Pomalidomide Krka

Patient Information Leaflet

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

pomalidomide
Pomalidomide Krka is expected to cause birth defects and may result in fetal death.

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

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

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

Contents of this leaflet

1. What Pomalidomide Krka is 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

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

What Pomalidomide Krka is
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
defences).
What Pomalidomide Krka is used for
Pomalidomide Krka is used to treat adults with a type of cancer called "multiple myeloma".
Pomalidomide Krka is used in combination with:

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

Or

• one other medicine, called "dexamethasone", in patients whose myeloma has worsened despite at least two prior 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 leads to damage of 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 occurs, it is referred to as a "response".
How Pomalidomide Krka works
Pomalidomide Krka works in several ways:

• by stopping the growth of myeloma cells
• by stimulating the immune system to attack cancer cells
• by inhibiting the formation of blood vessels that supply the 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 prior therapy, it can prevent multiple myeloma from worsening:

• On average, Pomalidomide Krka used with bortezomib and dexamethasone prevented the recurrence of multiple myeloma for 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 prior therapies, it can prevent multiple myeloma from worsening:

• On average, Pomalidomide Krka used with dexamethasone prevented the recurrence of multiple myeloma for 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, think you may be pregnant, or are planning a pregnancy, because Pomalidomide Krka is expected to be harmful to the unborn child. (Men and women taking this medicine should read the section “Pregnancy, contraception and breastfeeding – information for women and men” below).
• If there is any possibility that you may become pregnant unless you follow all necessary measures to avoid pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If there is any possibility of becoming pregnant, your doctor will record at each prescription that the necessary precautions have been taken and will provide you with confirmation of this.
• 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, consult your doctor. If you are unsure whether any of the conditions listed above 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 previously experienced blood clots. There is an increased risk of developing blood clots in the veins (thrombi) and arteries during treatment with Pomalidomide Krka. Your doctor may recommend additional treatments (e.g., warfarin) or reduce the dose of Pomalidomide Krka to lower the risk of blood clots;
• You have previously had an allergic reaction, such as rash, itching, swelling, dizziness, or difficulty breathing, during treatment with related medicines called

“thalidomide” or “lenalidomide”.

• You have had a heart attack, have heart failure, have breathing difficulties, or if you smoke, have high blood pressure, or high cholesterol levels.
• You have a high tumour burden throughout your body, including in the bone marrow. This could lead to a condition in which tumours break down and cause abnormal levels of chemicals in the blood, potentially leading to kidney failure. An irregular heartbeat may also occur. This condition is called tumour lysis syndrome.
• You have or have previously had neuropathy (nerve damage causing tingling or pain in the hands or feet).
• You have or have previously had hepatitis B infection. Treatment with Pomalidomide Krka may reactivate the hepatitis B virus in patients who carry the virus, leading to a recurrence of the infection. Your doctor must check whether you have ever had hepatitis B infection.
• You have or have previously had any combination of the following symptoms: facial or widespread rash, skin redness, high fever, flu-like symptoms, swollen lymph nodes (these are signs of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS), 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, your doctor must carefully evaluate the benefit and risk before prescribing this medicine. At any time during or after treatment, inform your doctor or nurse immediately if you experience blurred vision, loss of vision, double vision, difficulty speaking, weakness in one arm or leg, changes in walking or balance problems, persistent numbness, reduced sensation or loss of sensation, memory loss, or confusion. These may be symptoms of a serious and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If you had these symptoms before starting treatment with Pomalidomide Krka, inform your doctor of any changes in these symptoms.

After completing treatment, return any 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 Programme.
Women and men taking Pomalidomide Krka must not initiate a pregnancy or conceive a child, because pomalidomide is expected to be harmful to the unborn child. You and your partner must use effective contraceptive measures during treatment with this medicine.
Women
Do not take Pomalidomide Krka if you are pregnant, suspect you may be pregnant, or are planning a pregnancy, because this medicine is expected to be harmful to the unborn child. Before starting treatment, you must inform your doctor if there is any possibility that you could become pregnant, even if you think it is unlikely.
If there is any possibility of becoming pregnant:

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

If you become pregnant despite preventive measures:

• You must stop treatment immediately and contact your doctor right away.

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

• If your partner is pregnant or there is a possibility she may become pregnant, you must use condoms throughout the entire treatment period and for 7 days after treatment ends.
• If your partner becomes pregnant during treatment with Pomalidomide Krka, inform your doctor immediately. Your partner must also inform her doctor immediately.

You must not donate semen or sperm during treatment and for 7 days after treatment ends.
Blood donation and blood tests
You must not donate blood during treatment and for 7 days after treatment ends.
Before and during treatment with Pomalidomide Krka, you will undergo regular blood tests because this medicine may 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 starting treatment
• Weekly for the first 8 weeks of treatment
• At least once a month thereafter, for the entire duration of treatment with Pomalidomide Krka.

Based on the results of these tests, your doctor may adjust the dose of Pomalidomide Krka or stop treatment. Your doctor may also adjust the dose or stop treatment based on your overall health status.
Children and adolescents
The use of Pomalidomide Krka is not recommended in children and adolescents under 18 years of age.
Other medicines and Pomalidomide Krka
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This is because Pomalidomide Krka may affect the action of other medicines, and other medicines may affect the action of Pomalidomide Krka.
In particular, inform your doctor, pharmacist, or nurse before taking Pomalidomide Krka if you are taking any of the following medicines:

• Certain antifungals, such as ketoconazole
• Certain antibiotics (e.g., ciprofloxacin, enoxacin)
• Certain antidepressants, such as fluvoxamine.

Driving and using machines
Some people may experience fatigue, dizziness, fainting, confusion, or reduced alertness when taking Pomalidomide Krka. If this occurs, do not drive or operate 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 your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Pomalidomide Krka

Pomalidomide Krka must be prescribed and administered by a physician experienced in the treatment of multiple myeloma.
Always follow your doctor's instructions exactly when taking this medicine. 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

• Read the package leaflets for bortezomib and dexamethasone for more information about their use and side effects.
• Pomalidomide Krka, bortezomib, and dexamethasone are taken in "treatment cycles". Each cycle lasts 21 days (3 weeks).
• Refer to the table below to see which medicines to take each day during the 3-week cycle.
• Check the schedule daily and identify the correct day to know which medicines to take.
• On some days you will take all three medicines, on some days only two or one medicine, and on other days no medicine at all.

POM: Pomalidomide Krka; BOR: Bortezomib; DEX: Dexamethasone
Cycles 1 to 8 From Cycle 9 onwards
Medicine name Medicine name
Day POM BOR DEX Day POM 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 Krka with dexamethasone alone

• Refer to the dexamethasone package leaflet for more information on its use and side effects.
• Pomalidomide Krka and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
• Refer to the table below to see which medicines to take each day during the 4-week cycle.
• Check the schedule daily and identify the correct day to know which medicines to take.
• On some days you will take both medicines, on some days only one medicine, and on other days no medicine.

POM: Pomalidomide Krka; DEX: Dexamethasone
Medicine name
Day POM DEX
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 cycle.

Recommended dose of Pomalidomide Krka when taken with other medicines

Pomalidomide Krka with bortezomib and dexamethasone

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

Pomalidomide Krka with dexamethasone alone

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

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

If you have liver or kidney problems, your doctor will monitor your condition very closely 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 your skin, wash the skin immediately and thoroughly with soap and water.
• Healthcare providers, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should be removed carefully to avoid skin exposure, placed in a sealed polyethylene 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 must not handle the blister pack or capsule.
• Swallow the capsules whole, preferably with water.
• The capsules may be taken with or without food.
• Take the capsules at approximately the same time each day.

How to take Pomalidomide Krka capsules

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

1. Hold the blister by the edges and separate one end of the blister from the rest by gently tearing along the perforations around it.
2. Lift the edge of the foil and completely peel back the foil.
3. Push the capsule out onto your hand.
4. Swallow the capsule whole, preferably with water.

Your 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 your doctor tells you to stop.

If you take more Pomalidomide Krka than you should

If you take more Pomalidomide Krka than prescribed, contact your doctor or go to hospital immediately. Take the medicine pack 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 following day. Do not increase the number of capsules to make up for the missed dose of Pomalidomide Krka.

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

4. Possible side effects

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

Serious side effects

Stop taking Pomalidomide Krka and contact your doctor immediately if you experience any of the following serious side effects – urgent medical treatment may be required:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to reduced numbers of white blood cells, which fight infections).
• Bleeding or bruising without reason, including nosebleeds and intestinal or stomach bleeding (due to effects on blood cells called "platelets").
• Rapid breathing, rapid pulse, fever and chills, little or no urination, nausea and vomiting, confusion, unconsciousness (due to a blood infection called sepsis or septic shock).
• Severe, persistent, or bloody diarrhoea (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 may cause difficulty breathing (due to severe allergic reactions 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 skin growths. If you notice any skin changes during treatment with Pomalidomide Krka, inform your doctor as soon as possible.
• Reactivation of hepatitis B infection, which may cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, and nausea or vomiting. Inform your doctor immediately if you notice any of these symptoms.
• Widespread rash, high body temperature, swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome, toxic epidermal necrolysis, or Stevens-Johnson syndrome). Stop taking pomalidomide if you experience these symptoms and contact your doctor or seek immediate medical help. See also section 2.

Stop taking Pomalidomide Krka and contact your doctor immediately if you experience any of the serious side effects listed above: urgent medical treatment may be required.

Other side effects

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

• Shortness of breath (dyspnoea).
• Lung infections (pneumonia and bronchitis).
• Infections of the nose, sinuses, and throat caused by bacteria or viruses.
• Flu-like symptoms (influenza).
• Low number of red blood cells, which may cause anaemia leading to tiredness and weakness.
• Low levels of potassium in the blood (hypokalaemia), which may cause weakness, muscle cramps, muscle pain, palpitations, tingling or numbness, shortness of breath, mood changes.
• High blood sugar levels.
• Rapid and irregular heartbeat (atrial fibrillation).
• Decreased appetite.
• Constipation, diarrhoea, 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 hands or feet (peripheral sensory neuropathy).
• Swelling of the body, including arms and legs.
• Skin rashes.
• Urinary tract infection, which may cause a burning sensation when urinating or the need to urinate more frequently.

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

• Falls.
• Bleeding within the skull.
• Reduced ability to move or feel sensations in the hands, arms, feet, and legs due to damage to the nervous system (peripheral sensory-motor neuropathy).
• Numbness, itching, and pins-and-needles sensation on the skin (paraesthesia).
• Feeling of dizziness, with difficulty standing up and moving normally.
• Swelling due to fluid retention.
• Hives (urticaria).
• Itching.
• Herpes zoster (shingles).
• Heart attack (chest pain spreading to arms, neck, jaw, sweating, shortness of breath, nausea or vomiting).
• Chest pain, chest infection.
• Increased blood pressure.
• Simultaneous reduction in red blood cells, white blood cells, and platelets (pancytopenia), increasing the risk of bleeding and bruising. You may feel tired, weak, and breathless, and may be more likely to develop infections.
• Reduced number of lymphocytes (a type of white blood cells), often due to infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesaemia), which may cause tiredness, general weakness, muscle cramps, irritability, and may lead to low calcium levels in the blood (hypocalcaemia), possibly causing numbness and/or tingling in hands, feet, or lips, muscle cramps, muscle weakness, dizziness, confusion.
• Low levels of phosphate in the blood (hypophosphataemia), which may cause muscle weakness and irritability or confusion.
• High levels of calcium in the blood (hypercalcaemia), which may cause slowed reflexes and weakness of skeletal muscles.
• High levels of potassium in the blood, which may cause an abnormal heart rhythm.
• Low levels of sodium in the blood, which may cause tiredness and confusion, muscle spasms, seizures, or coma.
• High levels of uric acid in the blood, which may cause a form of arthritis called gout.
• Low blood pressure, which may cause dizziness or fainting.
• Painful or dry mouth.
• Altered sense of taste.
• Bloating.
• Feeling confused.
• Feeling low in mood (depressed mood).
• Loss of consciousness, fainting.
• Blurred vision (cataract).
• Kidney damage.
• Inability to urinate.
• Abnormal liver function tests.
• Pelvic pain.
• Weight loss.

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

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

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 stated on the blister pack and carton after
Exp/EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the
original container to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Unused
medicine must be returned to the pharmacist at the end of treatment. This will help protect the environment.

6. Package contents and other information

What Pomalidomide Krka contains

• The active substance is pomalidomide.
• The other components of the capsule contents are isomaltitol, crospovidone (type A), low-substituted hydroxypropylcellulose, and sodium stearyl fumarate.

Pomalidomide Krka 1 mg hard capsules:

• Each capsule contains 1 mg of pomalidomide.
• The other components in the capsule coating 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 coating 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 coating 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 coating 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 the contents of the pack

Pomalidomide Krka 1 mg hard capsules:
Hard gelatin capsules, size 2. Capsule length: 17.3±0.5 mm. The capsule body is from light yellow to brownish yellow with a black imprint "1". The capsule cap is blue. The capsule contents are a powder from light yellow to yellow.

Pomalidomide Krka 2 mg hard capsules:
Hard gelatin capsules, size 2. Capsule length: 17.3±0.5 mm. The capsule body is from orange to brownish orange with a white imprint "2". The capsule cap is blue. The capsule contents are a powder from light yellow to yellow.

Pomalidomide Krka 3 mg hard capsules:
Hard gelatin capsules, size 2. Capsule length: 17.3±0.5 mm. The capsule body is bluish green with a white imprint "3". The capsule cap is blue. The capsule contents are a powder from light yellow to yellow.

Pomalidomide Krka 4 mg hard capsules:
Hard gelatin capsules, size 2. Capsule length: 17.3±0.5 mm. The capsule body is light blue with a white imprint "4". The capsule cap is blue. The capsule contents are a powder from light yellow to yellow.

Each pack contains 14 x 1 or 21 x 1 hard capsule in peelable blisters, divisible for single dose, child-resistant packaging (calendar packs).
Not all pack sizes may be marketed.

Marketing Authorization 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 about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
KRKA Belgium, SA. UAB KRKA Lietuva
Tél/Tel: + 32 (0) 487 50 73 62 Tel: + 370 5 236 27 40

България Luxembourg/Luxemburg
КРКА България ЕООД KRKA Belgium, SA.
Teл.: + 359 (02) 962 34 50 Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika Magyarország
KRKA ČR, s.r.o. KRKA Magyarország Kereskedelmi Kft.
Tel: + 420 (0) 221 115 150 Tel.: + 36 (1) 355 8490

Danmark Malta
KRKA Sverige AB E. J. Busuttil Ltd.
Tlf: + 46 (0)8 643 67 66 (SE) Tel: + 356 21 445 885

Deutschland Nederland
TAD Pharma GmbH KRKA Belgium, SA.
Tel: + 49 (0) 4721 606-0 Tel: + 32 (0) 487 50 73 62 (BE)

Eesti Norge
KRKA, d.d., Novo mesto Eesti filiaal KRKA Sverige AB
Tel: + 372 (0) 6 671 658 Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα Österreich
ΒΙΑΝΕΞ Α.Ε. KRKA Pharma GmbH, Wien
Τηλ: +30 210 8009111 Tel: + 43 (0)1 66 24 300

España Polska
KRKA Farmacéutica, S.L. KRKA-POLSKA Sp. z o.o.
Tel: + 34 911 61 03 80 Tel.: + 48 (0)22 573 7500

France Portugal
KRKA France Eurl KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tél: + 33 (0)1 57 40 82 25 Tel: + 351 (0)21 46 43 650

Hrvatska România
KRKA - FARMA d.o.o. KRKA Romania S.R.L., Bucharest
Tel: + 385 1 6312 101 Tel: + 4 021 310 66 05

Ireland Slovenija
KRKA Pharma Dublin, Ltd. KRKA, d.d., Novo mesto
Tel: + 353 1 413 3710 Tel: + 386 (0) 1 47 51 100

Ísland Slovenská republika
LYFIS ehf. KRKA Slovensko, s.r.o.
Sími: + 354 534 3500 Tel: + 421 (0) 2 571 04 501

Italia Suomi/Finland
KRKA Farmaceutici Milano S.r.l. KRKA Finland Oy
Tel: + 39 02 3300 8841 Puh/Tel: + 358 20 754 5330

Κύπρος Sverige
KI.PA. (PHARMACAL) LIMITED KRKA Sverige AB
Τηλ: + 357 24 651 882 Tel: + 46 (0)8 643 67 66 (SE)

Latvija United Kingdom (Northern Ireland)
KRKA Latvija SIA KRKA Pharma Dublin, Ltd.
Tel: + 371 6 733 86 10 Tel: + 353 1 413 3710

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.