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ISOTRETINOIN 40MG SOFT CAPSULES

Active substance(s): ISOTRETINOIN

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Customer: Mylan

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Product: Isotretinoin Capsules 5, 10, 20 & 40 mg x 30
Code: ITEM CODE

Pharma: n/a

Dimensions: 200 x 596 mm
Proof # & Date: 2 1/06/10
PL: 045369/0723-0726

AWCC: n/a

Packed @: Catalent

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Supersedes: 10002619

Initial Revision: Warning text addition
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Mylan Design Department,
Albany Gate, Darkes Lane,
Potters Bar, Herts, EN6 1AG

PACKAGE LEAFLET: INFORMATION FOR THE USER

ISOTRETINOIN 5, 10, 20 &
40 mg SOFT CAPSULES
(isotretinoin)

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 further questions, please ask your
doctor or your pharmacist.
• This medicine has been prescribed for you
personally and you should 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 becomes serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Isotretinoin is and what it is used for.
2. Before you take Isotretinoin.
3. How to take Isotretinoin.
4. Possible side effects.
5. How to store Isotretinoin.
6. Further information.
1. WHAT ISOTRETINOIN IS AND WHAT IT IS USED
FOR
These capsules contain isotretinoin, which is a
medicine related to vitamin A. Isotretinoin is used
to treat severe types of acne that can cause
permanent scarring, which has not improved after
other anti-acne treatments. Isotretinoin can only
be prescribed by a doctor who has specialised in
the treatment of severe acne.
2. BEFORE YOU TAKE ISOTRETINOIN
Do not take Isotretinoin - if you:
• are pregnant, think you may be pregnant or are
planning a pregnancy
• are of a child-bearing age and you are not
following the Pregnancy Prevention Plan (see
box 'Pregnancy and breast-feeding, important'
opposite)
• are breast-feeding
• are allergic (hypersensitive) to isotretinoin, or
allergic to peanuts or soya (Isotretinoin contains
soya oil) or any of the other capsule ingredients
• are taking certain antibiotics called tetracyclines
• are younger than 12 years of age
• have a severe liver disease
• have a high level of vitamin A in your body
• have a high level of cholesterol or triglycerides
in your blood.

Pregnancy and breast-feeding, important:
Isotretinoin may cause serious damage
(malformations, such as a large head or no ears)
to your unborn child if you become pregnant
during treatment or during the 5 weeks after the
end of treatment. This drug may also cause a
miscarriage.
You must not take Isotretinoin if:
• you are pregnant or if you intend to be
pregnant during your treatment or up to
5 weeks after treatment ends
• you are breast-feeding. The medicine is likely
to pass into your milk and may harm your baby.
Before starting treatment women of
child-bearing age must discuss and agree to
the following points with the doctor:
• you have understood why you must not
become pregnant
• you have received a pregnancy prevention
brochure
• you have agreed to use at least one effective
method of contraception, and preferably two,
including a barrier method (condom or cap):
* at least 1 month before starting treatment
* during ongoing treatment
* for 5 weeks after treatment ends.
• you must use contraception even if you are not
sexually active or if you do not have menstrual
periods
• you understand and agree the need for monthly
follow-up visits and for medically supervised
pregnancy tests
* 1 month before starting treatment. The test is
conducted during the first 3 days of the
menstrual cycle (period)
* each month during the treatment
* 5 weeks after stopping it.
The result of each test must be negative: You
must not become pregnant at any time during
treatment or up to 5 weeks following the end of
treatment.
• you must sign (yourself or the adult responsible
for you) a consent form concerning treatment
and contraception, confirming that:
* you have been informed of the risks associated
with Isotretinoin treatment
* you agree to comply with the Pregnancy
Prevention Plan.
Information for male patients - Isotretinoin
treatment does not damage sperm. Isotretinoin
and its metabolites are present in very low levels
in your sperm. These levels are too low to harm
the unborn baby of your female partner.

Please tell your doctor if any of the above
statements apply to you.

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

Take special care with Isotretinoin - tell your
doctor if:
• you have or have had depression or other
mental health problems including previous
experience of suicidal behaviour
• you have problems with your kidneys or your
liver
• you are overweight
• you regularly drink a lot of alcohol
• you have diabetes, check your blood glucose
levels more closely throughout the period of
treatment
• you experience dryness of the skin or lips - you
can apply moisturising ointments or creams to
your skin and use a lip balm to reduce this effect
• your acne suddenly gets much worse - this
usually occurs within 7 to 10 days, and usually
does not require dose adjustment
• you are allergic to peanuts or soya.

Do not donate blood - Do not donate blood
during treatment and for 5 weeks after the end of
treatment. If a pregnant woman were to receive
your blood, her baby could be seriously damaged.

Before, during and after treatment you will have
regular blood tests to check that there are no
changes to your kidneys, liver, cholesterol and
blood sugar levels. If there are changes, your
doctor may decide to reduce the dose or stop
treatment.
Avoid exposure to the sun as much as possible
and do not use sun lamps and UV beds. If exposure
to the sun is unavoidable, use a sunscreen of at
least SPF 15. Reduce the amount of intensive
physical exercise as pain in your joints or muscles
may sometimes occur as part of your treatment.
You may find that your skin has become dry and
fragile. Avoid the use of cosmetic skin treatments,
for example do not apply anything that irritates
the skin, like peeling cream.
Avoid wax depilation and cosmetic procedures
designed to smooth your skin or to reduce scars
or aging signs (for example dermabrasion or laser
therapy) for at least 6 months after the end of
treatment. These procedures may cause skin
scarring, colour changes or peeling of the skin.
Your eyes may become sensitive and dry
throughout the treatment. Wear glasses rather
than contact lenses. You may need to wear
sunglasses to protect your eyes from being
dazzled.

Taking other medicines - Please tell your doctor
or your pharmacist if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.
It is very important to tell your doctor if you are
taking any medicine containing vitamin A.
Driving and using machines - Be careful when
driving or using machines at night because this
treatment may affect your night vision. This can
happen suddenly. It rarely continues once
treatment has ended.
Important information about some ingredients
of Isotretinoin - This drug contains soya-bean oil.
Do not take this medicine if you are allergic to
peanuts or soya.
3. HOW TO TAKE ISOTRETINOIN
Always take Isotretinoin as your doctor has told
you. You should check with your doctor or your
pharmacist if you are not sure. Your dosage is
calculated individually based on your body
weight and may be adjusted by your doctor
during treatment.
The usual starting dose is 0.5 mg/kg per day,
however your doctor will determine your
individual requirements.
The capsules should be taken once or twice a day
with food. Swallow the capsules whole without
chewing or sucking them.
Normally treatment lasts from 16 to 24 weeks.
You should always complete your course of
treatment. Your skin may continue to improve for
up to 8 weeks after the end of treatment. Most
patients only need one course of treatment.
Your doctor will review your dose after a few
weeks of treatment to determine if an
adjustment is required. Doses are usually within
the range of 0.5 - 1.0 mg/kg per day. If you have
problems with your kidneys then your doctor will
give you a lower dose.

If your doctor wishes you to have further
treatment, you should wait for a period of 8 weeks
before beginning a new course of treatment.
If you are not able to tolerate the recommended
dose, your doctor will reduce the dose you receive
and your treatment will last longer.
If you take more Isotretinoin than you should If you have taken more capsules than you should,
you may suffer from excessively high levels of
vitamin A. The signs and symptoms include
intense headaches, nausea or vomiting,
sleepiness, irritability and itching. Contact your
doctor, your pharmacist or the nearest hospital
as soon as possible. Take the container and any
remaining capsules with you.
If you forget to take Isotretinoin - Skip the
missed dose and take the next dose as normal.
Do not take a double dose to make up for the
forgotten dose.
If you have any further questions on the use of
this product, ask your doctor or your pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Isotretinoin can cause side
effects, although not everybody experiences these.
These are rare but serious side effects. If any of
the following happen, stop taking Isotretinoin
and tell your doctor or seek medical advice
immediately:
• depression or worsening of depression (sadness,
anxiety, becoming easily angered, aggression,
irritability, loss of concentration, sleeping too
much or too little, changes in weight or appetite,
changes in mood or abnormal behaviour)
• thinking about harming yourself or thinking
about committing suicide
• any other side effect related to your mental
health (such as hearing voices or seeing things
that are not there)
• persistent headache with nausea, vomiting or
visual disorders, drowsiness. This may occur
commonly with certain antibiotics (tetracyclines)
• violent pain in the abdomen, with or without
bloody diarrhoea, nausea and vomiting
• blurred vision or if you experience any difficulty
in seeing
• severe allergic reaction (anaphylaxis) causing
difficulty breathing, dizziness, collapse, shock,
severe itching and/or swelling
• serious skin rash (erythema multiforme)
appearing initially as circular patches often with
a central blister usually on arms and hands or
legs and feet but can affect any part of the body.
The other possible side effects are:
Very common (more than 1 in 10 patients):
• dry or chapped skin, particularly on the face and
lips
• red and fragile skin, rash or mild itching or mild
shedding of skin or a combination of these
symptoms
• dryness of the eyes, redness or dried crusts
• eye irritation or conjunctivitis - causing itching
and redness
• swelling of the eyelids
• back, muscle or joint pains
• you may bruise or bleed more easily
• change in liver function, which will be detected
by blood tests given by your doctor
• looking pale, feeling unusually tired
• your blood tests show a decrease in high density
lipoproteins (linked to cholesterol levels) or an
increase of blood triglycerides.
Common (less than 1 in 10 patients):
• headaches
• nasal dryness, nosebleeds
• symptoms of colds and flu, e.g. sore throat, runny
nose, nasal congestion, sneezing and cough
• increased levels of blood glucose with thirst and
increased urination
• increased levels of cholesterol (except HDL)
• presence of proteins or blood in the urine
• change in the number of white blood cells that
can make you more prone to developing an
infection.
Rare (less than 1 in 1,000 patients):
• hair loss (your hair should become normal again
when treatment is over)
• allergic skin reactions causing rash, itching and
swelling.
Very rare (less than 1 in 10,000 patients):
• sudden chest tightness and possible difficulty
breathing (bronchospasm), particularly in
patients with asthma
• dry throat which may cause hoarseness
• slight hearing loss
• inflammation of the kidneys - difficulty urinating
or even inability to urinate together with swollen
eyelids and severe tiredness
• increased levels of blood sugar
• high levels of uric acid in the blood
• increased levels of blood creatine phosphokinase
• dark urine, pale stools, yellowing of the eyes
and the skin, nausea, fever and severe tiredness
(Hepatitis)

• swelling of lymph glands
• your acne may get worse at the beginning of
treatment. However, this should improve as
you continue treatment
• increased skin pigmentation
• skin inflamed, swollen and darker than usual,
especially on the face
• increased sensitivity to the sun during
treatment
• excessive sweating
• bacterial infections at the base of the nails,
with swelling, redness or a discharge of pus
• nail changes
• increased body hair
• changes in the texture of your hair, thickening
of the hair. Your hair should become normal
again when treatment is over
• poor night vision. This can happen quite
suddenly
• changes in colour vision
• intense eye irritation, swelling of the cornea
(keratitis) and cataracts
• irritation while wearing contact lenses
• abnormal sensitivity to light. You may need
sunglasses to protect your eyes from being
dazzled
• redness, pain, swelling of blood vessels
• convulsions or seizures
• diabetes (causing increased level of blood
glucose with thirst and increased urination)
• blurred vision, difficulty seeing, headaches and
even a loss of vision
• severe acne
• a rash or abnormal reddening on the face
• widespread rash
• small, dull, red skin growths in the mouth and
nose
• arthritis, bone changes (for example, delayed
growth, changes to bone density, abnormal
bone growths)
• swelling of tendons and ligaments. Symptoms
include stiffness, swelling, ache, pain of the
joint.
If you experience pain in your joints or muscles,
reduce the amount of physical activity and
exercise you do during your treatment.
If any of the side effects gets serious, or if you
notice any side effect not listed in this leaflet,
please tell your doctor or pharmacist.
5. HOW TO STORE ISOTRETINOIN
Keep out of the reach and sight of children.
Do not use after the expiry date stated on the
box. This is given after the letters 'EXP'. The expiry
date refers to the last day of that month. Do not
store above 25°C. Store in the original packaging.
When you have finished your treatment, you
must return all the remaining capsules to your
pharmacist. Do not dispose yourself via
wastewater or household waste. These measures
will help to protect the environment.
6. FURTHER INFORMATION
What Isotretinoin 5 mg, 10 mg, 20 mg, 40 mg
soft capsules contain - The active substance is:
For a soft capsule of 5 mg: isotretinoin 5 mg
For a soft capsule of 10 mg: isotretinoin 10 mg
For a soft capsule of 20 mg: isotretinoin 20 mg
For a soft capsule of 40 mg: isotretinoin 40 mg.
The other ingredients are: soya-bean oil,
hydrogenated vegetable oil and beeswax yellow.
Composition of the capsule shell of 5 mg, 20 mg
and 40 mg: gelatin, glycerol, purified water, red
iron oxide (E172), yellow iron oxide (E172) and
titanium dioxide (E171).
Composition of the capsule shell of 10 mg:
gelatin, glycerol, purified water and red iron
oxide (E172).
What Isotretinoin 5 mg, 10 mg, 20 mg, 40 mg soft
capsules look like and contents of the pack Each Isotretinoin 5 mg soft capsule has a
bi-coloured opaque red/brown and cream
gelatin shell, with a bright yellow/orange fill. The
capsule is printed on one side in black ink with
the logo '5'.
Each Isotretinoin 10 mg soft capsule has a
red/brown gelatin shell, with a bright
yellow/orange fill. The capsule is printed on one
side in black ink with the logo 'I 10'.
Each Isotretinoin 20 mg soft capsule has a
bi-coloured opaque red/brown and cream
gelatin shell, with a bright yellow/orange fill. The
capsule is printed on one side in black ink with
the logo 'I 20'.
Each Isotretinoin 40 mg soft capsule has an
orange/brown opaque gelatin shell, with a bright
yellow/orange fill. The capsule is printed on one
side in black ink with the logo 'I 40'.
There are 30 capsules in each box.
Marketing Authorisation Holder: Mylan, Potters
Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturer: Catalent France Beinheim S.A.,
74 rue Principale, 67930 Beinheim, France.

This leaflet was last approved in: 10/2010

286355 10002619

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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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