Flexresan 20 mg soft capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Flexresan 20 mg soft capsules

Isotretinoin

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 or pharmacist.
• 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, because 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.

Leaflet contents

1. What Flexresan 20 mg soft capsules are and what they are used for
2. What you need to know before taking Flexresan 20 mg soft capsules
3. How to take Flexresan 20 mg soft capsules
4. Possible adverse effects
5. Storage of Flexresan 20 mg soft capsules
6. Contents of the pack and other information

1. What Flexresan 20 mg soft capsules is and what it is used for

Flexresan 20 mg soft capsules are orange-red in color and oval in shape. Each package contains 50 soft capsules.

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

Flexresan 20 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 are resistant to adequate courses of conventional treatment with systemic and topical antibacterial preparations.

2. What you need to know before taking Flexresan 20 mg soft capsules

Do not take Flexresan 20 mg:

• If you are pregnant or breastfeeding.
• If there is any possibility you could become pregnant, you must follow the precautions of 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 allergic to isotretinoin or any of the other ingredients of this medicine (listed in section 6).
• 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.
• If you have ever had a severe skin rash, peeling, blistering, and/or mouth sores after taking isotretinoin.

Warnings and precautions

Treatment with isotretinoin must be supervised by a doctor 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).

This medicine can cause serious skin reactions. Stop using Flexresan 20 mg and seek immediate medical attention if you notice any symptoms related to these serious skin reactions, as described in section 4.

Pregnancy Prevention Programme

Pregnant women must not take Flexresan 20 mg

This medicine can seriously harm the baby (the medicine is considered "teratogenic") – it may cause severe abnormalities of the brain, face, ears, eyes, heart, and certain glands in the baby (thymus and parathyroid). It also increases the risk of miscarriage. This can occur even if Flexresan 20 mg is taken for only a short time during pregnancy.

• Do not take Flexresan 20 mg if you are pregnant or think you might be pregnant.
• Do not take Flexresan 20 mg if you are breastfeeding. The medicine is likely to pass into your milk and may harm your baby.
• Do not take Flexresan 20 mg if you could become pregnant during treatment.
• Do not become pregnant within one month after stopping treatment, as the medicine may still remain in your body.

Women who could become pregnant must be prescribed Flexresan 20 mg under strict rules due to the risk of serious harm to the unborn baby

These are the rules:

• Your doctor must explain to you the risk of harm to the baby – you must understand why you must not become pregnant and what you need to do 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 Flexresan 20 mg.

Women must use effective contraception before, during, and after taking Flexresan 20 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 Flexresan 20 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 otherwise).

Women must agree to undergo pregnancy tests before, during, and after taking Flexresan 20 mg

• You must agree to 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 treatment with Flexresan 20 mg (unless your doctor decides otherwise), due to the possibility that the medicine may still remain in your body.
• You must agree to 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 will follow the above rules.

If you become pregnant while taking Flexresan 20 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 Flexresan 20 mg, you must consult your doctor. Your doctor may refer you to a specialist for advice.

Advice for men

Oral retinoid levels in the semen of men taking Flexresan 20 mg are too low to harm a 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.

You must not donate blood during treatment with this medicine or for one month after stopping Flexresan 20 mg, because a baby could be harmed if a pregnant woman receives your blood.

Consult your doctor or pharmacist before starting Flexresan 20 mg:

• If you have ever had mental health problems, including depression, aggressive tendencies, or mood changes. This also includes thoughts of self-harm or ending your life, as your mood may be affected while taking Flexresan 20 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 quickly identify any problems that need to be discussed with your doctor.

• If you experience persistent headache, nausea, vomiting, blurred vision, or severe (hemorrhagic: bloody stools) diarrhea, stop treatment immediately and contact your doctor as soon as possible.

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

• If you develop allergic reactions (skin redness, itching), inform your doctor, as treatment with Flexresan 20 mg may need to be stopped.

• 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 sunlight (even on cloudy days) and 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.

• Flexresan 20 mg may increase skin fragility. Chemical dermabrasion (controlled skin peeling to remove acne scars or lesions), laser skin treatment, and waxing must be avoided during treatment and for at least 6 months afterwards, as they may cause skin scarring or irritation.

• Avoid using creams or topical keratolytic or exfoliating preparations not prescribed by your doctor.

• Use a skin moisturizer and lip balm during treatment, as Flexresan 20 mg can dry the skin and lips.

• Isotretinoin may cause dry eyes, intolerance to contact lenses, and visual difficulties, including reduced night vision. 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 a lubricating eye ointment 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 Flexresan 20 mg, as muscle and joint pain have been observed during this treatment.

• Talk to your doctor if you experience persistent pain in the lower back or buttocks during treatment with Flexresan 20 mg. These symptoms may indicate sacroiliitis, a type of inflammatory back pain. Your doctor may stop treatment with Flexresan 20 mg and refer you to a specialist for management of inflammatory back pain. Additional evaluation, including imaging modalities such as MRI, may be required.

• 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 perform more frequent monitoring. Diabetic patients should also have more frequent blood glucose monitoring (blood sugar tests).

Using Flexresan 20 mg with other medicines

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 Flexresan 20 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

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

Breastfeeding

Fertility

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

Driving and use of machines

Flexresan 20 mg causes, in some cases, a reduction in night vision, which may occur suddenly during treatment. Rarely, these disturbances persist after discontinuation of the medication. If you experience 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.

3. How to take Flexresan 20 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 medicine.

Your doctor will tell you how long you should continue treatment with Flexresan 20 mg. Do not stop treatment earlier.

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

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.

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

Before starting treatment with Flexresan 20 mg, please read the "Pregnancy Prevention Plan" in the section "Warnings and Precautions".

If you think that the effect of Flexresan 20 mg is too strong or too weak, inform your doctor or pharmacist.

Use in patients with severe kidney function impairment

Treatment should be started with a lower dose of Flexresan, for example, 10 mg/day, which may be increased later.

Use in children

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

If you take more Flexresan 20 mg than you should

If you have taken more Flexresan 20 mg than you should, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or nearest hospital immediately, or call the Toxicology Information Service at telephone number 91 562 04 20.

If you forget to take Flexresan 20 mg

Do not take a double dose to make up for forgotten doses.

If you miss a dose, take the medicine as soon as possible and continue treatment as prescribed. However, if the next scheduled dose is approaching, it is better not to take the missed dose and wait for the next scheduled dose.

4. Possible adverse effects

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

Serious adverse effects

Mental health problems:

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

• Depression or related disorders. These signs include sad or changed mood, anxiety, feelings of emotional distress.
• Worsening of existing depression.
• Becoming violent or aggressive.

Very rare adverse effects (may affect 1 in 10,000 people)

• Some people have experienced feelings or thoughts of self-harm or ending their own lives (suicidal thoughts), attempted to end their own lives (suicide attempt), or 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 Flexresan 20 mg. This may not be sufficient to stop the effects: you may need further help, which your doctor can manage.

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

Other serious adverse effects

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

• Allergic reactions: chest tightness or difficulty breathing (especially if you are asthmatic), skin rashes, and itching. If you experience an allergic reaction, treatment must be stopped immediately and you should consult your doctor.

Very rare adverse effects (may affect 1 in 10,000 people)

• Metabolic disorders: excessive thirst, frequent need to urinate, indicative of elevated blood sugar levels, which could indicate the presence of diabetes. Your doctor may monitor your blood sugar levels more frequently during treatment.

• Increased intracranial pressure (of the brain): Very rarely, when isotretinoin is administered together with certain antibiotics, increased intracranial pressure, seizures, and somnolence have been observed. If you experience persistent headache accompanied by nausea, vomiting, and blurred vision, this could indicate benign intracranial hypertension. Stop taking isotretinoin immediately and consult your doctor.

• Gastrointestinal disorders: Pancreatitis (inflammation of the pancreas), gastrointestinal bleeding, 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 and consult your doctor.

Adverse effects of unknown frequency (cannot be estimated from available data)

• Skin and hair problems: 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 flat, non-elevated circular or target-shaped 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 are often preceded by headache, fever, and body aches (flu-like symptoms).
• Generalized red rash with peeling, lumps under the skin, and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute exanthematous pustulosis (GEP)).

If you experience any of these skin symptoms, stop taking isotretinoin and contact your doctor immediately.

• Anal fissure (small tear in the thin, moist tissue lining the anus).

Non-serious adverse effects

Common adverse effects (may affect up to 1 in 10 people)

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

You may feel your eyes are tired and slightly irritated. Very rarely, contact lens wearers have had to switch to glasses during treatment due to dry eyes. These adverse effects are usually reversible once treatment is stopped.

Dermabrasion and wax hair removal should be avoided during treatment and for at least six months afterwards, as they may cause skin scarring or irritation.

• Musculoskeletal disorders: Low back pain (lumbago), muscle pain, and joint pain have been frequently reported. These effects are reversible once treatment is stopped. Physical activity should be reduced as much as possible during isotretinoin therapy.

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

Acne may worsen during the first weeks of treatment. However, your acne and other symptoms should improve as you continue treatment.

Other rarely observed adverse effects include: excessive sweating and pruritus (itching), photosensitivity. You should take measures to protect yourself from sunlight, such as using a sunscreen with a high protection factor (at least SPF 15). Avoid exposure to ultraviolet light. Very rarely, your night vision or ability to distinguish colours may be affected, or you may need to wear sunglasses. In some cases, severe eye irritation or eyelid inflammation, corneal opacities, keratitis, and cataracts have occurred. If this happens, inform your doctor immediately so your vision can be monitored.

• Musculoskeletal disorders: Arthritis and occasional tendon pain have been reported very rarely.

• Local infections: Infections in the tissue around the base of the nails, pus-filled swellings, changes in the nails.

• Skin and hair changes: You may notice some changes in your hair (hair loss or, rarely, increased growth). This is usually temporary, and persistent hair thinning is rare. Thickening of surgical scars, increased facial pigmentation, and increased body hair levels may also occur.

• Blood and urine test abnormalities: Very rarely, a decrease in white blood cell count has been reported, and you may develop swollen lymph nodes. Blood clotting may be delayed. Occasionally, abnormal levels of urea, blood sugar, or liver enzymes in the blood have been observed. Your doctor may wish to perform some blood tests before, during, and at the end of your treatment.

In rare cases, isotretinoin may cause disorders in certain substances such as proteins and blood cells excreted in the urine. If you notice any changes in the appearance of your urine, consult your doctor.

• Lipid disorders: Since isotretinoin may cause abnormalities in blood levels of fat-like substances (triglycerides and cholesterol) in some patients, alcohol consumption is not recommended. If your doctor finds that your triglyceride levels are high, it may be necessary to reduce the dose of isotretinoin and follow a low-fat diet.

Adverse effects of unknown frequency (cannot be estimated from available data)

• Dark or brown-coloured urine
• Problems achieving or maintaining an erection
• Decreased libido
• Breast swelling 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 Flexresan 20 mg soft capsules

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

Do not store above 25°C.

Store in the original packaging to protect from light and moisture.

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.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their packaging to your pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of medicines and packaging 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 Flexresan 20 mg

• The active substance is isotretinoin. Each soft capsule contains 20 mg of isotretinoin.
• The other components are: Refined soybean oil, yellow beeswax, hydrogenated soybean oil, partially hydrogenated vegetable oil, gelatin, glycerol (E422), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), and purified water.

Appearance of the product and contents of the pack

Flexresan 20 mg soft capsules are orange-red colored oval soft capsules. Each pack contains 50 soft capsules.

Marketing Authorization Holder and Manufacturer

ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A.

C/ Sagitario, 14

03006 Alicante (Spain)

Date of the most recent revision of this leaflet: January 2026

Other sources of information

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/