POMALIDOMIDE 1 mg Hard Capsule

Зміст інструкції

1. Pomalidomide EVER PHARMA 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules
   1. What is Pomalidomide EVER PHARMA and what is it used for
   2. What you need to know before taking Pomalidomide EVER PHARMA
   3. How to take Pomalidomide EVER PHARMA
   4. Possible side effects
   5. How to store Pomalidomide EVER PHARMA
   6. Package Contents and Other Information

Pomalidomide EVER PHARMA 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules

pomalidomide

Generic medicine

Pomalidomide EVER PHARMA is expected to cause congenital malformations and may
cause fetal death.

• Do not take this medicine if you are pregnant or might become pregnant.
• Follow the advice on contraceptive methods described in this leaflet.

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Pomalidomide EVER PHARMA and what is it used for

What is Pomalidomide EVER PHARMA
Pomalidomide EVER PHARMA contains the active ingredient “pomalidomide”. This medicine is
related to thalidomide and belongs to a group of medicines that act on the immune system (the
body’s natural defenses).

What is Pomalidomide EVER PHARMA used for
Pomalidomide EVER PHARMA is used in the treatment of adults with a type of cancer
called “multiple myeloma”.
Pomalidomide EVER PHARMA is used together with:

• two other medicines, called “bortezomib” (a type of chemotherapeutic medicine) and “dexamethasone” (an anti-inflammatory medicine), in patients who have received at least one other therapy including lenalidomide.

Or

• another medicine, called “dexamethasone”, in patients in whom the myeloma has worsened despite at least two other therapies including lenalidomide and bortezomib.

What is multiple myeloma
Multiple myeloma is a type of cancer that affects a certain type of white blood cells (called
“plasma cells”). These cells grow uncontrollably and accumulate in the bone marrow.
This causes damage to the 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 happens, it is referred to as “response”.

How does Pomalidomide EVER PHARMA work
Pomalidomide EVER PHARMA works in several ways:

• stopping the development of myeloma cells
• stimulating the immune system to attack cancer cells
• stopping the formation of blood vessels that feed cancer cells.

The benefit of using Pomalidomide EVER PHARMA together with bortezomib and dexamethasone
When Pomalidomide EVER PHARMA is used together with bortezomib and dexamethasone, in patients
who have received at least one other therapy, it can prevent multiple myeloma from worsening:

• On average, Pomalidomide EVER PHARMA, used with bortezomib and dexamethasone, prevented the recurrence of multiple myeloma for a period of up to 11 months, compared to 7 months for patients treated with bortezomib and dexamethasone alone.

The benefit of using Pomalidomide EVER PHARMA together with dexamethasone
When Pomalidomide EVER PHARMA is used together with dexamethasone, in patients who have received
at least two other therapies, it can prevent multiple myeloma from worsening:

• On average, Pomalidomide EVER PHARMA, used with dexamethasone, prevented the recurrence of multiple myeloma for a period of up to 4 months, compared to 2 months for patients treated with dexamethasone alone.

2. What you need to know before taking Pomalidomide EVER PHARMA

Do not take Pomalidomide EVER PHARMA

• If you are pregnant or if you think you may be pregnant, or if you are planning a pregnancy, because Pomalidomide EVER PHARMA is expected to harm the fetus. (Men and women taking this medicine must read the “Pregnancy, contraception and breastfeeding – information for women and men” section below).
• If there is a possibility that you might become pregnant unless you follow all the necessary measures to avoid pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If there is a possibility that you might become pregnant, on each prescription your doctor will record that the necessary measures have been taken and will provide you with this 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 may be allergic, ask your doctor for advice.

If you are not sure whether any of the above conditions apply to you, consult your doctor, your
pharmacist or your nurse before taking Pomalidomide EVER PHARMA.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Pomalidomide EVER PHARMA
if:

• you have had episodes of blood clots in the past. During treatment with Pomalidomide EVER PHARMA there is a higher risk of blood clots forming in the veins (thrombosis) and in the arteries. Your doctor may recommend additional treatments (e.g. warfarin) or reduce the dose of Pomalidomide EVER PHARMA to reduce the likelihood of blood clots forming;
• if you have had an allergic reaction in the past, 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 difficulty breathing, or if you smoke, have high blood pressure or high levels of cholesterol;
• you have a high tumor burden throughout the body, including in the bone marrow. This could cause a condition in which tumors break down and cause the presence of unusual levels of chemicals in the blood, which can lead to kidney failure. An irregular heartbeat may also appear. This condition is called tumor lysis syndrome;
• you have or have had neuropathy (nerve damage that causes tingling or pain in the hands or feet).
• you have or have had hepatitis B infection in the past. Treatment with Pomalidomide EVER PHARMA may cause reactivation of the hepatitis B virus in patients carrying this virus, resulting in a recurrence of the infection. Your doctor must check if you have ever had a hepatitis B infection.
• you have or have had any combination of the following symptoms: rash on the face or more widespread, 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), or drug hypersensitivity syndrome, toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome (SJS), see also section 4 “Possible side effects”).

It is important to note that patients with multiple myeloma treated with pomalidomide may develop
other types of cancer; therefore, the doctor must carefully assess the benefit and risk when
prescribing this medicine.
At any time during or after treatment, immediately inform your doctor or nurse
if you experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in an
arm or leg, changes in the way you walk or problems with balance, persistent numbness, reduced
sensation or loss of sensation, memory loss or confusion. These may
be symptoms of a serious brain disease that can be fatal, known as
progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment
with Pomalidomide EVER PHARMA, tell your doctor about any changes in these symptoms.
At the end of treatment, return all unused capsules to your pharmacist.

Pregnancy, contraception and breastfeeding – information for women and men
The following instructions must be followed, as indicated in the Pomalidomide EVER PHARMA Pregnancy Prevention Program.
Women and men taking Pomalidomide EVER PHARMA must not start a
pregnancy or conceive a child, because pomalidomide is expected to harm the fetus. You and
your partner must use effective contraceptive measures during treatment with this
medicine.
Women
Do not take Pomalidomide EVER PHARMA if you are currently pregnant, if you suspect or
are planning a pregnancy, because this medicine is expected to harm the fetus. Before
starting treatment, you must inform your doctor if there is a possibility of becoming pregnant, even if you think it is unlikely.
If there is a 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 best contraceptive method for you.
• On each prescription, your doctor will ensure that you understand what measures need to be taken to prevent pregnancy.
• Your doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment and at least 4 weeks after the end of treatment.

If you become pregnant despite preventive measures:

• you must stop treatment immediately and consult your doctor immediately

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

• If your partner is pregnant or there is a possibility that she might become pregnant, you must use condoms throughout the duration of treatment and for 7 days after the end of treatment.
• If your partner becomes pregnant during treatment with Pomalidomide EVER PHARMA, inform your doctor immediately. Your partner should also inform her doctor immediately.

You must not donate seminal fluid or sperm during treatment and for 7 days after the end of
treatment.

Blood donation and blood tests
You must not donate blood during treatment and for 7 days after the end of treatment.
Before and during treatment with Pomalidomide EVER PHARMA you will undergo regular blood
tests, as this medicine can cause a reduction in blood cells that
fight infections (white blood cells) and cells that stop bleeding (platelets).
Your doctor will ask you to have blood tests:

• before treatment
• every week for the first 8 weeks of treatment
• at least once a month thereafter, throughout the period of treatment with Pomalidomide EVER PHARMA.

Based on the results of these tests, your doctor may change the dose of Pomalidomide EVER
PHARMA or stop treatment. Your doctor may also change the dose or stop the
treatment based on your overall health status.

Children and adolescents
The use of Pomalidomide EVER PHARMA is not recommended in children and adolescents under
18 years of age.

Other medicines and Pomalidomide EVER PHARMA
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines. This is because Pomalidomide EVER PHARMA can affect
the action of other medicines and other medicines can affect the action of Pomalidomide EVER
PHARMA.
In particular, tell your doctor, pharmacist or nurse before taking Pomalidomide EVER
PHARMA if you are taking any of the following medicines:

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

Driving and operating machinery
Some people may experience fatigue, dizziness, feeling faint, confusion or reduced
vigilance when taking Pomalidomide EVER PHARMA. If this happens, do not drive vehicles and do
not use tools or machinery.

Pomalidomide EVER PHARMA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

Pomalidomide EVER PHARMA contains lactose
Pomalidomide EVER PHARMA contains lactose monohydrate. If you have been diagnosed with a
lactose intolerance, contact your doctor before taking this medicine.

3. How to take Pomalidomide EVER PHARMA

Pomalidomide EVER PHARMA must be administered by a physician experienced in the treatment of
multiple myeloma.
Take the medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor, pharmacist or nurse.

When to take Pomalidomide EVER PHARMA with other medicines
Pomalidomide EVER PHARMA with bortezomib and dexamethasone
use and their effects.

• Pomalidomide EVER PHARMA, bortezomib and dexamethasone are taken in “treatment cycles”. Each cycle lasts 21 days (3 weeks).
• Consult the following table to find out what to take each day of the 3-week cycle: o Every day check the chart and find the correct day to know which medicines to take. o Some days you will take all 3 medicines, some days only 2 or 1 medicine and other days no medicine. POM: Pomalidomide; BOR: Bortezomib; DEX: Dexamethasone

Cycle 1 to 8 From Cycle 9 onwards

Name of the medicineName of the medicine
DayPOMBORDEXDayPOMBORDEX
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√
1515
1616
1717
1818
1919
2020
2121

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

Pomalidomide EVER PHARMA with dexamethasone alone
effects.

• Pomalidomide EVER PHARMA and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
• Consult the following table to find out what to take each day of the 4-week cycle: o Every day check the chart and find the correct day to know which medicines to take. o Some days you will take both medicines, some days only 1 medicine and other days no medicine.

POM: Pomalidomide; DEX: Dexamethasone

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

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

Dose of Pomalidomide EVER PHARMA to be taken with other medicines
Pomalidomide EVER PHARMA with bortezomib and dexamethasone

• The recommended initial dose of Pomalidomide EVER PHARMA is 4 mg once a day.
• The recommended initial dose of bortezomib will be established by the doctor based on your height and weight (1.3 mg/m of body surface area).
• The recommended initial dose of dexamethasone is 20 mg per day. However, if you are over 75 years of age, the recommended initial dose is 10 mg per day.

Pomalidomide EVER PHARMA with dexamethasone alone

• The recommended initial dose of Pomalidomide EVER PHARMA is 4 mg once a day.
• The recommended initial dose of dexamethasone is 40 mg per day. However, if you are over 75 years of age, the recommended initial dose is 20 mg per day.

The doctor may need to reduce the dose of Pomalidomide EVER PHARMA, bortezomib or dexamethasone
or discontinue one or more of these medicines based on the results of blood tests,
your general condition, other medicines you may be taking (e.g. ciprofloxacin,
enoxacin and fluvoxamine) and if adverse effects (in particular rash or
swelling) occur due to treatment.
If you have liver or kidney problems, the doctor will monitor your condition very carefully
during treatment with this medicine.

How to take Pomalidomide EVER PHARMA

• Do not break, open or chew the capsules. If the powder from a broken capsule comes into contact with the skin, wash the skin immediately and thoroughly with water and soap.
• Healthcare professionals, those providing assistance to the patient and family members must wear disposable gloves when handling the blister or the capsule. The gloves should then be removed carefully to avoid skin exposure, placed in a sealable polyethylene bag and disposed of in accordance with local regulations. Then wash your hands thoroughly with water and soap. Pregnant or suspected pregnant women should not handle the blister or capsule.
• Swallow the tablets whole, preferably with water.
• The capsules can be taken with or without food.
• Take the capsules every day at about the same time.

To remove the capsule from the blister, press on only one side of the capsule, pushing it through the
aluminum foil. Do not press on the center of the capsule, otherwise there is a risk of breaking it.

The doctor will inform you how and when to take Pomalidomide EVER PHARMA if you have
kidney problems and are undergoing dialysis.

Duration of treatment with Pomalidomide EVER PHARMA
You must continue the treatment cycles until the doctor tells you to stop the treatment

If you take more Pomalidomide EVER PHARMA than you should
If you take more Pomalidomide EVER PHARMA than you should, consult your doctor or go to
hospital immediately. Bring the medicine packaging with you.

If you forget to take Pomalidomide EVER PHARMA
If you forget to take Pomalidomide EVER PHARMA on the prescribed day, take the next capsule
as usual the next day. Do not increase the number of capsules you take to
make up for the Pomalidomide EVER PHARMA capsules you did not take the previous day.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects
Stop taking Pomalidomide EVER PHARMA and consult your doctor immediately if you
experience any of the following serious side effects – urgent medical treatment may be needed:

• Fever, chills, sore throat, cough, mouth sores, or any other sign of infection (due to a lower number of white blood cells, which fight infections).
• Bleeding or bruising easily, including nosebleeds and bleeding from the intestines or stomach (due to effects on blood cells called “platelets”).
• Rapid breathing, rapid heartbeat, fever and chills, decreased or absent urination, nausea and vomiting, confusion, loss of consciousness (due to a blood infection called sepsis or septic shock).
• Severe, persistent, or bloody diarrhea (possibly with stomach pain or fever) caused by bacteria called Clostridium difficile.
• Chest pain or pain and swelling in the legs, especially 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 can cause difficulty breathing (due to severe types of allergic reactions called angioedema and anaphylactic reaction).
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in the appearance or growths on the skin. If you notice any skin changes during treatment with Pomalidomide EVER PHARMA, tell your doctor as soon as possible.
• Reappearance of hepatitis B infection, which can cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, and nausea or vomiting. Tell your doctor immediately if you notice any of these symptoms.
• Widespread rash, high body temperature, swollen lymph nodes, and involvement of other organs of the body (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 seek your doctor or immediate medical attention. See also paragraph 2.

Stop taking Pomalidomide EVER PHARMA and consult your doctor immediatelyif you
experience any of the serious side effects listed above: urgent medical treatment may be needed.

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

• Shortness of breath (dyspnea).
• Lung infections (pneumonia and bronchitis).
• Infections of the nose, sinuses, and throat caused by bacteria or viruses.
• Flu-like symptoms (influenza).
• Low number of red blood cells, which can cause anemia with resulting fatigue and weakness.
• Low levels of potassium in the blood (hypokalemia), which can cause weakness, muscle cramps, muscle pain, palpitations, tingling or numbness, dyspnea, mood changes.
• High blood sugar levels.
• Fast and irregular heartbeat (atrial fibrillation).
• Decreased appetite.
• Constipation, diarrhea, or nausea.
• Vomiting.
• Abdominal pain.
• Lack of energy.
• Difficulty falling asleep or staying asleep.
• Dizziness, tremor.
• Muscle spasm, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling, or burning sensation on the skin, pain in the hands or feet (peripheral sensory neuropathy).
• Swelling of the body, including swelling of the arms and legs.
• Skin rashes.
• Urinary tract infection, which can cause a burning sensation during urination or the need to urinate more often.

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

• Falls.
• Bleeding inside the skull.
• Reduced ability to move or feel sensations in the hands, arms, feet, and legs due to damage to the nervous system (peripheral sensorimotor neuropathy).
• Numbness, itching, and pins and needles sensation on the skin (paresthesia).
• Feeling of dizziness, with difficulty getting up and moving normally.
• Swelling caused by fluids.
• Hives.
• Itching.
• Shingles (herpes zoster).
• Heart attack (chest pain radiating to the 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) which makes you more susceptible to bleeding and bruising. You may experience fatigue, weakness, and shortness of breath and are also more likely to develop infections.
• Reduced number of lymphocytes (a type of white blood cell) often caused by infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesemia), which can cause fatigue, generalized weakness, muscle cramps, irritability, and can lead to a decrease in calcium levels in the blood (hypocalcemia), with possible numbness and/or tingling of the hands, feet, or lips, muscle cramps, muscle weakness, dizziness, confusion.
• Low levels of phosphate in the blood (hypophosphatemia), which can cause muscle weakness and irritability or confusion.
• High levels of calcium in the blood (hypercalcemia), which can cause slowed reflexes and skeletal muscle weakness.
• High levels of potassium in the blood, which can cause an abnormal heart rhythm.
• Low levels of sodium in the blood, which can cause fatigue and confusion, muscle spasms, seizures, or coma.
• High levels of uric acid in the blood, which can cause a form of arthritis called gout.
• Low blood pressure, which can cause dizziness or fainting.
• Painful or dry mouth.
• Altered sense of taste.
• Bloated abdomen.
• Feeling confused.
• Feeling down (depressed mood).
• Loss of consciousness, fainting.
• Blurred vision (cataracts).
• Kidney damage.
• Inability to urinate.
• Abnormal liver function tests.
• Pelvic pain.
• Weight loss.

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

• Stroke.
• Inflammation of the liver (hepatitis), which can cause itching, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine, and abdominal pain.
• Disintegration of tumor cells, which releases toxic compounds into the bloodstream (tumor lysis syndrome). This can cause kidney problems.
• Thyroid gland not functioning sufficiently, which can cause symptoms such as fatigue, sluggishness, muscle weakness, slow heartbeat, and weight gain.

Side effects of unknown frequency(frequency cannot be estimated based on available data):

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through 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 EVER PHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the package after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use Pomalidomide EVER PHARMA if you notice damage or signs of tampering with the
medicine packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Pomalidomide EVER PHARMA contains

• The active ingredient is pomalidomide
• The other ingredients are lactose monohydrate, crospovidone (E1202), povidone (E1201), sodium lauryl sulfate and sodium stearyl fumarate (E485).

Pomalidomide EVER PHARMA 1 mg hard capsules:

• Each hard capsule contains 1 mg of pomalidomide.
• The capsule shell contains: gelatin (E441), titanium dioxide (E171), brilliant blue FCF (E133) and yellow iron oxide (E172).
• The printing ink contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172) and potassium hydroxide (E525).

Pomalidomide EVER PHARMA 2 mg hard capsules:

• Each hard capsule contains 2 mg of pomalidomide.
• The capsule shell contains: gelatin (E441), titanium dioxide (E171), brilliant blue FCF (E133), yellow iron oxide (E172) and red iron oxide (E172).
• The printing ink contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172) and potassium hydroxide (E525).

Pomalidomide EVER PHARMA 3 mg hard capsules:

• Each hard capsule contains 3 mg of pomalidomide.
• The capsule shell contains: gelatin (E441), titanium dioxide (E171), brilliant blue FCF (E133) and yellow iron oxide (E172).
• The printing ink contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172) and potassium hydroxide (E525).

Pomalidomide EVER PHARMA 4 mg hard capsules:

• Each hard capsule contains 4 mg of pomalidomide.
• The capsule shell contains: gelatin (E441), titanium dioxide (E171) and brilliant blue FCF (E133).
• The printing ink contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172) and potassium hydroxide (E525).

Description of the appearance of Pomalidomide EVER PHARMA and contents of the pack
Pomalidomide EVER PHARMA 1 mg hard capsules: Hard gelatin capsule (14.3 mm in
length), with opaque blue cap and opaque yellow body, with “T” printed on the cap and “1” on the body.
Pomalidomide EVER PHARMA 2 mg hard capsules: Hard gelatin capsule (18.0 mm in
length), with opaque blue cap and opaque orange body, with “T” printed on the cap and “2” on the body.
Pomalidomide EVER PHARMA 3 mg hard capsules: Hard gelatin capsule (18.0 mm in
length), with opaque blue cap and opaque green body, with “T” printed on the cap and “3” on the body.
Pomalidomide EVER PHARMA 4 mg hard capsules: Hard gelatin capsule (18.0 mm in
length), with opaque blue cap and opaque light blue body, with “T” printed on the cap and “4” on the body.
The capsules are packaged in blister packs, whole and divisible for a single dose, made of PVC/PE/PVDC-
Aluminum and in blister packs, whole and divisible for a single dose, made of PVC/PCTFE/PVC-Aluminum.
Packs:
1 mg: 21 capsules
2 mg: 21 capsules
3 mg: 14 capsules
4 mg: 21 capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Ever Pharma Italia S.r.l.
Via Riccardo Gigante 4
00143 Rome
Italy

Manufacturer
Actavis Group PTC ehf.,
Dalshraun 1
IS-220 Hafnarfjordur,
Iceland
Balkanpharma Dupnitsa
AD, Samokovsko
Shosse 3, 2600
Dupnitsa, Bulgaria
Merckle GmbH, Graf-
Arco-Str. 3, 89079 Ulm,
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
IT: Pomalidomide EVER PHARMA
SE: Pomalidomide EVER PHARMA