POMALIDOMIDE 1 мг Капсулы твердые

Содержание инструкции

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

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

pomalidomide

It is expected that Pomalidomide Krka will 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 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, 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 any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

What is Pomalidomide Krka
Pomalidomide Krka 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
defenses).

What is Pomalidomide Krka used for
Pomalidomide Krka is used in the treatment of adults with a type of cancer called
“multiple myeloma”.
Pomalidomide Krka 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 a “response”.

How does Pomalidomide Krka work
Pomalidomide Krka 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 Krka together with bortezomib and dexamethasone
When Pomalidomide Krka 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 Krka, 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 Krka together with dexamethasone When Pomalidomide Krka 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 Krka, 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 Krka

Do not take Pomalidomide Krka:

• If you are pregnant or think you may be pregnant, or if you are planning a pregnancy, because Pomalidomide Krka is expected to be harmful to 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, pharmacist or nurse before taking Pomalidomide Krka.

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

• you have had episodes of blood clots in the past. During treatment with Pomalidomide Krka there is a higher risk of blood clots forming in the veins (thrombi) and in the arteries. Your doctor may recommend additional treatments (e.g. warfarin) or reduce the dose of Pomalidomide Krka to reduce the likelihood of blood clots forming;
• you have had an allergic reaction in the past, such as skin rash, itching, swelling, feeling dizzy 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 Krka may cause reactivation of the hepatitis B virus in patients carrying this virus, leading to a recurrence of the infection. Your doctor should 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 Krka, tell your doctor about 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 Krka Pregnancy Prevention Program.
Women and men taking Pomalidomide Krka must not start a pregnancy or
conceive a child, because pomalidomide is expected to be harmful to the fetus. You and your partner must use effective contraceptive measures during treatment with this medicine.
Women
Do not take Pomalidomide Krka if you are currently pregnant, if you suspect or are planning a
pregnancy, because this medicine is expected to be harmful to 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. Discuss with your doctor the best method of contraception for you.
• On each prescription, your doctor will ensure that you understand the measures you need to take to prevent pregnancy.
• The doctor will arrange for 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 Krka passes into breast milk. Inform your doctor if you are breastfeeding or intend
to breastfeed. Your doctor will advise you whether to stop or continue breastfeeding.
Men
Pomalidomide Krka 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 Krka, 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 Krka you will undergo regular blood tests,
because 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 Krka.

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

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

Other medicines and Pomalidomide Krka
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines. This is because Pomalidomide Krka can affect the way other
medicines work and other medicines can affect the way Pomalidomide Krka works.
In particular, tell your doctor, pharmacist or nurse before taking Pomalidomide Krka 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 using machines
Some people may experience fatigue, dizziness, feeling faint, confusion or reduced
alertness when taking Pomalidomide Krka. If this happens, do not drive vehicles and do not use
tools or machinery.

Pomalidomide Krka contains sodium and isomaltitol
Pomalidomide Krka contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially
‘sodium-free’.
Pomalidomide Krka contains isomaltitol. If you have been diagnosed with an intolerance to some
sugars, contact your doctor before taking this medicine.

3. How to take Pomalidomide Krka

Pomalidomide Krka must be administered by a doctor 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 Krka with other medicines
Pomalidomide Krka with bortezomib and dexamethasone
use and their effects.

• Pomalidomide Krka, 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:
• Every day check the chart and find the correct day to know which medicines to take.
• Some days you will take all 3 medicines, some days only 2 or 1 medicine and other days no medicine.

POM:Pomalidomide Krka; BOR: Bortezomib; DEX: Dexamethasone

Cycle 1 to 8From Cycle 9 onwards
Medicine nameMedicine name
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 √
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 Krka with dexamethasone alone
its effects.

• Pomalidomide Krka 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:
• Every day check the chart and find the correct day to know which medicines to take.
• Some days you will take both medicines, some days only 1 medicine and other days no medicine.

POM:Pomalidomide Krka; DEX: Dexamethasone

Medicine name

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

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

• The recommended initial dose of Pomalidomide Krka 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 Krka with dexamethasone alone
• The recommended initial dose of Pomalidomide Krka 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 Krka, bortezomib or dexamethasone or
interrupt 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 undesirable effects (in particular skin 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 Krka

• 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 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. Women who are pregnant or suspected of being pregnant should not handle the blister or capsule.
• Swallow the capsules whole, preferably with water.
• The capsules can be taken with or without food.
• Take the capsules every day at approximately the same time.

Taking Pomalidomide Krka
Do not try to push the capsules out of the blister.
To remove the capsule from the blister:

• 1. Hold the blister by the edges and separate one end of the blister from the rest of the blister by gently tearing along the perforations around it.
• 2. Lift the edge of the foil and completely detach the foil.
• 3. Turn the capsule over into your hand.
• 4. Swallow the capsule whole, preferably with water.

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

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

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

If you forget to take Pomalidomide Krka
If you forget to take Pomalidomide Krka on the prescribed day, take the next capsule as
usual the next day. Do not increase the number of capsules to be taken to compensate for
forgetting Pomalidomide Krka 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 Krka 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 intestine or stomach (due to effects on blood cells called “platelets”).
• Rapid breathing, rapid pulse, 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 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 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 Krka, 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 in 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 medical attention immediately. See also paragraph 2.

Stop taking Pomalidomide Krka 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(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, shortness of breath, 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 when urinating or the need to urinate more often.

Common(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 dizzy, with difficulty getting up and moving normally.
• Swelling caused by fluid.
• Hives.
• Itching.
• Shingles (herpes zoster).
• Heart attack (chest pain that radiates 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 prone to bleeding and bruising. You may feel tired, weak, and short 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 cause a lowering of 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 weakness of skeletal muscles.
• 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.
• Abnormalities in liver function tests.
• Pelvic pain.
• Weight loss.

Uncommon(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 cancer cells, causing the release of toxic substances into the bloodstream (tumor lysis syndrome). This can cause kidney problems.
• Thyroid gland not functioning sufficiently, which can cause symptoms such as fatigue, lethargy, muscle weakness, slow heartbeat, and weight gain.

Not known(frequency cannot be estimated from 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 listed in Annex V . By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Pomalidomide Krka

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
Expiry/EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original package to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Unused medicine
should be returned to the pharmacist at the end of treatment. This will help protect the environment.

6. Contents of the pack and other information

What Pomalidomide Krka contains

• The active ingredient is pomalidomide.
• The other components of the capsule contents are isomaltitol, crospovidone (Type A) hypromellose with a low degree of substitution and sodium stearyl fumarate.

Pomalidomide Krka 1 mg hard capsules:

• Each capsule contains 1 mg of pomalidomide.
• The other components in the capsule shell are: gelatin, titanium dioxide (E171), yellow iron oxide (E172), indigo carmine (E132) and printing ink (shellac, black iron oxide (E172), potassium hydroxide).

Pomalidomide Krka 2 mg hard capsules:

• Each capsule contains 2 mg of pomalidomide.
• The other components in the capsule shell are: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) indigo carmine (E132) and printing ink (shellac, titanium dioxide, potassium hydroxide).

Pomalidomide Krka 3 mg hard capsules:

• Each capsule contains 3 mg of pomalidomide.
• The other components in the capsule shell are: gelatin, titanium dioxide (E171), yellow iron oxide (E172), indigo carmine (E132) and printing ink (shellac, titanium dioxide, potassium hydroxide).

Pomalidomide Krka 4 mg hard capsules:

• Each capsule contains 4 mg of pomalidomide.
• The other components in the capsule shell are: gelatin, titanium dioxide (E171), indigo carmine (E132) and printing ink (shellac, titanium dioxide, potassium hydroxide).

See section 2 “Pomalidomide Krka contains sodium and isomaltitol”.

Description of the appearance of Pomalidomide Krka and contents of the pack
Pomalidomide Krka 1 mg hard capsules (capsules):
Hard gelatin capsules, size 2. Capsule length: 17.3±0.5 mm. Capsule body from
light yellow to yellowish-brown with black marking 1. The capsule head is blue. The contents of the
capsule is a powder from light yellow to yellow.
Pomalidomide Krka 2 mg hard capsules (capsules):
Hard gelatin capsules, size 2. Capsule length: 17.3±0.5 mm. The capsule body is
orange to brownish-orange with white marking 2. The capsule head is blue. The contents
of the capsule is a powder from light yellow to yellow.
Pomalidomide Krka 3 mg hard capsules (capsules):
Hard gelatin capsules, size 2. Capsule length: 17.3±0.5 mm. The capsule body is
bluish-green with white marking 3. The capsule head is blue. The contents of the capsule is a
powder from light yellow to yellow.
Pomalidomide Krka 4 mg hard capsules (capsules):
Hard gelatin capsules, size 2. Capsule length: 17.3±0.5 mm. The capsule body is
blue with white marking 4. The capsule head is blue. The contents of the capsule is a powder from
light yellow to yellow.
Each pack contains 14 x 1 or 21 x 1 hard capsules in tearable blister packs, divisible for single dose
child-resistant (calendar packs).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA – FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
For further information on this medicine, contact the local representative of the Marketing Authorisation
Holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Malta

• E. J. Busuttil Ltd. Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Norge
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα
ΒΙΑΝΕΞ Α.Ε.
Τηλ: +30 210 8009111

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 80

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 101

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: + 358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

United Kingdom (Northern Ireland)
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10

Altre fonti d’informazioni
More detailed information on this medicine is available on the website of the European Medicines
Agency: https://www.ema.europa.eu.