POMALIDOMIDE 1 mg Kapsułki Twarde

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

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

omalidomide

It is expected that Pomalidomide Accord 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 you start to take 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 you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

What is Pomalidomide Accord
Pomalidomide Accord 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 Accord used for
Pomalidomide Accord is used in the treatment of adults with a type of cancer called
“multiple myeloma”.
Pomalidomide Accord 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 myelomaMultiple myeloma is a type of cancer that affects a certain type of white blood cells (called “plasma cells”). These cells grow uncontrollably and accumulate in the bone marrow. This causes damage to the bones and kidneys.

Multiple myeloma is generally incurable. However, treatment can reduce the signs and symptoms of the
disease or make them disappear for a certain period of time. When this happens, it is referred to as “response”.

How Pomalidomide Accord works
Pomalidomide Accord 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 Accord together with bortezomib and dexamethasone
When Pomalidomide Accord 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 Accord, 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 Accord together with dexamethasone
When Pomalidomide Accord 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 Accord, 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 Accord

Do not takePomalidomide Accord

• If you are pregnant or if you think you may be pregnant, or if you are planning a pregnancy, because Pomalidomide Accord is expected to harm the fetus. (Men and women taking this medicine must read the “Pregnancy, contraception and breastfeeding – information for women and men” section below).
• If there is a possibility that you might become pregnant unless you follow all the necessary measures to avoid pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If there is a possibility that you might become pregnant, on each prescription the doctor will record that the necessary measures have been taken and will provide you with this confirmation.
• If you are allergic to pomalidomide or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.

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

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

• you have had episodes of blood clots in the past. During treatment with Pomalidomide Accord there is a higher risk of blood clots forming in the veins (thrombosis) and in the arteries. Your doctor may recommend additional treatments (e.g. warfarin) or decrease the dose of Pomalidomide Accord to reduce the likelihood of blood clots forming;
• you have had an allergic reaction in the past, such as skin rash, itching, swelling, dizziness or difficulty breathing, during treatment with related medicines called “thalidomide” or “lenalidomide”;
• you have had a heart attack, have heart failure, have difficulty breathing, or if you smoke, have high blood pressure or high cholesterol levels;
• you have a high tumor burden throughout the body, including in the bone marrow. This could cause a condition in which the 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 Accord may cause reactivation of the hepatitis B virus in patients carrying this virus, resulting in 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 feeling, 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 Accord, inform your doctor of 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 Accord Pregnancy Prevention Program.
Women and men taking Pomalidomide Accord must not start a pregnancy or
conceive a child, because pomalidomide is expected to harm the fetus. You and your partner must use effective contraceptive measures during treatment with this medicine.
Women
Do not take Pomalidomide Accord if you are currently pregnant, if you suspect or are planning a
pregnancy, because this medicine is expected to harm the fetus. Before starting
treatment, you must inform your doctor if there is a possibility of you 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 contraceptive method for you.
• On each prescription, the doctor will ensure that you understand what measures you need to take to prevent pregnancy.
• The doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment and at least 4 weeks after the end of treatment.

If you become pregnant despite preventive measures:

• you must stop treatment immediately and consult your doctor immediately

Breastfeeding
It is not known whether Pomalidomide Accord 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 Accord 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 Accord, 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 Accord you will undergo regular blood tests,
because this medicine can cause a decrease 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, for the entire period of treatment with Pomalidomide Accord.

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

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

Other medicines and Pomalidomide Accord
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines. This is because Pomalidomide Accord can affect the way other medicines work and other medicines can affect the way Pomalidomide Accord works.
In particular, tell your doctor, pharmacist or nurse before taking Pomalidomide Accord
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 Accord. If this happens, do not drive vehicles and do not use
tools or machines.

Pomalidomide Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. How to take Pomalidomide Accord

Pomalidomide Accord 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 Accord with other medicines
Pomalidomide Accord with bortezomib and dexamethasone
use and their effects.

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

Cycle 1 to 8From Cycle 9 onwards
Name of the medicineName of the medicine
DayPOBORDEXDayPOMBORDEX
noMo
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 Accord with dexamethasone alone
its effects.

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

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

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

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

• The recommended initial dose of Pomalidomide Accord 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 Accord with dexamethasone alone

• The recommended initial dose of Pomalidomide Accord 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 Accord, bortezomib or dexamethasone or
stop one or more of these medicines based on the results of blood tests, your
general condition, other medicines you are taking (e.g. ciprofloxacin, enoxacin and
fluvoxamine) and if side effects occur (particularly rash or swelling) 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 Accord

• Do not break, open or chew the capsules. If the powder from a broken Pomalidomide Accord 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. Pregnant women who are known to be or suspected of being pregnant should not handle the blister or capsule.
• Swallow the tablets whole, preferably with water.
• The capsules can be taken with or without food.
• Take Pomalidomide Accord every day at approximately the same time.

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

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

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

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

If you forget to take Pomalidomide Accord
If you forget to take Pomalidomide Accord 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 the
omission of Pomalidomide Accord the previous day.
If you have any doubts 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 will experience them.

Serious side effects
Stop taking Pomalidomide Accord 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 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, little or no urination, nausea and vomiting, confusion, loss of consciousness (due to a blood infection called sepsis or septic shock).
• Severe, persistent, or bloody diarrhea (possibly with stomach pain or fever) caused by bacteria called Clostridium difficile.
• Chest pain or pain and swelling in the legs, especially the lower leg or calf (caused by blood clots).
• Shortness of breath (due to severe chest infection, lung inflammation, heart failure or blood clot).
• Swelling of the face, lips, tongue and throat, which can cause difficulty breathing (due to severe types of allergic reactions called angioedema and anaphylactic reaction).
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in the appearance or growths on the skin. If you notice any skin changes during treatment with Pomalidomide Accord, tell your doctor as soon as possible.
• Reappearance of hepatitis B infection, which can cause yellowing of the skin and eyes, dark brown urine, pain in the upper right abdomen, fever, and nausea or vomiting. Tell your doctor immediately if you notice any of these symptoms.
• Widespread rash, high body temperature, swollen lymph nodes and involvement of other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome, toxic epidermal necrolysis or Stevens-Johnson syndrome). Stop taking pomalidomide if these symptoms occur and see your doctor or seek medical attention immediately. See also section 2.

Stop taking Pomalidomide Accord and contact 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, dyspnea, mood changes.
• High levels of sugar in the blood.
• 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 radiating to the arms, neck, jaw, sweating, 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 experience fatigue, weakness, and shortness of breath and are also more likely to develop infections.
• Reduced number of lymphocytes (a type of white blood cells) often caused by infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesemia), which can cause fatigue, generalized weakness, muscle cramps, irritability and can lead to low levels of calcium in the blood (hypocalcemia), with possible numbness and/or tingling of the hands, feet or lips, muscle cramps, muscle weakness, dizziness, confusion.
• Low levels of phosphate in the blood (hypophosphatemia), which can cause muscle weakness and irritability or confusion.
• High levels of calcium in the blood (hypercalcemia), which can cause slowed reflexes and skeletal muscle weakness.
• High levels of potassium in the blood, which can cause an abnormal heart rhythm.
• Low levels of sodium in the blood, which can cause fatigue and confusion, muscle spasms, seizures or coma.
• High levels of uric acid in the blood, which can cause a form of arthritis called gout.
• Low blood pressure, which can cause dizziness or fainting.
• Painful or dry mouth.
• Altered sense of taste.
• Bloated abdomen.
• Feeling confused.
• Feeling down (depressed mood)
• Loss of consciousness, fainting.
• Blurred vision (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 can cause itching, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine, and abdominal pain.
• Breakdown of cancer cells, which releases toxic substances into the bloodstream (tumor lysis syndrome). This can cause kidney problems.
• Thyroid gland not working enough, which can cause symptoms such as fatigue, sluggishness, 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 Accord

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 carton after
Exp/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 Accord if you notice damage or signs of tampering with the packaging of the
medicine.
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. Package contents and other information

What Pomalidomide Accord contains

• The active ingredient is pomalidomide.
• The other ingredients are microcrystalline cellulose, maltodextrin and sodium stearyl fumarate.

Pomalidomide Accord 1 mg hard capsules:

• Each capsule contains 1 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).
• The printing ink contains: shellac, titanium dioxide (E171) and propylene glycol (E1520).

Pomalidomide Accord 2 mg hard capsules:

• Each capsule contains 2 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).
• The printing ink contains: shellac, titanium dioxide (E171) and propylene glycol (E1520).

Pomalidomide Accord 3 mg hard capsules:

• Each capsule contains 3 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E171), aluminium indigo carmine (E132), yellow iron oxide (E172) and red iron oxide (E172).
• The printing ink contains: shellac, titanium dioxide (E171) and propylene glycol (E1520).

Pomalidomide Accord 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), aluminium indigo carmine (E132) and erythrosine (E127).
• The printing ink contains: shellac, titanium dioxide (E171) and propylene glycol (E1520).

Description of the appearance of Pomalidomide Accord and contents of the pack
Pomalidomide Accord 1 mg hard capsules: hard gelatin capsule with a yellow body and red cap,
bearing the inscription “PLM 1” in white ink on the capsule body.
Pomalidomide Accord 2 mg hard capsules: hard gelatin capsule with an orange body and red
cap, bearing the inscription “PLM 2” in white ink on the capsule body.
Pomalidomide Accord 3 mg hard capsules: hard gelatin capsule with a turquoise body and red cap,
bearing the inscription “PLM 3” in white ink on the capsule body.
Pomalidomide Accord 4 mg hard capsules: hard gelatin capsule with a dark blue body and red cap,
bearing the inscription “PLM 4” in white ink on the capsule body.
Pomalidomide Accord is available in blisters of 7, 14 or 21 capsules or in perforated divisible blisters for
unit dose of 7 x 1, 14 x 1 or 21 x 1 capsules. Not all pack sizes may be marketed.

Marketing authorisation holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6 Planta,
08039 Barcelona,
Spain

Manufacturers
Synthon Hispania S.L.
Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat, Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen, Netherlands
Accord Healthcare Polska Sp. z.o.o.
ul.Lutomierska 50,
95 200, Pabianice, Poland
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT /
NL / NO / PL / PT / RO / SE / SI / SK
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Α.Ε.
Τηλ: +30 210 74 88 821

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency, http://www.ema.europa.eu. Furthermore, links to other websites on rare diseases and
related therapeutic treatments are provided.