Curacne 10 mg

Patient Information Leaflet: User Information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Curacne 10 mg (CURACNÉ 10 mg)

Soft capsules
Isotretinoin
Curacne 10 mg and CURACNÉ 10 mg are different trade names for the same medicine.

WARNING

May cause serious harm to an unborn child.
Women must use effective contraception methods.
Do not use during pregnancy or suspected pregnancy.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Curacne 10 mg and what is it used for
• 2. Important information before taking Curacne 10 mg
• 3. How to take Curacne 10 mg
• 4. Possible side effects
• 5. How to store Curacne 10 mg
• 6. Contents of the pack and other information

1. What is Curacne 10 mg and what is it used for

Curacne 10 mg contains the active substance isotretinoin. Isotretinoin belongs to a group of medicines called retinoids.
Curacne 10 mg is indicated for the treatment of severe forms of acne (such as nodular acne, conglobate acne, or acne with a risk of developing permanent scars) that are resistant to properly conducted standard treatment with systemic antibacterial medications and topical treatments (cream, gel, ointment, solution).
Treatment with Curacne 10 mg must be carried out under the supervision of a doctor with experience in the treatment of severe forms of acne with retinoids and monitoring of the patient during treatment.
Curacne 10 mg is not indicated for the treatment of acne that occurs before puberty and is not recommended for use in children under 12 years of age.

2. Important information before taking Curacne 10 mg

When not to take Curacne 10 mg:

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

Warnings and precautions

Before starting treatment with Curacne 10 mg, you should discuss the following with your doctor:

• If you have ever had mental health problems, including depression, anxiety, aggression, or mood swings, as well as thoughts of self-harm or suicide. This is because Curacne 10 mg may affect your mood.
• If you have kidney problems. In this case, your doctor should adjust the dose of isotretinoin.
• If you are overweight, have diabetes, high cholesterol or triglyceride levels in your blood, and consume large amounts of alcohol. In all these cases, your lipid and glucose levels in your blood must be regularly monitored. If this applies to you, your doctor will order more frequent blood tests. Patients with diabetes should closely monitor their blood glucose levels during treatment. Increased fasting blood sugar levels have been reported, and new cases of diabetes have been diagnosed during isotretinoin treatment.
• If you have liver problems. Curacne 10 mg may increase liver enzyme activity (aminotransferases). To check liver function (liver enzyme activity), your doctor will order regular blood tests before and during treatment. Reversible and transient increases in aminotransferase activity have been reported. In cases of persistent significant increases in liver enzyme activity, your doctor may consider reducing the dose or stopping treatment.
• If you have had intestinal disorders.

You must stop treatment with Curacne 10 mg and contact your doctor immediately:

• If you become pregnant during treatment or within a month after stopping treatment.
• If you experience the following symptoms:
• rash that may progress to widespread blistering or peeling of the skin, or ulcers of the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling of the eyes). This may be a severe skin reaction (e.g., erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), potentially life-threatening. These severe skin reactions are often preceded by headache, fever, and flu-like symptoms.
• difficulty breathing, itching, and/or hives, as these symptoms may indicate an allergic reaction. Some of these reactions may appear 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 severe diarrhea with blood in the stool;
• difficulty urinating or inability to urinate;
• impaired vision at night and/or vision disturbances;
• mental health problems: in particular, symptoms of depression (feeling unwell, tearfulness, self-harm, feeling isolated from family or friends).

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 medicine. They may notice such changes and help you identify problems that need to be discussed with your doctor.

• If you experience yellowing of the eyes or skin and a feeling of dizziness.

Special warning for women taking Curacne 10 mg:

Pregnancy and breastfeeding, Important Pregnancy Prevention Program

Women who are pregnant must not take Curacne 10 mg

This medicine may cause serious harm to an unborn child (the medicine has a teratogenic effect). It may cause serious damage to the brain, face, ear, eye, heart, and certain glands (thymus and parathyroid) of the fetus. It also increases the risk of miscarriage. These effects can occur even if Curacne 10 mg is taken for a short period during pregnancy.

• Do not take Curacne 10 mg if you are pregnant or think you may be pregnant.
• Do not take Curacne 10 mg during breastfeeding. The medicine is likely to pass into breast milk and may harm the baby.
• Do not take Curacne 10 mg if you may become pregnant during treatment.
• You must not become pregnant for one month after stopping treatment with Curacne 10 mg, as the medicine may still be present in your body.

Curacne 10 mg may be prescribed to female patients of childbearing potential only under strict conditions

The following conditions must be met:

• Your doctor must explain the risk of harm to an unborn child (birth defects); you must understand why you must not become pregnant and how to prevent it.
• You must discuss contraception with your doctor. Your doctor will provide you with information on contraception methods. Your doctor may refer you to a specialist for advice on contraception.
• Before starting treatment, your doctor will ask you to have a pregnancy test. The test must show that you are not pregnant at the start of treatment with Curacne 10 mg.

Female patients must use effective contraception methods before, during, and after treatment with Curacne 10 mg

• You must agree to use at least one highly effective method of contraception (e.g., an intrauterine device or contraceptive implant), or two effective methods that work in different ways (e.g., oral hormonal contraceptives and condoms). You should discuss with your doctor which methods are most suitable for you.
• You must use a contraceptive method for one month before taking Curacne 10 mg, during treatment, and for one month after stopping treatment with this medicine.
• You must use contraception even if you do not menstruate or are not currently sexually active (unless your doctor decides it is not necessary).

Female patients must agree to have pregnancy tests performed before, during, and after treatment with Curacne 10 mg

• You must agree to have regular follow-up visits with your doctor, ideally every month.
• You must agree to have regular pregnancy tests: before starting treatment, ideally every month during treatment, and one month after stopping treatment with Curacne 10 mg, as the medicine may still be present in your body (unless your doctor decides it is not necessary for you).
• You must agree to have additional pregnancy tests as recommended by your doctor.
• You must not become pregnant during and for one month after stopping treatment, as the medicine may still be present in your body.
• Your doctor will discuss all these issues with you, using a checklist, and ask you (or your parent or legal guardian) to sign it. This form confirms that you have been informed of the risks and agree to follow the above rules.

If you become pregnant while taking Curacne 10 mg, you muststop taking the medicine immediately and contact your doctor. Your doctor may refer you to a specialist for advice.
Additionally, if you become pregnant within one month after stopping treatment with Curacne 10 mg, you should contact your doctor. Your doctor may refer you to a specialist for advice.

Advice for men

The amount of oral retinoids in the semen of men taking Curacne 10 mg is too small to harm an unborn child. However, you should never share this medicine with anyone, especially women.

Additional precautions

You should never give this medicine to another person. All unused capsules should be returned to the pharmacist after treatment is stopped.

You should not donate blood while taking this medicine or for one month after stopping treatment with Curacne 10 mg. If your blood is given to a pregnant woman,

she may give birth to a child with birth defects.

Advice for all patients

• You should discuss with your doctor if you experience persistent back pain or pain in the buttocks during treatment. These symptoms may indicate inflammatory bowel disease, a type of back pain caused by inflammation. Your doctor may stop treatment with Curacne 10 mg and refer you to a specialist for treatment of back pain. Further evaluation, including imaging studies such as MRI, may be necessary.

Isotretinoin may cause dry eyes, corneal clouding, conjunctivitis, intolerance to contact lenses, and vision problems, including impaired night vision. There have been cases of dry eyes that did not improve after treatment was stopped. You should tell your doctor if you experience any of these symptoms. Your doctor may recommend using moisturizing eye ointments or tear substitutes. If you experience intolerance to contact lenses, your doctor may recommend wearing glasses during treatment. If you experience vision problems, your doctor may refer you to a specialist for advice and may recommend stopping isotretinoin.

• In the first few weeks of treatment, it is possible to experience an exacerbation of acne with inflammatory lesions on the skin, but this usually subsides during continued treatment within 7-10 days and usually without the need to adjust the dose.
• After several years of using isotretinoin in very high doses for the treatment of keratinization disorders (keratin accumulation), there have been reports of bone abnormalities (including delayed growth, extra growth, and decreased bone density) and calcifications in tendons and ligaments. Both the doses and duration of treatment, as well as the cumulative dose, were usually much higher than those recommended for the treatment of acne.
• Isotretinoin may increase blood lipid levels, such as triglycerides. Your doctor will order blood tests to check these values before, during, and after treatment with isotretinoin. If your lipid levels in your blood remain high, your doctor may reduce the dose or stop isotretinoin. Elevated lipid levels may also respond to dietary measures. Very high lipid levels are sometimes associated with life-threatening pancreatitis.

Children

Do not give Curacne 10 mg to children under 12 years of age, due to the lack of information on safety and efficacy in this age group, and it is not indicated for prepubertal acne.

Curacne 10 mg and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.

While taking Curacne 10 mg, do not take medicines containing

vitamin A, tetracycline antibiotics, or use any topical anti-acne products (other retinoids) .
During treatment with isotretinoin, do not use topical keratolytic or exfoliating anti-acne products, as local irritation may occur.

Pregnancy, breastfeeding, and fertility

For more information on pregnancy and contraception, see section 2, "Pregnancy Prevention Program".

Driving and using machines

During treatment, impaired night vision may occur, which may persist after treatment is stopped. These disturbances may occur suddenly, so you should be careful when driving or operating machinery.
Rarely, drowsiness and dizziness have been reported.
In case of these symptoms, do not drive, operate machinery, or engage in other activities where these symptoms could put you or others at risk.

Curacne 10 mg contains soybean oil

Do not use if you are hypersensitive to peanuts or soy.

Daily life advice:

• In case of dry skin or lips, use moisturizing creams or lip balm.
• Throughout the treatment period, do not use products that may irritate the skin, such as peeling creams.
• Avoid excessive sun exposure during treatment, as Curacne 10 mg may increase skin sensitivity.
• If you cannot avoid sun exposure, use sunscreens with a sun protection factor (SPF) of at least 15.
• Do not use UV lamps, sunbeds, or quartz lamps.
• During treatment and for six months after stopping treatment, avoid wax epilation, dermabrasion (a procedure that removes the skin to eliminate scars), and laser treatment, as this may lead to scarring, areas of insufficient or excessive skin pigmentation, and skin peeling.
• If you experience dry eyes, stop using contact lenses. Instead, wear glasses until the end of therapy.
• Wear sunglasses to protect your eyes from excessive sun exposure.
• Be careful when operating mechanical devices and driving at night, as vision disturbances may occur suddenly.
• During treatment with Curacne 10 mg, muscle and joint pain may occur. You should avoid strenuous physical exercise during this period.

3. How to take Curacne 10 mg

Dosage

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Curacne 5 mg, Curacne 10 mg, Curacne 20 mg, and Curacne 40 mg are available.
Treatment with isotretinoin should be started at a dose of 0.5 mg/kg body weight per day. For most patients, the dose is between 0.5 mg/kg body weight and 1 mg/kg body weight per day.
If you feel that the effect of Curacne 10 mg is too weak or too strong, you should tell your doctor.
The capsules should be taken orally with food, once or twice a day, with a glass of liquid. The capsules should be swallowed whole. Do not chew or suck the capsules.

Patients with severe renal impairment

In patients with severe renal impairment, treatment should be started with a lower dose (e.g., 10 mg/day).

Use in children

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

Patients with intolerance

In patients with symptoms of severe intolerance to the medicine after taking the recommended dose, treatment can be continued with the highest tolerated dose.
Treatment with Curacne 10 mglasts from 16 to 24 weeks. Skin condition may improve even within 8 weeks after stopping treatment.
Therefore, at least 8 weeks should pass from the end of treatment before your doctor can consider another course of treatment. In most patients, only one course of treatment is needed.

Taking more than the recommended dose of Curacne 10 mg

If you take more than the recommended dose of Curacne 10 mg, you may experience symptoms of hypervitaminosis A, such as severe headache, nausea, or vomiting, drowsiness, irritability, and itching.

In this situation, you should immediately contact your doctor, pharmacist, or the nearest

hospital.

Missing a dose of Curacne 10 mg

Do not take a double dose to make up for a missed dose. Continue to take the medicine as prescribed.
If you have any further doubts about taking the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Curacne 10 mg can cause side effects, although not everybody gets them.
Side effects often disappear during treatment, after changing the dose, or after stopping treatment (you should discuss this with your doctor), although some of them may persist even after treatment is stopped. If you experience any of these symptoms, you should tell your doctor, who will make a decision.

Some side effects can be serious

• Mental disorders

Rare side effects(may affect up to 1 in 100 people)

• Depression or related disorders. Symptoms include sadness, mood changes, anxiety, discomfort.
• Worsening of existing depression.
• Aggression or violence.

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

• Some people have had thoughts or ideas about self-harm or suicide (suicidal thoughts), attempted suicide (suicide attempts), or committed suicide. These people do not have to show symptoms of depression.
• Abnormal behavior.
• Psychotic symptoms: loss of contact with reality, e.g., the patient hears voices or sees things that do not exist.

In case of the above-mentioned mental disorders, you should

immediately contact your doctor. Your doctor may recommend stopping Curacne 10 mg.
Stopping the medicine may not be enough for these effects to disappear; additional help may be necessary, and your doctor can provide it.

• Rare side effects(may affect up to 1 in 1000 people): life-threatening allergic reactions (anaphylactic reactions: difficulty breathing or swallowing due to sudden swelling of the throat, face, lips, and mouth, as well as sudden swelling of the hands, feet, and ankles). If you experience any allergic reaction, you should stop taking Curacne 10 mg and contact your doctor.
• Unknown frequency(frequency cannot be estimated from the available data): severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which can be life-threatening and require immediate medical attention. The first symptoms include round spots, often with centrally located blisters, usually on the hands and feet or arms and legs. In more severe cases, blisters may appear on the chest and back. Other symptoms may also occur, such as eye infection (conjunctivitis) or ulcers of the mouth, throat, or nose. Severe skin reactions can progress to widespread peeling of the skin, which can be life-threatening. Severe skin reactions are often preceded by headache, fever, and flu-like symptoms.

In case of a severe rash or such skin symptoms, you should stop taking Curacne 10 mg immediately and contact your doctor.

All other side effects are grouped below by frequency of occurrence.

Very common: affecting more than 1 in 10 people

• Anemia, thrombocytopenia, elevated erythrocyte sedimentation rate (marker of acute inflammation).
• Increased triglyceride levels, decreased high-density lipoprotein (HDL) levels.
• Increased liver enzyme activity (elevated aminotransferases). Depending on the situation, your doctor may recommend blood tests or other necessary examinations.
• Red ulcers or deep cracks in the corners of the mouth and lips, conjunctivitis, dry skin, local peeling of the skin, itching, red skin rashes, skin fragility (injuries due to friction).
• Conjunctivitis with purulent discharge and itching, eye irritation, and dry eyes.
• Back pain (especially in adolescents), muscle and joint pain. Therefore, you should limit intense physical exercise during treatment. All these symptoms are reversible after treatment is stopped.

Common: affecting up to 1 in 10 people

• Increased blood sugar and cholesterol levels, hematuria, proteinuria.
• Decreased white blood cell count, which increases the patient's susceptibility to infections.
• Headache.
• Dryness of the nasal mucosa, nosebleeds, pharyngitis.

Rare: affecting up to 1 in 1000 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 severe abdominal pain with or without bloody diarrhea, nausea, and vomiting, you should stop taking isotretinoin and contact your doctor immediately.
• Liver disorders (hepatitis), nausea, vomiting, loss of appetite, malaise, fever, itching, yellowing of the skin and eyes.
• Kidney disorders: severe fatigue, difficulty urinating, or inability to urinate, swollen eyelids. If you experience such symptoms during treatment with isotretinoin, you should stop treatment and contact your doctor.
• Elevated blood sugar levels (indicating diabetes) with symptoms such as increased thirst, increased urination, increased appetite with weight loss, feeling unwell, dizziness, weakness, decreased mood, irritability, and general exhaustion. If you experience these symptoms, you should contact your doctor.
• Hypertension in the brain in patients who are also taking isotretinoin and certain antibiotics (tetracyclines). This hypertension is accompanied by chronic headaches with nausea, vomiting, or vision disturbances (possibly due to optic nerve swelling). You should stop taking Curacne 10 mg and contact your doctor as soon as possible.
• Seizures.
• Narrowing or blockage of blood vessels.
• Worsening of acne symptoms during the first few weeks of treatment, with inflammatory lesions on the skin.
• Severe forms of acne (fulminant acne): development of nodular, ulcerative, necrotic, and hemorrhagic lesions, appearing suddenly on the face and/or trunk, with or without fever and joint pain. In such cases, you should stop taking isotretinoin and contact your doctor immediately.
• Colitis.
• Local bacterial infections.
• Facial flushing, skin rash.
• Changes in hair, increased body hair, nail dystrophy, bacterial infections of the nail bed.
• Thickening of scars after surgery.
• Damage to skin blood vessels and mucous membranes.
• Increased sensitivity to sunlight (photoreactions, see "Daily life advice", point 2).
• Increased skin pigmentation, increased sweating.
• Enlarged lymph nodes.
• High levels of uric acid in the blood, which can cause gout.
• The medicine may cause impaired night vision and blurred vision, which may occur suddenly. These disturbances may persist even after treatment is stopped.
• Color blindness, severe eye irritation, corneal clouding, conjunctivitis, blurred vision, cataract, increased sensitivity to light, vision disturbances, intolerance to contact lenses. You should wear sunglasses to protect your eyes from excessive sun exposure. If you experience these symptoms during treatment, you should contact your doctor immediately.
• Hearing impairment.
• Sudden chest tightness with shortness of breath and wheezing (bronchospasm), especially if you have asthma, voice changes (hoarseness).
• Dryness in the throat, nausea.
• Malaise.
• Excessive tissue formation during wound healing (increased granulation tissue formation).
• Changes mainly affecting joints with accompanying pain and swelling, bone abnormalities (delayed growth, extra growth, and decreased bone density), calcifications in soft tissues, tendonitis.
• Activity of certain liver enzymes (creatine kinase), which are released during muscle fiber breakdown, may increase in patients taking isotretinoin who perform intense physical exercise, leading to muscle damage, which can cause kidney problems.
• Drowsiness, dizziness.

Unknown frequency (frequency cannot be estimated from the available data):

• Difficulty achieving or maintaining an erection.
• Decreased libido.
• Breast tenderness or enlargement in men.
• Vaginal dryness.
• Sacroiliitis, a type of back pain caused by inflammation, causing pain in the lower back or buttocks.
• Urethritis.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Curacne 10 mg

Keep this medicine out of the 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 month.
Do not store above 25°C. Store in the original packaging.
Keep the packaging tightly closed to protect from light.

After stopping treatment, return all remaining capsules to the pharmacy.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Curacne 10 mg contains

The active substance is isotretinoin.
1 soft capsule contains 10 mg of isotretinoin.
The other ingredients are purified soybean oil (see section 2), yellow wax, hydrogenated vegetable oil, and the capsule shell ingredients: gelatin, glycerol, purified water, iron oxide red (E 172).
Ink ingredients: SDA 35 alcohol, propylene glycol (E 1520), iron oxide black (E 172), polyvinyl acetate phthalate, water, isopropyl alcohol, macrogol, ammonium hydroxide.

What Curacne 10 mg looks like and contents of the pack

30 or 60 capsules in blisters, in a cardboard box.
Each 10 mg soft capsule has a red/brown gelatin shell with a light yellow/orange fill and is marked with "I 10" on one side.
For more detailed information on this medicine, you should consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in France, the country of export:

Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur, France

Manufacturer:

Catalent France Beinheim S.A.
74, rue Principale
67930 Beinheim, France
Catalent Germany Schorndorf GmbH
Steinbeisstrasse 1 and 2
Baden-Wuerttemberg
73614 Schorndorf, Germany
Catalent Germany Eberbach GmbH
Gammelsbacher Str. 2
Baden-Wuerttemberg
69412 Eberbach, Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in France, the country of export:34009 358 131 6 9

Parallel import authorization number: 59/25

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium ISOCURAL
Czech Republic CURACNE
France CURACNE
Italy ISORIAC
Luxembourg CURACNE
Poland CURACNE 10 mg
Spain ISOACNE

Availability category:

Prescription-only medicine requiring close monitoring during treatment.

For women of childbearing potential:

• Before issuing a prescription, the patient's consent to treatment and information on contraception must be obtained;
• The duration of treatment based on the issued prescription is limited to 30 days. Extension of treatment requires a new prescription;
• The medicine may only be dispensed if the prescription contains all the required information. Mandatory requirements:
• Start of treatment (first prescription).
• Obtaining the patient's consent to treatment and providing information on contraception.
• Use of at least one effective method of contraception for at least one month before starting treatment.
• Assessment of the patient's understanding of the planned treatment.
• Scheduling a pregnancy test (serum hCG).
• Continuation of treatment (subsequent prescriptions).
• Implementation of the effective contraception program.
• Assessment of the patient's understanding of the treatment being carried out.
• Determination of the date of the last pregnancy test (serum hCG).

Date of leaflet approval: 11.02.2025

[Information about the trademark]
Detailed and up-to-date information about this medicine is available by scanning the QR code on the leaflet using a smartphone. The same information is also available on the website http://inpharm.pl/do_pobrania/Retinoidy-karta-przypominajaca.doc.
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