DERCUTANE 20 mg SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the User

Dercutane 20 mg Soft Capsules

Isotretinoin

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

Contents of the Package Leaflet

1. What Dercutane 20 mg Soft Capsules are and what they are used for
2. What you need to know before taking Dercutane 20 mg Soft Capsules
3. How to take Dercutane 20 mg Soft Capsules
4. Possible side effects
5. Storage of Dercutane 20 mg Soft Capsules
6. Package Contents and Additional Information

1. What Dercutane 20 mg Soft Capsules are and what they are used for

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

Dercutane 20 mg is indicated for the treatment of severe forms of acne (e.g., nodular or conglobate acne, or acne with a risk of permanent scarring) that do not respond to conventional treatment with other medications (antibiotics).

2. What you need to know before taking Dercutane 20 mg Soft Capsules

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", see 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 any of the other components of this medication (listed in section 6).
• This medication contains soybean oil. Do not use this medication if you are allergic to peanuts or soybeans.

Warnings and Precautions

Treatment with isotretinoin should be monitored by a doctor specializing in the treatment of severe acne who is aware of all the risks of treatment with isotretinoin, as well as the danger of birth defects (teratogenicity).

Pregnancy Prevention Plan

Pregnant women should not take Dercutane 20 mg

This medication can seriously harm the baby (the medication is considered "teratogenic", it can cause severe brain, face, ear, eye, heart, and certain gland abnormalities - thymus and parathyroid - in the baby). It also increases the likelihood of spontaneous abortion. This can happen even if Dercutane 20 mg is taken only for a short period during pregnancy.

• Do not take Dercutane 20 mg if you are pregnant or if you 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 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, as the medication may still be present in your body.

Women who may become pregnant are prescribed Dercutane 20 mg 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 provide you with 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 Dercutane 20 mg.

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

• 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 Dercutane 20 mg, during treatment, and for a month after finishing 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 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 due to the fact that the medication may still be present in your body, 1 month after finishing treatment with Dercutane 20 mg (unless your doctor decides it is not necessary in your case).
• You must agree to have additional pregnancy tests if your doctor requests them.
• You must not become pregnant during treatment or during the month following treatment, as 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 Dercutane 20 mg, 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 Dercutane 20 mg, you should 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 Dercutane 20 mg 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 or for 1 month after stopping Dercutane 20 mg, as a baby could be harmed if a pregnant patient 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 ending your life. 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 you need to discuss with your doctor.

• If you experience constant headaches, nausea, vomiting, or blurred vision, or severe 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 should 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 acne may worsen during the first few weeks of treatment, although it should improve later.

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

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

• Avoid using creams or preparations that are keratolytic or exfoliating (for removing thickened skin) for topical use that have not been prescribed by your doctor.

• Use a moisturizing cream or ointment and a lip protector during treatment, as Dercutane 20 mg may dry out your skin and lips.

• Treatment with Dercutane 20 mg may cause a decrease in night vision that can sometimes appear suddenly (see "Driving and Using Machines"). Other visual disturbances may also occur (e.g., dry eyes). Intolerance to contact lenses may occur, which may require you to wear glasses during treatment with Dercutane 20 mg. Cases of dry eyes that do not resolve after treatment have been reported. Inform your doctor if you experience any of these symptoms. Your doctor may ask you to use an eye lubricant ointment or tear replacement therapy. If you use contact lenses and have developed intolerance, you may be advised to wear glasses during treatment. Your doctor may refer you to a specialist for advice if you experience visual difficulties, and it is possible that they may ask you to stop taking isotretinoin.

• It is recommended to reduce intense physical activity during treatment with Dercutane 20 mg, as muscle and joint pain have been observed during this treatment.

• Talk to your doctor if you experience persistent pain in the lower back or buttocks during treatment with Dercutane 20 mg capsules. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may interrupt treatment with Dercutane 20 mg capsules and refer you to a specialist for the treatment of inflammatory back pain. Further evaluation, including imaging modalities such as MRI, may be necessary.

• Your doctor should regularly monitor liver function and blood lipid levels. If you are diabetic, obese, frequently drink alcohol, or have any lipid metabolism disorders, it may be necessary for your doctor to perform more frequent checks. In diabetics, it is also recommended to perform blood glucose tests more frequently.

Other Medications and Dercutane 20 mg

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

Do not take vitamin A supplements or tetracyclines during treatment with Dercutane 20 mg. Their combined use increases the risk of side effects.

Pregnancy, Breastfeeding, and Fertility

Pregnancy

To obtain more information about pregnancy and contraception, see the "Pregnancy Prevention Plan" in the "Warnings and Precautions" section.

Breastfeeding

Fertility

There is no data to indicate that fertility or offspring in men are affected by taking isotretinoin.

Driving and Using Machines

Dercutane 20 mg can cause a decrease in night vision in some cases, which can appear suddenly during treatment. Rarely, these disturbances persist after the medication is stopped. If you notice these or other effects on your vision, or if you feel drowsy or dizzy, you should not drive, use machines, or perform any activity in which these symptoms could put you or others at risk.

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

This medication contains 11.89 mg of sorbitol (E420) per capsule.

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

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

3. How to Take Dercutane 20 mg Soft Capsules

Follow the instructions for administration of this medication 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 stop 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:

Usually, treatment starts with a dose of 0.5 mg per kilogram of body weight and 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 "Pregnancy Prevention Plan" in the "Warnings and Precautions" section.

Patients with Severe Renal Impairment:

Treatment should start with the lowest dose and be increased later.

Use in Children:

Dercutane 20 mg is not indicated for the treatment of acne that appears before puberty or in children under 12 years of age.

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

If you think the effect of Dercutane 20 mg is too strong or too weak, tell 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 Toxicology 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 make up for forgotten doses.

In case of forgetting a dose, you should take the medication as soon as possible, continuing treatment as prescribed. However, when the next administration is near, do not take the forgotten dose and wait for the next administration.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Severe Adverse Effects

Mental Problems

Rare(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(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 advise 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 that you inform your doctor if you have suffered from any disease such as depression, suicidal behavior, or psychosis, and if you are receiving any medication for the treatment of these diseases.

Other Severe Adverse 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 rashes and itching. If you experience an allergic reaction, therapy should be discontinued immediately and you should consult 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 together with some antibiotics (tetracyclines), increased intracranial pressure, seizures, and drowsiness have been observed. If you are affected by persistent headache with nausea, vomiting, and blurred vision, this could mean that you are suffering from benign intracranial hypertension. Stop taking isotretinoin as soon as possible and consult your doctor.

Gastrointestinal disorders: pancreatitis (inflammation of the pancreas), gastrointestinal bleeding (blood in the stool), colitis, ileitis (intestinal inflammation), 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.

Liver disorders: hepatitis. If your skin or eyes turn yellow and you feel tired, stop taking your medication as soon as possible and consult your doctor.

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

Frequency Not Known(cannot be estimated from the available data):

Skin disorders: severe skin rash (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) that can potentially be life-threatening and requires immediate medical attention. They initially appear as circular spots, often with a central blister, usually on arms and hands or legs and feet; more severe rashes can also include blisters on the chest and back. Additionally, symptoms such as eye infection (conjunctivitis) or ulcers in the mouth, throat, or nose may occur. More severe forms of rash can lead to generalized peeling of the skin, which can be life-threatening. These types of skin rashes can often be preceded by headache, fever, body aches (symptoms similar to the flu). In case you present this type of symptoms on the skin, stop taking this medication and contact your doctor immediately.

Non-Severe Adverse Effects

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

Skin and eye disorders:dryness of the skin, lips, and face. You may have inflammation of the throat or skin, cracking of the skin or lips, rash, mild itching, and slight peeling. This dryness can be reduced with the regular use of a good moisturizer from the start of treatment.

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

Muscle and bone disorders: lower back pain (lumbalgia), muscle pain, and joint pain. These effects are reversible once you stop treatment. You should try to reduce intense physical activity during treatment with isotretinoin.

Analytical disorders in blood and urine: decrease in hemoglobin in blood (anemia), decrease or increase in platelets, increase in liver enzymes (transaminases), increase in triglycerides in blood, and decrease in certain fats (high-density lipoproteins).

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

Analytical disorders in blood and urine: decrease in white blood cells that can make you more susceptible to infections, increase in cholesterol in blood, increase in blood sugar, detection of protein or blood in urine.

Nervous system disorders: headache.

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

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

Hair loss (your hair will return to normal after finishing treatment).

Cutaneous allergic reactions such as rash, itching, or swelling.

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

Other adverse effects that may occur are the following:

• Sudden pressure in the chest and possible difficulty breathing (bronchospasm), particularly in patients with asthma
• Dryness of the throat, which can 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, representative of an increase in blood sugar levels, which could indicate 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
• Swelling of the lymph glands
• Your acne may worsen at the beginning of treatment. However, it will improve as you continue treatment
• Increased skin pigmentation
• Inflamed skin, more swollen and darker than usual, 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 the nails
• Increased body hair
• Changes in hair texture, hair thickening. Your hair will return to normal after treatment
• Reduced night vision. This can occur suddenly.
• Changes in color vision
• Severe eye irritation, corneal swelling (keratitis), and cataracts
• Irritation when using contact lenses
• Abnormal sensitivity to light. You may need sunglasses to protect your eyes from glare
• Redness, pain, swelling of blood vessels
• Seizures or epilepsy, dizziness or increased sleepiness
• Blurred vision, vision difficulties, headaches, or even loss of vision
• Severe acne
• Abnormal redness of the face
• Generalized rash
• Arthritis, bone changes (e.g., growth retardation, changes in bone density, abnormal bone growth)
• Swelling of tendons and ligaments. Symptoms include stiffness, swelling, pain, and discomfort in the joints

Frequency Not Known(cannot be estimated from the available data)

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

Reporting of Adverse Effects

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

5. Storage of Dercutane 20 mg Soft Capsules

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

Do not store above 30 ºC.

Keep the blisters in the outer packaging to protect them from light and moisture.

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

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be thrown away through wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

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

6. Package Contents and Additional Information

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, yellow beeswax, and hydrogenated vegetable oil. The capsule shell contains gelatin, glycerol (E422), sorbitol (E420), cochineal red A (E124), titanium dioxide (E171), indigo lake (E132), and purified water.

Appearance of the Product and Package Contents

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

Marketing Authorization Holder and Manufacturer

Manufacturer

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

Date of the Last Revision of this Prospectus:February 2024

Detailed andupdatedinformationabout 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:http://www.aemps.gob.es