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Active substance(s): ISOTRETINOIN

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Package Leaflet: Information for the user

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep the leaflet. You may need to read it
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Rizuderm is and what it is used for
2. What you need to know before you take
Rizuderm Capsules
3. How to take Rizuderm Capsules
4. Possible side effects
5. How to store Rizuderm Capsules
6. Contents of the pack and other information


Rizuderm Capsules contain Isotretinoin which
belongs to a group of medicines known as
retinoids that are normally used to treat skin
Rizuderm Capsules are used to treat severe acne
(such as nodular or conglobate acne, or acne that
is at risk of causing permanent scarring) in adults
and adolescents from 12 years of age only after
puberty. Rizuderm Capsules are for patients
whose acne has not responded to other
Their use must be supervised by a dermatologist
(a doctor who specialises in the treatment of skin
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Do not take Rizuderm Capsules if you:
• are allergic to isotretinoin, peanut, soya or any
of the ingredients of this medicine (listed in
section 6)
• are pregnant or think you may be pregnant (see
’Important advice for female patients’ in the box
• are able to become pregnant but you haven’t
followed the necessary pregnancy prevention
measures that are listed in the pregnancy
prevention plan
• are breast-feeding
• have liver disease
• are taking certain antibiotics called tetracyclines
• have very high levels of vitamin A in your body
(Hypervitaminosis A)
• have very high levels of cholesterol or
triglycerides (a fat like substance) in your blood.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Rizuderm Capsules.
Important Advice for Female Patients.
Rizuderm will damage an unborn baby (in
medical language, it is teratogenic). It also
increases the risk of miscarriage so:
• You must not take Rizuderm Capsules if you
are pregnant or think you may be pregnant
• You must not take Rizuderm Capsules if you
are breast-feeding. The medicine is likely to
pass into your milk and harm your baby
• You must not take it if you could get pregnant
during treatment, or during the month after
Women who could get pregnant are only
prescribed Rizuderm Capsules under strict
rules, because of the risk of birth defects
(damage to the unborn baby). These are the
• You must only take Rizuderm Capsules if you

have severe acne that has not got better after
any other anti-acne treatments, including
antibiotics and skin treatment
• Your doctor must have explained the risk of
birth defects: you understand why you must not
get pregnant and what you need to do to
prevent it
• You must have discussed contraception (birth
control) with your doctor. They will give you
information on preventing pregnancy. He or she
may refer you to a specialist for contraceptive
• You must agree to use one, preferably two,
effective methods of contraception (including
condoms, or a cap plus spermicide) for one
month before taking Rizuderm Capsules, 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
• You must use contraception even if you do not
have periods or are not currently sexually active
(unless your doctor decides this is not
• You must be capable of complying with the
necessary pregnancy prevention measures that
are listed in the pregnancy prevention plan
• You must accept the need for monthly follow up
visits and more pregnancy tests as decided by
your doctor. You may have a test 5 weeks after
stopping Rizuderm Capsules. You must not
become pregnant at any time during treatment
or for one month after treatment ends
• Your doctor may ask you (or a guardian) to sign
a form that confirms that you have been told
about the risks, and that you accept the
necessary precautions
• Contact your dermatologist immediately if you
do become pregnant or think you may be
pregnant during treatment or in the first month
after treatment ends.
Your doctor has written information on pregnancy
and contraception for the users of Rizuderm
Capsules which he or she should show you. If

you haven’t seen this material already, ask your
Prescriptions for women who could get pregnant
are limited to 30 days treatment. A new
prescription is needed for more treatment. Each
prescription is only valid for 7 days.
Advice for Male patients
Isotretinoin treatment does not appear to damage
sperm. Isotretinoin and its metabolites are
present at very low levels in your semen. These
levels are considered too low to harm the unborn
baby of your female partner. You must remember
not to share your medication with anyone,
particularly not women.
Advice for all patients:
• Tell your doctor if you have or have had any
mental illness including depression, psychosis
or suicidal behaviour
• Severe skin reactions (e.g. erythema multiforme
(EM), Stevens-Johnson syndrome (SJS) and
toxic epidermal necrolysis (TEN)) have been
reported with the use of Rizuderm Capsules.
The rash may progress to widespread blistering
or peeling of the skin. You should also look for
ulcers in the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes)
• Rarely, Rizuderm Capsules may cause severe
allergic reactions some of which can affect skin
in the form of eczema, hives and bruises or red
patches on arms and legs. If you develop an
allergic reaction, stop taking Rizuderm
Capsules, seek urgent advice from a doctor and
tell him or her that you are taking this medicine
• Rizuderm Capsules may cause dry eyes,
intolerance to contact lenses and visual
difficulties including decreased night vision. Tell
your doctor if you have any of these symptoms.
Your doctor may ask you to use lubricating eye
ointment or tear replacement therapy. If you use
contact lenses and you have developed
intolerance to contact lenses, you may be
advised to wear glasses during the treatment.
Your doctor may refer you to a specialist for
advice if you develop visual difficulties and you

may be asked to stop taking Rizuderm
• Cut down on intensive exercise and physical
activity. Isotretinoin can cause muscle and joint
pain particularly in children and teenagers
undertaking vigorous physical activity
• Rizuderm Capsules has been associated with
inflammatory bowel disease. Your doctor will
take you off Rizuderm Capsules if you have
severe bloody diarrhoea without any history of
gastrointestinal disorders
• Benign intracranial hypertension has been
reported with Rizuderm Capsules and in some
cases where Rizuderm Capsules were used
together with tetracyclines (a type of antibiotic).
Stop taking Rizuderm Capsules and seek
urgent advice from your doctor if you develop
symptoms like headache, nausea, vomiting and
visual disturbances. Your doctor may refer you
to a specialist to check for swelling of optic disk
in the eye (papilloedema)
• Rizuderm Capsules may increase liver enzyme
levels. Your doctor will do blood tests before,
during and after taking Rizuderm to check these
levels. If they stay high, your doctor may lower
your dose or take you off Rizuderm Capsules
• Rizuderm Capsules commonly increase blood
fats, such as cholesterol or triglycerides. Your
doctor will test these levels before, during and
after treatment with Rizuderm Capsules. Tell
your doctor if you already have high blood fats,
diabetes (high blood sugars), are overweight or
an alcoholic. You may need blood tests more
often. If your blood fats stay high, your doctor
may lower your dose or take you off Rizuderm
• Tell your doctor if you have any kidney
problems. Your doctor may start you on a lower
dose of Rizuderm Capsules and then increase
it to the maximum tolerated dose
• Rizuderm Capsules may increase blood sugar
levels. In rare cases, people become diabetic.
Your doctor may monitor blood sugar levels
during treatment, particularly if you already
have diabetes, are overweight or are an
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• Your skin and lips are likely to get dry. Use a
moisturiser and lip balm during treatment
• Avoid chemical dermabrasion and laser
treatment of the skin and wax depilation during
and for at least 6 months after treatment as they
could cause scarring or irritation of the skin
• Avoid too much sun and do not use a sunlamp
or sunbed as your skin may be more sensitive.
Before going out in the sun apply a sun block to
exposed skin, particularly in strong sunlight
• Do not donate blood during therapy or for at
least one month after treatment with Rizuderm
• Do not give your medication to anyone else.
Return any unused capsules to the pharmacy.
Children and adolescents
The use of Rizuderm Capsules in children under
the age of 12 is not recommended. This is
because it is not known if it is safe or effective in
this age group.
Use in adolescents over 12 years of age only
after puberty.
Other medicines and Rizuderm Capsules
Tell your doctor or pharmacist if you are taking,
have recently taken or might use any other
medicines including herbal and non-prescription
• Do not use any other acne treatments unless
your doctor has told you to.
• Do not take tetracycline antibiotics when on
Rizuderm treatment.
• Do not take any vitamin A supplements.
Rizuderm Capsules with alcohol
It is best that you do not drink alcoholic drinks or
that you at least reduce the amount you usually
drink while on treatment.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this

Rizuderm Capsules must not be used during
pregnancy. If you are able to get pregnant, you
should use effective contraception one month
before, during and up to one month after
Rizuderm Capsules treatment.
If you do get pregnant while taking Rizuderm
Capsules, or in the month after treatment has
stopped, stop taking the medicine straight away,
and contact your doctor. He or she may refer you
to a specialist for advice.
If used during pregnancy, Rizuderm Capsules are
likely to damage your unborn baby (in medical
language it is teratogenic). It also increases the
risk of miscarriage.
Rizuderm Capsules can cause serious
abnormalities of brain, face, ear, eye, heart and
some glands (called the thymus gland and
parathyroid gland) of the unborn baby.
You must not take Rizuderm Capsules if you are
breast-feeding. The medicine is likely to pass into
your breast milk and may harm your baby.
Driving and using machinery
Your night vision may be affected by this
medicine and you may develop dry eyes or sight
problems. These changes can happen quite
suddenly, so always be cautious when driving or
operating machinery at night. Other visual
disturbances, drowsiness or dizziness have been
reported very rarely. If you experience any of
these, you should not drive or operate machinery.
Rizuderm Capsules contain sorbitol, maltitol
and soya
If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
Rizuderm Capsules contain soya oil. If you are
allergic to peanut or soya, do not use this
medicinal product.

Always take this medicine exactly as your doctor
or pharmacist has told you to. Check with your
doctor or pharmacist if you are not sure.
Adolescents, adults and the elderly:
The recommended starting dose is 0.5mg/kg
daily, e.g. if you weigh 60kg your starting dose
will be 30mg/day. Normally, you should not take
more than 1mg of Rizuderm per kilogram of
bodyweight per day.
• The capsules can be taken either once a day or
in two divided doses during the day.
• Take them with a meal or with a glass of milk.
• Swallow the capsules whole, do not suck or
chew them.
Your doctor will tell you how many capsules to
take, which may change after a few weeks of
treatment. This will depend on how you respond
to your medicine. For most patients the dose will
be between 0.5 and 1.0 mg/kg/day. If you think
that Rizuderm Capsules are too strong or too
weak, talk to your doctor or pharmacist.
If you have severe kidney problems, you will
usually start on a lower dose (such as 10 mg/day)
which will be increased up to the highest dose
your body can tolerate. If your body can’t tolerate
the recommended dose, you may be prescribed a
lower dose: that can mean you are treated for
longer and your acne might be more likely to
come back.
A normal course of treatment lasts between 1624 weeks. Most patients only need one course.
Your acne may continue to improve for up to 8
weeks after treatment. You won’t usually start
another course until then.
For a few patients, the acne may get worse
during the first 7-10 days of treatment. Your acne
should improve with continued treatment and may
continue to improve for a few months after
completion of the treatment course. Do not carry
on taking this medicine unless your doctor tells
you to.
Use in children:

Rizuderm Capsules must NOT be used to treat
children less than 12 years of age or before the
onset of puberty.
If you take more Rizuderm Capsules than you
If you take too many capsules or someone else
accidentally takes your medicine, contact your
doctor, pharmacist or nearest hospital straight
If you forget to take Rizuderm Capsules
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 to make up for a forgotten
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side
effects, although not everybody gets them. These
effects often wear off as your treatment continues
and your doctor can help you to deal with them.
Stop taking the capsules and contact your
doctor IMMEDIATELY if any of the following
• 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. Additional symptoms such as infection of
the eye (conjunctivitis) or ulcers of the mouth,
throat or nose may occur. 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, body aches (flu-like symptoms)
• symptoms of a severe allergic (hypersensitivity)
reaction such as wheezing or difficulty in
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breathing, swelling of face, tongue or throat,
itching, rash
• muscle weakness which can be potentially lifethreatening, may be associated with trouble
moving arms or legs, painful, swollen, bruised
areas of the body, dark-coloured urine, reduced
or no urine output, confusion or dehydration.
These are signs of rhabdomyolysis, a
breakdown of muscle tissue which can lead to
kidney failure. This may occur if you are doing
intensive physical activity while you’re on
Rizuderm Capsules
• persistent headache, nausea, vomiting and
blurred vision. You may have a rare condition
called intracranial hypertension
• dry eyes, sight problems, colour vision
disturbances or reduced night vision. These
changes can happen quite suddenly, but rarely
persist after treatment. Always be cautious
when driving or operating machinery at night.
Your doctor may want to monitor your vision
• yellow skin or eyes, and feeling tired. These
can be signs of hepatitis
• difficulty urinating (passing water), swollen and
puffy eyelids, feeling excessively tired. These
may be signs of kidney inflammation
• sudden tight chest, shortness of breath and
wheezing, particularly if you have asthma
• severe abdominal (tummy) pain, with or without
severe bloody diarrhoea, feeling sick (nausea)
and being sick (vomiting). These can be signs
of serious gut conditions.
Contact your doctor IMMEDIATELY if you get
any of the following symptoms. Your doctor
may tell you to stop taking this medicine.
• depression or related disorders. Signs of this
include sad or empty mood, mood changes,
anxiety, crying spells, irritability, loss of
pleasure or interest in social or sports activities,
sleeping too much or too little, changes in
weight or appetite, school or work performance
going down or trouble concentrating
• existing depression getting worse
• becoming violent or aggressive

• some people have had thoughts about hurting
themselves or ending their own lives (suicidal
thoughts), have tried to end their own lives
(attempted suicide), or have ended their lives
(suicide). These people may not appear to be
• unusual behaviour
• signs of psychosis: a loss of contact with reality,
such as hearing voices or seeing things that are
not there.
Other side effects:
Very common side effects (may affect more
than 1 in 10 people):
• inflammation, dryness and cracking of the skin
and lips. These can be relieved by the regular
use of a good moisturising cream and lip balm
from the start of treatment
• skin rash, mild itching and slight peeling of the
skin, or red, fragile skin
• inflammation of the eyelids
• dry, irritated eyes or conjunctivitis. This may be
a problem if you wear contact lenses. Ask your
pharmacist for suitable eye drops to help.
• changed levels of fats in the blood (including
HDL or triglycerides)
• raised liver enzymes seen in blood tests
• anaemia
• blood clotting may be affected, which means
that you may bruise or bleed more easily.
Common side effects (may affect up to 1 in 10
• headaches
• increased blood cholesterol
• changes in blood glucose levels especially in
• blood or protein in the urine
• more liable to get infections if the white blood
cells are affected
• the inside of the nose may become dry and
"crusted", which may lead to mild nosebleeds.
Applying a thin layer of petroleum jelly gently to
the inside of the nose will help
• sore or inflamed throat and nose.

Rare side effects (may affect up to 1 in every
1,000 people):
• changes to your hair (either a loss or, more
rarely, an increase). This is usually only
temporary and persistent hair thinning is rare.
Your hair should return to normal after the
treatment ends.
Very rare side effects (may affect up to 1 in
every 10,000 people):
• generally feeling unwell
• excess sweating or itching
• arthritis; bone disorders (delayed growth, extra
growth and changes in bone density); growing
bones may stop growing
• calcium deposits in soft tissue, sore tendons,
high levels of muscle breakdown products in
your blood if you exercise vigorously
• excessive thirst; frequent need to urinate; blood
tests show an increase in your blood sugar.
These can all be signs of diabetes
• dizziness, drowsiness, fits (convulsions)
• worsening of acne, which usually subsides
within 7-10 days of treatment
• thickened scarring after surgery
• inflammation of the pancreas, causing severe
pain in the abdomen and back
• dry throat, hoarseness
• increased skin pigmentation
• increased sensitivity to sunlight
• bacterial infections
• slight loss of hearing
• changes in the nails
• local bacterial infections such as infection of the
tissue around the base of the nail
• increased levels of a substance in your blood
known as uric acid. If you suffer from gout, this
could trigger an attack. Very high levels of uric
acid may affect your kidney function.
• inflammation of blood vessels (sometimes with
bruising and red patches)
• disease of the lymph nodes
• increased risk of infection, as leukocytes, which
are cells in your blood involved in fighting
infections, may decrease in number.

Most of the unwanted effects of Rizuderm will
disappear when you stop treatment.
If you are concerned about these or any other
side effect talk to your doctor.
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: By
reporting side effects, you can help provide more
information on the safety of this medicine.
Keep this medicine out of the sight and reach of

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Do not store above 25°C. Store in the original
container to protect from light. Do not use this
medicine after the expiry date printed on the
pack. The expiry date refers to the last day of that
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help to protect the environment.


What Rizuderm Capsules contain:
Each capsule contains 5 or 20mg of the active
ingredient isotretinoin.
The capsules also contain refined soya-bean oil,
yellow beeswax, hydrogenated soya-bean oil and

partially hydrogenated vegetable oil. The
capsules are made from gelatin, glycerol, titanium
dioxide (E171), ferrous oxide red (E172) and
ferrous oxide yellow (E172). The printing ink
(432BL) contains Brilliant Blue FCF dye, sorbitol,
maltitol, phosphatidylcholine and

Marketing Authorisation Holder: Alliance
Pharmaceuticals Limited, Bath Road,
Chippenham, SN15 2BB, UK.

What Rizuderm Capsules look like and
contents of the pack:
The soft gelatin capsules are red/orange, the 5mg
are marked ‘P5’, the 20mg are marked ‘P20’.
Each pack contains either 30 or 56 capsules.
Not all pack sizes may be marketed.

Rizuderm is a registered trademark of Alliance
Pharmaceuticals Limited.

Marketing Authorisation Holder and

© Alliance Pharmaceuticals Limited 2015.

Manufacturer: Pharmathen SA, Dervenakion 6,
Pallini 15351, Attikis, Greece.
This leaflet was last revised in December 2015.

Alliance and associated devices are registered
trademarks of Alliance Pharmaceuticals Limited.

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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.