Patient Information Leaflet: INFORMATION FOR THE PATIENT

Isdiben 10 mg Soft Capsules EFG

Isotretinoin

You can help by reporting any side effects you may get. The end of section 4 includes information on how to report these side effects.

Read the entire 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 questions, ask 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Isdiben is and what it is used for

2. What you need to know before taking Isdiben

3. How to take Isdiben

4. Possible side effects

5. Storage of Isdiben

6. Contents of the pack and additional information

Isdiben soft capsules contain isotretinoin.

• Isotretinoin is related to vitamin A.
• It belongs to a group of medicines called “retinoids”.

Isdiben is indicated for treating severe forms of acne.

• This acne can cause permanent scarring
• These types of acne are also known as nodular or conglobate acne

Isdiben is used when your acne has not improved after other treatments that may include antibiotics or dermatological treatments.

Your treatment should be supervised by a dermatologist. These doctors are specialists in skin problems.

Do not take Isdiben if:

• you are pregnant or breastfeeding.
• if you plan to become pregnant.

• if there is a possibility that you may become pregnant, you must follow the "Pregnancy Prevention Plan", consult the section "Warnings and precautions".

• you are allergic to peanuts or soy or to any of the components or to any of the components of Isdiben. This medication contains soy oil, in addition to isotretinoin. See section 6 (Other information) at the end of the prospectus to consult the complete list of ingredients
• you have been diagnosed with liver problems.
• you have been diagnosed with very high levels of fat in the blood (such as high cholesterol or triglycerides).
• you have been diagnosed with very high levels of vitamin A in your body (known as hypervitaminosis A).
• if you are being treated at the same time with a type of antibiotic called tetracyclines (see "Use of other medications").

Please consult your doctor if you are affected by any of these situationsdo not take this medication. Ask your doctor before taking it.

Use in children under 12 years

• Do not administer to children under 12 years. Only administer to those over 12 years if they have already reached puberty.

Special precautions with Isdiben

Do not take this medication if you are pregnant.

Pregnancy Prevention Plan

Pregnant women should not take isotretinoin.

This medication can severely harm the baby (the medication is considered "teratogenic") - it 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 occur even if Isdiben is taken for only a short period of time during pregnancy.

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

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

These are the rules:

• Su médico debe explicarle el riesgo de daño al bebé - usted debe entender por qué no debe quedarse embarazada y qué debe hacer para evitar quedarse embarazada.
• Debe haber hablado con su médico sobre la anticoncepción (control de la natalidad). El médico le dará información sobre cómo evitar quedarse embarazada. El médico puede enviarle a un especialista para que le de consejos sobre anticoncepción.
• Antes de comenzar el tratamiento, su médico le pedirá que se realice una prueba de embarazo. La prueba debe mostrar que no está embarazada cuando comienza el tratamiento con Isdiben.

Women must use effective contraceptives before, during, and after taking Isdiben

• 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 what methods would be suitable for you.
• Must use contraceptives for a month before taking Isdiben, during treatment, and for a month after stopping treatment.
• Must use contraceptives 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 agree to undergo pregnancy tests before, during, and after taking Isdiben

• Must agree to undergo regular follow-up visits, ideally every month.
• 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 Isdiben (unless your doctor decides that it is not necessary).Must agree to undergo additional pregnancy tests if your doctor requests them.
• Must not become pregnant during treatment or for a month after, as 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 Isdiben,stop taking the medication immediatelyand consult your doctor. Your doctor may refer you to a specialist for advice.

Additionally, if you become pregnant within a month of stopping Isdiben, you must consult your doctor. Your doctor may refer you to a specialist for advice.

Advice for men

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

Additional precautions

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

Do not donate blood during treatment with this medication, or for 1 month after stopping Isdiben, as a baby could be harmed if a pregnant woman receives your blood.

Warning for all patients

Consult your doctor before starting to take Isdiben:

• if you have ever had any mental health problems. This includes depression, aggressive tendencies, or mood changes. It also includes thoughts of self-harm or suicide. This is because your mood may be affected while taking Isdiben.
• Consult your doctor also if you are taking medications for any of these conditions. This is because your mood may be affected while taking isotretinoin.

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 that you need to discuss with your doctor.

Isotretinoin often 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 isotretinoin. During treatment, it is better not to consume alcoholic beverages or, at least, reduce the amount you used to drink. Consult your doctor if you already have high levels of fat in your blood, suffer from diabetes, are overweight, or consume too much alcohol. You may need to have blood tests more frequently. If your blood fat levels continue to be high, your doctor may reduce your dose or stop treatment with this medication.

• Isotretinoin can affect the liver

Your doctor will ask you to have a blood test before, during, and after treatment with isotretinoin to check liver function. If liver function is affected, your doctor may reduce your dose or stop treatment with isotretinoin.

• Isotretinoin can increase blood sugar levels.In rare cases, the person may develop diabetes. Your doctor may perform blood sugar level checks during treatment. This is especially important if you already have diabetes, are overweight, or consume too much alcohol.
• It is likely that your skin will become dry:use a moisturizing cream and lip balm. To prevent skin irritation, it is better not to use exfoliating products or other skin treatments for acne during treatment or for 6 months after, as this could cause scarring, skin irritation, or, in rare cases, changes in skin color.
• Severe skin reactions have been reported(e.g. erythema multiforme (EM), Stevens-Johnson syndrome (SSJ) and toxic epidermal necrolysis (TEN)) with the use of this medication.Skin rash can evolve into widespread blistering or skin peeling. 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, this medication can cause severe allergic reactions,some of which can affect the skin in the form of eczema, urticaria (skin rash with bumps) and bruises or red patches on arms and legs. If you experience an allergic reaction, stop taking the medication, immediately see your doctor, and tell them that you are taking this medication.
• Avoid exposure to the sun and do not use lamps or sunbeds.Your skin may become more sensitive to sunlight. Before exposing yourself to the sun, apply a high-protection sunscreen (SPF 50 or higher).
• Do not perform any cosmetic treatments on your skin.Isotretinoin may make your skin more fragile. Do not wax with wax or undergo dermoabrasion or laser treatments (to remove skin thickening or scars) during treatment or for 6 months after, as this could cause scarring, skin irritation, or, in rare cases, changes in skin color.
• Isotretinoin has been linked to inflammatory bowel disease.If you experience intense diarrhea with blood, and you do not have a history of gastrointestinal disorders, your doctor will stop treatment with isotretinoin.
• Isotretinoin can cause dry eyes, intolerance to contact lenses, and visual difficulties such as night vision loss.There have been reports of persistent dry eyes that do not resolve 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 have visual problems, your doctor may refer you to a specialist for advice, and may ask you to stop treatment with isotretinoin.
• In rare cases, this medication can cause benign intracranial hypertensionand, in some cases, when isotretinoin was used with tetracyclines (a type of antibiotic). Stop taking isotretinoin and immediately see your doctor if you experience symptoms such as headache, nausea, vomiting, and visual disturbances. Your doctor may refer you to a specialist to check if the optic nerve has become inflamed (papilledema).
• Reduce physical activity and intense exercise.Isotretinoin may cause muscle and joint pain, especially in young people.
• Talkto your doctor if you experience persistent pain in the lower back or buttocks during treatment with Isdiben. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may stop treatment with Isdiben and refer you to a specialist for pain treatment. You may need additional evaluation, including imaging modalities such as MRI.
• Do not take vitamin A supplementswhile taking this medication. Taking both products together may increase the risk of adverse effects.
• Contact your doctor if you have any kidney problems.Your doctor may start treatment with a lower dose of isotretinoin and gradually increase it to the maximum tolerated dose.
• Do not donate bloodwhile taking isotretinoin or for 1 month after stopping treatment. If a pregnant woman receives your blood, the fetus may be harmed.
• Remember that you must not share the medication with anyone else.You will need to return unused capsules at the end of treatment. Ask your doctor or pharmacist where you can return the capsules.

Driving and using machines

You may experience eye problems and vision may be affected during treatment. This can occur suddenly. In rare cases, night vision problems have continued after stopping treatment.

In very rare cases, drowsiness and dizziness have been reported. If this happens to you, do not drive, ride a bike, or use machinery.

Use with other medications

Do not take supplements containing vitamin A or tetracyclines(a type of antibiotic), or use other acne treatments that dry or peel your skin, while taking isotretinoin. You can use moisturizing and emollient products (creams or preparations that prevent water loss and have a soothing effect on the skin).

Consult your doctor or pharmacist if you are taking any other medication, including herbal products and over-the-counter products (such as multivitamin supplements) and skin products, or if you have taken them recently.

Pregnancy, breastfeeding, and fertility

For more information on pregnancy and contraception, see the section "Pregnancy Prevention Plan" in the section 2 "Warnings and Precautions".

Do not use Isdiben if you are pregnant or intend to become pregnant. Your doctor may provide you with more information.

Important information about some of the components of Isdiben soft capsules -

This medication contains soy oil.Do notuse it if you are allergic to peanuts or soy.

Follow exactly the administration instructions forisotretinoinprescribed by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Take the capsules one or two times a day.

Take them during meals or immediately after meals. Swallow them whole with the help of a liquid or a bite of food

Your doctor may adjust your dose after a few weeks.This will depend on how you feel the medication. For most people, the dose will range from 0.5 to 1 mg per kilogram of body weight per 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 (e.g., 10 mg per 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 means that the treatment will be longer and it is more likely that your acne will recur.

Treatment usually lasts between 4 and 6 months.Most people only need one cycle. Your acne may continue to improve up to 8 weeks after treatment. You will normally not start another cycle before this time has elapsed.

Acne may worsen in some people during the first week of treatment. It usually improves as treatment progresses.

If you take more Isdiben than 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.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the nearest hospital immediately, or call the Toxicology Information Service, phone: 91 562 04 20.

If you forget to take a dose.

If you forget to take a dose, take it as soon as you remember. However, if it is almost time to take the next dose, skip the missed dose and continue treatment as usual. Do not take two doses at the same time.

This medication may cause side effects, although not everyone will experience them. Often, these side effects decrease or disappear when treatment is stopped. Your doctor can help you manage them.

Stop taking this medication and contact your doctor immediately if you experience any of the following side effects,although this may not be enough to make them go away and you may need more help (your doctor may be able to arrange this).

Mental health problems

You may not be aware of some changes in your mood and behavior, so it's very important to discuss this with your friends and family who are taking this medication. They may be able to notice these changes and help you quickly identify any problems you should discuss with your doctor.

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

• Depression or related disorders. These signs include feeling sad or irritable, anxiety, emotional distress.
• Worsening of existing depression.
• Becoming violent or aggressive.

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

• Some people have had thoughts or feelings of 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 to be 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 of these mental health problems.Your doctor may prescribe you to stop taking Isdiben. This may not be enough to stop the effects: you may need more help, and your doctor may be able to arrange this.

Rash and other skin symptoms

Frequency unknown(cannot be estimated from available data)

• This medication may cause severe skin rashes, which can be potentially life-threatening and require urgent medical attention. They often start with rashes on arms, hands, legs, or feet, which may contain blisters. In more severe skin rashes, 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.
• If you start to peel a large area of skin, it's a sign of a serious condition and you should go to the hospital immediately. Bring the medication with you. The most severe forms of skin rash can cause widespread skin peeling, which can be fatal. If you experience symptoms similar to the flu (headache, fever, body aches), they may be followed by a severe skin rash, so be aware and prepared to act quickly.

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

• Dry skin, especially on the lips and face; red and painful skin, cracked and inflamed lips, rash, mild itching, and light peeling. If you use a moisturizing cream from the start of treatment, you may reduce the risk of these disorders.
• The skin may become more fragile and red than usual, especially on the face.

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

• Hair loss, which is usually temporary. Your hair will return to normal after treatment ends.

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

• Acne may worsen in the first few weeks, but symptoms improve over time.
• Red, swollen, and darker-than-usual skin, especially on the face.
• Excessive sweating or itching.
• Increased sensitivity to light.
• Bacterial infections of the nail base and other changes in the nails.
• Swelling, suppurating, and pus.
• Thickening of surgical scars.
• Increased body hair.

Allergic reactions

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

• Severe allergic reactions such as difficulty breathing or swallowing caused by sudden swelling of the throat, face, lips, and mouth. Also, sudden swelling of the hands, feet, and ankles. If you have an allergic reaction, stop taking isotretinoine immediately and contact your doctor.
• Skin allergic reactions such as rash or itching.

Other problems

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

• Increased levels of liver enzymes in blood tests.

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

• Yellowing of the skin and eyes and feeling more tired than usual. They may be signs of hepatitis.
• Difficulty urinating, swelling of the eyelids, feeling more tired than usual. They may be signs of kidney problems.
• Severe abdominal pain, accompanied or not by bloody diarrhea, nausea, and vomiting. They may be signs of severe intestinal disorders.
• Long-lasting headache, accompanied or not by nausea, vomiting, and changes in vision, such as blurred vision. They may be signs of benign intracranial hypertension, especially if isotretinoine is taken with tetracycline antibiotics.
• Other eye problems, such as blurred or distorted vision and corneal opacity (clouding of the cornea) or cataracts.
• Dark-colored urine (similar to cola).
• Muscle weakness that can be potentially life-threatening; it may be associated with difficulty moving arms or legs, pain, swelling, bruising on the body, dark-colored urine, reduced or no urine production, confusion, or dehydration. They are signs of muscle tissue breakdown (rhabdomyolysis) that can lead to kidney failure. This could occur if you engage in intense physical activity while taking this medication.

Stop taking this medication and contact your doctor immediately if you experience any of the side effects listed above.However, this may not be enough to make them go away and you may need more help (your doctor may be able to arrange this).

• Contact your doctor immediately if you experience any of the following side effects.Your doctor may prescribe you to stop taking this medication.

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

• Increased tendency to bruise and bleed: if the number of blood cells responsible for clotting decreases.
• Anemia (weakness, dizziness, pale skin): if the number of red blood cells decreases.
• Increased susceptibility to infections with symptoms such as chills, sudden fever, sore throat, or flu-like symptoms: if the number of white blood cells (cells that protect the body from infections and other diseases) decreases.
• Conjunctivitis and eyelid inflammation; eyes appear dry and irritated. Consult your pharmacist for a suitable eye drop. If you have dry eyes and wear contact lenses, you may need to switch to glasses.
• Back pain; muscle pain; joint pain, especially in adolescents.To avoid worsening bone and muscle problems, reduce the intensity of physical activity while taking isotretinoine.
• Changes in blood lipid levels (such as HDL cholesterol and triglycerides).

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

• Headache.
• Dryness and crusting inside the nasal passages.
• Throat and nasal inflammation and pain.
• Increased susceptibility to infections, if white blood cells are affected.
• Elevated cholesterol levels in the blood.
• Protein or blood in the urine.
• Allergic reactions such as rash or itching.

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

• Seizures, drowsiness, dizziness.
• Deterioration of night vision; blurred or colorblind vision and worsening of color vision.
• Increased sensitivity to light; you may need to wear sunglasses to protect your eyes from excessive sunlight.
• Swelling of lymph nodes (nodes located in the neck, armpits, and groin).
• Dry throat, hoarseness.
• Sudden chest tightness, shortness of breath, and wheezing, especially if you have asthma.
• Difficulty hearing.
• Extreme thirst; frequent urination; elevated blood sugar levels. They may be signs of diabetes.
• General feeling of discomfort.
• Elevated uric acid levels in blood tests.
• Bacterial infections.
• Inflammation of blood vessels (sometimes with bruises or red spots).
• Arthritis; bone disorders (delayed growth, increased growth, and changes in bone density); growing bones may stop growing.
• Calcium deposits in soft tissues.
• Tendon pain.
• Elevated creatine phosphokinase levels in blood tests.

Frequency unknown:(frequency cannot be estimated from available data)

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

• Contact your doctor immediately if you experience any of the side effects mentioned above.Your doctor may prescribe you to stop taking this medication.
• To avoid worsening bone and muscle problems, you should reduce the intensity of physical activity while taking this medication.

• If you experience any side effect that concerns you,consult your doctor or pharmacist, even if it's a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it's a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: 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 store at a temperature above 25°C. Store the blister in the original packaging and keep the blister in the cardboard box to protect it from light.

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.

Return any remaining capsules to your pharmacist once your treatment is completed.Only store leftover medication if instructed to do so by your doctor.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at your local SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Isdiben 10 mg soft gelatin capsules EFG:

The active ingredient is isotretinoin.

Each Isdiben 10 mg soft gelatin capsule contains 10 mg of isotretinoine.

The other components are:refined soybean oil, hydrogenated vegetable oil, yellow beeswax, lecithin, and medium-chain triglycerides.

Composition of the Isdiben 10 mg capsule:gelatin, glycerol, purified water, and red iron oxide (E172) (paste).

Appearance of the product and contents of the packaging

Isdiben 10 mg soft gelatin capsules consist of a red/brown gelatin coating, with a bright yellow/orange filling. The capsule is engraved in black on one face with the logo “I 10”.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Isdin, S.A.

Provençals 33

08019 Barcelona

Spain

Responsible for manufacturing:

Catalent France Beinheim S.A.

74 rue Principale

67930 Beinheim

France

or

Catalent Germany Eberbach GmbH,

Gammelsbacher Str. 2,

69412 Eberbach,

Germany

or

Catalent Germany Schorndorf GmbH,

Steinbeisstrasse 2,

D-73614 Schorndorf,

Germany

You can request more information about this medication by contacting your doctor or pharmacist.

Last revision date of this prospectus: February 2024

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

Detailed andupdatedinformation about this product is available by scanning the QR code included in the prospectus using a smartphone. The same information is also available at the following link:https://cima.aemps.es/info/66121.