Pomalidomide Grindex 4 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pomalidomida Grindeks 1mg hard capsules EFG

Pomalidomida Grindeks 2mg hard capsules EFG

Pomalidomida Grindeks 3mg hard capsules EFG

Pomalidomida Grindeks 4mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Pomalidomida Grindeks is and what it is used for
2. What you need to know before taking Pomalidomida Grindeks
3. How to take Pomalidomida Grindeks
4. Possible side effects
5. How to store Pomalidomida Grindeks
6. Contents of the pack and other information

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

What is Pomalidomide Grindeks

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

What Pomalidomide Grindeks is used for

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

Pomalidomide is used with:

• Two other medicines, called bortezomib (a type of chemotherapy medicine) and dexamethasone (an anti-inflammatory medicine) in people who have received at least one previous treatment, including lenalidomide.

or

• One other medicine, called dexamethasone, in people whose myeloma has worsened despite having received at least two other treatments, including lenalidomide and bortezomib.

What is multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cells (called plasma cells). These cells grow out of control and accumulate in the bone marrow. As a result, bones and kidneys become damaged.

Multiple myeloma usually cannot be cured. However, treatment can reduce or eliminate the signs and symptoms of the disease for a period of time. When this happens, it is called a response.

How Pomalidomide Grindeks works

Pomalidomide works in several ways:

• by interrupting the growth of myeloma cells
• by stimulating the immune system to attack cancer cells
• by interrupting the formation of blood vessels that nourish cancer cells

Benefit of using pomalidomide with bortezomib and dexamethasone

When pomalidomide is used with bortezomib and dexamethasone in people who have already received at least one other treatment, it may delay the progression of multiple myeloma.

Typically, the combination of pomalidomide with bortezomib and dexamethasone prevents the recurrence of multiple myeloma for up to 11 months, compared with 7 months observed in patients who receive only bortezomib and dexamethasone.

Benefit of using pomalidomide with dexamethasone

When pomalidomide is used with dexamethasone in people who have already received at least two other treatments, it may delay the progression of multiple myeloma.

Typically, the combination of pomalidomide with dexamethasone prevents the recurrence of multiple myeloma for up to 4 months, compared with 2 months observed in patients who receive only dexamethasone.

2. What you need to know before starting to take Pomalidomide Grindeks

Do not take Pomalidomide Grindeks:

• if you are pregnant, think you might be pregnant, or intend to become pregnant, since pomalidomide is expected to be harmful to the fetus. (Men and women taking this medicine should read the section Pregnancy, contraception and breastfeeding: information for men and women below.)
• if you could become pregnant, unless you follow all necessary measures to prevent pregnancy (see the section Pregnancy, contraception and breastfeeding: information for men and women). If you could become pregnant, your doctor will record on each prescription that the necessary precautions have been taken and will provide you with this confirmation.
• if you are allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor for advice.

If you are unsure whether any of the above situations apply to you, consult your doctor, pharmacist, or nurse before taking pomalidomide.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Pomalidomide Grindeks if:

• You have previously had blood clots. During treatment with pomalidomide, you have an increased risk of developing blood clots in your veins and arteries. Your doctor may recommend additional treatments (e.g., warfarin) or reducing the dose of pomalidomide to lower the risk of blood clots.
• You have ever had an allergic reaction, such as rash, itching, swelling, dizziness, or difficulty breathing while taking related medicines called thalidomide or lenalidomide.
• You have had a heart attack, suffer from heart failure, have difficulty breathing, or if you smoke, have high blood pressure, or high cholesterol levels.
• You have a high overall tumor burden in the body, including in the bone marrow. This could lead to a condition in which tumors break down and release unusual levels of chemicals into the blood, which in turn may cause kidney failure. You may also experience irregular heartbeats. This condition is called tumor lysis syndrome.
• You suffer from or have previously had neuropathy (nerve damage causing tingling or pain in the feet or hands).
• You have or have previously had an infection with hepatitis B virus. Treatment with pomalidomide may reactivate the hepatitis B virus in carriers, leading to a recurrence of the infection. Your doctor must check whether you have ever had a hepatitis B virus infection.
• You are experiencing or have previously experienced a combination of any of the following symptoms: facial or widespread rash, skin redness, high fever, flu-like symptoms, swollen lymph nodes (symptoms of a serious skin reaction known as drug reaction with eosinophilia and systemic symptoms [DRESS] or drug hypersensitivity syndrome, toxic epidermal necrolysis [TEN], or Stevens-Johnson syndrome [SJS]. See also section 4 “Possible side effects”).

It is important to note that patients with multiple myeloma treated with pomalidomide may develop other types of cancer, so your doctor must carefully evaluate the benefits and risks when prescribing this medicine.

At any time during or after treatment, inform your doctor or nurse immediately if you experience: blurred vision, loss of vision or double vision, difficulty speaking, weakness in one arm or leg, a change in the way you walk or balance problems, persistent numbness, reduced sensation, or loss of sensation, memory loss, or confusion. These may all be symptoms of a serious and potentially life-threatening brain condition known as progressive multifocal leukoencephalopathy (PML). If you had any of these symptoms before starting treatment with pomalidomide, inform your doctor if you notice any changes in these symptoms.

At the end of treatment, you must return all unused capsules to the pharmacist.

Pregnancy, contraception and breastfeeding: information for men and women

You must follow the instructions provided in the Pomalidomide Pregnancy Prevention Programme. Men and women taking pomalidomide must not father children or become pregnant. This is because pomalidomide is expected to be harmful to the fetus. You and your partner must use effective contraceptive methods while taking this medicine.

Women

Do not take pomalidomide if you are pregnant, think you might be pregnant, or intend to become pregnant. This is because this medicine is expected to be harmful to the fetus. Before starting treatment, you must inform your doctor if there is any possibility you could become pregnant, even if you think this is unlikely.

If you could become pregnant:

• You must use effective contraception at least 4 weeks before starting treatment, throughout the time you are taking the medicine, and for at least 4 weeks after stopping treatment. Your doctor will advise you on the most suitable contraceptive methods for you.
• Each time your doctor prescribes a new prescription, they will ensure you understand the necessary measures to prevent pregnancy.
• Your doctor will schedule pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment.

If you become pregnant despite preventive measures:

• You must stop treatment immediately and inform your doctor immediately.

Breastfeeding

It is unknown whether pomalidomide is excreted in human breast milk. Inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will advise you whether you should continue or stop breastfeeding.

Men

Pomalidomide is present in human semen.

• If your partner is pregnant or could become pregnant, you must use condoms throughout the time you are taking the medicine and for 7 days after stopping treatment.
• If your partner becomes pregnant while you are taking pomalidomide, inform your doctor immediately. Your partner must also inform her doctor immediately.

You must not donate semen or sperm during treatment and for 7 days after stopping treatment.

Blood donation and blood tests

You must not donate blood during treatment and for 7 days after stopping treatment.

Before starting treatment with pomalidomide and during treatment, you will have periodic 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 in the number of cells that help stop bleeding (platelets).

Your doctor should request blood tests:

• before starting treatment
• weekly during the first 8 weeks of treatment
• at least once a month while continuing pomalidomide treatment

Your doctor may adjust the dose of pomalidomide or interrupt your treatment, depending on the results of these tests. Your doctor may also change the dose or interrupt this medicine due to your overall health status.

Children and adolescents

The use of pomalidomide is not recommended in children and adolescents under 18 years of age.

Other medicines and Pomalidomide Grindeks

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines. This is because pomalidomide may affect how other medicines work. Other medicines may also affect how pomalidomide works.

Specifically, inform your doctor, pharmacist, or nurse before taking pomalidomide if you are taking any of the following medicines:

• certain antifungals, such as ketoconazole
• certain antibiotics (e.g., ciprofloxacin, enoxacin)
• certain antidepressants, such as fluvoxamine

Driving and using machines

Some people experience fatigue, dizziness, fainting, confusion, or reduced alertness while taking pomalidomide. If you experience these effects, avoid driving or operating tools or machinery.

Pomalidomide Grindeks contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially "sodium-free".

Pomalidomide Grindeks contains azo dyes

The capsules contain the azo dyes brilliant black PN (all strengths), carmoisine, ponceau 4R (all strengths), and orange-yellow FCF (only the 2 mg capsules). These dyes may cause allergic reactions.

3. How to take Pomalidomide Grindeks

Pomalidomide must be prescribed by a physician experienced in the treatment of multiple myeloma.

Always follow exactly your doctor's instructions for taking this medicine. If you are unsure, consult your doctor, pharmacist, or nurse again.

When to take Pomalidomide Grindeks with other medicines

Pomalidomide with bortezomib and dexamethasone

• Refer to the package leaflet provided with bortezomib and dexamethasone for additional information on their use and effects.
• Pomalidomide, bortezomib, and dexamethasone are administered in "treatment cycles". Each cycle lasts 21 days (3 weeks).
• Refer to the following chart to see which medicines to take each day during the 3-week cycle:
  • Each day, check the chart and identify the correct day to see which medicines you should take.
  • On some days, you will take all three medicines; on other days, only one or two medicines; and on some days, none of them.

PMD: Pomalidomide; BOR: Bortezomib; DEX: Dexamethasone

Cycle 1 to 8 and beyond Cycle 9 and beyond

After completing each 3-week cycle, start a new one.

Pomalidomide with dexamethasone only

• Refer to the package leaflet provided with dexamethasone for additional information on its use and effects.
• Pomalidomide and dexamethasone are administered in "treatment cycles". Each cycle lasts 28 days (4 weeks).
• Refer to the following chart to see which medicines to take each day during the 4-week cycle:
  • Each day, check the chart and identify the correct day to see which medicines you should take.
  • On some days, you will take both medicines; on other days, only one; and on some days, neither.

PMD: Pomalidomide; DEX: Dexamethasone

	Name of the medicine
Day	PMD	DEX
1	√	√
2	√
3	√
4	√
5	√
6	√
7	√
8	√	√
9	√
10	√
11	√
12	√
13	√
14	√
15	√	√
16	√
17	√
18	√
19	√
20	√
21	√
22		√
23
24
25
26
27
28

After completing each 4-week cycle, start a new one.

How much pomalidomide to take with other medicines

Pomalidomide with bortezomib and dexamethasone

• The recommended starting dose of pomalidomide is 4 mg daily.
• The recommended starting dose of bortezomib will be calculated by your doctor according to your height and weight (1.3 mg/m2 body surface area).
• The recommended starting dose of dexamethasone is 20 mg daily. However, if you are over 75 years old, the recommended starting dose is 10 mg daily.

Pomalidomide with dexamethasone only

• The recommended dose of pomalidomide is 4 mg daily.
• The recommended starting dose of dexamethasone is 40 mg daily. However, if you are over 75 years old, the recommended starting dose is 20 mg daily.

Your doctor may need to reduce the dose of pomalidomide, bortezomib or dexamethasone, or interrupt one or more of these medicines, depending on your blood test results and general condition, whether you are taking other medicines (e.g., ciprofloxacin, enoxacin and fluvoxamine), and whether you experience adverse effects (especially rash or swelling) as a result of treatment.

If you have liver or kidney problems, your doctor will carefully monitor your condition while you are receiving this medicine.

How to take Pomalidomida Grindeks

• Do not chew, crush or open the capsules. If the powder from a broken pomalidomide capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
• Healthcare professionals, caregivers and family members should wear disposable gloves when handling the blister pack or capsule. Afterwards, gloves should be carefully removed to avoid skin exposure, placed into a sealed polyethylene plastic bag, and disposed of according to local requirements. Then, hands should be thoroughly washed with soap and water. Pregnant women or women who suspect they may be pregnant must not handle the blister pack or capsule.
• Swallow the capsules whole, preferably with water.
• You may take the capsules with or without food.
• Take pomalidomide at approximately the same time each day.

To remove the capsule from the blister, press only one end of the capsule so that it comes through the foil. Do not press the center of the capsule, as it may break.

Your doctor will advise you on how and when to take pomalidomide if you have kidney problems and are undergoing dialysis treatment.

Duration of treatment with Pomalidomida Grindeks

You should continue treatment cycles until your doctor tells you to stop treatment.

If you take more Pomalidomida Grindeks than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Pomalidomida Grindeks

If you forget to take pomalidomide on the day you were supposed to, take the next capsule the following day at your usual time. Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

If you experience any of the following serious adverse effects, stop treatment with pomalidomide and see a doctor immediately, as you may require urgent medical treatment:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to a decrease in white blood cells that fight infections).
• Bleeding or bruising without apparent cause, including nosebleeds and intestinal or stomach bleeding (due to effects on blood cells called platelets).
• Rapid breathing, fast pulse, fever and chills, little or no ability to urinate, nausea and vomiting, confusion, unconsciousness (due to a blood infection called sepsis or septic shock).
• Severe, persistent, or bloody diarrhoea (possibly accompanied by stomach pain or fever) caused by the bacterium Clostridium difficile.
• Chest or leg pain and swelling, especially in the lower leg or calves (caused by blood clots).
• Shortness of breath (due to a severe chest infection, lung inflammation, heart failure, or blood clots).
• Swelling of the face, lips, tongue, and throat, which may cause breathing difficulties (due to severe allergic reactions known as angioedema and anaphylactic reaction).
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which may cause changes in the appearance of the skin or skin lumps. If you notice any skin changes while taking pomalidomide, inform your doctor as soon as possible.
• Reactivation of hepatitis B virus infection, which may cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, nausea, or malaise. Inform your doctor immediately if you experience any of 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 "drug-induced hypersensitivity syndrome", toxic epidermal necrolysis, or Stevens-Johnson syndrome). If you experience these symptoms, stop taking pomalidomide and contact your doctor or seek immediate medical attention. See also section 2.

If you experience any of the following serious adverse effects, stop treatment with pomalidomide and see a doctor immediately because you may require urgent medical treatment.

Other adverse effects

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

• Shortness of breath (dyspnoea).
• Lung infection (pneumonia and bronchitis).
• Infections of the nose, sinuses, and throat caused by bacteria or viruses.
• Flu-like symptoms (influenza-like illness).
• Low red blood cell count, which may cause anaemia leading to fatigue and weakness.
• Low levels of potassium in the blood (hypokalaemia), which may cause weakness, muscle cramps and pain, palpitations, tingling or numbness, dyspnoea, and mood changes.
• High blood sugar levels.
• Fast and irregular heartbeat (atrial fibrillation).
• Loss of appetite.
• Constipation, diarrhoea, or nausea.
• Dizziness (vomiting).
• Abdominal pain.
• Lack of energy.
• Difficulty falling asleep or staying asleep.
• Dizziness, tremors.
• Muscle spasms, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling, or burning sensation in the skin, pain in the hands or feet (sensory peripheral neuropathy).
• Generalised swelling, including swelling of the arms and legs.
• Skin rashes.
• Urinary tract infection, which may cause a burning sensation when urinating or the need to urinate more frequently.

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

• Falls.
• Bleeding within the skull.
• Reduced ability to move or feel (sensation) in the hands, feet, and legs due to nerve damage (sensory-motor peripheral neuropathy).
• Numbness, itching, and tingling of the skin (paraesthesia).
• Sensation of dizziness, making it difficult to stand and move normally.
• Swelling caused by fluid retention.
• Hives (urticaria).
• Itching of the skin.
• Shingles (herpes zoster).
• Heart attack (chest pain spreading to the arms, neck, and jaw, sweating, shortness of breath, nausea or vomiting).
• Chest pain, chest infection.
• High blood pressure.
• A reduction in the number of red blood cells, white blood cells, and platelets simultaneously (pancytopenia), making you more prone to bleeding and bruising. You may feel tired and weak, have difficulty breathing, and be more susceptible to infections.
• Decreased number of lymphocytes (a type of white blood cell), often caused by infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesaemia), which may cause fatigue, generalised weakness, muscle cramps, and irritability, and may lead to low levels of calcium in the blood (hypocalcaemia), causing numbness or tingling in the hands, feet, or lips, muscle cramps, muscle weakness, dizziness, confusion.
• Low levels of phosphate in the blood (hypophosphataemia), which may cause muscle weakness, irritability, or confusion.
• High levels of calcium in the blood (hypercalcaemia), which may slow reflexes and cause weakness in skeletal muscles.
• High levels of potassium in the blood, which may cause an abnormal heart rhythm.
• Low levels of sodium in the blood, which may cause fatigue and confusion, muscle twitching, seizures (epileptic fits), or coma.
• High levels of uric acid in the blood, which may cause a type of arthritis called gout.
• Low blood pressure, which may cause dizziness or fainting.
• Pain or dryness of the mouth.
• Changes in taste.
• Swollen abdomen.
• Feeling confused.
• Feeling low in mood (depression).
• Loss of consciousness, fainting.
• Cloudiness in the eye (cataract).
• Kidney damage.
• Inability to urinate.
• Abnormal results in liver function tests.
• Pelvic pain.
• Weight loss.

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

• Stroke.
• Inflammation of the liver (hepatitis), which may cause itchy skin, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine, and abdominal pain.
• Breakdown of cancer cells resulting in the release of toxic substances into the bloodstream (tumour lysis syndrome). This may lead to kidney problems.
• Underactive thyroid gland, which may cause symptoms such as fatigue, lethargy, muscle weakness, slow heart rate, and weight gain.

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

Rejection of solid organ transplants (such as heart or liver).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pomalidomida Grindeks

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and on the carton after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use this medicine if deterioration or signs of improper handling of the medicine are observed.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pomalidomide Grindeks

Pomalidomide Grindeks 1 mg hard capsules EFG:

• The active substance is pomalidomide. Each capsule contains 1 mg of pomalidomide.
• The other components are pregelatinized starch, maltodextrin, crospovidone, colloidal anhydrous silica, and sodium stearyl fumarate.
• The capsule shell contains gelatin, titanium dioxide (E-171), and colourants: (iron oxide yellow (E-172), iron oxide black (E-172), Black PN (E-151), Patent Blue V (E-131), carmoisine, Ponceau 4R (E-122), Brilliant Blue FCF (E-133)) and white printing ink (shellac, titanium dioxide [E-171], sodium hydroxide, propylene glycol [E-1520], and povidone [E-1201]).

Pomalidomide Grindeks 2 mg hard capsules EFG:

• The active substance is pomalidomide. Each capsule contains 2 mg of pomalidomide.
• The other components are pregelatinized starch, maltodextrin, crospovidone, colloidal anhydrous silica, and sodium stearyl fumarate.
• The capsule shell contains gelatin, titanium dioxide (E-171), and colourants: (Orange Yellow FCF (E-110), Black PN (E-151), Patent Blue V (E-131), carmoisine, Ponceau 4R (E-122)) and white printing ink (shellac, titanium dioxide [E-171], sodium hydroxide, propylene glycol [E-1520], and povidone [E-1201]).

Pomalidomide Grindeks 3 mg hard capsules EFG:

• The active substance is pomalidomide. Each capsule contains 3 mg of pomalidomide.
• The other components are pregelatinized starch, maltodextrin, crospovidone, colloidal anhydrous silica, and sodium stearyl fumarate.
• The capsule shell contains gelatin, titanium dioxide (E-171), and colourants: (Black PN (E-151), Patent Blue V (E-131), carmoisine, Ponceau 4R (E-122), Brilliant Blue FCF (E-133), erythrosine (E-127)) and white printing ink (shellac, titanium dioxide [E-171], sodium hydroxide, propylene glycol [E-1520], and povidone [E-1201]).

Pomalidomide Grindeks 4 mg hard capsules EFG:

• The active substance is pomalidomide. Each capsule contains 4 mg of pomalidomide.
• The other components are pregelatinized starch, maltodextrin, crospovidone, colloidal anhydrous silica, and sodium stearyl fumarate.
• The capsule shell contains gelatin, titanium dioxide (E-171), and colourants: (Brilliant Blue FCF (E-133), Black PN (E-151), Patent Blue V (E-131), carmoisine, Ponceau 4R (E-122), erythrosine (E-127)) and white printing ink (shellac, titanium dioxide [E-171], sodium hydroxide, propylene glycol [E-1520], and povidone [E-1201]).

Nature of the product and contents of the pack

Pomalidomide Grindeks 1 mg hard capsules are hard gelatin capsules, size 4 (approximately 14 mm × 5 mm), with a light grey body printed with "P1" in white ink and a dark blue opaque cap.

Pomalidomide Grindeks 2 mg hard capsules are hard gelatin capsules, size 3 (approximately 16 mm × 6 mm), with an opaque orange body printed with "P2" in white ink and a dark blue opaque cap.

Pomalidomide Grindeks 3 mg hard capsules are hard gelatin capsules, size 2 (approximately 18 mm × 6 mm), with a light blue body printed with "P3" in white ink and a dark blue opaque cap.

Pomalidomide Grindeks 4 mg hard capsules are hard gelatin capsules, size 1 (approximately 19 mm × 7 mm), with an opaque blue body printed with "P4" in white ink and a dark blue opaque cap.

The capsules are presented in blisters of 14 or 21 capsules (2 or 3 blisters per pack, with 7 capsules in each blister) or in single-dose perforated blisters of 14 x 1 or 21 x 1 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

AS GRINDEKS
Krustpils iela 53,
Riga, LV-1057,
Latvia

Further information about this medicinal product is available upon request from the local representative of the Marketing Authorization Holder

Grindeks Kalceks España, S.L.
C/ José Abascal, 58 – 2º Dcha.
28003, Madrid, Spain

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

Austria	Pomalidomid Grindeks 1 mg, 2 mg, 3 mg, 4 mg hard capsules
Belgium	Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg capsules
Bulgaria	Pomalidomid Grindeks 1 mg, 2 mg, 3 mg, 4 mg твърди капсули Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg hard capsules
Czech Republic	Pomalidomide Grindeks
Denmark	Pomalidomid Grindeks
Estonia	Pomalidomide Grindeks
Finland	Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg hard capsules
France	POMALIDOMIDE GRINDEKS 1 mg, capsule POMALIDOMIDE GRINDEKS 2 mg, capsule POMALIDOMIDE GRINDEKS 3 mg, capsule POMALIDOMIDE GRINDEKS 4 mg, capsule
Germany	Pomalidomid Grindeks 1 mg, 2 mg, 3 mg, 4 mg hard capsules
Greece	Pomalidomide/Grindeks
Hungary	Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg hard capsule
Ireland	Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg hard capsule
Italy	Pomalidomide Grindeks
Latvia	Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg hard capsules
Lithuania	Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg hard capsules
Netherlands	Pomalidomide Grindeks 1 mg hard capsules Pomalidomide Grindeks 2 mg hard capsules Pomalidomide Grindeks 3 mg hard capsules Pomalidomide Grindeks 4 mg hard capsules
Norway	Pomalidomide Grindeks
Poland	Pomalidomide Grindeks
Portugal	Pomalidomida Grindeks 1 mg, 2 mg, 3 mg, 4 mg capsule
Romania	Pomalidomida Grindeks 1 mg capsule Pomalidomida Grindeks 2 mg capsule Pomalidomida Grindeks 3 mg capsule Pomalidomida Grindeks 4 mg capsule
Slovenia	Pomalidomid Grindeks 1 mg, 2 mg, 3 mg, 4 mg hard capsules
Slovak Republic	Pomalidomid Grindeks 1 mg hard capsules Pomalidomid Grindeks 2 mg hard capsules Pomalidomid Grindeks 3 mg hard capsules Pomalidomid Grindeks 4 mg hard capsules
Spain	Pomalidomida Grindeks 1 mg hard capsules EFG Pomalidomida Grindeks 2 mg hard capsules EFG Pomalidomida Grindeks 3 mg hard capsules EFG Pomalidomida Grindeks 4 mg hard capsules EFG
Sweden	Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg hard capsules

Date of the last revision of this leaflet: 10/2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/