Curacne 5 mg
Curacne 10 mg
Curacne 20 mg
Curacne 40 mg
soft capsules
Isotretinoinum
WARNING
CAN CAUSE SEVERE HARM TO THE UNBORN CHILD.
Women must use effective contraceptive methods.
Do not use during pregnancy or if pregnancy is suspected.
Please read the package leaflet carefully before taking 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, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If the patient experiences any adverse reactions, including those not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Package leaflet contents

What Curacne is and what it is used for
Important information before taking Curacne
How to take Curacne
Possible side effects
How to store Curacne
Contents of the pack and other information

1. What Curacne is and what it is used for

Curacne contains the active substance isotretinoin. Isotretinoin belongs to a group of medicines called retinoids.
Curacne 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 must be carried out under the supervision of a physician experienced in treating severe acne with retinoids and in monitoring patients during treatment.
Curacne 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

When not to take Curacne:

If the patient is pregnant or breastfeeding.
If there is any risk that the patient could 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 blood lipid levels (cholesterol, triglycerides).
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 Curacne, 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 may affect the patient's mood.
If the patient has kidney problems. In such cases, the treating physician should adjust the isotretinoin dose.
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 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 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 must be stopped immediately and the doctor contacted if:

The patient becomes pregnant during treatment or within one month after stopping treatment.
The following symptoms occur:
o Skin rash, which may progress to widespread blistering or peeling of the skin, 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).
o Difficulty breathing, itching, and/or urticaria (hives), as these may indicate an allergic reaction. Some of these reactions may manifest as bruises or red spots on the arms and legs.
o Headache with nausea, vomiting, or impaired vision;
o Severe abdominal pain, nausea, vomiting, or acute diarrhoea with blood in the stool;
o Difficulty urinating or inability to urinate;
o Night blindness and/or visual disturbances;
o Mental health problems: particularly symptoms of depression (low mood, tearfulness, self-harming behaviour, feeling isolated 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 taking this medicine. They may notice such changes and help the patient quickly identify problems requiring discussion with the doctor.
If the patient develops yellowing of the eyes or skin and feels dizzy.

Special warning for women taking Curacne:
Pregnancy and breastfeeding, Important
Pregnancy Prevention Programme
Women who are pregnant must not take Curacne
This medicine can severely harm the unborn child (the drug 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 is taken for only a short time during pregnancy.

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

Curacne may be prescribed to women of childbearing potential 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 her doctor. The doctor will provide information on methods of preventing pregnancy. 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 Curacne treatment.

Women must use effective contraception methods before, during, and after treatment with Curacne.

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 with different mechanisms (e.g. oral hormonal contraceptives and condoms). Discuss with the doctor which methods are most suitable.
The patient must use contraception for one month before starting Curacne, throughout 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.

The patient must agree to regular follow-up visits with the doctor, ideally monthly.
The patient must agree to regular pregnancy testing: before starting treatment, ideally monthly during treatment, and one month after stopping Curacne, as the drug may still be present in the body (unless the doctor decides otherwise for a particular patient).
The patient must agree to 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 drug may still be present in her body.
The treating doctor will discuss all issues with the patient using a checklist and will 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 a woman becomes pregnant while taking Curacne, she must immediately stop taking the medicine and contact her doctor. The doctor may refer her to a specialist for advice.
Additionally, a woman who becomes pregnant within one month after stopping Curacne treatment 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 is too low to harm their partner's unborn child. However, this medicinal product must never be shared with anyone else, especially women.
Additional precautions
Never give 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. 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 Curacne treatment. These symptoms may indicate sacroiliitis, a type of inflammatory back pain. The doctor may discontinue Curacne and refer the patient to a specialist for treatment of inflammatory back pain. Further evaluation, including imaging such as MRI, may be necessary.
Isotretinoin may cause dry eyes, corneal clouding, keratitis, intolerance to contact lenses, and visual problems, including night blindness. Cases of persistent dry eyes after treatment have been reported. Inform the doctor if any of these symptoms occur. The doctor may recommend lubricating eye ointments or artificial tears. 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 and may recommend stopping isotretinoin.
In the first weeks of treatment, acne may worsen with inflammatory skin lesions, but this usually resolves during continued treatment within 7–10 days and generally without the need to adjust the dose.
After several years of using isotretinoin at very high doses for keratinization 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. 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. Elevated lipid levels may also respond to dietary measures. High lipid levels are sometimes associated with pancreatitis, which can be life-threatening.
Children
Do not give Curacne to children under 12 years of age due to lack of safety and efficacy data in this age group, and it is not indicated for prepubertal acne.
Curacne and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use, including those available without a prescription.
Do not take medicines containing vitamin A, tetracycline antibiotics, or topical acne products (other retinoids) while using Curacne.
During isotretinoin treatment, avoid using topical keratolytic or exfoliating acne treatments, as local irritation may occur.
Fertility, pregnancy, and lactation
More information on pregnancy and contraception can be found in section 2, "Pregnancy Prevention Programme".
Driving and operating machinery
Night vision impairment 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.
Somnolence and dizziness have been reported very rarely.
If these symptoms occur, do not drive, operate machinery, or engage in other activities where such symptoms could endanger the patient or others.
Curacne contains soya oil
Do not use if hypersensitivity to peanuts or soya has been diagnosed.
Lifestyle advice:
If skin or lips become dry, use moisturizing creams or ointments and lip balm.
Avoid using skin-irritating products such as peeling creams during treatment.
Avoid excessive sun exposure during treatment, as Curacne 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 under quartz lamps.
Avoid waxing, dermabrasion (a procedure where the epidermis is removed to eliminate scars), and laser treatment during treatment and for 6 months after stopping, as these may lead to scarring, areas of hypo- or hyperpigmentation, 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 machinery or driving at night, as visual disturbances may occur suddenly.
Muscle and joint pain may occur during Curacne treatment. Avoid strenuous physical exercise during this period.

3. How to take Curacne

Dosage
This medicine should always be taken as directed by the physician or pharmacist. In case of doubt,
consult your doctor 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 to 1 mg/kg body weight per day.
If the patient feels that the effect of Curacne is too weak or too strong, the doctor should be informed.
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, treatment may be continued
using the highest dose tolerated by the patient, even if lower than the recommended dose.

Curacne treatment course 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 considers
initiating another treatment course, if necessary. Most patients require only a single course of treatment.

Accidental overdose of Curacne
If a dose of Curacne larger 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 doctor, pharmacist, or go to the nearest hospital.

Missed dose of Curacne
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 regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicinal product may cause adverse reactions, although not everyone experiences them.
Adverse reactions often subside during treatment, after 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, inform your treating physician, who will make an appropriate decision.
Some adverse reactions may be severe

Mental disorders

Rare reactions (may affect up to 1 in 1,000 people)
o Depression or related disorders. Symptoms include sadness, mood changes, anxiety, and feelings of emotional discomfort.
o Worsening of existing depression.
o Tendency towards violence or aggression.
Very rare reactions (may affect up to 1 in 10,000 people)
o Some individuals have experienced thoughts or images of self-harm or suicide (suicidal thoughts), attempted suicide (suicide attempts), or died by suicide.
These individuals may not show symptoms of depression.
o Unusual behaviour.
o 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 above symptoms of psychiatric disorders occur, contact your doctor immediately.
Your doctor may recommend discontinuing Curacne. Discontinuation of the medicine may not be sufficient for these effects to resolve; additional support may be required, which your doctor can provide.

Rare reactions (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 should be stopped immediately and medical advice sought.
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 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 also appear on the chest and back. Other symptoms may include 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, treatment with Curacne should be stopped immediately and medical advice sought.
All other adverse reactions are grouped below according to their frequency of occurrence.
Very common: affecting more than 1 in 10 people

Anaemia, thrombocytopenia, thrombocytosis.
Elevated ESR (marker of acute inflammation).
Increased triglyceride levels, decreased high-density lipoprotein (HDL) levels.
Increased liver enzyme activity (elevated 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: affecting less than 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 nasal mucosa, nosebleeds, nasopharyngitis.

Rare: affecting less than 1 in 1,000 people

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

Very rare: affecting less than 1 in 10,000 people

Pancreatitis, gastrointestinal haemorrhage, colitis. In case of acute abdominal pain, with or without bloody diarrhoea, nausea, and vomiting, treatment with isotretinoin should be discontinued and medical advice sought immediately.
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 immediately.
Elevated blood glucose levels (indicative of diabetes), accompanied by symptoms such as: increased thirst, increased frequency of urination, increased appetite with concomitant 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, administration of Curacne should be stopped and medical advice sought immediately.
Seizures.
Vascular stenosis or occlusion.
Worsening of acne symptoms during the first few weeks of treatment, manifesting as inflammatory skin lesions.
Severe forms of acne (fulminant acne): development of sudden inflammatory, ulcerated, necrotic, and haemorrhagic lesions on the face and/or trunk, with or without fever and joint pain. In such cases, isotretinoin should be discontinued and medical advice sought immediately.
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 (paronychia).
Thickening of surgical scars.
Damage to skin and mucosal blood vessels.
Increased sensitivity to sunlight (photosensitivity reactions, see Daily life advice, 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 has ended.
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 in the chest with shortness of breath and wheezing (bronchospasm), particularly if the patient suffers from asthma, voice changes (hoarseness).
Dryness of the throat, nausea.
Malaise.
Excessive tissue formation during wound healing (increased granulation tissue).
Joint-related changes with accompanying pain and swelling, bone abnormalities (delayed growth, excessive growth, reduced bone density), calcium deposits in soft tissues, tendonitis.
Increased activity of certain liver enzymes (creatine kinase), released during muscle fibre breakdown, particularly during intense physical exercise in patients treated with isotretinoin, abnormal muscle breakdown which may lead to kidney function disorders.
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 in males.
Vaginal dryness.
Sacroiliitis, a type of inflammatory back pain causing pain in the lower back or buttocks.
Urethritis.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Curacne 40 mg

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
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. Such measures help protect the environment.

6. Contents of the pack and other information

What Curacne contains
Curacne 5 mg, soft capsules
The active substance is isotretinoin.
One soft capsule contains 5 mg of isotretinoin.
The other ingredients are: highly refined soybean oil (see section 2), yellow wax, hydrogenated vegetable oil, and for the capsule shell: gelatin, glycerol, purified water, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171) 50% in glycerol.

Curacne 10 mg, soft capsules
The active substance is isotretinoin.
One soft capsule contains 10 mg of isotretinoin.
The other ingredients are: highly refined soybean oil (see section 2), yellow wax, hydrogenated vegetable oil, and for the capsule shell: gelatin, glycerol, purified water, iron oxide red (E 172).

Curacne 20 mg, soft capsules
The active substance is isotretinoin.
One soft capsule contains 20 mg of isotretinoin.
The other ingredients are: highly refined soybean oil (see section 2), yellow wax, hydrogenated vegetable oil, and for the capsule shell: gelatin, glycerol, purified water, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171) 50% in glycerol.

Curacne 40 mg, soft capsules
The active substance is isotretinoin.
One soft capsule contains 40 mg of isotretinoin.
The other ingredients are: highly refined soybean oil (see section 2), yellow wax, hydrogenated vegetable oil, and for 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 alcohol 35, propylene glycol (E 1520), iron oxide black (E 172), polyvinyl acetophthalate, water, isopropyl alcohol, macrogol, ammonium hydroxide.

What Curacne looks like and contents of the pack
Curacne 10 mg, Curacne 20 mg – 30 or 60 capsules in blister packs, contained in a cardboard box.
Curacne 5 mg, Curacne 40 mg – 30 capsules in blister packs, contained in a cardboard box.

Each 5 mg soft capsule has a two-coloured, opaque red/brown-cream gelatin shell with a light yellow/orange filling and printed with "5" on one side.
Each 10 mg soft capsule has a red/brown gelatin shell with a light yellow/orange filling and printed with "I 10" on one side.
Each 20 mg soft capsule has a two-coloured, opaque red/brown-cream gelatin shell with a light yellow/orange filling and printed with "I 20" on one side.
Each 40 mg soft capsule has an opaque orange/brown gelatin shell with a light orange/yellow filling and printed with "I40" on one side.

Marketing Authorisation Holder
Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur
France

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

Catalent Germany Schorndorf GmbH
Steinbeisstrasse 1 & 2
Schorndorf, Baden-Wuerttemberg
Germany

Catalent Germany Eberbach GmbH
Gammelsbacher Str. 2
Eberbach, Baden-Wuerttemberg
Germany

This medicinal product is authorised in the following European Economic Area countries under the following names:

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

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

For women of childbearing potential:

Prior to issuing a prescription, it is mandatory to obtain the patient's consent to treatment and to provide information on contraception.
The treatment duration covered by a single prescription is limited to 30 days. Any extension requires a new prescription.
The medicine may only be dispensed if the prescription contains all required information. Mandatory requirements:

o Starting treatment (first prescription):
- Patient’s consent to treatment (signed form) and provision of information on contraception.
- Use of at least one effective contraceptive method 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).
o Continuing treatment (subsequent prescriptions):
- Continued implementation of an effective contraceptive regimen.
- Assessment of the patient’s understanding of the ongoing treatment.
- Confirmation of the date of the last pregnancy test (serum hCG).

For further information about Curacne, please consult a specialist physician or the local representative of the Marketing Authorisation Holder:
Pierre Fabre Dermo-Cosmetique Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw
Phone: 22 559 63 60, Fax: 22 559 63 59

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