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ISOTRETINOIN 20MG CAPSULES

Active substance: ISOTRETINOIN

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Patient Information Leaflet:

RIZUDERM® 5MG AND 20MG
CAPSULES
Please read this leaflet carefully before taking
Rizuderm Capsules. Keep the leaflet in case
you want to refer to it again. If you want to know
more about Rizuderm Capsules or have any
questions, you should ask your doctor or
pharmacist.
1.

WHAT RIZUDERM

IS USED FOR

Rizuderm Capsules contain Isotretinoin which
belongs to a group of medicines known as
retinoids that are normally used to treat skin
problems.
Ruzuderm Capsules are used to treat severe
acne, for patients whose acne has not responded
to other treatments. Their use must be supervised
by a dermatologist (a doctor who specialises in
the treatment of skin problems).
Rizuderm Capsules should not be used to treat
acne occurring before the onset of puberty.
2. BEFORE TAKING RIZUDERM CAPSULES
You must not take Rizuderm Capsules and
should talk to your doctor immediately if you:
 are pregnant or think you may be pregnant (see
’Important advice for female patients’ in the box
opposite)
 have liver disease
 are breast-feeding
 are taking certain antibiotics called tetracyclines
 are allergic to Rizuderm Capsules or any of the
ingredients it contains
 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
 are allergic to soya
Rizuderm capsules do not contain peanut oil but
do contain soya oil and some patients who are
allergic to peanuts may suffer a cross reactivity to
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soya protein. If you have a peanut allergy you
should discuss this with your doctor.
Important Advice for Female Patients.
Rizuderm will damage an unborn baby 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.
 You must use one, preferably two, effective
methods of contraception (including condom,
cap or spermicide) for one month before
Rizuderm treatment, during treatment and for
one month after treatment ends.
 Your doctor will ask you to take a pregnancy
test before, during and after your treatment.
These must be negative. You should start
taking Rizuderm Capsules on the second or
third day of your menstrual cycle.
 You must not become pregnant at any time
during treatment or for one month after
treatment ends.
 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.
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.
Advice for all patients:
 Tell your doctor if you have or have had any
mental illness including depression, psychosis
or suicidal behaviour.
 Tell your doctor if you, or members of your
family, have a history of high fat levels in the
blood. Your doctor may reduce the dose of
Rizuderm or suggest you go on a low-fat diet.
Rizuderm may increase blood fats and may
also increase liver enzymes (transaminases).

Blood tests will be performed before, during and
after Rizuderm treatment to check your blood
fat and liver enzyme levels.
 Tell your doctor if you have diabetes mellitus
(sugar diabetes), are overweight, have a rare
intolerance to some sugars or you are an
alcoholic. Rizuderm may increase your blood
sugar levels, so your doctor may want to
monitor this during treatment.
 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.
Taking/using other medicines
 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.
Tell your doctor or pharmacist if you are taking or
have recently taken any other medicine including
those obtained without a prescription.
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.

3. HOW TO TAKE RIZUDERM CAPSULES
Always take the capsules as your doctor tells you
to. Your doctor will tell you how many to take,
which may change after a few weeks of
treatment. This will depend on how you respond
to your medicine.
Adolescents, adults and the elderly:
The usual 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.
A normal course of treatment lasts between 4-6
months.
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 dermatologist
tells you to.
Children:
Rizuderm Capsules must NOT to be used to treat
children less than 12 years of age or before the
onset of puberty.
If you forget 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.
If you take too many Rizuderm Capsules or
someone else accidentally takes your medicine,
contact your doctor, pharmacist or nearest
hospital straight away.
Your doctor has prescribed this medicine for you.
Never give it to others as it may harm them, even
if their symptoms are the same as yours.
Continued overleaf…..

4. POSSIBLE SIDE EFFECTS
As with all medicines Rizuderm Capsules may
cause some undesirable effects in some patients.
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
occur:
 symptoms of a severe allergic (hypersensitivity)
reaction such as wheezing or difficulty in
breathing, swelling of face, tongue or throat,
itching, rash
 severe diarrhoea, especially if it contains blood
 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.
Contact your doctor IMMEDIATELY if you get
any of the following symptoms. Your doctor
may tell you to stop taking this medicine.
 mood changes, anxiety, depression or
worsening of depression, aggressive
tendencies, thoughts or attempts of suicide,
abnormal behaviour or mental disorder.
Very common and common side effects:
 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
 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
 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
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 back pain (particularly in children and
adolescents), muscle and joint aches and
pains, which may be more likely if you take
vigorous exercise
 blood or protein in the urine
 changes in blood glucose levels especially in
diabetics
 increased blood cholesterol
 anaemia
 headaches
 blood clotting may be affected, which means
that you may bruise or bleed more easily.
Rare side effects:
 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:
 tiredness
 feeling sick
 sweating
 diabetes
 dizziness, drowsiness, fits (convulsions)
 worsening of acne, which usually subsides
within 7-10 days of treatment
 swellings discharging pus
 abdominal pain, diarrhoea, inflammatory bowel
disease
 inflammation of the pancreas, causing severe
pain in the abdomen and back
 inflammation of the liver
 kidney disease
 difficulty breathing (especially in people who
have previously suffered from asthma or have
allergies to certain substances)
 dry throat, hoarseness
 blurred vision, inflammation of the cornea
 increased skin pigmentation
 increased sensitivity to sunlight
 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
 arthritic pain, soreness of the tendons
 changes in the bone may occur with use of high
doses of Rizuderm for periods in excess of the
normal course of treatment, but these are very
unlikely during a normal course of treatment.
Skin and hair problems (Unknown frequency)
Serious skin rashes (erythema multiforme,
Stevens-Johnson syndrome, and toxic epidermal
necrolysis), which are potentially life-threatening
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).
If you develop a rash or these skin symptoms,
stop taking Rizuderm and contact your doctor
immediately.
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.

5. STORING RIZUDERM CAPSULES
Keep this medicine out of the reach and sight of
children.
Do not store above 25°C. Store in the original
container to protect from light. Do not use after
the expiry date printed on the pack. Return any
left over medicine to your pharmacist.
6.

FURTHER INFORMATION

What is in this medicine:
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
lysophosphatidylcholine.
What this medicine looks like and contents of
the pack:
The soft gelatine capsules are red and orange,
the 5mg are marked ‘P5’, the 20mg are marked
‘P20’. Each pack contains either 30 or 56
capsules.
Marketing authorisation holder: Alliance
Pharmaceuticals Limited, Bath Road,
Chippenham, SN15 2BB, UK.
Manufacturer: Pharmathen SA, Dervenakion 6,
Pallini 15351, Attikis, Greece.
This leaflet was last revised in November 2011
Rizuderm is a registered trade mark of Alliance
Pharmaceuticals Limited.
Alliance and associated devices are registered
trademarks of Alliance Pharmaceuticals Limited.
© Alliance Pharmaceuticals Limited 2011.

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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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