Curacne 10 mg

Warning! Keep the package leaflet! Information on the immediate packaging in a foreign language.
Curacne 10 mg (CURACNÉ 10 mg)
soft capsules
Isotretinoin
Curacne 10 mg and CURACNÉ 10 mg are different trade names of the same medicinal product.
WARNING
CAN CAUSE SEVERE HARM TO THE UNBORN CHILD.
Women must use effective methods of 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Curacne 10 mg is and what it is used for
2. Important information before taking Curacne 10 mg
3. How to take Curacne 10 mg
4. Possible side effects
5. How to store Curacne 10 mg
6. Contents of the pack and other information

1. What Curacne 10 mg is and what it is used for

Curacne 10 mg contains the active substance isotretinoin. Isotretinoin belongs to a group of medicines called retinoids.
Curacne 10 mg is indicated for the treatment of severe forms of acne (such as nodular acne, conglobate acne, or acne with risk of permanent scarring) that have not responded to appropriate standard therapy with systemic antibacterial agents and topical treatments (cream, gel, ointment, lotion).
Treatment with Curacne 10 mg must be supervised by a physician experienced in the treatment of severe acne with retinoids and in monitoring patients during therapy.
Curacne 10 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 10 mg

When not to use Curacne 10 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 (excess vitamin A in the blood).
• If the patient has elevated levels of lipids (cholesterol, triglycerides) in the blood.
• If the patient is being treated concurrently with tetracycline antibiotics.
• If the patient is taking vitamin A or other retinoids (acitretin, alitretinoin).

Warnings and precautions
Before starting Curacne 10 mg, discuss the following with your doctor:

• If the patient has ever experienced mental health problems, including depression, anxiety, aggressive tendencies or mood swings, or thoughts of self-harm or suicide. This is because Curacne 10 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 10 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 marked increase in liver enzyme activity, the doctor may consider reducing the dose or discontinuing treatment.
• If the patient has gastrointestinal disorders.

Treatment with Curacne 10 mg must be stopped immediately and the doctor contacted if:

• The patient becomes pregnant during treatment or within one month after its completion.
• The following symptoms occur:
  • Rash, which may progress to extensive blistering or skin peeling, or ulceration of the mouth, throat, nose, genital organs, and conjunctivitis (redness and swelling of the eyes). This 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 accompanied by 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 (low mood, tearfulness, self-harm, feeling detached from family or friends).

The patient may not notice certain changes in mood and behaviour, so it is very important
to inform friends and family members about taking this medicine. These individuals may
notice such changes and help the patient quickly identify problems requiring discussion
with the doctor.

• If the patient develops yellowing of the eyes or skin and experiences dizziness.

Special warning for women taking Curacne 10 mg:
Pregnancy and breastfeeding, Important
Pregnancy Prevention Programme
Women who are pregnant must not take Curacne 10 mg
This medicine can severely harm the unborn child (it has a "teratogenic" effect). It may
cause severe brain, facial, ear, eye, heart, and glandular (thymus and parathyroid)
abnormalities in the foetus. It also increases the risk of miscarriage. These effects may
occur even if Curacne 10 mg is taken for only a short period during pregnancy.

• Do not take Curacne 10 mg if the patient is pregnant or suspects she may be pregnant.
• Do not take Curacne 10 mg during breastfeeding. The medicine is likely to pass into breast milk and may harm the infant.
• Do not take Curacne 10 mg if the patient could become pregnant during treatment.
• The patient must not become pregnant for one month after stopping treatment, as the medicine may still be present in her body.

Curacne 10 mg may be prescribed to women of childbearing potential only if strict adherence
to specific requirements is ensured. This is due to the risk of severe birth defects in the unborn child.
The following conditions must be met:

• The doctor must explain to the patient the risk of harm to the unborn child (birth defects); the patient must understand why she must not become pregnant and how to prevent it.
• The patient must discuss contraception (birth control methods) with the doctor. The doctor will provide information on contraceptive methods. The doctor may refer the patient to a specialist for contraceptive advice.
• Before starting treatment, the doctor will request a pregnancy test. The test must confirm that the patient is not pregnant at the start of treatment with Curacne 10 mg.

Patients must use effective contraceptive methods before, during, and after treatment
with Curacne 10 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.
• The patient must use a contraceptive method for one month before starting Curacne 10 mg, during 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 it is unnecessary).

Patients must agree to undergo pregnancy tests before, during, and after treatment
with Curacne 10 mg.

• The patient must agree to attend regular follow-up visits with the doctor, ideally monthly.
• The patient must agree to undergo regular pregnancy tests: before starting treatment, ideally monthly during treatment, and one month after stopping Curacne 10 mg, as the medicine may still be present in the patient's body (unless the doctor decides it is unnecessary for a particular patient).
• The patient must agree to additional pregnancy tests as recommended by the treating physician.
• The patient must not become pregnant during or within one month after stopping treatment, as the medicine may still be present in her body.
• The treating doctor will discuss all issues with the patient using a checklist and will ask the patient (or her parent or legal guardian) to sign it. This form confirms that the patient has been informed of the risks and agrees to follow the above requirements.

If the patient becomes pregnant while taking Curacne 10 mg, she must
immediately stop taking the medicine and contact her doctor. The doctor may
refer the patient to a specialist for advice.
Additionally, a patient who becomes pregnant within one month after stopping Curacne 10 mg
should contact her treating doctor. The doctor may refer her to a specialist for advice.
Advice for men
The concentration of oral retinoids in the semen of men taking Curacne 10 mg is too
low to harm their partner's unborn child. However, this medicine must never be shared
with anyone else, especially women.
Additional precautions
Never pass this medicine on to another person. All unused capsules must be
returned to the pharmacist after treatment is completed.
Do not donate blood while taking this medicine or within one month after
stopping Curacne 10 mg. If a pregnant woman receives the patient's blood,
she may give birth to a child with congenital abnormalities.
Advice for all patients

• Discuss with the doctor if persistent lower back or buttock pain occurs during treatment with Curacne 10 mg. These symptoms may indicate sacroiliitis, a type of inflammatory back pain. The doctor may discontinue Curacne 10 mg and refer the patient to

a specialist for treatment of inflammatory back pain. Further evaluation, including imaging such as magnetic resonance imaging (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 dry eye that did not resolve after treatment ended have been reported. Inform the 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 recommend wearing glasses during treatment. If visual problems occur, the doctor may refer the patient to a specialist for advice and may recommend discontinuing isotretinoin.
• In the first weeks of treatment, acne may worsen with inflammatory skin lesions, but this usually improves during continued treatment within 7–10 days and generally does not require dose adjustment.
• After several years of using isotretinoin at very high doses for keratinization disorders (keratin accumulation), bone abnormalities (including delayed growth, increased bone growth, and reduced bone density) and calcium deposits in tendons and ligaments have been observed. In these cases, both the doses and duration of treatment, as well as cumulative dose, generally far exceeded those recommended for acne treatment.
• Isotretinoin may increase blood levels of lipids such as triglycerides. The doctor will order tests to monitor these values before, during, and after isotretinoin treatment. If lipid levels remain high, the doctor may reduce the dose or discontinue isotretinoin. Dietary measures may also help manage elevated lipid levels. High lipid levels are sometimes associated with pancreatitis, which can be life-threatening.

Children
Do not give Curacne 10 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 10 mg and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any
medicines the patient plans to take, including those available without a prescription.
Do not take medicines containing vitamin A, tetracycline antibiotics,
or apply any topical anti-acne products (other retinoids) while using Curacne 10 mg.
During isotretinoin treatment, avoid using topical anti-acne keratolytic or exfoliating agents, as local irritation may occur.
Effect on fertility, pregnancy, and lactation
Further 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 and operating machinery.
Drowsiness and dizziness have been reported very rarely.
If any of these symptoms occur, do not drive, operate machinery, or engage in other activities where such symptoms could endanger the patient or others.
Curacne 10 mg contains soya oil
Do not use if hypersensitivity to peanuts or soya has been diagnosed.
Daily life advice:

• In case of dry skin or lips, use moisturising ointments, creams, and lip balm.
• Avoid using products that may irritate the skin, such as peeling creams, throughout the treatment period.
• Avoid excessive sun exposure during treatment, as Curacne 10 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, sunbathe in tanning beds, or use quartz lamps.
• Avoid waxing, dermabrasion (a procedure in which the epidermis is removed to eliminate scars), and laser treatment during treatment and for 6 months after its completion, as these may lead to scarring, areas of inadequate or excessive pigmentation, or epidermal peeling.
• If dry eye syndrome occurs, discontinue use of contact lenses. Wear glasses instead until therapy ends.
• Wear sunglasses to protect the eyes from excessive sun exposure.
• Exercise caution when operating machinery and driving at night, as visual disturbances may occur suddenly.
• Muscle and joint pain may occur during treatment with Curacne 10 mg. During this time, avoid strenuous physical exercise.

3. How to take Curacne 10 mg

Dosage
This medicine should always be used exactly as directed by the physician or pharmacist. In case of doubt,
consult the physician or pharmacist.
The following products are available on the market: Curacne 5 mg, Curacne 10 mg, Curacne 20 mg, Curacne 40 mg.
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 10 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 10 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 10 mg
If more than the recommended dose of Curacne 10 mg is taken, symptoms of hypervitaminosis A may occur,
such as severe headache, nausea or vomiting, drowsiness, irritability, and itching.
In this situation, seek immediate medical advice from a physician, pharmacist, or the nearest hospital.
Missed dose of Curacne 10 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions often resolve during treatment, after a dose adjustment, or upon discontinuation of treatment (this should be discussed with a doctor), although some may persist even after treatment has ended.
If they occur, the treating physician should be informed so appropriate decisions can be made.
Some adverse reactions may be severe

• Psychiatric disorders

Uncommon reactions (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 pre-existing depression.
• Tendency towards violence or aggression.

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

• Some individuals have experienced thoughts or images of self-harm or suicide (suicidal thoughts), attempted suicide, or died by suicide. These individuals may not necessarily 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 above psychiatric symptoms occur, contact a doctor immediately. The doctor may recommend discontinuation of Curacne 10 mg. Stopping the medication may not be sufficient for these symptoms to resolve; additional support may be required, which the doctor can provide.
• Uncommon reactions (may affect up to 1 in 1,000 people): sudden, life-threatening allergic reactions (anaphylactic reactions: difficulty breathing or swallowing due to sudden swelling of the throat, face, lips, and oral cavity, as well as sudden swelling of hands, feet, and ankles). If any allergic reaction occurs, stop taking Curacne 10 mg and contact a doctor.
• 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 the 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 ulcers in the mouth, throat, or nose. Severe forms of skin reactions may progress to widespread skin peeling, which may be life-threatening. Severe skin reactions are often preceded by headache, fever, and body aches (flu-like symptoms).

If a severe rash or such skin symptoms appear, stop taking Curacne 10 mg immediately and contact a doctor.
All other adverse reactions are grouped below according to their frequency of occurrence.
Very common: occurring in 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). Depending on the situation, the treating physician may recommend blood tests or other necessary examinations.
• Red ulcers or deep cracks at the corners of the mouth and lips, skin inflammation, dry skin, local 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: occurring in 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: occurring in less than 1 in 1,000 people

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

Very rare: occurring in 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 a doctor as soon as possible.

• Liver disorders (hepatitis), nausea, vomiting, loss of appetite, malaise, fever, itching, yellowing of the skin and eyes (jaundice).

• Kidney disorders: severe fatigue, difficulty urinating, or even inability to urinate, swollen eyelids. If such symptoms occur during isotretinoin treatment, the patient should stop treatment and contact a doctor.

• Elevated blood glucose levels (indicative of diabetes) with accompanying symptoms such as: increased thirst, increased urination, increased appetite with simultaneous weight loss, fatigue, dizziness, weakness, low mood, irritability, general exhaustion. If these symptoms occur, contact a doctor.

• Benign intracranial hypertension in patients simultaneously taking isotretinoin and certain antibiotics (tetracyclines). This condition is associated with chronic headaches accompanied by nausea, vomiting, or visual disturbances (possibly due to optic nerve swelling (papilloedema)). In such cases, discontinue Curacne 10 mg and contact a 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 a doctor immediately.

• Colitis.

• Local bacterial infections.

• Facial erythema, skin rash.

• Changes in hair, increased body hair, nail dystrophy, bacterial infections of the skin around the nails.

• Thickening of post-surgical scars.

• Damage to skin blood vessels and mucous membranes.

• Increased sensitivity to sunlight (photosensitivity reactions, see "Advice on daily living", point 2).

• Increased skin pigmentation, increased sweating.

• Enlarged lymph nodes.

• High blood uric acid levels, which may lead to gout.

• The medicine may cause sudden night blindness and blurred vision. These disturbances may persist even after treatment has ended.

• Colour blindness, severe eye irritation, corneal clouding, keratitis, blurred vision, cataract, increased light sensitivity, visual disturbances, intolerance to contact lenses. In such cases, the patient should wear sunglasses to protect the eyes from glare. If such symptoms occur during treatment, the patient should contact a doctor immediately.

• Hearing impairment.

• Sudden chest tightness with shortness of breath and wheezing (bronchospasm), especially if the patient has 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, extra growth, and reduced bone density), calcium deposits in soft tissues, tendonitis.

• Increased activity of certain liver enzymes (creatine kinase), which are released during muscle fibre breakdown, especially during intense physical exercise in patients treated with isotretinoin, potentially leading to muscle breakdown and kidney function disorders.

• Drowsiness, dizziness.

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

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

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

5. How to store Curacne 10 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 stated month.
Do not store above 25°C. Store in the original packaging.
Keep the container tightly closed to protect from light.
After completion of treatment, return all unused capsules to a pharmacy.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Curacne 10 mg contains
The active substance is isotretinoin.
Each soft capsule contains 10 mg of isotretinoin.
Other ingredients: purified soybean oil (see section 2), yellow wax, hydrogenated vegetable oil,
and components of the capsule shell: gelatin, glycerol, purified water, iron oxide red (E 172).
Ink composition: SDA 35 alcohol, propylene glycol (E 1520), iron oxide black (E 172),
polyvinyl acetophthalate, water, isopropyl alcohol, polyethylene glycol, ammonium hydroxide.

What Curacne 10 mg looks like and contents of the pack
30 or 60 soft capsules in blisters, packed in a cardboard box.
Each 10 mg soft capsule has a red/brown gelatin shell with a light yellow/orange fill and the imprint “I 10” on one side.

For more detailed information about this medicinal product, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in France, 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, country of export: 34009 358 131 6 9
Parallel Import Licence Number: 59/25

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

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

Prescription status:
Prescription-only medicine requiring strict monitoring during treatment.

For women of childbearing potential:

• Prior to prescription, the patient must give informed consent to treatment and receive information regarding contraception.
• The duration of treatment covered by a single prescription is limited to 30 days. Any extension requires a new prescription.
• The medicine may only be dispensed if the prescription contains all required information.

Starting treatment (first prescription):

• Patient’s informed consent to treatment (signed form) and provision of information on contraception.
• 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 proposed treatment.
• Scheduling of a pregnancy test (serum hCG).

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