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ISOTRETINOIN 10MG SOFT CAPSULES

Active substance(s): ISOTRETINOIN

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

Your doctor will show you written information on pregnancy and contraception. If you have not seen
this information, ask your doctor.
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.
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
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’
• 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 sun-protection 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.
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.
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.
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.
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.
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.
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 (frequency cannot be estimate from the available data)
● 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 life-threatening, may be associated with trouble moving
arms or legs, painful, swollen, bruised areas of the body, dark-coloured 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.
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 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
Unknown (frequency cannot be estimated from the available data)
● Problems getting or maintaining an erection
● Lower libido

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 [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 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 and 20 mg Soft Capsules contain
The active substance is isotretinoin
Each capsule of 5 mg contains 5 mg isotretinoin
Each capsule of 10 mg contains 10 mg isotretinoin
Each capsule of 20 mg contains20 mg isotretinoin.
-

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
triglycerides.

-

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”
Isotretinoin 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.
Catalent Germany Eberbach GmbH, Gammelsbacher Str. 2,69412 Eberbach, Germany
Catalent Germany Schorndorf GmbH, Steinbeisstrasse 2, D-73614 Schorndorf, Germany
McDermott Laboratories Ltd, 35-36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
You can find out more about this medicine from your doctor or pharmacist

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.

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