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Active substance(s): ISOTRETINOIN

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Package leaflet: Information for the patient
Isotretinoin 5 mg, 10 mg, 20 mg Soft Capsules

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
These capsules contain isotretinoin, which is a medicine related to vitamin A and one of a group of
medicines called retinoids.
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. 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
“Important Advice for Women” below)

are breast-feeding

are allergic to isotretinoin, or allergic to peanuts or soya (Isotretinoin contains soya-bean oil,
refined) or any of the other capsule ingredients (listed in section 6)

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

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. You can apply moisturising ointments
or creams to your skin and use a lip balm to reduce this effect. 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.
Your acne may suddenly get worse, usually within 7 to 10 days of beginning treatment, however this
usually does not require dose adjustment.


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 month 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 1 month 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.

Advice for Men:

Isotretinoin treatment does not damage sperm.

Isotretinoin and its metabolites are present in very low levels in your semen.

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 1 month 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,
including medicines obtained without a prescription.

Do not take any medicine or supplement containing vitamin A, any tetracyclines (a type of antibiotic) or use
any skin treatments for acne 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).
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. Drowsiness and dizziness have
been reported very rarely. If this happens to you, you should not drive or operate machinery.
Isotretinoin contains soya-bean oil, refined
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.
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:

Rare (may affect up to 1 in 1,000 people)

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)

severe allergic reaction (anaphylaxis) causing difficulty breathing, dizziness, collapse, shock,
severe itching and/or swelling.
Very rare (may affect up to 1 in 10,000 people)

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)

diabetes (causing increased level of blood glucose with thirst and increased urination)

a severe form of acne, which may also cause pain and stiffness in the joints, together with swelling
of the neck and loss of appetite

inflammation of the kidneys: difficulty urinating or even inability to urinate together with swollen
eyelids and severe tiredness

convulsions or seizures

violent pain in the abdomen, with or without bloody diarrhoea, nausea and vomiting

blurred vision or if you experience any difficulty in seeing

swelling of the cornea (keratitis)

slower, delayed or reduced bone growth
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).
Not known (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
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

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):


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
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

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

feeling generally unwell

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, particularly at the base of the nails, with swelling, redness or a discharge of

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

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

blurred vision, difficulty seeing, headaches and even a loss of vision

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, 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 tissues
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 [To be completed nationally]. By
reporting side effects you can help provide more information on the safety of this medicine.
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 package and keep the blister in the outer carton in order
to protect from light.
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 protect the environment.
6. Contents of the pack and other information
What Isotretinoin 5 mg, 10 mg and 20 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.

The other ingredients are: soya-bean oil, refined (see section 2, “Isotretinoin contains soya-bean
oil, refined”), hydrogenated vegetable oil and beeswax, yellow, lecithin and medium chain


Composition of the capsule shell of 5 mg and 20 mg: gelatin, glycerol, purified water, red iron
oxide (E172), yellow iron oxide (E172), titanium dioxide (E171).


Composition of the capsule shell of 10 mg: gelatin, glycerol, purified water, red iron oxide (E172).

What Isotretinoin 5 mg, 10 mg and 20 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 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”
The capsules come in blister packs of 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 or 180. Not all
pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: [To be completed nationally]
Manufacturer: Catalent France Beinheim S.A., 74 rue Principale, 67930 Beinheim, France.
Manufacturer: McDermott Laboratories Ltd, 35-36 Baldoyle Industrial Estate, Grange Road, Dublin
13, Ireland
This leaflet was last revised in [To be completed nationally].


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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.