Prospect: information for the user

Dercutane 5 mg soft capsules

Isotretinoin

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

• Keep this prospect, 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 only to you, and you should not give it to others who 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.What Dercutane 5 mg soft capsules are and for what they are used

2.What you need to know before starting to take Dercutane 5 mg soft capsules

3.How to take Dercutane 5 mg soft capsules

4.Possible adverse effects

5Storage of Dercutane 5 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 on the skin.

Dercutane 5 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 5 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 in case of allergy 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

Pregnant women should not take Dercutane 5 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 happen even if Dercutane 5 mg is taken only for a short period of time during pregnancy.

• Do not take Dercutane 5 mg if you are pregnant or think you may be pregnant.
• Do not take Dercutane 5 mg if you are breastfeeding. It is likely that the medication will pass to your milk and can harm your baby.
• Do not take Dercutane 5 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.

Pregnant women who may become pregnant are prescribed Dercutane 5 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 should not become pregnant and what you must do to avoid becoming pregnant.
• You must have spoken with your doctor about contraception (birth control). The doctor will give you information on how to avoid becoming pregnant. The doctor may send you to a specialist to give you advice on contraception.
• Before starting treatment, your doctor will ask you to undergo a pregnancy test. The test must show that you are not pregnant when you start treatment with Dercutane 5 mg.

Pregnant women must use effective contraceptives before, during, and after taking Dercutane 5 mg

• You must agree to use at least one very reliable contraceptive method (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 contraceptives for one month before taking Dercutane 5 mg, during treatment, and for one 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 that it is not necessary).

Pregnant women must accept undergoing pregnancy tests before, during, and after taking Dercutane 5 mg

• You must agree to undergo regular follow-up visits, ideally every month.
• You must agree to undergo 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 5 mg (unless your doctor decides that in your case it is not necessary).
• You must agree to undergo additional pregnancy tests if your doctor asks you to.
• You must not become pregnant during treatment or during the month following, 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 5 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 of stopping taking Dercutane 5 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 5 mg are too low to harm the babies of their partners. However, you should 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 5 mg because a baby could be harmed if a pregnant woman receives your blood.

Consult your doctor before starting to take Dercutane 5 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 5 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.

1. If you experience constant 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.

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

1. If you experience allergic reactions (skin redness, itching); inform your doctor, as they may interrupt treatment with Dercutane 5 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 5 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.

• Use a moisturizing cream or lotion and a lip balm during treatment because Dercutane 5 mg may dry out your skin and lips.

• Treatment with Dercutane 5 mg may cause a decrease in night vision that may appear suddenly (see “Driving and using machines”). In rare cases, these changes persist after stopping medication. You may also experience other visual changes (for example, dry eyes). You may develop intolerance to contact lenses that may require you to wear glasses during treatment with Dercutane 5 mg. Cases of persistent dry eyes have been reported that do not resolve after stopping treatment. Inform your doctor if you experience any of these symptoms. Your doctor may ask you to use an eye lubricant or a tear replacement therapy. If you use contact lenses and have developed intolerance to them, 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 5 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 5 mg soft capsules. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may interrupt treatment with Dercutane 5 mg soft capsules and refer you to a specialist for back pain treatment. Further evaluation may be required, including imaging modalities such as MRI.

1. Your doctor must regularly monitor your liver function and blood lipid levels. If you are diabetic, obese, frequently drink alcohol, or have any lipid metabolism disorder, your doctor may need to perform more frequent checks. Diabetics are also recommended to perform more frequent blood glucose checks (determinations of sugar in the blood).

Other medications and Dercutane 5 mg

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

Do not take vitamin A supplements or tetracyclines during treatment with Dercutane 5 mg. Taking them together increases the risk of adverse effects.

Pregnancy, breastfeeding, and fertility

Pregnancy

For more information on pregnancy and contraception, see the “Pregnancy Prevention Plan”, in the section “Pregnancy and prevention program”.

Breastfeeding

Fertility

There is no evidence that fertility or offspring of men are affected by taking isotretinoin.

Driving and using machines

Dercutane 5 mg may cause a decrease in night vision that may appear suddenly during treatment. Rarely, these changes persist after stopping medication. If you experience any of these or other visual effects, or if you feel drowsy or dizzy, you should not drive, use machines, or perform any activity that may put you or others at risk.

Dercutane 5 mg contains soy oil, sodium, and sorbitol

This medication contains 3.50mg of sorbitol (E420) in each capsule.

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. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication. Your doctor will inform you of the duration of your treatment with Dercutane 5 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 5 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 5 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 effect of Dercutane 5 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Dercutane 5 mg than you should

If you have taken more Dercutane 5 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 5 mg

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

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 symptoms 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 own lives (suicidal thoughts), have attempted to end their own lives (suicide attempt), or have ended their own lives (suicide). These people may not appear to be depressed.
• Unusual behavior.
• Signs of psychosis: loss of contact with reality, such as hearing voices or seeing things that are not there.

Immediately contact your doctor if you experience any of these mental problems.Your doctor may prescribe you to stop taking Dercutane 5 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, treatment must be interrupted immediately and you must 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 with some antibiotics (tetracyclines), increased intracranial pressure, seizures, and drowsiness 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 extremely 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 appear initially as circular spots, 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 experience inflammation of the throat or skin, skin may become rough or dry, you may have hives, mild itching, and light peeling. 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 treatment with isotretinoin.

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:

• Acute 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 eyelid swelling 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
• Lymph node swelling
• 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
• Nail changes
• 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 swelling (keratitis), and cataracts
• Irritation when using contact lenses
• Abnormal sensitivity to light. You may need sunglasses to protect your eyes from glare
• Swelling, pain, and redness of 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)
• Ligament and tendon swelling. 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, pharmacist, 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 25 °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 use this medication if you observe visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGREpoint of the pharmacy. Please ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

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

Composition of Dercutane 5 mg soft capsules

• The active ingredient is isotretinoin. Each soft capsule contains 5 mg of isotretinoin.
• The other components (excipients) 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), titanium dioxide (E171), and purified water.

Appearance of the product and content of the container

Dercutane 5 mg is presented in the form of soft capsules; each capsule has a light pink-cream to cream-colored coating, containing a yellow/orange viscous liquid. Each container contains 50 soft capsules.

Holder of the marketing authorization and responsible for manufacturing

or

TOLL MANUFACTURING SERVICES, S.L

C/ Aragoneses, 2

28850 Alcobendas (Madrid)

Spain

Last review date of this leaflet: February 2024

The detailed and updated information 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