ISOACNE 20 mg SOFT CAPSULES

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

ISOACNE 20mg soft capsules

Isotretinoin

WARNING

IN CASE OF PREGNANCY, IT CAN SERIOUSLY HARM THE BABY

Women must use effective contraceptives throughout treatment.

Do not use it if you are pregnant or think you may be pregnant.

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 questions, 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 is Isoacne 20 mg soft capsules (hereinafter referred to as Isoacne) and what is it used for

2 – What you need to know before taking Isoacne

3 – How to take Isoacne

4 – Possible side effects

5 – Storage of Isoacne

6 – Contents of the pack and further information

1. What is Isoacne and what is it used for

Isoacne contains isotretinoin as the active substance and belongs to the group of medicines known as retinoids.

Isoacne is indicated for the treatment of severe acne (such as nodular or conglobate acne or acne that can leave permanent scars), resistant to conventional treatments with both oral antibiotics and local therapy (cream, gel, ointment, or lotion).

Isoacne should only be prescribed under the supervision of a doctor with experience in the use and monitoring of retinoids in the treatment of severe acne.

Isoacne is not indicated for the treatment of acne that appears before puberty, and its administration is not recommended in children under 12 years of age.

2. What you need to know before taking Isoacne

Do not take Isoacne:

• 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 are allergic to isotretinoin or any of the other components of this medication (listed in section 6), especially peanuts or soy.
• If you have severe liver disease (liver failure).
• In case of hypervitaminosis A (very high levels of vitamin A in the body).
• If you have high levels of lipids in the blood (cholesterol, triglycerides).
• If you are taking any antibiotic from the tetracycline family.
• If you are taking vitamin A or other retinoids (acitretin, alitretinoin).

Warnings and precautions

Consult your doctor before starting to take Isoacne:

• If you have ever had any mental health problems. This includes depression, anxiety, 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 Isoacne.
• If you have any kidney problems. Your doctor may adjust the dose of isotretinoin.
• If you are overweight or have diabetes mellitus, have high levels of cholesterol or triglycerides, or consume large amounts of alcohol.

In these cases, there may be an increase in lipid and triglyceride levels in the blood.

If you are in any of these situations, your doctor may recommend more frequent blood tests. Elevated blood sugar levels have been reported in fasting and new cases of diabetes have been diagnosed during therapy with isotretinoin.

If you have diabetes mellitus, monitor your blood glucose levels more closely throughout treatment.

• If you have any liver problems.

Isoacne may cause your liver enzyme levels to increase. Your doctor will prescribe regular blood tests before and during treatment to check the condition of your liver. Transient and reversible increases in liver transaminases have been reported.

Persistent elevation of these enzyme levels may cause your doctor to reduce the dose of Isoacne or interrupt treatment.

• If you have a history of intestinal disorders.

Stop treatment immediately and consult your doctor quickly:

• If you become pregnant during treatment or during the month following treatment interruption.
• If you notice that you have:

• A rash that can progress to blisters or generalized peeling of the skin, or ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). This could be a severe skin reaction (e.g., erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) that can be potentially fatal. These severe skin rashes are often preceded by headache, fever, and body aches (symptoms similar to those of the flu).
• Difficulty breathing, itching, and/or skin rashes. These symptoms may be due to an allergic reaction, and some may affect the skin in the form of bruising or red spots on the arms and legs.
• Headache along with nausea, vomiting, or vision problems.
• Severe stomach pain, nausea, or vomiting, or intense diarrhea with blood in the stool.
• Difficulty or even inability to urinate.
• Decreased night vision and/or visual disturbances.
• Mental health problems: in particular, signs of depression (strong feeling of sadness or outbursts of crying, attempts at self-harm, or withdrawal from family or friends).

It is possible that 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 notice that your eyes or skin take on a yellowish color and you feel dizzy.

Special warnings for women:

Advice for men

The levels of oral retinoids in the semen of men taking Isoacne 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, nor during 1 month after stopping Isoacne, as a baby could be harmed if a pregnant patient receives your blood.

Advice for all patients

• Talk to your doctor if you experience persistent pain in the lower back or buttocks during treatment with Isoacne. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may interrupt treatment with Isoacne and refer you to a specialist for the treatment of inflammatory back pain. Further evaluation may be necessary, including imaging modalities such as magnetic resonance imaging.

• Isotretinoin may cause dry eyes, corneal opacities, keratitis, intolerance to contact lenses, and visual disturbances, including decreased night vision. Cases of dry eyes that do not resolve after treatment interruption have been reported. Inform your doctor if you have any of these symptoms. Your doctor may ask you to use an eye lubricant or artificial tears. If you wear contact lenses and have developed 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 disturbances, and it is possible that you may be asked to stop taking isotretinoin.

• Worsening of acne may occur during the first few weeks of treatment with inflammatory lesions on the skin, but this usually disappears with continued treatment within 7 to 10 days and usually does not require a dose adjustment.

• Bone abnormalities (including growth retardation, excessive growth, and reduced bone density) and calcium deposits in tendons and ligaments have occurred after several years of administration at very high doses for the treatment of keratinization disorders (keratin accumulation). The dose levels, treatment duration, and total accumulated dose in these cases generally far exceeded those recommended for the treatment of acne.

• Isotretinoin may cause hyperlipidemia (specifically, an increase in triglycerides). Your doctor will evaluate these levels before, during, and after treatment with isotretinoin. If hyperlipidemia persists, your doctor may reduce your dose or discontinue isotretinoin. Hyperlipidemia can also be treated with dietary measures. Excessive levels are sometimes associated with pancreatitis, which is potentially fatal.

Children

Do not give this medication to children under 12 years of age, as it is not known whether it is safe or effective in this age group and it is not indicated in prepubertal acne.

Use of Isoacne with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to take any other medication, including medications obtained without a prescription.

Do not take medications that contain vitamin A or tetracyclines (a type of antibiotic) or use any skin treatment for acne (other retinoids) during treatment with Isoacne.

Concomitant administration of isotretinoin with topical keratolytics or exfoliating anti-acne agents should be avoided, as it may increase local irritation.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Be cautious if you drive or operate machinery at night, as your night vision may be impaired during treatment, sometimes suddenly.

These vision changes rarely persist after treatment interruption.

Rarely, drowsiness and dizziness have been reported.

If this happens to you, do not drive or operate machinery, nor participate in any other activity where the symptoms may put you or others at risk.

Isoacne contains soybean oil.

Do not use this medication in case of peanut or soy allergy.

Recommendations for daily life:

• Apply moisturizing creams or ointments to your skin and use a lip balm during treatment if you suffer from dry skin or lips.
• In general, avoid applying any irritating skin products (e.g., exfoliating creams) during treatment.
• Avoid excessive sun exposure: Isoacne may increase sun sensitivity during treatment.

If you cannot avoid sun exposure, apply a sunscreen (at least protection factor 15).

Do not use UV lamps, sunbeds, or tanning booths.

• Avoid waxing during treatment and for at least 6 months after treatment interruption. Also, avoid surgical dermabrasion and laser treatments (cosmetic procedures designed to smooth the skin, reduce scars, and signs of aging). These procedures may cause scarring, hypo/hyperpigmentation (discoloration or excessive pigmentation of the skin), or epidermal detachment.
• If you have severe dry eyes, try using glasses instead of contact lenses during treatment.
• You may need to wear sunglasses to protect your eyes from glare.
• Take all necessary precautions if you drive or operate machinery at night, as changes in vision (defective night vision) can occur suddenly.
• Refrain from vigorous physical exercise during treatment with Isoacne, as treatment can sometimes cause muscle and joint pain.

3. How to take Isoacné

Dosage

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual initial dose is 0.5 mg per kilogram of body weight per day (0.5 mg/kg/day).

For most patients, the dose will be between 0.5 and 1.0 mg/kg/day.

If you feel that the effect of Isoacné is too strong or too weak, inform your doctor.

The capsules should be taken once or twice a day during a meal (with a glass of water). Swallow the capsules whole without chewing or sucking them.

Patients with severe renal insufficiency

In patients with severe renal insufficiency, treatment should be started with the lowest dose (e.g., 10 mg/day).

Use in children

Isoacné is not indicated in children for the treatment of prepubertal acne and is not recommended for use in children under 12 years of age.

Patients with intolerance

In patients who present with severe intolerance to the recommended dose, the doctor may continue treatment with the maximum tolerated dose.

A treatment cycle with Isoacnélasts between 16 and 24 weeks. It is possible that the condition of your skin will continue to improve until 8 weeks after the end of treatment.

Therefore, wait for at least this period of 8 weeks before starting a new treatment cycle, if necessary. In most cases, patients only need one treatment cycle.

If you take more Isoacné than you should

If you have taken more Isoacné than you should, you may suffer from hypervitaminosis A, whose symptoms are severe headaches, nausea or vomiting, drowsiness, irritability, and itching.

If you have taken more Isoacné than you should, consult your doctor or pharmacist immediately, or go to the nearest hospital as soon as possible.

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

If you forgot to take Isoacné

If you have forgotten to take a dose of Isoacné, do not take a double dose to make up for the forgotten doses.

Continue with the scheduled doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can have adverse effects, although not all people suffer from them.

These effects often reverse during treatment or after interruption of treatment or dose modification (consult your doctor about this), however, some may persist after treatment is discontinued. Your doctor can help you with the situation.

Some adverse effects can be serious

• Mental problems

Rare 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 discomfort.
• Worsening of existing depression
• Becoming violent or aggressive

Very rare effects(may affect up to 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 indicate that you should stop taking Isoacné. This may not be enough to stop the effects: you may need more help, and your doctor can manage it.

• Rare effects(may affect up to 1 in 1,000 people): Sudden allergic reaction (anaphylactic reactions: difficulty breathing or swallowing caused by a sudden swelling of the throat, face, lips, and mouth. Additionally, sudden swelling of hands, feet, and ankles).

If you have an allergic reaction, stop taking Isoacné and contact your doctor.

• Frequency not known(cannot be estimated from available data): Severe skin rashes (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which are potentially fatal and require immediate medical attention. These rashes initially appear as circular spots, often with central blisters, usually on the arms and hands, or the legs and feet. The more intense rashes can include blisters on the chest and back. Other symptoms, such as eye infection (conjunctivitis) or ulcers in the mouth, throat, or nose, may occur. The intense forms of rash can progress to generalized skin peeling, which can be potentially fatal. These severe skin rashes are often preceded by headache, fever, body aches (symptoms similar to those of the flu).

If you develop a severe rash or these skin symptoms, stop taking Isoacné and contact a doctor immediately.

All other adverse effects are listed below by frequency.

Very frequent adverse effects: may affect more than 1 in 10 people

• Decrease in red blood cell count (anemia), decrease in platelet count, and increase in platelet count.

• Increased sedimentation rate (marker of acute inflammation).
• Increased fatty acids in blood (increase in triglycerides in blood), decrease in fat/protein ratio (decrease in high-density lipoproteins).

• Elevated liver enzymes (increase in transaminases).

Consequently, your doctor may request blood tests and take appropriate measures.

• Red sores or deep cracks in the corner of the mouth or lips, skin inflammation, dry skin, localized peeling, itching, red skin rash, skin fragility (friction injury).

• Inflammation of the eyelids, itching in the eyes, and crusts on the eyelids (conjunctivitis), eye irritation, and dryness in the eyes.

• Back pain (particularly in adolescent patients), muscle and joint pain. It is therefore recommended to reduce physical exercise during treatment. All these effects are reversible after treatment interruption.

Frequent adverse effects: may affect up to 1 in 10 people

• Increased glucose in blood and some type of fat (cholesterol), presence of proteins or blood in urine.
• Decrease in white blood cell count that makes you more prone to infections.
• Headache.
• Nasal dryness, nasal bleeding, and rhinopharyngitis.

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

• Cutaneous allergic reactions, hypersensitivity.
• Hair loss (alopecia).

Very rare adverse effects: may affect up to 1 in 10,000 people

• Pancreatitis, or gastrointestinal bleeding or inflammatory bowel disease. In case of deep abdominal pain, with or without bloody diarrhea, nausea, and vomiting, stop taking isotretinoin and call your doctor as soon as possible.
• Liver disorder (hepatitis) including nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes.
• Kidney disease including severe fatigue, difficulty urinating or inability to urinate, and swollen eyelids. If you experience these symptoms while taking isotretinoin, interrupt treatment and contact your doctor.
• High blood sugar levels (diabetes), with symptoms that include excessive thirst, large amounts of urine, increased appetite with weight loss, fatigue, drowsiness, weakness, depression, irritability, and general malaise. In these cases, consult your doctor.
• Benign intracranial hypertension has occurred in some patients taking isotretinoin concomitantly with certain antibiotics (tetracycline).

This hypertension is expressed with persistent headaches, with nausea, vomiting, or blurred vision (possibly caused by inflammation of the optic nerve (papilledema)). Stop taking Isoacné and contact your doctor as soon as possible.

• Seizures.
• Narrowing or blockage of blood vessels.
• Worsening of acne during the first weeks of treatment with inflammatory lesions on the skin.

• Severe form of acne (fulminant acne): development of inflammatory nodules, ulcerated, necrotic, and hemorrhagic lesions, sudden onset on the face and/or trunk, with or without fever and joint pain. In this case, stop taking isotretinoin and contact your doctor as soon as possible.

• Colitis.
• Localized bacterial infection may occur.

• Facial erythema, cutaneous erythema.
• Changes in hair, abnormal hairiness, nail disorders, and nail infection.
• Thickened scarring after surgery.
• Benign vascular skin and mucous membrane lesions.
• Increased sensitivity to the sun (photosensitivity reaction, see recommendations for daily life, in section 2). Increased pigmentation, excessive sweating.
• Increased volume of lymph nodes.
• Elevated uric acid levels in blood that can cause gout.
• This medication may affect night vision and cause sudden vision disorders. Rarely, these effects persist after treatment is finished.
• Difficulty distinguishing colors, severe eye irritation, corneal opacity, eye irritation, or sensation of having something in the eyes (keratitis), blurred vision, vision problems (cataracts), increased sensitivity to light, visual disturbances, and poor tolerance to contact lenses. You may need to wear sunglasses to protect your eyes from glare.

If the medication causes you the slightest vision difficulty, inform your doctor immediately.

• Hearing impairment.
• Sudden chest tightness with difficulty breathing and wheezing (bronchospasm), particularly in patients with asthma, abnormal voice changes (hoarseness).
• Dry throat, nausea.
• Discomfort.
• Excessive tissue production during wound healing (increased granulation tissue formation).

• Disorders, mainly in the joints with pain and swelling, bone abnormalities (growth retardation (caused by premature fusion of the epiphyses), increased growth, and reduced bone density), calcium deposits in soft tissues, tendon inflammation.
• Blood levels of an enzyme (creatine phosphokinase) released during muscle fiber degradation may increase in the case of intense physical exercise in patients taking isotretinoin, muscle rupture that can cause kidney disorders.

• Drowsiness and dizziness.

Frequency not known: cannot be estimated from available data

• Difficulty achieving 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 of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Isoacné

Keep this medication out of sight and reach of children.

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

Do not store at a temperature above 25°C. Keep in the original packaging. Keep the container perfectly closed to protect it from light.

When you finish treatment, you must return all unused capsules to your pharmacist.

Medications should not be thrown down the drain or into the trash. Deposit the containers and medications you no longer need in the SIGRE Point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information.

Composition of Isoacné 20 mg soft capsules

• The active ingredient is isotretinoin. Each capsule contains 20 mg of isotretinoin.

• The other components are: Soybean oil (see section 2), hydrogenated vegetable oil, and yellow beeswax.

Capsule composition: Gelatin, glycerol, purified water, red iron oxide (E172), yellow iron oxide (E172), 50% titanium dioxide (E171) in glycerol.

Black ink composition: SDA 35 alcohol, propylene glycol (E1520), black iron oxide, polyvinyl acetate phthalate, water, isopropyl alcohol, polyethylene glycol, ammonia hydroxide.

Product appearance and package contents

Each 20 mg capsule has an opaque gelatin coating, bicolored red/brown and cream, with a bright yellow/orange filling. Printed on one side with the logo “I 20”.

Marketing authorization holder

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11

08005 Barcelona - Spain

Phone: 93 483 30 00

Fax: 93 483 30 59

Manufacturer

CATALENT FRANCE BEINHEIM SA

74, rue Principale

F-67930 Beinheim, France

Or

Catalent Germany Schorndorf GmbH

Steinbeisstrasse 1 and 2

Schorndorf, Baden-Wuerttemberg

73614, Germany

Or

CATALENT GERMANY EBERBACH GmbH

Gammelsbacher Str. 2

Eberbach, Baden-Wuerttemberg

69412, Germany

This medication is authorized in other EEA Member States with the following names:

• Belgium ISOCURAL
• Czech Republic CURACNE
• France CURACNE
• Italy ISORIAC
• Luxembourg CURACNE
• Poland CURACNE
• Spain ISOACNÉ

Date of the last revision of this prospectus:March 2024

Prescription and dispensing conditions

Isoacné is a prescription medication that requires special medical control during treatment.

For women of childbearing age

• Before prescription, the patient must consent to take precautions and use contraceptive methods.
• The prescription duration is limited to one month of treatment. Continuing treatment requires a new prescription.
• Only if the following mandatory conditions for prescription are met can the treatment be dispensed:
• • For the first prescription:
  • • Signature of informed consent on contraceptive precautions.
    • Use of at least one effective contraceptive method, from at least one month before the start of treatment.
    • Evaluation of the patient's level of understanding.
    • Date of pregnancy test (hCG in plasma).

• For subsequent prescriptions:
• • Continue with effective contraceptive methods.
  • Evaluation of the patient's level of understanding.
  • Date of the last pregnancy test (hCG in plasma).

You can obtain additional information about Isoacné by consulting your doctor or pharmacist.

Detailed and updated information about 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: https://cima.aemps.es/cima/publico/home.html and the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/