Pomalidomide Zentiva

Patient Information Leaflet

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

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

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

Please 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

What Pomalidomide Zentiva is
Imnovid 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 Pomalidomide Zentiva is used for
Pomalidomide Zentiva is used to treat adults with a type of cancer called "multiple myeloma".

Pomalidomide Zentiva 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 previous 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 to the bones and kidneys.
Multiple myeloma is generally incurable. However, treatment can reduce or eliminate signs and symptoms of the disease for a certain period of time. When this occurs, it is referred to as a "response".

How Pomalidomide Zentiva works
Imnovid 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 Zentiva with bortezomib and dexamethasone
When Pomalidomide Zentiva 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 Zentiva 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 Zentiva with dexamethasone
When Pomalidomide Zentiva 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 Zentiva 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 should know before taking Pomalidomide Zentiva

Do not take Pomalidomide Zentiva

• If you are pregnant or think you might be pregnant, or if you are planning a pregnancy, because it is expected that Pomalidomide may harm the unborn baby. (Men and women taking this medicine must read the section “Pregnancy, contraception and breastfeeding – information for women and men” below.)
• If there is any chance you could 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 chance you could become 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 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 above conditions apply to you, consult your doctor,
pharmacist or nurse before taking Pomalidomide Zentiva.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Pomalidomide Zentiva if:

• you have previously had episodes of blood clots. During treatment with Pomalidomide Zentiva, there is an increased risk of blood clots forming in the veins (thrombi) and arteries. Your doctor may recommend additional treatments (e.g. warfarin) or reduce the dose of Pomalidomide Zentiva to reduce the likelihood 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, which may lead 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 Zentiva may cause reactivation of the hepatitis B virus in patients who carry the virus, leading to 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 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, 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 and potentially fatal brain disease known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms before starting treatment with Pomalidomide Zentiva, inform your doctor of any changes in these symptoms.
After treatment is completed, 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 outlined in the Pomalidomide Zentiva Pregnancy Prevention Programme. Women and men taking Pomalidomide Zentiva must not become pregnant or father a child, because pomalidomide is expected to harm the unborn baby. You and your partner must use effective contraceptive measures during treatment with this medicine.
Women
Do not take Pomalidomide Zentiva if you are pregnant, suspect you may be pregnant, or are planning a
pregnancy, because this medicine is expected to harm the unborn baby. Before starting treatment, you must inform your doctor if there is any chance you could become pregnant, even if you think it is unlikely.
If there is any chance you could become pregnant:

• you must use effective contraceptive methods 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 Zentiva 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 Zentiva passes into human seminal fluid.

• If your partner is pregnant or there is any chance she could become pregnant, you must use condoms throughout the entire treatment period and for 7 days after treatment ends.
• If your partner becomes pregnant during your treatment with Pomalidomide Zentiva, 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 Zentiva, 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 Zentiva.

Based on the results of these tests, your doctor may adjust the dose of Pomalidomide Zentiva or
discontinue treatment. Your doctor may also adjust the dose or discontinue treatment based on your overall health status.
Children and adolescents
The use of Pomalidomide Zentiva is not recommended in children and adolescents under 18 years of age.
Other medicines and Pomalidomide Zentiva
Inform your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because Pomalidomide Zentiva may affect the action of other medicines. Other medicines may also affect the action of Pomalidomide Zentiva.
In particular, inform your doctor, pharmacist or nurse before taking Pomalidomide Zentiva 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 using machines
Some people may experience fatigue, dizziness, fainting, confusion or reduced alertness when taking Pomalidomide Zentiva. If this occurs, do not drive or operate tools or machinery.
Pomalidomide Zentiva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially ‘sodium-free’.

3. How to take Pomalidomide Zentiva

Pomalidomide Zentiva must be administered by a physician experienced in the treatment of multiple myeloma.
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.

When to take Pomalidomide with other medicines

Pomalidomide Zentiva with bortezomib and dexamethasone

• Read the package leaflet of bortezomib and dexamethasone for further information on their use and side effects.
• Pomalidomide Zentiva, 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:
  o Each day, check the chart and find the correct day to determine which medicines to take.
  o 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.
  PML: Pomalidomide Zentiva; BOR: Bortezomib; DEX: Dexamethasone

Cycles 1 to 8         From Cycle 9 onwards

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

Pomalidomide Zentiva with dexamethasone alone

• Refer to the dexamethasone package leaflet for further information on its use and effects.
• Pomalidomide Zentiva and dexamethasone are taken in "treatment cycles". Each cycle lasts 28 days (4 weeks).
• Consult the following table to know which medicines to take each day of the 4-week cycle:
  o Each day, check the chart and find the correct day to know which medicines to take.
  o On some days you will take both medicines, on some days only one medicine, and on other days no medicine.

PML: Pomalidomide Zentiva; DEX: Dexamethasone

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

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

• The recommended starting dose of Pomalidomide Zentiva 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 Zentiva with dexamethasone alone

• The recommended starting dose of Pomalidomide Zentiva 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 Zentiva, bortezomib, or dexamethasone, or
discontinue one or more of these medicines based on 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 Zentiva

• 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 providers, 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 in a sealed polyethylene bag, and disposed of according to local regulations. Hands should then be thoroughly washed with water and soap. Pregnant women (confirmed or suspected) 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.

To remove the capsule from the blister, press on only one side of the capsule, pushing it through the aluminium foil. Do not press on the centre of the capsule, as this may cause it to break.

Your doctor will advise you on how and when to take Pomalidomide Zentiva if you have kidney problems and are undergoing dialysis.
Duration of treatment with Pomalidomide Zentiva
You should continue treatment cycles until your doctor tells you to stop.
If you take more Pomalidomide Zentiva than you should
If you take more Pomalidomide Zentiva than you should, contact your doctor or go to hospital immediately. Take the medicine pack with you.
If you forget to take Pomalidomide Zentiva
If you forget to take Pomalidomide Zentiva on the prescribed day, take the next capsule as usual the following day. Do not increase the number of capsules taken to make up for the missed dose of Pomalidomide Zentiva the previous day.
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 everybody gets them.

Serious side effects
Stop taking Pomalidomide Zentiva and contact 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 ulcers, or any other sign of infection (due to reduced numbers of white blood cells, which fight infection).
• Bleeding or bruising without reason, 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 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 called 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 Zentiva, 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 body 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 Zentiva and contact your doctor immediately if 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 (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.
• Fast and irregular heartbeat (atrial fibrillation).
• Loss of appetite.
• Constipation, diarrhoea, or nausea.
• Vomiting.
• Abdominal pain.
• Lack of energy.
• Difficulty falling asleep or staying asleep.
• Dizziness, tremor.
• Muscle spasms, 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 nerve system damage (peripheral sensory-motor neuropathy).
• Numbness, itching, and pins-and-needles sensation on the skin (paraesthesia).
• Dizzy feeling, with difficulty standing up and moving normally.
• Swelling caused by fluid retention.
• Hives (urticaria).
• Itching.
• Herpes zoster (shingles).
• Heart attack (chest pain spreading to the 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), making you more prone to bleeding and bruising. You may feel tired, weak, and breathless, and you may be more likely to develop infections.
• Reduced number of lymphocytes (a type of white blood cell), often due to infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesaemia), which may cause tiredness, generalised 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, irritability, or confusion.
• High levels of calcium in the blood (hypercalcaemia), which may cause slowed reflexes and skeletal muscle weakness.
• High levels of potassium in the blood, which may cause 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.
• 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 may cause itching, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine, and abdominal pain.
• Breakdown of tumour cells, leading to 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 available data):

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via 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 Zentiva

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 outer carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use Pomalidomide Zentiva if you notice any damage or signs of tampering with the medicine packaging.
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 Zentiva contains

• The active substance is pomalidomide.
• The other components are microcrystalline cellulose; maltodextrin; sodium stearate fumarate as capsule contents.

Pomalidomide Zentiva 1 mg hard capsules

• Each capsule contains 1 mg of pomalidomide.
• The capsule shell consists of: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and printing ink.

Pomalidomide Zentiva 2 mg hard capsules

• Each capsule contains 2 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and printing ink.

Pomalidomide Zentiva 3 mg hard capsules

• Each capsule contains 3 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigotine (E132) and printing ink.

Pomalidomide Zentiva 4 mg hard capsules

• Each capsule contains 4 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigotine (E132), erythrosine (E127) and printing ink.

The printing ink contains shellac (E904), titanium dioxide (E171) and propylene glycol (E1520).
Description of the appearance of Pomalidomide Zentiva and pack contents
Pomalidomide Zentiva 1 mg hard capsules: red cap and yellow body, marked with "PLM 1".
Pomalidomide Zentiva 2 mg hard capsules: red cap and orange body, marked with "PLM 2".
Pomalidomide Zentiva 3 mg hard capsules: red cap and turquoise body, marked with "PLM 3".
Pomalidomide Zentiva 4 mg hard capsules: red cap and dark blue body, marked with "PLM 4".
Blister OPA/Al/PVC/Al or unit dose divisible blister.
Pack sizes: 14x1, 21x1, 14 or 21 capsules. Not all pack sizes may be marketed.
Marketing Authorization Holder
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic
Manufacturer
Synthon Hispania S.L.
Calle De Castello 1
08830 Sant Boi de Llobregat
Spain
or
Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Zentiva, k.s. Zentiva, k.s.
Tél/Tel: +32 (78) 700 112 Tel: +370 52152025
[email protected] [email protected]
България Luxembourg/Luxemburg
Zentiva, k.s. Zentiva, k.s.
Тел: +359 244 17 136 Tél/Tel: +352 208 82330
[email protected] [email protected]
Česká republika Magyarország
Zentiva, k.s. Zentiva Pharma Kft.
Tel: +420 267 241 111 Tel.: +36 1 299 1058
[email protected] [email protected]
Danmark Malta
Zentiva Denmark ApS Zentiva, k.s.
Tlf: +45 787 68 400 Tel: +356 2034 1796
[email protected] [email protected]
Deutschland Nederland
Zentiva Pharma GmbH Zentiva, k.s.
Tel: +49 (0) 800 53 53 010 Tel: +31 202 253 638
[email protected] [email protected]
Eesti Norge
Zentiva, k.s. Zentiva Denmark ApS
Tel: +372 52 70308 Tlf: +45 787 68 400
[email protected] [email protected]
Ελλάδα Österreich
Zentiva, k.s. Zentiva, k.s.
Τηλ: +30 211 198 7510 Tel: +43 720 778 877
[email protected] [email protected]
España Polska
Zentiva Spain S.L.U. Zentiva Polska Sp. z o.o.
Tel: +34 91 111 58 93 Tel: +48 22 375 92 00
[email protected] [email protected]
France Portugal
Zentiva France Zentiva Portugal, Lda
Tél: +33 (0) 800 089 219 Tel: +351 210601360
[email protected] [email protected]
Hrvatska România
Zentiva d.o.o. ZENTIVA S.A.
Tel: +385 1 6641 830 Tel: +4 021.304.7597
[email protected] [email protected]
Ireland Slovenija
Zentiva, k.s. Zentiva, k.s.
Tel: +353 818 882 243 Tel: +386 360 00 408
[email protected] [email protected]
Ísland Slovenská republika
Zentiva Denmark ApS Zentiva, a.s.
Sími: +354 539 5025 Tel: +421 2 3918 3010
[email protected] [email protected]
Italia Suomi/Finland
Zentiva Italia S.r.l. Zentiva Denmark ApS
Tel: +39 800081631 Puh/Tel: +358 942 598 648
[email protected] [email protected]
Κύπρος Sverige
Zentiva, k.s. Zentiva Denmark ApS
Τηλ: +30 211 198 7510 Tel: +46 840 838 822
[email protected] [email protected]
Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu