Pomalidomide Grindeks

Patient Information Leaflet

Pomalidomide Grindeks 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules

pomalidomide
Generic medicine
Pomalidomide Grindeks is expected to cause birth defects and may result in fetal death.

• Do not take this medicine if you are pregnant or could become pregnant.
• You must follow the advice on contraceptive methods described in this leaflet.

Please read all of this leaflet carefully before taking this medicine, as 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. Do not give it to others, even if they have the same symptoms as you, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What Pomalidomide Grindeks is
Pomalidomide Grindeks contains the active substance “pomalidomide”. This medicine is related to
thalidomide and belongs to a group of medicines that act on the immune system (the body’s natural
defences).
What Pomalidomide Grindeks is used for
Pomalidomide Grindeks is used to treat adults with a type of cancer called “multiple myeloma”.
Pomalidomide Grindeks is used in combination with:

• two other medicines – called ‘bortezomib’ (a chemotherapy medicine) and ‘dexamethasone’ (an anti-inflammatory medicine) in patients who have received at least one prior therapy, including lenalidomide. Or
• one other medicine – called ‘dexamethasone’ in patients whose myeloma has worsened despite having received at least two prior therapies, including lenalidomide and bortezomib.

What is multiple myeloma
Multiple myeloma is a type of cancer that affects a certain kind of white blood cells (called “plasma
cells”). These cells grow uncontrollably and accumulate in the bone marrow. This causes damage to
bones and kidneys.
Multiple myeloma is generally incurable. However, treatment can reduce the signs and symptoms of the
disease or make them disappear for a certain period of time. When this occurs, it is referred to as a
“response”.
How Pomalidomide Grindeks works
Pomalidomide Grindeks works in several ways:

• by stopping the growth of myeloma cells
• by stimulating the immune system to attack cancer cells
• by inhibiting the formation of blood vessels that supply nutrients to cancer cells.

Benefit of using Pomalidomide Grindeks with bortezomib and dexamethasone
When pomalidomide is used with bortezomib and dexamethasone in patients who have received at least
one prior therapy, it can prevent multiple myeloma from worsening.
On average, pomalidomide used with bortezomib and dexamethasone prevented the recurrence of multiple
myeloma for up to 11 months, compared with 7 months in patients treated with bortezomib and
dexamethasone alone.
Benefit of using Pomalidomide Grindeks with dexamethasone
When Pomalidomide Grindeks is used with dexamethasone in patients who have received at least two
prior therapies, it can prevent multiple myeloma from worsening.
On average, Pomalidomide Grindeks used with dexamethasone prevented the recurrence of multiple
myeloma for up to 4 months, compared with 2 months in patients treated with dexamethasone alone.

2. What you should know before taking Pomalidomide Grindeks

Do not take Pomalidomide Grindeks:

• if you are pregnant or think you may be pregnant, or if you are planning a pregnancy, because Pomalidomide Grindeks is expected to be harmful to the unborn child. (Men and women taking this medicine should read the section “Pregnancy, contraception and breastfeeding – information for women and men” below.)
• if there is any possibility that you may become pregnant unless you follow all necessary measures to avoid pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If there is any possibility of becoming pregnant, your doctor will record at each prescription that the necessary precautions have been taken and will provide you with confirmation.
• if you are allergic to pomalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you are allergic, consult your doctor.

If you are unsure whether any of the above conditions apply to you, consult your doctor,
pharmacist, or nurse before taking Pomalidomide Grindeks.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Pomalidomide Grindeks if:

• you have previously had episodes of blood clots. During treatment with Pomalidomide Grindeks, there is an increased risk of developing blood clots in veins and arteries. Your doctor may recommend additional treatments (e.g., warfarin) or reduce the dose of Pomalidomide Grindeks to lower the risk of blood clots.
• you have previously had an allergic reaction, such as rash, itching, swelling, dizziness, or difficulty breathing, during treatment with related medicines called “thalidomide” or “lenalidomide”.
• you have had a heart attack, have heart failure, have breathing difficulties, smoke, have high blood pressure, or high cholesterol levels.
• you have a high tumour burden throughout your body, including in the bone marrow. This could lead to a condition in which tumours break down and cause abnormal levels of chemicals in the blood, potentially leading to kidney failure. You may also experience irregular heartbeat. This condition is called tumour lysis syndrome.
• you have or have previously had neuropathy (nerve damage causing tingling or pain in hands or feet).
• you have or have previously had hepatitis B infection. Treatment with Pomalidomide Grindeks may reactivate the hepatitis B virus in patients who carry the virus, leading to a recurrence of the infection. Your doctor must check whether you have ever had hepatitis B infection.
• you have or have previously had any combination of the following symptoms: facial or widespread rash, skin redness, high fever, flu-like symptoms, swollen lymph nodes (these are signs of a serious skin reaction, called drug reaction with eosinophilia and systemic symptoms (DRESS), 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; therefore, your doctor must carefully evaluate the benefit and risk 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, balance problems, persistent numbness, reduced sensation or loss of sensation,
memory loss, or confusion. These may all be symptoms of a serious and potentially fatal brain disease known
as progressive multifocal leukoencephalopathy (PML). If you had these symptoms before starting treatment
with Pomalidomide Grindeks, inform your doctor of 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 women and men
The following instructions must be followed as indicated in the Pomalidomide Grindeks pregnancy prevention programme. Women and men taking Pomalidomide Grindeks must not become pregnant or father a child. This is because pomalidomide is expected to be harmful to the unborn child. You and your partner must use effective contraception during treatment with this medicine.
Women
Do not take Pomalidomide Grindeks if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, because this medicine is expected to be harmful to the unborn child. Before starting treatment, you must inform your doctor if there is any possibility that you could become pregnant, even if you think it is unlikely.
If there is any possibility of becoming pregnant:

• you must use effective contraceptive methods for at least 4 weeks before starting treatment, throughout the duration of treatment, and for at least 4 weeks after stopping treatment. Consult your doctor about the most suitable contraceptive method for you.
• at each prescription, your doctor will confirm that you understand the necessary measures to prevent pregnancy.
• your doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment, and for at least 4 weeks after treatment ends.

If you become pregnant despite preventive measures:

• you must stop treatment immediately and contact your doctor immediately.

Breastfeeding
It is not known whether Pomalidomide Grindeks passes into breast milk. Inform your doctor if you are breastfeeding or plan to breastfeed. Your doctor will advise you whether to stop or continue breastfeeding.
Men
Pomalidomide Grindeks passes into human seminal fluid.

• If your partner is pregnant or there is any possibility she may become pregnant, you must use condoms throughout the duration of treatment and for 7 days after stopping treatment.
• If your partner becomes pregnant during treatment with Pomalidomide Grindeks, 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 and during treatment with Pomalidomide Grindeks, you will have regular blood tests because this medicine may cause a reduction in blood cells that fight infections (white blood cells) and in cells that stop bleeding (platelets).
Your doctor will ask you to have blood tests:

• before starting treatment
• weekly for the first 8 weeks of treatment
• thereafter at least once a month, for the entire duration of treatment with Pomalidomide Grindeks.

Based on the results of these tests, your doctor may adjust the dose of Pomalidomide Grindeks or stop treatment. Your doctor may also adjust the dose or stop treatment based on your overall health status.
Children and adolescents
The use of Pomalidomide Grindeks 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 take any other medicines. This is because Pomalidomide Grindeks may affect how other medicines work. Also, some other medicines may affect how Pomalidomide Grindeks works.
In particular, inform your doctor, pharmacist, or nurse before taking Pomalidomide Grindeks 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 may experience fatigue, dizziness, faintness, confusion, or reduced alertness when taking Pomalidomide Grindeks. If this occurs, do not drive or operate tools or machinery.
Pomalidomide Grindeks contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule and is therefore considered essentially sodium-free.
Pomalidomide Grindeks contains azo dyes.
The capsules contain the azo dyes Brilliant Black PN (all strengths), Azorubine – Carmoisine (all strengths), and Sunset Yellow FCF (only the 2 mg capsules). These dyes may cause allergic reactions.

3. How to take Pomalidomide Grindeks

Pomalidomide Grindeks must be prescribed by a physician experienced in the treatment of multiple myeloma.
Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor, pharmacist, or nurse.

When to take Pomalidomide Grindeks with other medicines
Pomalidomide Grindeks with bortezomib and dexamethasone

• Refer to the package leaflets of bortezomib and dexamethasone for further information on their use and effects.
• Pomalidomide Grindeks, bortezomib, and dexamethasone are taken in "treatment cycles". Each cycle lasts 21 days (3 weeks).
• Refer to the table below to see which medicines to take each day of the 3-week cycle.
  o Each day, check the table and find the correct day to see which medicines to take.
  o On some days you will take all three medicines, on some days only two or one medicine, and on some days none.

PMD: Pomalidomide Grindeks; BOR: Bortezomib; DEX: Dexamethasone
Cycle 1 to 8
Cycle 9 onwards

| Medicine name | | | | | Medicine name | | | |-------------------|---|---|---|---|-------------------|---|---| | Day | PMD | BOR | DEX | | Day | PMD | BOR | DEX | | 1 | √ | √ | √ | | 1 | √ | √ | √ | | 2 | √ | √ | | | 2 | √ | √ | √ | | 3 | √ | | √ | | 3 | √ | √ | | | 4 | √ | √ | √ | | 4 | √ | | √ | | 5 | √ | √ | | | 5 | √ | | | | 6 | √ | | | | 6 | √ | | | | 7 | √ | | | | 7 | √ | | | | 8 | √ | √ | √ | | 8 | √ | √ | √ | | 9 | √ | √ | | | 9 | √ | √ | | | 10 | √ | | | | 10 | √ | √ | | | 11 | √ | √ | √ | | 11 | √ | | √ | | 12 | √ | √ | | | 12 | √ | | | | 13 | √ | | | | 13 | √ | | | | 14 | √ | | | | 14 | √ | | | | 15 | | | | | 15 | √ | | | | 16 | | | | | 16 | | | | | 17 | | | | | 17 | | | | | 18 | | | | | 18 | | | | | 19 | | | | | 19 | | | | | 20 | | | | | 20 | | | | | 21 | | | | | 21 | | | |

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

Pomalidomide Grindeks with dexamethasone only

• Refer to the package leaflet of dexamethasone for further information on its use and effects.
• Pomalidomide Grindeks and dexamethasone are taken in "treatment cycles". Each cycle lasts 28 days (4 weeks).
• Refer to the table below to see which medicines to take each day of the 4-week cycle.
  o Each day, check the table and find the correct day to see which medicines to take.
  o On some days you will take both medicines, on some days only one medicine, and on some days none.

PMD: Pomalidomide Grindeks; DEX: Dexamethasone

| Medicine name | | | |-------------------|---|---| | 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 | √ | |

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

How much Pomalidomide Grindeks to take with other medicines
Pomalidomide Grindeks with bortezomib and dexamethasone

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

Pomalidomide Grindeks with dexamethasone only

• The recommended dose of Pomalidomide Grindeks is 4 mg once daily.
• The recommended starting dose of dexamethasone is 40 mg once daily. However, if you are over 75 years of age, the recommended starting dose is 20 mg once daily.

Your doctor may need to reduce the dose of Pomalidomide Grindeks, bortezomib, or dexamethasone, or discontinue treatment with one or more of these medicines based on blood test results, your general condition, other medicines you may be taking (e.g., ciprofloxacin, enoxacin, and fluvoxamine), and if you experience side effects (particularly rash or swelling) due to treatment.

If you have liver or kidney problems, your doctor will monitor your condition closely during treatment with this medicine.

How to take Pomalidomide Grindeks

• Do not break, open, or chew the capsules. If the powder from a broken Pomalidomide Grindeks capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
• Healthcare providers, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should then be carefully removed to prevent skin exposure, placed in a sealed polyethylene plastic bag, and disposed of according to local requirements. Hands should be washed thoroughly 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.
• The capsules may be taken with or without food.
• Take Pomalidomide Grindeks at approximately the same time each day.

To remove the capsule from the blister pack, press only on one side of the capsule, pushing it through the aluminum foil. Do not press on the center of the capsule, as this may break it.

Your doctor will inform you how and when to take Pomalidomide Grindeks if you have kidney problems and are undergoing dialysis.

Duration of treatment with Pomalidomide Grindeks
You must continue treatment cycles until your doctor tells you to stop.

If you take more Pomalidomide Grindeks than you should
If you take more Pomalidomide Grindeks than prescribed, contact your doctor or go to a hospital immediately. Bring the medicine packaging with you.

If you forget to take Pomalidomide Grindeks
If you forget to take Pomalidomide Grindeks on the prescribed day, take the next capsule as usual the following day. Do not increase the number of capsules to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Serious side effects
Stop taking Pomalidomide Grindeks and contact your doctor immediately if you notice any of the
following serious side effects – urgent medical treatment may be needed:

• Fever, chills, sore throat, cough or any other sign of infection (due to reduced number of white blood cells, which fight infections).
• Bleeding or bruising without reason, including nosebleeds and bleeding from the intestine or stomach (due to effects on blood cells called "platelets").
• Rapid breathing, increased pulse, fever and chills, reduced or absent urination, nausea and vomiting, confusion, loss of consciousness (due to blood infection called sepsis or septic shock).
• Severe and persistent diarrhoea, or diarrhoea with blood (possibly also stomach pain or fever), caused by a bacterium called Clostridium difficile.
• Chest pain or pain and swelling in the legs, especially in the lower leg or calf (caused by blood clots).
• Shortness of breath (due to severe chest infection, lung inflammation, heart failure or blood clot).
• Swelling of the face, lips, tongue and throat, which may cause difficulty breathing (due to a severe allergic reaction called 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 growths. If you notice any skin changes during treatment with Pomalidomide Grindeks, inform your doctor as soon as possible.
• Reactivation of hepatitis B infection, which may cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, nausea or vomiting. Inform your doctor immediately if you notice 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 hypersensitivity syndrome, toxic epidermal necrolysis or Stevens-Johnson syndrome). Stop taking pomalidomide if these symptoms occur and contact your doctor or seek immediate medical help. See also section 2.

Stop taking Pomalidomide Grindeks and contact your doctor immediately if you notice any of the
serious side effects listed above – urgent medical treatment may be needed.
Other side effects
Very common (may affect more than 1 in 10 people):

• Shortness of breath (dyspnoea),
• Lung infections (pneumonia and bronchitis).
• Infections of the nose, sinuses and throat caused by bacteria or viruses.
• Flu-like symptoms (influenza).
• Reduction in the number of red blood cells, which may cause anaemia leading to tiredness and weakness.
• Low levels of potassium in the blood (hypokalaemia) which may cause weakness, muscle cramps, muscle pain, palpitations, tingling or numbness, shortness of breath, mood changes.
• High levels of sugar in the blood.
• Rapid and irregular heartbeat (atrial fibrillation).
• Loss of appetite.
• Constipation, diarrhoea or nausea.
• Feeling unwell (vomiting).
• Abdominal pain.
• Lack of energy.
• Difficulty falling asleep or staying asleep.
• Dizziness, tremor.
• Muscle spasms, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling or burning sensation on the skin, pain in hands or feet (peripheral sensory neuropathy).
• Swelling of the body, including swelling of the arms and legs.
• Skin rashes.
• Urinary tract infection, which may cause a burning sensation during urination or increased need to urinate.

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

• Falls.
• Bleeding within the skull.
• Reduced ability to move or feel in the hands, arms, feet and legs due to nerve damage (peripheral sensory-motor neuropathy).
• Numbness, itching and tingling on the skin (paraesthesia).
• Dizziness, difficulty standing or moving normally.
• Swelling due to fluid retention.
• Hives.
• Itchy skin.
• Herpes zoster (shingles).
• Heart attack (chest pain spreading to arms, neck, jaw, sweating, shortness of breath, nausea or vomiting).
• Chest pain, chest infection.
• Increased blood pressure.
• Simultaneous reduction in the number of red blood cells, white blood cells and platelets (pancytopenia), making you more prone to bleeding and bruising. You may feel tired, weak and short of breath. You are also more likely to develop infections.
• Reduction in lymphocytes (a type of white blood cells), often caused by infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesaemia), which may cause tiredness, generalised weakness, muscle cramps, irritability, and may lead to low levels of calcium in the blood (hypocalcaemia), which may cause numbness and/or tingling in 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 cause slowed reflexes and musculoskeletal weakness.
• High levels of potassium in the blood, which may cause abnormal heart rhythm.
• Low levels of sodium in the blood, which may cause tiredness and confusion, muscle spasms, seizures or coma.
• High levels of uric acid in the blood, which may cause a form of arthritis called gout.
• Low blood pressure, which may cause dizziness or fainting.
• Mouth ulcers or dry mouth.
• Altered sense of taste.
• Abdominal swelling.
• Confusion.
• Feeling low (depressed mood).
• Loss of consciousness, fainting.
• Blurred vision (cataract).
• Kidney damage.
• Inability to urinate.
• Abnormal liver tests.
• Pelvic pain.
• Weight loss.

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

• Stroke.
• Inflammation of the liver (hepatitis), which may cause itching, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine and abdominal pain.
• Breakdown of tumour cells, causing the release of toxic substances into the bloodstream (tumour lysis syndrome). This may cause kidney problems.
• Reduced thyroid activity, which may cause symptoms such as tiredness, lethargy, muscle weakness, reduced heart rate, weight gain.

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

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

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pomalidomide 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 carton after Exp.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Pomalidomide Grindeks if you notice any damage or signs of tampering with the medicine packaging.
Do not dispose of any medicine via wastewater or household waste. Unused medicine must be returned to the pharmacist at the end of treatment. This will help protect the environment.

6. Package contents and other information

What Pomalidomide Grindeks contains
Pomalidomide Grindeks 1 mg hard capsules:

• The active substance is pomalidomide. Each capsule contains 1 mg of pomalidomide.
• The other components are: pregelatinized starch, maltodextrin, crospovidone, anhydrous colloidal silica, sodium stearyl fumarate.
• The capsule shell contains: gelatin, titanium dioxide (E171), colourants (iron yellow oxide (E172), iron black oxide (E172), brilliant black PN (E151), patent blue V (E131), azorubine - carmoisine (E122), brilliant blue FCF (E133)) and white ink (shellac, titanium dioxide (E171), sodium hydroxide, propylene glycol (E1520) and povidone (E1201)).

Pomalidomide Grindeks 2 mg hard capsules:

• The active substance is pomalidomide. Each capsule contains 2 mg of pomalidomide.
• The other components are: pregelatinized starch, maltodextrin, crospovidone, anhydrous colloidal silica, sodium stearyl fumarate.
• The capsule shell contains: gelatin, titanium dioxide (E171), colourants (sunset yellow FCF (E110), brilliant black PN (E151), patent blue V (E131), azorubine - carmoisine (E122)) and white ink (shellac, titanium dioxide (E171), sodium hydroxide, propylene glycol (E1520) and povidone (E1201)).

Pomalidomide Grindeks 3 mg hard capsules:

• The active substance is pomalidomide. Each capsule contains 3 mg of pomalidomide.
• The other components are: pregelatinized starch, maltodextrin, crospovidone, anhydrous colloidal silica, sodium stearyl fumarate.
• The capsule shell contains: gelatin, titanium dioxide (E171), colourants (brilliant black PN (E151), patent blue V (E131), azorubine - carmoisine (E122), brilliant blue FCF (E133), erythrosine (E127)) and white ink (shellac, titanium dioxide (E171), sodium hydroxide, propylene glycol (E1520) and povidone (E1201)).

Pomalidomide Grindeks 4 mg hard capsules:

• The active substance is pomalidomide. Each capsule contains 4 mg of pomalidomide.
• The other components are: pregelatinized starch, maltodextrin, crospovidone, anhydrous colloidal silica, sodium stearyl fumarate.
• The capsule shell contains: gelatin, titanium dioxide (E171), colourants (brilliant blue FCF (E133), brilliant black PN (E151), patent blue V (E131), azorubine - carmoisine (E122), erythrosine (E127)) and white ink (shellac, titanium dioxide (E171), sodium hydroxide, propylene glycol (E1520) and povidone (E1201)).

Description of the appearance of Pomalidomide Grindeks and contents of the pack
Pomalidomide Grindeks 1 mg hard capsules are hard gelatin capsules, size 4 (approximately 14 mm x 5 mm), with a light grey body, printed "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 x 6 mm), with an opaque orange body, printed "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 x 6 mm), with a blue body, printed "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 x 7 mm), with an opaque blue body, printed "P4" in white ink, and a dark blue opaque cap.
The capsules are supplied in packs of 14 or 21 capsules (2 or 3 blisters per pack, with 7 capsules in each blister) or in perforated unit dose blisters containing 14 x 1 capsules or 21 x 1 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53,
Rīga, LV-1057,
Latvia

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria Pomalidomid Grindeks 1 mg, 2 mg, 3 mg, 4 mg Hartkapseln
Belgium Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg gélules
Bulgaria Помалидомид Гриндекс 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 kovat kapselit
France POMALIDOMIDE GRINDEKS 1 mg, gélule
POMALIDOMIDE GRINDEKS 2 mg, gélule
POMALIDOMIDE GRINDEKS 3 mg, gélule
POMALIDOMIDE GRINDEKS 4 mg, gélule
Germany Pomalidomid Grindeks 1 mg, 2 mg, 3 mg, 4 mg Hartkapseln
Greece Pomalidomide/Grindeks
Hungary Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg kemény kapszula
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 cietās kapsulas
Lithuania Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg kietosios kapsulės
Netherlands Pomalidomide Grindeks 1 mg harde capsules
Pomalidomide Grindeks 2 mg harde capsules
Pomalidomide Grindeks 3 mg harde capsules
Pomalidomide Grindeks 4 mg harde capsules
Norway Pomalidomide Grindeks
Poland Pomalidomide Grindeks
Portugal Pomalidomida Grindeks 1 mg, 2 mg, 3 mg, 4 mg cápsula
Romania Pomalidomidă Grindeks 1 mg capsule
Pomalidomidă Grindeks 2 mg capsule
Pomalidomidă Grindeks 3 mg capsule
Pomalidomidă Grindeks 4 mg capsule
Slovenia Pomalidomid Grindeks 1 mg, 2 mg, 3 mg, 4 mg trde kapsule
Slovakia Pomalidomid Grindeks 1 mg tvrdé kapsuly
Pomalidomid Grindeks 2 mg tvrdé kapsuly
Pomalidomid Grindeks 3 mg tvrdé kapsuly
Pomalidomid Grindeks 4 mg tvrdé kapsuly
Spain Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg cápsula dura
Sweden Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg hårda kapslar