FLEXRESAN 10 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Flexresan 10 mg Soft Capsules

Isotretinoin

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What Flexresan 10 mg soft capsules are and what they are used for
2. What you need to know before taking Flexresan 10 mg soft capsules
3. How to take Flexresan 10 mg soft capsules
4. Possible side effects
5. Storage of Flexresan 10 mg soft capsules
6. Package contents and additional information

1. What Flexresan 10 mg soft capsules are and what they are used for

Flexresan 10 mg are orange-red, oval-shaped soft capsules. Each package contains 50 soft capsules.

Isotretinoin belongs to a group of medications called systemic anti-acne preparations that work by suppressing the activity of the sebaceous glands (which produce fat) and reducing the size of these glands. Additionally, an anti-inflammatory effect of isotretinoin on the skin has been described.

Flexresan 10 mg is indicated for the treatment of severe forms of acne (e.g., nodular or conglobate acne, or acne with a risk of permanent scarring) that are resistant to adequate cycles of conventional treatment with systemic and topical antibacterial preparations.

2. What you need to know before taking Flexresan 10 mg soft capsules

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", 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 components of this medication (listed in section 6).
• If you are taking tetracyclines (a type of antibiotic).
• This medication contains soybean oil. Do not use this medication if you are allergic to peanuts or soy.

Warnings and Precautions

Treatment with isotretinoin should be monitored by a doctor specializing in the treatment of severe acne who is aware of all the risks of treatment with isotretinoin, as well as the danger of birth defects in the fetus (teratogenicity).

Pregnancy Prevention Plan

Pregnant women must not take Flexresan 10 mg

This medication can seriously harm the baby (the medication is considered "teratogenic") - it can cause serious abnormalities of the brain, face, ear, eyes, heart, and certain glands of the baby (thymus and parathyroid). It also increases the likelihood of spontaneous abortion. This can happen even if Flexresan 10 mg is taken only for a short period 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 into your milk and 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, as the medication may still be present in your body.

Women who may become pregnant are prescribed Flexresan 10 mg under strict rules. This is due to the risk of serious harm to the baby

These are the rules:

• Your doctor must explain the risk of harm to the baby - you must understand why you should not become pregnant and what you must do to avoid becoming pregnant.
• You must have discussed contraception (birth control) with your doctor. The doctor will provide you with information on how to avoid becoming pregnant. The doctor may refer you to a specialist for contraceptive advice.
• 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 taking Flexresan 10 mg

• You must agree to use at least one very 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 would be suitable for you.
• You must use contraceptives for one month before taking Flexresan 10 mg, during treatment, and for one month after finishing treatment.
• You must use contraceptives even if you do not have your period or are not sexually active (unless your doctor decides it is not necessary).

Women must accept to have pregnancy tests before, during, and after taking Flexresan 10 mg

• You must agree to have regular follow-up visits, ideally every month.
• You must agree to have regular pregnancy tests, ideally every month during treatment, and, because the medication may still be present in your body, one month after finishing treatment with Flexresan 10 mg (unless your doctor decides it is not necessary in your case).
• You must agree to have additional pregnancy tests if your doctor requests them.
• You must not become pregnant during treatment or during the month following treatment, as it is possible that the medication 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 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 refer you to a specialist for advice.

Additionally, if you become pregnant within one month after stopping Flexresan 10 mg, you must consult your doctor. Your doctor may refer 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 baby of their partners. However, you should never share your medication with anyone.

Additional Precautions

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

Do not donate blood during treatment with this medication, or during one month after stopping Flexresan 10 mg, as a baby could be harmed if a pregnant patient 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 taking Flexresan 10 mg.

Mental Health Problems

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

• If you experience constant headaches, nausea, vomiting, or blurred vision, or severe diarrhea (hemorrhagic: with blood in the stool), stop treatment immediately and contact your doctor as soon as possible.
• If you have kidney problems, inform your doctor, as you may need to start treatment with a lower dose.

If you experience allergic reactions (skin redness, itching), inform your doctor, as they may need to interrupt treatment with Flexresan 10 mg.

• It is possible that acne may worsen during the first few weeks of treatment, although it should improve later.
• Your skin may become more sensitive to the sun's effects. Avoid exposure to the sun (even on cloudy days) and UV lamps while taking this medication. If you are going to be in the sun, apply a product with a high sun protection factor (at least 15) before exposure.
• Flexresan 10 mg may increase skin fragility. Chemical dermabrasion (controlled skin scraping to remove scars or lesions after acne), laser skin treatment, and wax depilation should be avoided during treatment and for at least 6 months after, as they may cause scarring or skin irritation.
• Avoid using topical keratolytic or exfoliating anti-acne preparations that have not been prescribed by your doctor.
• Use a moisturizing cream or ointment and a lip protector during treatment, as Flexresan 10 mg may dry out your skin and lips.
• Isotretinoin may cause dry eyes, intolerance to contact lenses, and visual difficulties, including decreased night vision. Cases of dry eyes that do not resolve after treatment have been reported. Inform your doctor if you experience any of these symptoms. Your doctor may recommend that you use an eye lubricant or tear replacement therapy. If you wear contact lenses and have developed intolerance, you may be advised to wear glasses during treatment. Your doctor may refer you to a specialist if you experience visual difficulties, and it is possible that you may need to stop taking isotretinoin.
• It is recommended to reduce intense physical activity during treatment with Flexresan 10 mg, as muscle and joint pain have been observed during this treatment.
• Tell 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 the treatment of inflammatory back pain. Further evaluation, including imaging modalities such as MRI, may be necessary.
• Your doctor should regularly monitor your liver function and blood lipid levels. If you are diabetic, obese, frequently drink alcohol, or have any lipid metabolism disorders, your doctor may need to perform more frequent checks. Diabetics are also advised to have their blood glucose levels checked more frequently.

Using Flexresan 10 mg with other medications

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

Do not take vitamin A supplements or tetracyclines during treatment with Flexresan 10 mg. Taking them together increases the risk of side effects.

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

Pregnancy, Breastfeeding, and Fertility

Pregnancy

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

Breastfeeding

Fertility

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

Driving and Using Machines

Flexresan 10 mg can cause a decrease in night vision in some cases, which may occur suddenly during treatment.

Rarely, these changes may persist after the medication is stopped. If you notice these or other effects on your vision, or if you feel drowsy or dizzy, you should not drive, use machines, or perform any activity that could put you or others at risk.

3. How to take Flexresan 10 mg soft capsules

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will tell you how long to take Flexresan 10 mg. Do not stop treatment before this.

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 and day (0.5 mg/kg/day). Your doctor may adjust this dose after a few weeks, depending 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 16 to 24 weeks. Acne may continue to improve for up to 8 weeks after finishing treatment. Most patients only need one treatment cycle.

Before starting treatment with Flexresan 10 mg, read the "Pregnancy Prevention Plan" in the "Warnings and Precautions" section.

If you think the effect of Flexresan 10 mg is too strong or too weak, tell 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, and increased later.

Use in children

Flexresan 10 mg is not indicated for the treatment of acne that appears before puberty or in children under 12 years of age.

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 or call the Toxicology Information Service, phone 91 562 04 20.

If you forget to take Flexresan 10 mg

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

If you forget a dose, you should take the medication as soon as possible, continuing treatment as prescribed. However, when the next administration is near, it is better not to take the forgotten dose and wait for the next administration.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Severe Adverse Effects

Mental Problems:

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

• Depression or related disorders. These signs include a sad or altered 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 had feelings or thoughts 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 to be depressed.
• Unusual behavior.
• 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 signs of any of these mental problems.Your doctor may advise 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 handle it.

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

Other Severe 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) with skin rashes and itching. If you experience an allergic reaction, therapy should be discontinued 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, representative of an increase in your blood sugar levels, which could mean the presence of diabetes. Your doctor may monitor your blood sugar levels more frequently during your treatment.

• Increased intracranial pressure (of the brain): In very rare cases, when isotretinoin is administered together with some antibiotics, increased intracranial pressure, seizures, and drowsiness have been observed. If you are affected by persistent headache with nausea, vomiting, and blurred vision, this could mean that you are suffering from benign intracranial hypertension. Stop taking isotretinoin as soon as possible 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 diarrhea with blood, and vomiting, stop taking isotretinoin as soon as possible and consult your doctor.

• Liver disorders: 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 disorders: Glomerulonephritis (inflammation of the kidneys). You may feel excessively tired, stop urinating, and have swollen and bulging eyelids. If this happens while you are taking your medication, discontinue therapy and consult your doctor.

Adverse Effects of Unknown Frequency (cannot be estimated from the available data)

• Skin and hair problems: Severe skin rash (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) that can potentially be life-threatening and require immediate medical attention. They initially appear as circular spots, often with a central blister, usually on arms and hands or legs and feet; more severe rashes can 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 skin rash can lead to generalized peeling of the skin, which can be life-threatening. These types of skin rash can often be preceded by headache, fever, body aches (symptoms similar to the flu).

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

Non-Severe Adverse Effects

Frequent Adverse Effects (may affect up to 1 in 10 people)

• Skin and eye disorders: You should expect dry skin, especially on the lips and face. You may have inflammation of the throat or skin, your skin or lips may crack, you may have a rash, some mild itching, and mild peeling. This dryness can be reduced with the regular use of a good moisturizer from the beginning of treatment.

You may feel your eyes tired and slightly irritated. Very rarely, people who use contact lenses have had to wear glasses during treatment due to dry eyes. Normally, these adverse effects are reversible once treatment is discontinued.

Dermabrasion and wax depilation should be avoided during treatment and for at least six months after treatment, as they can cause scarring or skin irritation.

• Muscle and bone disorders: Lower back pain (lumbalgia), muscle pain, and joint pain have been frequently reported. These effects are reversible once treatment is discontinued. You should try to reduce intense physical activity during isotretinoin therapy.

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

It is possible that acne may worsen during the first few weeks of treatment. However, your acne and other symptoms should improve as you continue with treatment.

Other adverse effects observed rarely are: excessive sweating and pruritus (itching), photosensitivity. You should take measures to protect yourself from the sun, such as using a sunscreen product with a high protection factor (at least SPF 15). Avoid exposure to ultraviolet light. Very rarely, you may experience changes in your night vision or your ability to distinguish colors, or you may need to wear sunglasses. On other occasions, intense eye irritation or eyelid inflammation, corneal opacities, keratitis, and cataracts have occurred. If this happens, inform your doctor immediately, so they can monitor your vision.

• Muscle and bone disorders: Arthritis and occasional tendon pain have been reported in very rare cases.

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

• Changes in skin and hair: 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 thickening of scar tissue after surgical interventions, increased facial pigmentation, and body hair levels.

• Blood and urine analytical changes: In very rare cases, it has been reported that the white blood cell count may decrease, and you may experience lymph node inflammation. The coagulation process may be delayed. Abnormal levels in blood urea, sugar, or liver enzymes have also been observed sporadically. Your doctor may want 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 change in the appearance of your urine, consult your doctor.

• Lipid changes: Since isotretinoin can produce anomalies in blood levels of fat-like substances (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, 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 the available data)

• Dark or brown urine
• Difficulty getting or maintaining an erection
• Decreased libido
• Breast inflammation with or without sensitivity in men
• Vaginal dryness
• Sacroiliitis, a type of inflammatory low back pain that causes pain in the buttocks or lower back
• Urethral inflammation

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Flexresan 10 mg Soft Capsules

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

Do not store above 25°C.

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

Do not use this medicine 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 wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

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

6. Package Contents and Additional Information

Composition of Flexresan 10 mg

• The active ingredient is isotretinoin. Each soft capsule contains 10 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 Package Contents

Flexresan 10 mg soft capsules are soft capsules of orange-red color and oval shape. Each package contains 50 soft capsules.

Marketing Authorization Holder and Manufacturer

ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A.

C/ Sagitario, 14

03006 Alicante (Spain)

Date of the Last Revision of this Prospectus:March 2024

Other Sources of Information

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