Curacne 10 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 THE UNBORN CHILD.
Women must use effective contraceptive methods.
Do not use during pregnancy or suspected pregnancy.

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), resistant to properly conducted standard treatment with systemic antibacterial drugs 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 a risk that the patient may become pregnant, it is necessary to follow the precautions listed in the Pregnancy Prevention Program, 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 soy.
• If the patient has liver failure (severe liver disease).
• If the patient has hypervitaminosis A (too high a concentration 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 the patient has 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 the patient's mood.
• If the patient has kidney problems. In this case, the doctor should adjust the dose of isotretinoin.
• If the patient is overweight, has diabetes, high cholesterol or triglycerides in the blood, and consumes large amounts of alcohol. In all these cases, lipid and glucose levels in the blood must be regularly monitored. If this situation applies to the patient, the doctor will order more frequent blood tests. Patients with diabetes during treatment should strictly control their blood glucose levels. Increased fasting blood sugar levels have been reported, as well as new cases of diabetes diagnosed during isotretinoin treatment.
• If the patient has liver problems. Curacne may increase liver enzyme activity (aminotransferases). To check liver function (liver enzyme activity), the 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, the doctor will consider reducing the dose of the medicine or discontinuing treatment.
• If the patient has had gastrointestinal disorders.

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

• If the patient becomes pregnant during treatment or within a month after its completion.
• If the following symptoms occur: 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 body aches (flu-like symptoms).

o breathing difficulties, itching, and/or hives, as these symptoms may indicate an allergic reaction. Some of these reactions may occur on the skin in the form of bruises 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 (bad mood, tearfulness, desire for self-harm, feeling of isolation from family or friends).
The 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 the patient experiences 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 the unborn child (the medicine has a teratogenic effect). It may cause severe damage to the brain, face, ear, eye, heart, and some 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.
• The patient must not become pregnant for a month after the end of treatment, as the medicine may still be present in the patient's body.

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

The following conditions must be met:

• The doctor must explain to the patient the risk of damage to the unborn child (congenital malformations); 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 contraceptive methods 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 a month before taking Curacne, during treatment, and for a month after completing treatment with this medicine. 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 after a month after completing treatment with Curacne, as 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 recommended by the doctor.
• The patient must not become pregnant during and for a month after completing treatment, as the medicine may still be present in the patient's body.
• The doctor will discuss all these issues 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 risk 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 a month after completing 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 sperm of men taking Curacne is too small to harm the unborn child of their partner. However, this medicinal product should never be shared with anyone else, especially women.

Additional precautions

Never give this medicinal product to another person. All unused capsules should be returned to the pharmacist after completing treatment.

Do not donate blood during treatment with this medicine or for a month after stopping Curacne. If the patient's blood is given to a pregnant woman, she may give birth to a child with congenital malformations.

Advice for all patients

o You should discuss with your doctor if you experience persistent back pain or pain in the buttocks during treatment with Curacne. These symptoms may indicate sacroiliitis, a type of inflammatory back pain. The doctor may discontinue treatment with Curacne and refer the patient 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. The doctor may recommend using moisturizing eye ointments or tear substitutes. If you experience intolerance to contact lenses, the doctor may recommend wearing glasses during treatment. If you experience vision problems, the doctor may refer you to a specialist for advice and may recommend discontinuing isotretinoin.

o In the first few weeks of treatment, it is possible to exacerbate acne with inflammatory skin changes, 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 to treat disorders of keratinization (keratin accumulation), there have been reports of bone abnormalities (including delayed growth, additional 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 increase the level of lipids in the blood, such as triglycerides. The doctor will order checks on these values before, during, and after treatment with isotretinoin.

If the level of lipids in the blood remains high, the doctor may reduce the dose or discontinue isotretinoin. Elevated 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 the 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, antibiotics from the tetracycline group, or use any topical anti-acne products (other retinoids) .

During treatment with isotretinoin, do not use topical anti-acne products with a keratolytic or exfoliating effect, as local irritation may occur.

Fertility, pregnancy, and lactation

More information on pregnancy and contraception can be found in section 2, "Pregnancy Prevention Program".

Driving and using machines

During treatment, impaired night vision may occur, which in rare cases may persist after treatment is stopped. These disturbances may occur suddenly, so caution is advised when driving or operating machinery.

Rarely, drowsiness and dizziness have been reported.

In the event of these symptoms, do not drive, operate machinery, or engage in other activities where these symptoms could put you or others at risk.

Curacne contains soybean oil

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

Daily life advice:

• 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 exfoliating creams.
• Avoid excessive sun exposure during treatment, as Curacne may increase skin sensitivity to sunlight.
• If you cannot avoid sun exposure, use creams with a sun protection factor (SPF) of at least 15.
• Do not use UV lamps, sunbeds, or quartz lamps.
• During treatment and for 6 months after its completion, 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 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 pains 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. In 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, you should talk to 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 at 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 using the highest tolerated dose.
Treatment with Curacnelasts from 16 to 24 weeks. The condition of the skin may improve even within 8 weeks after the end of treatment.
Therefore, at least 8 weeks should pass from the end of the course before the doctor can consider another treatment course. 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 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 can cause side effects, although not everybody gets them.
Side effects often resolve during treatment, after a dose change, or after discontinuing treatment (you should discuss this with your doctor), although some of them may persist even after treatment is stopped. If they occur, you should inform your doctor, who will make a decision.

Some side effects can be serious

• Psychiatric disorders

Rare 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 effects(may affect up to 1 in 10,000 people)
o Some people have had thoughts or fantasies 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 actually exist.

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

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

• Rare 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.
• Frequency not known(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 occur 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 body aches (flu-like symptoms).

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

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

Very common: occurring in more than 1 in 10 people

• Anemia (low red blood cell count), low platelet count, high platelet count.
• Increased ESR (a marker of acute inflammation).
• Increased triglyceride levels, decreased HDL (high-density lipoprotein) levels.
• Increased liver enzyme activity (aminotransferases). Depending on the situation, the 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, intense physical exercise should be limited during treatment. All these symptoms are reversible after treatment is stopped.

Common: occurring in less than 1 in 10 people

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

Rare: occurring in less than 1 in 100 people

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

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

• Pancreatitis, gastrointestinal bleeding, colitis. In the event of severe abdominal pain accompanied by (or without) bloody diarrhea, nausea, and vomiting, you should stop taking 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.
• 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 sugar levels (indicating diabetes) with accompanying symptoms such as increased thirst, increased urination, increased appetite with weight loss, feeling of tiredness, dizziness, weakness, decreased mood, irritation, and general exhaustion. If these symptoms occur, 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, 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 changes.
• Severe forms of acne (acne fulminans): development of inflammatory, ulcerative, necrotic, and hemorrhagic skin changes, appearing suddenly on the face and/or trunk, with or without fever and joint pain. In such a case, you should stop taking isotretinoin and contact your doctor as soon as possible.
• Colitis.
• Local bacterial infections.
• Flush, skin rash.
• Changes in hair, increased body hair, nail dystrophy, bacterial infections of the nail bed.
• Thickening of post-operative scars.
• Damage to skin and mucous membrane blood vessels.
• Increased sensitivity to sunlight (photoreactions, see Daily life advice, section 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 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, additional growth, and decreased bone density), calcifications in soft tissues, tendonitis.
• The activity of some liver enzymes (creatine kinase) released during muscle fiber breakdown may increase in patients taking isotretinoin who perform intense physical exercise, which can lead to kidney function disorders.
• Drowsiness, dizziness.

Frequency not known (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 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:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 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 stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
Do not store above 25°C. Store in the original packaging.
Keep the packaging tightly closed to protect from light.

After completing 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. These measures 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.
One soft capsule contains 5 mg of isotretinoin.
The medicine also contains 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), and 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 medicine also contains purified soybean oil (see section 2), yellow wax, hydrogenated vegetable oil, and the following ingredients in the capsule shell: gelatin, glycerol, purified water, and iron oxide red (E 172).
Curacne 20 mg, soft capsules
The active substance is isotretinoin.
One soft capsule contains 20 mg of isotretinoin.
The medicine also contains 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), and 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 medicine also contains 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), and titanium dioxide (E 171) 50% in glycerol.
Ingredients of the ink: SDA 35 alcohol, propylene glycol (E 1520), iron oxide black (E 172), polyvinyl acetate phthalate, 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:

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 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 the treatment period requires the issuance of a new prescription;
• The medicine may only be dispensed if all required information is present on the prescription. Mandatory requirements: o Initiation of treatment (first prescription).
• Obtaining the patient's consent to treatment and providing information on contraception.
• Using at least one effective contraceptive method for at least one month before starting treatment.
• Assessing the patient's understanding of the planned treatment.
• Scheduling a pregnancy test date (serum hCG).

o
Continuation of treatment (subsequent prescriptions).

• Implementing the effective contraception program.
• Assessing the patient's understanding of the treatment being carried out.
• Specifying the date of the last pregnancy test (serum hCG).

For more detailed information on Curacne, you should consult a specialist doctor and the local representative of the marketing authorization holder:
Pierre Fabre Dermo-Cosmetique Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw
tel.: 22 559 63 60, fax: 22 559 63 59
Date of last update of the leaflet:03/2024
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