Isotiorga 40 mg soft capsules: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Isotiorga 20 mg soft capsules EFG

Isotiorga 40 mg soft capsules

WARNING

MAY CAUSE SERIOUS HARM TO THE UNBORN CHILD IF USED DURING PREGNANCY

Women must use effective contraception throughout treatment.

Do not use if you are pregnant or think you may be pregnant.

Read the entire 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

What Isotiorga is and what it is used for
What you need to know before taking Isotiorga
How to take Isotiorga
Possible adverse effects
How to store Isotiorga
Contents of the pack and other information

1. What Isotiorga is and what it is used for

This medicine contains isotretinoin, a substance related to vitamin A and belonging to the group of medicines known as retinoids (used for the treatment of acne).

Isotiorga is indicated for the treatment of severe forms of acne (for example, nodular acne, acne conglobata, or acne with risk of permanent scarring) in adults and adolescents aged 12 years and older, only after puberty. This medicine is indicated for the treatment of acne that is resistant to conventional treatments, including both antibiotic therapy and topical dermatological treatments.

Treatment with Isotiorga must be supervised by a dermatologist (a doctor specialized in treating skin disorders).

2. What you need to know before taking Isotiorga

Do not take Isotiorga

if you are pregnant or breastfeeding
if there is any possibility you could become pregnant, you must follow the precautions outlined in the "Pregnancy and Pregnancy Prevention Programme" section; see "Warnings and precautions"
if you are allergic to isotretinoin, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6)
if you have liver disease
if you have high levels of lipids in your blood (e.g., cholesterol or triglycerides)
if you have very high levels of vitamin A in your body (hypervitaminosis A)
if you are taking any antibiotic from the tetracycline family (see section "Other medicines and Isotiorga")
if you have ever had a severe skin rash, peeling, blistering, and/or mouth sores after taking isotretinoin.

If any of these apply to you, consult your doctor before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

If you have ever had any mental health problems, including depression, aggressive tendencies, or mood changes, or if you have had thoughts of self-harm or suicide. This is because your mood may be affected while taking this medicine.

Take special care with Isotiorga:

This medicine may cause serious skin reactions. Stop using Isotiorga and seek immediate medical attention if you notice any symptoms related to these serious skin reactions, as described in section 4.

Pregnancy Prevention Programme

Pregnant women must not take Isotiorga

This medicine can seriously harm the unborn baby (the medicine is considered "teratogenic") – it may cause severe abnormalities in the baby's brain, face, ears, eyes, heart, and certain glands (thymus and parathyroid). It also increases the risk of miscarriage. This can happen even if the medicine is taken for only a short time during pregnancy.

Do not take this medicine if you are pregnant or think you might be pregnant.
Do not take this medicine if you are breastfeeding. The medicine may pass into your milk and harm your baby.
Do not take this medicine if you could become pregnant during treatment.
Do not become pregnant during the month following discontinuation of this treatment, as the medicine may still remain in your body.

Women who could become pregnant must follow strict rules when prescribed Isotiorga. This is due to the risk of serious harm to the unborn baby.

These rules are:

Your doctor must explain the risk of fetal harm to you (you must understand why you must not become pregnant and what you need to do to prevent pregnancy).
You must have discussed contraception (birth control) with your doctor. Your doctor will provide information on how to avoid pregnancy. Your doctor may refer you to a specialist for contraceptive advice.
Before starting treatment, your doctor will require you to take a pregnancy test. The test must confirm that you are not pregnant when you begin treatment with this medicine.

Women must use effective contraception before, during, and after taking Isotiorga

You must agree to use at least one highly reliable method of contraception (e.g., an intrauterine device or contraceptive implant) or two effective methods that work in different ways (e.g., a hormonal contraceptive pill and a condom). Discuss with your doctor which methods are suitable for you.
You must use contraception for one month before starting this medicine, during treatment, and for one month after stopping treatment.
You must use contraception even if you are not having periods or are not sexually active (unless your doctor decides it is not necessary).

Women must agree to undergo pregnancy tests before, during, and after taking Isotiorga

You must agree to regular follow-up visits, ideally every month.
You must agree to regular pregnancy tests, ideally every month during treatment and one month after stopping treatment (due to the possibility of residual medicine in your body), unless your doctor decides otherwise.
You must agree to additional pregnancy tests if requested by your doctor.
You must not become pregnant during treatment or during the month after stopping treatment, as the medicine may still be present 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 checklist confirms that you have been informed of the risks and will follow the above rules.

If you become pregnant while taking this medicine, stop taking it immediately and consult your doctor. Your doctor may refer you to a specialist for advice.

Additionally, if you become pregnant more than one month after stopping isotretinoin, you should consult your doctor. Your doctor may refer you to a specialist for advice.

Your doctor has written information on pregnancy prevention for isotretinoin users, which they must provide to you.

Advice for men

Levels of oral retinoids in semen of men taking isotretinoin are too low to harm a baby. However, you must never share your medicine with anyone.

Additional precautions

Never give this medicine to anyone else. Please return any unused capsules to your pharmacist at the end of treatment.

Do not donate blood during treatment with this medicine or for one month after stopping isotretinoin, as a baby could be harmed if a pregnant woman receives your blood.

Mental health issues

You may not notice changes in your mood or behavior, so it is very important to inform your friends and family that you are taking this medicine. They may notice these changes and help you identify any problems early so you can discuss them with your doctor.

Warnings for all patients

Inform your doctor if you have ever had any mental health problems (including depression, suicidal thoughts, or psychosis), or if you are taking medication for any of these conditions.
Serious skin reactions (e.g., erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN)) have been reported with isotretinoin use. The skin rash may progress to widespread blistering or peeling of the skin. Also be alert for mouth, throat, nose, or genital ulcers, and the development of conjunctivitis (redness and swelling of the eyes).
In rare cases, isotretinoin may cause severe allergic reactions, some of which may affect the skin as eczema, hives, or bruising or red spots on arms and legs. If you experience an allergic reaction, stop taking isotretinoin, seek immediate medical attention, and inform the doctor that you are taking this medicine.
Reduce physical activity and intense exercise. This medicine may cause muscle and joint pain, especially in children and adolescents who engage in intense physical activity.
Talk to your doctor if you experience persistent lower back or buttock pain during treatment. These symptoms may indicate sacroiliitis, a type of inflammatory back pain. Your doctor may stop treatment and refer you to a specialist for management of inflammatory back pain. Further evaluation, including imaging such as MRI, may be needed.
Isotretinoin has been associated with inflammatory bowel disease. If you develop severe bloody diarrhea and have no history of gastrointestinal disorders, your doctor will discontinue treatment with this medicine.
Isotretinoin may cause dry eyes, intolerance to contact lenses, and visual difficulties such as reduced night vision. Cases of persistent dry eyes after stopping treatment have been reported. Contact your doctor if you experience any of these symptoms. Your doctor may recommend using a lubricating eye ointment or artificial tears. If you wear contact lenses and develop intolerance, you may be advised to wear glasses during treatment. If you experience visual disturbances, your doctor may refer you to a specialist and may ask you to stop treatment.
Cases of benign intracranial hypertension have been reported with isotretinoin use, and in some cases when the medicine was used together with tetracyclines (a type of antibiotic). Stop taking this medicine and contact your doctor immediately if you experience symptoms such as headache, nausea, vomiting, or vision changes. Your doctor may refer you to a specialist to check for optic disc swelling (papilledema).
Isotretinoin may increase liver enzyme levels. Your doctor will request blood tests before, during, and after treatment to monitor these levels. If levels remain high, your doctor may reduce your dose or discontinue treatment.
Isotretinoin often increases blood lipid levels, such as cholesterol or triglycerides. Your doctor will request blood tests before, during, and after treatment. During treatment, it is best to avoid alcohol or at least reduce your usual intake. Consult your doctor if you already have high blood lipid levels, diabetes (high blood sugar), are overweight, or are alcoholic. You may need more frequent blood tests. If your blood lipid levels remain high, your doctor may reduce your dose or discontinue treatment.
Contact your doctor if you have any kidney problems. Your doctor may start treatment with a lower dose and gradually increase it to the maximum tolerated dose.
Contact your doctor if you have fructose intolerance. Your doctor will not prescribe this medicine if you have fructose or sorbitol intolerance.
Isotretinoin may increase blood sugar levels. Rarely, a person may develop diabetes. Your doctor may monitor your blood sugar levels during treatment, especially if you already have diabetes, are overweight, or are alcoholic.
Your skin is likely to become dry. Use a moisturizing cream and lip balm during treatment. To prevent skin irritation, avoid using exfoliating products or acne treatments.
Avoid excessive sun exposure and do not use sunlamps or tanning beds. Your skin may become more sensitive to sunlight. Apply sunscreen with a high protection factor (SPF 15 or higher) before sun exposure.
Do not undergo any cosmetic skin treatments. This medicine may make your skin fragile. Do not wax, or undergo dermabrasion or laser treatments (to remove thickened skin layers or scars) during treatment or for six months after. This could lead to scarring, skin irritation, or, in rare cases, changes in skin color.

Children and adolescents

The use of this medicine is not recommended in children under 12 years of age, as it is not known whether it is safe or effective in this age group.

Use in children over 12 years of age only after puberty.

Other medicines and Isotiorga

Talk to 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).
Do not use topical acne treatments while taking this medicine. You may use moisturizers and emollients (skin creams or preparations that prevent water loss and have a softening effect on the skin).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.

For more information about pregnancy and contraception, see section 2 "Pregnancy and Pregnancy Prevention Programme".

Driving and using machines

During treatment, you may experience problems with night vision. These may appear suddenly. In rare cases, they may persist after stopping treatment. Very rarely, drowsiness and dizziness have been reported. If this happens, you must not drive or operate machinery.

Isotiorga contains

Soybean oil. Must not be used if you are allergic to peanuts or soy.
Sorbitol: Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, consult your doctor before you (or your child) take or receive this medicine.
Isotiorga 20 mg: This medicine contains up to 7 mg of sorbitol in each soft capsule.
Isotiorga 40 mg: This medicine contains up to 10 mg of sorbitol in each soft capsule.
Isotiorga 40 mg: Ponceau 4R red. May cause allergic reactions.
Isotiorga 20 mg: Orange Yellow S. May cause allergic reactions.

3. How to take Isotiorga

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The usual starting dose is 0.5 mg per kilogram of body weight per day (0.5 mg/kg/day). Therefore, if you weigh 60 kg, you will normally start with a daily dose of 30 mg.

Take the capsules once or twice a day. Take them with a full stomach. Swallow the capsules whole with a drink or some food.

After a few weeks, your doctor may adjust your dose. This will depend on how the medicine affects you. For most people, the dose will range between 0.5 and 1.0 mg/kg/day. If you think this medicine is too strong or too weak, consult your doctor or pharmacist.

If you have severe kidney problems, you will usually start with a lower dose (such as 10 mg/day), which will be gradually increased until the maximum dose your body can tolerate is reached. If your body cannot tolerate the recommended dose, a lower dose may be prescribed: this may mean that treatment will take longer and it is more likely that your acne will return.

A treatment cycle usually lasts between 16 and 24 weeks. Most patients need only one cycle. Your acne may continue to improve for up to eight weeks after treatment ends. You will not usually start another cycle before this time has passed.

Some people notice that acne worsens during the first few weeks of treatment. It usually improves as treatment progresses.

If you take more Isotiorga than you should

If you take too many capsules, or if someone else accidentally takes your medicine, contact your doctor or pharmacist immediately, or go to the nearest hospital.

If you forget to take Isotiorga

If you forget a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue your treatment as before. Do not take a double dose (two doses together) to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Some of the adverse effects associated with isotretinoin use are dose-related. Adverse effects are usually reversible after dose adjustment or discontinuation of treatment; however, some may persist even after treatment has been stopped. Some adverse effects can be serious, and you must contact your doctor immediately, who will help you manage them.

Adverse effects requiring immediate medical attention:

Skin problems

Stop taking isotretinoin and seek immediate medical attention if you notice any of the following symptoms of severe skin reactions:

Red, flat patches on the trunk, often with bull's-eye or circular shapes, frequently with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome [SJS]/toxic epidermal necrolysis [TEN]).
Generalized reddish rash with skin peeling, lumps under the skin, and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis [AGEP]).

Mental health problems

Uncommon effects (may affect up to 1 in 1,000 people)

Depression or related disorders. These signs 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, declining school or work performance, or difficulty concentrating.
Worsening of existing depression.
Becoming violent or aggressive.

Very rare effects (may affect up to 1 in 10,000 people)

Some people have had thoughts of self-harm or ending their lives (suicidal thoughts), have attempted suicide, or died by suicide. These individuals may not appear depressed.
Unusual behavior.
Signs of psychosis: loss of contact with reality, such as hearing voices or seeing things that are not there.

Contact your doctor immediately if you experience any signs of these mental health problems. Your doctor may instruct you to stop taking this medicine. This may not be sufficient to stop the effects—you may need further help, which your doctor can provide.

Allergic reactions

Uncommon effects (may affect up to 1 in 1,000 people)

Severe reactions (anaphylactic): difficulty breathing or swallowing due to sudden swelling of the throat, face, lips, and mouth. Also sudden swelling of the hands, feet, and ankles.

Very rare effects (may affect up to 1 in 10,000 people)

Sudden chest tightness, difficulty breathing, and wheezing, especially if you have asthma.

If you have a severe reaction, seek emergency medical help immediately.

If you have an allergic reaction, stop taking this medicine and contact your doctor.

Muscle and bone problems

Frequency not known (frequency cannot be estimated from available data)

Muscle weakness that may be potentially life-threatening, possibly associated with difficulty moving arms or legs, pain, swelling, bruising, dark or brown-colored urine, reduced or absent urination, confusion, or dehydration. These are signs of rhabdomyolysis, a breakdown of muscle tissue that can lead to kidney failure. This may occur if you engage in intense physical activity while taking this medicine.

Liver and kidney problems

Very rare effects (may affect up to 1 in 10,000 people)

Yellowing of the skin or eyes and feeling tired. These may be signs of hepatitis. Stop taking this medicine immediately and consult your doctor.
Difficulty urinating (passing water), swollen eyelids, and feeling excessively tired. These may be signs of kidney inflammation.

Stop taking Isotiorgade immediately and consult your doctor.

Nervous system disorders

Very rare effects (may affect up to 1 in 10,000 people)

Persistent headache accompanied by malaise (nausea), vomiting, and vision disturbances including blurred vision. These may be signs of benign intracranial hypertension, especially if this medicine is taken with antibiotics called tetracyclines. Stop taking Isotiorgade immediately and consult your doctor.

Gastrointestinal disorders

Very rare effects (may affect up to 1 in 10,000 people)

Severe abdominal (stomach) pain, with or without severe bloody diarrhea, malaise (nausea), and vomiting. These may be signs of serious intestinal diseases.

Stop taking Isotiorgade immediately and consult your doctor.

Frequency not known

Anal fissure (small tear in the thin, moist tissue lining the anus).

Eye disorders

Very rare effects (may affect up to 1 in 10,000 people)

Blurred vision.

If you experience blurred vision, stop taking Isotiorgade immediately and consult your doctor. If you experience any other changes in vision, inform a doctor as soon as possible.

Other adverse effects:

Very common side effects with Isotiorga: (may affect more than 1 in 10 people)

Dry skin, especially of the lips and face; inflamed skin, cracked and inflamed lips, skin rash, mild itching, and slight peeling. Use a moisturizing cream from the start of treatment.
Skin becomes more fragile and redder than usual, especially on the face.
Back, muscle, and joint pain, especially in children and adolescents. To prevent muscle and bone disorders from worsening, reduce intense physical activity while taking this medicine.
Inflammation of the eyes (conjunctivitis) and eyelid area. Dry and irritated eyes. Consult your pharmacist for an appropriate eye drop. If you have dry eyes and wear contact lenses, you may need to switch to glasses.
Elevated liver enzyme levels in blood tests.
Changes in blood fat levels (such as HDL cholesterol or triglycerides).
Increased bruising, bleeding, or clotting, if blood cells responsible for clotting are affected.
Anemia (weakness, dizziness, pale skin) if red blood cells are affected.

Common side effects with Isotiorga: (may affect up to 1 in 10 people)

Headache.
Elevated blood cholesterol levels.
Protein or blood in the urine.
Increased susceptibility to infections if white blood cells are affected.
Dryness and crusting inside the nasal passages leading to minor nosebleeds.
Pain and inflammation of the throat and nose.
Allergic reactions such as skin rash or itching. If you have an allergic reaction, stop taking this medicine and contact your doctor.

Uncommon side effects with Isotiorga: (may affect up to 1 in 1,000 people)

Hair loss (alopecia). This is usually temporary. Your hair should return to normal after treatment ends.

Very rare side effects with Isotiorga: (may affect up to 1 in 10,000 people)

Decreased night vision; worsening of color blindness and color vision.
Increased sensitivity to light. You may need to wear sunglasses to protect your eyes from bright sunlight.
Other visual problems including blurred, distorted, or cloudy vision (corneal opacity and cataracts).
Excessive thirst; frequent need to urinate; increased blood sugar levels in tests. These may be symptoms of diabetes.
Acne may worsen during the first few weeks, but symptoms should improve over time.
Inflamed, swollen, and darker-than-usual skin, especially on the face.
Excessive sweating or itching.
Arthritis; bone disorders (delayed growth, extra bone growth, changes in bone density). May stop bone growth.
Formation of calcium deposits in soft tissues, painful tendons, high levels of muscle breakdown products in the blood if intense exercise is performed.
Increased sensitivity to light.
Bacterial infections at the base of the nail, nail changes.
Inflammation, pus formation, suppuration.
Thickening of scars after surgery.
Increased body hair.
Seizures, drowsiness, dizziness.
Swollen lymph nodes.
Dry throat, hoarseness.
Hearing problems.
General malaise.
Elevated uric acid levels in the blood.
Bacterial infections.
Inflammation of blood vessels (sometimes with bruising and red spots).

Frequency not known: (frequency cannot be estimated from available data)

Dark or brown-colored urine.
Difficulty achieving or maintaining an erection.
Decreased libido.
Breast swelling with or without tenderness in men.
Vaginal dryness.
Sacroiliitis, a type of inflammatory lower back pain causing pain in the buttocks or lower back.
Urethritis (inflammation of the urethra).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Isotiorga

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after {EXP}. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Store below 25 °C.

Keep in the original packaging and retain the blister within the outer carton to protect from light.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their packaging should be returned to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

Return any leftover capsules to your pharmacist. Only keep them if your doctor specifically instructs you to do so.

6. Contents of the pack and other information

Composition of Isotiorga

The active substance is isotretinoin.

The other excipients are: all-rac-alpha-tocopheryl acetate, hydrogenated vegetable oil (type II), hydrogenated soybean oil, yellow beeswax, refined soybean oil, gelatin, glycerol, partially dehydrated liquid sorbitol, titanium dioxide (E-171), patent blue V (E-131) and Ponceau 4R (E-124) for the 40 mg capsules, sunset yellow FCF (E-110) for the 20 mg capsules, and purified water.

Appearance of the product and contents of the pack

Isotiorga is available as soft capsules containing 20 mg or 40 mg of isotretinoin.

Isotiorga 20 mg: soft capsules, whitish to cream-colored, size 6, oval-shaped. The capsule length is approximately 13.8 mm and the width is approximately 8.1 mm.

Isotiorga 40 mg: soft capsules, purple-colored, size 12, oval-shaped. The capsule length is approximately 16.1 mm and the width is approximately 10.1 mm.

Blister packs made of orange PVC/TE/PVdC with aluminium foil backing.

Soft capsules 20 mg

Pack sizes: 30, 50, 60 and 100 capsules

Soft capsules 40 mg

Pack sizes: 30 capsules

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratoires Bailleul S.A.

14-16 Avenue Pasteur

L-2310 Luxembourg

Luxembourg

Manufacturer

GAP S.A.

46, Agissilaou str.,

173 41 Agios Dimitrios, Attiki,

Greece

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria	Isotiorga 10 mg, 20 mg, 40 mg soft capsules
Belgium	Isotiorga 10 mg, 20 mg soft capsules
Czech Republic	Asotiorga
Estonia	Isotiorga
Germany	Isotiorga 10 mg, 20 mg soft capsules
Greece	Isotretinoin/Bailleul 20 mg, 40 mg soft capsules
Hungary	Isotiorga 20 mg soft capsules
Italy	Isotiorga
Luxembourg	Isotiorga 20 mg soft capsules
Portugal	Isotiorga 10 mg, 20 mg soft capsules
Romania	Isotiorga 10 mg, 20 mg soft capsules
Slovak Republic	Isotiorga 20 mg soft capsules
Spain	Isotiorga 20 mg, 40 mg soft capsules

Date of the most recent review of this leaflet: March 2026

Detailed and up-to-date information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Detailed and up-to-date information about this product is also available by scanning the QR code included in the leaflet using a smartphone. The same information is also available at the following link: PENDING INCLUSION OF LINK AND QR CODE.