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ISOTRETINOIN 20 MG CAPSULES

Active substance(s): ISOTRETINOIN

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Package leaflet: Information for the user
Isotretinoin 10 mg capsules
Isotretinoin 20 mg capsules
Isotretinoin
THIS MEDICINE IS VERY HARMFUL TO THE UNBORN BABY.

Please read both brochures regarding pregnancy prevention programme and the box in
section 2 under “Do not take 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 any 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
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 is used to treat severe forms of acne, which have not improved with intake of
antibiotics and local acne treatments, such as:
• acne with formation of lumps
• acne with blackheads or
• acne at the risk of permanent scarring.
Isotretinoin, the active substance contained in Isotretinoin is similar to vitamin A. It reduces
sebum production by preventing blackheads forming and reducing skin inflammation.
2. What you need to know before you take Isotretinoin
Do not take Isotretinoin
if you are/have:
- pregnant or breast-feeding, or if there is any possibility of being pregnant
See section 2 “Pregnancy prevention programme” and “Pregnancy and Breast-feeding”
- a woman of childbearing age who does not fulfil every condition in the pregnancy
prevention programme
See section 2”Pregnancy prevention programme”
- a reduced liver function
- very high fat levels in your blood, such as cholesterol, triglycerides

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See subsection “Be aware of the following”
abnormally high vitamin A levels in your body
allergic to
o isotretinoin, soya, peanut or any of the other ingredients of this medicine (listed
in section 6)
if you are taking any of the following medicines:
o antibiotics with active substance names ending in “cycline”, such as
tetracycline.
These antibiotics may lead to benign pressure increases in the skull.

Warnings and precautions
Female patients
If you are a woman of childbearing age you must be extra cautious. You may take this
medicine only if you comply with all the preconditions of the subsequent pregnancy
prevention programme.
Important!
Pregnancy prevention programme
Isotretinoin can cause deformities in the unborn child (teratogenic) when used during
pregnancy. The abnormalities mainly affect
- the brain and spinal cord
- the heart and the large blood vessels
See section 2 under “Pregnancy”
These risks occur even if isotretinoin has been taken briefly during pregnancy, or you’ve
conceived within 1 month after stopping treatment. Isotretinoin also increases the risk of
spontaneous abortion.
You must not take Isotretinoin if you are pregnant or if you might become pregnant at any
time during treatment. Pregnancy must be avoided absolutely, including within 1 month after
treatment stops.
You must comply with the following preconditions if you are a woman of childbearing age
and your doctor prescribes you Isotretinoin:
You suffer from severe acne as described in section 1.
Your doctor has explained the isotretinoin deformity risk and you understand that you
must not become pregnant
neither during therapy with Isotretinoin
nor in the first month after stopping treatment.
You know how to prevent pregnancy, and you are able to reliably use the required
contraceptive methods.
Your doctor has informed you about
contraception, including a patient information brochure and a brochure for
contraception, and has referred you to a gynaecologist who explains how to use the
various methods of effective contraception.
You understand and accept the necessity of effective contraception
without interruption
starting 1 month prior to treatment with Isotretinoin
during the entire duration of treatment with Isotretinoin and
for 1 month after the Isotretinoin treatment ends.
You must use at least 1, preferably 2 effective methods of contraception. If 2 methods are
used, 1 of those should be a barrier method.
You will find all details regarding contraception during Isotretinoin use in the brochure
for contraception issued by your doctor. This is part of the stipulated pregnancy
prevention programme.

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Before you start contraception, your doctor will ask you to take a medically supervised
pregnancy test. This test must have a negative result. A second medically supervised
pregnancy test must also be negative, following at least 1 month of consistent
contraception. This test is to be taken within 3 days prior to prescription or on the day of
prescription.
You doctor has informed you, and you understand the necessity to:
immediately discontinue treatment and consult a doctor without delay if there is the
possibility that you might have become pregnant.
You must follow the instructions for effective contraception unless your doctor decides
that this is not necessary for you:
even if you have no monthly period in general or
if you are not sexually active at present.
You understand and accept the necessity of regular, monthly examinations.
You understand and accept the need to perform pregnancy tests:
usually monthly during treatment and
5 weeks after stopping treatment.
You or your parent have confirmed to your doctor that you
have been informed about the risks of treatment with Isotretinoin and
agree to the necessary precautionary measures.
Your doctor will ask you or your parent to sign a document containing this confirmation.

Stop taking Isotretinoin immediately and inform your doctor if you become pregnant
- during treatment with Isotretinoin or
- within 1 month after stopping treatment.
Your doctor will refer you for examination and advice to a gynaecologist or a specialist
experienced in the field of infant abnormalities.
Your doctor will give you written information about the preconditions of Isotretinoin
treatment. If for any reasons you do not receive these documents, ask for them.
Prescribing and dispensing restrictions
In women who might become pregnant the prescribed quantity per prescription is limited to a
need of 30 days.
Your pharmacist may give you Isotretinoin only within 7 days of the prescription. The
prescription expires after 7 days have passed.
Male patients
Acquaint yourself with the warnings for female patients.
Available data illustrates that levels of maternal exposure from the semen of males receiving
isotretinoin, are insufficient to be associated with deformities in unborn children.
- You must remember not to share your medication with anyone, particularly not women.
Stop treatment and consult your doctor immediately if you experience any of the
following symptoms:
- nausea, vomiting, upper abdominal pain
These may be signs of pancreas inflammation.
- headache, nausea, vomiting or visual disturbances
These may be signs of increased pressure in the skull.
See above under “Do not take Isotretinoin”
- severe bloody diarrhoea, severe abdominal pain or cramps
These may be signs of severe bowel inflammation.
- severe allergic reactions such as
o skin rash, often with blue and red spots

o itching
o swelling of the face, hands and legs
o breathing difficulties
o circulatory disorders up to collapse
This might be a dangerous allergic shock reaction.
Ask your doctor for advice if you are/have:
- ever had higher than normal fat levels, such as triglycerides, cholesterol
- had prior, existing or develop mental disorders, such as
o unexplained sadness or anxiety
o mood swings or other signs of depression
o crying fits
o irritability
o trouble in concentrating
o no longer enjoy social or sporting activities
o begin to avoid contact with your friends or family
o you are getting too much, or too little, sleep
o notice changes in appetite, weight, or your performance at school/work
o experience suicidal thoughts or attempts
o hear voices, or see things, that do not exist
Contact your doctor immediately, if you think that you may have developed such
disorders. He may possibly tell you that you must stop taking Isotretinoin without delay.
It is possible that ending treatment is ineffective, in which case your doctor will refer you
to a specialist.
- visual disturbances
Inform your doctor should these occur, so that he can monitor your vision accordingly. If
necessary, ask for referral to an ophthalmologist. It may be that you must discontinue
Isotretinoin.
Dry eyes can be treated by using a lubricating eye ointment or a tear replacement
preparation.
- wear contact lenses and experience dry eyes
It may be necessary to wear glasses during treatment with Isotretinoin.
- increase of liver enzymes
In many cases, the changes are in the normal range and may return to baseline values
during treatment. However, if the increase persists, your doctor may reduce the dose or
discontinue Isotretinoin.
- reduced kidney function
See section 3 “How to take Isotretinoin”.
- an increased risk of side effects, for example if you are:
o diabetic
o overweight
o regularly drink large amounts of alcohol or
o suffer from diseases relating to the absorption, processing and/or for
conversion of fats
Your doctor may need to monitor your health, blood fat and/or blood sugar levels
more frequently.
Be aware of the following:
never pass this medicine on to others.
do not donate blood during Isotretinoin treatment and for 1 month afterwards.
If a pregnant woman receives your blood, her child might be born with severe abnormalities.
return unused capsules to your pharmacist after the end of treatment.
blood fat value, liver and bile level checks
Your doctor will check these values

before treatment
1 month after starting treatment and
subsequently at 3 monthly intervals unless more frequent monitoring is required.
High fat values usually normalise after dosage reduction or when treatment stops, but may
also respond to dietary measures.
You must discontinue treatment with Isotretinoin if these values are too high, or if signs
of pancreas inflammation occur. Values in excess of 800 mg/dl or 9 mmol/l are
sometimes associated with acute pancreas inflammation, which may be fatal.
Do not take vitamin A supplements while taking Isotretinoin. Taking both together may
increase the risk of side effects.
Skin
Worsening of acne is uncommonly observed in the first weeks of treatment, but this
subsides during continued treatment, usually within 7 to 10 days, and does not require
dose adjustment in most cases.
Your skin may be more sensitive to sunlight during therapy.
Therefore avoid too long exposure to sunlight, and do not use UV lamps or solaria.
Before going into the sun, apply sun protection at least protection factor 15, and wear
long clothes.
Isotretinoin can make your skin more sensitive. Avoid during treatment and for at least 6
months afterwards:
a) aggressive chemical skin abrasion and laser treatment to remove the
upper skin layer or scars
b) hair removal by wax
Do not use creams and/or substances for external use that peel or detach skin layers.
Otherwise skin irritations may occur.
Use moisturising skin ointment or cream and lip balm during Isotretinoin treatment to
avoid dry skin and dry lips.
Muscle, joints and bones
Avoid vigorous physical activity, as this may lead to increased symptoms of muscle and joint
pain.
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Other medicines and Isotretinoin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
The following two medicines may not be used during treatment with Isotretinoin:
- antibiotics with active substance names ending in “cycline”, such as tetracycline
- vitamin A preparations
See also section 2 “Do not take Isotretinoin”.
Pregnancy and breast-feeding
Pregnancy
Isotretinoin must not be taken during pregnancy.
Please follow all instructions listed in section 2 under the headings:
- “Do not take Isotretinoin” and
- Pregnancy prevention programme”.
High risk of extremely serious and severe foetal abnormalities occur if you are pregnant
during Isotretinoin use, such as:
- water on the brain
- abnormalities of the cerebellum
- decrease in skull size

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facial abnormalities
cleft palate
abnormalities of the external ear like absence of the auricle, small or absent external ear
canal
- eye abnormalities, such as abnormally small eye with small cornea
- heart and blood vessel abnormalities, such as congenital heart deformity, abnormal
positioning of great vessels, openings in cardiac partition
- thymic gland and parathyroid gland abnormalities.
In addition, intake of Isotretinoin increases the risk of spontaneous abortion.
Breast-feeding
You must not take Isotretinoin during breast-feeding, as isotretinoin can possibly pass into
mother’s milk and may harm your child.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Only drive or operate machinery if your doctor approves this and informs you about the
risks. You must be cautious if you are engaging in such activities.
It is possible that your night vision may worsen. This may occur suddenly. This impairment
can persist in rare cases after the end of treatment. Sleepiness, dizziness and visual
disturbances may occur. If you experience these effects, you should not drive, operate
machinery or take part in any other activities where the symptoms put either yourself or
others at risk.
See section 2 “Take special care with Isotretinoin” and section 4 “Possible side effects”.
Important information about some of the ingredients of Isotretinoin
Isotretinoin contains
• soya oil. If you are allergic to peanut or soya, do not use this medicinal product.
Soya oil may lead to severe allergic reactions in rare cases.
• sorbitol. If you have been told by your doctor that you are intolerant to some sugars,
contact your doctor before taking this medicinal product.
3. How to take Isotretinoin
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Your doctor will calculate the dose and inform you of how many Isotretinoin capsules you
must take.
Unless otherwise prescribed the usual dose is:
Adults and adolescents 12 years and over
- Starting dose: 0.5 mg per kilogram body weight daily.
Your doctor can adjust the dose after some weeks. This depends on how you tolerate the
medicine.
- In most patients, the continue dose will be between 0.5 and 1.0 mg per kg bodyweight.
Reduced kidney function
If your kidney function is severely reduced, your doctor will prescribe you a lower starting
dose.

He may increase your dose to the continue dose described above or to the highest dose you
tolerate.
Children younger than 12 years
Isotretinoin is not recommended in this age group.
Duration of use
This depends on the daily dose and is usually 16 to 24 weeks.
Your acne can further improve for a period of up to 8 weeks after the treatment ends.
Most patients require only 1 treatment cycle. Your doctor may prescribe a further period of
treatment, if necessary. However, this further treatment cycle should not be started until at
least 8 weeks have elapsed.
Method of use
Take the capsules whole with 1 glass of water:
- once or twice daily and
- together with food.
If you take more Isotretinoin than you should
Contact your doctor, pharmacist or nearest hospital immediately if you have taken more than
the prescribed dosage.
This also applies if anyone else has taken your capsules without doctors’ prescription.
If you forget to take Isotretinoin
If you forget to intake a dose, take it as soon as you remember. However, if it is almost time for
your next dose, skip the forgotten dose and take the medicine as usual. Do not take double a
dose.
If you stop taking Isotretinoin
Do not stop Isotretinoin therapy without consulting your doctor, as acne may recur.
This does not apply to symptoms listed in section 2 under “Do not take Isotretinoin” or if you are
pregnant. Stop taking Isotretinoin immediately if any of these occurs.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects generally recede after a change of dosage, or therapy is stopped. However some
may persist after the treatment ends.
Side effects can occur with the following frequencies:
Very common, occurs in more than 1 per 10 users
• reduced number of red blood cells
• elevated sink speed of red blood cells in blood samples which cannot coagulate
• increased or decreased blood platelets count
• inflammation of the eyelid margin
• pink-eye
• dry mucous membranes, e.g. dry lips, dry eyes
• eye irritation














increased liver enzyme values known as transaminases
see section “Take special care with Isotretinoin”
inflammation of the lips
skin inflammation
dry skin
local exfoliation
itching
inflammatory-reddish skin rash
increased risk of skin damage due to rubbing
muscle and joint pain
back pain, particularly in children and adolescents
increase in blood lipid values, called triglycerides
reduction in certain cholesterol, known as HDL

Common, occurs in 1 to 10 per 100 users
• reduction in the number of neutrophilic white blood cells
• headache
• inflammation in the nasal-throat area
• nasal dryness
• nosebleed
• increase in cholesterol in the blood
• increase in blood sugar values
• blood in urine
• excretion of protein with the urine
Rare, occurs in 1 to 10 per 10,000 users
• allergic skin reaction
• dangerous allergic shock reaction
• depression
• exacerbation of depression
• aggressive tendencies
• anxiety
• mood changes
• hair loss
Very rare, occurs in fewer than 1 per 10,000 users
• infections of skin and mucous-secreting lining due to certain bacteria
• disorder of the lymph nodes
• diabetes
• increased uric acid concentration in the blood
• behavioural abnormalities
• psychotic disorders
• suicidal thoughts
• suicide attempt
• suicide
• benign increase in skull pressure
• seizures
• sleepiness
• dizziness
• blurred vision















































clouding of the eye lens or cornea
colour blindness or limited colour vision
contact lens intolerance
night blindness
inflammation of the eye cornea
swelling of the optic nerve head; a sign of a benign increase in skull pressure
unpleasant eye sensitivity to light
visual disturbances
deterioration in hearing
diseases due to blood vessel inflammation such as Wegener‘s granulomatosis, allergic
blood vessel inflammation
cramp of bronchial muscles, particularly in patients with asthma
hoarseness
inflammation of the large intestine
inflammation of the small intestine
dry throat
stomach and/ or bowel bleeding
diarrhoea with bloody stool
inflammatory bowel disease
nausea
inflammation of the pancreas, see section “Take special care with Isotretinoin”
inflammation of the liver
severe acne with blackheads, sudden fever and increased white blood cell count
deterioration or flare-up of acne
inflammatory reddening of the skin in the face
skin rash
hair changes
increased hair growth
developmental anomaly of the nails
inflammation of nail folds
increased sensitivity to light with reactions on the skin or on the nerve system
bleeding easily
fast-growing lumps over the skin which are painful and which bleeding easily known as
pyogenic granuloma
increased pigmentation of the skin
increased sweating
arthritis
calcification of soft tissues such as ligaments and tendons
premature closure of epiphyseal growth plates which lead to decreased growth
enlargement of bone substance extending from the bone surface like a bump or spur
reduced bone density
tendon inflammation
muscle weakness, tenderness or pain and particularly, if at the same time, you feel
unwell or have a high temperature it may be caused by an abnormal muscle breakdown
which can be life-threating and lead to kidney problems.
kidney inflammation known as glomerulonephritis
increased formation of red, scar like tissue which can lead to scarring
feeling unwell
increased levels in the blood of the creatinine phosphokinase enzyme

Unknown, frequency cannot be estimated from the available data
• 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.


If you get any side effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
5. How to store Isotretinoin
Keep this medicine out of the sight and reach of children!
Do not use Isotretinoin after the expiry date which is stated on the carton after “EXP.”. The
expiry date refers to the last day of that month.
Storage conditions
- Keep the blister in the outer carton, in order to protect from light.
- Do not store above 25 °C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines not longer required. These measures will help to protect the
environment.
6.

Contents of the pack and other information

What Isotretinoin contains
The active substance is isotretinoin.
Isotretinoin 10 mg Capsules: one soft capsule contains 10 mg isotretinoin.
Isotretinoin 20 mg Capsules: one soft capsule contains 20 mg isotretinoin.
The other ingredients are:
- Capsule content: soya-bean oil, refined, soya-bean oil (partly hydrogenated), ascorbyl
palmitate, all-rac-alpha-tocopherol, beeswax, yellow.
- Capsule shell: gelatine, glycerine (E 422), sorbitol liquid (non-crystallising), purified
water, ferric oxide red (E 172), titanium dioxide (E 171).
What Isotretinoin looks like and contents of the pack
Isotretinoin 10 mg Capsules: matt red, oval soft gelatine capsule with a glossy surface and
available in packs containing 20, 30, 50, 60 and 100 soft capsules.
Isotretinoin 20 mg Capsules: red-brown and white, oval soft gelatin capsule with a glossy surface
and available in packs containing 20, 30, 50, 56, 60 and 100 soft capsules.

Not all pack sizes may be marketed.
Marketing authorisation holder
Sandoz Limited
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
United Kingdom
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Or
HEXAL A/S
Kannalholmen 8-12
DK-2650 Hvidovre, Denmark
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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