Background pattern
Pomalidomide Sandoz

Pomalidomide Sandoz

About the medicine

How to use Pomalidomide Sandoz

Leaflet accompanying the packaging: patient information

Pomalidomide Sandoz, 1 mg, hard capsules

Pomalidomide Sandoz, 2 mg, hard capsules

Pomalidomide Sandoz, 3 mg, hard capsules

Pomalidomide Sandoz, 4 mg, hard capsules

Pomalidomide

It is expected that Pomalidomide Sandoz will cause severe birth defects and may lead to fetal death.

  • The medicine must not be taken if the patient is pregnant or may become pregnant.
  • The patient must follow the advice on contraception given in this leaflet.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

  • The patient should keep the leaflet to be able to read it again if necessary.
  • In case of any doubts, the patient should consult a doctor, pharmacist, or nurse.
  • This medicine has been prescribed to a specific person. It must not be given to others. The medicine may harm another person, even if their symptoms are the same.
  • If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Pomalidomide Sandoz and what is it used for

What is Pomalidomide Sandoz

Pomalidomide Sandoz contains the active substance pomalidomide. This medicine is similar to thalidomide and belongs to a group of medicines that affect the immune system (the body's natural defense).

What is Pomalidomide Sandoz used for

Pomalidomide Sandoz is used to treat adults with a type of blood cancer called multiple myeloma.

Pomalidomide Sandoz is used in combination with:

  • two other medicines, bortezomib (a type of chemotherapy) and dexamethasone (an anti-inflammatory medicine), in patients who have already received at least one other type of treatment containing lenalidomide

or

  • one other medicine, dexamethasone, in patients with multiple myeloma that has worsened despite receiving at least two other types of treatment containing lenalidomide and bortezomib.

What is multiple myeloma

Multiple myeloma is a cancer that affects a type of white blood cell called plasma cells. These cells grow uncontrollably and accumulate in the bone marrow, causing damage to the bones and kidneys.

Multiple myeloma usually cannot be cured. However, treatment can relieve the symptoms of the disease or make them disappear for a while - this is called a "response" to treatment.

How does Pomalidomide Sandoz work

Pomalidomide Sandoz works in several ways:

  • by stopping the growth of myeloma cells
  • by stimulating the immune system to attack cancer cells
  • by preventing the formation of blood vessels that feed cancer cells

Benefits of taking Pomalidomide Sandoz with bortezomib and dexamethasone

Pomalidomide Sandoz taken with bortezomib and dexamethasone in patients who have already received at least one other type of treatment may slow down the progression of multiple myeloma.

  • Pomalidomide taken with bortezomib and dexamethasone usually delayed the progression of multiple myeloma by 11 months - compared to 7 months in patients who took only bortezomib and dexamethasone.

Benefits of taking Pomalidomide Sandoz with dexamethasone

Pomalidomide Sandoz taken with dexamethasone in patients who have already received at least two other types of treatment may slow down the progression of multiple myeloma.

  • Pomalidomide taken with dexamethasone usually delayed the progression of multiple myeloma by 4 months - compared to 2 months in patients who took only dexamethasone.

2. Important information before taking Pomalidomide Sandoz

When not to take Pomalidomide Sandoz:

  • if the patient is pregnant, thinks she may be pregnant, or plans to become pregnant - as it is expected that Pomalidomide Sandoz will harm the fetus (men and women taking this medicine must read the section "Pregnancy, contraception, and breastfeeding - information for men and women" below).
  • if the patient may become pregnant, unless all necessary measures are taken to prevent pregnancy (see the section "Pregnancy, contraception, and breastfeeding - information for men and women"). If the patient may become pregnant, the doctor will ensure that the patient understands the necessary measures to prevent pregnancy and will provide confirmation to the patient.
  • if the patient is allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic, they should consult their doctor for advice.

If the patient is not sure if any of the above situations apply to them, they should consult their doctor, pharmacist, or nurse before taking Pomalidomide Sandoz.

Warnings and precautions

Before taking Pomalidomide Sandoz, the patient should discuss with their doctor, pharmacist, or nurse if:

  • they have ever had blood clots in the past. During treatment with Pomalidomide Sandoz, there is an increased risk of blood clots in the veins and arteries. The doctor may prescribe additional treatment (e.g., warfarin) or reduce the dose of Pomalidomide Sandoz to reduce the risk of blood clots.

2

The patient should emphasize that in patients with multiple myeloma treated with pomalidomide, there may be an increased risk of developing additional types of cancer. Therefore, the treating doctor should carefully assess the benefits and risks of prescribing this medicine to the patient.

At any time during treatment or after treatment has ended, the patient should immediately inform their doctor or nurse if they experience: blurred vision, loss of vision, or double vision, difficulty speaking, weakness in the arms or legs, change in walking or balance problems, persistent numbness, decreased sensation, or loss of sensation, memory loss, or disorientation. All these symptoms may indicate a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If these symptoms occurred before taking Pomalidomide Sandoz, the patient should inform their doctor about any changes in these symptoms.

Pregnancy, contraception, and breastfeeding - information for men and women

While taking Pomalidomide Sandoz, the patient must follow the pregnancy prevention program. Women taking Pomalidomide Sandoz must not become pregnant, and men taking Pomalidomide Sandoz must not father a child, as it is expected that this medicine will harm the fetus. Both the patient and their partner must use effective contraception during treatment with this medicine.

Women

Pomalidomide Sandoz must not be taken if the patient is pregnant, thinks she may be pregnant, or plans to become pregnant, as it is expected that this medicine will harm the fetus. Before starting treatment, the patient must tell her doctor if she may become pregnant, even if she thinks it is unlikely.

If the patient may become pregnant:

  • she must use effective methods of pregnancy prevention for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after treatment ends. The patient should discuss with her doctor which method of pregnancy prevention is best for her.
  • each time the medicine is prescribed, the doctor will ensure that the patient understands the necessary measures to prevent pregnancy
  • the doctor will order pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends.

If the patient becomes pregnant despite using preventive measures:

  • she must stop treatment immediately and inform her doctor immediately.

Breastfeeding

It is not known if Pomalidomide Sandoz passes into human milk. If the patient is breastfeeding or plans to breastfeed, she must tell her doctor. The doctor will advise the patient whether to stop or continue breastfeeding.

Men

Pomalidomide Sandoz passes into human semen.

  • if the patient's partner is pregnant or may become pregnant, the patient must use condoms during the entire treatment period and for 7 days after treatment ends.
  • if the patient's partner becomes pregnant while the patient is taking Pomalidomide Sandoz, the patient must inform their doctor immediately. The partner should also consult a doctor immediately.

The patient must not donate sperm (semen) during treatment and for 7 days after treatment ends.

Blood donation and blood tests

During treatment and for 7 days after treatment ends, the patient must not donate blood.

Before and during treatment with Pomalidomide Sandoz, the patient will have regular blood tests. This is because the medicine may cause a decrease in the number of blood cells that help fight infections (white blood cells) and the number of cells that help prevent bleeding (platelets).

The doctor will order blood tests:

  • before treatment
  • every week during the first 8 weeks of treatment
  • then at least once a month for as long as the patient takes Pomalidomide Sandoz.

The doctor may change the dose of Pomalidomide Sandoz or stop treatment based on the patient's blood test results, their overall health, the use of other medicines (e.g., ciprofloxacin, enoxacin, and fluvoxamine), and if the patient experiences side effects due to treatment (especially rash and swelling).

If the patient has kidney disease and is on dialysis, the doctor will advise on how and when to take Pomalidomide Sandoz.

Children and adolescents

Pomalidomide Sandoz is not recommended for use in children and adolescents under 18 years of age.

Pomalidomide Sandoz and other medicines

The patient must tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, as Pomalidomide Sandoz may affect the way other medicines work. Other medicines may also affect the way Pomalidomide Sandoz works.

Before taking Pomalidomide Sandoz, the patient must inform their doctor, pharmacist, or nurse if they are taking any of the following medicines:

  • certain antifungal medicines, such as ketoconazole
  • certain antibiotics (e.g., ciprofloxacin, enoxacin)
  • certain antidepressant medicines, such as fluvoxamine.

Driving and using machines

While taking Pomalidomide Sandoz, some patients may experience fatigue, dizziness, fainting, disorientation, or decreased alertness. If these symptoms occur, the patient should not drive, use tools, or operate machinery.

Pomalidomide Sandoz contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Pomalidomide Sandoz

Pomalidomide Sandoz must be prescribed by a doctor with experience in treating multiple myeloma.

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should consult their doctor, pharmacist, or nurse.

When to take Pomalidomide Sandoz with other medicines

Pomalidomide Sandoz with bortezomib and dexamethasone

  • The patient should read the leaflets for bortezomib and dexamethasone to get more information about their use and effects.
  • Pomalidomide Sandoz, bortezomib, and dexamethasone are taken in treatment cycles. Each cycle lasts 21 days (3 weeks).
  • The following table shows which medicines to take on which days of the 3-week cycle: find the day and check which medicines to take. On some days, the patient takes all 3 medicines, on some days 2 medicines, and on some days no medicines.

POM: Pomalidomide; BOR: bortezomib; DEX: dexamethasone

Table with cycles 1 to 8 of treatment, with columns Day, POM, BOR, and DEX, containing checkmarks in the corresponding cells
  • After completing each 3-week cycle, the patient starts a new cycle.

Pomalidomide Sandoz only with dexamethasone

  • The patient should read the leaflet for dexamethasone to get more information about its use and effects.
  • Pomalidomide Sandoz and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
  • The following table shows which medicines to take on which days of the 4-week cycle: find the day and check which medicines to take. On some days, the patient takes both medicines, on some days 1 medicine, and on some days no medicine.

POM: Pomalidomide; DEX: dexamethasone

Table with cycles 9 and subsequent treatment, with columns Day, POM, BOR, and DEX, containing checkmarks in the corresponding cells
  • After completing each 4-week cycle, the patient starts a new cycle.

How much Pomalidomide Sandoz to take with other medicines

Pomalidomide Sandoz with bortezomib and dexamethasone

  • The recommended starting dose of Pomalidomide Sandoz is 4 mg per day.
  • The recommended starting dose of bortezomib will be determined by the doctor based on the patient's weight and body surface area (1.3 mg/m2).
  • The recommended starting dose of dexamethasone is 20 mg per day. However, in patients over 75 years of age, the recommended starting dose is 10 mg per day.

Pomalidomide Sandoz only with dexamethasone

  • The recommended dose of Pomalidomide Sandoz is 4 mg per day.
  • The recommended starting dose of dexamethasone is 40 mg per day. However, in patients over 75 years of age, the recommended starting dose is 20 mg per day.

The doctor may reduce the dose of Pomalidomide Sandoz, bortezomib, or dexamethasone, or stop treatment with one or more of these medicines, based on the patient's blood test results, their overall health, the use of other medicines (e.g., ciprofloxacin, enoxacin, and fluvoxamine), and if the patient experiences side effects due to treatment (especially rash and swelling).

If the patient has liver or kidney disease, the doctor will closely monitor the patient's health while taking this medicine.

How to take Pomalidomide Sandoz

  • Do not break, open, or chew the capsules. If the powder from a damaged capsule comes into contact with the skin, wash the skin immediately with soap and water.
  • Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister or capsule. The gloves should be removed carefully to avoid skin exposure, placed in a sealed plastic bag, and disposed of according to local regulations. Then, wash hands thoroughly with soap and water. Pregnant women or those who think they may be pregnant should not touch the blister or capsule. The capsules should be swallowed whole, preferably with water. The capsules can be taken with or without food. Pomalidomide Sandoz should be taken at approximately the same time every day.

To remove a capsule from the blister, press the blister only on one end of the capsule and push it out through the foil. Do not press the blister in the middle of the capsule, as this may damage the capsule.

Sequence of drawings showing a hand removing a capsule from a blister by pressing one end and pushing it out

If the patient has kidney disease and is on dialysis, the doctor will advise on how and when to take Pomalidomide Sandoz.

Duration of treatment with Pomalidomide Sandoz

The patient should continue treatment cycles until the doctor advises to stop treatment.

Taking a higher dose of Pomalidomide Sandoz than recommended

If the patient takes a higher dose of Pomalidomide Sandoz than recommended, they should immediately inform their doctor or go to the hospital. The patient should bring the packaging of the medicine with them.

Missing a dose of Pomalidomide Sandoz

If the patient misses a dose of Pomalidomide Sandoz on the day it is due, they should take the next capsule at the scheduled time the next day. The patient should not take a double dose to make up for the missed capsule of Pomalidomide Sandoz.

If the patient has any further questions about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Pomalidomide Sandoz can cause side effects, although not everybody gets them.

Severe side effects

If the patient experiences any of the following severe side effects, they should stop taking Pomalidomide Sandoz and immediately consult their doctor - they may need urgent treatment:

  • fever, chills, sore throat, cough, mouth ulcers, or any other signs of infection (due to low white blood cell count) bleeding or bruising without cause, including nosebleeds, bleeding from the gut or stomach (due to low platelet count)
  • rapid breathing, rapid heartbeat, fever, and chills, passing very little or no urine, nausea, and vomiting, confusion, loss of consciousness (due to a blood infection called sepsis or septic shock)
  • severe, persistent, or bloody diarrhea (also with abdominal pain or fever) caused by bacteria called Clostridium difficile blood clots in the lungs (pulmonary embolism) or legs and arms (deep vein thrombosis)
  • shortness of breath (due to severe chest infections, pneumonia, heart failure, or blood clots)
  • swelling of the face, lips, tongue, and throat, which may cause difficulty breathing (due to severe allergic reactions called angioedema and anaphylaxis)
  • certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma) that may cause changes in the appearance of the skin or the development of skin growths. If the patient notices any changes in their skin while taking Pomalidomide Sandoz, they should inform their doctor as soon as possible. recurrence of hepatitis B virus infection, which may cause yellowing of the skin and eyes (jaundice), dark urine, abdominal pain on the right side, fever, nausea, and vomiting. The patient should immediately consult their doctor if they notice these symptoms.
  • widespread rash, high body temperature, swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS, or hypersensitivity reaction, toxic epidermal necrolysis, or Stevens-Johnson syndrome). If the patient experiences these symptoms, they should immediately stop taking pomalidomide and consult their doctor or seek immediate medical attention. See also section 2.

If the patient experiences any of the above severe side effects, they should stop taking Pomalidomide Sandoz and immediately consult their doctor- they may need urgent treatment.

Other side effects

Very common(may affect more than 1 in 10 people):

  • shortness of breath (dyspnea)
  • lung infections (pneumonia and bronchitis)
  • infections of the nose, sinuses, and throat caused by bacteria or viruses
  • flu-like symptoms (influenza)
  • decrease in red blood cell count, which may cause fatigue and weakness
  • low potassium levels in the blood (hypokalemia), which may cause weakness, muscle cramps, muscle pain, irregular heartbeat, tingling, or numbness, shortness of breath, mood changes
  • high blood sugar levels
  • irregular heartbeat (atrial fibrillation)
  • loss of appetite
  • constipation, diarrhea, or nausea
  • vomiting
  • abdominal pain
  • fatigue
  • difficulty sleeping or staying asleep
  • dizziness, tremors
  • muscle cramps, muscle weakness
  • bone pain, back pain
  • numbness, tingling, or burning sensation in the skin, pain in the hands or feet (peripheral sensory neuropathy)
  • swelling of the body, including hands and feet
  • rash
  • urinary tract infection, which may cause burning sensation while urinating or frequent urination.

Common(may affect up to 1 in 10 people):

  • falls
  • bleeding in the brain
  • decreased ability to move or feel in the arms, legs, hands, and feet due to nerve damage (peripheral sensory-motor neuropathy)
  • numbness, tingling, and burning sensation in the skin (paresthesia)
  • dizziness, which may cause difficulty maintaining balance
  • swelling caused by fluid accumulation
  • hives
  • itching
  • shingles
  • heart attack (chest pain radiating to the arms, neck, jaw, sweating, shortness of breath, nausea, or vomiting)
  • chest pain, infection in the chest
  • high blood pressure
  • decrease in all blood cell counts (pancytopenia), which may cause increased risk of bleeding and bruising. The patient may feel tired, weak, and short of breath, and be more prone to infections
  • decrease in lymphocyte count (a type of white blood cell), often caused by infection (lymphopenia)
  • low magnesium levels in the blood (hypomagnesemia), which may cause fatigue, general weakness, muscle cramps, irritability, and may lead to low calcium levels in the blood (hypocalcemia), which may cause numbness, tingling, or burning sensation in the hands, feet, or lips, muscle cramps, muscle weakness, dizziness, confusion
  • low phosphate levels in the blood (hypophosphatemia), which may cause muscle weakness and irritability or confusion
  • high calcium levels in the blood (hypercalcemia), which may cause slowed reflexes and muscle weakness
  • high potassium levels in the blood, which may cause irregular heartbeat
  • low sodium levels in the blood, which may cause fatigue, confusion, tremors, seizures (convulsions), or coma
  • high uric acid levels in the blood, which may lead to gout
  • low blood pressure, which may cause dizziness or fainting
  • mouth pain or dry mouth
  • changes in taste
  • swelling of the abdomen
  • confusion
  • depression
  • loss of consciousness, fainting
  • cloudy vision (cataract)
  • kidney damage
  • inability to urinate
  • abnormal liver test results
  • pelvic pain
  • weight loss.

Uncommon(may affect up to 1 in 100 people):

  • stroke
  • liver inflammation, which may cause itching, yellowing of the skin and eyes (jaundice), dark urine, abdominal pain on the right side, and fever
  • breakdown of cancer cells, which may cause the release of toxic substances into the blood (tumor lysis syndrome). This may lead to kidney disease
  • underactive thyroid gland, which may cause fatigue, lethargy, muscle weakness, slow heartbeat, weight gain.

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

  • rejection of a transplanted organ (such as a heart or liver).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via the online reporting system at https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

By reporting side effects, the patient can help provide more information on the safety of this medicine.

5. How to store Pomalidomide Sandoz

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after EXP.

The expiry date refers to the last day of the month stated.

There are no special storage instructions for this medicine.

Do not use this medicine if the patient notices any damage or signs of opening of the packaging.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Pomalidomide Sandoz contains

  • The active substance is pomalidomide.
  • The other ingredients are microcrystalline cellulose (E 460), maltodextrin, and sodium stearyl fumarate

Pomalidomide Sandoz, 1 mg, hard capsule

  • Each capsule contains 1 mg of pomalidomide.
  • The capsule body contains: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and white ink
  • The white ink contains: shellac, titanium dioxide (E 171), propylene glycol

Pomalidomide Sandoz, 2 mg, hard capsule

  • Each capsule contains 2 mg of pomalidomide.
  • The capsule body contains: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and white ink
  • The white ink contains: shellac, titanium dioxide (E 171), propylene glycol

Pomalidomide Sandoz, 3 mg, hard capsule

  • Each capsule contains 3 mg of pomalidomide.
  • The capsule body contains: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), indigo carmine (E 132), and white ink
  • The white ink contains: shellac, titanium dioxide (E 171), propylene glycol

Pomalidomide Sandoz, 4 mg, hard capsule

  • Each capsule contains 4 mg of pomalidomide.
  • The capsule body contains: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), indigo carmine (E 132), erythrosine, and white ink
  • The white ink contains: shellac, titanium dioxide (E 171), propylene glycol

What Pomalidomide Sandoz looks like and contents of the pack

Pomalidomide Sandoz, 1 mg, hard capsules

Yellow and red hard gelatin capsules, with white printing "PLM 1" along the capsule body.

Pomalidomide Sandoz, 2 mg, hard capsules

Orange and red hard gelatin capsules, with white printing "PLM 2" along the capsule body.

Pomalidomide Sandoz, 3 mg, hard capsules

Turquoise and red hard gelatin capsules, with white printing "PLM 3" along the capsule body.

Pomalidomide Sandoz, 4 mg, hard capsules

Dark blue and red hard gelatin capsules, with white printing "PLM 4" along the capsule body.

The hard capsules are packed in blisters or single-dose blisters in a cardboard box.

The pack contains 14, 21, 56, 63, 14x1, or 21x1 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50C

02-672 Warszawa

tel. 22 209 70 00

Manufacturer

Synthon Hispania S.L.

Calle De Castello 1

08830 Sant Boi De Llobregat

Barcelona, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands

Pomalidomide Sandoz 1 mg, hard capsules

Pomalidomide Sandoz 2 mg, hard capsules

Pomalidomide Sandoz 3 mg, hard capsules

Pomalidomide Sandoz 4 mg, hard capsules

Austria

Pomalidomid Sandoz 1 mg - Hartkapseln

Pomalidomid Sandoz 2 mg - Hartkapseln

Pomalidomid Sandoz 3 mg - Hartkapseln

Pomalidomid Sandoz 4 mg - Hartkapseln

Czech Republic

Pomalidomide Sandoz

Cyprus

Pomalidomide/Sandoz

Germany

Pomalidomid HEXAL 1 mg Hartkapseln

Pomalidomid HEXAL 2 mg Hartkapseln

Pomalidomid HEXAL 3 mg Hartkapseln

Pomalidomid HEXAL 4 mg Hartkapseln

Denmark

Pomalidomide Sandoz

Estonia

Pomalidomide Sandoz

Greece

Pomalidomide/Sandoz

Spain

Pomalidomida Sandoz 1 mg cápsulas duras EFG

Pomalidomida Sandoz 2 mg cápsulas duras EFG

Pomalidomida Sandoz 3 mg cápsulas duras EFG

Pomalidomida Sandoz 4 mg cápsulas duras EFG

Finland

Pomalidomide Sandoz 1 mg kapselit, kovat

Pomalidomide Sandoz 2 mg kapselit, kovat

Pomalidomide Sandoz 3 mg kapselit, kovat

Pomalidomide Sandoz 4 mg kapselit, kovat

Synthon B.V.
Microweg 22
6545 CM Nijmegen, Netherlands
Salutas Pharma GmbH Otto-Von-Guericke-Allee 1 39179 Barleben Saxony-Anhalt, Germany

France

POMALIDOMIDE SANDOZ 1 mg, gélule

POMALIDOMIDE SANDOZ 2 mg, gélule

POMALIDOMIDE SANDOZ 3 mg, gélule

POMALIDOMIDE SANDOZ 4 mg, gélule

Hungary

Pomalidomide Sandoz 1 mg kemény kapszula

Pomalidomide Sandoz 2 mg kemény kapszula

Pomalidomide Sandoz 3 mg kemény kapszula

Pomalidomide Sandoz 4 mg kemény kapszula

Iceland

Pomalidomide Sandoz

Ireland

Pomalidomide Rowex 1 mg hard capsules

Pomalidomide Rowex 2 mg hard capsules

Pomalidomide Rowex 3 mg hard capsules

Pomalidomide Rowex 4 mg hard capsules

Italy

Pomalidomide Sandoz

Latvia

Pomalidomide Sandoz 1 mg cietā kapsula

Pomalidomide Sandoz 2 mg cietā kapsula

Pomalidomide Sandoz 3 mg cietā kapsula

Pomalidomide Sandoz 4 mg cietā kapsula

Lithuania

Pomalidomide Sandoz 1 mg kietosios kapsulės

Pomalidomide Sandoz 2 mg kietosios kapsulės

Pomalidomide Sandoz 3 mg kietosios kapsulės

Pomalidomide Sandoz 4 mg kietosios kapsulės

Malta

Pomalidomide Sandoz 1 mg capsule, hard

Pomalidomide Sandoz 2 mg capsule, hard

Pomalidomide Sandoz 3 mg capsule, hard

Pomalidomide Sandoz 4 mg capsule, hard

Norway

Pomalidomide Sandoz

Poland

Pomalidomide Sandoz

Romania

Pomalidomida Sandoz 1 mg, capsule

Pomalidomida Sandoz 2 mg, capsule

Pomalidomida Sandoz 3 mg, capsule

Pomalidomida Sandoz 4 mg, capsule

Slovakia

Pomalidomide Sandoz 1 mg

Pomalidomide Sandoz 2 mg

Pomalidomide Sandoz 3 mg

Pomalidomide Sandoz 4 mg

Slovenia

Pomalidomid Sandoz 1 mg trde kapsule

Pomalidomid Sandoz 2 mg trde kapsule

Pomalidomid Sandoz 3 mg trde kapsule

Pomalidomid Sandoz 4 mg trde kapsule

Sweden

Pomalidomide Sandoz

Date of last revision of the leaflet:06/2025

{logo of the marketing authorization holder}

  • Country of registration
  • Active substance
  • Prescription required
    Yes
  • Importer
    Salutas Pharma GmbH Synthon B.V. Synthon Hispania S.L.

Talk to a doctor online

Need help understanding this medicine or your symptoms? Online doctors can answer your questions and offer guidance.

5.0(21)
Doctor

Ekaterina Agapova

Neurology8 years of experience

Dr. Ekaterina Agapova is a neurologist specialising in the diagnosis and treatment of neurological conditions and chronic pain. She provides online consultations for adults, combining evidence-based medicine with a personalised approach.

She offers expert care for:

  • Headaches and migraines, including tension-type and cluster headaches.
  • Neck and back pain, both acute and chronic.
  • Chronic pain syndromes – fibromyalgia, neuropathic pain, post-traumatic pain.
  • Mononeuropathies – carpal tunnel syndrome, trigeminal neuralgia, facial nerve palsy.
  • Polyneuropathies – diabetic, toxic, and other types.
  • Multiple sclerosis – diagnosis, monitoring, long-term support.
  • Dizziness and coordination disorders.
  • Sleep disturbances – insomnia, daytime sleepiness, fragmented sleep.
  • Anxiety, depression, and stress-related conditions.

Dr. Agapova helps patients manage complex neurological symptoms like pain, numbness, weakness, poor sleep, and emotional distress. Her consultations focus on accurate diagnosis, clear explanation of findings, and tailored treatment plans.

If you’re struggling with chronic pain, migraines, nerve disorders, or sleep problems, Dr. Agapova offers professional guidance to restore your well-being.

CameraBook a video appointment
More times
5.0(37)
Doctor

Yevgen Yakovenko

General surgery11 years of experience

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

CameraBook a video appointment
More times
5.0(12)
Doctor

Jonathan Marshall Ben Ami

Family medicine8 years of experience

Dr. Jonathan Marshall Ben Ami is a licensed family medicine doctor in Spain. He provides comprehensive care for adults and children, combining general medicine with emergency care expertise to address both acute and chronic health concerns.

Dr. Ben Ami offers expert diagnosis, treatment, and follow-up for:

  • Respiratory infections (cold, flu, bronchitis, pneumonia).
  • ENT conditions such as sinusitis, ear infections, and tonsillitis.
  • Digestive issues including gastritis, acid reflux, and irritable bowel syndrome (IBS).
  • Urinary tract infections and other common infections.
  • Management of chronic diseases: high blood pressure, diabetes, thyroid disorders.
  • Acute conditions requiring urgent medical attention.
  • 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.

CameraBook a video appointment
More times
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.

CameraBook a video appointment
More times
View all doctors

Get updates and exclusive offers

Be the first to know about new services, marketplace updates, and subscriber-only promos.

Subscribe
Follow us on social media
FacebookInstagram
Logo
Oladoctor
Find a doctor
Doctors by specialty
Services
Choose language
© 2025 Oladoctor. All rights reserved.
VisaMastercardStripe