Curacne 5 mg

Patient Information Leaflet: User Information

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

Curacne 5 mg (CURACNÉ 5 mg)

Soft capsules
Isotretinoin
Curacne 5 mg and CURACNÉ 5 mg are different trade names for the same medicine.

WARNING

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

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

• Keep this leaflet, so you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Curacne 5 mg and what is it 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 is Curacne 5 mg and what is it 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 a risk of developing permanent scars) that are resistant to properly conducted standard treatments with systemic antibacterial medications and topical treatments (creams, gels, ointments, solutions).
Treatment with Curacne 5 mg must be carried out under the supervision of a doctor with experience in treating severe forms of acne with retinoids and monitoring the patient during treatment.
Curacne 5 mg is not indicated for the treatment of acne that occurs before puberty and is not recommended for use in children under 12 years of age.

2. Important information before taking Curacne 5 mg

When not to use Curacne 5 mg:

• If the patient is pregnant or breastfeeding.
• If there is a risk that the patient may become pregnant, it is necessary to follow the precautions listed 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 levels of lipids (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 5 mg, discuss 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 5 mg may affect the patient's mood.
• If the patient has kidney problems. In this case, the doctor should modify the dose of isotretinoin.
• If the patient is overweight, has diabetes, high cholesterol or triglyceride levels 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 5 mg 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 liver enzyme activity have been reported. In cases of persistent significant increased liver enzyme activity, the doctor may consider reducing the dose or discontinuing treatment.
• If the patient has had gastrointestinal disorders.

Stop treatment with Curacne 5 mg and contact your doctor immediately:

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

The patient may not notice certain 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 5 mg:

Pregnancy and breastfeeding, Important Pregnancy Prevention Program

Pregnant women must not take Curacne 5 mg

This medicine may cause serious harm to an unborn child (the medicine has a teratogenic effect). It may cause serious damage to the brain, face, ear, eye, heart, and some glands (thymus and parathyroid) of the fetus. It also increases the risk of miscarriage. These effects can occur even if Curacne 5 mg is taken for a short period during pregnancy.

• Do not take Curacne 5 mg if you are pregnant or think you may be pregnant.
• Do not take Curacne 5 mg during breastfeeding. The medicine is likely to pass into breast milk and may harm the baby.
• Do not take Curacne 5 mg if you may become pregnant during treatment.
• The patient must not become pregnant for a month after stopping treatment, as the medicine may still be present in the patient's body.

Curacne 5 mg may be prescribed to female patients of childbearing potential under certain conditions, due to the risk of serious birth defects.

The following conditions must be met:

• The doctor must explain the risk of harm to the unborn child (birth defects) to the patient; the patient must understand why they 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 on contraception methods. The doctor may refer the patient to a specialist for contraception advice.
• 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.

Female patients must use effective contraception methods before, during, and after treatment with Curacne 5 mg.

• The patient must agree to use at least one highly effective contraception method (e.g., 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 are most suitable for them.
• The patient must use a contraceptive method for a month before taking Curacne 5 mg, during treatment, and for a month after stopping the medicine.
• The patient must use contraception even if they do not menstruate or are not currently sexually active (unless the doctor determines that it is not necessary).

Female patients must agree to have pregnancy tests before, during, and after treatment with Curacne 5 mg.

• 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 a month after stopping Curacne 5 mg, as the medicine may still be present in the patient's body (unless the doctor decides that 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 stopping 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 risks and agrees to follow the above rules.

If the patient becomes pregnant while taking Curacne 5 mg, 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 stopping treatment with Curacne 5 mg, 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 5 mg is too small to harm an unborn child. However, never share this medicine with anyone, especially women.

Additional precautions

Never give this medicine to another person. All unused capsules should be returned to the pharmacist after treatment is completed.

Do not donate blood while taking this medicine or for a month after stopping Curacne 5 mg. If the patient's blood is given to a pregnant woman, she may give birth to a child with birth defects.

She may give birth to a child with birth defects.

Advice for all patients

• Talk to your doctor if you experience persistent back pain or pain in the buttocks during treatment. These symptoms may indicate inflammatory back pain, a type of back pain caused by inflammation. The doctor may stop treatment with Curacne 5 mg and refer the patient to a specialist for back pain treatment. Further evaluation, including imaging tests such as MRI, may be necessary.
• Isotretinoin may cause dry eyes, corneal clouding, conjunctivitis, intolerance to contact lenses, and vision problems, including impaired night vision.

There have been cases of dry eyes that did not improve after treatment was stopped. If any of these symptoms occur, the patient should inform their doctor. The doctor may recommend using moisturizing eye ointments or tear substitutes. If contact lens intolerance occurs, the doctor may recommend wearing glasses during treatment. If vision problems occur, the doctor may refer the patient to a specialist for advice and may recommend stopping isotretinoin.

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

Children

Do not give Curacne 5 mg 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 5 mg and other medicines

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

While taking Curacne 5 mg, do not take medicines containing

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

Fertility, pregnancy, and lactation

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

Driving and using machines

During treatment, impaired night vision may occur, which may persist after treatment is stopped. These disturbances may occur suddenly, so caution is advised when driving or operating machinery.
Rarely, drowsiness and dizziness have been reported.
If these symptoms occur, do not drive, operate machinery, or engage in other activities that may put the patient or others at risk.

Curacne 5 mg contains soybean oil

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

Advice on daily life:

• In case of dry skin or lips, use moisturizing creams or lip balms.
• Throughout the treatment period, do not use products that may irritate the skin, such as peeling creams.
• Avoid excessive sun exposure during treatment, as Curacne 5 mg may increase skin sensitivity.
• If sun exposure cannot be avoided, 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, 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 sun exposure.
• Be careful when operating mechanical devices and driving at night, as vision disturbances may occur suddenly.
• During treatment with Curacne 5 mg, muscle and joint pain may occur. During this period, avoid strenuous physical exercise.

3. How to take Curacne 5 mg

Curacne 5 mg, Curacne 10 mg, Curacne 20 mg, and Curacne 40 mg are available.

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 5 mg is too weak or too strong, talk to your doctor.
The capsules should be taken orally with food, once or twice a day, with a glass of water. 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 maximum tolerated dose.
Treatment with Curacne 5 mglasts from 16 to 24 weeks. Skin condition may improve even within 8 weeks after stopping treatment.
Therefore, at least 8 weeks should pass from the end of 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 5 mg than recommended

If a higher dose of Curacne 5 mg than recommended is taken, symptoms of hypervitaminosis A may occur, such as severe headache, nausea, or vomiting, drowsiness, irritability, and itching.

In this situation, contact a doctor, pharmacist, or the nearest

hospitalimmediately.

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

4. Possible side effects

Like all medicines, Curacne 5 mg can cause side effects, although not everybody gets them.
Side effects often disappear during treatment, after changing the dose, or after stopping treatment (which should be discussed with the doctor), although some of them may persist even after treatment is stopped. If they occur, the patient should inform their doctor, who will make a decision.

Some side effects may be serious

• Psychiatric disorders

Rare side effects(may affect up to 1 in 1000 people)

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

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

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

If the patient experiences any of the above psychiatric disorders, they should

contact their doctor immediately. The doctor may recommend stopping Curacne 5 mg.
Stopping the medicine may not be enough for these effects to disappear; additional help may be necessary, and the doctor can provide it.

• Rare side effects(may affect up to 1 in 1000 people): sudden life-threatening allergic reactions (anaphylactic reactions: difficulty breathing or swallowing caused by sudden swelling of the throat, face, lips, and mouth, as well as sudden swelling of the hands, feet, and ankles). If the patient experiences any allergic reaction, they should stop taking Curacne 5 mg and contact their doctor.

Rare side effects(may affect up to 1 in 1000 people): 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 infections (conjunctivitis) or ulcers of the mouth, throat, or nose. Severe skin reactions are often preceded by headache, fever, and flu-like symptoms.

• 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 infections (conjunctivitis) or ulcers of the mouth, throat, or nose. Severe skin reactions are often preceded by headache, fever, and flu-like symptoms.

If the patient experiences a severe rash or such skin symptoms, they should stop taking Curacne 5 mg immediatelyand contact their doctor.

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

Very common: affecting more than 1 in 10 people

• Anemia, thrombocytopenia, thrombocytosis.
• Accelerated ESR (marker of acute inflammation).
• Increased triglyceride levels, decreased HDL cholesterol levels.
• Increased liver enzyme activity (aminotransferase levels).
• Red ulcers or deep cracks in the corners of the mouth and lips, skin inflammation, 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: affecting up to 1 in 10 people

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

Rare: affecting up to 1 in 1000 people

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

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

• Pancreatitis, gastrointestinal bleeding, colitis. If the patient experiences severe abdominal pain with or without bloody diarrhea, nausea, and vomiting, they should stop taking isotretinoin and contact their 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 the patient experiences such symptoms during treatment with isotretinoin, they should stop treatment and contact their doctor.
• Increased blood sugar levels (indicating diabetes) with symptoms such as increased thirst, increased urination, increased appetite with weight loss, feeling unwell, dizziness, weakness, decreased mood, irritability, and general exhaustion. If these symptoms occur, the patient should contact their doctor.
• High blood pressure in the brain in patients who are also taking tetracycline antibiotics. This is accompanied by chronic headaches with nausea, vomiting, or vision disturbances (possibly due to papilledema). In this case, the patient should stop taking Curacne 5 mg and contact their doctor as soon as possible.
• Seizures.
• Narrowing or blockage of blood vessels.
• Worsening of acne symptoms during the first few weeks of treatment, with inflammatory lesions on the skin.
• Severe forms of acne (acne fulminans): development of inflammatory, ulcerated, necrotic, and hemorrhagic lesions on the face and/or trunk, with or without fever and joint pain. In this case, the patient should stop taking isotretinoin and contact their doctor immediately.
• Colitis.
• Local bacterial infections.
• Facial flushing, skin rash.
• Changes in hair, increased body hair, nail dystrophy, bacterial infections of the nail bed.
• Thickening of post-operative scars.
• Damage to skin blood vessels and mucous membranes.
• Increased sensitivity to sunlight (photoreactions, see "Advice on daily life", point 2).
• Increased skin pigmentation, increased sweating.
• Enlarged lymph nodes.
• High levels of uric acid in the blood, which can cause gout.
• The medicine may cause impaired night vision and blurred vision, which may occur suddenly. These disturbances may persist even after treatment is stopped.
• Color blindness, severe eye irritation, corneal clouding, conjunctivitis, blurred vision, cataract, increased sensitivity to light, vision disturbances, intolerance to contact lenses. In this case, the patient should wear sunglasses to protect their eyes from glare. If such symptoms occur during treatment, the patient should contact their doctor immediately.
• Hearing impairment.
• Sudden chest tightness with shortness of breath and wheezing (bronchospasm), especially if the patient has asthma, voice changes (hoarseness).
• Dryness in the throat, nausea.
• Malaise.
• Excessive tissue growth during wound healing (increased granulation tissue formation).
• Changes mainly affecting joints with accompanying pain and swelling, bone abnormalities (delayed growth, extra growth, and decreased bone density), calcification in soft tissues, tendonitis.
• The activity of some liver enzymes (creatine kinase) released during muscle fiber breakdown may increase in patients taking isotretinoin who engage in intense physical exercise, leading to muscle breakdown, which can cause kidney problems.
• Drowsiness, dizziness.

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

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

Reporting side effects

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

5. How to store Curacne 5 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. The expiry date refers to the last day of the month.
Do not store above 25°C. Store in the original packaging.
Keep the packaging tightly closed to protect from light.

After treatment is completed, return all remaining capsules to the pharmacy.

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

6. Contents of the pack and other information

What Curacne 5 mg contains

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), titanium dioxide (E 171) 50% in glycerol.
The ink composition is: SDA 35 alcohol, propylene glycol (E 1520), iron oxide black (E 172), polyvinyl acetate phthalate, water, isopropyl alcohol, macrogol, ammonium hydroxide.

What Curacne 5 mg looks like and contents of the pack

30 capsules in blisters, in a cardboard box.
Each soft capsule has a two-color, non-transparent red/brown-orange gelatin shell with a light yellow/orange filling and is printed with "5" on one side.
For more detailed information on the medicine, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in France, the country of export:

Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur
France

Manufacturer:

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

Parallel importer:

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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
French marketing authorization number:34009 358 125 6 8

Parallel import authorization number: 423/24

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 5 mg
Spain ISOACNE

Availability category:

Medicine available on prescription, requiring close monitoring during treatment.

For women of childbearing potential:

• Before issuing a prescription, it is necessary to obtain the patient's consent to undergo treatment and provide information on contraception;
• The duration of treatment based on the issued 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:
• Start of treatment (first prescription).
• Obtaining patient consent for treatment and providing information on contraception.
• Use of at least one highly effective contraception method, at least one month before starting treatment.
• Assessment of the patient's understanding of the planned treatment.
• Scheduling a pregnancy test (serum hCG).
• Continuation of treatment (subsequent prescriptions).
• Implementation of an effective contraception program.
• Assessment of the patient's understanding of the treatment being carried out.
• Determination of the date of the last pregnancy test (serum hCG).

Date of leaflet approval: 29.11.2024

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