ISOTIORGA 20 mg SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the User

Isotiorga20 mg soft capsules EFG

Isotiorga40 mg soft capsules

WARNING

IN CASE OF PREGNANCY, IT CAN SERIOUSLY HARM THE BABY

Women must use effective contraceptive methods throughout treatment.

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

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What is Isotiorga and what is it used for
2. What you need to know before taking Isotiorga
3. How to take Isotiorga
4. Possible side effects
5. Storage of Isotiorga
6. Package contents and additional information

1. What is Isotiorga and what is it used for

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

Isotiorgais indicated for the treatment of severe forms of acne(such as nodular acne, conglobate acne, or acne with a risk of permanent scarring) in adults and adolescents from 12 years of age, only after puberty. This medication is indicated for the treatment of acne when it is resistant to usual treatments, both with antibiotics and topical treatments.

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

2. What you need to know before taking Isotiorga

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 Pregnancy Prevention Plan", see the section "Warnings and precautions"
• if you are allergic to isotretinoin, peanuts, or soy, or any of the other components of this medication (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 the body (hypervitaminosis A)
• if you are taking any antibiotic from the tetracycline family (see section "Other medications and Isotiorga")

If you are 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 changes. It also includes thoughts of self-harm or ending your life. This is because your mood may be affected while taking this medication.

Pregnancy Prevention Plan

Pregnant women must not take Isotiorga

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

• Do not take this medication if you are pregnant or think you may be pregnant.
• Do not take this medication if you are breastfeeding. It is likely that the medication will pass into your milk and may harm your baby.
• Do not take this medication if you can become pregnant during treatment.
• Do not become pregnant during the month following the interruption of this treatment, as the medication may still be present in your body.

Women who may become pregnant have been prescribedIsotiorgaunder strict rules. This is due to the risk of serious harm to the baby.

These are the rules:

• Your doctor must explain the risk of fetal damage to you (you must understand why you should not become pregnant and what you should do to avoid becoming pregnant).
• You must have discussed contraception (birth control) with your doctor. The doctor will give you information on how to avoid becoming pregnant. The doctor may refer you to a specialist for contraception advice.
• 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 contraceptives before, during, and after takingIsotiorga

• You must agree to use at least one very reliable contraceptive method (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 would be suitable for you.
• You must use contraceptives for a month before taking this medication, during treatment, and for a month after finishing treatment.
• You must use contraceptives even if you do not have your period or are not sexually active (unless your doctor decides it is not necessary).

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

• You must agree to have regular follow-up visits, ideally every month.
• You must agree to have regular pregnancy tests, ideally every month during treatment, and, because the medication may still be present in your body, 1 month after finishing treatment with this medication (unless your doctor decides it is not necessary in your case).
• You must agree to have additional pregnancy tests if your doctor requests them.
• You must not become pregnant during treatment or during the month following treatment, as the medication 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 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 a month of stopping isotretinoin, you must consult your doctor. Your doctor may refer you to a specialist for advice.

Your doctor has written information about pregnancy prevention for users ofisotretinointhat they should give you.

Advice for men

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

Additional precautions

Never give this medication to another person. Please take any unused capsules to your pharmacist at the end of treatment.

Do not donate blood during treatment with this medication, nor during the month following the end of treatment withisotretinoin, as a baby could be harmed if a pregnant patient receives your blood.

Mental health problems

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

Warnings for all patients

• Tell 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 (TEN)) have been reported with the use ofisotretinoin. The skin rash can evolve into generalized blistering or peeling of the skin. You should also pay attention to 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 bruising or red spots on the arms and legs. If you experience an allergic reaction, stop taking isotretinoin, go to the doctor immediately, and tell them that you are taking this medication.
• Reduce physical activity and intense exercise.This medication can 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 can be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may interrupt treatment with this medication and refer you to a specialist for the treatment of inflammatory back pain. You may need additional evaluation, including imaging modalities such as MRI.
• Isotretinoinhas been associated with inflammatory bowel disease.If you experience severe diarrhea with blood and have no history of gastrointestinal disorders, your doctor will withdraw treatment with this medication.
• Isotretinoincan cause dry eyes, intolerance to contact lenses, and visual difficulties such as decreased night vision.In rare cases, dry eyes have not resolved after treatment was stopped. Contact your doctor if you experience any of these symptoms. Your doctor may recommend the use of an eye lubricant 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 disturbances, your doctor may refer you to a specialist for advice and may ask you to stop treatment with this medication.
• There have been reports of benign intracranial hypertension with the use ofisotretinoinand, in some cases, when this medication was used in combination with tetracyclines (a type of antibiotic). Stop taking this medication and consult your doctor immediately if you experience symptoms such as headache, nausea, vomiting, and vision changes. Your doctor may refer you to a specialist to check for papilledema (inflammation of the optic nerve).
• Isotretinoincan 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 the dose or withdraw treatment with this medication.
• Isotretinoinoften increases blood fat levels,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 to reduce the amount you drink. Consult your doctor if you already have high blood fat levels, suffer from diabetes (high blood sugar), are overweight, or are an alcoholic. You may need to have blood tests more frequently. If your blood fat levels remain high, your doctor may reduce the dose or withdraw 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 problems.Your doctor will not prescribe this medication if you have fructose intolerance or sorbitol intolerance.
• Isotretinoincan 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 suffer from diabetes, are overweight, or are an alcoholic.
• It is likely that your skin will become dry. Use a moisturizing cream and lip balm during treatment. To prevent skin irritation, it is best not to use exfoliating products or anti-acne products.
• 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 a sunscreen with a high protection factor (SPF 15 or higher).
• Do not undergo any cosmetic skin treatments.This medication can make your skin fragile. Do not wax or undergo dermabrasion or laser treatments (to remove thickening of the skin's corneal layer 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 use in children under 12 years of age. This is because it is not known if it is safe or effective in this age group.

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

Other medications andIsotiorga

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

• Do not take vitamin A supplements or tetracyclines(a type of antibiotic)
• Do notuse anti-acne skin treatments while taking this medication. You can use moisturizing and emollient products (skin creams 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 about pregnancy and contraception, see section 2 "Pregnancy and Pregnancy Prevention Program"

Driving and using machines

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

Isotiorgacontains

• Soybean oil.Do not use 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) have an intolerance to some sugars or 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.
• Isotiorga40 mg:Red Ponceau 4R.May cause allergic reactions.
• Isotiorga20 mg:Orange Yellow S.May cause allergic reactions.

3. How to take Isotiorga

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

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

Take the capsules once or twice 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 about the medication. For most people, the dose will range between 0.5 and 1.0 mg/kg/day. If you think this medication is too strong or too mild, consult your doctor or pharmacist.

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

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

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

If you take moreIsotiorgathan you should

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

If you forget to takeIsotiorga

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

4. Possible side effects

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

Side effects that require immediate medical attention:

Skin problems

Unknown frequency(frequency cannot be estimated from available data)

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

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

Mental problems

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

• Depression or related disorders. These signs include a 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, decreased school or work performance, or problems 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 own lives (suicidal thoughts), have attempted to end their own lives (suicide attempt), or have ended their lives (suicide). It is possible that these people do not appear to be 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 signs of any of these mental problems.Your doctor may advise you to stop taking this medication. This may not be enough to stop the effects: you may need more help and your doctor can handle it.

Allergic reactions

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

• Severe reactions (anaphylactic): difficulty breathing or swallowing caused by a 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, 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 life-threatening, may be associated with difficulty moving the arms or legs, pain, swelling, bruising on the body, dark urine, reduced or absent urination, confusion, or dehydration. These are signs of rhabdomyolysis, a muscle tissue breakdown 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 effects(may affect up to 1 in 10,000 people)

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

Stop taking Isotiorgaimmediately and consult your doctor.

Nervous system disorders

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

• Persistent headache along with a feeling of discomfort (nausea), vomiting, and changes in vision including blurred vision. These can be signs of benign intracranial hypertension,especially if this medication is taken with antibiotics called tetracyclines. Stop taking Isotiorgaimmediately and consult your doctor.

Intestinal and stomach disorders

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

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

Stop taking Isotiorgaimmediately and consult your doctor.

Eye disorders

Very rare effects(may 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 a doctor as soon as possible.

Other side effects:

Very common side effects with Isotiorga:(may 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 slight peeling. Use a moisturizing cream from the start of treatment.
• The skin becomes more fragile and redder than usual, especially on the face.
• Back pain, muscle and joint pain, especially in children and adolescents. To avoid worsening muscle and bone disorders,reduce intense physical activity while taking this medication.
• Eye inflammation (conjunctivitis) and eyelid inflammation. Dry and irritated eyes. Consult your pharmacist for a suitable eye drop.
• Elevated liver enzyme levels in blood tests.
• Changes in blood fat levels (such as HDL cholesterol or triglycerides).
• Bruises, bleeding, or clotting more commonly, if the 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 cholesterol levels in the blood.
• Protein or blood in the urine.
• Increased likelihood of developing infections if white blood cells are affected.
• Dryness and crust formation inside the nasal passages, causing minor bleeding.
• Throat and nose pain and inflammation.
• Allergic reactions such as skin rash or itching. If you have an allergic reaction, stop taking this medication and contact your doctor.

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

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

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

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

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

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

• Dark or brown urine.
• Difficulty getting or maintaining an erection
• Decreased libido
• Breast swelling with or without sensitivity in men
• Vaginal dryness
• Sacroiliitis, a type of inflammatory lower back pain that causes pain in the buttocks or lower back.
• Urethra inflammation

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use, https://www.notificaram.es/.

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

5. Storage of Isotiorga

Keep this medication out of sight and reach of children.

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

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

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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

Return any leftover capsules to your pharmacist.Only keep them if your doctor tells you to.

6. Package contents and additional information

Composition ofIsotiorga

The active ingredient is isotretinoin.

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

Appearance of the product and package contents

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

Isotiorga 20 mg: soft capsules, 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.

Isotiorga 40 mg: 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 /aluminum paper blisters.

Soft capsules of 20 mg

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

Soft capsules of 40 mg

Package sizes: 30 capsules

Not all package sizes may be marketed.

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 medication is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: January 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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