Isdiben 20 mg soft capsules EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: INFORMATION FOR THE PATIENT

Isdiben 20 mg Soft capsules EFG

Isotretinoin

WARNING

IN CASE OF PREGNANCY MAY SERIOUSLY HARM THE BABY.

Women must use effective contraception throughout treatment.

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

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

Please 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Isdiben is and what it is used for

Isdiben soft capsules contain isotretinoin.

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

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

This type of acne may lead to permanent scarring.
These forms of acne are also known as nodular or conglobata acne.

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

Your treatment must be supervised by a dermatologist. These doctors are specialists in skin disorders.

2. What you need to know before taking Isdiben

Do not take Isdiben if:

You are pregnant or breastfeeding.
You plan to become pregnant.
If there is any possibility you could become pregnant, you must follow the precautions outlined in the “Pregnancy Prevention Programme”; see section “Warnings and precautions”.
You are allergic to peanuts or soya, or to any of the components of Isdiben. This medicine contains soya oil, in addition to isotretinoin. See section 6 (Other information) at the end of this leaflet for the full list of ingredients.
You have been diagnosed with liver problems.
You have been diagnosed with very high levels of fats in your blood (such as elevated 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 with other medicines”).

If any of these situations apply to you, please consult your doctor again and do not take this medicine. Ask your doctor before taking it.

Use in children under 12 years

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

Special precautions with Isdiben

Do not take this medicine if you are pregnant.

Pregnancy Prevention Programme

Pregnant women must not take isotretinoin.

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

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

Women who could become pregnant must take Isdiben under strict rules due to the risk of serious harm to the baby.

These rules are:

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

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

You must agree to use at least one highly 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 contraception for one month before starting Isdiben, throughout treatment, and for one month after stopping treatment.
You must use contraception even if you do not have periods or are not sexually active (unless your doctor decides it is not necessary).

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

You must agree to attend regular follow-up visits, ideally every month.
You must agree to undergo regular pregnancy tests, ideally every month during treatment and one month after stopping Isdiben (due to possible residual medicine in your body), unless your doctor decides otherwise. You must agree to additional pregnancy tests if requested by your doctor.
You must not become pregnant during treatment or within one month after stopping, as the medicine may still be present in your body.
Your doctor will discuss all these points with you using a checklist and will ask you (or a parent/guardian) to sign it. This checklist confirms that you have been informed of the risks and will follow the above rules.

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

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

Advice for men

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

Additional precautions

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

Do not donate blood during treatment with this medicine 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 Isdiben:

If you have ever had any mental health problems, including depression, aggressive tendencies, or mood changes. This also includes thoughts of self-harm or ending your life, as your mood may be affected while taking Isdiben.
Also consult your doctor if you are taking medicines for any of these conditions, as your mood may be affected while taking isotretinoin.

Mental health problems

You may not notice some changes in your mood and behaviour, so it is very important to inform your friends and family that you are taking this medicine. They may notice these changes and help you quickly identify any issues that need to be discussed with your doctor.

Isotretinoin often increases levels of fats in the blood, such as cholesterol or triglycerides. Your doctor will request blood tests before, during, and after treatment with isotretinoin. During treatment, it is best not to consume alcoholic beverages or, at minimum, to reduce your usual intake. Consult your doctor if you already have high blood fat levels, suffer from diabetes, are overweight, or consume excessive alcohol. You may need more frequent blood tests. If your blood fat levels remain high, your doctor may reduce your dose or discontinue treatment.

Isotretinoin may affect the liver

Your doctor will request blood tests before, during, and after treatment with isotretinoin to monitor liver function. If liver function is impaired, your doctor may reduce your dose or discontinue treatment.

Isotretinoin may increase blood sugar levels. Rarely, a person may develop diabetes. Your doctor may monitor your blood sugar levels during treatment. This is especially important if you already have diabetes, are overweight, or consume excessive alcohol.
Your skin is likely to become dry: use a moisturizing cream and lip balm. To prevent skin irritation, avoid using "exfoliating" products or other acne treatments.
Severe skin reactions have been reported (e.g., erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN)) with this medicine. Skin rashes may progress to widespread blistering or peeling of the skin. Be alert for 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 medicine may cause severe allergic reactions, some of which may affect the skin in the form of eczema, urticaria (rash with bumps), or bruises or red spots on the arms and legs. If you experience an allergic reaction, stop taking the medicine, seek immediate medical attention, and inform the doctor that you are taking this medicine.
Avoid sun exposure and do not use sunlamps or tanning beds. Your skin may become more sensitive to sunlight. Apply a high-protection sunscreen (SPF 50 or higher) before sun exposure.
Do not undergo any cosmetic skin treatments. Isotretinoin may make your skin more fragile. Do not wax hair or undergo dermabrasion or laser treatments (to remove thickened skin layers or scars) during treatment or within 6 months after, as this could lead to scarring, skin irritation, or, in rare cases, changes in skin colour.
Isotretinoin has been associated with inflammatory bowel disease. If you experience severe diarrhoea with blood and have no history of gastrointestinal disorders, your doctor will discontinue isotretinoin treatment.
Isotretinoin may cause dry eyes, intolerance to contact lenses, and visual difficulties such as reduced night vision. Cases of persistent dry eyes after treatment discontinuation have been reported. Contact your doctor if you experience any of these symptoms. Your doctor may recommend using an ocular lubricating ointment or artificial tears. If you wear contact lenses and develop intolerance, you may be advised to wear glasses during treatment. If you experience visual disturbances, your doctor may refer you to a specialist and may ask you to stop isotretinoin treatment.
Cases of benign intracranial hypertension have been reported with isotretinoin use, and in some cases when isotretinoin was used with tetracyclines (a type of antibiotic). Stop taking isotretinoin and consult your doctor immediately if you experience symptoms such as headache, nausea, vomiting, or vision disturbances. Your doctor may refer you to a specialist to check for optic disc swelling (papilledema).
Reduce physical activity and intense exercise. Isotretinoin may cause muscle and joint pain, especially in young people.
Talk to your doctor if you experience persistent lower back or buttock pain during Isdiben treatment. These symptoms may indicate sacroiliitis, a type of inflammatory back pain. Your doctor may discontinue Isdiben and refer you to a specialist for inflammatory back pain treatment. Additional evaluation, including imaging such as MRI, may be required.
Do not take vitamin A supplements while taking this medicine. Taking both together may increase the risk of adverse effects.
Contact your doctor if you have 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 blood while taking isotretinoin or for one month after treatment. If your blood is transfused to a pregnant woman, the fetus could be harmed.
Remember not to share this medicine with anyone else. You will need to return any unused capsules at the end of treatment. Ask your doctor or pharmacist where you can return them.

Driving and use of machines

You may experience eye problems and impaired vision during treatment. This may occur suddenly. In rare cases, night vision problems have persisted after treatment discontinuation.

Very rarely, drowsiness and dizziness have been reported. If this occurs, do not drive, ride a bicycle, or operate machinery.

Use with other medicines

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 may 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 medicines, including herbal and over-the-counter products (such as multivitamin supplements) and topical skin products, or if you have recently taken any.

Pregnancy, breastfeeding, and fertility

For more information on pregnancy and contraception, see the “Pregnancy Prevention Programme” section in section 2 “Warnings and precautions”.

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

This medicine contains soya oil. Do not use if you are allergic to peanuts or soya.

3. How to take Isdiben

Follow exactly the administration instructions for isotretinoin given 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 (0.5 mg/kg/day). Therefore, if you weigh 60 kg, you will normally start with a daily dose of 30 mg.

Take the capsules once or twice a day.

Take them during meals or immediately after eating. Swallow the capsules whole with a drink or a bite of food.

After a few weeks, your doctor may adjust your dose. This will depend on how the medicine affects you. For most people, the dose will range between 0.5 and 1 mg per kilogram of body weight per day. If you think this medicine is too strong or too weak, consult your doctor or pharmacist.

If you have severe kidney problems, you will usually start with a lower dose (e.g., 10 mg daily), which will be gradually increased to reach the maximum dose your body can tolerate. If your body cannot tolerate the recommended dose, a lower dose may be prescribed. This means that treatment will take longer and it is more likely that your acne will return.

A treatment cycle usually lasts between 4 and 6 months. Most people only need one cycle. Your acne may continue to improve for up to 8 weeks after treatment ends. Normally, you should not start another cycle before this time has passed.

In some people, acne may worsen during the first week of treatment. Usually, it improves as treatment progresses.

If you take more Isdiben than you should

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the nearest hospital immediately, or call the Toxicology Information Service at: 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 for your next dose, skip the missed dose and continue your treatment as before. Do not take two doses at the same time.

4. Possible adverse effects

This medicine may cause adverse effects, although not everyone experiences them. Often, these effects decrease or disappear when treatment is stopped. Your doctor can help you manage them.

Stop taking this medicine and contact your doctor immediately if you experience signs of any of the following adverse effects, although this may not be sufficient to make them go away and you may need further help (your doctor can arrange this).

Mental health problems

You may not be aware of certain changes in your mood and behaviour, which is why it is very important to inform your friends and family that you are taking this medicine. They may notice these changes and help you quickly identify any problems that you should discuss with your doctor.

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

Depression or related disorders. These signs include sad or altered mood, anxiety, feelings of emotional distress.
Worsening of existing depression.
Becoming violent or aggressive.

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

Some people have had feelings or thoughts about harming themselves or ending their own lives (suicidal thoughts), have attempted to end their own lives (suicide attempt), or have died by suicide. These individuals may not appear depressed.
Unusual behaviour.
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 health problems. Your doctor may tell you to stop taking Isdiben. This may not be enough to stop the effects: you may need further help, and your doctor can arrange this.

Rash and other skin symptoms

Frequency not known (cannot be estimated from available data)

This medicine may cause severe skin rashes, which can be potentially life-threatening and require urgent medical attention. These often start as hives on the arms, hands, legs, or feet, which may contain blisters. In more severe 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 a large area of your skin begins to peel off, this is a dangerous sign and you should go directly to hospital. Bring the medicine with you. The most severe forms of skin rash can cause widespread peeling of the skin, which can be fatal. If you experience flu-like symptoms (headache, fever, body aches), these may be followed by a severe skin rash, so you should be alert and ready to act quickly.

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

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

Rare adverse 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 adverse effects (may affect up to 1 in 10,000 people)

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

Allergic reactions

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

Severe allergic reactions such as difficulty breathing or swallowing due to 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.
Skin allergic reactions such as rash or itching.

Other problems

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

Increased levels of liver enzymes in blood tests.

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

Yellowing of the skin and eyes and feeling more tired than usual. These may be signs of hepatitis.
Difficulty urinating, swollen eyelids, feeling more tired than usual. These may be signs of kidney problems.
Severe abdominal pain, with or without bloody diarrhoea, nausea, and vomiting. These may be signs of serious intestinal disorders.
Prolonged headache, with nausea, vomiting, and changes in vision such as blurred vision. These may be signs of benign intracranial hypertension, especially if isotretinoin is taken with tetracycline antibiotics.
Other eye problems, such as blurred or distorted vision and cloudiness on the eye surface (corneal opacity, cataracts).
Dark-coloured urine (similar to cola).
Muscle weakness that may be potentially fatal; it may be associated with difficulty moving arms or legs, pain, swelling, bruised areas on the body, dark-coloured urine, little or no urine output, confusion, or dehydration. These are signs of muscle tissue breakdown (rhabdomyolysis), which can lead to kidney failure. This could occur if you engage in intense physical activity while taking this medicine.
Stop taking this medicine and contact your doctor immediately if you experience symptoms of any of the adverse effects listed above. However, this may not be sufficient to make them go away and you may need further help (your doctor can arrange this).
Contact your doctor immediately if you experience symptoms of any of the following adverse effects. Your doctor may tell you to stop treatment with this medicine.

Very common adverse 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.
Anaemia (weakness, dizziness, pale skin): if the number of red blood cells in the blood decreases.
Greater susceptibility to infections with symptoms such as chills, sudden fever, sore throat, or flu-like symptoms: if the number of white blood cells (the cells that protect the body from infections and other diseases) in the blood decreases.
Inflammation of the eyes (conjunctivitis) and eyelids; eyes may feel dry and irritated. Consult your pharmacist for a suitable eye drop. If you have dry eyes and wear contact lenses, you may need to wear glasses instead.
Back pain; muscle pain; joint pain, especially in adolescents. To prevent bone and muscle problems from worsening, reduce the intensity of physical activity while taking isotretinoin.
Changes in blood fat levels (such as HDL cholesterol and triglycerides).

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

Headache.
Dryness and crusting inside the nostrils.
Pain and inflammation of the throat and nose.
Greater susceptibility to infections, if white blood cells are affected.
Elevated blood cholesterol levels.
Protein or blood in the urine.
Allergic reactions such as skin rash or itching.

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

Seizures, drowsiness, dizziness.
Impaired night vision; blurred vision or colour blindness and worsening of colour vision.
Increased sensitivity to light; you may need to wear dark glasses to protect your eyes from excessive sunlight.
Swelling of the lymph nodes (glands in the neck, armpits, and groin).
Dry throat, hoarseness.
Sudden tightness in the chest, shortness of breath, and wheezing, especially if you have asthma.
Hearing difficulties.
Extreme thirst; frequent need to urinate; increased blood sugar levels in blood tests. These may all be symptoms of diabetes.
General feeling of malaise.
Elevated levels of uric acid in blood tests.
Bacterial infections.
Inflammation of blood vessels (sometimes with bruising or red spots).
Arthritis; bone disorders (growth retardation, increased growth, and changes in bone density); growing bones may stop growing.
Calcium deposits in soft tissues.
Tendon pain.
Increased levels of creatine phosphokinase in blood tests.

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

Problems achieving or maintaining an erection.
Decreased libido.
Breast swelling with or without tenderness in men.
Vaginal dryness.
Urethritis.
Sacroiliitis, a type of inflammatory lower back pain causing pain in the buttocks or lower back.
Contact your doctor immediately if you experience signs of any of the adverse effects listed above. Your doctor may tell you to stop treatment with this medicine.
To prevent bone and muscle problems from worsening, you should reduce the intensity of physical activity while taking this medicine.
If you experience any adverse effect that concerns you, whether or not it is listed in this leaflet, consult your doctor.

Reporting of adverse effects

If you experience any kind of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Isdiben

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

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

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

Return any leftover capsules to your pharmacist once your treatment is finished. Only keep leftover medicine if your doctor specifically instructs you to do so.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your usual pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Isdiben 20 mg soft capsules EFG:

The active substance is isotretinoin.

Each Isdiben 20 mg soft capsule contains 20 mg of isotretinoin.

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

Capsule composition of Isdiben 20 mg: gelatin, glycerol, purified water, red iron oxide (E172), yellow iron oxide (E172) and titanium dioxide (E171).

Appearance of the product and contents of the container

Isdiben 20 mg soft capsules have a red/brown and cream-colored gelatin shell, with a bright yellow/orange filling. The capsule is printed in black on one side with the logo “I 20”.

Isdiben is available in cardboard boxes containing 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 or 180 capsules. Only certain pack sizes may 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

Catalent Germany Eberbach GmbH,

Gammelsbacher Str. 2,

69412 Eberbach,

Germany

Catalent Germany Schorndorf GmbH,

Steinbeisstrasse 2,

D-73614 Schorndorf,

Germany

You can request further information about this medicine from your doctor or pharmacist.

Date of latest revision of this leaflet: February 2024

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

Detailed and up-to-date 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: https://cima.aemps.es/info/66121.