ISDIBEN 40 mg SOFT CAPSULES

Introduction

Package Leaflet: INFORMATION FOR THE PATIENT

Isdiben 40 mg Soft Capsules

Isotretinoin

You can contribute by reporting any adverse effects you may have. The last part of section 4 includes information on how to report these adverse effects.

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

1. What Isdiben soft capsules are and what they are used for

Isdiben soft capsules contain isotretinoin.

• Isotretinoin is related to vitamin A.
• It belongs to a group of medications called "retinoids".

Isdiben is indicated for the treatment of severe forms of acne.

• This acne can cause permanent scarring
• These types of acne are also called 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.

2. What you need to know before taking Isdiben soft capsules

Do not take Isdiben if:

• You are pregnant or breastfeeding.
• You plan to become pregnant.

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

• You are allergic to peanuts or soy or any of the components or any of the components of Isdiben. This medication contains soybean oil, in addition to isotretinoin. See section 6 (Other information) at the end of the package leaflet for the complete list of ingredients
• You have been diagnosed with liver problems.
• You have been diagnosed with very high levels of fats 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).
• You are being treated at the same time with a type of antibiotic called tetracyclines (see "Use of other medications").

If you are affected by any of these situations, please consult your doctor again and do 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 children 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 seriously harm the baby (the medication is considered "teratogenic") - it can cause serious abnormalities of the brain, face, ear, eyes, heart, and certain glands of the baby (thymus and parathyroid). It also increases the likelihood of spontaneous abortion. This can happen even if Isdiben is taken for a short period during pregnancy.

• Do not take Isdiben if you are pregnant or if you 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 may 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 because the medication may still be present in your body.

Women who may become pregnant are prescribed Isdiben under 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 harm to the baby - 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 Isdiben.

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

• You must agree to use at least one very reliable contraceptive method (e.g., an intrauterine device or a 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 Isdiben, during treatment, and for a month after finishing the treatment.
• You must use contraceptives even if you do not have your period or if you are not sexually active (unless your doctor decides it is not necessary).

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

• 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 Isdiben (unless your doctor decides it is not necessary). You must agree to have additional pregnancy tests if your doctor asks you to.
• You must not become pregnant during treatment or during the month after, because it is possible that 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 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 after 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 baby of their partners. However, you should never share your medication with anyone.

Additional precautions

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

Do not donate blood during treatment with this medication, nor during 1 month after stopping Isdiben, because a baby could be harmed if a pregnant patient 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 ending your life. This is because your mood may be affected while taking Isdiben.
• Also, consult your doctor if you are taking medications for any of these diseases. 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 that you 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.

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 best not to consume alcoholic beverages or, at least, reduce the amount you used to take. Consult your doctor if you already have high blood fat levels, suffer from diabetes, are overweight, or consume too much alcohol. You may need to have blood tests more often. If your blood fat levels remain high, your doctor may reduce the dose or stop treatment with this medication.

• Isotretinoin may 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 the dose or stop treatment with isotretinoin.

• Isotretinoin may 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 suffer from diabetes, are overweight, or consume too much alcohol.
• It is likely that your skin will dry out:use a moisturizing cream and lip balm. To prevent skin irritation, it is best not to use products called "exfoliants" or other products against acne.
• Severe skin reactions(e.g., erythema multiforme (EM), Stevens-Johnson syndrome (SSJ), and toxic epidermal necrolysis (TEN)) have been reported with the use of this medication. 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, 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 bruising or red spots on arms and legs. If you experience an allergic reaction, stop taking the medication, go to the doctor immediately, and tell them you are taking this medication.
• Avoid exposure to the sun and do not use sunlamps or sunbeds.Your skin may become more sensitive to sunlight. Before exposing yourself to the sun, apply a sunscreen with a high protection factor (SPF 50 or higher).
• Do not undergo any cosmetic skin treatments.Isotretinoin can make your skin more 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 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 suffer from severe diarrhea with blood and have no history of gastrointestinal disorders, your doctor will stop treatment with isotretinoin.
• Isotretinoin may cause dry eyes, intolerance to contact lenses, and visual difficulties such as decreased night vision.Cases of dry eyes that do not resolve after treatment have been reported. Contact your doctor if you experience any of these symptoms. Your doctor may recommend the use of an ocular lubricant 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 disturbances, your doctor may refer you to a specialist for advice and may ask you to stop treatment with isotretinoin.
• Episodes of benign intracranial hypertensionhave been reported with the use of isotretinoin, and in some cases, when isotretinoin was used together with tetracyclines (a type of antibiotic). Stop taking isotretinoin 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 if the optic disc has become inflamed (papilledema).
• Reduce physical activity and intense exercise.Isotretinoin can cause muscle and joint pain, especially in young people.
• Talk to 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 the treatment of inflammatory back pain. Further evaluation may be necessary, 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 during the month after treatment. If a pregnant woman receives your blood, the fetus could be harmed.
• Remember that you should not share the medication with anyone else.You will have to return any unused capsules to your pharmacist at the end of treatment. Ask your doctor or pharmacist where you can return the capsules.

Driving and using machines

You may have problems with your eyes and your vision may be affected during treatment. This can appear suddenly. In rare cases, night vision problems have continued after 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), nor 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 softening 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 "Pregnancy Prevention Plan" section in section 2 "Warnings and Precautions".

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

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

3. How to take Isdiben soft capsules

Follow your doctor's administration instructions for isotretinoinexactly. Consult your doctor or pharmacist if you have any doubts.

The usual starting dose is 0.5 mg per kilogram of body weight and per day (0.5 mg/kg/day). Consequently, 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 during meals or immediately after. Swallow them whole with the help of a liquid or a bite of 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 mg per kilogram of body weight and day. If you think this medication is too strong or too weak, consult your doctor or pharmacist.

If you have serious kidney problems,you will normally start with a lower dose (e.g., 10 mg per day) that will be increased until you reach the maximum dose your body can accept. If your body cannot accept the recommended dose, you may be prescribed a lower dose. This means that the treatment will be longer and it is more likely that your acne will recur.

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

It is possible that in some people the acne may worsen during the first week of treatment. It usually improves as the treatment progresses.

If you take more Isdiben than 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.

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

If you forgot to take a dose.

If you forgot 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 the treatment as before. Do not take two doses at the same time.

4. Possible side effects

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

Stop taking this medication and contact your doctor immediately if you experience signs of any of the following side effects,although this may not be enough for them to disappear, and you may need more help (your doctor can arrange it).

Mental health problems

You may not be aware of some changes in your mood and behavior, so it is very important that you discuss with your friends and family that you are taking this medication. They may notice these changes and help you identify any problems that 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 a sad or altered mood, anxiety, feelings of 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 feelings or thoughts about self-harm or ending their own lives (suicidal thoughts), have attempted to end their own lives (suicide attempt), or have ended their own lives (suicide). These people may not seem 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 signs of any of these mental problems.Your doctor may indicate that you should stop taking Isdiben. This may not be enough to stop the effects: you may need more help, and your doctor can arrange it.

Rash and other skin symptoms

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

• This medication can cause severe skin rashes, which can be potentially life-threatening and require urgent medical attention. They often start with hives on the arms, hands, legs, or feet, which can contain blisters. In the most severe skin 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.
• If a large area of skin starts to peel, it is a dangerous sign and you should go to the hospital immediately. Bring the medication with you. The most severe forms of skin rash can cause the skin to peel off in general, which can be fatal. If you experience symptoms similar to those of the flu (headache, fever, body aches), they can be followed by a severe skin rash, so you should be alert 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, skin rash, mild itching, and slight peeling. If you use a moisturizing cream from the beginning of treatment, you can reduce the risk of these disorders.
• The skin may become more fragile and reddened than usual, especially on the face.

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

• Hair loss, which is usually a temporary effect. Your hair will return to normal after the end of treatment.

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.
• Inflamed, swollen, and darker skin than usual, 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, suppuration, 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 a 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 isotretinoin immediately and contact your doctor.
• Allergic skin reactions such as rash or itching.

Other problems

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 forming clots decreases.

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

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

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

• Headache.
• Dryness and crust formation inside the nasal passages.
• Pain and inflammation of the throat and nose.
• Increased tendency to develop infections if white blood cells are affected.
• High cholesterol levels in the blood.
• Protein or blood in the urine.
• Allergic reactions such as skin rash or itching.

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

• Seizures, drowsiness, dizziness.
• Worsening of night vision; blurred vision or color blindness and worsening of color vision.
• Increased sensitivity to light; you may need to wear dark glasses to protect your eyes from excessive sunlight.
• Swelling of the 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.
• Hearing difficulties.
• Extreme thirst; frequent need to urinate; increased sugar levels in blood tests. They can all be symptoms of diabetes.
• General feeling of discomfort.
• High uric acid levels in blood tests.
• Bacterial infections.
• Inflammation of blood vessels (sometimes with bruising or red spots).
• Arthritis; bone disorders (growth delay, increased growth, and changes in bone density); growing bones may stop growing.
• Calcium deposits in soft tissues.
• Tendon pain.
• Increased creatine phosphokinase levels in blood tests.

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

• Difficulty getting or maintaining an erection.
• Decreased libido.
• Breast inflammation with or without tenderness in men.
• Vaginal dryness.
• Urethra inflammation.
• Sacroiliitis, a type of inflammatory low back pain that causes pain in the buttocks or lower back.Contact your doctor immediately if you experience signs of any of the above side effects.Your doctor may indicate that you should 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,whether it is included in this leaflet or not, consult your doctor.

Reporting side effects

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

5. Storage of Isdiben soft capsules

Keep this medication out of sight and reach of children.

Do not store above 25°C. Keep the blister pack in the original packaging and keep the blister pack in the cardboard box to protect it from light.

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

Return any leftover capsules to your pharmacist once the treatment is finished.Only keep leftover medication if your doctor tells you to.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and any unused medication in the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Isdiben 40 mg soft capsules:

The active ingredient is isotretinoin.

Each Isdiben 40 mg soft capsule contains 40 mg of isotretinoin.

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

Composition of the Isdiben 40 mg capsule:gelatin, glycerol, purified water, red iron oxide (E172), yellow iron oxide (E172), and titanium dioxide (E171).

Appearance of the product and package contents

Isdiben 40 mg soft capsules consist of a two-color orange/brown opaque gelatin capsule with a bright yellow/orange filling. The capsule is engraved in black on one side with the logo "I40".

Isdiben is available in boxes containing 30, 50, or 100 capsules. Some pack sizes may not be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

ISDIN S.A.

Provençals 33

08019 Barcelona

Spain

Manufacturer:

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 from your doctor or pharmacist.

Date of last revision of this leaflet: February 2024

Detailed and updated information about 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 about 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:https://cima.aemps.es/info/66121.