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ROACCUTANE 10MG SOFT CAPSULES

Active substance(s): ISOTRETINOIN / ISOTRETINOIN / ISOTRETINOIN

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Package leaflet: Information for the user

Roaccutane® 
10 mg and 20 mg
soft capsules
Isotretinoin
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 again.
● If you have more 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 Roaccutane is and what it is used for
2. What you need to know before you take
Roaccutane
3. How to take Roaccutane
4. Possible side effects
5. How to store Roaccutane
6. Contents of the pack and other information

1. What Roaccutane is and what it is
used for
Roaccutane contains isotretinoin – a substance
related to vitamin A, and one of a group of
medicines called retinoids (for treatment of acne).
Roaccutane is used to treat severe types of 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.
You will use Roaccutane when your acne has not
got better with anti-acne treatments, including
antibiotics and skin treatments.
Roaccutane treatment must be supervised by a
dermatologist (a doctor specialised in the treatment
of skin problems).

2. What you need to know before you
take Roaccutane
Do not take Roaccutane:
● If you are pregnant or think you may be
● If you are breastfeeding
● If you are able to become pregnant but are
unable or unwilling to follow the necessary
pregnancy prevention measures that are listed in
the Roaccutane Pregnancy Prevention
Programme
● If you are allergic to isotretinoin, peanut or
soya or any other ingredients of this medicine
(listed in section 6)
● If you have liver disease
● If you have very high levels of blood fats
(e.g. high cholesterol or triglycerides)
● If you have very high levels of vitamin A in
your body (hypervitaminosis A)
● If you are receiving treatment with
tetracyclines (a type of antibiotic) at the same
time (see “Other medicines and Roaccutane”)
If any of these apply to you, go back to your
doctor before taking any Roaccutane.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Roaccutane.
Important advice for women
Roaccutane is likely to damage an unborn baby
(in medical language it is teratogenic).
It also increases the risk of
miscarriage.
● You must not take
Roaccutane when you’re
pregnant.
● You must not take
Roaccutane if you are
breastfeeding. The medicine is likely to pass
into your milk and may harm your baby.
● You must not take it if you could get pregnant
during treatment, or during the month after
treatment.
Women who could get pregnant are only
prescribed Roaccutane under strict rules,
because of the risk of birth defects (damage to
the unborn baby).
These are the rules:
● You must only take Roaccutane if you have
severe acne that has not got better after any
other anti-acne treatments, including antibiotics
and skin treatments.
● 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
advice.
● You must agree to use one or preferably two
effective methods of contraception, including
condoms or a cap plus spermicide, for a month
before taking Roaccutane, during treatment and
for a month afterwards. 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 necessary).
● You must be capable of complying with the
necessary pregnancy prevention measures that
are listed in the Roaccutane Pregnancy
Prevention Programme.
● 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 Roaccutane. You must not get pregnant
during treatment and for a month afterwards.
● 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.
If you do get pregnant while taking Roaccutane,
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.
Your doctor has written information on
pregnancy and contraception for the users of
Roaccutane which he should show you. If you
haven’t seen this material already, ask your doctor.
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 men
Roaccutane does not appear to damage sperm.
Very low levels of isotretinoin are present in the
semen of men taking Roaccutane, which is too little
to harm the unborn baby of your partner. You must
remember not to share your medication with
anyone, particularly not women.
Advice for all patients
● Tell your doctor if you have ever had any
mental illness (including depression, suicidal
behaviour or psychosis), or if you take medicines
for any of these conditions.
● Severe Skin reactions (e.g. erythema
multiforme (EM), Stevens-Johnson syndrome
(SJS) and toxic epidermal necrolysis (TEN))
have been reported with the use of
Roaccutane. 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).

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● Rarely, Roaccutane 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 Roaccutane, seek urgent
advice from a doctor and tell him that you are
taking this medicine.
● Cut down on intensive exercise and physical
activity. Roaccutane can cause muscle and joint
pain particularly in children and teenagers
undertaking vigorous physical activity.
● Roaccutane has been associated with
inflammatory bowel disease. Your doctor will
take you off Roaccutane if you have severe
bloody diarrhoea without any history of
gastrointestinal disorders.
● Roaccutane 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 Roaccutane.
● Benign intracranial hypertension has been
reported with Roaccutane use and in some
cases where Roaccutane was used together with
tetracyclines (a type of antibiotic). Stop taking
Roaccutane 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).
● Roaccutane may increase liver enzyme levels.
Your doctor will do blood tests before, during
and after Roaccutane treatment to check these
levels. If they stay high, your doctor may lower
your dose or take you off Roaccutane.
● Roaccutane commonly increases blood fats,
such as cholesterol or triglycerides. Your doctor
will test these levels before, during and after
Roaccutane treatment. It is best that you do not
drink alcoholic drinks or that you at least reduce
the amount you usually drink while on treatment.
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 Roaccutane.
● Tell your doctor if you have any kidney
problems. Your doctor may start you on a lower
dose of Roaccutane and then increase it to the
maximum tolerated dose.
● Tell your doctor if you have problems of
fructose intolerance. Your doctor will not
prescribe Roaccutane if you have intolerance to
fructose or sorbitol.
● Roaccutane 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 alcoholic.
● Your skin is likely to get dry. Use a skin
moisturising ointment or cream and a lip balm
during treatment. To prevent skin irritation you
should avoid using exfoliating or anti-acne
products.
● Avoid too much sun and do not use a sunlamp or sun-bed. Your skin may become more
sensitive to sunlight. Before you go out in the
sun, use a sun-protection product with a high
protection factor (SPF 15 or higher).
● Don’t have any cosmetic skin treatments.
Roaccutane may make your skin more fragile.
Don’t have any waxing (hair removal),
dermabrasion or laser treatments (removing
horny skin or scars) during treatment, or for at
least 6 months after treatment. They could cause
scarring, skin irritation, or rarely, changes in the
colour of your skin.
● You must remember not to share your
medication with anyone else. You should
return unused capsules at the end of your
treatment. Talk to you doctor or pharmacist
regarding where to return
the capsules.
● Do not donate blood
while you are taking
Roaccutane or for one
month afterwards. If
someone who is pregnant
is given your blood, the baby may be born with
birth defects.
Children and adolescents
The use of Roaccutane 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 Roaccutane
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines including herbal and non-prescription
products.
● Do not take vitamin A supplements or
tetracyclines (a type of antibiotic), or use any
skin treatments for acne while you are on
Roaccutane. It is fine to use moisturisers and
emollients (skin creams or preparations that
prevent water loss and have a softening effect on
the skin).
● Avoid the use of topical keratolytic or
exfoliative anti-acne agents while you are on
Roaccutane.
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 medicine.
Pregnancy
Roaccutane must not be used during pregnancy. If
you are able to get pregnant, you should use
effective contraception during and up to one month
after Roaccutane treatment.
If you do get pregnant while taking Roaccutane,
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, Roaccutane is likely to
damage an unborn baby (in medical language it is
teratogenic). It also increases the risk of
miscarriage.
Roaccutane can cause serious abnormalities of
brain, face, ear, eye, heart and some glands
(called the thymus gland and parathyroid gland)
of the unborn baby.
Breast-feeding
You must not take Roaccutane if you are
breastfeeding. The medicine is likely to pass into
your breast milk and may harm your baby.
Driving and using machines
You may not see as well at night during your
treatment. This can happen suddenly. In rare cases
this has continued after the treatment has stopped.
Drowsiness and dizziness have been reported very
rarely. If this happens to you, you should not drive
or operate machinery.
Roaccutane contains
● Soya-bean oil. If you are allergic to peanut or
soya, do not take this medicinal product.
● Sorbitol. If you have been told by your doctor
that you have an intolerance to some sugars,
contact your doctor before taking this medicine.

3. How to take Roaccutane
Always take Roaccutane exactly as your doctor has
told you. Check with your doctor or pharmacist if
you are not sure.
The usual starting dose is 0.5 mg per kilogram
body weight per day (0.5 mg/kg/day). So if you
weigh 60 kg, your dose will usually start at 30 mg a
day.
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148x594 mm

Folding Format:

148x297 mm

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Date

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Take the capsules once or twice daily.
Take on a full stomach. Swallow them whole, with
a drink or a mouthful of food.
After a few weeks your doctor may adjust your
dose. This depends 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. If you think that
Roaccutane is 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 course of treatment usually lasts for 16 to
24 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.
Some people find their acne gets worse during the
first weeks of treatment. It usually improves as
treatment goes on.
If you take more Roaccutane capsules than you
should
If you take too many capsules or someone else
accidentally takes your medicine, contact your
doctor, pharmacist or nearest hospital immediately.
If you forget to take a dose
If you miss a dose take it as soon as you can.
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 (two doses close together).

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them. The
effects often wear off, or stop when treatment is
stopped. Others can be serious and you must
immediately contact your doctor.
Side effects requiring immediate medical
attention:
Skin problems
Frequency not known (frequency cannot be
estimated from available data)
● 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).
If you develop a serious rash or these skin
symptoms, stop taking Roaccutane and contact
your doctor immediately.
Mental problems
Rare effects (may affect up to 1 in every
1000 people)
● 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.
Very rare effects (may affect
up to 1 in every 10,000 people)
● 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 depressed.
● Unusual behaviour.
● Signs of psychosis: a loss of contact with reality,
such as hearing voices or seeing things that are
not there.
Contact your doctor straight away if you get
signs of any of these mental problems. Your
doctor may tell you to stop taking Roaccutane.
That may not be enough to stop the effects: you
may need more help, and your doctor can arrange
this.
Allergic reactions
Rare effects (may affect up to 1 in every
1000 people)
● Serious (anaphylactic) reactions: difficulty
breathing or swallowing caused by sudden
swelling of the throat, face, lips and mouth.
Also sudden swelling of the hands, feet and
ankles.
Very rare effects (may affect up to 1 in every
10,000 people)
● Sudden tight chest, shortness of breath and
wheezing, particularly if you have asthma.
If you have a serious reaction, get emergency
medical help immediately.
If you have any allergic reaction, stop taking
Roaccutane and contact your doctor.
Bones and muscles
Frequency not known (frequency cannot be
estimated from available data)
● Muscle weakness which can be potentially
life-threatening, 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 Roaccutane.

Other side effects:
Very common side effects with Roaccutane:
(may affect more than 1 in 10 people)
● Dryness of the skin, especially of the lips and
face; inflamed skin, chapped and inflamed lips,
rash, mild itching and slight peeling. Use a
moisturising cream from the start of treatment.
● Skin becomes more fragile and redder than
usual, especially the face.
● Back pain; muscle pain; joint pain particularly in
children and teenagers. To avoid making any
bone or muscle problems worse, cut down on
intensive physical activity while you’re on
Roaccutane.
● Inflammation of the eye (conjunctivitis) and
eyelid area; eyes feel dry and irritated. Ask a
pharmacist for suitable eye drops. If you get dry
eyes and wear contact lenses, you may need to
wear glasses instead.
● Raised liver enzymes seen in blood tests.
● Changed levels of fats in the blood (including
HDL or triglycerides).
● Bruising, bleeding or clotting more easily ‑ if
clotting cells are affected.
● Anaemia – weakness, dizziness, pale skin – if
red blood cells are affected.
Common side effects with Roaccutane: (may
affect up to 1 in 10 people)
● Headache.
● Higher levels of cholesterol in the blood.
● Protein or blood in the urine.
● More liable to get infections if the white blood
cells are affected.
● Inside of the nose becomes dry and crusted,
causing mild nosebleeds.
● Sore or inflamed throat and nose
● Allergic reactions such as rash, itchiness.
If you have any allergic reaction, stop taking
Roaccutane and contact your doctor.
Rare side effects with Roaccutane: (may affect up
to 1 in 1,000 people)
● Hair loss (alopecia). This is usually only
temporary. Your hair should return to normal
after the treatment ends.
Very rare side effects with Roaccutane: (may
affect up to 1 in 10,000 people)
● You may see less well at night; colour blindness
and colour vision gets worse.
● Sensitivity to light may increase; you may find
that you need to wear sunglasses to protect your
eyes from too bright sunlight.
● Other sight problems including blurred vision,
distorted vision, cloudy surface on the eye
(corneal opacity, cataracts).
● Excessive thirst; frequent need to urinate; blood
tests show an increase in your blood sugar.
These can all be signs of diabetes.
● Acne can get worse in the first few weeks, but
symptoms should improve with time.
● Skin inflamed, swollen, and darker than usual,
especially on the face.
● Excess sweating or itching.
● Arthritis; bone disorders (delayed growth, extra
growth and changes to 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.
● Increased sensitivity to light.
● Bacterial infections at the base of the nail,
changes to nails.
● Swellings, discharging, pus.
● Thickened scarring after surgery.
● Increased body hair.
● Convulsions, drowsiness, dizziness.
● Lymph glands may become swollen.
● Dry throat, hoarseness.
● Hearing difficulties.
● Generally feeling unwell.
● High levels of uric acid in the blood.
● Bacterial infections.
● Inflammation of the blood vessels (sometimes
with bruising, red patches).
Unknown frequency: (frequency cannot be
estimated from the available data)
● Dark or cola-coloured urine
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 at 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 Roaccutane
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
(EXP) stated on the pack and blister.
Do not store above 25 °C.
Store in the original package and keep blister in the
outer carton in order to protect from moisture and
light.
Return left over capsules to your pharmacist.
Only keep them if your doctor tells you to.

6. Contents of the pack and other
information
What Roaccutane contains:
● The active substance in Roaccutane is isotretinoin.
● The other ingredients are refined soya-bean oil,
hydrogenated soya-bean oil, partially
hydrogenated soya-bean oil, yellow beeswax,
gelatin, glycerol, sorbitol (see section 2),
mannitol, hydrogenated hydrolysed starch,
titanium dioxide (E171), red iron oxide (E172),
printing ink containing shellac, black iron oxide
(E172) and propylene glycol.
What Roaccutane looks like and contents of the
pack:
Roaccutane comes in soft capsules containing either
10 mg or 20 mg isotretinoin.
The 10 mg capsules are oval, opaque, coloured
brown-red and marked ROA 10.
The 20 mg capsules are oval, opaque, coloured
brown-red and white and marked ROA 20.

Liver and kidney problems
Very rare effects (may affect up to 1 in every
10,000 people)
● Yellow skin or eyes, and feeling tired. These can
be signs of hepatitis. Stop taking Roaccutane
straight away and contact your doctor.

The capsules come in blister packs of 20, 30, 50 or
100 capsules.

● Difficulty urinating (passing water), swollen and
puffy eyelids, feeling excessively tired. These
may be signs of kidney inflammation.
Stop taking Roaccutane straight away and
contact your doctor.

Marketing Authorisation Holder
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City, AL7 1TW
United Kingdom

Nervous system problems
Very rare effects (may affect up to 1 in every
10,000 people)
● Lasting headache, along with feeling sick
(nausea), being sick (vomiting) and change in
your eyesight including blurred vision. These
may be signs of benign intracranial hypertension,
especially if Roaccutane is taken with antibiotics
called tetracycline.
Stop taking Roaccutane straight away and
contact your doctor.
Gut and stomach problems
Very rare effects (may affect up to 1 in every
10,000 people)
● 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.
Stop taking Roaccutane straight away and
contact your doctor.
Eye disorders
Very rare effects (may affect up to 1 in every
10,000 people)
● Blurred vision.
If you get blurred vision, stop taking Roaccutane
straight away and contact your doctor. If your
sight is affected in any other way tell a doctor as
soon as you can.
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Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:

Manufacturer
Roche Pharma AG
Emil-Barell-Str. 1
D-79639 Grenzach-Wyhlen
Germany
This medicinal product is authorised in the Member
States of the EEA under the following names:
Belgium, Estonia, Ireland, Latvia, Lithuania,
Luxembourg, The Netherlands, Slovakia, Slovenia,
United Kingdom: Roaccutane
Finland, Hungary: Roaccutan
This leaflet was last revised in June 2015
Other sources of information
Detailed information on this medicine is available
on the web site of the member state.
United Kingdom
The Medicines and Healthcare Products Regulatory
Agency (www.mhra.gov.uk)

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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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