Curacne 5 mg: detailed information

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Curacne 5 mg (Isoacné 5 mg)
soft capsules
Isotretinoinum
Curacne 5 mg and Isoacné 5 mg are different trade names for the same medicine.
WARNING
MAY CAUSE SEVERE HARM TO THE UNBORN CHILD.
Women must use effective contraceptive methods.
Do not use during pregnancy or if pregnancy is suspected.
▼This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. Patients can also help by reporting any adverse reactions that occur after using the medicine. For information on how to report adverse reactions, see section 4.
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Curacne 5 mg is and what it is used for
What you need to know before taking Curacne 5 mg
How to take Curacne 5 mg
Possible side effects
How to store Curacne 5 mg
Contents of the pack and other information

1. What Curacne 5 mg is and what it is used for

Curacne 5 mg contains the active substance isotretinoin. Isotretinoin belongs to a group of medicines called retinoids.
Curacne 5 mg is indicated for the treatment of severe forms of acne (such as nodular acne, conglobate acne, or acne with risk of permanent scarring) that are resistant to properly conducted standard treatment with systemic antibacterial agents and topical treatments (cream, gel, ointment, lotion).
Treatment with Curacne 5 mg must be carried out under the supervision of a physician experienced in the treatment of severe acne with retinoids and in monitoring patients during therapy.
Curacne 5 mg is not indicated for the treatment of acne occurring before puberty, and its use is not recommended in children under 12 years of age.

2. Important information before taking Curacne 5 mg

When not to use Curacne 5 mg:

If the patient is pregnant or breastfeeding.
If there is any risk that the patient may become pregnant, it is necessary to follow the precautions outlined in the Pregnancy Prevention Programme; see section "Warnings and precautions".
If the patient is allergic to isotretinoin or any of the other ingredients of this medicine (listed in section 6), particularly peanuts or soya.
If the patient has liver failure (severe liver disease).
If the patient has hypervitaminosis A (excessively high levels of vitamin A in the blood).
If the patient has elevated levels of lipids (cholesterol, triglycerides) in the blood.
If the patient is being treated simultaneously with antibiotics of the tetracycline group.
If the patient is taking vitamin A or other retinoids (acitretin, alitretinoin).

Warnings and precautions
Before starting treatment with Curacne 5 mg, discuss the following with your doctor:

If the patient has ever had mental health problems, including depression, anxiety, aggressive tendencies or mood swings, or thoughts of self-harm or suicide. This is because Curacne 5 mg may affect the patient's mood.
If the patient has kidney problems. In such a case, the treating physician should adjust the dose of isotretinoin.
If the patient is overweight, has diabetes, high cholesterol or triglyceride levels in the blood, or consumes large amounts of alcohol. In all these cases, lipid and triglyceride levels in the blood must be monitored regularly. If this applies to the patient, the doctor will order more frequent blood tests. Patients with diabetes should closely monitor their blood glucose levels during treatment. Increased fasting blood glucose levels have been reported, and new-onset diabetes has been diagnosed during isotretinoin treatment.
If the patient has liver problems. Curacne 5 mg may increase liver enzyme activity (aminotransferases). To monitor liver function (liver enzyme activity), the doctor will order regular blood tests before and during treatment. Transient and reversible increases in aminotransferase activity have been observed. If there is a persistent and marked increase in liver enzyme activity, the doctor may consider reducing the dose or discontinuing treatment.
If the patient has intestinal disorders.

Treatment with Curacne 5 mg must be stopped immediately and the doctor contacted if:

The patient becomes pregnant during treatment or within one month after its completion,
The following symptoms occur:
- Breathing difficulties, itching and/or hives, as these may indicate an allergic reaction. Some of these reactions may manifest on the skin as bruises or red spots on the arms and legs.
- Headache with nausea, vomiting, or impaired vision;
- Severe abdominal pain, nausea or vomiting, or acute diarrhoea associated with blood in the stool;
- Difficulty urinating or inability to urinate;
- Impaired night vision and/or visual disturbances;
- Mental health problems: particularly symptoms of depression (feeling unwell, tearfulness, self-harming behaviour, feeling detached from family or friends).

The patient may not notice certain changes in mood or behaviour, so it is very important to inform friends and family members about the use of this medicine. These individuals may notice such changes and help the patient identify problems requiring discussion with the doctor.

If the patient develops yellowing of the eyes or skin, or experiences dizziness.

Special warning for women taking Curacne 5 mg:
Pregnancy and breastfeeding, Important
Pregnancy Prevention Programme
Women who are pregnant must not take Curacne 5 mg
This medicine can severely harm the unborn child (the medicine has a "teratogenic" effect). It may cause serious damage to the brain, face, ears, eyes, heart, and certain glands (thymus and parathyroid glands) of the foetus. It also increases the risk of miscarriage. These effects may occur even if Curacne 5 mg is taken for only a short period during pregnancy.

Do not take Curacne 5 mg if the patient is pregnant or suspects she may be pregnant.
Do not take Curacne 5 mg during breastfeeding. The medicine is likely to pass into breast milk and may harm the baby.
Do not take Curacne 5 mg if the patient could become pregnant during treatment.
The patient must not become pregnant for one month after stopping treatment, as the medicine may still be present in her body.

Curacne 5 mg may be prescribed to women capable of becoming pregnant only if strict adherence to specific rules is ensured. This is due to the risk of severe birth defects in the unborn child.
The following conditions must be met:

The doctor must explain to the patient the risk of harm to the unborn child (birth defects); the patient must understand why she must not become pregnant and how to prevent it.
The patient must discuss contraception (birth control methods) with the doctor. The doctor will provide information on methods of preventing pregnancy. The doctor may refer the patient to a specialist for advice on contraception.
Before starting treatment, the doctor will request a pregnancy test. The test must confirm that the patient is not pregnant at the start of treatment with Curacne 5 mg.

Patients must use effective contraceptive methods before, during, and after treatment with Curacne 5 mg.

The patient must agree to use at least one highly reliable method of contraception (e.g., intrauterine device or contraceptive implant), or two effective methods that work in different ways (e.g., oral hormonal contraceptives and condoms). The most suitable methods for the patient should be discussed with the doctor.
The patient must use a contraceptive method for one month before starting Curacne 5 mg, during treatment, and for one month after stopping the medicine.
The patient must use contraception even if she does not menstruate or is not currently sexually active (unless the doctor determines this is unnecessary).

Patients must agree to undergo pregnancy tests before, during, and after treatment with Curacne 5 mg.

The patient must agree to attend regular follow-up visits with the doctor, ideally every month.
The patient must agree to undergo regular pregnancy tests: before starting treatment, ideally every month during treatment, and one month after stopping treatment with Curacne 5 mg, as the medicine may still be present in the patient's body (unless the doctor decides this is unnecessary for a particular patient).
The patient must agree to undergo additional pregnancy tests as recommended by the treating physician.
The patient must not become pregnant during or within one month after stopping treatment, as the medicine may still be present in her body.
The treating physician will discuss all issues with the patient using a checklist and ask the patient (or her parent or legal guardian) to sign it. This form confirms that the patient has been informed of the risks and agrees to follow the rules outlined above.

If the patient becomes pregnant while taking Curacne 5 mg, treatment must be stopped immediately and the doctor contacted. The doctor may refer the patient to a specialist for advice.
Additionally, a patient who becomes pregnant within one month after stopping treatment with Curacne 5 mg should contact her treating physician. The doctor may refer the patient to a specialist for advice.
Advice for men
The concentration of oral retinoids in the semen of men taking Curacne 5 mg is too low to harm the unborn child of their partner. However, this medicinal product must never be shared with anyone else, especially women.
Additional precautions
This medicinal product must never be given to another person. All unused capsules must be returned to the pharmacist after treatment is completed.
The patient must not donate blood while taking this medicine or within one month after stopping Curacne 5 mg. If a pregnant woman receives the patient's blood, she may give birth to a child with congenital malformations.
Advice for all patients

Discuss with the doctor if the patient experiences persistent lower back or buttock pain during treatment with Curacne 5 mg. These symptoms may indicate sacroiliitis, a type of inflammatory back pain. The doctor may discontinue treatment with Curacne 5 mg and refer the patient to a specialist for management of inflammatory back pain. Further evaluation, including imaging studies such as magnetic resonance imaging, may be required.
Isotretinoin may cause dry eyes, corneal opacities, keratitis, intolerance to contact lenses, and visual problems, including impaired night vision. Cases of dry eyes that did not resolve after treatment ended have been reported. Inform the doctor if any of these symptoms occur. The doctor may recommend lubricating eye ointments or artificial tear preparations. If contact lens intolerance occurs, the doctor may recommend wearing glasses during treatment. If visual problems occur, the doctor may refer the patient to a specialist for advice and may recommend discontinuing isotretinoin.
Severe skin reactions (such as erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) have been reported with the use of isotretinoin. Rash may progress to widespread blistering or skin peeling. Also watch for mouth, throat, nose, or genital ulcers and conjunctivitis (redness and swelling of the eyes).
In the first weeks of treatment, acne may worsen with inflammatory skin lesions, including severe acne (fulminant acne), but this usually improves during continued treatment, typically within 7–10 days, and generally without the need to adjust the dose.
After several years of using isotretinoin at very high doses for the treatment of keratinisation disorders (keratin accumulation), bone abnormalities (including delayed growth, extra bone growth, and reduced bone density) and calcium deposits in tendons and ligaments have been observed. In these cases, both the dose and duration of treatment, as well as the cumulative dose, generally far exceeded those recommended for acne treatment.
Isotretinoin may increase blood levels of lipids such as triglycerides. The doctor will order tests to monitor these values before, during, and after isotretinoin treatment. If lipid levels remain high, the doctor may reduce the dose or discontinue isotretinoin. Dietary measures may also help manage elevated lipid levels. Very high lipid levels are sometimes associated with pancreatitis, which can be life-threatening.

Children
Do not give Curacne 5 mg to children under 12 years of age due to lack of information on safety or efficacy in this age group, and it is not indicated for prepubertal acne.
Curacne 5 mg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription.
Do not take medicines containing vitamin A, antibiotics of the tetracycline group, or apply any topical anti-acne products (other retinoids) while using Curacne 5 mg.
During isotretinoin treatment, avoid using topical anti-acne products with keratolytic or exfoliating action, as local irritation may occur.
Effect on fertility, pregnancy, and lactation
More information on pregnancy and contraception can be found in section 2, "Pregnancy Prevention Programme".
Driving and operating machinery
Impaired night vision may occur during treatment, which in rare cases may persist after treatment ends. These disturbances may appear suddenly; therefore, caution is advised when driving or operating machinery.
Drowsiness and dizziness have been reported very rarely.
If any of these symptoms occur, the patient should not drive, operate machinery, or engage in other activities where such symptoms could endanger the patient or others.
Curacne 5 mg contains purified soya oil
Do not use if hypersensitivity to peanuts or soya has been diagnosed.
Daily life advice:

If skin or lips become dry, use moisturising creams or ointments and lip balm.
Avoid using products that may irritate the skin, such as peeling creams, throughout the treatment period.
Avoid excessive sun exposure during treatment, as Curacne 5 mg may increase skin sensitivity.
If sun exposure cannot be avoided, use sunscreen creams with a sun protection factor (SPF) of at least 15.
Do not use UV lamps, sunbathe in tanning beds, or use quartz lamps.
Avoid waxing, dermabrasion (a procedure in which the epidermis is removed to eliminate scars), and laser treatment during treatment and for 6 months after its completion, as this may lead to scarring, areas of insufficient or excessive skin pigmentation, or epidermal peeling.
If dry eye syndrome occurs, discontinue use of contact lenses. Wear glasses instead until therapy ends.
Wear sunglasses to protect the eyes from excessive sun exposure.
Exercise caution when operating mechanical devices or driving at night, as visual disturbances may occur suddenly.
Muscle and joint pain may occur during treatment with Curacne 5 mg. During this period, strenuous physical exercise should be avoided.

3. How to take Curacne 5 mg

Dosage
This medicine should always be taken as directed by the physician or pharmacist. In case of doubt,
consult your physician or pharmacist.
Treatment with isotretinoin should be initiated at a dose of 0.5 mg/kg body weight per day. For most patients,
the dose ranges from 0.5 mg/kg body weight to 1 mg/kg body weight per day.
If the patient feels that the effect of Curacne 5 mg is too weak or too strong, this should be reported to the
physician.
Capsules should be taken orally with food, once or twice daily, accompanied by a glass of liquid. The capsules
should be swallowed whole. Do not chew or suck the capsules.

Patients with severe renal impairment
For patients with severe renal impairment, treatment should be initiated at a lower dose (e.g. 10 mg/day).

Use in children
Isotretinoin is not indicated for the treatment of acne occurring before puberty and is not recommended for use in children under 12 years of age.

Patients with intolerance
In patients experiencing symptoms of severe intolerance to the drug at the recommended dose, treatment may be continued using the highest dose tolerated by the patient.

The course of treatment with Curacne 5 mg lasts from 16 to 24 weeks. Skin condition may continue to improve for up to 8 weeks after completion of treatment.
Therefore, at least 8 weeks should elapse after the end of a treatment course before the physician considers initiating another course. Most patients require only a single course of treatment.

Accidental overdose of Curacne 5 mg
If a dose higher than recommended is taken, symptoms of hypervitaminosis A may occur, such as severe headache, nausea or vomiting, drowsiness, irritability, and itching.
In this case, seek immediate medical advice from a physician, pharmacist, or go to the nearest hospital.

Missed dose of Curacne 5 mg
Do not take a double dose to make up for a missed dose. Continue taking the medicine as prescribed.
If you have any further doubts about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects often resolve during treatment, after a dose adjustment or discontinuation of treatment
(do discuss this with your doctor), although some may persist even after treatment has ended.
If they occur, you should inform your treating physician, who will make an appropriate decision.
Some adverse effects may be severe

Psychiatric disorders.

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

Depression or related disorders. Symptoms include sadness, mood changes, anxiety, and feelings of emotional discomfort.
Worsening of existing depression.
Tendency towards violence or aggression.

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

Some individuals have experienced thoughts or images of self-harm or suicide (suicidal thoughts), attempted suicide, or completed suicide. These individuals may not show symptoms of depression.
Unusual behaviour.
Psychotic symptoms: loss of contact with reality, e.g. the patient hears voices or sees things that do not exist in reality.

If any of the psychiatric symptoms described above occur, contact your doctor
immediately. The doctor may recommend discontinuation of Curacne 5 mg.
Stopping the medicine may not be sufficient for these effects to resolve; additional help may be required, which the doctor can provide.

Rare effects (may affect up to 1 in 1,000 people): sudden, life-threatening allergic reactions (anaphylactic reactions: difficulty breathing or swallowing due to sudden swelling of the throat, face, lips, and oral cavity, as well as sudden swelling of hands, feet, and ankles). If the patient experiences any allergic reaction, administration of Curacne 5 mg should be discontinued and medical advice sought.
Frequency unknown (frequency cannot be estimated from available data): severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which may be life-threatening and require immediate medical attention. Initial symptoms include round spots, often with centrally located blisters, usually appearing on hands and palms or feet and soles. In more severe cases, blisters may appear on the chest and back. Other symptoms may also occur, such as eye infection (conjunctivitis) or ulceration of the mouth, throat, or nose. Severe forms of skin lesions may progress to widespread skin peeling, which may be life-threatening. Severe skin reactions are often preceded by headache, fever, and body aches (flu-like symptoms).
If severe rash or such skin symptoms appear,
administration of Curacne 5 mg should be stopped immediately and a doctor contacted.
All other adverse effects are grouped below according to their frequency of occurrence.
Very common: affecting more than 1 in 10 people
Anaemia, thrombocytopenia, thrombocytosis.
Increased ESR (marker of acute inflammation).
Increased triglyceride levels, decreased high-density lipoprotein (HDL) levels.
Elevated liver enzyme activity (increased aminotransferase activity). Depending on the situation, the treating physician may recommend blood tests or other necessary examinations.
Red ulcers or deep cracks at the corners of the mouth and lips, skin inflammation, dry skin, localised skin peeling, itching, red skin lesions, skin fragility (injuries due to friction).
Blepharitis, conjunctivitis with purulent discharge and itching, eye irritation, and dry eyes.
Back pain (especially in adolescents), muscle and joint pain. Therefore, intense physical exercise should be avoided during treatment. All these symptoms are reversible after treatment ends.

Common: affecting up to 1 in 10 people

Increased blood glucose and cholesterol levels, haematuria, proteinuria.
Decreased white blood cell count, leading to increased susceptibility to infections.
Headaches.
Dryness of the nasal mucosa, nosebleeds, nasopharyngitis.

Uncommon: affecting up to 1 in 1,000 people

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

Very rare: affecting up to 1 in 10,000 people

Pancreatitis, gastrointestinal bleeding, colitis. In case of acute abdominal pain, with or without bloody diarrhoea, nausea, and vomiting, isotretinoin should be discontinued and medical advice sought immediately.
Liver disorders (hepatitis), nausea, vomiting, loss of appetite, malaise, fever, itching, jaundice (yellowing of the skin and eyes).
Kidney disorders: severe fatigue, difficulty urinating or even inability to urinate, swollen eyelids. If such symptoms occur during isotretinoin treatment, the patient should discontinue treatment and contact a doctor.
Elevated blood glucose levels (indicative of diabetes), accompanied by symptoms such as increased thirst, increased urination, increased appetite with simultaneous weight loss, fatigue, dizziness, weakness, low mood, irritability, and general exhaustion. If these symptoms occur, contact your doctor.
Mild intracranial hypertension in patients concurrently taking isotretinoin and certain antibiotics (tetracyclines). This hypertension is associated with chronic headaches accompanied by nausea, vomiting, or visual disturbances (likely due to optic disc swelling). In such cases, administration of Curacne 5 mg should be discontinued and a doctor contacted as soon as possible.
Seizures.
Narrowing or blockage of blood vessels.
Worsening of acne symptoms during the first few weeks of treatment, manifesting as inflammatory skin lesions, severe forms of acne (fulminant acne). Nevertheless, continuing treatment should lead to gradual improvement of acne symptoms and other complaints.
Colitis.
Localised bacterial infections.
Facial erythema, skin rash.
Changes in hair, increased body hair growth, nail dystrophy, bacterial infections of the skin around the nails.
Thickening of surgical scars.
Damage to skin blood vessels and mucous membranes.
Increased sensitivity to sunlight (photosensitivity reactions, see Daily Life Advice, point 2).
Increased skin pigmentation, increased sweating.
Enlarged lymph nodes.
High blood uric acid levels, which may lead to gout.
The medicine may cause sudden worsening of night vision and blurred vision. These disturbances may persist even after treatment ends.
Colour blindness, severe eye irritation, corneal clouding, keratitis, blurred vision, cataract, increased light sensitivity, visual disturbances, intolerance to contact lenses. In such cases, the patient should wear sunglasses to protect the eyes from glare. If such symptoms occur during treatment, the patient should contact a doctor immediately.
Hearing impairment.
Sudden chest tightness with shortness of breath and wheezing (bronchospasm), especially if the patient suffers from asthma, voice changes (hoarseness).
Dryness of the throat, nausea.
Malaise.
Excessive tissue formation during wound healing (increased granulation tissue).
Changes mainly affecting joints, with accompanying pain and swelling, bone structure abnormalities (delayed growth, additional growth, and reduced bone density), calcium deposits in soft tissues, tendonitis.
Increased activity of certain liver enzymes (creatine kinase), which are released during muscle fibre breakdown, may occur in patients undergoing isotretinoin treatment who perform intense physical exercise, leading to muscle breakdown that may impair kidney function.
Drowsiness, dizziness.

Frequency unknown (frequency cannot be estimated from available data):

Difficulty achieving or maintaining erection.
Reduced libido.
Breast swelling with or without tenderness in men.
Vaginal dryness.
Sacroiliitis, a type of inflammatory back pain causing pain in the lower back or buttocks.
Urethritis.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Curacne 5 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging.
Keep the container tightly closed to protect from light.
After completion of treatment, return all unused capsules to the pharmacy.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Curacne 5 mg contains
The active substance is isotretinoin.
Each soft capsule contains 5 mg of isotretinoin.
The other ingredients are: purified soybean oil (see section 2.), yellow wax, hydrogenated vegetable oil,
and, in the capsule shell: gelatin, glycerol, purified water, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171) 25% in glycerol.
Ink composition: SDA alcohol 35, propylene glycol, iron oxide black, polyvinyl acetate phthalate, water, isopropyl alcohol, polyethylene glycol, ammonium hydroxide.

What Curacne 5 mg looks like and contents of the pack
30 capsules in blisters, packed in a cardboard box.
Each soft capsule 5 mg has a two-coloured, opaque red/brown-cream gelatin shell with a light yellow/orange core and printed with "5" on one side.

For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in Spain, the country of export:
Pierre Fabre Ibérica, S.A.
C/ Ramón Trias Fargas, 7-11
08005 Barcelona, Spain

Manufacturer:
Catalent France Beinheim SA
74, rue Principale
67930 Beinheim, France

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

Marketing Authorisation Number in Spain, the country of export: 653587.5
Parallel Import Authorisation Number: 52/24

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Belgium ISOCURAL
Czech Republic CURACNE
France CURACNE
Italy ISORIAC
Luxembourg CURACNE
Poland CURACNE 5 mg
Spain ISOACNE

Availability category:
Prescription-only medicine requiring strict monitoring during treatment.

For women of childbearing potential:

Prior to prescription, the patient must give her consent to treatment and receive information regarding contraception.
The duration of treatment based on a single prescription is limited to 30 days. Any extension of treatment requires a new prescription.
The medicine may only be dispensed if the prescription contains all mandatory information. Required criteria:
Initiation of treatment (first prescription):
- Patient’s consent to treatment (signed form) and provision of information on contraception.
- Use of at least one effective method of contraception for at least one month prior to starting treatment.
- Assessment of the patient’s understanding of the planned treatment.
- Scheduling of a pregnancy test (serum hCG).
Continuation of treatment (subsequent prescriptions):
- Ongoing use of effective contraception.
- Assessment of the patient’s understanding of the ongoing treatment.
- Confirmation of the date of the last pregnancy test (serum hCG).

For more detailed information about Curacne, please consult a specialist physician.
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