Leaflet: information for the user

Isotiorga20 mg soft capsules EFG

Isotiorga40 mg soft capsules

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Isotiorga is and what it is used for

2. What you need to know before starting to take Isotiorga

3. How to take Isotiorga

4. Possible side effects

5. Storage of Isotiorga

6. Contents of the pack and additional information

This medication contains isotretinoin, a substance related to vitamin A and belonging to the group of medications known asretinoids(for the treatment of acne).

Isotiorgais indicated for treating severe forms of acne(for example, nodular acne, conglobate acne, or acne with a risk of permanent scarring) in adults and adolescents aged 12 years or older after puberty. This medication is indicated for the treatment of acne when it is resistant to usual treatments, both with antibiotics and with dermatological treatments.

Treatment with Isotiorga must be supervised by a dermatologist(a doctor specializing in the treatment of skin problems).

Do not takeIsotiorga

• if you are pregnant or breastfeeding
• if there is a possibility that you may become pregnant, you must follow the precautions of "Pregnancy and Birth Control Plan", see the section "Warnings and Precautions"
• if you are allergic to isotretinoin, peanuts, or soy or any of the other components (listed in section 6)
• if you have liver disease
• if you have high levels of lipids in the 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 Medications andIsotiorga")

If you find yourself in any of these situations, consult your doctor before taking this medication.

Warnings and Precautions

Consult your doctor or pharmacist before taking this medication.

• If you have ever had any type of mental health problem. This includes depression, aggressive tendencies, or mood swings. Also includes thoughts of self-harm or ending your life. This is because your mood may be affected while taking this medication.

Pregnancy and Birth Control Plan

Pregnant women should not take Isotiorga

This medication can severely harm the baby (the medication is considered "teratogenic") - can cause severe brain, face, ear, eye, heart, and certain gland abnormalities in the baby (thyroid and parathyroid). It also increases the likelihood of spontaneous abortion. This can happen even if this medication is taken only for a short period of time during pregnancy.

• You should not take this medication if you are pregnant or if you think you may be pregnant.
• You should not take this medication if you are breastfeeding. It is likely that the medication will pass into your milk and harm your baby.
• You should not take this medication if you may become pregnant during treatment.
• You should not become pregnant during the month after stopping treatment due to the fact that there may still be medication in your body.

Women who may become pregnant are prescribedIsotiorgaunder strict rules. This is due to the risk of severe harm to the baby.

These are the rules:

• Your doctor must explain the risk of fetal damage (you must understand why you should not become pregnant and what you should do to avoid becoming pregnant).
• You must have discussed birth control (contraception) with your doctor. The doctor will give you information on how to avoid becoming pregnant. The doctor may refer you to a specialist to advise on birth control.
• Before starting treatment, your doctor will ask you to have a pregnancy test. The test must show that you are not pregnant when you start treatment with this medication.

Women must use effective birth control before, during, and after takingIsotiorga

• You must agree to use at least one very reliable method (e.g. an intrauterine device or an implantable contraceptive) or two effective methods that work in different ways (e.g. a hormonal contraceptive pill and a condom). Discuss with your doctor which methods would be suitable for you.
• You must use birth control during a month before taking this medication, during treatment, and during a month after stopping treatment.
• You must use birth control even if you do not have a period or if you are not sexually active (unless your doctor decides that it is not necessary).

Women must accept pregnancy tests before, during, and after taking Isotiorga

• You must agree to have regular follow-up visits, ideally every month.
• You must agree to undergo regular pregnancy tests, ideally every month during treatment, and, due to the fact that there may still be medication in your body, 1 month after stopping treatment with this medication (unless your doctor decides that in your case it is not necessary).
• You must agree to undergo additional pregnancy tests if your doctor requests them.
• You should not become pregnant during treatment or during a month after, because it is possible that there may still be medication 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 about the risks and that you will follow the above rules.

If you become pregnant while taking this medication,stop taking the medication immediatelyand consult your doctor. Your doctor may refer you to a specialist for advice.

Additionally, if you become pregnant after stopping isotretinoin treatment, you must consult your doctor. Your doctor may refer you to a specialist for advice.

Your doctor has written information on pregnancy prevention for isotretinoin users that they will provide to you.

Advice for men

The levels of oral retinoids in the semen of men taking isotretinoin are too low to harm their partners' babies. However, you should never share your medication with anyone.

Additional precautions

You should never administer this medication 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 medication, or during a month after stopping isotretinoin treatment, because a baby could be harmed if a pregnant woman receives your blood.

Mental health problems

You may not notice some changes in your mood and behavior, so it is very important to tell your friends and family that you are taking this medication. They may notice these changes and help you identify any problems you need to discuss with your doctor.

Warnings for all patients

• Inform your doctor if you have ever had any mental health problems(this includes depression, suicidal tendencies, or psychosis), or if you are taking medications for any of these conditions.
• Severe skin reactions (e.g. erythema multiforme (EM), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (NET)) have been reported with the use of isotretinoin. The skin rash may evolve into widespread blistering or skin peeling. You should also be aware of the formation of ulcers in the mouth, throat, nose, or genitals, as well as the development of conjunctivitis (redness and swelling of the eyes).
• In rare cases, isotretinoin can cause severe allergic reactions,some of which can affect the skin in the form of eczema, urticaria, and bruises or red patches on arms and legs. If you experience an allergic reaction, stop taking isotretinoin, go to your doctor immediately, and tell them that you are taking this medication.
• Reduce physical activity and intense exercise.This medicationcan cause muscle and joint pain, especially in children and adolescents who engage in intense physical activity.
• Talk to your doctor if you experience persistent pain in the lower back or buttocks during treatment with this medication. These symptoms may be signs of sacroiliitis, an inflammatory back pain. Your doctor may interrupt treatment with this medication and refer you to a specialist for back pain treatment. Additional evaluation may be required, including imaging modalities such as MRI.
• Isotretinoin has been linked to inflammatory bowel disease.If you experience intense diarrhea with blood and do not have a history of gastrointestinal disorders, your doctor will remove you from treatment with this medication.
• Isotretinoin can cause dry eyes, intolerance to contact lenses, and visual difficulties such as night vision loss. Cases of persistent dry eyes have been reported after stopping treatment.Contact your doctor if you experience any of these symptoms. Your doctor may recommend the use of an eye lubricating ointment or artificial tears. If you are a contact lens user and develop intolerance, you may be advised to use glasses during treatment. If you experience visual problems, your doctor may refer you to a specialist for advice and may ask you to stop treatment with this medication.
• Benign intracranial hypertension has been reported with the use of isotretinoinand, in some cases, whenthis medicationwas used in combination with tetracyclines (a type of antibiotic). Stop takingthis medicationand consult your doctor immediately if you experience symptoms such as headache, nausea, vomiting, and visual disturbances. Your doctor may refer you to a specialist to check if the papilla of the eye has become inflamed (papilledema).
• Isotretinoin can increase liver enzyme levels.Your doctor will ask you to have a blood test before, during, and after treatment with this medication to check these levels. If they remain high, your doctor may reduce your dose or remove you from treatment with this medication.
• Isotretinoin often increases levels of fats in the blood,such as cholesterol or triglycerides. Your doctor will ask you to have a blood test before, during, and after treatment with this medication. During treatment, it is best not to consume alcoholic beverages or, at least, reduce the amount you normally drink. Consult your doctor if you already have high levels of fats in the blood, have diabetes (high blood sugar), are overweight, or are an alcoholic. You may need to have blood tests more frequently. If your levels of fats in the blood continue to be high, your doctor may reduce your dose or remove you from treatment with this medication.
• Contact your doctor if you have any kidney problems.Your doctor may start treatment with a lower dose of this medication and gradually increase it to the maximum tolerated dose.
• Contact your doctor if you have fructose intolerance.Your doctor will not prescribe this medication if you have fructose intolerance or sorbitol intolerance.
• Isotretinoin can increase blood sugar levels.In rare cases, the person may develop diabetes. Your doctor may perform blood sugar level checks during treatment, especially if you already have diabetes, are overweight, or are an alcoholic.
• It is likely that your skin will dry out.Use a moisturizing cream and lip balm during treatment. To prevent skin irritation, it is best not to use 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. Before exposing yourself to the sun, apply high-protection sunscreen (SPF15 or higher).
• Do not undergo any cosmetic treatments on your skin.This medicationcan weaken your skin. Do not wax with wax or undergo dermoabrasion or laser treatments (to remove skin thickening or scars) during treatment or in the six months following treatment. This could cause scarring, skin irritation, or, in rare cases, changes in skin color.

Children and adolescents

This medication is not recommended for children under 12 years old. This is because it is not known if it is safe or effective in this age group.

Use in children over 12 years old only after puberty.

Other medications andIsotiorga

Consult your doctor or pharmacist if you are taking, have taken recently, or may take any other medication.

• Do not take vitamin A supplements or tetracyclines(a type of antibiotic)
• Do notuse skin treatments for acne while taking this medication. You may use moisturizing creams and emollients (creams for the skin or preparations that prevent water loss and have a soothing 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, ask your doctor for advice before taking this medication.

For more information on pregnancy and birth control, see section 2 "Pregnancy and Birth Control Plan"

Driving and using machines

During treatment, you may experience night vision problems. These may appear suddenly. In rare cases, they have continued after stopping treatment. In very rare cases, drowsiness and dizziness have been reported. If this happens to you, do not drive or use machines.

Isotiorgacontains

• Soybean oil.You should not use it if you are allergic to peanuts or soy.
• Sorbitol:Sorbitol is a source of fructose. If your doctor has told you that you (or your child) suffer from 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, consult your doctor before you (or your child) take or receive this medication.
• Isotiorga20 mg:This medication contains up to 7 mg of sorbitol in each soft capsule.
• Isotiorga40 mg:This medication contains up to 10 mg of sorbitol in each soft capsule.
• Isotiorga40mg: red Ponceau 4R.This may cause allergic reactions.
• Isotiorga20 mg: yellow-orange S.This may cause allergic reactions.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Usual starting doseis 0.5mg per kilogram of body weight and per day (0.5mg/kg/day). Therefore, if you weigh 60kg, you will normally start with a dose of 30 mg per day.

Take the capsules one or two times a day.Take them with a full stomach. Swallow them whole with a drink or some food.

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

If you have severe kidney problems,you will normally start with a lower dose (such as 10mg/day) that will be gradually increased to reach the maximum dose your body can tolerate. If your body cannot tolerate the recommended dose, they may prescribe a lower dose: this may mean that the treatment will be longer and it is more likely that your acne will recur.

Treatment cycles usually last between 16 and 24 weeks.Most patients only need one cycle. Your acne may continue to improve up to eight weeks after treatment. Normally, you will not start another cycle before this time has elapsed.

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

If you take moreIsotiorgathan you should

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

If you forgot to takeIsotiorga

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

Like all medications, this medication may cause side effects, although not everyone will experience them. Some side effects associated with taking isotretinoin are related to the dose. Side effects are generally reversible after changing the dose or suspending treatment, however, some may continue once treatment is interrupted. Some side effects can be severe and you should contact your doctor immediately, who will help you remedy them.

Side effects that require immediate medical attention:

Skin problems

Unknown frequency(frequency cannot be estimated from available data)

• Severe skin eruptions (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which are potentially fatal and require immediate medical attention. These initially appear as circular rashes, often with central blisters, usually on arms and hands or legs and feet. In more severe eruptions, blisters may form on the chest and back. They may be accompanied by other symptoms such as eye infection (conjunctivitis) or ulcers in the mouth, throat, or nose. Severe skin eruptions can progress to a generalized peeling of the skin that can be fatal. These severe skin eruptions are usually preceded by headache and body aches and fever (similar to flu symptoms).

If you experience a severe rash or these symptoms on your skin, stop takingthis medicationand consult your doctor immediately.

Mental problems

Rare side effects(can affect up to 1 in 1,000 people)

• Depression or related disorders. These signs include a sad or empty mood, mood swings, 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, decreased school or work performance, or difficulty concentrating.
• Worsening of existing depression.
• Becoming violent or aggressive.

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

• Some people have had thoughts about self-harm or ending their lives (suicidal thoughts), have attempted to end their lives (suicide attempt), or have ended their lives (suicide). These people may not appear depressed.
• Unusual behavior.
• Signs of psychosis: loss of contact with reality, such as hearing voices or seeing things that do not exist.

Contact your doctor immediately if you experience any signs of these mental problems.Your doctor may prescribe you to stop taking this medication. That may not be enough to stop the effects: you may need more help, and your doctor may manage it.

Allergic reactions

Rare side effects(can affect up to 1 in 1,000 people)

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

Very rare side effects(can 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, get emergency medical help immediately.

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

Muscle and bone problems

Unknown frequency(frequency cannot be estimated from available data)

• Muscle weakness that can be potentially fatal, may be associated with difficulty moving arms or legs, pain, swelling, bruises on the body, dark urine, reduced or absent urination, confusion, or dehydration. These are signs of rhabdomyolysis, a muscle tissue rupture that can cause kidney failure. This can occur if you engage in intense physical activity while taking this medication.

Liver and kidney problems

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

• Yellow skin or eyes and feeling tired. These may be signs of hepatitis. Stop taking this medication immediately and consult your doctor.
• Difficulty urinating (expelling water), swollen and inflamed eyelids, excessive tiredness. These may be signs of kidney inflammation.

Stop taking Isotiorgaimmediately and consult your doctor.

Nervous system problems

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

• Durable headache along with nausea(nausea), vomiting, and alterations in vision including blurred vision. These may be signs ofbenign intracranial hypertension,especially if this medication is taken with antibiotics called tetracyclines.Stop taking Isotretinoína Bailleul immediately and consult your doctor.

Gastrointestinal and stomach problems

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

• Severe abdominal pain (stomach pain), with or without severe diarrhea with blood, feeling of nausea(nausea)and vomiting. These may be signs of severe intestinal diseases.

Stop taking Isotiorgaimmediately and consult your doctor.

Eye problems

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

• Blurred vision.

If you have blurred vision, stop taking Isotiorgaimmediately and consult your doctor.If your vision suffers any other alteration, inform your doctor as soon as possible.

Other side effects:

Very frequent side effects with Isotiorga:(can affect more than 1 in 10 people)

• Dry skin, especially on the lips and face; inflamed skin, cracked and inflamed lips, skin rash, mild itching, and mild peeling. Use a moisturizing cream from the start of treatment.
• The skin becomes more fragile and more red than usual, especially on the face.
• Back, muscle, and joint pain, especially in children and adolescents.To avoid worsening muscle and bone problems,reduce intense physical activity while taking this medication.
• Inflammation of the eyes (conjunctivitis) and eyelid area. Dry and irritated eyes. Consult the pharmacist to indicate a suitable eye drop. If you have dry eyes and wear contact lenses, you may need to wear glasses.
• Elevated liver enzymes in blood tests.
• Changes in blood lipid levels (such as HDL cholesterol or triglycerides).
• Bleeding, bruising, or clotting more commonly, if blood cells responsible for clotting are affected.
• Anemia (weakness, dizziness, pale skin) if red blood cells are affected.

Frequent side effects with Isotiorga:(can affect up to 1 in 10 people)

• Headache.
• Elevated cholesterol levels in the blood.
• Proteins or blood in the urine.
• Increased susceptibility to infections if white blood cells are affected.
• Dryness and crusting inside the nasal passages causing light bleeding.
• 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 medication and contact your doctor.

Rare side effects with Isotiorga:(can affect up to 1 in 1,000 people)

• Hair loss(alopecia). It is usually a temporary effect. Your hair should return to normal after completing treatment.

Very rare side effects withIsotiorga:(can affect up to 1 in 10,000 people)

• Decreased night vision; color blindness and color vision worsen.
• Increased sensitivity to light. You may need to wear sunglasses to protect your eyes from bright sunlight.
• Other visual problems including blurred, distorted, and cloudy vision (corneal opacity and cataracts).
• Excessive thirst; frequent urination and increased blood sugar levels in tests. These may be symptoms of diabetes.
• Acne may worsen during the first weeks, but symptoms should improve over time.
• Inflamed, swollen, and darker skin, especially on the face.
• Excessive sweating or itching.
• Arthritis; bone disorders (delayed growth, excessive growth, and bone density changes). It may stop bone growth.
• 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, changes in nails.
• Inflammation, pus, and suppurative.
• Thickening of scars after surgery.
• Increased body hair.
• Convulsions, drowsiness, and dizziness.
• Lymph nodes may become inflamed.

• Dry throat, hoarseness.
• Ear problems.
• General discomfort.
• Elevated uric acid levels in the blood.
• Bacterial infections.
• Inflammation of blood vessels (sometimes with bruises and red spots).

Unknown frequency:(frequency cannot be estimated from available data)

• Dark or brown urine.
• Difficulty achieving or maintaining an erection.
• Decreased libido.
• Swollen breasts with or without breast tenderness in men.
• Vaginal dryness.
• Sacroiliitis, a type of low back inflammatory pain that causes pain in the buttocks or lower back.
• Urethral inflammation.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through theSpanish Medicines Vigilance System,https://www.notificaram.es/.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after {CAD}. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

Store below 25°C.

Store in the original packaging and keep the blister pack in the outer packaging to protect from light.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and

medications that you no longer need at the SIGREpoint of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Return any remaining capsules to your pharmacist.Only store them if your doctor instructs you to.

Composition ofIsotiorga

The active ingredient is isotretinoin.

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

Appearance of the product and contents of the package

Isotiorgais presented in soft capsules containing 20mg or 40mg of isotretinoin.

Isotiorga20mg: soft capsules, off-white to cream-colored, size 6, oval.The length of the capsule is approximately 13.8 mm and the width is approximately 8.1 mm.

Isotiorga40mg: soft capsules, purple, size 12, oval. The length of the capsule is approximately 16.1 mm and the width is approximately 10.1 mm.

PVC/TE/PVdC orange blisters/aluminum foil.

Soft capsules of 20 mg

Pack sizes: 30, 50, 60, and 100 capsules

Soft capsules of 40 mg

Pack sizes: 30 capsules

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratoires Bailleul S.A.

14-16 Avenue Pasteur

L-2310 Luxembourg

LUXEMBOURG

Responsible manufacturer

GAP S.A.

46, Agissilaou str.,

173 41 Agios Dimitrios, Attiki,

Greece

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

Last review date of this leaflet: January 2024

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

Detailed andupdatedinformation on this product is available by scanning the QR code included in the leaflet through a smartphone. The same information is also available at the following link: PENDING TO INCLUDE LINK AND QR CODE