Background pattern

Curacne 5 mg

About the medicine

How to use Curacne 5 mg

Patient Information Leaflet: User Information

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

Curacne 5 mg

Soft capsules
Isotretinoin

WARNING

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

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient

  • You should keep this leaflet so that you can read it again if you need to.
  • If you have any doubts, you should consult your doctor or pharmacist.
  • This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
  • If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

  • 1. What is Curacne 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 permanent scarring), resistant to properly conducted standard treatment with systemic antibacterial drugs and topical treatments (cream, gel, ointment, solution).
Treatment with Curacne 5 mg should be carried out under the supervision of a doctor with experience in the treatment of severe forms of acne with retinoids and monitoring of the patient during treatment.
Curacne is not indicated for the treatment of acne that occurs before puberty and is not recommended for use in children under 12 years of age.

2. Important information before taking Curacne 5 mg

When not to take 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 specified 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 lipid levels (cholesterol, triglycerides) in the blood.
  • If the patient is being treated with antibiotics from the tetracycline group.
  • If the patient is taking vitamin A or other retinoids (acitretin, alitretinoin).

Warnings and precautions

Before starting treatment with Curacne 5 mg, you should discuss the following with your doctor:

  • If you have 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 your mood.
  • If you have kidney problems. In this case, your doctor should adjust the dose of isotretinoin.
  • If you are overweight, have diabetes, high cholesterol or triglyceride levels in the blood, and consume large amounts of alcohol. In all these cases, lipid and glucose levels in the blood must be regularly monitored. If this situation applies to you, your doctor will order more frequent blood tests. Patients with diabetes should strictly control their blood glucose levels during treatment. Increased fasting blood sugar levels have been reported, as well as new cases of diabetes diagnosed during isotretinoin treatment.
  • If you have liver problems. Curacne 5 mg may increase liver enzyme activity (aminotransferases). To check liver function (liver enzyme activity), your doctor will order regular blood tests before and during treatment. Cases of transient and reversible increased liver enzyme activity have been reported. In the event of persistent significant increased liver enzyme activity, your doctor may consider reducing the dose or discontinuing treatment.
  • If you have had intestinal disorders.

You must stop treatment with Curacne 5 mg and contact your doctor immediately:

  • If you become pregnant during treatment or within a month after treatment.
  • If you experience the following symptoms:
  • rash that may progress to widespread blistering or peeling of the skin, or ulcers of the mouth, throat, nose, genitals, and conjunctivitis (redness and swelling of the eyes). This may be a severe skin reaction (e.g., erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), potentially life-threatening. These severe skin reactions are often preceded by headache, fever, and flu-like symptoms.
  • difficulty breathing, 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 (bad mood, tearfulness, desire for self-harm, feeling of alienation from family or friends).

You may not notice certain changes in your mood and behavior, so it is very important to tell your friends and family members that you are taking this medicine. They may notice such changes and help you quickly identify problems that need to be discussed with your doctor.

  • If you experience 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

Women who are pregnant 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 may 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.
  • You must not become pregnant for a month after stopping treatment because the medicine may still be present in your body.

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

The following conditions must be met:

  • Your doctor must explain the risk of harm to the unborn child (birth defects); you must understand why you must not become pregnant and how to prevent it.
  • You must discuss contraception with your doctor. Your doctor will provide you with information about contraception methods. Your doctor may refer you to a specialist for advice on contraception.
  • Before starting treatment, your doctor will ask you to have a pregnancy test. The test must show that you are not pregnant at the start of treatment with Curacne 5 mg.

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

  • You must agree to use at least one highly effective method of contraception (e.g., an intrauterine device or contraceptive implant), or two effective methods that work in different ways (e.g., oral hormonal contraceptives and condoms). You should discuss with your doctor which methods are most suitable for you.
  • You must use a contraceptive method for a month before taking Curacne 5 mg, during treatment, and for a month after stopping treatment.
  • You must use contraception even if you do not menstruate or are not currently sexually active (unless your doctor decides it is not necessary).

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

  • You must agree to have regular check-ups with your doctor, ideally every month.
  • You must agree to have regular pregnancy tests: before starting treatment, ideally every month during treatment, and a month after stopping treatment with Curacne 5 mg, because the medicine may still be present in your body (unless your doctor decides it is not necessary for you).
  • You must agree to have additional pregnancy tests as advised by your doctor.
  • You must not become pregnant during and for a month after stopping treatment, because the medicine may still be present in your body.
  • Your doctor will discuss all these issues with you, using a checklist, and ask you (or your parent or legal guardian) to sign it. This form confirms that you have been informed of the risks and agree to follow the above rules.

If you become pregnant while taking Curacne 5 mg, you muststop taking the medicine immediately and contact your doctor. Your doctor may refer you to a specialist for advice.
Additionally, if you become pregnant within a month after stopping treatment with Curacne 5 mg, you should contact your doctor. Your doctor may refer you 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, you should never share this medicinal product with anyone else, especially women.

Additional precautions

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

You must not donate blood while taking this medicine or for a month after stopping Curacne 5 mg. If your 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

  • You should discuss with your doctor if you experience persistent back pain or pain in the buttocks during treatment. These symptoms may indicate sacroiliitis, a type of inflammatory back pain. Your doctor may stop treatment with Curacne 5 mg and refer you to a specialist for treatment of back pain. Further evaluation, including imaging studies, 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. You should inform your doctor if you experience any of these symptoms. Your doctor may recommend using moisturizing eye ointments or tear substitutes. If you experience intolerance to contact lenses, your doctor may advise you to wear glasses during treatment. If you experience vision problems, your doctor may refer you 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 for the treatment of disorders of keratinization (keratin accumulation), there have been reports of bone abnormalities (including delayed growth, extra growth, and decreased bone density) and calcifications in tendons and ligaments. Both the doses and duration of treatment, as well as the cumulative dose, were generally much higher than those recommended for the treatment of acne.
  • Isotretinoin may cause an increase in blood lipid levels, such as triglycerides. Your doctor will order blood tests to check these values before, during, and after treatment with isotretinoin. If your lipid levels in the blood remain high, your doctor may reduce the dose or stop 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 in prepubertal acne.

Curacne 5 mg and other medicines

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

While taking Curacne 5 mg, do not take medicines containing

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

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

During treatment, impaired night vision may occur, which may persist after treatment is stopped. Be careful when driving or operating machinery, as vision disturbances may occur suddenly. Rarely, drowsiness and dizziness have been reported.
In case of these symptoms, do not drive, operate machinery, or engage in other activities that may put you 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 balm.
  • 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 you cannot avoid sun exposure, use sunscreens with a sun protection factor (SPF) of at least 15.
  • Do not use UV lamps, sunbeds, or quartz lamps.
  • During treatment and for 6 months after stopping treatment, avoid wax epilation, dermabrasion (a procedure that removes the skin to eliminate scars), and laser treatment, as this may cause scarring, areas of insufficient or excessive skin pigmentation, and skin exfoliation.
  • If you experience dry eye syndrome, stop using contact lenses. Instead, wear glasses until the end of therapy.
  • Wear sunglasses to protect your eyes from excessive sunlight.
  • Be careful when operating mechanical devices and driving at night, as vision disturbances may occur suddenly.
  • During treatment with Curacne 5 mg, muscle and joint pain may occur. During this period, avoid strenuous physical exercise.

3. How to take Curacne 5 mg

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, you should tell your doctor.
The capsules should be taken orally with food, once or twice a day, with a glass of liquid. The capsules should be swallowed whole. Do not chew or suck the capsules.

Patients with severe renal impairment

In patients with severe renal impairment, treatment should be started with 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 with 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 time of stopping treatment before your doctor can consider another course of treatment. In most patients, only one course of treatment is needed.

Taking a higher dose of Curacne 5 mg than recommended

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

In this situation, you should immediately contact your doctor, pharmacist, or the nearest

hospital.

Missing a dose of Curacne 5 mg

Do not take a double dose to make up for a missed dose. Continue to take the medicine as prescribed.
If you have any further doubts about taking the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Curacne 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 (you should discuss this with your doctor), although some of them may persist even after treatment is stopped. If they occur, you should inform your doctor, who will take appropriate action.

Some side effects may be serious

  • Psychiatric disorders

Rare side effects(may affect up to 1 in 100 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 necessarily 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.

In case of the above-mentioned psychiatric disorders, you should

immediately contact your doctor. Your 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 your doctor can provide it.

  • Rare side effects(may affect up to 1 in 1000 people): life-threatening allergic reactions (anaphylactic reactions: difficulty breathing or swallowing due to sudden swelling of the throat, face, lips, and mouth, as well as sudden swelling of the hands, feet, and ankles). If you experience any allergic reaction, you should stop taking Curacne 5 mg and contact your doctor.
  • Frequency not known(frequency cannot be estimated from the available data): severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis), which can be life-threatening and require immediate medical attention. The first symptoms include round spots, often with centrally located blisters, usually on the hands and feet or arms and legs. In more severe cases, blisters may occur on the chest and back. Other symptoms may also occur, such as eye infections (conjunctivitis) or ulcers of the mouth, throat, or nose. Severe skin reactions may progress to widespread peeling of the skin, which can be life-threatening. Severe skin reactions are often preceded by headache, fever, and flu-like symptoms.

In case of severe rash or such skin symptoms, you should stop taking Curacne 5 mg immediately and contact your doctor.

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

Very common: affecting more than 1 in 10 people

  • Anemia, thrombocytopenia, thrombocytosis.
  • Increased ESR (a marker of acute inflammation).
  • Increased triglyceride levels, decreased HDL (high-density lipoprotein) levels.
  • Increased liver enzyme activity (aminotransferase levels).
  • As appropriate, your doctor may order blood tests or other necessary tests.
  • Red ulcers or deep cracks in the corners of the mouth and lips, conjunctivitis, dry skin, local peeling of the skin, itching, red skin rashes, skin fragility (injuries due to friction).
  • Conjunctivitis with purulent discharge and itching, eye irritation, and dry eyes.
  • Back pain (especially in adolescents), muscle and joint pain. Therefore, you should limit intense physical exercise 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 affects the increased susceptibility of patients to infections.
  • Headaches.
  • 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. In case of severe abdominal pain with or without bloody diarrhea, nausea, and vomiting, you should stop taking isotretinoin and contact your 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 you experience such symptoms during treatment with isotretinoin, you should stop treatment and contact your doctor.
  • Increased blood sugar levels (indicating diabetes) with symptoms such as increased thirst, increased urination, increased appetite with weight loss, feeling of tiredness, dizziness, weakness, decreased mood, irritability, general feeling of being unwell. If you experience these symptoms, you should contact your doctor.
  • Hypertension in the brain in patients who are also taking isotretinoin and certain antibiotics (tetracyclines). This hypertension is accompanied by chronic headaches with nausea, vomiting, or vision disturbances (possibly due to optic nerve swelling). You should stop taking Curacne 5 mg and contact your 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 skin lesions.
  • Severe forms of acne (acne fulminans): sudden development of inflammatory, ulcerative, necrotic, and hemorrhagic lesions on the face and/or trunk, with or without fever and joint pain. In such a case, you should stop taking isotretinoin and contact your doctor 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 (phototoxicity 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 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, you should wear sunglasses to protect your eyes from glare. If you experience such symptoms during treatment, you should contact your doctor immediately.
  • Hearing impairment.
  • Sudden chest tightness with shortness of breath and wheezing (bronchospasm), especially if you have asthma, voice changes (hoarseness).
  • Feeling of dryness in the throat, nausea.
  • General feeling of being unwell.
  • Excessive tissue formation during wound healing (increased granulation tissue formation).
  • Changes mainly affecting the joints with accompanying pain and swelling, bone abnormalities (delayed growth, extra growth, and decreased bone density), calcifications in soft tissues, tendonitis.
  • Activity of some liver enzymes (creatine kinase), which are released during muscle fiber breakdown, may increase in patients taking isotretinoin who perform intense physical exercise, muscle breakdown, which can lead to kidney function disorders.

fizycznych przez pacjentów leczonych izotretynoiną, nieprawidłowy rozpad mięśni, które mogą
prowadzić do zaburzeń czynności nerek.

  • 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, occurring in men.
  • Vaginal dryness.
  • Sacroiliitis, a type of inflammatory back pain, causing pain in the lower back or buttocks.
  • Urethritis.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 this 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 stated.
Do not store above 25°C. Store in the original packaging.
Keep the packaging tightly closed to protect from light.

After stopping treatment, return all remaining capsules to the pharmacy.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines 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.
1 soft capsule contains 5 mg of isotretinoin.
The other ingredients are purified soybean oil (see section 2), yellow wax, hydrogenated vegetable oil, and the capsule shell contains: gelatin, glycerol, purified water, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171) 50% in glycerol.
The ink ingredients are: 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 this medicine, you should consult the marketing authorization holder or the parallel importer.

Marketing authorization 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

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Spanish authorization number:653587.5

Parallel import authorization number: 335/24

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:

Prescription-only medicine 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 may only be dispensed if the prescription contains all the required information. Mandatory requirements:
  • Start of treatment (first prescription).
  • Obtaining the patient's consent to undergo treatment and providing information on contraception.
  • Use of at least one effective method of contraception for at least a 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 the 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 approval of the leaflet: 02.09.2024

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.
QR code
[Information about the trademark]

  • Country of registration
  • Active substance
  • Prescription required
    Yes
  • Marketing authorisation holder (MAH)
    Pierre Fabre Iberica, S.A.

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  • Headaches, migraines, and minor injuries.
  • Wound care, health check-ups, and ongoing prescriptions.

With a patient-focused and evidence-based approach, Dr. Ben Ami supports individuals at all stages of life — offering clear medical guidance, timely interventions, and continuity of care.

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5.0(4)
Doctor

Salome Akhvlediani

Pediatrics11 years of experience

Dr Salome Akhvlediani is a paediatrician providing online consultations for children of all ages. She supports families with preventive care, diagnosis, and long-term management of both acute and chronic conditions.

Her areas of focus include:

  • Fever, infections, cough, sore throat, and digestive issues.
  • Preventive care – vaccinations, regular check-ups, and health monitoring.
  • Allergies, asthma, and skin conditions.
  • Nutritional advice and healthy development support.
  • Sleep difficulties, fatigue, and behavioural concerns.
  • Ongoing care for chronic or complex health conditions.
  • Guidance for parents and follow-up after medical treatment.

Dr Akhvlediani combines professional care with a warm, attentive approach – helping children stay healthy and supporting parents at every stage of their child’s growth.

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