Curacne 5 mg

Patient Information Leaflet: User Information

Curacne 5 mg

Curacne 10 mg

Curacne 20 mg

Curacne 40 mg

Soft capsules
Isotretinoin

WARNING

CAN CAUSE SERIOUS HARM TO AN UNBORN CHILD.
Women must use effective methods of contraception.
Do not use during pregnancy or if pregnancy is suspected.

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

• You should keep this leaflet, so 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 as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Curacne and what is it 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 a risk of scarring), which are resistant to properly conducted standard treatment with systemic antibacterial medications and topical treatments (cream, gel, ointment, solution).
Treatment with Curacne 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 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

When not to take Curacne:

• 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 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, 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 may affect your mood.
• If you have kidney problems. In this case, your doctor may need to adjust the dose of isotretinoin.
• If you are overweight, have diabetes, high cholesterol or triglyceride levels in the blood, and consume large amounts of alcohol. In all these cases, lipid and glucose levels in the 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 blood glucose levels on an empty stomach have been reported, and new cases of diabetes have been diagnosed during isotretinoin treatment.
• If you have liver problems. Curacne may increase liver enzyme activity (aminotransferases). To check liver function (liver enzyme activity), your doctor will order regular blood tests before and during treatment. Cases of transient and reversible increased aminotransferase activity have been reported. In the event of persistent significant increased liver enzyme activity, your doctor may consider reducing the dose of the medicine or stopping treatment.
• If you have had gastrointestinal disorders.

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

• If you become pregnant during treatment or within a month after stopping treatment.
• If you experience the following symptoms: a 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), which can be life-threatening. These severe skin reactions are often preceded by headache, fever, and flu-like symptoms.

o breathing difficulties, itching, and/or hives, as these symptoms may indicate an allergic reaction. Some of these reactions may appear on the skin as bruising or red spots on the arms and legs.
o headache with nausea, vomiting, or impaired vision;
o severe abdominal pain, nausea, or vomiting, or severe diarrhea with blood in the stool;
o difficulty urinating or inability to urinate;
o impaired vision at night and/or vision disturbances;
o mental health problems: in particular, symptoms of depression (feeling unwell, tearfulness, desire for self-harm, feeling isolated from family or friends).
Patient may not notice some changes in their mood and behavior, so it is very important to tell friends and family members about taking this medicine. These people may notice such changes and help the patient quickly identify problems that need to be discussed with the doctor.

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

Special warning for women taking Curacne:

Pregnancy and breastfeeding, Important Pregnancy Prevention Program

Women who are pregnant must not take Curacne

This medicine can seriously harm 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 is taken for a short period during pregnancy.

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

Curacne may be prescribed to female patients of childbearing potential only under certain conditions

The following conditions must be met:

• The doctor must explain the risk of damage to the unborn child (birth defects) to the patient; 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 the patient with information about birth control methods. The doctor may refer the patient to a specialist who will provide advice on contraception.
• Before starting treatment, the doctor will ask the patient to have a pregnancy test. The test must show that the patient is not pregnant at the start of treatment with Curacne.

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

Curacne.

• The patient 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). The patient should discuss with the doctor which methods will be most suitable for them.

The patient must use a contraceptive method for one month before taking Curacne, during treatment, and for one month after stopping treatment. The patient must use contraception even if they do not menstruate or are not currently sexually active (unless the doctor decides it is not necessary).

• The patient must agree to have regular pregnancy tests before, during, and after treatment with Curacne.
• The patient must agree to have regular check-ups with the doctor, ideally every month.
• The patient must agree to have regular pregnancy tests: before starting treatment, ideally every month during treatment, and one month after stopping treatment with Curacne, because the medicine may still be present in the patient's body (unless the doctor decides it is not necessary for the patient).
• The patient must agree to have additional pregnancy tests as advised by the doctor.
• The patient must not become pregnant during and for one month after stopping treatment, because the medicine may still be present in the patient's body.
• The doctor will discuss all these matters with the patient, using a checklist, and ask the patient (or their parent or legal guardian) to sign it. This form confirms that the patient has been informed of the risks and agrees to follow the above rules.

If the patient becomes pregnant while taking Curacne, they must stop taking the medicine immediatelyand contact their doctor. The doctor may refer the patient to a specialist for advice.
Additionally, if the patient becomes pregnant within one month after stopping treatment with Curacne, they should contact their doctor. The doctor may refer the patient to a specialist for advice.

Advice for men

The amount of oral retinoids in the semen of men taking Curacne 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 must not donate blood while taking this medicine or for one month after stopping Curacne. If your blood is given to a pregnant woman, she may give birth to a child with birth defects.

Advice for all patients

o You should discuss with your doctor if you experience persistent back pain or pain in the buttocks during treatment. These symptoms may indicate sacroiliitis, a type of inflammatory back pain. Your doctor may stop treatment with Curacne and refer you to a specialist for treatment of inflammatory back pain. Further evaluation, including imaging studies such as MRI, may be necessary.
o 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 resolve after treatment was stopped. You should inform 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.
o 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 resolves during continued treatment within 7-10 days and usually without the need to adjust the dose.
o 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 generally much higher than those recommended for the treatment of acne.
o Isotretinoin may cause an increase in 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 the blood remain high, your doctor may reduce the dose or stop isotretinoin. High lipid levels may also respond to dietary measures. Very 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 a lack of information on safety or efficacy in this age group, and it is not indicated for prepubertal acne.

Curacne and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

While taking Curacne, 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 exfoliative anti-acne products, as local irritation may occur.
During treatment with Curacne, do not take vitamin Aor other retinoids (acitretin, alitretinoin) .
For more information on pregnancy and contraception, see section 2, "Pregnancy Prevention Program".

Fertility, pregnancy, and lactation

See section 2, "Pregnancy Prevention Program", for more information on pregnancy and contraception.

Driving and using machines

During treatment, impaired night vision may occur, which may persist after treatment is stopped. Be careful when driving or operating machinery.
Rarely, drowsiness and dizziness have been reported.
If you experience any of these symptoms, do not drive, operate machinery, or engage in other activities that may put you or others at risk.

Curacne contains soybean oil

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

Advice on daily life:

• In case of dry skin or lips, use moisturizing creams or lip balms.
• During the entire treatment period, do not use products that can irritate the skin, such as peeling creams.
• Avoid excessive sun exposure during treatment, as Curacne may increase skin sensitivity to sunlight.
• 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 sunlamps.
• During treatment and for 6 months after stopping treatment, avoid wax epilation, dermabrasion (a procedure that removes the skin to remove scars), and laser treatment, as this may cause scarring, areas of insufficient or excessive skin pigmentation, and skin peeling.
• If you experience dry eye syndrome, stop using contact lenses. Instead, wear glasses until the end of therapy.
• Wear sunglasses to protect your eyes from excessive sunlight.
• Be careful when operating mechanical devices and driving at night, as vision disturbances may occur suddenly.
• During treatment with Curacne, muscle and joint pain may occur. During this period, avoid strenuous physical exercise.

3. How to take Curacne

Dosage

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
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 is too weak or too strong, talk to your doctor.
Take the capsules by mouth with food, once or twice a day, with a glass of water. Swallow the capsules whole. Do not chew or suck the capsules.

Patients with severe kidney impairment

In patients with severe kidney 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 maximum tolerated dose.
Curacne treatmentlasts from 16 to 24 weeks. Skin condition may improve within 8 weeks after stopping treatment.
Therefore, at least 8 weeks should pass from the end of the course before the doctor can consider a second course of treatment. In most patients, only one course of treatment is needed.

Taking a higher dose of Curacne than recommended

If you take a higher dose of Curacne than recommended, 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.

Hospital.

Missing a 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 about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Curacne can cause side effects, although not everybody gets them.
Side effects often resolve during treatment, after a dose change, or after stopping treatment (you should discuss this with your doctor), although some may persist even after treatment is stopped. If they occur, you should inform your doctor, who will take appropriate action.

Some side effects can be serious

• Psychiatric disorders

Rare side effects(may affect up to 1 in 100 people)
o Depression or related disorders. Symptoms include sadness, mood changes, anxiety, discomfort.
o Exacerbation of existing depression.
o Aggression or violence.
Very rare side effects(may affect up to 1 in 10,000 people)
o 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.
o Abnormal behavior.
o Psychotic symptoms: loss of contact with reality, e.g., the patient hears voices or sees things that do not exist in reality.

In case of the above-mentioned psychiatric disorders, you should immediately contact your doctor.

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

• Rare side effects(may affect up to 1 in 100 people): sudden 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 and contact your doctor.
• Unknown frequency(frequency cannot be estimated from 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 severe rash or such skin symptoms, you should immediately stop taking Curacne and contact your doctor.

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

Very common: occurs in more than 1 in 10 people

• Anemia, thrombocytopenia, thrombocytosis.
• Increased erythrocyte sedimentation rate (ESR), a marker of acute inflammation.
• Increased triglyceride levels, decreased high-density lipoprotein (HDL) levels.
• Increased liver enzyme activity (aminotransferases). Depending on the situation, your doctor may order 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 strenuous physical exercise during treatment. All these symptoms are reversible after treatment is stopped.

Common: occurs in less than 1 in 10 people

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

Rare: occurs in less than 1 in 100 people

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

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

• Pancreatitis, gastrointestinal bleeding, colitis. If you experience 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.
• Increased blood glucose levels (indicating diabetes) with symptoms such as increased thirst, increased urination, increased appetite with weight loss, feeling tired, dizziness, weakness, decreased mood, irritability, and general exhaustion. If you experience these symptoms, you should contact your doctor.
• High blood pressure in the brain in patients who are also taking isotretinoin and certain antibiotics (tetracyclines). This hypertension is accompanied by chronic headaches with nausea and vomiting or vision disturbances (possibly due to papilledema). You should then stop taking Curacne and contact your doctor as soon as possible.
• Seizures.
• Narrowing or blockage of blood vessels.
• Exacerbation of acne symptoms during the first few weeks of treatment, with inflammatory skin lesions.
• Severe forms of acne (acne fulminans): development of inflammatory, ulcerative, necrotic, and hemorrhagic lesions 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 disorders, bacterial infections of the nail bed.
• Thickening of postoperative scars.
• Damage to skin and mucous membrane blood vessels.
• Increased sensitivity to sunlight (photoreactions, see "Advice on daily life", point 2).
• Increased skin pigmentation, increased sweating.
• Enlargement of 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 then wear sunglasses to protect your eyes from glare. If you experience such 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).
• Feeling of dryness in the throat, nausea.
• Malaise.
• Excessive tissue formation during wound healing (increased granulation tissue formation).
• Changes mainly affecting the 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 engage in strenuous physical exercise, muscle breakdown, which can lead to kidney function disorders.
• Drowsiness, dizziness.

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

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

Reporting side effects

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

5. How to store Curacne

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package.
Keep the package 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 no longer required. This will 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.
1 soft capsule contains 5 mg of isotretinoin.
The other ingredients are purified soybean oil (see section 2), yellow wax, hydrogenated vegetable oil, and the following ingredients in 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.
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 following ingredients in the capsule shell: gelatin, glycerol, purified water, iron oxide red (E 172).
Curacne 20 mg, soft capsules
The active substance is isotretinoin.
1 soft capsule contains 20 mg of isotretinoin.
The other ingredients are purified soybean oil (see section 2), yellow wax, hydrogenated vegetable oil, and the following ingredients in 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.
1 soft capsule contains 40 mg of isotretinoin.
The other ingredients are purified soybean oil (see section 2), yellow wax, hydrogenated vegetable oil, and the following ingredients in the capsule shell: gelatin, glycerol, purified water, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171) 50% in glycerol.
Ingredients of the ink: SDA 35 alcohol, propylene glycol (E 1520), iron oxide black (E 172), polyvinyl octanoate, 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 blisters, in a cardboard box.
Curacne 5 mg, Curacne 40 mg - 30 capsules in blisters, in a cardboard box.
Each 5 mg soft capsule has a two-color, opaque red/brown-yellow capsule shell with a light yellow/orange fill and is printed with "5" on one side.
Each 10 mg soft capsule has a red/brown capsule shell with a light yellow/orange fill and is printed with "I 10" on one side.
Each 20 mg soft capsule has a two-color, opaque red/brown-yellow capsule shell with a light yellow/orange fill and is printed with "I 20" on one side.
Each 40 mg soft capsule has an orange/brown, opaque capsule shell with a light orange/yellow fill and is printed with "I40" on one side.

Marketing authorization 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
73614
Germany
Catalent Germany Eberbach GmbH
Gammelsbacher Str. 2
Eberbach, Baden-Wuerttemberg
69412
Germany

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
Spain
ISOACNE

Availability category:

Prescription-only medicine requiring close monitoring during treatment.

For women of childbearing potential:

• Before prescribing, it is necessary to obtain the patient's consent to treatment and provide information on contraception;
• The duration of treatment based on the prescription is limited to 30 days. Extension of treatment requires a new prescription;
• The medicine can only be dispensed if all required information is present on the prescription. Mandatory requirements: o Initiation of treatment (first prescription).
• Obtaining patient 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).

o
Continuation of treatment (subsequent prescriptions).

• Implementation of the effective contraception program.
• Assessment of the patient's understanding of the ongoing treatment.
• Determining the date of the last pregnancy test (serum hCG).

For more information on Curacne, you should contact your doctor or the local representative of the marketing authorization holder:
Pierre Fabre Dermo-Cosmetique Polska Sp. z o.o.
Belwederska Street 20/22
00-762 Warsaw
phone: 22 559 63 60, fax: 22 559 63 59
Date of last update of the leaflet:03/2024
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