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ISOTRETINOIN 20 MG SOFT CAPSULES

Active substance(s): ISOTRETINOIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

IsotretInoIn
5 mg, 10 mg, 20 mg, 40 mg
soft capsules

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.

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have 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.

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.

(isotretinoin)

What is in this leaflet:
1. What Isotretinoin is and what it is used for.
2. What you need to know before
you take Isotretinoin.
3. How to take Isotretinoin.
4. Possible side effects.
5. How to store Isotretinoin.
6. Contents of the pack and other 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 or under the
supervision of a dermatologist (a doctor who has
specialised in the treatment of severe acne and
skin problems).
2. What you need to knoW 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' below)
• 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.
Please tell your doctor if any of the above statements
apply to you.
Warnings and precautions
talk to your doctor or pharmacist before taking this
medicine 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.
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.
you should take the following precautions while
taking this medicine (see also section 4, Possible
Side Effects):
• Avoid exposure to the sun as much as possible, and
do not use sun lamps or UV beds at all. 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.
Important advice for Women
Pregnancy and breast‑feeding:
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.

advice for Men:
• 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.
• You must remember not to share your medication
with anyone, particularly not women.
advice for all patients:
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.
other medicines and Isotretinoin
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
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.
this medicine contains soya‑bean oil
Do not take this medicine if you are allergic to
peanuts or soya.
3. hoW to take IsotRetInoIn
Always take this medicine exactly as your doctor has
told you. 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 recommended 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.
You may find your acne gets worse during the first
weeks of treatment, but this usually improves as
treatment goes on.
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 gets them.
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.
The following are serious side effects occurring with
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 Isotretinoin and contact your
doctor immediately.
the other possible side effects are:
Very common (may affect more than 1 in 10 people):
• 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 (may affect up to 1 in 10 people):
• 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 (may affect up to 1 in 1,000 people):
• hair loss (your hair should become normal again
when treatment is over)
• allergic skin reactions causing rash, itching,
and swelling.
Very rare (may affect up to 1 in 10,000 people):
• 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
• increase 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 at the face
• increased sensitivity to the sun during treatment
• excessive sweating
• bacterial infections
• 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 cloudy surface of the eye (cataracts)
• irritation while wearing contact lenses
• abnormal sensitivity of light. You may need
sunglasses to protect your eyes from being dazzled.
• inflammation of blood vessels (sometimes with
bruising, red patches)
• dizziness, drowsiness
• 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.
• calcium deposits in soft tissue
• inflammation of the pancreas.
If you experience pain in your joints or muscles,
reduce the amount of physical activity and exercise
you do during your treatment. If the pain gets more
severe or you get unexplained muscle tenderness,
weakness or cramps, please consult your doctor
because in very rare cases, these muscle problems can
be serious (rhabdomyolysis).
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.
Also you can help to make sure that medicines
remain as safe as possible by reporting any
unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard. Alternatively you
can call Freephone 0808 100 3352 (available from
10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper
form available from your local pharmacy.
5. hoW to stoRe IsotRetInoIn
keep this medicine out of the sight and reach
of children.
do not use this medicine after the expiry date stated
on the box 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.
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.
6. Contents of the PaCk and
otheR InfoRMatIon
What Isotretinoin 5 mg, 10 mg, 20 mg, 40 mg
soft Capsule contains
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 and 40 mg
soft Capsule looks 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 oval 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 oval
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 oval capsule
is printed on one side in black ink with the logo 'I 20'.
Each Isotretinoin 40 mg Soft Capsule, has an opaque
orange/brown gelatin shell, with a bright yellow/
orange fill. The oval capsule is printed on one side in
black ink with the logo 'I 40'.
This medicine is available in pack sizes of 30, 50
or 100 capsules. Not all pack sizes may be marketed.
Marketing authorisation holder and Manufacturer
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 revised in 04/2013.

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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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