Curacne 5 mg

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Curacne 5 mg is and what it is used for

Curacne 5 mg contains the active substance isotretinoin. Isotretinoin belongs to a group of medicines called retinoids.
Curacne 5 mg is indicated for the treatment of severe forms of acne (such as nodular acne, conglobate acne, or acne with a risk of permanent scarring), which are resistant to properly conducted standard treatment with systemic antibacterial agents and topical medications (cream, gel, ointment, lotion).
Treatment with Curacne 5 mg must be carried out under the supervision of a physician experienced in treating severe acne with retinoids and in monitoring patients during treatment.
Curacne 5 mg is not indicated for the treatment of acne occurring before puberty, and its use is not recommended in children under 12 years of age.

2. Important information before taking Curacne 5 mg

When not to use Curacne 5 mg:

• If the patient is pregnant or breastfeeding.
• If there is any risk that the patient may become pregnant, it is essential to follow the precautions outlined in the Pregnancy Prevention Programme; see section “Warnings and precautions”.
• If the patient is allergic to isotretinoin or any of the other ingredients of this medicine (listed in section 6), particularly peanuts or soya.
• If the patient has liver failure (severe liver disease).
• If the patient has hypervitaminosis A (excessively high levels of vitamin A in the blood).
• If the patient has elevated levels of lipids (cholesterol, triglycerides) in the blood.
• If the patient is currently being treated with tetracycline antibiotics.
• If the patient is taking vitamin A or other retinoids (e.g. acitretin, alitretinoin).

Warnings and precautions
Before starting treatment with Curacne 5 mg, discuss the following with your doctor:

• If the patient has ever had mental health problems, including depression, anxiety, aggressive tendencies or mood swings, or thoughts of self-harm or suicide. This is because Curacne 5 mg may affect the patient's mood.
• If the patient has kidney problems. In such cases, the 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 therapy.
• If the patient has liver problems. Curacne 5 mg may increase liver enzyme activity (aminotransferases). To assess liver function (liver enzyme activity), the doctor will order regular blood tests before and during treatment. Cases of transient and reversible increases in aminotransferase activity have been reported. If there is a persistent and significant increase in liver enzyme activity, the doctor may consider reducing the dose or discontinuing treatment.
• If the patient has gastrointestinal disorders.

Immediately stop treatment with Curacne 5 mg and contact your doctor if:

• The patient becomes pregnant during treatment or within one month after stopping treatment.
• The following symptoms occur:
  • A rash that may progress to widespread blistering or peeling of the skin, or ulceration of the mouth, throat, nose, genital organs, or conjunctivitis (redness and swelling of the eyes). These may indicate a severe skin reaction (e.g. erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis), potentially life-threatening. These severe skin reactions are often preceded by headache, fever, and body aches (flu-like symptoms);
  • Breathing difficulties, itching, and/or urticaria (hives), as these may indicate an allergic reaction. Some of these reactions may appear on the skin as bruises or red spots on the arms and legs;
  • Headache with nausea, vomiting, or impaired vision;
  • Severe abdominal pain, nausea or vomiting, or acute diarrhoea associated with blood in the stool;
  • Difficulty urinating or inability to pass urine;
  • Impaired night vision and/or visual disturbances;
• Mental health problems: particularly symptoms of depression (feeling unwell, tearfulness, self-harming thoughts, feeling detached 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, or experiences dizziness.

Special warning for women taking Curacne 5 mg:
Pregnancy and breastfeeding, Important
Pregnancy Prevention Programme
Women who are pregnant must not take Curacne 5 mg
This medicine can severely harm the unborn child (the 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 5 mg is taken for only a short time during pregnancy.

• Do not take Curacne 5 mg if the patient is pregnant or suspects she may be pregnant.
• Do not take Curacne 5 mg during breastfeeding. The drug is likely to pass into breast milk and may harm the infant.
• Do not take Curacne 5 mg if the patient could become pregnant during treatment.
• The patient must not become pregnant for one month after stopping treatment, as the drug may still be present in her body.

Curacne 5 mg may be prescribed to women of childbearing potential only if strict rules are rigorously followed. This is due to the risk of severe birth defects.
The following conditions must be met:

• The doctor must explain to the patient the risk of foetal damage (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 ask the patient to undergo a pregnancy test. The test must confirm that the patient is not pregnant at the start of treatment with Curacne 5 mg.

Women must use effective contraceptive methods before, during, and after treatment with Curacne 5 mg.

• The patient must agree to use at least one highly reliable method of contraception (e.g. intrauterine device or contraceptive implant), or two effective methods acting in different ways (e.g. oral hormonal contraceptives and condoms). Discuss with the doctor which methods are most suitable for the patient.
• The patient must use contraception for one month before starting Curacne 5 mg, 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 not necessary).

Women must agree to undergo pregnancy tests before, during, and after treatment with Curacne 5 mg.

• The patient must agree to attend regular follow-up visits with her doctor, ideally every month.
• The patient must agree to undergo regular pregnancy tests: before starting treatment, ideally every month during treatment, and one month after stopping Curacne 5 mg, as the drug may still be present in her body (unless the doctor decides otherwise).
• The patient must agree to undergo additional pregnancy tests as recommended by her 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 physician will discuss all issues with the patient using a checklist and 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 above-mentioned rules.

If the patient becomes pregnant while taking Curacne 5 mg, she must immediately stop taking the medicine and contact her doctor. The doctor may refer her to a specialist for advice.
Additionally, a patient who becomes pregnant within one month after stopping Curacne 5 mg should contact her doctor. The doctor may refer her to a specialist for advice.
Advice for men
The amount of oral retinoids in the semen of men taking Curacne 5 mg is too low to harm their partner's unborn child. However, this medicinal product must never be shared with anyone else, especially women.
Additional precautions
Never pass this medicinal product to another person. All unused capsules must be returned to the pharmacist after treatment ends.
Do not donate blood while taking this medicine or within one month after stopping Curacne 5 mg. If a pregnant woman receives the patient's blood, she may give birth to a child with congenital malformations.
Advice for all patients

• Discuss with your doctor if you experience persistent lower back or buttock pain during treatment with Curacne 5 mg. These symptoms may indicate sacroiliitis, a type of inflammatory back pain. The doctor may discontinue treatment with Curacne 5 mg and refer the patient to a specialist for management of inflammatory back pain. Further evaluation, including imaging such as MRI, may be necessary.
• Isotretinoin may cause dry eyes, corneal opacities, keratitis, intolerance to contact lenses, and visual problems, including night vision impairment.

Cases of persistent dry eye that did not resolve after treatment ended have been reported. Inform your doctor if any of these symptoms occur. The doctor may recommend lubricating eye ointments or artificial tear preparations. If contact lens intolerance occurs, the doctor may advise wearing glasses during treatment. If visual problems occur, the doctor may refer the patient to a specialist for advice and may consider discontinuing isotretinoin.

• In the first few weeks of treatment, acne may worsen with inflammatory skin lesions, but this usually 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 keratinisation disorders (keratin accumulation), bone abnormalities (including delayed growth, increased bone growth, and reduced bone density) and calcification of tendons and ligaments have been observed. In these cases, both the dose, duration of treatment, and 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. Dietary measures may also help reduce elevated lipid levels. Excessively high lipid levels are sometimes associated with pancreatitis, which can be life-threatening.

Children
Do not give Curacne 5 mg to children under 12 years of age due to lack of information on safety or efficacy in this age group, and it is not indicated for prepubertal acne.
Curacne 5 mg and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, including those obtained without a prescription.
Do not take medicines containing vitamin A, tetracycline antibiotics, or apply any topical acne treatments (other retinoids) to the skin while using Curacne 5 mg.
During isotretinoin treatment, avoid using topical acne treatments with keratolytic or exfoliating properties, as local irritation may occur.
Effect on fertility, pregnancy, and lactation
More information on pregnancy and contraception can be found in section 2, “Pregnancy Prevention Programme”.
Driving and operating machinery
Impaired night vision may occur during treatment, which in rare cases may persist after treatment ends. These disturbances may appear suddenly; therefore, caution is advised when driving or operating machinery.
Drowsiness and dizziness have been reported very rarely.
If any of these symptoms occur, do not drive, operate machinery, or participate in other activities where such symptoms could endanger the patient or others.
Curacne 5 mg contains soya oil
Do not use if hypersensitivity to peanuts or soya has been diagnosed.
Lifestyle advice:

• In case of dry skin or lips, use moisturising creams or ointments and lip balm.
• Avoid using skin-irritating products such as peeling creams throughout the treatment period.
• Avoid excessive sun exposure during treatment, as Curacne 5 mg may increase skin sensitivity.
• If sun exposure cannot be avoided, use sunscreen with a sun protection factor (SPF) of at least 15.
• Do not use UV lamps, sunbathe in tanning beds, or 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 its end, as these may lead to scarring, areas of insufficient or excessive skin pigmentation, or epidermal peeling.
• If dry eye syndrome occurs, discontinue use of contact lenses. Wear glasses instead until the end of therapy.
• Wear sunglasses to protect eyes from excessive sun exposure.
• Exercise caution when operating mechanical equipment and driving at night, as visual disturbances may occur suddenly.
• Muscle and joint pain may occur during treatment with Curacne 5 mg. Strenuous physical exercise should be avoided during this period.

3. How to take Curacne 5 mg

The following are available in the market: Curacne 5 mg, Curacne 10 mg, Curacne 20 mg, Curacne 40 mg.
Dosage
This medicine should always be taken as prescribed by the physician or pharmacist. In case of doubt,
consult your physician 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 body weight to 1 mg/kg body weight per day.
If the patient feels that the effect of Curacne 5 mg is too weak or too strong, they should inform the physician.
The capsules should be taken orally with food, once or twice daily, with a glass of liquid. The capsules should be swallowed whole. Do not chew or suck the capsules.
Patients with severe renal impairment
In patients with severe renal impairment, treatment should be initiated at a lower dose (e.g. 10 mg/day).
Use in children
Isotretinoin is not indicated for the treatment of acne occurring before puberty and is not recommended for use in children under 12 years of age.
Patients with intolerance
In patients experiencing symptoms of severe intolerance to the drug at the recommended dose, treatment may be continued using the highest dose tolerated by the patient.
Treatment with Curacne 5 mg lasts from 16 to 24 weeks. Skin condition may continue to improve for up to 8 weeks after completion of treatment.
Therefore, at least 8 weeks should elapse after the end of treatment before the physician considers initiating another course of treatment, if necessary. Most patients require only a single course of treatment.
Taking more than the recommended dose of Curacne 5 mg
If more than the recommended dose of Curacne 5 mg 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 physician, pharmacist, or the nearest hospital.
Missed dose of Curacne 5 mg
Do not take a double dose to make up for a missed dose. Continue taking the medicine as prescribed.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects often resolve during treatment, after a dose adjustment or discontinuation of treatment
(this should be discussed with your doctor), although some of them may persist even after treatment
has ended. If they occur, inform your treating physician, who will make an appropriate decision.
Some adverse effects may be severe

• Psychiatric disorders

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

• Depression or related disorders. Symptoms include sadness, mood changes, anxiety, and feelings of emotional discomfort.
• Worsening of existing depression.
• Tendency towards violence or aggression.

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

• Some individuals have experienced thoughts or images related to self-harm or suicide (suicidal thoughts), attempted suicide, or completed suicide. These individuals may not show symptoms of depression.
• Unusual behaviour.
• Psychotic symptoms: loss of contact with reality, e.g. the patient hears voices or sees things that do not exist in reality.

If any of the psychiatric symptoms described above occur, contact your doctor
immediately. Your doctor may recommend discontinuation of Curacne 5 mg.
Stopping the medication may not be sufficient for these effects to resolve; additional help may be
required, which your doctor can provide.

• Rare effects (may affect up to 1 in 1,000 people): sudden, life-threatening allergic reactions (anaphylactic reactions: difficulty breathing or swallowing due to sudden swelling of the throat, face, lips, and mouth, as well as sudden swelling of hands, feet, and ankles). If the patient experiences any allergic reaction, administration of Curacne 5 mg should be discontinued and medical advice sought immediately.

• 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 appear on the chest and back. Other symptoms may also occur, such as eye infection (conjunctivitis) or ulceration of the mouth, throat, or nose. Severe forms of skin lesions may progress to extensive skin peeling, which may be life-threatening. Severe skin reactions are often preceded by headache, fever, and body aches (flu-like symptoms).

If a severe rash or such skin symptoms appear, stop taking Curacne 5 mg immediately and contact your doctor.
All other adverse effects are grouped below according to their frequency of occurrence.
Very common: affecting more than 1 in 10 people

• Anaemia, thrombocytopenia, thrombocytosis.
• Increased ESR (marker of acute inflammation).
• Increased triglyceride levels, decreased levels of high-density lipoproteins (HDL).
• Elevated liver enzyme activity (increased aminotransferase activity).
• Your treating physician 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 the nasal mucosa, nosebleeds, nasopharyngitis.

Uncommon: 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, discontinue isotretinoin and contact your doctor as soon as possible.
• Liver disorders (hepatitis), nausea, vomiting, loss of appetite, malaise, fever, itching, jaundice (yellowing of the skin and eyes).
• Kidney disorders: severe fatigue, difficulty urinating, or even inability to urinate, swollen eyelids. If such symptoms occur during isotretinoin treatment, the patient should discontinue treatment and contact their doctor.
• Elevated blood glucose levels (indicative of diabetes), accompanied by symptoms such as increased thirst, increased urination, increased appetite with simultaneous weight loss, fatigue, dizziness, weakness, low mood, irritability, and general exhaustion. If these symptoms occur, contact your doctor.
• Benign intracranial hypertension in patients who are simultaneously taking isotretinoin and certain antibiotics (tetracyclines). This condition is characterised by chronic headaches associated with nausea, vomiting, or visual disturbances (possibly due to optic nerve swelling (papilloedema)). In such cases, discontinue Curacne 5 mg and contact your doctor as soon as possible.
• Seizures.
• Vascular narrowing or blockage.
• Worsening of acne symptoms during the first few weeks of treatment, manifesting as inflammatory skin lesions.
• Severe forms of acne (fulminant acne): sudden development of inflammatory, ulcerative, necrotic, and haemorrhagic lesions on the face and/or trunk, with or without fever and joint pain. In such cases, discontinue isotretinoin and contact your doctor immediately.
• Colitis.
• Localised bacterial infections.
• Facial erythema, skin rash.
• Changes in hair, increased body hair, nail dystrophy, bacterial infections of the skin around the nails.
• Thickening of surgical scars.
• Damage to skin and mucosal blood vessels.
• Increased sensitivity to sunlight (photosensitivity reactions, see section 2, "Advice on daily living").
• Increased skin pigmentation, increased sweating.
• Enlarged lymph nodes.
• High levels of uric acid in the blood, which may lead to gout.
• The medicine may cause worsening of night vision and blurred vision, which may occur suddenly. These disturbances may persist even after treatment ends.
• Colour blindness, severe eye irritation, corneal clouding, keratitis, blurred vision, cataracts, increased light sensitivity, visual disturbances, intolerance to contact lenses. In such cases, patients 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 tightness in the chest with shortness of breath and wheezing (bronchospasm), especially if the patient suffers from asthma, voice changes (hoarseness).
• Dryness of the throat, nausea.
• Malaise.
• Excessive tissue formation during wound healing (increased granulation tissue).
• Changes mainly affecting joints with accompanying pain and swelling, bone abnormalities (delayed growth, additional growth, and reduced bone density), calcium deposits in soft tissues, tendonitis.
• Activity of certain liver enzymes (creatine kinase), which are released during muscle fibre breakdown, may increase in patients undergoing isotretinoin treatment who perform intense physical exercise, leading to abnormal muscle breakdown, which may impair kidney function.
• Drowsiness, dizziness.

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

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

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

5. How to store Curacne 5 mg

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging.
Keep the container tightly closed to protect from light.
After completion of treatment, return any unused capsules to the pharmacy.
Medicines should 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 packaging and other information

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

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

For more detailed information about this medicine, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation 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
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing authorisation number in France, the country of export: 34009 358 125 6 8
Parallel import authorisation number: 423/24

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

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

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

For women of childbearing potential:

• Prior to prescription, the patient must provide consent to treatment and receive information on contraception.

• The treatment duration based on 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 mandatory information. Required elements:

  Starting treatment (first prescription):

  • Patient's consent to treatment (signed form) and provision of contraceptive information.
  • Use of at least one effective method of contraception 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).

  Continuation of treatment (subsequent prescriptions):

  • Ongoing use of effective contraception.
  • Assessment of the patient's understanding of the ongoing treatment.
  • Confirmation of the date of the last pregnancy test (serum hCG).

Detailed and up-to-date information on this medicine is available by scanning with a smartphone the QR code located on the package leaflet. The same information is also available at the website: http://inpharm.pl/do_pobrania/Retinoidy-karta-przypominajaca.doc.
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