What it is and what it is used for

for 2. What you need to know before you take Isotretinoin 20 mg 3. How to take Isotretinoin 20 mg 4. Possible side effects 5. How to store Isotretinoin 20 mg 6. Contents of the pack and other information

this age group. Use in adolescents over 12 years of age only after puberty.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOTRETINOIN 20 MG (continued…) Your prescriber must have considered that there is no other appropriate treatment before starting your isotretinoin therapy. Other medicines and Isotretinoin 20 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 20 mg because the risk of getting side effects may increase. Do not use any skin treatments for acne during treatment with Isotretinoin 20 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). Avoid the use of topical keratolytic or exfoliative anti-acne agents during treatment with Isotretinoin 20 mg. Pregnancy and breast-feeding Pregnancy Isotretinoin 20 mg must not be taken during pregnancy, as Isotretinoin the active compound of Isotretinoin 20 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

1. WHAT ISOTRETINOIN 20 MG IS AND WHAT IT IS USED FOR Isotretinoin 20 mg soft capsules contains the active ingredient isotretinoin. This is a vitamin A derivative, belonging to the retinoid class of medicines. Isotretinoin 20 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.

What you need to know before you take it

E ISOTRETINOIN 20 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 20 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 20 mg. Do not take Isotretinoin 20 mg ! If you are pregnant or breastfeeding. ! 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

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 20 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.

(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 20 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 20 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 20 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 20mg. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may discontinue treatment with Isotretinoin 20mg 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 20 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 20 mg is taken only for a short time during pregnancy. ! !

! !

You must not take Isotretinoin 20 mg if you are pregnant or if you think you might be pregnant. You must not take Isotretinoin 20 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 20 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 20 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 20 mg. Women must use effective contraception before, during and after taking Isotretinoin 20 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 20 mg, during treatment and for a month afterwards.

Ponceau 4R (E124) may cause allergic reactions.

over 12 years of age only after puberty.

How to take it

ISOTRETINOIN 20 MG

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.

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 20 mg is too strong or too weak, talk to your doctor or pharmacist.

Isotretinoin 20 mg contains soya oil, sorbitol and Ponceau 4R (E124). If you are allergic to peanut or soya, do not use this medicinal product.

Patients with severe renal insufficiency If you have severe kidney problems, Isotretinoin 20 mg should be started at a lower dose such as 10 mg/day and then increased up to the highest tolerated dose.

This medicine contains 17 mg sorbitol in each capsule. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Children The use of Isotretinoin 20 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

Duration of treatment A course of 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 20 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 20 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.

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-

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Artwork No.

180225/6

Customer

Accord

Description

Isotretinoin 20mg Leaflet

Market

UK

Language

English

Dimensions

600 x 210 mm

Min. Font Size

9 pt

Version No.

8

Date

02-04-26

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 20 mg ! !

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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 20 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 20 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 20 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.

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 20mg 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 20mg 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).

Unvarnish area

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.

One month after the end of treatment with Isotretinoin 20 mg another medically supervised pregnancy test must be carried out, because it takes about 1 month before the active substance contained in Isotretinoin 20 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 20 mg are too low to harm their partners' unborn baby. However, you must never share your medication with anyone. Additional precautions

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 20 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.

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 20 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 20 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

Stop taking Isotretinoin 20mg and contact your doctor if any of the following side effects occur.

the skin, dryness of the mucosa e.g. of the lips, the nasal mucosa, and the eyes.

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.

Also the following side effects may occur:

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 20mg. 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

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 20mg). Common (may affect up to 1 in every 10 people) ! Headache ! Neutrophilic leucozytes 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

changes and help you quickly identify any problems that you need to talk to your doctor about. Other precautions ! Isotretinoin 20 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 20 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 20 mg may increase your liver enzyme levels. Your doctor will do some blood tests before, during and at the end of your Isotretinoin 20 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 20 mg therapy. ! Isotretinoin 20 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 20 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 20 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 20 mg may not be enough and you may require further psychiatric or psychological

! Convulsions, drowsiness, dizziness ! Inflammation of the colon mucosa and intestinal mucosa ! Dry throat ! Pancreatitis (see section 2. Before you take Isotretinoin 20 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/hypertosis) ! 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)

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 20 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 20 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 20 mg has been very rarely associated with a condition called benign

! 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.

How to store it

ISOTRETINOIN 20 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 container. Keep container in the outer carton. 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.

intracranial hypertension. ! If you experience severe haemorrhagic diarrhoea (e.g. blood in your stool). Isotretinoin 20 mg has on very rare occasions been associated with inflammatory bowel disease. What to avoid when taking Isotretinoin 20 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 20 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 20 mg may make your skin more fragile and this could cause scarring or irritation of the skin. ! Reduce intensive physical activity during Isotretinoin 20 mg therapy, because muscle and joint pain have been observed during Isotretinoin 20 mg treatment. ! Do not donate blood either during or for one month after Isotretinoin 20 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 20 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

Contents of the pack and other information

What Isotretinoin 20 mg contains The active substance is isotretinoin. Each capsule contains 20 mg of isotretinoin. The other ingredients are Soya-bean oil (see section 2), DL-alphatocopherol, disodium edetate, butylhydroxyanisole, soya-bean oil (partly) hydrogenated (see section 2), beeswax yellow and vegetable oil hydrogenated. The capsule shell contains gelatin, glycerol, sorbitol solution 70% (non-crystallising) (see section 2), Ponceau 4R (E124) (see section 2), titanium dioxide, water purified, and Indigotine Lacquer (E132). What Isotretinoin 20 mg looks like and contents of the pack The soft-gelatin capsules are maroon coloured. The capsules come in blister packs of 28, 30, 56 or 60 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

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