
Also the following side effects may
occur:
The following symptoms are the
most commonly reported undesirable
effects with isotretinoin: dryness of
the skin, dryness of the mucosa e.g.
of the lips, the nasal mucosa, and
the eyes.






Abnormal behavoiur
Psychotic disorder
Suicidal thoughts
Suicidal attempt
Suicide

Very rare (may affect up to 1 in every
10,000 people)






Depression
Worsening of depression
Aggressive behaviour
Anxiety
Mood alterations

Rare (may affect up to 1 in every 1000
people)

10,000 people)

Very rare (may affect up to 1 in every
• Loss of hair

Rare (may affect up to 1 in every 1000
people)
• Headache
• Neutrophilic leucozytes decreased
(a kind of white blood cells)
• Nosebleed
• Nasal dryness
ammation of the nasal mucosa,
respectively pharyngeal mucosa
• Blood cholesterol increased
• Blood sugar levels (blood glucose)
increased
• Blood in the urine
• Excretion of protein in the urine
people)

Common (may affect up to 1 in every 10
• Muscle pain
• Back pain (particularly in children
and adolescent patients)
• Increase in the level of liver
enzymes (see Section 2: Before
you take Isotretinoin 5mg)

If you are a girl or women of
child bearing age you can
only receive Isotretinoin 5 mg
treatment if:
• you have severe acne (such
as nodular or conglobate

Male patients

your blood sugar levels
and in
rare cases diabetes mellitus has
been diagnosed. Your doctor may
monitor your blood sugar levels
during your tr eatment, particularly if
you have diabetes, are overweight,
or are an alcoholic.
• Use a skin moisturising ointment
or cream and a lip balm
during
treatment as you may experience
skin and/or lip dryness during
Isotretinoin 5 mg therapy.

If you forget to take Isotretinoin
5 mg

• Lymph node disease
(lymphadenopathy)
• Contect lens intolerance
• Corneal opacity
• Intolerance to light
• Hearing impaired
• Narrowing of the airways
(bronchospasm), particularly in
patients with asthma
• Hoarseness
• Increase in blood sugar levels
(Diabetes mellitus)
• Increase in uric acid blood levels
• Inlammation of joints
cations in soft tissues
(ligaments and tendons)
• Prematurely ending of growing
bones
• Formation of excessive bony tissue
(exostosis/hypertosis)
• Reduced bone density
• Tendonitis
• Blood creatine phosphokinase
increased
• Bacterial infections of the skin and
mucous membranes
ammation
(for example Wegener’s
granulomatosis, alleregic vasculitis)
• Increased formation of tissue,
which may cause thickened
scarring after surgical interventions
• Malaise

to isotretinoin, soya, peanut or
any of the excipients
• if you have liver disease
• if you have very high levels of
lipids (cholesterol, triglycerides) in
your blood
• if you have very high levels
of vitamin A in your body

Written information on this
subject is available from your
doctor. If you haven’t received
this material please contact
your doctor.

Five weeks after the end of
treatment with Isotretinoin 5 mg
another medically supervised
pregnancy test must be carried
out, because it takes about 1
month before the active substance
contained in Isotretinoin 5 mg is
completely eliminated from the body.
This test will exclude the possibility
of a pregnancy during this period.

• Isotretinoin 5 mg may increase

Patients with severe renal
ciency

may be pregnant

• if you are breast-feeding
• if you are allergic (hypersensitive)

You must not take Isotretinoin
5 mg if you are pregnant or
may become pregnant at any
time during treatment and for
one month after treatment
has stopped.

If you become pregnant
while on Isotretinoin 5 mg
therapy or during the month
after treatment has stopped,
immediately stop taking the
medicine and contact your
doctor. Your doctor may refer
you to a specialist for evaluation
and advice.

Contact your doctor straight

Do not take Isotretinoin 5 mg
• if you are pregnant or think you

The percentage of deformities
is high even if isotretinoin was
taken only for a short period
during pregnancy or when you
get pregnant within 4 weeks
following the end of treatment.

rst pregnancy test is
negative, you must start using an
effective contraceptive method.
A second medically supervised
pregnancy test must be carried out
one month after starting a consistent
and effective contraceptive method
and before starting the treatment,
and not more than 3 days before the
visit to the prescribing doctor. If the
result of this second pregnancy test
is negative, your doctor will issue
rst pr escription for Isotretinoin
5 mg. This pr escription is limited to
30 days of treatment.

Afterwards you will receive a new
prescription covering your needs for
another 30 days.

Stop taking Isotretinoin 5mg and
contact your doctor straight away
if any of the following side effects
occur.

l
when you take Isotretinoin 5 mg.
Additionally, you should receive
information materials from your
doctor. If not, ask your doctor for
this information. If your doctor has
not explained the precautionary
measures or you have not understood
them, please contact your doctor
before you start taking Isotretinoin 5 mg.

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

Your doctor will inform you about

Isotretinoin is teratogenic.
That means it is likely to
damage an unborn baby.
These deformities include
central nervous system
and cardiovascular abnormalities
and cleft palate. There is also
an increased incidence of
sponatenous abortion.

ammation
• Convulsions, drowsiness, dizziness
ammation of the colon mucosa
and intestinal mucosa
• Dry throat
• Pancreatitis (see section 2.
Before you take Isotretinoin 5 mg)
• Severe acne (acne fulminans)
are)
• Skin redness, particulalrly on the
face
• Skin rash
• Hair disorders
• Increased levels of body hair
• Changes in the nails, infections of
the tissue around the base of the
nails
• Sensitivity to light
• Pus forming swellings (pyogenic
granuloma)
• Increased pigmentation of the skin
• Sweating increased

Isotretinoin should only be
prescribed by or under the
supervision of a dermatologist
(a
doctor specialised in the treatment of
skin problems) with understanding of
the risks of isotretinoin therapy and
monitoring requirements.

Important

Your doctor will provide you with
information brochures that you
must read carefully and may refer
you to a gynaecologist, who will
explain about contraception and
recommend the contraceptive
methods suitable for you. Your doctor
or gynaecologist will carry out a
medically supervised pregnancy
test before you start to use the
contraception
rst 3
days of your menstrual cycle) in
order to exclude the possibility that
you might already be pregnant. If you
do not have a regular period the test
should be carried out about 3 weeks
after the last unprotected sexual
intercourse. The test must have a
minimum sensitivity of 25 mIU/mL.
Your doctor will document the date
and result of this pregnancy test.

ammation of the eyelid area
ammation
• Dry eye
• Eye irritation
• Blood levels of fat like substances
(triglyceride) increased
• HDL-cholesterol (high density
lipoprotein) decreased
ciency of red blood cells
• Red blood cell sedimentation rate
increased
• Number of blood plates increased
or decreased
ammation of lips
ammation of the skin
• Dryness of skin
• Localised shedding of layers of
skin
• Itching
• Rash with redness
• Skin fragility (risk of frictional
trauma)
• Joint pain

Pregnancy Prevention Programme

Pregnancy tests

away if you get any of the
following symptoms. Your
doctor may tell you to stop taking
Isotretinoin 5mg.

lling
ned
all-rac- α-Tocopherol
Disodium edetate
Butylhydroxyanisole (E 320)
Soya-bean oil, partially hydrogenated
Hydrogenated vegetable oil
Beeswax, yellow

et:
1. What Isotretinoin 5 mg is and
what it is used for
2. Before you take Isotretinoin 5 mg
3. How to take Isotretinoin 5 mg
4. Possible side effects
5. How to store Isotretinoin 5 mg
6. Further information

Take special care with
Isotretinoin 5 mg

Prescriptions are limited to 30
days treatment for women of
childbearing potential. Continuation
of treatment requires a new
prescription, and each prescription is
only valid for seven days.

If you have unregular menses,
the timing of this pregnancy
ect your sexual
activity and should be
undertaken approximately 3
weeks after you had
unprotected sexual
intercourse.
• you understand and accept
the need for monthly follow
up visits and maybe further
pregnancy tests as decided
by your doctor. You may then
have a pregnancy test 5
weeks after stopping your
therapy with Isotretinoin 5 mg.
You must not become
pregnant at any time during
treatment or for one month
after treatment ends.
• your doctor may ask you (or
your guardian) to sign an
acknowledgment form
rm that you
have been informed about
the risks of Isotretinoin 5 mg
treatment and that you accept
the necessary precautionary
measures.

Very rare (may affect up to 1 in every
10,000 people)

et carefully
before you start taking this
medicine.

et. 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 gets
serious, or if you notice any
side effects not listed in this
et, please tell your doctor
or pharmacist.

2. BEFORE YOU TAKE
ISOTRETINOIN 5 MG

Due to the high risk that a child with
congenital defects will result if
pregnancy occurs you should only
take Isotretinoin 5 mg if all the
conditions of the pregnancy
prevention programme are met.
Please talk about these issues with
your doctor.

acne or acne at risk of
permanent scarring) which
has not got better after other
anti-acne treatments,
including oral antibiotics.
• your doctor has explained
the teratogenic risk of
isotretinoin , and you
understand why you must not
get pregnant and how to
prevent pregnancy.
• you are using effective birth
control (contraception)
without interruption:
1. your doctor will discuss
this with you and give
you information on
pregnancy prevention
including a brochure on
contraception explaining
the different methods.
Your doctor may refer you
to a specialist
for contraceptive advice.
2. you must agree to use at
least one and preferably
two effective methods of
contraception including
a barrier method (i.e. the
pill and condoms) for one
month before Isotretinoin
5 mg treatment, during
treatment and for one
month after treatment ends.
Before you start treatment
your doctor will ask you
to take a pregnancy test
which must be negative.
3. you must use
contraception even if you
do not have periods or
are not curr ently sexually
active, unless your doctor
decides this is not
necessary.
• you accept that a medically
supervised pregnancy test
rst
will be performed
3 days of your menstrual
cycle prior to starting therapy.

This medicinal product contains
sorbitol. If you have been told by
your doctor that you have an
intolerance to some sugars, contact
your doctor before taking this
medicinal product.

THIS MEDICINAL
PRODUCT IS STRONGLY
TERATOGENIC
Please see the brochures
on the contraceptive
programme and the
information you are given
et in
section 2 under the heading
“Pregnancy Prevention
Programme”.

type of antibiotic medicine)

(a

• Gastric and intestinal bleeding,
haemorrhagic diarrhoea,

Isotretinoin

Isotretinoin 5 mg capsules contains
the active ingredient isotretinoin. This
is a vitamin A derivative, belonging
to the retinoid class of medicines.
Isotretinoin 5 mg is used to treat
severe forms of acne
(such as
nodular or conglobate acne, or
acne at risk of permanent scarring)
which has not got better after other
anti-acne treatments, including oral
antibiotics.

(hypervitaminosis A)

• if you are taking tetracyclines

If you miss a dose, take it as soon as
possible. However if it is nearly time
for your next dose, skip the missed
dose and carry on as before. Do not
take a double dose.

Isotretinoin
5 mg capsules

1. WHAT ISOTRETINOIN
5 MG IS AND WHAT
IT IS USED FOR

If you have severe kidney problems,
Isotretinoin 5 mg should be started
at a lower dose such as 10 mg/day
and then increased up to the highest
tolerated dose.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

304846

The other ingredients are

The active substance is Isotretinoin.
Each capsule contains 5 mg of
isotretinoin.

What Isotretinoin 5 mg contains

6. FURTHER
INFORMATION
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.
Important! Please return any
unused capsules to your
pharmacist at the end of
treatment. Only keep it if your
doctor tells you to.
Do not store above 30°C. Store in
the original package.
Do not use Isotretinoin 5 mg after the
expiry date which is stated on the
carton. The expiry date refers to the
last day of that month.
Keep out of the reach and sight of
children.

5. HOW TO STORE
ISOTRETINOIN 5 MG

This leaflet was last revised in:
September 2015.
This medicinal product is
authorised in the Member States
of the EEA under the following
names:
UK:
Isotretinoin 5 mg capsules
AT:
Ciscumed 5 mg – Kapsen

Marketing Authorisation Holder and
Manufacturer
Ennogen Healthcare Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
The capsules come in blister packs
of 10, 15, 20, 30, 50 or 60 capsules.
[Not all pack sizes may be marketed.]
The soft-gelatin capsules are faint
pinkish/cream to cream coloured
oval, containing a yellow/orange,
opaque, viscous liquid.

What Isotretinoin 5 mg looks
like and contents of the pack
Capsule shell
Gelatin
Glycerol
Sorbitol, liquid (non-crystallising)
(E 420)
ed water
Titanium dioxide (E 171)

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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