PATIENT INFORMATION LEAFLET

ISOACNÉ 55 mg soft capsules

Isotretinoin

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

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

1 – What Isoacné 5 mg soft capsules (hereafter referred to as Isoacné) are and for what they are used

2 – What you need to know before you start taking Isoacné

3 – How to take Isoacné

4 – Possible side effects

5 – Storage of Isoacné

6 – Contents of the pack and additional information

Isoacné contains isotretinoína as the active ingredient and belongs to a group of medications known as retinoids.

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

Isoacné 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.in the treatment of severe acne.

Isoacné is not indicated for the treatment of acne that appears before puberty and is not recommended for administration to children under 12years of age.

Do not take Isoacné:

• 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 to any of the other components of this medication (listed in section 6), especially peanuts or soy.
• If you have liver insufficiency (a serious liver disease).
• In case of hypervitaminosisA (very high levels of vitaminA 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 Isoacné:

• If you have ever had any mental health problems. This includes depression, anxiety, aggressive tendencies, or mood changes. Also included are thoughts of self-harm or ending your life. This is because your mood may be affected while taking Isoacné.
• If you have any kidney problems. Your doctor will be able to adjust your 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 in the morning and new cases of diabetes have been reported during isotretinoin therapy.

If you have diabetes mellitus, control your blood glucose levels more closely during the entire treatment.

• If you have any liver problems.

Isoacné may cause an increase in your transaminase levels (liver enzymes). Your doctor will prescribe regular blood tests, before and during treatment, to check the state of your liver. Transient and reversible increases in liver transaminases have been reported.

Persistent increases in these enzyme levels may cause your doctor to reduce your dose of Isoacné or stop treatment.

• If you have a history of gastrointestinal problems.

Stop treatment immediately and consult your doctor quickly:

• If you become pregnant during treatment or within one month after stopping treatment.
• If you notice that you have:

You may not notice some changes in your mood and behavior, so it is very important to 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 discuss with your doctor.

?If you perceive that your eyes or skin take on a yellowish color and feel dizzy.

Special warnings for women:

Advice for men

The levels of oral retinoids in the semen of men taking Isoacné are too low to harm their partners' babies. However, you should never share your medication with anyone.

Additional precautions

Never give this medication to anyone else. Please take 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 Isoacné because a baby could be harmed if a pregnant woman 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 Isoacné. These symptoms may be signs of sacroiliitis, a type of inflammatory back pain. Your doctor may stop treatment with Isoacné and refer you to a specialist for back pain treatment. You may need additional evaluation, including imaging modalities such as MRI.

• Isotretinoin can cause dry eyes, corneal opacities, keratitis, intolerance to contact lenses, and visual difficulties, including night vision impairment. Cases of persistent dry eyes have been reported after stopping treatment.

• It may take 7 to 10 days for the initial worsening of acne to resolve, but this usually does not require a dose adjustment.

• Severe bone abnormalities (including growth retardation, excessive growth, and reduced bone density) and calcification deposits in tendons and ligaments have been reported after several years of high-dose administration for skin disorders (keratinization disorders). The dose levels, treatment duration, and total accumulated dose in these cases far exceeded the recommended doses for acne treatment.

• Isotretinoin can cause hyperlipidemia (specifically, elevated triglycerides). Your doctor will evaluate these levels before, during, and after treatment with isotretinoin. If hyperlipidemia persists, your doctor may reduce your dose or stop 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 old, as it is not known if it is safe or effective in this age group and is not indicated for prepubertal acne.

Use of Isoacné with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to take any other medication, including over-the-counter medications.

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

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

Pregnancy, lactation, and fertility

For more information on pregnancy and birth control, see the “Pregnancy Prevention Plan” section in the “Warnings and Precautions” section.

Driving and operating machinery

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

These impairments rarely persist after stopping treatment.

Rarely, drowsiness and dizziness have been reported.

If this happens to you, do not drive or operate machinery or participate in any other activity that may put you or others at risk.

Isoacné contains soy oil.

Do not use this medication if you are allergic to peanuts or soy.

Recommendations for daily life:

• Apply moisturizing creams or lotions to your skin and use a lip balm during treatment if you experience dry skin or lips.
• Generally, avoid applying any irritating skin products (e.g., exfoliating creams) during treatment.
• Avoid excessive sun exposure: Isoacné may increase sun sensitivity during treatment.

If you cannot avoid sun exposure, apply a sunscreen (factor 15 or higher).

Do not use UV lamps, beds, or tanning cabins.

• Avoid waxing during treatment and at least 6 months after stopping treatment. Also, avoid dermoabrasion and laser treatments (cosmetic procedures created to smooth the skin, reduce scars, and signs of aging). These procedures may cause scarring, hypohyperpigmentation (skin discoloration or excessive coloration), or epidermal detachment.
• If you experience intense dry eyes, try using glasses instead of contact lenses during treatment.
• You may need to wear sunglasses to protect your eyes from glare.
• Be cautious if you drive or operate machinery at night, as your night vision may be impaired during treatment, sometimes suddenly.
• Avoid strenuous exercise during treatment with Isoacné, as the treatment may cause muscle and joint pain.

Dosage

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in 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 think the effect of Isoacné is too strong or too weak, inform your doctor.

The capsules should be taken one or two times 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 begin with the lowest dose (for example, 10 mg/day).

Use in children

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

Patients with intolerance

In patients who present a 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 your skin condition may continue to improve up to 8weeks after the end of treatment.

Therefore, wait at least 8 weeks before starting a new treatment cycle, if necessary. Most 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 experience hypervitaminosisA, 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 Toxicological Information Service, phone 91 562 04 20.

If you forgot to take Isoacné

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

Continue with the scheduled doses.

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

Like all medications, this medication may have side effects, although not everyone will experience them.

These side effects often reverse during treatment or after stopping treatment or adjusting the dose (consult your doctor about this), however, some may persist after stopping treatment. Your doctor can help you with the situation.

Some side effects can be serious

• Mental problems

Rare side effects(may affect up to 1 in 10,000 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 up to 1 in 100,000 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 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 signs of any of these mental problems. Your doctor may tell you to stop taking Isoacné. That may not be enough to stop the effects: you may need more help, and your doctor can manage it.

• Rare side effects(may affect up to 1 in 10,000 people): Anaphylactic reactions: sudden and rapid swelling of the throat, face, lips, and mouth. Also, sudden swelling of the hands, feet, and ankles.

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

• Unknown frequency(cannot be estimated from available data):Severe skin eruptions (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which are potentially fatal and require immediate medical attention. These eruptions initially appear as circular macules, often with central blisters, usually on the arms and hands, or legs and feet. More intense eruptions may include blisters on the chest and back. Other symptoms may include eye infection (conjunctivitis) or mouth, throat, or nasal ulcers. More intense eruptions may progress to generalized skin peeling, which can be potentially fatal. These severe skin eruptions are often preceded by headache, fever, body aches (similar to flu symptoms).

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

All other side effects are listed below by frequency.

Very common side effects: may affect more than 1 in 10 people

• Decreased red blood cell count (anemia), decreased platelet count, and increased platelet count.

• Increased sedimentation rate (acute inflammation marker).
• Increased blood fats (increased triglycerides in blood), decreased ratio of fat to protein (decreased high-density lipoproteins).

• Elevated liver enzymes (increased transaminases).

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

• Red 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).

• Eye inflammation, eye itching, and eyelid crusts (conjunctivitis), eye irritation, and dry eyes.

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

Common side effects:may affect up to 1 in 10 people

• Increased blood sugar and some type of fat (cholesterol), presence of proteins or blood in urine.
• Decreased white blood cell count that makes you more prone to infections.
• Headache.
• Runny nose, nosebleeds, and rhinopharyngitis.

Rare side effects: may affect up to 1 in 10,000 people

• Allergic skin reactions, hypersensitivity.
• Hair loss (alopecia).

Very rare side effects: may affect up to 1 in 100,000 people

• Pancreatitis, or gastrointestinal hemorrhage or inflammatory bowel disease. If you have deep abdominal pain, with or without bloody diarrhea, nausea, and vomiting, stop taking isotretinoine and contact your doctor as soon as possible.
• Liver disease (hepatitis) including nausea, vomiting, loss of appetite, general discomfort, 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 isotretinoine, interrupt treatment and contact your doctor.
• Very high blood sugar (diabetes), with symptoms that include excessive thirst, large amounts of urine, increased appetite with weight loss, fatigue, drowsiness, weakness, depression, irritability, and general discomfort. In these cases, consult your doctor.
• Benign intracranial hypertension has occurred in some patients taking isotretinoine concomitantly with certain antibiotics (tetracycline).

This hypertension is expressed with persistent headaches, nausea, vomiting, or blurred vision (possibly caused by an 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 (acne fulminans): development of inflamed nodules, ulcerated, necrotic, and hemorrhagic lesions, appearing suddenly on the face and/or trunk, with or without fever and joint pain. In this case, stop taking isotretinoine and contact your doctor as soon as possible.

• Colitis.
• Localized bacterial infection.

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

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

• Audio dysfunction.
• Sudden chest tightness with difficulty breathing and wheezing (bronchospasm), particularly in patients with asthma, abnormal voice changes (hoarseness).
• Throat dryness, nausea.
• Discomfort.
• Excessive tissue formation during wound healing (increased granulation tissue formation).

• Alterations, mainly in joints with pain and swelling, bone anomalies (caused by premature fusion of epiphyses), increased growth, and reduced bone density, calcification deposits in soft tissues, tendon inflammation.
• Levels of an enzyme (creatine phosphokinase) released during muscle fiber degradation may increase in the case of intense physical exercise, in patients taking isotretinoine, muscle rupture that can cause kidney problems.

• Drowsiness and dizziness.

Unknown frequency: cannot be estimated from available data

• Difficulty achieving or maintaining an erection
• Decreased libido
• Male breast inflammation with or without sensitivity in men
• Vaginal dryness
• Sacroiliitis, a type of low back inflammatory pain that causes pain in the buttocks or lower back
• Urethritis

Reporting of side effects:

If you experienceany type of side effect, consult your doctor or pharmacist even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly tothrough the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://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 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 above25ºC. Store 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 in the trash.Deposit the containers and medications you do not need at the SIGRE collection pointof the pharmacy.Ask your pharmacist if you are unsure how to dispose of the containers and medications you do not need. By doing so, you will help protect the environment.

Composition of Isoacné 5 mg soft capsules

- The active ingredient is isotretinoin. Each capsule contains 5 mg of isotretinoin.

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

Composition of the capsule: Gelatin, glycerol, purified water, red iron oxide (E172), yellow iron oxide (E172), 50% titanium dioxide (E171) in glycerol.

Composition of the black ink: SDA 35 alcohol, propylene glycol (E1520), iron oxide black, polyvinyl acetate phthalate, water, isopropyl alcohol, polyethylene glycol, ammonium hydroxide.

Appearance of the product and contents of the package

Each 5 mg capsule has an opaque, bicolor red/brown gelatin coating and a bright yellow/orange filling. Printed on one side with the logo "5".

Marketing Authorization Holder

PIERRE FABRE IBÉRICA, S.A.

C/ Ramón Trias Fargas, 7-11

08005 Barcelona - Spain

Telephone: 93 483 30 00

Fax: 93 483 30 59

Responsible for manufacturing

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 medicinal product is authorized in other Member States of the EEA with the following names:

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

Last update date of this prospectus: March 2024

Prescription and dispensing conditions

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

For fertile women

• Before prescribing, the patient must agree to take precautions and use contraceptive methods.
• The duration of the prescription is limited to one month of treatment. Continuing treatment requires a new prescription.
• Only if the following mandatory conditions for prescription are met, the treatment can 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 using effective contraceptive methods.
• Evaluate the patient's level of understanding.
• Date of last pregnancy test (hCG in plasma).