Curacne 5 mg

Warning! Keep the package leaflet. Information on the immediate packaging is in a foreign language.
Curacne 5 mg (Isoacné 5 mg)
5 mg, soft capsules
Isotretinoinum
Curacne 5 mg and Isoacné 5 mg are different trade names for the same medicinal product.
WARNING
CAN CAUSE SEVERE HARM TO THE UNBORN CHILD.
Women must use effective methods of contraception.
Do not use during pregnancy or if pregnancy is suspected.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Leaflet Contents

1. What Curacne 5 mg is and what it is used for
2. Important information before taking Curacne 5 mg
3. How to take Curacne 5 mg
4. Possible side effects
5. How to store Curacne 5 mg
6. 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 medications (cream, gel, ointment, lotion).
Treatment with Curacne 5 mg must be carried out under the supervision of a physician experienced in treating severe acne with retinoids and in monitoring patients during treatment.
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 essential 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 concurrently with tetracycline antibiotics.
• If the patient is taking vitamin A or other retinoids (e.g. 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, 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 cases, the prescribing doctor 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 therapy.
• If the patient has liver problems. Curacne 5 mg may increase liver enzyme activity (aminotransferases). To assess liver function (liver enzyme activity), the doctor will order regular blood tests before and during treatment. Cases of transient and reversible increases in aminotransferase activity have been reported. If there is a persistent and significant increase in liver enzyme activity, the doctor may consider reducing the dose or discontinuing treatment.
• If the patient has gastrointestinal 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 treatment ends.
• The following symptoms occur:
• Rash, which may progress to widespread blistering or skin peeling, or ulceration of the mouth, throat, nose, or genital organs, and conjunctivitis (redness and swelling of the eyes). These may indicate a severe skin reaction (e.g. erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis), potentially life-threatening. These severe skin reactions are often preceded by headache, fever, and body aches (flu-like symptoms).
• Breathing difficulties, itching, and/or urticaria (hives), as these 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 accompanied by nausea, vomiting, or impaired vision;
• Severe abdominal pain, nausea or vomiting, or acute diarrhoea with blood in the stool;
• Difficulty urinating or inability to pass urine;
• Impaired night vision and/or visual disturbances;
• Mental health problems: particularly symptoms of depression (low mood, tearfulness, self-harming behaviour, feeling detached from family or friends).

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

• If the patient develops yellowing of the eyes or skin, or feels dizzy.

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 is "teratogenic"). It may cause serious malformations of 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 infant.
• 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 of childbearing potential only if strict rules are followed,
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 her doctor. The doctor will provide information on contraceptive methods. The doctor may refer the patient to a specialist for contraceptive advice.
• 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.

Women 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 acting in different ways (e.g. oral hormonal contraceptives and condoms). Discuss with the doctor which methods are most suitable for the patient.
• 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 is not menstruating or is not currently sexually active (unless the doctor determines this is unnecessary).

Women 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 her doctor, ideally monthly.
• The patient must agree to undergo regular pregnancy tests: before starting treatment, ideally monthly during treatment, and one month after stopping Curacne 5 mg, as the medicine may still be present in her body (unless the doctor decides this is unnecessary for a particular patient).
• The patient must agree to undergo additional pregnancy tests as recommended by her doctor.
• The patient must not become pregnant during or within one month after treatment, as the medicine may still be present in her body.
• The prescribing doctor will discuss all issues with the patient using a checklist and ask the patient (or her parent or legal guardian) to sign it. This document 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, she must immediately stop taking the medicine and contact her doctor. The doctor may refer her to a specialist for advice.
Additionally, a patient who becomes pregnant within one month after stopping Curacne 5 mg should contact her doctor. The doctor may refer her to a specialist for advice.
Advice for men
The amount 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 medicine must never be shared with anyone else, especially women.
Additional precautions
Never pass this medicinal product to another person. All unused capsules must be returned to the pharmacist after treatment ends.
Do 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 abnormalities.
Advice for all patients

• Discuss with your doctor if you experience 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 Curacne 5 mg and refer the patient to a specialist for treatment of inflammatory back pain. Further evaluation, including imaging such as magnetic resonance imaging, may be necessary.

• Isotretinoin may cause dry eyes, corneal clouding, keratitis, intolerance to contact lenses, and visual problems, including impaired night vision. Cases of persistent dry eye that did not resolve after treatment ended have been reported. Inform your 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 advise wearing glasses during treatment. If visual problems occur, the doctor may refer the patient to a specialist for advice and may consider discontinuing isotretinoin.

• In the first few weeks of treatment, acne may worsen with inflammatory skin lesions, but this usually improves during continued treatment within 7–10 days and generally does not require dose adjustment.

• After several years of using isotretinoin at very high doses for keratinisation disorders (keratin accumulation), bone abnormalities (including delayed growth, increased 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 cumulative dose, generally far exceeded those recommended for acne treatment.

• Isotretinoin may increase blood levels of lipids such as triglycerides. Your 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. Elevated lipid levels may also respond to dietary management. Very high lipid levels are sometimes associated with pancreatitis, which may 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 you are currently taking or have recently taken, as well as any you plan to take, including those available without a prescription.
Do not take medicines containing vitamin A, tetracycline antibiotics, or apply any topical anti-acne products (other retinoids) to the skin while using Curacne 5 mg.
During isotretinoin treatment, do not use topical anti-acne agents with keratolytic or exfoliating properties, 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, do not drive, operate machinery, or engage in other activities where these 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 skin-irritating products 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 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 where the epidermis is removed to eliminate scars), and laser treatments during treatment and for 6 months after its end, as these may lead to scarring, areas of inadequate 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 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 time, avoid strenuous physical exercise.

3. How to take Curacne 5 mg

Dosage
This medicine should always be taken as prescribed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Curacne is available in the following strengths: 5 mg, 10 mg, 20 mg, 40 mg.
Treatment with isotretinoin should be initiated at a dose of 0.5 mg/kg body weight per day. In 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, they should inform their doctor.
The capsules should be taken orally with food, once or twice daily, 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 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 medicine despite 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 treatment before the doctor may initiate another treatment course if necessary. 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 such a case, seek immediate medical advice from a doctor, pharmacist, or 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like any medicine, this medicine can cause side effects, although not everybody gets them.
Side effects often resolve during treatment, after a dose adjustment or discontinuation of treatment
(this should be discussed with your doctor), although some may persist even after treatment has ended.
If they occur, you should inform your doctor, who will make an appropriate decision.
Some side effects may be serious

• Psychiatric disorders

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

• Some individuals have had thoughts or images of self-harm or suicide (suicidal thoughts), attempted suicide, or died by 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.
Your doctor may recommend discontinuation of Curacne 5 mg. Stopping the medicine may not be sufficient for these effects to resolve; additional help may be needed, which your doctor can provide.

• Rare side 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 any allergic reaction occurs, discontinue Curacne 5 mg and contact your doctor.
• Frequency not known (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. Early signs 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 extensive 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, discontinue Curacne 5 mg immediately and contact your doctor.

All other side effects are grouped below according to their frequency of occurrence.
Very common: affects more than 1 in 10 people

• Anaemia, thrombocytopenia, thrombocytosis.
• Increased ESR (marker of acute inflammation).
• Increased triglyceride levels, decreased levels of high-density lipoproteins (HDL).
• Elevated liver enzyme activity (increased aminotransferase activity). Your doctor may recommend blood tests or other necessary examinations as appropriate.
• Red ulcers or deep cracks at the corners of the mouth and lips, skin inflammation, dry skin, localised skin peeling, itching, red skin eruptions, 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: affects 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.
• Headache.
• Dryness of nasal mucosa, nosebleeds, nasopharyngitis.

Rare: affects up to 1 in 1,000 people

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

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

• Pancreatitis, gastrointestinal haemorrhage, colitis. In case of acute abdominal pain, with or without bloody diarrhoea, nausea, and vomiting, discontinue isotretinoin and contact your doctor as soon as possible.

• Liver disorders (hepatitis), nausea, vomiting, loss of appetite, malaise, fever, itching, yellowing of the skin and eyes (jaundice).

• Kidney disorders: severe fatigue, difficulty urinating or even inability to urinate, swollen eyelids. If such symptoms occur during isotretinoin treatment, the patient should stop treatment and contact their doctor.

• Elevated blood glucose levels (indicative of diabetes), accompanied by symptoms such as increased thirst, increased frequency of urination, increased appetite with simultaneous weight loss, fatigue, dizziness, weakness, low mood, irritability, and general exhaustion. If these symptoms occur, contact your doctor.

• Benign intracranial hypertension in patients taking isotretinoin and certain antibiotics (tetracyclines) simultaneously. This condition is characterised by chronic headaches associated with nausea, vomiting, or visual disturbances (possibly due to optic nerve swelling (papilloedema)). In such cases, discontinue Curacne 5 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, manifesting as inflammatory skin lesions.

• Severe forms of acne (fulminant acne): sudden development of inflammatory, ulcerative, necrotic, and haemorrhagic lesions on the face and/or trunk, with or without fever and joint pain. In such cases, discontinue isotretinoin and contact your doctor immediately.

• Colitis.

• Localised bacterial infections.

• Facial erythema, skin rash.

• Changes in hair, increased body hair, nail dystrophy, bacterial inflammation of the skin around the nails (paronychia).

• Thickening of surgical scars.

• Damage to skin and mucous membranes.

• Increased sensitivity to sunlight (photosensitivity reactions, see Advice on daily living, point 2).

• Increased skin pigmentation, increased sweating.

• Enlarged lymph nodes.

• High levels of uric acid in the blood, which may lead to gout.

• The medicine may cause worsening of night vision and blurred vision, which may occur suddenly. These disturbances may persist even after treatment ends.

• Colour blindness, severe eye irritation, corneal clouding, keratitis, blurred vision, cataract, increased sensitivity to light, 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 their doctor immediately.

• Hearing impairment.

• Sudden tightness of the chest with shortness of breath and wheezing (bronchospasm), especially if the patient has asthma, voice changes (hoarseness).

• Sensation of dryness in the throat, nausea.

• Malaise.

• Excessive tissue formation during wound healing (increased granulation tissue).

• Changes mainly affecting joints with accompanying pain and swelling, bone abnormalities (delayed growth, excessive growth, and reduced bone density), calcium deposits in soft tissues, tendonitis.

• Increased activity of certain liver enzymes (creatine kinase), released during muscle fibre breakdown, may increase in patients undergoing intense physical exercise while on isotretinoin treatment, leading to muscle breakdown, which may impair kidney function.

• Drowsiness, dizziness.

Frequency not known (frequency cannot be estimated from available data):

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

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Reporting side effects helps provide more information on the safety of this 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 any unused capsules to the pharmacy.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Package contents and other information

What Curacne 5 mg contains
The active substance is isotretinoin.
Each soft capsule contains 5 mg of isotretinoin.
Other ingredients: purified soybean oil (see section 2), yellow wax, hydrogenated vegetable oil,
and components of the capsule shell: gelatin, glycerol, purified water, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171) 50% in glycerol.
Ink composition: SDA 35 alcohol, propylene glycol (E 1520), iron oxide black, polyvinyl acetophthalate, water, isopropyl alcohol, macrogol, ammonium hydroxide.

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

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

Marketing Authorization 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
F-67930 Beinheim
France
Catalent Germany Schorndorf GmbH
Steinbeisstrasse 1 and 2
Schorndorf, Baden-Wuerttemberg
Germany
Catalent Germany Eberbach GmbH
Gammelsbacher Str. 2
Eberbach, Baden-Wuerttemberg
Germany

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Spanish Marketing Authorization Number (country of export): 653587.5
Parallel Import Authorization Number: 347/25

This medicinal product is authorized for marketing in the European Economic Area member states under the following trade names:

• Czech Republic, France, Poland: CURACNE 5 mg
• Spain: ISOACNE 5 mg
• Belgium: ISOCURAL 5 mg
• Italy: ISORIAC 5 mg

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

For women of childbearing potential:

• Prior to prescription, the patient must give informed consent to treatment and receive information regarding contraception.
• The duration of treatment based on a single prescription is limited to 30 days. Any extension requires a new prescription.
• The medicine may only be dispensed if all required information is present on the prescription. Mandatory requirements:

  • Initiation of treatment (first prescription):

    • Patient's informed consent to treatment (signed form) and provision of contraceptive counseling.
    • Use of at least one effective method of contraception for at least one month prior to starting treatment.
    • Assessment of patient's understanding of the planned treatment.
    • Scheduling of a pregnancy test (serum hCG).

  • Continuation of treatment (subsequent prescriptions):

    • Ongoing adherence to an effective contraceptive regimen.
    • Assessment of patient's understanding of ongoing treatment.
    • Confirmation of the date of the last pregnancy test (serum hCG).

For more detailed information about Curacne 5 mg, please consult a specialist physician or the local representative of the marketing authorization holder.
Comprehensive and up-to-date information about this medicine is available by scanning the QR code on the package leaflet with a smartphone. The same information is also available at the website: http://sirpl.org/Retinoidy
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