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ISOTRETINOIN 10MG SOFT CAPSULES

Active substance(s): ISOTRETINOIN / ISOTRETINOIN / ISOTRETINOIN

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Package leaflet: Information for the patient

Isotretinoin
5 mg, 10 mg, 20 mg, 40 mg
soft capsules
(isotretinoin)

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. See section 4.
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
Isotretinoin Soft Capsules contain isotretinoin:
• Isotretinoin is related to vitamin A.
• It belongs to a group of medicines called ‘retinoids’.
Isotretinoin is used to treat severe types of acne:
• This is acne that can cause scars which do not go away
• These types of acne are also called ‘nodular’ or
‘conglobate’ acne.
Isotretinoin is used when your acne has not got better
with any other treatments. This includes antibiotics and
skin treatments.
Your treatment must be supervised by a specialist doctor
– called a ‘dermatologist’. This is a doctor who specialises in
treating skin problems.

2. What you need to know before you take
Isotretinoin
Do not take Isotretinoin - if:
• You are allergic to peanut or soya or any other ingredient
of Isotretinoin. This medicine contains soya oil, as well as
isotretinoin. See section 6 (Further information) at the end
of this leaflet for a full list of ingredients.
• You are pregnant or think you may be pregnant
• You are breast-feeding
• You have been diagnosed with liver problems
• You have been diagnosed with very high levels of blood
fats (such as high cholesterol or triglycerides)
• You have been diagnosed with very high levels of
vitamin A in your body (called ‘hypervitaminosis A’)
• If you are receiving treatment with tetracyclines (a type
of antibiotic) at the same time (see “Other medicines
and Isotretinoin”)
If any of these apply to you, go back to your doctor and
do not take any of this medicine. Talk to your doctor first,
before you take it.
Use in young people over 12:
• Do not give to children under 12. Only give to young
people over 12 years of age if they have finished all the
changes of puberty.
Special precautions with Isotretinoin
Do not take this medicine when you are pregnant.
Women who are pregnant must not take Isotretinoin
This medicine is likely to seriously damage an unborn
baby (in medical language it is ‘teratogenic’). It also makes
a miscarriage more likely:
• You must not take Isotretinoin when you are pregnant.
• You must not take Isotretinoin 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 in the month after stopping the treatment
when some of the medicine may still be left in your body.
Women who could get pregnant are only prescribed
Isotretinoin under strict rules. This is because of the
risk of serious damage to the unborn baby
These are the rules:
• Your doctor must have explained the risk of damage
to the unborn baby - you must understand why you
must not get pregnant and what you need to do to stop
getting pregnant.
• You must have talked about contraception (birth
control) with your doctor. They will give you information
how not to get pregnant. They may send you to a
specialist for contraceptive advice.
• Before you start treatment your doctor will ask you to
take a pregnancy test, which must be negative.
Women must use effective contraception while
taking Isotretinoin:
• You must agree to use one or preferably two effective
methods of contraception – one will probably be a pill,
together with a condom or a cap plus spermicide.
• You must use contraception for a month before taking
Isotretinoin, during treatment and for a month afterwards.
• You must use contraception even if you do not have
periods or are not currently having sex (unless your
doctor decides this is not necessary).
• You must agree to follow up visits every month and
more pregnancy tests if you doctor asks you.
• You will also have a pregnancy test 5 weeks after
stopping Isotretinoin. You must not get pregnant during
treatment or for a month afterwards because some of
the medicine may still be in your body.
• Your doctor may ask you (or a parent/guardian) to sign a
form. This form confirms that you have been told about
the risks, and that you will follow the rules above.

* It also includes thoughts about hurting yourself or
ending your life.
Also tell your doctor if you take medicines for any of these
illnesses. This is because your mood may be affected while
taking isotretinoin.
Isotretinoin often increases blood fats, such as cholesterol
or triglycerides. Your doctor will do blood tests before,
during and after isotretinoin 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, are
over-weight, or if you have problems with drinking too
much alcohol. You may need blood tests more often. If your
blood fats stay high, your doctor may lower your dose, or
take you off this medicine:
• Isotretinoin may affect your liver
Your doctor will do blood tests before, during and after
isotretinoin treatment to check how your liver is working.
If your liver function is affected, your doctor may lower
your dose or take you off isotretinoin.
• Isotretinoin may increase blood sugar levels. In rare
cases, people become diabetic. Your doctor may check
blood sugar levels during treatment. This is particularly if
you already have diabetes, are over-weight, or if you have
problems with drinking too much alcohol.
• Your skin is likely to get dry - use a moisturiser and lip
balm. To prevent skin irritation it is best not to use things
called ‘exfoliators’ or other anti-acne products.
• Severe Skin reactions (e.g. erythema multiforme (EM),
Stevens-Johnson syndrome (SJS) and toxic epidermal
necrolysis (TEN)) have been reported with the use of this
medicine. 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, this medicine may cause severe allergic
reactions some of which can affect skin in the form of
eczema, hives (lumpy rash) and bruises or red patches on
arms and legs. If you develop an allergic reaction, stop
taking this medicine, seek urgent advice from a doctor
and tell him that you are taking this medicine.
• Keep out of the sun - and do not use a sun-lamp
or sun-bed. Your skin may become more sensitive
to sunlight. Before you go out in the sun, use a sunprotection product with a high protection factor (SPF
50 or higher).
• Do not have any cosmetic skin treatments. Isotretinoin
may make your skin more fragile. Do not 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.
• Isotretinoin has been associated with inflammatory
bowel disease. Your doctor will take you off isotretinoin if
you have severe bloody diarrhoea without any history of
gastrointestinal disorders.
• Isotretinoin 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 isotretinoin.
• Benign intracranial hypertension has been reported
with Isotretinoin and in some cases where isotretinoin
was used together with tetracyclines (a type of antibiotic).
Stop taking Isotretinoin 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).
• Cut down on hard exercise and physical activity.
Isotretinoin can cause muscle and joint pain particularly
in young people.
• Do not take vitamin A supplements while taking this
medicine. Taking both together may increase the risk of
side effects.
• Tell your doctor if you have any kidney problems. Your
doctor may start you on a lower dose of isotretinoin and
then increase it to the maximum tolerated dose.
• Do not donate blood while you are taking isotretinoin or
for one month afterwards. If someone who is pregnant is
given your blood, the unborn baby may be damaged
• 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.
Driving and using machines
You may experience problems with your eyes and not see
as well during your treatment. This can happen suddenly. In
rare cases, night vision problems have continued after the
treatment has stopped.
Drowsiness and dizziness have been reported very rarely.
If this happens to you, you should not drive, ride a bike or
operate machinery.
Taking other medicines
Do not take any vitamin A supplements or tetracyclines
(a type of antibiotic), or use any other treatment for acne
that will make your skin dry out or peel while you are
taking Isotretinoin.
It is fine to use moisturisers and emollients (skin creams or
preparations that prevent water loss and have a softening
effect on the skin).
Tell your doctor or pharmacist if you are taking any other
medicines – including herbal and non-prescription
products (including multi-vitamin supplements) and
anything else you put on your skin – or if you have taken
any recently.
Isotretinoin Soft Capsules contain
Soya-bean oil. If you are allergic to peanuts or soya, do
not take this medicinal product.

3. How to take Isotretinoin
Always take isotretinoin exactly as your doctor has told
you. Check with your doctor or your pharmacist if you are
not sure.

If you do get pregnant while taking Isotretinoin, or in
the month after treatment has stopped, stop taking the
medicine straight away, and contact your doctor. He or
she may send you to a specialist for advice.

The usual starting dose is 0.5 mg per kilogram (kg) of body
weight per day (0.5 mg/kg / day). So, if you weigh 60 kg,
your dose will usually start at 30 mg per day.

Your doctor will show you written information on
pregnancy and contraception. If you have not seen this
information, ask your doctor.

Take the capsules once or twice daily.
Take them during or after a meal. Swallow them whole,
with a drink or a mouthful of food.

Prescriptions for women who could get pregnant are
only for a month at a time. A new prescription is needed
for more treatment. You have to take the prescription to
the pharmacist/chemist within 7 days – if it is later, the
chemist cannot give you the medicine.

After a few weeks your doctor may adjust your dose. This
depends on how you are getting on with your medicine.
For most people the dose will be between 0.5 and 1 mg per
kg of body weight per day. If you think that your medicine
is too strong or too weak, talk to your doctor or pharmacist.

Advice for men
Isotretinoin does not appear to damage sperm. Very low
levels of isotretinoin are present in the semen of men taking
Isotretinoin. But this is too little to harm the unborn baby
of your partner. However, you must remember not to share
your medication with anyone - particularly not women.

If you have severe kidney problems, you will usually start
on a lower dose (such as 10 mg per day) which will be
increased up to the highest dose that your body can take.
If your body cannot take the recommended dose, you may
be prescribed a lower dose. That may mean that you are
treated for a longer time and your acne might be more
likely to come back.

Advice for all patients:
• Tell your doctor if you have ever had any mental
health problems
* This includes depression and serious mental health
problems called ‘psychosis’

Description Isotretinoin_40mg_5mg_10mg_20mg_30
Component Type Leaflet
Affiliate Item Code 1068490
Superceded Affiliate Item Code 693526/790715
TrackWise PR No. 1068490
MA No.
Packing Site/Printer

PL 04569/1343,
1344,1345,1346
Catalant Germany Schorndorf
GmbH (Schorndorf - DE)

Supplier Code PCD443053

A course of treatment usually lasts for 4 to 6 months.
Most people only need one course. Your acne may continue
to improve for up to 8 weeks after treatment. Usually you
will not start another course until then.

Date: 05 Jan 17

Pharma Code TBC

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Some people find their acne gets worse during the first
weeks of treatment. Usually it improves as treatment
goes on.
If you take more Isotretinoin capsules than you should
If you take too many capsules or someone else accidently
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 two doses at the same time.

4. Possible side effects
This medicine can have side effects, although not
everybody gets them. These effects often wear off, or will
stop when your treatment is stopped. Your doctor can help
you to deal with them.
Stop taking this medicine and contact your doctor
straight away if you get signs of any of the following side
effects. That may not be enough to stop the side effects.
You may need more help, which your doctor can arrange
for you.
Mental health problems
You may not notice some of these changes in your mood
and behaviour and so it is very important that you tell your
friends and family that you are taking this medicine. They
may notice these changes and help you quickly identify any
problems that you need to talk to your doctor about.
Rare effects (may affect up to 1 in every 1,000 people):
• Depression or related mental health problems. 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.
Rash and other skin symptoms
Unknown frequency:
• This medicine can cause serious skin rashes, which can be
life-threatening, and you will need emergency medical
help. They often start as circular patches on your arms,
hands, legs or feet, and may have blisters in them. More
severe rashes may appear as blisters on your chest and
back. You may get other symptoms with it like an eye
infection (conjunctivitis), or ulcers in your mouth, throat
or nose.
• If a large area of skin starts to peel, this is a danger sign
and you need to go to a hospital straight away. Take
your medicine with you. Severe forms of rash may lead
to widespread peeling of the skin, which can be life
threatening. If you get flu-like symptoms (headache,
fever, body aches) they may be followed by the serious
skin rash, so watch out carefully for this and be ready to
act quickly.
Very common effects (may affect more than 1 in every
10 people):
• Dryness of the skin, especially of the lips and face; red and
sore skin, chapped and inflamed lips, rash, mild itching
and slight peeling. If you use a moisturising cream from
the start of treatment you can reduce the risk of this
happening.
• Skin can become more fragile and redder than usual,
especially on your face.
Rare effects (may affect up to 1 in every 1,000 people):
• Hair loss, which is usually only temporary. Your hair
should return to normal after the treatment ends.
Very rare effects (may affect up to 1 in every 10,000 people):
• Your acne can get worse in the first few weeks, but
symptoms should improve with time.
• Skin inflamed, swollen, and darker than usual, especially
on your face.
• Feeling very sweaty or itchy.
• Increased sensitivity to light.
• Bacterial infections in the nail bed and other nail changes.
• Swellings, discharging, pus.
• Thickened scarring after surgery.
• Increased body hair.
Allergic reactions
Rare effects (may affect up to 1 in every 1,000 people):
• Serious allergic reactions such as difficulty breathing or
swallowing caused by sudden swelling of the throat, face,
lips and mouth. Also sudden swelling of the hands, feet
and ankles. If you have any allergic reaction, stop taking
isotretinoin and contact your doctor.
• Allergic skin reactions such as rash, itchiness.
Other problems
Very common effects (may affect more than 1 in every
10 people):
• Raised liver enzymes seen in blood tests.
Very rare effects (may affect up to 1 in every 10, 000 people):
• Yellow skin or eyes, and feeling more tired than usual.
These can be signs of hepatitis.
• Difficulty urinating (passing water), swollen or puffy
eyelids, feeling more tired than usual. These may be signs
of kidney problems.
• Severe abdominal (tummy) pain, with or without bloody
diarrhoea, feeling sick (nausea) and being sick (vomiting).
These can be signs of serious gut conditions.
• Long lasting headache along with feeling sick (nausea),
being sick (vomiting) and change in your eyesight
including blurred vision. These may be signs of benign
cranial hypertension, especially if isotretinoin is taken
with antibiotics called tetracycline
• Other sight problems including blurred vision, distorted
vision, cloudy surface on the eye (corneal opacity, cataracts).
• Dark or cola-coloured urine
• Muscle weakness which can be potentially lifethreatening, may be associated with trouble moving arms
or legs, painful, swollen, bruised areas of the body, darkcoloured urine, reduced or no urine output, confusion or
dehydration. These are signs of a breakdown of muscle
tissue which can lead to kidney failure ‘rhabdomyolysis’.
This may occur if you are doing intensive physical activity
while you are on this medicine.
Stop taking this medicine and contact your doctor
straight away if you get signs of any of the above side
effects. That may not be enough to stop the side effects.
You may need more help, which your doctor can arrange
for you.

number of white blood cells (which help protect the body
from infection and disease) goes down.
• 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.
• Back pain; muscle pain; joint pain particularly in
teenagers. To avoid making any bone or muscle
problems worse, cut down on intensive physical activity
while you are taking isotretinoin.
• Changed levels of fats in the blood (including HDL
or triglycerides).
Common effects (may affect up to 1 in every 10 people):
• Headache
• Inside of the nose becomes dry and crusted, causing
mild nosebleeds.
• Sore or inflamed throat and nose.
• More liable to get infections, if the white blood cells
are affected.
• Higher levels of cholesterol in the blood.
• Protein or blood in the urine.
• Allergic reactions such as rash, itchiness.
Very rare effects (may affect up to 1 in every 10,000 people):
• Convulsions, drowsiness, dizziness
• You may see less well at night; have blurred vision or
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
• Lymph glands (the glands around your neck, in your
armpits and groin) may become swollen.
• Dry throat, hoarseness
• Sudden tight chest shortness of breath and wheezing, ,
particularly if you have asthma
• Hearing difficulties.
• Feeling very thirsty; frequent need to urinate; blood tests
show an increase in your blood sugar. These can all be
signs of diabetes.
• Generally feeling unwell.
• High levels of uric acid showing up in blood tests.
• Bacterial infections.
• Inflammation of blood vessels (sometimes with bruising,
red patches)
• Arthritis; bone disorders (delayed growth, extra growth
and changes to bone density); growing bones may
stop growing.
• Calcium deposits in soft tissue
• Sore tendons,
• Increased levels of creatine phosphokinase showing up in
blood tests
Contact your doctor straight away if you get signs of any
of the above side effects. Your doctor may tell you to stop
taking this medicine.
To avoid making any bone or muscle problems worse, you
should cut down on intensive physical activity while you
are taking this medicine.
If you notice any side effects that you are worried
about, whether they are listed in this leaflet or not, talk to
your doctor.
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 Isotretinoin
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package
and keep the blister in the outer carton in order to protect
from light.
Do not use after the expiry EXP stated on the pack and
blister. The expiry date refers to the last day of that month
Return any capsules that you have left over at the end
of your treatment, to your pharmacist. Only keep this
medicine if your doctor tells you to.

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 isotretinoin
Each capsule of 5 mg contains 5 mg isotretinoin
Each capsule of 10 mg contains10 mg isotretinoin
Each capsule of 20 mg contains 20 mg isotretinoin.
Each capsule of 40 mg contains 40 mg isotretinoin.
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”.
Isotretinoin capsules come in blister packs 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.
Catalent Germany Eberbach GmbH, Gammelsbacher Str.
2,69412 Eberbach, Germany
Catalent Germany Schorndorf GmbH, Steinbeisstrasse 2,
D-73614 Schorndorf, Germany
You can find out more about this medicine from your
doctor or pharmacist.

Contact your doctor straight away if you get signs of any
of the following side effects. Your doctor may tell you to
stop taking this medicine.
Very common effects (may affect more than 1 in every
10 people):
• Bruising or bleeding more easily - if the number of blood
clotting cells goes down.
• Anaemia – weakness, dizziness, pale skin – if the number
of red blood cells goes down.
• More likely to get infections with symptoms like chills,
sudden fever, sore throat or flu-like symptoms - if the

Description Isotretinoin_40mg_5mg_10mg_20mg_30
Component Type Leaflet
Affiliate Item Code 1068490
Superceded Affiliate Item Code 693526/790715
TrackWise PR No. 1068490
MA No.
Packing Site/Printer

PL 04569/1343,
1344,1345,1346
Catalant Germany Schorndorf
GmbH (Schorndorf - DE)

Supplier Code PCD443053

This leaflet was last revised in 12/2016.

Date: 05 Jan 17

Pharma Code TBC

No. of colours

SAP No. N/A

Colours

Vendor Job No. 443526
Trackwise Proof No. 3
Glams Proof No. N/A
Client Market United Kingdom

1

1068490

Time: 10:55
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with

Keyline/Drawing No. N/A

Main Font

Barcode Info N/A

Dimensions

Myriad Pro
200 x 596 mm

Body Text Size 10 pt
Min Text Size used 10 pt

Sign-offs

v1/May 2015

Expand Transcript

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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