Pomalidomide grindeks

Package leaflet: Information for the patient

Pomalidomide Grindeks, 1 mg, hard capsules
Pomalidomide Grindeks, 2 mg, hard capsules
Pomalidomide Grindeks, 3 mg, hard capsules
Pomalidomide Grindeks, 4 mg, hard capsules
Pomalidomide
Pomalidomide Grindeks is expected to cause severe birth defects and may lead to fetal death.

• Do not take this medicine if you are pregnant or may become pregnant.
• You must follow the contraceptive advice provided in this leaflet.

Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Pomalidomide Grindeks is and what it is used for
2. Important information 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

Pomalidomide Grindeks 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 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, bortezomib (a chemotherapy medicine) and dexamethasone (an anti-inflammatory medicine), in patients who have already received at least one prior treatment containing lenalidomide

or

• one other medicine, dexamethasone, in patients with multiple myeloma whose disease has worsened despite having previously received at least two prior treatments containing lenalidomide and bortezomib.

What is multiple myeloma
Multiple myeloma is a cancer that affects a certain type of blood cell (called plasma cells). These cells grow uncontrollably and accumulate in the bone marrow, causing damage to bones and kidneys.
Multiple myeloma is generally incurable. However, treatment may relieve the signs and symptoms of the disease or cause them to disappear for a period of time—this is known as a "response" to treatment.

How Pomalidomide Grindeks works
Pomalidomide Grindeks works in several different ways:

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

Benefits of using Pomalidomide Grindeks with bortezomib and dexamethasone
When Pomalidomide Grindeks is used together with bortezomib and dexamethasone in patients who have already received at least one prior treatment, it may slow the progression of multiple myeloma.
Pomalidomide Grindeks used with bortezomib and dexamethasone typically delayed the recurrence of multiple myeloma for up to 11 months—compared to 7 months in patients who received only bortezomib and dexamethasone.

Benefits of using Pomalidomide Grindeks with dexamethasone
When Pomalidomide Grindeks is used together with dexamethasone in patients who have already received at least two prior treatments, it may slow the progression of multiple myeloma.
Pomalidomide Grindeks used with dexamethasone typically delayed the recurrence of multiple myeloma for up to 4 months—compared to 2 months in patients who received dexamethasone alone.

2. Important information before using Pomalidomide Grindeks

When not to take Pomalidomide Grindeks

• if the patient is pregnant, suspects she is pregnant, or plans to become pregnant, because Pomalidomide Grindeks is expected to be harmful to the fetus (men and women taking this medicine must read the section titled "Pregnancy, contraception and breastfeeding – information for women and men" below).
• if the patient could become pregnant unless she uses all required methods of contraception (see section "Pregnancy, contraception and breastfeeding – information for women and men"). If the patient could become pregnant, the doctor will always document during prescription that the patient has understood all necessary contraceptive measures she must use, and will provide confirmation of this to the patient.
• if the patient is allergic to pomalidomide or any of the other ingredients of this medicine listed in section 6). If an allergic reaction to the medicine is suspected, consult a doctor for advice.

If the patient is unsure whether any of the above situations apply, consult a doctor, pharmacist, or nurse before starting treatment with Pomalidomide Grindeks.
Warnings and precautions
Before starting treatment with Pomalidomide Grindeks, discuss with the doctor, pharmacist, or nurse if:

• the patient has ever had blood clots in the past. Treatment with Pomalidomide Grindeks increases the risk of developing blood clots in veins and arteries. The doctor may prescribe additional treatment (e.g., warfarin) or reduce the dose of Pomalidomide Grindeks to lower the risk of blood clots.
• the patient has ever had an allergic reaction such as rash, itching, swelling, dizziness, or breathing difficulties while taking similar medicines called "thalidomide" and "lenalidomide".
• the patient has had a heart attack, has heart failure, experiences breathing difficulties, or if he or she smokes, has high blood pressure, or high cholesterol levels.
• the patient has extensive tumour involvement in the body, including in the bone marrow. This may lead to tumour lysis syndrome, a condition in which tumours break down rapidly, causing abnormal levels of chemicals in the blood, which may lead to kidney failure. The patient may also experience irregular heartbeats.
• the patient has or has had neuropathy (nerve damage causing tingling or pain in hands or feet).
• the patient has or has had hepatitis B virus infection. Taking Pomalidomide Grindeks may reactivate the virus in previously infected patients, leading to recurrence of infection. The doctor should check whether the patient has been previously infected with hepatitis B virus.
• the patient has or has had any combination of the following symptoms: facial rash or widespread rash, redness of the skin, high fever, flu-like symptoms, swollen lymph nodes (patient-observed symptoms of a severe 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 should be emphasized that in patients with multiple myeloma treated with pomalidomide, there may be an increased risk of developing other types of cancer. Therefore, the treating doctor should carefully evaluate the benefits and risks associated with prescribing this medicine.
At any time during or after completion of treatment, immediately inform the doctor or nurse if any of the following symptoms occur: vision disturbances, loss of vision, double vision, difficulty speaking, weakness in arms or legs, change in walking pattern or balance problems, persistent numbness, reduced sensation, or loss of sensation, memory loss, or disorientation.
All these symptoms may indicate a serious and potentially life-threatening brain condition called progressive multifocal leukoencephalopathy. If these symptoms occurred before treatment with Pomalidomide Grindeks, inform the doctor about any changes in these symptoms.
After completing treatment, the patient should return all unused capsules to the pharmacy.
Pregnancy, contraception and breastfeeding – information for women and men
As indicated below, pregnancy prevention programme requirements must be followed during treatment with Pomalidomide Grindeks. Women taking Pomalidomide Grindeks must not become pregnant, and men treated with pomalidomide must not allow their female partner to become pregnant, because this medicine is expected to harm the unborn child. The patient and his/her partner must use effective contraception methods during treatment with this medicine.
Women
Do not use Pomalidomide Grindeks if the patient is pregnant, suspects she is pregnant, or plans to become pregnant, because this medicine is expected to harm the unborn child. Before starting treatment, the patient should inform the treating doctor that she could become pregnant, even if she considers it unlikely.
If the patient could become pregnant:

• she must use effective methods of contraception for at least 4 weeks before starting treatment, throughout the entire treatment period, and for at least 4 weeks after treatment ends. The patient should discuss with her treating doctor which method of contraception is best for her.

• each time the medicine is prescribed, the treating doctor will confirm that the patient understands all necessary contraceptive methods she must use to prevent pregnancy.

• the treating doctor will order pregnancy tests before treatment, no less frequently than every 4 weeks during treatment, and at least 4 weeks after treatment ends.

If the patient becomes pregnant despite using preventive methods:

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

Breastfeeding
It is not known whether Pomalidomide Grindeks passes into human milk. If the patient is breastfeeding or plans to breastfeed, she must inform her treating doctor. The treating doctor will advise whether she should stop or continue breastfeeding.
Men
Pomalidomide Grindeks passes into human semen.

• If the partner is pregnant or could become pregnant, the man must use condoms throughout the entire treatment period and for 7 days after treatment ends.
• If the partner of a man undergoing treatment with Pomalidomide Grindeks becomes pregnant, inform the doctor immediately. The partner should immediately consult a doctor. The patient must not donate blood or sperm 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 Grindeks, the patient will undergo regular blood tests. This is because the medicine may reduce the number of blood cells (white blood cells) that help fight infections, and reduce the number of platelets that help stop bleeding.
The treating doctor should schedule blood tests for the patient:

• before treatment,
• weekly during the first 8 weeks of treatment,
• thereafter at least once a month for as long as the patient is taking Pomalidomide Grindeks.

The treating doctor may adjust the dose of Pomalidomide Grindeks or discontinue treatment based on the patient's blood test results. The treating doctor may also change the dose or discontinue the medicine due to the patient's overall health condition.
Children and adolescents
Pomalidomide Grindeks is not recommended for use in children and adolescents under 18 years of age.
Pomalidomide Grindeks and other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, because Pomalidomide Grindeks may affect the action of other medicines. Other medicines may also affect the action of Pomalidomide Grindeks.
Before taking Pomalidomide Grindeks, inform the doctor, pharmacist, or nurse, especially if the patient is taking any of the following medicines:

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

Driving and operating machinery
While taking Pomalidomide Grindeks, some people may experience fatigue, dizziness, fainting, disorientation, or reduced alertness. If such symptoms occur, the patient should not drive, use tools, or operate machinery.
Pomalidomide Grindeks
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is considered "sodium-free".
Pomalidomide Grindeks contains azo dyes
The capsules contain azo dyes: brilliant black PN (all strengths), azorubine (carmoisine) (all strengths), and orange-yellow FCF (only 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.
This medicine should always be taken exactly as directed by the physician. If in doubt, consult
your doctor, pharmacist, or nurse.

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

• Read the package leaflets for bortezomib and dexamethasone for further information about their use and effects.
• Pomalidomide Grindeks, bortezomib, and dexamethasone are administered in treatment cycles. Each cycle lasts 21 days (3 weeks).
• The table below shows which medicines should be taken on each day of the 3-week cycle:
  o Each day, locate the corresponding day in the table and check which medicines to take.
  o On some days, all three medicines are taken; on other days, only two or one medicine, or no medicine at all.

PMD: Pomalidomide Grindeks; BOR: bortezomib; DEX: dexamethasone
Cycles 1 to 8 Cycle 9 and 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, begin a new cycle.

Pomalidomide Grindeks with dexamethasone only

• Read the package leaflet for dexamethasone for further information about its use and effects.
• Pomalidomide Grindeks and dexamethasone are administered in treatment cycles. Each cycle lasts 28 days (4 weeks).
• The table below shows which medicines should be taken on each day of the 4-week cycle:
  o Each day, locate the corresponding day in the table and check which medicines to take.
  o On some days, both medicines are taken; on other days, only one medicine, or no medicine at all.

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, begin a new cycle.

What dose of Pomalidomide Grindeks should be taken 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 determined by the physician based on the patient's height and body weight (1.3 mg/m² body surface area).
• The recommended starting dose of dexamethasone is 20 mg once daily. However, if the patient is 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 the patient is over 75 years of age, the recommended starting dose is 20 mg once daily.

Your doctor may reduce the dose of Pomalidomide Grindeks, bortezomib, or dexamethasone, or
discontinue treatment with one or more of these medicines, depending on blood test results,
the patient's general health, concomitant use of other medicines (e.g. ciprofloxacin, enoxacin,
and fluvoxamine), or if treatment-related adverse reactions occur (especially rash and swelling).

If the patient has liver or kidney disease, the treating physician will closely monitor the
patient's health during treatment with this medicine.

How to take Pomalidomide Grindeks

• 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 and thoroughly with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should be carefully removed to avoid skin exposure, placed in a sealed polyethylene plastic bag, and disposed of according to local regulations. Hands should then be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant should not handle the blister pack or capsule.
• Swallow the capsules whole—preferably with water.
• The capsules may be taken with or without food.
• Pomalidomide Grindeks should be taken approximately at the same time each day.

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

If the patient has kidney problems and is on dialysis, the treating physician will advise
how and when to take Pomalidomide Grindeks.

Duration of treatment with Pomalidomide Grindeks
Continue treatment cycles until the physician decides to discontinue therapy.

If you take more Pomalidomide Grindeks than you should
If a patient takes more than the prescribed dose, they should immediately contact their
physician or go to the hospital. The patient should bring the medicine packaging with them.

If you forget to take Pomalidomide Grindeks
If a patient misses a dose of Pomalidomide Grindeks on the day it should have been taken,
take the next capsule at the usual time the following day. Do not take a double dose to make up for a missed capsule of Pomalidomide Grindeks.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If any of the following serious adverse reactions occur, stop taking Pomalidomide Grindeks
immediately and contact a doctor without delay – immediate treatment may be required.

• Fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (due to reduced number of white blood cells which help fight infection).
• Bleeding or bruising without cause, including nosebleeds, or bleeding from the intestines or stomach (due to the effect of the medicine on blood cells called platelets).
• Rapid breathing, fast 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 diarrhoea (also with abdominal pain or fever) caused by bacteria called Clostridium difficile.
• Chest pain or leg pain and swelling, particularly in the calf (due to blood clots).
• Shallow breathing (due to severe chest infections, pneumonia, heart failure or blood clots).
• Swelling of the face, lips, tongue and throat, possibly causing difficulty in breathing (due to severe forms of allergic reaction 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 the development of skin growths. If a patient notices any changes on the skin while taking Pomalidomide Grindeks, this should be reported to the doctor as quickly as possible.
• Reactivation of hepatitis B virus infection, which may cause yellowing of the skin and whites of the eyes, dark-coloured urine, pain in the right side of the abdomen, fever, nausea and vomiting. Seek medical advice immediately if these symptoms occur.
• Widespread rash, high body temperature, swollen lymph nodes and involvement of other organs (drug rash with eosinophilia and systemic symptoms also known as DRESS or drug hypersensitivity syndrome, toxic epidermal necrolysis or Stevens-Johnson syndrome). If these symptoms occur, stop taking pomalidomide immediately and contact a doctor or seek immediate medical help. See also section 2.

If any of the above serious adverse reactions occur, stop taking Pomalidomide Grindeks
immediately and contact a doctor without delay – immediate treatment may be required.
Other adverse reactions
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.
• Influenza-like symptoms (flu).
• Decreased number of red blood cells which may lead to anaemia causing fatigue 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 blood sugar levels.
• Fast and irregular heartbeat (atrial fibrillation).
• Loss of appetite.
• Constipation, diarrhoea or nausea.
• Vomiting.
• Abdominal pain.
• Lack of energy.
• Difficulty falling asleep or staying asleep.
• Dizziness, tremor.
• Muscle cramps, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling or burning sensation of the skin, pain in hands or feet (sensory peripheral neuropathy).
• Swelling of the body, including hands and feet.
• Skin rashes.
• Urinary tract infection, which may cause burning when passing urine or the need to pass urine more frequently.

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

• Fainting.
• Bleeding within the skull.
• Reduced ability to move or feel in the hands, arms, feet and legs due to nerve damage (sensory-motor peripheral neuropathy).
• Numbness, itching and tingling of the skin (paraesthesiae).
• Sensation of spinning in the head making it difficult to maintain proper standing position and normal movement.
• Swelling caused by fluid accumulation.
• Urticaria.
• Skin rashes.
• Itching of the skin.
• Shingles.
• Heart attack (chest pain spreading to arms, neck, jaw, feeling of sweating and breathlessness, nausea or vomiting).
• Chest pain, infection in the chest area.
• Increased blood pressure.
• Simultaneous decrease in the number of red and white blood cells and platelets (pancytopenia), making the patient more susceptible to bleeding and bruising. The patient may feel tired, weak and short of breath. The patient also becomes 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, general weakness, muscle cramps, irritability and may lead to low levels of calcium in the blood (hypocalcaemia), which may cause numbness and/or tingling of hands, feet or lips, muscle cramps, muscle weakness, pre-syncope, confusion.
• Low levels of phosphates in the blood (hypophosphataemia) which may cause muscle weakness and irritability or confusion.
• High levels of calcium in the blood (hypercalcaemia) which may cause slowed reflexes and skeletal muscle weakness.
• High levels of potassium in the blood which may cause irregular 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 lead to joint inflammation in the form of gout.
• Low blood pressure which may cause dizziness or fainting.
• Pain or dryness in the mouth.
• Changes in taste sensation.
• Abdominal swelling.
• Feeling of disorientation.
• Depression.
• Loss of consciousness, fainting.
• Clouding of the eye (cataract).
• Kidney damage.
• Inability to pass urine.
• Abnormal liver function tests.
• Pelvic pain.
• Weight loss.

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

• Stroke.
• Hepatitis, which may cause itching of the skin, yellowing of the skin and whites of the eyes (jaundice), pale-coloured stools, dark-coloured urine and abdominal pain.
• Tumour lysis syndrome (breakdown of tumour cells leading to release of toxic substances into the blood), which may lead to kidney problems.
• Hypothyroidism, which may cause symptoms such as fatigue, lethargy, muscle weakness, slow heart rate, weight gain.

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

• Rejection of transplanted solid organs (such as heart or liver).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps 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 or Expiry date (EXP). The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use Pomalidomide Grindeks if you notice any damage or signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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 ingredients are: pregelatinized starch LM grade, maltodextrin, crospovidone, colloidal anhydrous silica, sodium stearyl fumarate.
• The capsule shell contains: gelatin, titanium dioxide (E171), colourants (iron oxide yellow (E172), iron oxide black (E172), brilliant black (E151), patent blue V (E131), azorubine (E122), brilliant blue FCF (E133)) and white printing ink (shellac, titanium dioxide (E171), sodium hydroxide, propylene glycol and povidone).

Pomalidomide Grindeks, 2 mg, hard capsules

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

Pomalidomide Grindeks, 3 mg, hard capsules

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

Pomalidomide Grindeks, 4 mg, hard capsules

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

What Pomalidomide Grindeks looks like and contents of the pack
Pomalidomide Grindeks, 1 mg are hard gelatin capsules of 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 are hard gelatin capsules of size 3 (approximately 16 mm × 6 mm) with an orange, opaque body, printed with "P2" in white ink, and a dark blue, opaque cap.
Pomalidomide Grindeks, 3 mg are hard gelatin capsules of 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 are hard gelatin capsules of size 1 (approximately 19 mm × 7 mm) with a blue, opaque body, printed with "P4" in white ink, and a dark blue, opaque cap.
The capsules are available in packs of 14 or 21 capsules (2 or 3 blisters per pack, each blister containing 7 capsules) or in packs of 14 x 1 or 21 x 1 capsules in a perforated, single-dose blister, all contained in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS GRINDEKS
Krustpils iela 53,
Rīga, LV-1057,
Latvia
Tel.: +371 67083205
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area 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
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
Greece Pomalidomide/Grindeks
Spain Pomalidomida Grindeks 1 mg, 2 mg, 3 mg, 4 mg cápsula dura
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
Ireland Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg hard capsule
Lithuania Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg kietosios kapsulės
Latvia Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg cietās kapsulas
Germany Pomalidomid Grindeks 1 mg, 2 mg, 3 mg, 4 mg Hartkapseln
Norway Pomalidomide Grindeks
Poland Pomalidomide Grindeks
Portugal Pomalidomida Grindeks 1 mg, 2 mg, 3 mg, 4 mg cápsula
Czech Republic Pomalidomide Grindeks
Romania Pomalidomidă Grindeks 1 mg capsule Pomalidomidă Grindeks 2 mg capsule Pomalidomidă Grindeks 3 mg capsule Pomalidomidă Grindeks 4 mg capsule
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
Slovenia Pomalidomid Grindeks 1 mg, 2 mg, 3 mg, 4 mg trde kapsule
Sweden Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg hårda kapslar
Hungary Pomalidomide Grindeks 1 mg, 2 mg, 3 mg, 4 mg kemény kapszula
Italy Pomalidomide Grindeks