Curacne 5 mg: detailed information

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Curacne 5 mg (ISOACNÉ 5 mg)
soft capsules
Isotretinoinum
Curacne 5 mg and ISOACNÉ 5 mg are different trade names for the same medicine.
WARNING
CAN CAUSE SEVERE HARM TO THE UNBORN CHILD.
Women must use effective contraceptive methods.
Do not use during pregnancy or if pregnancy is suspected.
Please read the entire leaflet carefully before using 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 give it to others. The medicine may harm someone else, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is Curacne 5 mg and what is it used for
Important information before taking Curacne 5 mg
How to take Curacne 5 mg
Possible side effects
How to store Curacne 5 mg
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 permanent scarring) that 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 forms of 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 being treated concurrently 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 dose of isotretinoin.
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 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 marked increase in liver enzyme activity, the doctor may consider reducing the dose or discontinuing treatment.
If the patient has intestinal disorders.

Treatment with Curacne 5 mg must be stopped immediately and the patient should contact their doctor if:

The patient becomes pregnant during treatment or within one month after stopping treatment.
The following symptoms occur:
- Skin rash which may progress to widespread blistering or peeling of the skin, ulceration of the mouth, throat, nose, genital organs, or conjunctivitis (redness and swelling of the eyes). This may be a severe skin reaction (e.g. erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis), potentially life-threatening. These serious skin reactions are often preceded by headache, fever, and body aches (flu-like symptoms).
- Difficulty breathing, 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 (low mood, tearfulness, self-harming behaviour, feelings of isolation from family or friends).

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

If the patient develops yellowing of the eyes or skin and 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 medicine has a "teratogenic" effect). It may cause serious brain, facial, ear, eye, heart, and gland (thymus and parathyroid) abnormalities in 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 medicine is likely to pass into breast milk and may harm the infant.
Do not take Curacne 5 mg if the patient may become pregnant during treatment.
The patient must not become pregnant for one month after stopping treatment, as the medicine may still be present in the body.

Curacne 5 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 pregnancy.
The patient must discuss contraception (birth control methods) with the 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 request 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). The most appropriate methods for the patient should be discussed with the doctor.
The patient must use a contraceptive method for one month before starting Curacne 5 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 this is unnecessary).

Women must agree to undergo pregnancy testing before, during, and after treatment with Curacne 5 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 5 mg, as the medicine may still be present in the body (unless the doctor decides testing is unnecessary for the individual patient).
The patient must agree to undergo 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 the body.
The treating physician 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-mentioned requirements.

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 treatment with Curacne 5 mg should contact her treating physician. 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 abnormalities.
Advice for all patients

Discuss with the doctor if the patient experiences 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 required.
Isotretinoin may cause dry eyes, corneal clouding, 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 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 consider discontinuing isotretinoin.
In the first weeks of treatment, acne may worsen with inflammatory skin lesions, but this usually resolves 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, 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 treatment. If lipid levels remain high, the doctor may reduce the dose or discontinue isotretinoin. Elevated lipid levels may also respond to dietary management. Very 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 safety and efficacy data 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, as well as any medicines planned for use, including those available without prescription.
Do not take medicines containing vitamin A, tetracycline antibiotics, or use any topical anti-acne products (other retinoids) on the skin while taking Curacne 5 mg.
During isotretinoin treatment, avoid using topical anti-acne products 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.
Daily living advice:

In case of dry skin or lips, use moisturising creams or ointments and lip balm.
Avoid using products that may irritate the skin, such as peeling creams, during the entire 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 use quartz lamps.
Avoid waxing, dermabrasion (a procedure where the epidermis is removed to eliminate scars), and laser treatments during treatment and for 6 months after its completion, 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 therapy ends.
Wear sunglasses to protect eyes from excessive sun exposure.
Exercise caution when operating mechanical equipment or driving at night, as visual disturbances may occur suddenly.
Muscle and joint pain may occur during treatment with Curacne 5 mg. During this period, strenuous physical exercise should be avoided.

3. How to take Curacne 5 mg

Dosage
This medicine should always be used according to the recommendations of your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Treatment with isotretinoin should be initiated at a dose of 0.5 mg/kg body weight per day. In 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, this should be reported to the doctor.
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, treatment may be continued using the highest dose tolerated by the patient.

Curacne 5 mg treatment course 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 doctor can initiate another treatment course, 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 your doctor, 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 regarding the use of this medicine, consult your doctor 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 changing the dose or stopping treatment
(this should be discussed with a doctor), although some may persist even after treatment has been discontinued.
If they occur, the treating physician should be informed, who will make an appropriate decision.
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 existing depression.
Tendency towards violence or aggression.

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

Some individuals have had thoughts or mental images of self-harm or suicide (suicidal thoughts), attempted suicide, or died by 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 a doctor immediately.
The doctor may recommend discontinuation of Curacne 5 mg.
Stopping the medication may not be sufficient for these symptoms to resolve; additional help 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 the patient experiences any allergic reaction, administration of Curacne 5 mg should be stopped immediately and a doctor should be contacted.
Frequency unknown (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 ulcers in the mouth, throat, or nose. Severe forms of skin lesions 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 severe rash or such skin symptoms appear, administration of Curacne 5 mg should be stopped immediately and a doctor should be contacted.
All other adverse reactions 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).
As appropriate, 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, localised skin peeling, itching, red skin eruptions, skin fragility (injuries due to friction).
Blepharitis, conjunctivitis with purulent discharge and itching, eye irritation, 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 ends.

Common: affecting less than 1 in 10 people

Increased blood glucose and cholesterol levels, haematuria, proteinuria.
Decreased number of white blood cells in the blood, leading to increased susceptibility to infections.
Headache.
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, treatment with isotretinoin should be stopped and a doctor contacted 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 stop treatment and contact a doctor.
Increased blood glucose levels (indicating 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 such symptoms occur, contact a doctor.
Benign intracranial hypertension in patients who are simultaneously taking isotretinoin and certain antibiotics (tetracyclines). This hypertension is associated with chronic headaches accompanied by nausea, vomiting, or visual disturbances (possibly due to optic nerve swelling (papilloedema)). In such cases, administration of Curacne 5 mg should be stopped and a doctor contacted as soon as possible.
Seizures.
Narrowing or blockage of blood vessels.
Worsening of acne symptoms during the first few weeks of treatment, manifested by 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, isotretinoin treatment should be stopped and a doctor contacted 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 "Advice on daily life", point 2).
Increased skin pigmentation, increased sweating.
Enlarged lymph nodes.
High levels of uric acid in the blood, which may cause gout.
The medicine may cause sudden worsening of night vision 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 tightness in the chest 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, additional bone 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 unknown (frequency cannot be estimated from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions 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 reactions helps to gather more information on the safety of the 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 stated month.
Do not store above 25°C. Store in the original packaging.
Keep the container tightly closed to protect from light.
After treatment ends, return any remaining capsules to a pharmacy.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Curacne 5 mg contains
The active substance is isotretinoin.
Each soft capsule contains 5 mg of isotretinoin.
Other ingredients are: highly refined soybean oil (see section 2), yellow wax, hydrogenated vegetable oil,
and the following components of the capsule shell: gelatin, glycerol, purified water, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171) 50% in glycerol.
Ink composition: SDA alcohol 35, 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, 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 Spain, the country of export:
PIERRE FABRE IBÉRICA, S.A.
C/ Ramón Trias Fargas, 7-11
08005 Barcelona, Spain

Manufacturer:
CATALENT FRANCE BEINHEIM SA
74, rue Principale
F-67930 Beinheim, France
CATALENT GERMANY SCHORNDORF GmbH
Steinbeisstrasse 1 and 2
Schorndorf, Baden-Wuerttemberg
73614, Germany
CATALENT GERMANY EBERBACH GmbH
Gammelsbacher Str. 2
Eberbach, Baden-Wuerttemberg
69412, Germany

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

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

Marketing Authorisation Number in Spain, the country of export: 653587.5
Parallel Import Licence Number: 335/24

This medicinal product is authorised for marketing in the Member States of the European Economic Area under the following trade names:
Czech Republic, France, Poland: CURACNE 5 mg
Spain: ISOACNÉ 5 mg
Belgium: ISOCURAL
Italy: ISORIAC

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

For women of childbearing potential:

Prior to prescribing, it is mandatory to obtain the patient’s consent to treatment and to provide information regarding contraception;
The duration of treatment based on a prescription is limited to 30 days. Any extension of treatment requires a new prescription;
The medicine may only be dispensed if all required information is present on the prescription. Mandatory requirements:
- Initiation of treatment (first prescription):
  - Confirmation that treatment has been initiated (first prescription issued).
  - 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 planned treatment.
  - Scheduling of a pregnancy test (serum hCG).
- Continuation of treatment (subsequent prescriptions):
  - Ongoing implementation of an effective contraception programme.
  - 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 with a smartphone the QR code located on the package leaflet. The same information is also available at the following website: http://inpharm.pl/do_pobrania/Retinoidy-karta-przypominajaca.doc.
QR Code