Prospect: information for the patient

Dercutane 30 mg soft capsules

Isotretinoin

Read this prospect carefully before starting to takethis medication, because 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 medication has been prescribed only to you, and you should not give it to other peopleeven if they have thesame 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 30 mg soft capsules are and for what they are used

2.What you need to know before starting to take Dercutane 30 mg soft capsules

3.How to take Dercutane 30 mg soft capsules

4.Possible adverse effects

5.Storage of Dercutane 30 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 30 mg is indicated for treating severe forms of acne (for example, nodular or conglobate acne or acne with a risk of permanent scarring) that do not respond to conventional treatment with other medicines (antibiotics).

Do not take Dercutane 30 mg

• If you are allergic to isotretinoin or any of the other components of this medication (listed in section 6).
• 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 “Warnings and Precautions” section.
• 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).
• 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 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 30 mg

This medication can severely harm the baby (the medication is considered “teratogenic”, can cause severe abnormalities of the brain, face, ear, eye, heart, and certain glands of the baby -thyroid and parathyroid-). It also increases the risk of spontaneous abortion. This can occur even if Dercutane 30 mg is taken only for a short period of time during pregnancy.

• Do not take Dercutane 30 mg if you are pregnant or think you may be pregnant.
• Do not take Dercutane 30 mg if you are breastfeeding. It is likely that the medication will pass to your milk and harm your baby.
• Do not take Dercutane 30 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 30 mg under strict rules. This is due to the risk of severe 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 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 30 mg.

Women must use effective contraception before, during, and after taking Dercutane 30 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 30 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 30 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 30 mg (unless your doctor decides that 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 30 mg, stop taking the medication immediately and consult your doctor. Your doctor may send you to a specialist for advice.

Additionally, if you become pregnant within a month after stopping Dercutane 30 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 30 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 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 30 mg because a baby could be harmed if a pregnant woman receives your blood.

Consult your doctor before starting to take Dercutane 30 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 30 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 30 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 30 mg may increase skin fragility. Chemical peeling (controlled removal of skin to remove scars or lesions after acne), laser treatment of the skin, and waxing 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 lip balm during treatment because Dercutane 30 mg may dry out your skin and lips.

• Treatment with Dercutane 30 mg may cause a decrease in night vision that may appear suddenly (see “Driving and using machines”). In addition, other visual disturbances (such as dry eyes) may occur. You may develop intolerance to contact lenses that may require you to wear glasses during treatment with Dercutane 30 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 30 mg, as muscle and joint pain have been observed during this treatment.

• Discuss with your doctor if you experience persistent pain in the lower back or buttocks during treatment with Dercutane 30 mg soft capsules. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may interrupt treatment with Dercutane 30 mg soft capsules and refer you to a specialist for treatment of inflammatory back pain. Additional evaluation may be required, including imaging modalities such as MRI.

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

Other medications and Dercutane 30 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 30 mg. Their combined use increases the risk of adverse effects.

Do not use topical keratolytics or exfoliating agents for acne as they may increase local irritation.

Pregnancy, breastfeeding, and fertility

Pregnancy

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

Breastfeeding

Fertility

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

Driving and using machines

Dercutane 30 mg may cause a decrease in night vision that may appear suddenly during treatment. Rarely, these disturbances 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 may put you or others at risk.

Dercutane 30 mg contains soy oil, sodium, and sorbitol

Thismedicationcontains 15.05mg of sorbitol (E420) in each capsule.

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. 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 30 mg. Do not discontinue treatment before.

Other presentations are available based on the recommended dosage by your doctor.

The capsules are taken with food, once or twice a day. You must swallow the capsules whole without crushing 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 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 30 mg, consult the “Pregnancy Prevention Plan”, in the “Warnings and Precautions” section.

Use in patients withsevererenalfunction impairment

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

Use in children

Dercutane 30 mg is not indicated for treating acne that appears before puberty or in children under 12 years old.

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

If you estimate that the effect of Dercutane 30 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Dercutane 30 mg than you should

If you have taken more Dercutane 30 mg than you should, consult your doctor or pharmacist immediately.

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

If you forgot to take Dercutane 30 mg

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

In case of a missed 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 medicines, this medicine can cause side effects, although not everyone will experience them. Generally, such side effects resolve as treatment continues. Your doctor will help you manage them if they occur.

Severe side effects

Mental problems

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

• Depression or related disorders. These symptoms include feeling sad or irritable, anxiety, and 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 appear 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 30 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 side effects

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

Allergic reactions:allergic reaction with chest tightness or difficulty breathing (especially if you are asthmatic) with skin rashes and itching. If you experience an allergic reaction, treatment 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 drowsiness have been observed. If you are affected by 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.

Gastrointestinal alterations: pancreatitis (pancreas inflammation), gastrointestinal hemorrhage (blood in the stool), colitis, ileitis (intestinal inflammation), and inflammatory bowel disease. If you experience severe abdominal painwith or without severe diarrhea with blood, and vomiting, stop taking isotretinoin as soon as possible and consult your doctor.

Liver alterations: 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 alterations: glomerulonephritis (kidney inflammation). 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):

Skin alterations: severe skin rash (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) that may be life-threatening and require 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 rashes may also include blisters on chest and back. Additionally, they may present symptoms such as eye infection (conjunctivitis) or ulcers in the mouth, throat, or nose. More severe forms of skin rash may lead to generalized skin peeling that may be life-threatening. These types of skin rash 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):

Skin and eye alterations:dry skin, lips, and face. You may have throat or skin inflammation, skin or lip dryness, itching, or mild peeling. This dryness can be reduced 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.

Musculoskeletal and bone alterations: 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.

Blood and urine analytical alterations: 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):

Blood and urine analytical alterations: 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 throat and nasal inflammation.

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

• Hair loss (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
• Renal 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 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 light sensitivity. You may need sunglasses to protect your eyes from glare.
• Swollen, painful, or 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 rash
• Arthritis, bone changes (e.g., growth delay, bone density changes, 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
• Inflamed 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.
• Urethral inflammation

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 for 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.

Store theblisterin theouter packagingto protect them from light and moisture.

No special storage conditions are required.

Do not use this medication 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 medication if you observe visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

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

Composition of Dercutane 30 mg:

• The active ingredient isisotretinoína. Each soft capsule contains 30 mg ofisotretinoína.
• The other components (excipients) are: refined soybean oil,partially hydrogenated soybean oil, hydrogenated soybean oil, all-rac-alfa-tocoferol, disodium edetate, butylhydroxyanisole (E320)andbeeswax.The capsule coating contains: gelatin, glycerol (E422),sorbitolliquid(non-crystallizable)(E420), titanium dioxide (E171), iron oxide red (E172) and purified water.

Appearance of the product and contents of the package

Dercutane 30 mg is presented in the form of soft capsules, each capsule has a pink-colored coating containing a viscous, opaque yellow/orange liquid. Each package contains 30 or 50 soft capsules. Some package sizes may only be marketed.

Marketing authorization holderandresponsibleformanufacturing

Marketing authorization holder:

INDUSTRIAL FARMACEUTICA CANTABRIA, S.A.

Barrio Solía 30,

La Concha de Villaescusa

39690 Cantabria (Spain)

Responsible for Manufacturing:

TOLL MANUFACTURING SERVICES, S.L.

C/ Aragoneses 2,

28108 Alcobendas (Madrid)

Spain

or

INDUSTRIAL FARMACEUTICA CANTABRIA, S.A.

C/ Pirita, 9

28850 Torrejón de Ardoz (Madrid)

Spain

or

EDEFARM, S.L.

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante (Valencia)

Spain

Last review date of thisprospecto:February 2024

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