Prospect: information for the user

Dercutane 20 mg soft capsules

Isotretinoin

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

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist or nurse.
• This medicine has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. Dercutane 20 mg soft capsules and its use

2. What you need to know before starting to take Dercutane 20 mg soft capsules

3. How to take Dercutane 20 mg soft capsules

4. Possible adverse effects

5. Storage of Dercutane 20 mg soft capsules

6. Contents of the package and additional information

Isotretinoin belongs to a group of medicines called systemic acne treatments that work by suppressing the activity of sebaceous glands (oil-producing glands) and reducing the size of these glands. Additionally, isotretinoin has been described as having an anti-inflammatory effect at the skin level.

Dercutane 20 mg is indicated for treating severe forms of acne (for example, nodular or conglobate acne or acne with a risk of permanent scarring) that does not respond to conventional treatment with other medicines (antibiotics).

Do not take Dercutane 20 mg:

• If you are pregnant or breastfeeding.
• If there is a possibility that you may become pregnant, you must follow the precautions of the “Pregnancy Prevention Plan”, consult the section “Warnings and Precautions”.
• If you have liver problems.
• If you have very high levels of lipids (cholesterol, triglycerides) in your blood.
• If you have very high levels of vitamin A in your body (hypervitaminosis A).
• If you are taking tetracyclines (a type of antibiotic).
• If you are allergic to isotretinoin or to any of the other components of this medication (listed in section 6).
• This medication contains soy oil. Do not use this medication if you are allergic to peanuts or soy.

Warnings and Precautions

The treatment with isotretinoin must be monitored by a doctor specialized in the treatment of severe acne who knows all the risks of treatment with isotretinoin, as well as the danger of fetal malformations (teratogenicity).

Pregnancy Prevention Plan

Women who are pregnant must not take Dercutane 20 mg

This medication can severely damage the baby (the medication is considered “teratogenic”, can cause severe brain, face, ear, eye, heart, and certain gland malformations -thyroid and parathyroid-). It also increases the risk of spontaneous abortion. This can occur even if Dercutane 20 mg is taken only for a short period of time during pregnancy.

• Do not take Dercutane 20 mg if you are pregnant or think you may be pregnant.
• Do not take Dercutane 20 mg if you are breastfeeding. It is likely that the medication will pass into your milk and can harm your baby.
• Do not take Dercutane 20 mg if you may become pregnant during treatment.
• Do not become pregnant during the month following the interruption of this treatment because it is possible that there may still be medication in your body.

Women who may become pregnant are prescribed Dercutane 20 mg under strict rules. This is due to the risk of severe damage to the baby.

These are the rules:

• Your doctor must explain the risk of damage to the baby, you must understand why you must not become pregnant and what you must do to avoid becoming pregnant.
• You must have spoken with your doctor about contraception (birth control). Your doctor will give you information on how to avoid becoming pregnant. Your doctor may send you to a specialist to give you advice on contraception.
• 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 Dercutane 20 mg.

Women must use effective contraception before, during, and after taking Dercutane 20 mg

• You must agree to use at least one very reliable method of contraception (for example, an intrauterine device or an implantable contraceptive) or two effective methods that work in different ways (for example, a hormonal contraceptive pill and a condom). Discuss with your doctor which methods would be suitable for you.
• You must use contraception during a month before taking Dercutane 20 mg, during treatment, and during a month after finishing treatment.
• You must use contraception even if you do not have your period or if you are not sexually active (unless your doctor decides that it is not necessary).

Women must agree to have pregnancy tests before, during, and after taking Dercutane 20 mg

• 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 it is possible that there may still be medication in your body, 1 month after finishing treatment with Dercutane 20 mg (unless your doctor decides that in your case 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 a month after, because it is possible that there may still be medication in your body.
• Your doctor will discuss all these points with you, using a checklist, and will ask you (or a parent/guardian) to sign it. This checklist confirms that you have been informed about the risks and that you will follow the above rules.

If you become pregnant while taking Dercutane 20 mg,stop taking the medication immediatelyand consult your doctor. Your doctor may send you to a specialist for advice.

Additionally, if you become pregnant within a month after stopping taking Dercutane 20 mg, you must consult your doctor. Your doctor may send you to a specialist for advice.

Advice for men

The levels of oral retinoids in the semen of men taking Dercutane 20 mg are too low to harm the babies of their partners. However, you must never share your medication with anyone.

Additional precautions

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

You must not donate blood during treatment with this medication, nor during 1 month after stopping Dercutane 20 mg because a baby could be harmed if a pregnant woman receives your blood.

Consult your doctor before starting to take Dercutane 20 mg:

• 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 Dercutane 20 mg.

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.

• If you experience persistent headaches, nausea, vomiting, or blurred vision, or intense diarrhea (hemorrhagic: with blood in the stool); stop treatment immediately and contact your doctor as soon as possible.

• If you have kidney problems; inform your doctor, as you will need to start treatment with a lower dose.

• If you experience allergic reactions (skin redness, itching); inform your doctor, as they may interrupt treatment with Dercutane 20 mg.

• It is possible that your acne may worsen during the first weeks of treatment, although it should improve later.

• Your skin may become more sensitive to sunlight. Avoid exposure to the sun (even on cloudy days) and ultraviolet lamps (UVA), while taking this medication. If you do go out in the sun, apply a product with a high protection factor, of at least 15, before exposure.

• Dercutane 20 mg may increase skin fragility. Chemical peeling (controlled skin scraping to remove scars or lesions after acne), laser skin treatment, and wax depilation should be avoided during treatment and for at least 6 months after, as they may cause skin scarring or irritation.

• Avoid using topical creams or preparations that are not prescribed by your doctor, such as keratolytic or exfoliating creams.

• Use a moisturizing cream or lotion and lip balm during treatment because Dercutane 20 mg may dry out your skin and lips.

• Treatment with Dercutane 20 mg may cause a decrease in night vision that may occur suddenly during treatment. Rarely, these changes persist after stopping medication. If you notice these or other visual effects, or if you feel drowsy or dizzy, you should not drive, use machines, or engage in any activity that could put you or others at risk.

• Dercutane 20 mg contains soy oil, sorbitol, sodium, and red cochineal A.

• This medication contains 11.89 mg of sorbitol (E420) in each capsule.

• This medication may cause allergic reactions because it contains red cochineal A (E124). It may cause asthma, especially in patients allergic to aspirin.

• This medication contains less than 23 mg of sodium (1mmol) per capsule; it is essentially “sodium-free”.

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

Remember to take your medication. Your doctor will indicate the duration of your treatment with Dercutane 20 mg. Do not discontinue treatment before.

The capsules are taken with food, once or twice a day. You must swallow the capsules whole without chewing or sucking them.

Use in adults, including adolescents and elderly people:

Usually, treatment starts with a dose of 0.5 mg per kilogram of body weight per day (0.5 mg/kg/day). Your doctor may adjust this dose after a few weeks based on your response to treatment. The dose varies between 0.5 and 1.0 mg/kg/day in most cases.

Before starting treatment with Dercutane 20 mg, consult the “ Prevention of Pregnancy Plan ”, in the “Warnings and Precautions” section.

Patients with severe renal insufficiency:

Treatment should start with the lowest dose and increase it later.

Use in children:

Dercutane 20 mg is not indicated for treating acne that appears before puberty or in children under 12 years old.

The usual treatment cycle lasts from 16 to 24 weeks. Acne may continue to improve up to 8 weeks after completing treatment. Most patients only need one treatment cycle.

If you estimate that the action of Dercutane 20 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Dercutane 20 mg than you should

If you have taken more Dercutane 20 mg than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 , indicating the medication and the amount ingested.

If you forget to take Dercutane 20 mg

Do not take a double dose to compensate for the missed doses.

If you forget a dose, take the medication as soon as possible and continue treatment as prescribed. However, when the next administration is near, do not take the missed dose and wait for the next administration.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Severe side effects

Mental problems

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

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

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

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

Immediately contact your doctor if you experience signs of any of these mental problems.Your doctor may prescribe you to stop taking Dercutane 20 mg. This may not be enough to stop the effects: you may need more help, and your doctor can manage it.

It is very important to inform your doctor if you have had any disease such as depression, suicidal behavior, or psychosis and if you are receiving any medication for the treatment of these diseases.

Other severe side effects

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

Allergic reactions: severe allergic reaction with chest tightness or difficulty breathing (especially if you are asthmatic) with skin eruptions and itching. If you experience an allergic reaction, therapy must be interrupted immediately and you must consult with your doctor.

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

Increased intracranial pressure (of the brain): in very rare cases, when isotretinoin is administered with some antibiotics (tetracyclines), increased intracranial pressure, seizures, and somnolence have been observed. If you are affected by a persistent headache with nausea, vomiting, and blurred vision, this may mean that you are suffering from benign intracranial hypertension. Stop taking isotretinoin as soon as possible and consult your doctor.

Alterations of the digestive system: pancreatitis (inflammation of the pancreas), gastrointestinal hemorrhage (blood in the stool), colitis, ileitis (inflammation of the intestine), and inflammatory bowel disease. If you experience severe abdominal pain with or without severe diarrhea with blood, and vomiting, stop taking isotretinoin as soon as possible and consult your doctor.

Alterations of the liver: hepatitis. If your skin or eyes turn yellow and you feel tired, stop taking your medication as soon as possible and consult your doctor.

Alterations of the kidney:glomerulonephritis (inflammation of the kidneys). You may feel excessively tired, stop urinating, and have inflamed and swollen eyelids. If this happens while you are taking your medication, suspend the treatment with this medication and consult your doctor.

Unknown frequency(cannot be estimated from available data):

Alterations of the skin:severe skin eruption (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) that may put your life at risk and requires immediate medical attention. They initially appear as circular patches, often with a central blister, usually on arms and hands or legs and feet; more severe eruptions may also include blisters on chest and back. Additionally, you may experience symptoms such as eye infection (conjunctivitis) or ulcers in the mouth, throat, or nose. More severe forms of skin eruption may lead to generalized peeling of the skin that may put your life at risk. These types of skin eruptions may often be preceded by headache, fever, body aches (symptoms similar to the flu).Immediately stop taking this medication and contact your doctor if you present this type of skin symptoms.

Mild side effects

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

Alterations of the skin and eyes:dry skin, lips, and face. You may have inflammation of the throat or skin, skin may become rough or dry, you may have itching, mild peeling, and dryness. This dryness may decrease with regular use of a good moisturizing cream from the beginning of treatment.

You may feel your eyes irritated or with conjunctivitis, itching, and redness. You may also notice swollen eyelids. Normally, these side effects are reversible once treatment is stopped.

Alterations of muscles and bones:lower back pain, muscle pain, and joint pain. These side effects are reversible once you stop treatment. You should try to reduce intense physical activity during isotretinoin treatment.

Alterations in blood and urine analysis:decreased hemoglobin in blood (anemia), decreased or increased platelets, increased liver enzymes (transaminases), increased triglycerides in blood, and decreased certain fats (high-density lipoproteins).

Common(may affect up to 1 in 10 people):

Alterations in blood and urine analysis: decreased white blood cells that may make you more susceptible to infections, increased cholesterol in blood, increased blood sugar, detection of proteins or blood in urine.

Nervous system disorders: headache.

Respiratory disorders: nasal bleeding, dry nose, or inflammation of the nose and throat.

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

Loss of hair (your hair will return to normal after treatment is completed).

Allergic skin reactions such as rash, itching, or swelling.

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

Other side effects that may occur are the following:

• Sudden chest pressure and possible difficulty breathing (bronchospasm), particularly in patients with asthma
• Dry throat, which may cause hoarseness
• Mild hearing loss
• Kidney inflammation: difficulty urinating or even inability to urinate, along with swollen eyelids and severe fatigue
• Excessive thirst, frequent need to urinate, indicative of increased blood sugar levels, which may mean the presence of diabetes. Your doctor may monitor your blood sugar levels more frequently during treatment
• Increased uric acid levels in blood
• Increased creatine phosphokinase levels in blood
• Swollen lymph nodes
• Your acne may worsen at the beginning of treatment. However, it will improve as you continue treatment
• Increased skin pigmentation
• Inflamed, swollen, and darker-than-normal skin, especially on the face
• Increased sensitivity to the sun during treatment
• Increased sweating
• Bacterial infections at the base of the nails, with swelling, redness, and pus
• Changes in nails
• Increased body hair
• Changes in hair texture, hair thickening. Your hair will return to normal after treatment is completed
• Reduced night vision. This may occur suddenly.
• Changes in color vision
• Intense eye irritation, corneal inflammation (keratitis), and cataracts
• Irritation when using contact lenses
• Abnormal sensitivity to light. You may need sunglasses to protect your eyes from glare
• Swollen, painful, and inflamed blood vessels
• Seizures or epilepsy, dizziness, or excessive sleep
• Blurred vision, vision difficulties, headaches, or even loss of vision
• Severe acne
• Abnormal redness or inflammation of the face
• Generalized eruption
• Arthritis, bone changes (e.g., delayed growth, changes in bone density, abnormal bone growth)
• Swollen tendons and ligaments. Symptoms include stiffness, swelling, pain, and discomfort in the joints

Unknown frequency(cannot be estimated from available data)

• Difficulty achieving or maintaining an erection
• Decreased libido
• Inflammation of the breasts with or without sensitivity in men
• Vaginal dryness
• Sacroiliitis, a type of low back inflammatory pain that causes pain in the buttocks or lower back.
• Inflammation of the urethra

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of 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 above 30 °C.

Store the blistersin the outer packagingto protect them from light and moisture.

Do not use this medicationafter the expiration date that appears on the box, after CAD. The expiration date is the last day of the month indicated.

Do not usethis medicationif you observe visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGREpoint of the pharmacy.Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Return unused capsules to your pharmacist. Store them only if your doctor asks you to.

Composition ofDercutane 20 mg soft capsules

• The active ingredient is isotretinoin. Each soft capsule contains 20 mg of isotretinoin.
• The other components are:refined soybean oil, DL-alpha-tocopherol, disodium edetate, butylhydroxyanisole (E320), partially hydrogenated soybean oil, beeswax, and hydrogenated vegetable oil. The capsule coating contains gelatin, glycerol (E422), sorbitol (E420), cochineal red A (E124), titanium dioxide (E171), indigotine (E132), and purified water.

Appearance of the product and contents of the packaging

Dercutane 20 mg is presented in the form of soft capsules; each capsule has a granate-colored coating, containing a yellow/orange viscous liquid.Each package contains 50 soft capsules.

Holder of the marketing authorization and responsible for manufacturing

Responsible for manufacturing

INDUSTRIAL FARMACÉUTICA CANTABRIA, S.A.

C/ Pirita, 9

28850 Torrejón de Ardoz (Madrid)

Spain

or

TOLL MANUFACTURING SERVICES, S.L.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet:February 2024

Detailed andupdatedinformation about this product is available by scanning the QR code included in the leaflet through a smartphone. The same information is also available at the following link:http://www.aemps.gob.es