Dercutane 5 mg soft capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dercutane 5 mg soft capsules

Isotretinoin

Read the entire leaflet carefully before you start taking 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 only, and you should not give it to others, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Dercutane 5 mg soft capsules is and what it is used for
2. What you need to know before taking Dercutane 5 mg soft capsules
3. How to take Dercutane 5 mg soft capsules
4. Possible adverse effects
5. How to store Dercutane 5 mg soft capsules
6. Contents of the pack and other information

1. What Dercutane 5 mg soft capsules are and what they are used for

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

Dercutane 5 mg is indicated for the treatment of severe forms of acne (for example, nodular acne or acne conglobata, or acne with risk of permanent scarring) that is unresponsive to conventional treatment with other medicines (antibacterials).

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

Do not take Dercutane 5 mg

• If you are pregnant or breastfeeding.
• If there is any possibility 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).
• If you are allergic to isotretinoin or to any of the other ingredients of this medicine (listed in section 6).
• This medicine contains soya oil. Do not use this medicine if you are allergic to peanut or soya.

Warnings and precautions

Treatment with isotretinoin must be supervised by a physician specialized 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 5 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 spontaneous abortion. This can occur even if Dercutane 5 mg is taken for only a short time during pregnancy.

• Do not take Dercutane 5 mg if you are pregnant or think you might be pregnant.
• Do not take Dercutane 5 mg if you are breastfeeding. The medicine is likely to pass into your milk and may harm your baby.
• Do not take Dercutane 5 mg if you could become pregnant during treatment.
• Do not become pregnant within one month after stopping this treatment, as the medicine may still remain in your body.

Women who could become pregnant must take Dercutane 5 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 prevent 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 5 mg.

Women must use effective contraception before, during, and after taking Dercutane 5 mg

• You must agree to use at least one highly reliable contraceptive method (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 5 mg, throughout treatment, and for one month after stopping treatment.
• You must use contraception even if you do not have 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 5 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 for one month after stopping Dercutane 5 mg (unless your doctor decides otherwise), 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 remain 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 5 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 5 mg, 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 5 mg are too low to harm a baby of their partner. 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 5 mg, because a baby could be harmed if a pregnant woman receives your blood.

Talk to your doctor before starting Dercutane 5 mg if:

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

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

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

3. If you experience allergic reactions (skin redness, itching); inform your doctor, as treatment with Dercutane 5 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 you go in the sun, apply a sunscreen product with a high protection factor of at least 15 before exposure.

• Dercutane 5 mg may increase skin fragility. Chemical dermabrasion (controlled scraping of the skin to remove acne scars or lesions), laser skin treatment, and wax depilation should be avoided during treatment and for at least 6 months afterwards, as they may cause scarring or skin 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 moisturizer and lip balm during treatment, as Dercutane 5 mg can dry the skin and lips.

• Treatment with Dercutane 5 mg may cause decreased 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 5 mg. Cases of 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 may ask you to stop taking isotretinoin.

• It is advisable 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 stop treatment with Dercutane 5 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.

1. Your doctor should 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 monitor you more frequently. In diabetic patients, more frequent blood glucose monitoring (blood sugar tests) is also recommended.

Other medicines and Dercutane 5 mg

Inform 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 5 mg. Taking them together increases the risk of adverse effects.

Pregnancy, breastfeeding and fertility

Pregnancy

For more information on pregnancy and contraception, please refer to the "Pregnancy Prevention Plan" in the "Pregnancy and Prevention Program" section.

Breastfeeding

Fertility

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

Driving and use of machines

Dercutane 5 mg may in some cases cause a reduction in night vision, which may occur suddenly during treatment. Rarely, these disturbances persist after discontinuation of the medication. If you notice these or other effects on your vision, 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 5 mg contains soya oil, sodium and sorbitol

This medicine contains 3.50 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 5 mg soft capsules

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

Remember to take your medication. Your doctor will tell you how long you should take Dercutane 5 mg. Do not stop treatment prematurely.

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

Use in adults, including adolescents and elderly patients:

Usually, treatment starts at 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 depending on your response to treatment. The dose typically ranges between 0.5 and 1.0 mg/kg/day in most cases.

Before starting treatment with Dercutane 5 mg, please review the "Pregnancy Prevention Plan" in the section "Warnings and Precautions".

Patients with severe renal impairment:

Treatment should be initiated with the lowest dose, which may be increased later.

Use in children:

Dercutane 5 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 from 16 to 24 weeks. Acne may continue to improve for up to 8 weeks after completion of treatment. Most patients require only one treatment cycle.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 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 make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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 irritable 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 advise you to stop taking Dercutane 5 mg. This may not be sufficient to stop the effects: you may need further help, which your doctor can manage.

It is very important that you inform your doctor if you have previously suffered from conditions such as depression, suicidal behaviour, or psychosis, and if you are taking any medication for the treatment of these conditions.

Other serious 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) accompanied by 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 become yellowish 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 puffy and swollen eyelids. If this occurs while you are taking your medication, discontinue 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 requires 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 rashes may often be preceded by headache, fever, and 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: dryness of the skin, lips, and face. You may experience inflammation of the throat or skin, cracking of the skin or lips, rash, mild itching, and mild 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. Normally, these adverse effects are reversible once treatment is stopped.

Muscle and bone disorders: low 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 test abnormalities: decreased haemoglobin in blood (anaemia), decreased or increased platelets, increased liver enzymes (transaminases), increased blood triglycerides, and decreased certain fats (high-density lipoproteins).

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

Blood and urine test 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, dry 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 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
• Inflammation of the kidneys: difficulty urinating or even inability to urinate, along with swollen eyelids and severe fatigue
• Excessive thirst, frequent need to urinate, indicative of increased blood sugar levels, which may suggest the presence of 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 lymph glands
• Your acne may worsen at the beginning of treatment. However, it will improve as treatment continues
• Increased skin pigmentation
• Inflamed, more swollen, and darker than normal skin, 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, 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 vision loss
• Severe acne
• Abnormal rash or 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 joints

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

• Difficulty achieving or maintaining an erection
• Decreased libido
• Breast enlargement with or without tenderness in men
• Vaginal dryness
• Sacroiliitis, a type of inflammatory low back pain causing pain in the buttocks or lower back
• 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 5 mg soft capsules

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

Do not store above 25 °C.

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

Do not use this medicine after the expiry date stated on the carton 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 Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help 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 5 mg soft capsules

• The active substance 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, yellow beeswax, and hydrogenated vegetable oil. The capsule shell contains: gelatin, glycerol (E422), sorbitol (E420), titanium dioxide (E171), and purified water.

Appearance of the product and contents of the pack

Dercutane 5 mg is presented as soft capsules; each capsule has a light cream to cream-colored coating, containing an opaque yellow/orange viscous liquid. Each pack contains 50 soft capsules.

Marketing Authorization Holder and Manufacturer

o

TOLL MANUFACTURING SERVICES, S.L
C/ Aragoneses, 2
28850 Alcobendas (Madrid)
Spain

Date of the most recent review of this leaflet: February 2024

Detailed and up-to-date information about 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