Pomalidomide Krka 4 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pomalidomida Krka 1 mg hard capsules

Pomalidomida Krka 2 mg hard capsules

Pomalidomida Krka 3 mg hard capsules

Pomalidomida Krka 4 mg hard capsules

pomalidomide

Pomalidomide Teva is expected to cause severe birth defects and may result in fetal death. Do not take this medicine if you are pregnant or may be pregnant. You must follow the contraceptive measures described in this leaflet.

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the adverse effects are not listed in this leaflet. See section 4.

Contents of the 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 adverse effects
5. How to store Pomalidomide Krka
6. Contents of the pack and other information

1. What is Pomalidomide Krka and what is it 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 affect 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 with:

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

Or

• another medicine called "dexamethasone" in people whose myeloma has worsened despite having received at least two other types of treatment, including the medicines lenalidomide and bortezomib.

What is multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cells (called "plasma cells"). These cells grow uncontrollably and accumulate in the bone marrow, damaging bones and kidneys.

Multiple myeloma is generally not curable. However, treatment can reduce or eliminate the signs and symptoms of the disease for a period of time. When this occurs, it is referred to as a "response".

How Pomalidomide Krka works

Pomalidomide Krka works in several ways:

• It stops the growth of myeloma cells;
• It stimulates the immune system to attack cancer cells;
• It stops the formation of blood vessels that feed cancer cells.

Benefit of using Pomalidomide Krka with bortezomib and dexamethasone

When Pomalidomide Krka is used with bortezomib and dexamethasone in people who have received at least one other treatment, it can delay the progression of multiple myeloma:

• Typically, the combination of pomalidomide with bortezomib and dexamethasone delayed the recurrence of multiple myeloma for up to 11 months, compared with 7 months in patients receiving bortezomib and dexamethasone alone.

Benefit of using Pomalidomide Krka with dexamethasone

When Pomalidomide Krka is used with dexamethasone in people who have received at least two other treatments, it can delay the progression of multiple myeloma:

• Typically, the combination of pomalidomide and dexamethasone delayed the recurrence of multiple myeloma for up to 4 months, compared with 2 months in patients receiving dexamethasone alone.

2. What you need to know before starting Pomalidomide Krka

Do not take Pomalidomide Krka:

• if you are pregnant, think you might be pregnant, or intend to become pregnant, as Pomalidomide Krka is expected to be harmful to the unborn baby. (Men and women taking this medicine should read the section “Pregnancy, contraception and breastfeeding – information for women and men” below);
• if you can become pregnant, unless you are taking all necessary measures to avoid pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If you can become pregnant, your doctor will confirm with each prescription that all necessary precautions 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, consult your doctor.

If you are not sure whether any of the above situations apply to you, consult your doctor, pharmacist, or nurse before starting to take Pomalidomide Krka.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Pomalidomide Krka if:

• you have ever had blood clots in the past. During treatment with Pomalidomide Krka, you have an increased risk of developing blood clots in your veins or arteries. Your doctor may recommend additional treatments (e.g., warfarin) or reducing your dose of Pomalidomide Krka to lower the risk of blood clots;
• you have previously experienced an allergic reaction, such as skin rash, itching, swelling, dizziness, or breathing problems while taking related medicines called “thalidomide” or “lenalidomide”;
• you have had a heart attack, have heart failure, have difficulty breathing, or if you are a smoker, have high blood pressure or high cholesterol levels;
• you have a high overall tumor burden in the body, including in the bone marrow. This could lead to a condition in which tumors break down and release unusual levels of chemicals into the blood, which in turn may cause kidney failure. You may also experience irregular heartbeats. This condition is called tumor lysis syndrome;
• you currently suffer from or have previously had neuropathy (nerve damage causing tingling or pain in your feet or hands);
• you have or have previously had hepatitis B virus 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 should check whether you have ever had a hepatitis B virus infection;
• you are currently experiencing or have previously experienced a combination of any of the following symptoms: facial or widespread rash, redness of the skin, high fever, flu-like symptoms, enlarged lymph nodes (symptoms of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms or DRESS syndrome, 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, so your doctor must carefully evaluate the benefits and risks 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 or double vision, difficulty speaking, weakness in one arm or leg, a change in the way you walk, problems with balance, persistent numbness, reduced sensation or loss of sensation, memory loss or confusion. All of these may be symptoms of a serious and potentially life-threatening brain disease known as progressive multifocal leukoencephalopathy (PML). If you had any of these symptoms before starting treatment with Pomalidomide Krka, inform your doctor immediately if you notice 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 men and women

You must follow the instructions included in the Pomalidomide Krka Pregnancy Prevention Programme. Men and women taking Pomalidomide Krka must not father a child or become pregnant. This is because pomalidomide is expected to be harmful to the unborn baby. You and your partner must use effective contraception methods while taking this medicine.

Women

Do not take Pomalidomide Krka if you are pregnant, think you might be pregnant, or intend to become pregnant. This is because this medicine is expected to be harmful to the unborn baby. Before starting treatment, you must inform your doctor if there is any possibility that you could become pregnant, even if you think this is unlikely.

If you can become pregnant:

• you must use effective contraceptive methods starting at least 4 weeks before beginning treatment, throughout the entire treatment period, and for at least
• 4 weeks after stopping treatment. Your doctor will advise you on the most appropriate contraceptive methods;
• each time your doctor prescribes a new prescription, they will ensure that you understand the necessary measures to prevent pregnancy;
• your doctor will schedule 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 inform your doctor immediately.

Breastfeeding

It is unknown whether Pomalidomide Krka passes into human breast milk. Inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will advise you whether you can continue or should stop breastfeeding.

Men

Pomalidomide Krka passes into human semen.

• If your partner is pregnant or could become pregnant, you must use condoms throughout the entire treatment period and for 7 days after stopping treatment.
• If your partner becomes pregnant while you are taking pomalidomide, 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 stopping treatment.

Blood donation and blood tests

You must not donate blood during treatment and for 7 days after treatment has ended. Before starting treatment with Pomalidomide Krka and during treatment, you will have periodic blood tests. This is because your medicine may cause a decrease in the number of blood cells that help fight infections (white blood cells) and in the number of cells that help stop bleeding (platelets).

Your doctor will request that you have blood tests:

• before starting treatment;
• weekly during the first 8 weeks of treatment;
• at least once a month while continuing to take Pomalidomide Krka.

Your doctor may adjust the dose of Pomalidomide Krka or interrupt your treatment, depending on the results of these tests. Your doctor may also adjust the dose or interrupt this medicine due to your overall health condition.

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 need to take any other medicines. This is because Pomalidomide Krka may affect how other medicines work. In addition, some medicines may affect how Pomalidomide Krka works.

In particular, inform your doctor, pharmacist, or nurse before taking Pomalidomide Krka if you are 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 use of machines

Some people experience fatigue, fainting, confusion, or reduced alertness while taking Pomalidomide Krka. If this happens to you, do not drive or operate tools or machinery.

Pomalidomide Krka contains sodium and isomaltose

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; hence, it is essentially “sodium-free”.

Pomalidomide Krka contains isomaltose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Pomalidomida Teva

Pomalidomida Krka must be prescribed and administered by a physician experienced in the treatment of multiple myeloma.

Always follow exactly the instructions provided by your doctor regarding the use of this medicine.

If you have any doubts, consult your doctor, pharmacist, or nurse.

When to take Pomalidomida Krka with other medicines

Pomalidomida Krka in combination with bortezomib and dexamethasone

• Refer to the package leaflet provided with bortezomib and dexamethasone for additional information on their use and effects.

• Pomalidomida Krka, bortezomib, and dexamethasone are taken in treatment cycles. Each cycle lasts 21 days (3 weeks).

• See the following chart to determine which medicines to take each day during the 3-week cycle:

• Each day, consult the chart and identify the correct day to see which medicines you should take.

• On some days, you will take all three medicines; on other days, only one or two medicines; and on some days, none of them.

POM: Pomalidomida Krka; BOR: bortezomib; DEX: dexamethasone

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

Pomalidomida Krka with dexamethasone alone

• Refer to the package leaflet provided with dexamethasone for additional information on its use and effects.

• Pomalidomida Krka and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).

• See the following chart to determine which medicines to take each day during the 4-week cycle:

• Each day, consult the chart and identify the correct day to see which medicines you should take.

• On some days, you will take both medicines; on other days, only one medicine; and on some days, neither of them.

POM: Pomalidomida Krka; DEX: dexamethasone

	Medication 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 one.

How much Pomalidomide Krka to take 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 calculated by your doctor according to your height and weight (1.3 mg/m2 body surface area).
• The recommended starting dose of dexamethasone is 20 mg once daily. However, if you are over 75 years of age, the recommended starting dose is 10 mg once daily.

Pomalidomide Krka with dexamethasone alone

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

Your doctor may need to reduce the dose of Pomalidomide Krka, bortezomib, or dexamethasone, or interrupt one or more of these medicines depending on your blood test results and general condition, whether you are taking other medicines (e.g., ciprofloxacin, enoxacin, and fluvoxamine), and if you experience adverse effects (especially rash or swelling) as a result of treatment.

If you have liver or kidney problems, your doctor will carefully monitor your condition while you are receiving 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 professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should then be carefully removed to avoid skin exposure, placed into a sealed polyethylene plastic bag, and disposed of according to local requirements. Afterwards, hands should be thoroughly washed 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.
• You may take the capsules with or without food.
• You should take the capsules at approximately the same time each day.

How to take this medicine

Do not attempt to remove the capsules from the blister pack.

To remove the capsule from the blister:

1. Hold the blister by the edges and gently tear along the perforations to separate one blister cell from the rest.
2. Lift and completely peel back the edge of the foil.
3. Tip the capsule into your hand.
4. Swallow the capsule whole, preferably with water.

Your doctor will advise you on how and when to take Pomalidomida Krka if you have kidney problems and are undergoing dialysis treatment.

Duration of treatment with Pomalidomida Krka

You must continue the treatment cycles until your doctor tells you to stop.

If you take more Pomalidomida Krka than you should

If you take more Pomalidomida Krka than you should, inform your doctor or go to hospital immediately.

Take the medicine package with you.

If you forget to take Pomalidomida Krka

If you forget to take Pomalidomida Krka on the day you were supposed to, take the next capsule the following day at your usual time. Do not take extra capsules to make up for the dose of Pomalidomida Krka that you missed the previous day.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Serious adverse effects

If you experience any of the following serious adverse effects, stop treatment with Pomalidomide Krka and contact a doctor immediately, as you may require urgent medical treatment:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to decreased white blood cells responsible for fighting infection).
• Bleeding or bruising without apparent cause, including nosebleeds and intestinal or stomach bleeding (due to effects on blood cells called "platelets").
• Rapid breathing, fast pulse, fever and chills, little or no urine output, nausea and vomiting, confusion, unconsciousness (due to a blood infection called sepsis or septic shock).
• Severe, persistent, or bloody diarrhoea (possibly accompanied by stomach pain or fever) caused by the bacterium Clostridium difficile.
• Chest or leg pain and swelling, especially in the lower leg or calves (caused by blood clots).
• Difficulty breathing (due to a severe chest infection, lung inflammation, heart failure, or blood clots).
• Swelling of the face, lips, tongue, and throat, which may cause breathing difficulties (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 lumps on the skin. If you notice changes in your skin while taking Pomalidomide Krka, inform your doctor as soon as possible.
• Reactivation of hepatitis B virus infection, which may cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, nausea, or malaise. Inform your doctor immediately if you notice any of these symptoms.
• Widespread rash, high body temperature, swollen lymph nodes, and effects on other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome 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 attention. See also section 2.

If you experience any of the following serious adverse effects, stop treatment with Pomalidomide Krka and contact a doctor immediately, as you may require urgent medical treatment.

Other adverse effects

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

• Difficulty breathing (dyspnoea).
• Lung infection (pneumonia and bronchitis).
• Infections of the nose, sinuses, and throat caused by bacteria or viruses.
• Flu-like symptoms (influenza).
• Low red blood cell count, which may lead to anaemia causing fatigue and weakness.
• Low blood potassium levels (hypokalaemia), which may cause weakness, muscle cramps and pain, palpitations, tingling or numbness, dyspnoea, and 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 or staying asleep.
• Dizziness, tremor.
• Muscle spasms, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling, or burning sensation in the skin, pain in hands or feet (peripheral sensory neuropathy).
• Generalised swelling, including swelling of 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):

• Fall.
• Bleeding within the skull.
• Reduced ability to move or feel (sensation) in the hands, feet, and legs due to neurological damage (peripheral sensorimotor neuropathy).
• Numbness, itching, or tingling in the skin (paraesthesia).
• Sensation of dizziness or vertigo, making it difficult to stand or move normally.
• Swelling due to fluid retention.
• Hives (urticaria).
• Itching of the skin.
• Shingles (herpes zoster).
• Heart attack (chest pain spreading to arms, neck, and jaw, sweating, shortness of breath, nausea or vomiting).
• Chest pain, chest infection.
• Increased blood pressure.
• Reduction in the number of red blood cells, white blood cells, and platelets simultaneously (pancytopenia), making you more prone to bleeding and bruising. You may feel tired and weak and have difficulty breathing. You will also be more susceptible to infections.
• Decreased number of lymphocytes (a type of white blood cell), often due to infection (lymphopenia).
• Low blood magnesium levels (hypomagnesaemia), which may cause fatigue, generalised weakness, muscle cramps, and irritability, and may lead to low blood calcium levels (hypocalcaemia), causing numbness or tingling in hands, feet, or lips, muscle cramps, muscle weakness, dizziness, confusion.
• Low blood phosphate levels (hypophosphataemia), which may cause muscle weakness, irritability, or confusion.
• High blood calcium levels (hypercalcaemia), which may slow reflexes and cause skeletal muscle weakness.
• High blood potassium levels, which may cause an abnormal heart rhythm.
• Low blood sodium levels, which may cause fatigue and confusion, muscle twitching, seizures (epileptic convulsions), or coma.
• High blood uric acid levels, which may cause a type of arthritis called gout.
• Low blood pressure, which may cause dizziness or fainting.
• Dry or sore mouth.
• Changes in taste.
• Swollen abdomen.
• Confusion.
• Feeling low (depressed mood).
• Loss of consciousness, fainting.
• Cloudiness in the eye (cataract).
• Kidney damage.
• Inability to urinate.
• Abnormal results in 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 itchy skin, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine, and abdominal pain.
• Breakdown of tumour cells resulting in the release of toxic substances into the bloodstream (tumour lysis syndrome). This may lead to kidney problems.
• Underactive thyroid gland, which may cause symptoms such as fatigue, lethargy, muscle weakness, slow heart rate, and weight gain.

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Pomalidomide Krka Storage

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 packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original container to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pomalidomida Krka

• The active substance is pomalidomide.
• The other components contained in the capsule are: isomaltose, crospovidone (type A), low-substituted hydroxypropylcellulose, and sodium stearyl fumarate.

Pomalidomida Krka 1 mg hard capsules EFG

• Each capsule contains 1 mg of pomalidomide.
• The other components of 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).

Pomalidomida Krka 2 mg hard capsules EFG

• Each hard capsule contains 2 mg of pomalidomide.
• The other components of 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 (E171), potassium hydroxide).

Pomalidomida Krka 3 mg hard capsules EFG

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

Pomalidomida Krka 4 mg hard capsules EFG

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

See section 2 “Pomalidomida Krka contains sodium and isomaltose”.

Nature and contents of the container

Pomalidomida Krka 1 mg hard capsules EFG (capsules):

Hard gelatin capsules, size 2. Capsule length: 17.3±0.5 mm. The capsule body is light yellow to yellowish-brown with a black mark "1". The capsule cap is blue. The capsule contents consist of light yellow to yellow powder.

Pomalidomida Krka 2 mg hard capsules EFG (capsules):

Hard gelatin capsules, size 2. Capsule length: 17.3±0.5 mm. The capsule body is orange to brownish-orange with a white mark "2". The capsule cap is blue. The capsule contents consist of light yellow to yellow powder.

Pomalidomida Krka 3 mg hard capsules EFG (capsules):

Hard gelatin capsules, size 2. Capsule length: 17.3±0.5 mm. The capsule body is blue-green with a white mark "3". The capsule cap is blue. The capsule contents consist of light yellow to yellow powder.

Pomalidomida Krka 4 mg hard capsules EFG (capsules):

Hard gelatin capsules, size 2. Capsule length: 17.3±0.5 mm. The capsule body is light blue with a white mark "4". The capsule cap is blue. The capsule contents consist of light yellow to yellow powder.

Pomalidomida Krka is available in packs containing 14 x 1 or 21 x 1 hard capsule in single-dose perforated blisters with adhesive seal, child-resistant packaging (calendar pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer responsible for manufacturing

KRKA – FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

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

Belgium/Belgium/Belgium KRKA Belgium, SA. Tel/Tel: + 32 (0) 487 50 73 62	Lithuania UAB KRKA Lietuva Tel: + 370 5 236 27 40
	Luxembourg/Luxembourg KRKA Belgium, SA. Tél/Tel: + 32 (0) 487 50 73 62 (BE)
Czech Republic KRKA CR, s.r.o. Tel: + 420 (0) 221 115 150	Hungary KRKA Magyarország Kereskedelmi Kft. Tel.: + 36 (1) 355 8490
Denmark KRKA Sverige AB Tlf.: + 46 (0)8 643 67 66 (SE)	Malta J. Busuttil Ltd. Tel: + 356 21 445 885
Germany TAD Pharma GmbH Tel: + 49 (0) 4721 606-0	Netherlands KRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE)
Estonia KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658	Norway KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE)
Greece VIANEX S.A. Tel: +30 210 8009111	Austria KRKA Pharma GmbH, Vienna Tel: + 43 (0)1 66 24 300
Spain KRKA Farmacéutica, S.L. Tel: + 34 911 61 03 80	Poland 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
Croatia KRKA - FARMA d.o.o. Tel: + 385 1 6312 101	Romania KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05
Ireland KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3710	Slovenia KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 100
Iceland LYFIS ehf. Tel: + 354 534 3500	Slovakia KRKA Slovensko, s.r.o. Tel: + 421 (0) 2 571 04 501
Italy KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8841	Finland/Suomi KRKA Finland Oy Puh/ Tel: + 358 20 754 5330
Cyprus KI.PA. (PHARMACAL) LIMITED Tel: + 357 24 651 882	Sweden KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE)
Latvia KRKA Latvija SIA Tel: + 371 6 733 86 10

Date of the most recent review of this leaflet

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.