Prospecto: information for the user

Flexresan 10 mg soft capsules

Isotretinoína

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1. What isFlexresan10 mg soft capsules and what it is used for

2. What you need to know before starting to takeFlexresan10 mg soft capsules

3. How to takeFlexresan10 mg soft capsules

4. Possible adverse effects

5. Storage ofFlexresan10 mg soft capsules

6. Contents of the pack and additional information

Flexresan10 mg are red-orange soft capsules in oval shape. Each package contains 50 soft capsules.

Isotretinoína belongs to a group of medicines called systemic acne treatments that work by suppressing the activity of sebaceous glands (fat-producing glands) and reducing the size of these glands. Additionally, isotretinoína has been described as having an anti-inflammatory effect at the skin level.

Flexresan10 mg is indicated for treating severe forms of acne (for example, nodular or conglobata acne or acne with a risk of permanent scarring) that is resistant to adequate conventional treatment cycles with systemic and topical antibacterial preparations.

Do not take Flexresan 10 mg:

- If you are pregnant or breastfeeding.

- If there is a possibility that you may become pregnant, you must follow the precautions of the “Pregnancy Prevention Plan”, consult the section “Warnings and Precautions”.

- If you have liver problems.

- If you have very high levels of lipids (cholesterol, triglycerides) in your blood.

- If you have very high levels of vitamin A in your body (hypervitaminosis A).

- If you are allergic to isotretinoin or to any of the other components of this medication (included in section 6).

- If you are taking tetracyclines (a type of antibiotic).

- This medication contains soy oil. Do not use this medication in case of allergy to peanuts or soy.

Warnings and Precautions

The treatment with isotretinoin should be monitored by a doctor specialized in the treatment of severe acne that 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 Flexresan 10 mg

This medication can severely damage the baby (the medication is considered "teratogenic") - it can cause severe abnormalities of the brain, face, ear, eyes, heart, and certain glands of the baby (thyroid and parathyroid). It also increases the risk of spontaneous abortion. This can occur even if Flexresan 10 mg is taken only for a short period of time during pregnancy.

• Do not take Flexresan 10 mg if you are pregnant or think you may be pregnant.
• Do not take Flexresan 10 mg if you are breastfeeding. It is likely that the medication will pass to your milk and can harm your baby.
• Do not take Flexresan 10 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 prescribedFlexresan 10 mgunder strict rules. This is due to the risk of severe damage to the baby

These are the rules:

• Your doctor must explain the risk of damage to the baby - you must understand why you should not become pregnant and what you should do to avoid becoming pregnant.
• You must have talked to your doctor about birth control (contraception). 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 birth control.
• 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 Flexresan 10 mg.

Women must use effective contraceptives before, during, and after takingFlexresan 10 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 contraceptives for a month before taking Flexresan 10 mg, during treatment, and for a month after finishing treatment.
• You must use contraceptives even if you do not have your period or if you are not sexually active (unless your doctor decides that it is not necessary).

Women must accept having pregnancy tests before, during, and after takingFlexresan 10 mg

• You must agree to have regular follow-up visits, ideally every month.
• You must agree to undergo regular pregnancy tests, ideally every month during treatment, and, because it is possible that there may still be medication in your body, 1 month after finishing treatment with Flexresan 10 mg (unless your doctor decides that in your case it is not necessary).
• You must agree to undergo additional pregnancy tests if your doctor asks you to.
• You must not become pregnant during treatment or during the month following, because it is possible that there may still be medication in your body.
• Your doctor will discuss all these points with you, using a checklist, and will ask you (or a parent/guardian) to sign it. This checklist confirms that you have been informed about the risks and that you will follow the above rules.

If you become pregnant while taking Flexresan 10 mg,stop taking the medication immediatelyand consult your doctor. Your doctor may send you to a specialist for advice.

Additionally, if you become pregnant within a month of stopping taking Flexresan 10 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 Flexresan 10 mg are too low to harm the babies of their partners. However, you should never share your medication with anyone.

Additional precautions

You must never give this medication to anyone else. Please take any unused capsules to your pharmacist at the end of treatment.

You must not donate blood during treatment with this medication, nor during 1 month after stopping Flexresan 10 mg because a baby could be harmed if a pregnant woman receives your blood.

Consult your doctor or pharmacist before starting to take Flexresan 10 mg:

- If you have ever had any mental health problems. This includes depression, aggressive tendencies, or mood changes. It also includes thoughts of self-harm or ending your life. This is because your mood may be affected while takingFlexresan10 mg.

Mental health problems

You may not notice some changes in your mood and behavior, so it is very important that you tell your friends and family that you are taking this medication. They may notice these changes and help you identify any problems you need to talk to your doctor about.

• 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 because you will need to start treatment with a lower dose.

If you experience allergic reactions (skin redness, itching), inform your doctor because they may interrupt treatment withFlexresan10 mg.

- It is possible that acne may worsen during the first weeks of treatment, although it should improve later.

- The 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.

-Flexresan10 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, because they can cause skin scarring or irritation.

- Avoid using creams or topical preparations that have not been prescribed by your doctor.

- Use a moisturizing cream or lotion and a lip balm during treatment becauseFlexresan10 mg can dry out your skin and lips.

- Isotretinoin can cause dry eyes, intolerance to contact lenses, and visual difficulties, including decreased night vision. Cases of persistent dry eyes have been reported 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 develop 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 withFlexresan10 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 10 mg. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may interrupt treatment with Flexresan 10 mg and refer you to a specialist for treatment of inflammatory back pain. Further evaluation may be necessary, including imaging modalities such as MRI.

- Your doctor should regularly monitor 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.

Use of Flexresan 10 mg with other medications

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 withFlexresan10 mg. Taking them together increases the risk of adverse effects.

Do not take 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 section “Warnings and Precautions”.

Breastfeeding

Fertility

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

Driving and using machines

Flexresan10 mg can cause a decrease in night vision in some cases, which can occur suddenly during treatment.

Rarely, these changes persist after stopping medication. If you notice these or other effects on your vision, 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.

Follow exactly the administration instructions for this medication as indicated by your doctor. 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 Flexresan 10 mg. Do not discontinue treatment before.

The capsules are taken with food, once or twice a day. You must swallow the capsules whole without chewing or sucking them.

Usually, treatment starts with a dose of 0.5 mg per kilogram of body weight per day (0.5 mg/kg/day). Your doctor may adjust this dose after a few weeks based on your response to treatment. The dose varies between 0.5 and 1.0 mg/kg/day in most cases.

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

Before starting treatment with Flexresan 10 mg, consult the “Pregnancy Prevention Plan”, in the “Warnings and Precautions” section.

If you estimate that the action of Flexresan 10 mg is too strong or too weak, inform your doctor or pharmacist.

Use in patients with severe kidney function impairment

Treatment should start with a lower dose of Flexresan, for example, 10 mg/day, and increase it later.

Use in children

Flexresan 10 mg is not indicated for treating acne that appears before puberty or in children under 12 years old.

If you take more Flexresan 10 mg than you should

If you have taken more Flexresan 10 mg than you should, consult 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.

If you forgot to take Flexresan 10 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, it is better not to 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.

Severe side effects

Mental problems:

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

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

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

• Some people have had thoughts or feelings about self-harm or ending their own lives (suicidal thoughts), have attempted to end their own lives (suicide attempt), or have ended their own lives (suicide). These people may not seem 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 Flexresan 10 mg. This may not be enough to stop the effects: you may need more help, and your doctor can manage it.

It is very important to inform your doctor if you have had any disease such as depression, suicidal behavior, or psychosis and if you are receiving any medication for the treatment of these diseases.

Other severe side effects

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

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

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

• Metabolic changes: excessive thirst, frequent urination, indicative of high blood sugar levels, which may indicate the presence of diabetes. Your doctor may monitor your blood sugar levels more frequently during treatment.

• Increased intracranial pressure (brain): In very rare cases, when isotretinoin is administered with some antibiotics, increased intracranial pressure, seizures, and drowsiness have been observed. If you are affected by persistent headaches with nausea, vomiting, and blurred vision, this may indicate that you are experiencing benign intracranial hypertension. Stop taking isotretinoin as soon as possible and consult your doctor.

• Gastrointestinal changes: pancreatitis (pancreas inflammation), gastrointestinal bleeding, colitis, ileitis (intestinal inflammation), and inflammatory bowel disease. If you experience severe abdominal pain with or without severe diarrhea with blood, and vomiting, stop taking isotretinoin as soon as possible and consult your doctor.

• Liver changes: 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 changes: glomerulonephritis (kidney inflammation). You may feel excessively tired, unable to urinate, and have inflamed eyelids and bulging eyes. If this happens while taking your medication, stop therapy and consult your doctor.

Side 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) 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, you may experience symptoms such as eye infection (conjunctivitis) or mouth, throat, or nasal ulcers. More severe skin rashes may lead to generalized skin peeling that may be life-threatening. These types of skin rashes are often preceded by headache, fever, and body aches (similar to flu symptoms).

In case of this type of skin symptoms, stop taking isotretinoin and contact your doctor immediately.

Mild side effects

Frequent side effects (may affect up to 1 in 10 people)

• Skin and eye changes: You should expect to experience dry skin, especially on lips and face. You may have throat or skin inflammation, cracked skin or lips, itching, and 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 tired and slightly irritated. Very rarely, people who wear contact lenses have needed to use glasses during treatment due to eye dryness. Normally, these side effects are reversible once treatment is stopped.

Avoid dermabrasion and waxing during treatment and for at least six months after treatment, as they may cause skin scarring or irritation.

• Muscle and bone changes: Frequent reports of back pain, muscle pain, and joint pain. These effects are reversible once you stop treatment. Try to reduce intense physical activity during isotretinoin therapy.

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

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

Other rare side effects observed include excessive sweating and pruritus (itching). Take measures to protect yourself from the sun, such as using a high-protection sunscreen product (at least SPF 15). Avoid exposure to ultraviolet light. Very rarely, you may experience impaired night vision or color perception, or need to wear sunglasses. In other cases, you may experience intense eye irritation or eyelid inflammation, corneal opacities, keratitis, and cataracts. If this happens, inform your doctor immediately, so they can monitor your vision.

• Muscle and bone changes: Rare reports of arthritis and occasional tendon pain.

• Local infections: Infections of the tissue around the base of the nails, swelling that drains pus, changes in the nails.

• Skin and hair changes: You may notice some changes in your hair (loss or, rarely, an increase). This is usually only temporary and persistent hair thinning is rare. You may also experience increased facial pigmentation and body hair growth.

• Blood and urine analytical changes: Rarely reported decreases in white blood cell count and possible lymph node inflammation. You may experience delayed blood clotting. Abnormal blood levels of urea, sugar, or liver enzymes have also been observed sporadically. Your doctor may want to perform 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 urine. If you notice any change in the appearance of your urine, consult your doctor.

• Lipid changes: Since isotretinoin may cause abnormalities in blood levels of substances similar to fats (triglycerides and cholesterol) in some patients, it is recommended that you do not consume alcoholic beverages. If your doctor checks that you have high triglyceride levels, you may need to reduce your isotretinoin dose and follow a low-fat diet.

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

• Dark or brown urine
• Difficulty achieving or maintaining an erection
• Decreased libido
• Inflammation of the breasts with or without breast tenderness 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 theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

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

Composition of Flexresan 10 mg

-The active ingredient is isotretinoine. Each soft capsule contains 10 mg of isotretinoine.

- The other components are: Refined soybean oil, yellow beeswax, hydrogenated soybean oil, partially hydrogenated vegetable oil, gelatin, glycerol (E422), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), and purified water.

Appearance of the product and contents of the packaging

Flexresan10 mg soft capsules are red-orange soft capsules of oval shape. Each package contains 50 soft capsules.

Holder of the marketing authorization and responsible for manufacturing

ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A

C/ Sagitario, 14

03006 Alicante (Spain)

Date of the last review of this leaflet:March 2024

Other sources of information

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