Isotretinoin 30 mg soft capsules – patient leaflet, side effects, dosage

1. What Isotretinoin 30 mg is and what it is used for

Isotretinoin 30 mg soft capsules contains the active ingredient isotretinoin. This is a vitamin A derivative, belonging to the retinoid class of medicines. Isotretinoin 30 mg is used to treat severe forms of acne (such as nodular or conglobate acne, or acne at risk of permanent scarring) which has not got better after other anti-acne treatments, including oral antibiotics.

Isotretinoin treatment must be supervised by a dermatologist (a doctor specialised in the treatment of skin problems).

Your prescriber must have

considered that there is no other appropriate treatment before starting your isotretinoin therapy.

2. What you need to know before you take Isotretinoin

30 mg

Isotretinoin should only be prescribed by or under the supervision of a dermatologist (a doctor specialised in the treatment of skin problems) with understanding of the risks of isotretinoin therapy and monitoring requirements.

Your doctor will inform you about the precautions you have to fulfil when you take Isotretinoin 30 mg.

Additionally, you should receive information materials from your doctor. If not, ask your doctor for this information. If your doctor has not explained the precautionary measures or you have not

understood them, please contact your doctor before you start taking Isotretinoin 30 mg.

Do not take Isotretinoin 30 mg

! If you are pregnant or breast-feeding.

! If there is any chance you could become pregnant, you must follow the precautions under "Pregnancy and prevention programme", see section on "Warnings and precautions".

! if you are allergic to isotretinoin, soya, peanut or any of the other ingredients of this medicine Isotretinoin 30 mg

soft capsules

Isotretinoin

PACKAGE LEAFLET:

INFORMATION FOR THE USER

What is in this leaflet:

1. 1.

   What Isotretinoin 30 mg is and

   what it is used for

2. 2.

   What you need to know before you

   take Isotretinoin 30 mg

3. 3. How to take Isotretinoin 30 mg
4. 4. Possible side effects
5. 5. How to store Isotretinoin 30 mg
6. 6.

   information

   (listed in section 6)

   ! if you have liver disease ! if you have very high levels of blood fats (e.g. high cholesterol or triglycerides)

   ! if you have very high levels of vitamin A in your body

   (hypervitaminosis A)

   ! if you are taking tetracyclines (a type of antibiotic medicine). ! if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking isotretinoin.

   Due to the high risk that a child with congenital defects will result if pregnancy occurs you should only take Isotretinoin 30 mg if all the conditions of the pregnancy prevention programme are met. Please talk about these issues with your doctor.

   Warnings and precautions

   Talk to your doctor or pharmacist before taking Isotretinoin 30 mg: ! If you have ever had any kind of mental health problems. This includes depression, aggressive tendencies or mood changes. It also includes thoughts about hurting yourself or ending your life. This is because your mood may be affected while taking

   Isotretinoin 30 mg.

   Your doctor will discuss how best to monitor your mental health during your treatment.

   Talk to your doctor if you experience persistent pain in your lower back or buttocks during treatment with Isotretinoin 30mg. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may discontinue treatment with Isotretinoin 30mg and refer you to a specialist for treatment of

   inflammatory back pain. Further evaluation may be needed including imaging modalities such as MRI.

   Pregnancy Prevention Programme

   Women who are pregnant must not take Isotretinoin 30 mg

   This medicine can seriously harm an unborn baby (the medicine is said to be 'teratogenic') – it can cause serious abnormalities of the unborn baby's brain, face, ear, eye, heart and certain glands (thymus gland and parathyroid gland). It also

   makes a miscarriage more likely. This may happen even if Isotretinoin 30 mg is taken only for a short time during pregnancy.

   ! You must not take Isotretinoin 30

   mg if you are pregnant or if you think you might be pregnant. ! You must not take Isotretinoin 30

   mg if you are breast-feeding. The medicine is likely to pass into your milk and may harm your baby.

   ! You must not take Isotretinoin 30

   mg if you could get pregnant during treatment.

   ! You must not get pregnant for

   one month after stopping this treatment because some medicine may still be left in your body.

   Women who could get pregnant are prescribed Isotretinoin 30 mg under strict rules. This is because of the risk of serious harm to the unborn baby.

   These are the rules:

   ! Your doctor must explain the risk

   of harm to the unborn baby - you must understand why you must not get pregnant and what you need to do to prevent getting pregnant.

   ! You must have talked about

   contraception (birth control) with your doctor. The doctor will give you information on how not to get pregnant. The doctor may send you to a specialist for

   contraception advice.

   ! Before you start treatment, your

   doctor will ask you to take a pregnancy test. The test must show that you are not pregnant when starting treatment with Isotretinoin 30 mg.

   Women must use effective contraception before, during and after taking Isotretinoin 30 mg

   ! You must agree to use at least

   one very reliable method of contraception (for example an intra uterine device or

   contraceptive implant) or, two effective methods that work in different ways (for example a hormonal contraceptive pill and a condom). Discuss with your doctor which methods would be suitable for you.

   ! You must use contraception for a

   month before taking

   Isotretinoin 30 mg, during

   treatment and for a month

   afterwards.

   ! You must use contraception

   even if you do not have

   periods or you are not

   sexually active (unless your

   doctor decides this is not

   necessary).

   Women must agree to pregnancy testing before, during and after taking

   Isotretinoin 30 mg

   ! You must agree to regular

   follow-up visits, ideally every

   month.

   ! You must agree to have

   regular pregnancy tests,

   ideally every month during

   treatment and, because some

   medicine may still be left in

   your body, 1 month after

   stopping Isotretinoin 30 mg

   (unless your doctor decides

   this is not necessary in your

   case).

   ! You must agree to extra

   pregnancy tests if your doctor

   asks you.

   ! You must not get pregnant

   during treatment or for a

   month afterwards because

   some medicine may still be

   left in your body.

   ! Your doctor will discuss all

   these points with you, using a

   checklist and will ask you (or a

   parent/guardian) to sign it.

   This form confirms that you

   have been told about the risks

   and that you will follow the

   rules above.

   If you get pregnant while taking

   Isotretinoin 30 mg, stop taking the

   medicine straight away, and

   contact your doctor. Your doctor

   may send you to a specialist for

   advice.

   Also, if you become pregnant

   within one month after you stop

   taking Isotretinoin 30 mg, you

   should contact your doctor. Your

   doctor may send you to a

   specialist for advice.

   Written information on this subject is available from your doctor. If you haven't received

   this material please contact your doctor.

   Prescriptions are limited to 30 days treatment for women of childbearing potential.

   Continuation of treatment requires a new prescription, and each prescription is only valid for seven days.

   Pregnancy tests

   Your doctor will provide you with information brochures that you must read carefully and may refer you to a gynaecologist, who will explain about contraception and recommend the contraceptive methods suitable for you. Your doctor or gynaecologist will carry out a medically supervised pregnancy test before you start to use the contraception (during the first 3 days of your menstrual cycle) in order to exclude the possibility that you might already be pregnant. If you do not have a regular period the test should be carried out about 3 weeks after the last unprotected sexual intercourse. The test must have a minimum sensitivity of 25 mIU/mL. Your doctor will document the date and result of this pregnancy test.

   If the first pregnancy test is negative, you must start using an effective contraceptive method.

   A second medically supervised pregnancy test must be carried out one month after starting a consistent and effective contraceptive method and before starting the treatment, and not more than 3 days before the visit to the prescribing doctor. If the result of this second pregnancy test is negative, your doctor will issue your first prescription for Isotretinoin 30 mg. This prescription is limited to 30 days of treatment.

   After this you must see your doctor at regular intervals, ideally every month.

   As a rule further medically supervised pregnancy tests must be carried out monthly on the day of the prescribing visit or in the 3 days before the visit throughout the course of treatment.

   Afterwards you will receive a new prescription covering your needs for another 30 days.

   One month after the end of treatment with Isotretinoin 30 mg another medically supervised

   pregnancy test must be carried out, because it takes about 1 month before the active substance contained in Isotretinoin 30 mg is completely eliminated from the body. This test will exclude the possibility of a pregnancy during this period.

   For those patients that are

   considered by the prescriber to have compelling reasons to indicate that there is no risk of pregnancy, once stable on isotretinoin (after the first 1-3 months), the prescription duration may be for longer than 30 days (up to 12 weeks).

   Advice for men

   The levels of oral retinoid in the semen of men taking Isotretinoin 30 mg are too low to harm their partners' unborn baby. However, you must never share your medication with anyone.

   Additional precautions

   You should never give this medicinal product to another person. Please take any unused capsules to your pharmacist at the end of treatment.

   You should not donate blood during treatment with this medicine and for 1 month after stopping Isotretinoin 30 mg because an unborn baby could be harmed if a pregnant patient receives your blood.

   This medicine can cause serious skin reactions. Stop using Isotretinoin 30 mg and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

   Mental health problems

   You may not notice some 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.

   Other precautions

   ! Isotretinoin 30 mg may increase the levels of fats such as triglycerides or cholesterol in

   your blood. Your doctor will do some blood tests in order to monitor these levels before, during and at the end of your Isotretinoin 30 mg treatment. Tell your doctor if you already have high levels of these substances in your blood or if you have diabetes, are

   overweight, or are an alcoholic, as you may need to have blood tests more frequently.

   ! Isotretinoin 30 mg may increase your liver enzyme levels. Your doctor will do some blood tests before, during and at the end of your Isotretinoin 30 mg treatment to check your liver values. In cases where liver enzyme values remain high your doctor may reduce your dose or stop your Isotretinoin 30 mg therapy.

   ! Isotretinoin 30 mg may increase your blood sugar levels and in rare cases diabetes mellitus has been diagnosed. Your doctor may monitor your blood sugar levels during your treatment, particularly if you have diabetes, are

   overweight, or are an alcoholic. ! Use a skin moisturising

   ointment or cream and a lip balm during treatment as you may experience skin and/or lip dryness during Isotretinoin 30 mg therapy.

   Contact your doctor

   ! If you have any kind of mental problems, or, if you think you have signs of depression while taking Isotretinoin 30 mg such as feeling very sad for no reason, crying spells, difficulty concentrating or you become withdrawn from your friends or family. Your doctor may refer you for appropriate treatment if necessary. Stopping therapy with Isotretinoin 30 mg may not be enough and you may require further psychiatric or psychological help. Rare cases of depression, worsening depression, anxiety, mood changes, psychotic

   symptoms and very rarely suicidal thoughts, suicide attempts and suicide have been reported. ! Severe skin reactions (e.g. erythema multiforme (EM), Stevens-Johnsons syndrome (SJS) and toxic epidermal necrolysis (TEN)) have been reported with the use of

   Isotretinoin. 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).

   ! If you suffer from kidney failure. In this case therapy has to begin with a lower dose.

   ! Isotretinoin 30 mg may cause dry eyes, intolerance to contact lenses and visual difficulties including decreased night vision. Cases of dry eyes not resolving after discontinuation of therapy have been reported. Always be cautious when driving or operating machinery at night because these slight changes can happen quite suddenly. 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 30 mg.

   Stop treatment immediately and contact your doctor as soon as possible

   ! If you experience an allergic reaction (skin redness, itching) or a serious anaphylactic reaction. ! If you experience a persistent headache, nausea, vomiting and blurred vision. Isotretinoin 30 mg has been very rarely associated with a condition called benign intracranial hypertension.

   ! If you experience severe haemorrhagic diarrhoea (e.g. blood in your stool). Isotretinoin 30 mg has on very rare occasions been associated with inflammatory bowel disease.

   What to avoid when taking Isotretinoin 30 mg

   ! Avoid too much sun and do not use a sun-lamp or sun-bed. Your skin may become more sensitive to sunlight during Isotretinoin 30 mg therapy. Before going out in the sun apply a sun-protection product with a high protection factor of at least SPF 15.

   ! Cosmetic procedures such as dermabrasion or laser treatments (removing horny skin or scars) and wax epilation should be avoided during and for at least 6 months

   after treatment; Isotretinoin 30 mg may make your skin more fragile and this could cause scarring or irritation of the skin.

   ! Reduce intensive physical activity during Isotretinoin 30 mg therapy, because muscle and joint pain have been observed during Isotretinoin 30 mg treatment. ! Do not donate blood either during or for one month after Isotretinoin 30 mg treatment. If someone who is pregnant receives your donated blood, her baby may be born with serious birth defects. ! Isotretinoin has been associated with sexual problems. These include problems getting or maintaining an erection, lower libido, vaginal dryness, orgasm difficulties and reduced sensation in the genitals. There have been reports of long-lasting sexual problems where the symptoms have continued despite stopping treatment with isotretinoin. Talk to your doctor if you experience any sexual problems during treatment.

   Children and adolescents

   The use of Isotretinoin 30 mg in children under the age of 12 is not recommended. This is because it is not known if it is safe or effective in this age group. Use in adolescents over 12 years of age only after puberty.

   Your prescriber must have considered that there is no other appropriate treatment before starting your isotretinoin therapy.

   Other medicines and Isotretinoin 30 mg

   Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

   Do not take vitamin A supplements or tetracyclines (a type of antibiotic) during therapy with Isotretinoin 30 mg because the risk of getting side effects may increase.

   Do not use any skin treatments for acne during treatment with

   Isotretinoin 30 mg because local irritation may increase. It is fine to use moisturisers and emollients (skin creams or preparations that prevent water loss and have a softening effect on the skin).

   1. 2. What you need to know

before you take

Isotretinoin

30 mg

(continued...)

Avoid the use of topical

keratolytic or exfoliative anti-acne

agents during treatment with

Isotretinoin 30 mg.

Pregnancy and breast-feeding

Pregnancy

Isotretinoin 30 mg must not be

taken during pregnancy, as

Isotretinoin the active compound

of Isotretinoin 30 mg is highly

teratogenic. If pregnancy does

occur in spite of the described

precautions (Pregnancy

prevention programme) during

treatment or in the month

following, there is a great risk of

very severe and serious damage

to the unborn baby.

The foetal deformities associated

with exposure to isotretinoin include

central nervous system

abnormalities (hydrocephalus,

cerebellar malformation/

abnormalities, microcephaly), facial

dysmorphia, cleft palate, external

ear abnormalities (absence of

external ear, small or absent

external auditory canals), eye

abnormalities (microphthalmia),

cardiovascular abnormalities

(conotruncal malformations such as

tetralogy of Fallot, transposition of

great vessels, septal defects),

thymus gland abnormality and

parathyroid gland abnormalities.

There is also an increased incidence

of spontaneous abortion.

If pregnancy occurs or might be

likely in a woman treated with

isotretinoin, treatment must be

stopped immediately and the

patient should contact her doctor

without delay.

For more information on pregnancy

and contraception, see section 2

"Pregnancy and prevention

programme".

Breast-feeding

You should not take Isotretinoin

30 mg if you are breast-feeding,

because isotretinoin is likely to pass

into the milk and may harm the baby.

Driving and using machines

Your night vision may get worse

during your treatment. This can

happen suddenly. In rare cases this

has continued after the treatment

has stopped. You should therefore

be cautious when driving or

operating machines.

Drowsiness, dizziness and visual

disturbances have been reported

very rarely. If you experience any of

these effects, you should not drive,

operate machinery or take part in

any other activities where these

symptoms could put either yourself

or others at risk.

Isotretinoin 30 mg contains soya

oil and sorbitol

If you are allergic to peanut or soya,

do not use this medicinal product.

This medicine contains 21.5 mg

sorbitol in each capsule. Sorbitol is a

source of fructose. If your doctor has

told you that you (or your child) have

an intolerance to some sugars or if

you have been diagnosed with

hereditary fructose intolerance (HFI),

a rare genetic disorder in which a

person cannot break down fructose,

talk to your doctor before you (or

your child) take or receive this

medicine.

3. How to take Isotretinoin

30 mg

Always take this medicine exactly as

your doctor has told you. Check with

your doctor or pharmacist if you are

not sure. !The capsules should be taken

with food once or twice daily. !Swallow the capsules whole, do

not chew or suck them.

Occasionally your acne may get

worse during the first weeks of

treatment. It should improve with

continued treatment.

Dosage

Your doctor will prescribe an

individual dose in accordance

with your body weight and other

clinical parameters like renal

insufficiency, etc.

The specific individual doses might

be better matched by other available

strengths.

Adults including adolescents and

the elderly

The usual starting dose is 0.5 mg per

kilogram body weight per day (0.5

mg/kg/day). After a few weeks your

doctor may adjust your dose. This

will depend on how you are getting

on with your medicine. For most

patients the dose will be between 0.5

and 1.0 mg/kg/day.

If you have the impression that the

effect of Isotretinoin 30 mg is too

strong or too weak, talk to your

doctor or pharmacist.

Patients with severe renal

insufficiency

If you have severe kidney problems,

Isotretinoin should be started at a

lower dose such as 10 mg/day and

then increased up to the highest

tolerated dose.

Use in Children and adolescents

The use of Isotretinoin 30 mg in

children under the age of 12 is not

recommended. This is because it is

not known if it is safe or effective in

this age group. Use in adolescents

over 12 years of age only after

puberty.

Patients with intolerance

If you cannot tolerate the

recommended dose, your doctor

may continue your treatment at a

lower dose with the consequence of

a longer therapy duration and a

higher risk of relapse.

Duration of treatment

A course treatment usually lasts

for 16 to 24 weeks. Your acne may

continue to improve for up to 8

weeks after the treatment finishes.

Therefore, a further course of

treatment should not be started until

at least this period has elapsed.

Most patients only need a single

course of treatment.

Remember this medicine is for

you

Only a doctor can prescribe it for

you. Never give it to others. It may

harm them even if their symptoms

appear similar to yours.

If you take more Isotretinoin 30

mg than you should

The following symptoms are

possible: severe headache, nausea

or vomiting, somnolence, irritability

and itching. If you take too many

capsules or someone else

accidentally takes your medicine,

contact your doctor, pharmacist

or nearest hospital immediately.

If you forget to take Isotretinoin

30 mg

If you miss a dose, take it as soon

as possible. However if it is nearly

time for your next dose, skip the

missed dose and carry on as before.

Do not take a double dose to make

up for a forgotten dose.

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.

Some of the side effects associated

with the use of isotretinoin are dose-

related. The side effects are

generally reversible after altering the

dose or discontinuation of treatment;

however some may persist after

treatment has stopped.

Go to a doctor straight away and

stop taking Isotretinoin 30 mg if

any of the following serious skin

reactions occur.

Unknown frequency (frequency

cannot be estimated from the

available data) !Reddish non elevated, target-like

or circular patches on the trunk,

often with central blisters, skin

peeling, ulcers of mouth, throat,

nose, genitals and eyes. These

serious skin rashes can be

preceded by fever and flu-like

symptoms (Stevens-Johnson

syndrome (SJS)/ toxic epidermal

necrolysis (TEN)). Severe forms

of rash may progress to

widespread peeling of the skin

which can be life threatening. !Additional symptoms such as

infection of the eye (conjunctivitis)

or ulcers of the mouth, throat or

nose may occur !A red, scaly widespread rash with

bumps under the skin and blisters

accompanied by fever. The

symptoms usually appear at the

initiation of treatment [acute

generalised exanthematous

pustulosis (AGEP)].If you develop

a rash or these skin symptoms,

stop taking Isotretinoin 30 mg and

contact your doctor immediately.

Rare (may affect up to 1 in every

1000 people) !Allergic skin reaction (symptoms

include reddening of the skin,

rash, itching) !Severe allergic response

(anaphylactic reactions), which

may cause shock (symptoms

include, difficulty in breathing or

swallowing, sudden swelling of

the throat, face, lips and tongue,

reddening of the skin and

dizziness) !Hypersensitivity (symptoms

include reddening of the skin,

rash, itching).

Stop taking Isotretinoin 30 mg

and contact your doctor if any of

the following side effects occur.

Very rare (may affect up to 1 in

every 10,000 people) !Gastric and intestinal bleeding,

haemorrhagic diarrhoea,

inflammatory bowel disease and

nausea

!Kidney inflammation !Benign intracranial hypertension !Oedema of the optic disc

(papilloedema, as sign of benign

intracranial hypertension) !Blurred vision !Clouding of the surface of the eye

(cataract) !Colour blindness (colour vision

deficiencies) !Decreased night vision !Eye inflammation !Visual disturbances.

Mental health problems

Contact your doctor straight away

if you get any of the following

symptoms. Your doctor may tell you

to stop taking Isotretinoin 30 mg.

Rare (may affect up to 1 in every

1000 people) !Becoming violent or aggressive.

Very rare (may affect up to 1 in every

10,000 people) !Unusual behaviour. !Signs of psychosis: a loss of

contact with reality, such as

hearing voices or seeing things that

are not there.

Frequency not known (frequency

cannot be estimated from available

data) !Depression or related disorders.

Signs of this include sad or altered

mood, anxiety, feelings of

emotional discomfort, !Existing depression getting worse. !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.

The following symptoms are the most

commonly reported undesirable

effects with isotretinoin: dryness of

the skin, dryness of the mucosa e.g.

of the lips, the nasal mucosa, and the

eyes.

Also the following side effects may

occur:

Very common (may affect more

than 1 in every 10 people) !Inflammation of the eyelid area !Eye inflammation !Dry eye !Eye irritation !Blood levels of fat like substances

(triglyceride) increased !HDL-cholesterol (high density

lipoprotein) decreased !Deficiency of red blood cells !Red blood cell sedimentation rate

increased !Number of blood plates increased

or decreased !Inflammation of lips !Inflammation of the skin !Dryness of skin !Localised shedding of layers of

skin !Itching !Rash with redness !Skin fragility (risk of frictional

trauma) !Joint pain !Muscle pain !Back pain (particularly in children

and adolescent patients) !Increase in the level of liver

enzymes (see Section 2: Before

you take Isotretinoin 30 mg).

Common (may affect up to 1 in

every 10 people) !Headache !Neutrophilic leukocytes decreased

(a kind of white blood cells) !Nosebleed !Nasal dryness !Inflammation of the nasal mucosa,

respectively pharyngeal mucosa !Blood cholesterol increased !Blood sugar levels (blood glucose)

increased !Blood in the urine !Excretion of protein in the urine.

Rare (may affect up to 1 in every

1000 people) !Loss of hair.

Very rare (may affect up to 1 in

every 10,000 people) !Liver inflammation !Convulsions, drowsiness,

dizziness !Inflammation of the colon mucosa

and intestinal mucosa !Dry throat

!Pancreatitis (see section 2. Before

you take Isotretinoin 30 mg) !Severe acne (acne fulminans) !Worsening of acne (acne flare) !Skin redness, particularly on the

face !Skin rash !Hair disorders !Increased levels of body hair !Changes in the nails, infections of

the tissue around the base of the

nails !Sensitivity to light !Pus forming swellings (pyogenic

granuloma) !Increased pigmentation of the skin !Sweating increased !Lymph node disease

(lymphadenopathy) !Contact lens intolerance !Corneal opacity !Intolerance to light !Hearing impaired !Narrowing of the airways

(bronchospasm), particularly in

patients with asthma !Hoarseness !Increase in blood sugar levels

(diabetes mellitus) !Increase in uric acid blood levels !Inflammation of joints !Calcifications in soft tissues

(ligaments and tendons) !Prematurely ending of growing

bones !Formation of excessive bony

tissue (exostosis/hyperostosis) !Reduced bone density !Tendonitis !Blood creatine phosphokinase

increased !Bacterial infections of the skin and

mucous membranes !Blood vessel inflammation (for

example Wegener's

granulomatosis, allergic vasculitis) !Increased formation of tissue,

which may cause thickened

scarring after surgical

interventions !Malaise.

Unknown frequency (frequency

cannot be estimated from available

data) !Dark or cola-coloured urine !Problems getting or maintaining

an erection !Lower libido

!Breast swelling with or without

tenderness in male

!Vaginal dryness

!Sacroiliitis, a type of inflammatory

back pain causing pain in your

buttocks or lower back

!Inflammation of the urethra.

!Difficulties having an orgasm

!Reduced sensation in the genitals

!Anal fissure (a small tear in the

thin, moist tissue that lines the

anus)

!Rectal bleeding or blood in your

stools

Reporting of side effects:

If you get any side effects, talk to

your doctor, pharmacist or nurse.

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 or

search for MHRA Yellow Card in the

Google Play or Apple App Store. By

reporting side effects you can help

provide more information on the

safety of this medicine.

5. How to store Isotretinoin

30 mg

Keep this medicine out of the

sight and reach of children.

Do not use this medicine after the

expiry date which is stated on the

carton. The expiry date refers to the

last day of that month.

Do not store above 30°C. Store in

the original package and keep blister

in the outer carton in order to protect

from moisture and light.

Important! Please return any

unused capsules to your

pharmacist at the end of

treatment. Only keep it if your

doctor tells you to.

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 30 mg contains !The active substance is isotretinoin.

Each capsule contains 30mg of

isotretinoin. !The other ingredients are Soya-bean

oil refined, DL-alpha-tocopherol,

disodium edetate,

butylhydroxyanisole, soya-bean oil

(partly) hydrogenated, soya-bean oil

hydrogenated and beeswax yellow. !The capsule shell contains gelatin,

glycerol, sorbitol liquid (non-

crystallising), titanium dioxide, water

purified, and iron oxide red.

What Isotretinoin 30 mg looks like

and contents of the pack

The soft-gelatin capsules are pink

coloured.

The capsules come in blister packs

of 30 and 56 capsules.

[Not all pack sizes may be marketed.]

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS,

UK.

Manufacturer

Ennogen Healthcare International Ltd

Unit G3, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS,

UK.

This leaflet was last revised in April

2026.

Other sources of information

Detailed information on this medicine

is available on the Medicines and

Healthcare Products Regulatory

Agency website: www.mhra.gov.uk

WARNING

CAN SERIOUSLY HARM AN UNBORN BABY

Women must use effective

contraception

Do not use if you are pregnant or

think you may be pregnant

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.

See section 4.

▼This medicine is subject to

additional monitoring. This will allow

quick identification of new safety

information. You can help by

reporting any side effects you may

get. See the end of section 4 for

how to report side effects.

ENV04