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 result in 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 so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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 regimen containing lenalidomide

or

• one other medicine, dexamethasone, in patients with multiple myeloma whose disease has worsened despite having previously received at least two prior treatment regimens including 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, leading to bone and kidney damage.
Multiple myeloma is generally considered incurable. However, treatment may relieve both objective and subjective symptoms of the disease or cause the disease to go into remission 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 in combination 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 in combination 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 "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 methods 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, she/he should 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 experienced 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/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 a condition called tumour lysis syndrome, in which tumours break down rapidly, causing abnormal levels of chemical substances 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 a 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 (observed symptoms of a severe skin reaction known as "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 should be emphasized that in patients with multiple myeloma treated with pomalidomide,
development of additional types of cancer may occur. Therefore, the treating physician should
carefully assess 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 the following symptoms occur: vision disturbances, loss of vision or 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 of these symptoms may indicate a serious and potentially life-threatening brain disorder
called progressive multifocal leukoencephalopathy (PML). If these symptoms occurred before
starting 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 cause pregnancy in their partners,
because this medicine is expected to harm the unborn child. The patient and his/her partner should
use effective methods of contraception 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 contraception methods 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 contraception method is most suitable for her.

• each time the medicine is prescribed, the treating doctor will ensure 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 inform her treating doctor without delay.

Breastfeeding
It is not known whether Pomalidomide Grindeks passes into human breast milk. If the patient is
breastfeeding or intends 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 seek medical advice without delay. The patient must not donate sperm or 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 Grindeks, regular blood tests will be performed. This
is because this 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:

• 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 interrupt treatment based
on the patient's blood test results. The treating doctor may also change the dose or discontinue
treatment 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 currently taken, recently used, or planned for
use, 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 using machines
While taking Pomalidomide Grindeks, some people may experience fatigue,
dizziness, fainting, disorientation or reduced alertness. If such symptoms occur
in the patient, driving, using tools or operating machinery should be avoided.
Pomalidomide Grindeks medicine
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 prescribed by your doctor. 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 should be taken.
  o On some days, all 3 medicines are taken; on other days, only 2 or 1 medicine is taken, and on some days, no medicines are taken.

PMD: Pomalidomide Grindeks; BOR: bortezomib; DEX: dexamethasone
Cycles 1 to 8 Cycle 9 and onwards
Medicine Medicine
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 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 should be taken.
  o On some days, both medicines are taken; on other days, only 1 medicine is taken, and on some days, no medicines are taken.

PMD: Pomalidomide Grindeks; DEX: dexamethasone
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 √

After completing each 4-week cycle, start 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 doctor 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 status, concomitant use of other medicines (e.g. ciprofloxacin, enoxacin, and fluvoxamine), and 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
Treatment cycles should be continued until the doctor decides to discontinue treatment.

Taking more than the recommended dose of Pomalidomide Grindeks
If a dose higher than recommended is taken, the patient should immediately inform the doctor or go to the hospital. The patient should bring the medicine packaging.

Missing a dose of Pomalidomide Grindeks
If a dose of Pomalidomide Grindeks is missed 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 the 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 your doctor without delay – immediate treatment may be required.

• Fever, chills, sore throat, cough, mouth ulcers, or any other signs of infection (due to reduced numbers of white blood cells, which help fight infection).
• Bleeding or bruising without cause, including nosebleeds, or intestinal or stomach bleeding (due to the medicine's effect 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, which may cause breathing difficulties (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 the patient notices any skin changes 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 urine, right-sided abdominal pain, fever, nausea, and vomiting. Seek medical advice immediately if these symptoms occur.
• Widespread rash, high fever, 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 your doctor or seek urgent medical help. See also section 2.

If any of the above serious adverse reactions occur, stop taking Pomalidomide Grindeks
immediately and contact your 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.
• Flu-like symptoms (influenza).
• Decreased number of red blood cells, which may lead to anaemia causing fatigue and weakness.
• Low blood potassium levels (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 maintaining sleep.
• 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.
• Rash.
• 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).
• A spinning sensation in the head, making it difficult to maintain proper standing posture and movement.
• Swelling caused by fluid accumulation.
• Urticaria (hives).
• Rash.
• Itching of the skin.
• Shingles (herpes zoster).
• 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 red blood cells, 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 blood magnesium levels (hypomagnesaemia), which may cause fatigue, generalised weakness, muscle cramps, irritability, and may lead to low blood calcium levels (hypocalcaemia), which may cause numbness and/or tingling in hands, feet, or lips, muscle cramps, muscle weakness, pre-syncope, confusion.
• Low blood phosphate levels (hypophosphataemia), which may cause muscle weakness and irritability or confusion.
• High blood calcium levels (hypercalcaemia), which may cause slowed reflexes and skeletal muscle weakness.
• High blood potassium levels, which may cause irregular heartbeat.
• Low blood sodium levels, which may cause fatigue and confusion, muscle twitching, seizures (epileptic fits), or coma.
• High blood uric acid levels, 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.
• Low mood (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 stools, dark urine, and abdominal pain.
• Tumour lysis syndrome, which is the breakdown of tumour cells leading to the release of toxic substances into the blood. This may lead to kidney problems.
• Hypothyroidism, which may cause symptoms such as fatigue, lethargy, muscle weakness, slow heart rate, and 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 your 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 to provide more information on the safety of the 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, indicated as EXP or Expiry date (EXP). The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Do not use Pomalidomide Grindeks if you notice any damage or signs of tampering with the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Packaging 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, maltodextr inflammation, 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 perforated dose-divided blisters, 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