Dercutane 30 mg soft capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dercutane 30 mg soft capsules

Isotretinoin

WARNING IN CASE OF PREGNANCY MAY SERIOUSLY HARM THE BABY. Women must use effective contraception throughout treatment. Do not use if you are pregnant or think you may be pregnant.

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally; do not give it to others, even if they have the same symptoms as you, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Dercutane 30 mg soft capsules are and what they are used for
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 pack and other information

1. What Dercutane 30 mg soft capsules are and what they are used for

Isotretinoin belongs to a group of medicines known as systemic anti-acne preparations that work by suppressing the activity of the sebaceous (fat-producing) glands and reducing the size of these glands. In addition, isotretinoin has been shown to have an anti-inflammatory effect on the skin.

Dercutane 30 mg is indicated for the treatment of severe forms of acne (for example, nodular or conglobata acne or acne with risk of permanent scarring) that do not respond to conventional treatment with other medications (antibacterials).

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

Do not take Dercutane 30 mg

• If you are allergic to isotretinoin or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding.
• If there is any possibility that you could become pregnant, you must follow the precautions outlined in the "Pregnancy Prevention Programme". 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).
• This medicine contains soya oil. Do not use this medicine if you are allergic to peanuts or soya.

Warnings and precautions

Treatment with isotretinoin must be supervised by a doctor experienced in the treatment of severe acne who is fully aware of all the risks associated with isotretinoin therapy, including the risk of fetal malformations (teratogenicity).

Pregnancy Prevention Programme

Pregnant women must not take Dercutane 30 mg

This medicine can severely harm the unborn baby (the medicine is considered "teratogenic" and may cause serious abnormalities in the baby's brain, face, ears, eyes, heart, and certain glands – thymus and parathyroid glands). It also increases the risk of miscarriage. This can occur even if Dercutane 30 mg is taken for only a short time during pregnancy.

• Do not take Dercutane 30 mg if you are pregnant or think you might be pregnant.
• Do not take Dercutane 30 mg if you are breastfeeding. The medicine is likely to pass into your breast milk and may harm your baby.
• Do not take Dercutane 30 mg if you could become pregnant during treatment.
• Do not become pregnant during the month following discontinuation of treatment, as the medicine may still remain in your body.

Women who could become pregnant must only be prescribed Dercutane 30 mg under strict rules due to the risk of serious harm to the unborn baby.

These rules are:

• Your doctor must explain to you the risk of harm to the unborn baby. You must understand why you must not become pregnant and what steps you need to take to avoid pregnancy.
• You must have discussed contraception (birth control) with your doctor. Your doctor will provide information on how to avoid pregnancy. Your doctor may refer you to a specialist for contraceptive advice.
• Before starting treatment, your doctor will require you to take a pregnancy test. The test must confirm that you are not pregnant when starting treatment with Dercutane 30 mg.

Women must use effective contraception before, during, and after taking Dercutane 30 mg

• You must agree to use at least one highly reliable method of contraception (e.g., an intrauterine device or contraceptive implant) or two effective methods that work in different ways (e.g., a hormonal contraceptive pill and a condom). Discuss with your doctor which methods are suitable for you.
• You must use contraception for one month before starting Dercutane 30 mg, throughout treatment, and for one month after stopping treatment.
• You must use contraception even if you are not having periods or are not sexually active (unless your doctor decides it is not necessary).

Women must agree to undergo pregnancy tests before, during, and after taking Dercutane 30 mg

• You must agree to attend regular follow-up visits, ideally every month.
• You must agree to undergo regular pregnancy tests, ideally every month during treatment and one month after stopping Dercutane 30 mg (unless your doctor decides it is not necessary), because the medicine may still remain in your body.
• You must agree to undergo additional pregnancy tests if requested by your doctor.
• You must not become pregnant during treatment or within one month after stopping treatment, as the medicine may still be present in your body.
• Your doctor will discuss all these points with you using a checklist and will ask you (or a parent/guardian) to sign it. This checklist confirms that you have been informed of the risks and that you will follow the above rules.

If you become pregnant while taking Dercutane 30 mg, stop taking the medicine immediately and consult your doctor. Your doctor may refer you to a specialist for advice.

Additionally, if you become pregnant within one month after stopping Dercutane 30 mg, you must consult your doctor. Your doctor may refer you to a specialist for advice.

Advice for men

Levels of oral retinoids in the semen of men taking Dercutane 30 mg are too low to harm a partner's unborn baby. However, you must never share your medicine with anyone.

Additional precautions

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

Do not donate blood during treatment with this medicine or for one month after stopping Dercutane 30 mg, as harm to a fetus could occur if a pregnant woman receives your blood.

Consult your doctor before starting Dercutane 30 mg:

• If you have ever had any mental health problems, including depression, aggressive tendencies, or mood changes. This 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 to inform your friends and family that you are taking this medicine. They may notice these changes and help you identify any issues that you need to discuss with your doctor.

• If you experience persistent headache, nausea, vomiting, blurred vision, or severe (haemorrhagic: with blood in the stool) diarrhoea; stop treatment immediately and contact your doctor as soon as possible.

• If you have kidney problems; inform your doctor, as treatment should be started at a lower dose.

• If you develop allergic reactions (skin redness, itching); inform your doctor, as treatment with Dercutane 30 mg may need to be stopped.

• Acne may worsen during the first few weeks of treatment, although it should improve later.

• Your skin may become more sensitive to sunlight. Avoid exposure to sunlight (even on cloudy days) and to ultraviolet (UVA) lamps while taking this medicine. If sun exposure is unavoidable, apply a sunscreen product with a high protection factor of at least 15 before exposure.

• Dercutane 30 mg may increase skin fragility. Chemical dermabrasion (controlled skin peeling to remove acne scars or lesions), laser skin treatments, and wax hair removal should be avoided during treatment and for at least 6 months afterwards, as they may cause skin scarring or irritation.

• Avoid using topical keratolytic or exfoliating creams or preparations (to remove thickened skin) that have not been prescribed by your doctor.

• Use a skin moisturizing cream or ointment and a lip balm during treatment, as Dercutane 30 mg can dry the skin and lips.

• Treatment with Dercutane 30 mg may cause reduced night vision, which may sometimes appear suddenly (see section "Driving and use of machines"). Other visual disturbances may also occur (e.g., dry eyes). Intolerance to contact lenses may develop, which may require you to wear glasses during treatment with Dercutane 30 mg. Cases of persistent dry eyes that do not resolve after stopping treatment have been reported. Inform your doctor if you experience any of these symptoms. Your doctor may recommend using an eye lubricant or tear replacement therapy. If you wear contact lenses and develop intolerance, you may be advised to wear glasses during treatment. Your doctor may refer you to a specialist if you experience visual difficulties, and you may be asked to stop taking isotretinoin.

• It is advisable to reduce intense physical activity during treatment with Dercutane 30 mg, as muscle and joint pain have been observed during treatment.

• Talk to 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 stop treatment with Dercutane 30 mg soft capsules and refer you to a specialist for management of inflammatory back pain. Additional evaluation, including imaging modalities such as magnetic resonance imaging (MRI), may be required.

• Your doctor must regularly monitor liver function and blood lipid levels. If you are diabetic, obese, drink alcohol frequently, or have any lipid metabolism disorder, your doctor may need to perform more frequent monitoring. In diabetic patients, more frequent blood glucose monitoring (blood sugar tests) is also recommended.

Other medicines and Dercutane 30 mg

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take vitamin A supplements or tetracyclines during treatment with Dercutane 30 mg. Taking them together increases the risk of adverse effects.

Do not use topical keratolytic or anti-acne exfoliating agents, as they may increase local irritation.

Pregnancy, breastfeeding and fertility

Pregnancy

The use of isotretinoin during pregnancy can cause severe congenital malformations in the fetus and may increase the risk of miscarriage. Pregnancy is an absolute contraindication for treatment with Dercutane 30 mg. Your doctor must ensure that you are not pregnant before starting treatment, and you must avoid pregnancy throughout the entire treatment period and for one month after completion of treatment. If you become pregnant while taking Dercutane 30 mg, stop taking the medication immediately and consult your doctor.

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

Breastfeeding

You should not take Dercutane 30 mg while breastfeeding because isotretinoin may pass into breast milk and harm the newborn.

Fertility

There are no data indicating that fertility or offspring in men are affected by taking isotretinoin.

Driving and use of machines

Dercutane 30 mg may in some cases reduce night vision, which can occur suddenly during treatment. Rarely, these disturbances persist after discontinuation of the medication. If you experience these or other visual effects, or if you feel drowsy or dizzy, you should not drive, operate machinery, or engage in any activity where these symptoms could place you or others at risk.

Dercutane 30 mg contains soya oil, sodium, and sorbitol

This medicine contains 15.05 mg of sorbitol (E420) in each capsule.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule, i.e., essentially "sodium-free".

3. How to take Dercutane 30 mg soft capsules

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine. Your doctor will indicate how long your treatment with Dercutane 30 mg should last. Do not stop treatment early.

Other dosage forms are available depending on the dosage recommended by your doctor.

The capsules should be taken with food, once or twice daily. Swallow the capsules whole without chewing or sucking them.

Use in adults, including adolescents and elderly patients

The usual starting dose is 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 depending on your response to treatment. The dose usually ranges between 0.5 and 1.0 mg/kg/day in most cases.

Before starting treatment with Dercutane 30 mg, please read the "Pregnancy Prevention Programme" in the section "Warnings and Precautions".

Use in patients with severe renal function impairment

Treatment should be started at the lowest dose and increased later if necessary.

Use in children

Dercutane 30 mg is not indicated for the treatment of acne occurring before puberty or in children under 12 years of age.

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

If you think 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 prescribed, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the nearest hospital immediately, or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Dercutane 30 mg

Do not take a double dose to make up for a missed dose.

If you miss a dose, take the medicine as soon as possible and continue your treatment as prescribed. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the scheduled time.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. In general, such effects diminish as treatment continues. Your doctor will help you manage them if they occur.

Serious adverse effects

Mental health 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 experienced feelings or thoughts about self-harm or ending their lives (suicidal thoughts), have attempted to end their lives (suicide attempt), or have died by suicide. These individuals may not appear depressed.
• Unusual behaviour.
• Signs of psychosis: loss of contact with reality, such as hearing voices or seeing things that are not there.

Contact your doctor immediately if you experience any signs of these mental health problems. Your doctor may instruct you to stop taking Dercutane 30 mg. This may not be sufficient to stop the effects: you may need further help, which your doctor can provide.

It is very important that you inform your doctor if you have ever had a condition such as depression, suicidal behaviour or psychosis, and if you are taking any medication to treat these conditions.

Other serious adverse 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), skin rash and itching. If you experience an allergic reaction, treatment must be stopped immediately and you should consult your doctor.

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

Increased intracranial pressure (of the brain): very rarely, when isotretinoin is administered together with certain antibiotics (tetracyclines), increased intracranial pressure, seizures and drowsiness have been observed. If you experience persistent headache with nausea, vomiting and blurred vision, this may indicate 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 stools), colitis, ileitis (intestinal inflammation) and inflammatory bowel disease. If you experience severe abdominal pain with or without severe bloody diarrhoea and vomiting, stop taking isotretinoin immediately and consult your doctor.

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

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

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

Skin disorders: severe skin rash (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis) which may potentially be life-threatening and require immediate medical attention. These initially appear as circular spots, often with a central blister, usually on arms and hands or legs and feet; more severe rashes may 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 may lead to widespread skin peeling which can be life-threatening. These types of skin rash may often be preceded by headache, fever, body aches (flu-like symptoms). If you develop any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Non-serious adverse effects

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

Skin and eye disorders: dry skin, lips and face. You may experience throat or skin inflammation, cracked skin or lips, rash, mild itching and slight peeling. This dryness can be reduced by regularly using a good moisturising cream from the start of treatment.

You may feel eye irritation or conjunctivitis, itching and redness. You may also notice swollen eyelids. These adverse effects are usually reversible once treatment is stopped.

Musculoskeletal and connective tissue disorders: back pain (lumbago), 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.

Blood and urine laboratory abnormalities: decreased haemoglobin in blood (anaemia), decreased or increased platelets, increased liver enzymes (transaminases), increased blood triglycerides and decreased levels of certain fats (high-density lipoproteins).

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

Blood and urine laboratory abnormalities: decreased white blood cells which may make you more susceptible to infections, increased blood cholesterol, increased blood sugar, detection of protein or blood in urine.

Nervous system disorders: headache.

Respiratory disorders: nosebleeds, nasal dryness 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 treatment ends).
• Skin 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 include:

• Sudden chest tightness 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 and frequent need to urinate, indicative of increased blood sugar levels, which may suggest diabetes. Your doctor may monitor your blood sugar levels more frequently during treatment.
• Increased blood uric acid levels.
• Increased blood creatine phosphokinase levels.
• Swelling of the lymph glands.
• Your acne may worsen at the beginning of treatment. However, it will improve as treatment continues.
• Increased skin pigmentation.
• Skin that is inflamed, more swollen and darker than normal, especially on the face.
• Increased sensitivity to sunlight 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 ends.
• Reduced night vision. This may occur suddenly.
• Changes in colour vision.
• Severe eye irritation, swelling of the cornea (keratitis) and cataracts.
• Irritation when using contact lenses.
• Abnormal sensitivity to light. You may need sunglasses to protect your eyes from glare.
• Redness, pain and swelling of blood vessels.
• Seizures or epilepsy, dizziness or increased sleepiness.
• Blurred vision, vision difficulties, headaches, or even vision loss.
• Severe acne.
• Rash or abnormal redness of the face.
• Generalised rash.
• Arthritis, bone changes (e.g. growth delay, 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 available data):

• Difficulty achieving or maintaining an erection.
• Decreased libido.
• Breast inflammation with or without tenderness in men.
• Vaginal dryness.
• Sacroiliitis, a type of inflammatory low back pain causing buttock or lower back pain.
• Urethritis (inflammation of the urethra).

Reporting of adverse effects

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

5. Storage of Dercutane 30 mg soft capsules

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

Store the blister pack in the outer packaging to protect it from light and moisture.

No special storage conditions required.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection pointat your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.

Return any unused capsules to your pharmacist. Keep them only if your doctor instructs you to do so.

6. Contents of the pack and other information

Composition of Dercutane 30 mg:

• The active substance is isotretinoin. Each soft capsule contains 30 mg of isotretinoin.
• The other components (excipients) are: refined soybean oil, partially hydrogenated soybean oil, hydrogenated soybean oil, all-rac-alpha-tocopherol, disodium edetate, butylhydroxyanisole (E320), and yellow beeswax. The capsule shell contains: gelatin, glycerol (E422), liquid sorbitol (non-crystallizable) (E420), titanium dioxide (E171), iron oxide red (E172), and purified water.

Appearance of the medicinal product and contents of the pack

Dercutane 30 mg is presented as soft capsules, each capsule having a rose-colored coating containing an opaque yellow/orange viscous liquid. Each pack contains 30 or 50 soft capsules. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

INDUSTRIAL FARMACEUTICA CANTABRIA, S.A.

Barrio Solía 30,

La Concha de Villaescusa

39690 Cantabria (Spain)

Manufacturer:

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

Date of the most recent revision of this package leaflet: February 2024

Detailed and up-to-date information on this product is available by scanning the QR code included in the leaflet using a smartphone. The same information is also available at the following link: http://www.aemps.gob.es