Eltrombopag glenmark

Package leaflet: Information for the patient

Eltrombopag Glenmark, 25 mg, film-coated tablets
Eltrombopag Glenmark, 50 mg, film-coated tablets
Eltrombopagum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Eltrombopag Glenmark is and what it is used for

Eltrombopag Glenmark contains the active substance eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists. This medicine is used to increase the number of platelets in the patient's blood. Platelets are blood components that help reduce or prevent the risk of bleeding.

Eltrombopag Glenmark is used in the treatment of a blood clotting disorder called immune (primary) thrombocytopenia in patients over 1 year of age who have already been treated with other medicines (corticosteroids or immunoglobulins) that were ineffective.

Immune thrombocytopenia is caused by a low number of platelets in the blood (thrombocytopenia). People with immune thrombocytopenia are at increased risk of bleeding. Symptoms that patients with immune thrombocytopenia may notice include petechiae (small, flat, red, round spots under the skin), bruising, nosebleeds, bleeding gums, and difficulty stopping bleeding after a cut or injury.

Eltrombopag Glenmark may also be used to treat low platelet counts (thrombocytopenia) in adults with hepatitis C virus (HCV) infection who have experienced difficulties due to side effects during antiviral treatment with interferon. Many people with hepatitis C have low platelet counts, not only due to the disease itself but also as a result of certain antiviral medicines used in treatment. Taking Eltrombopag Glenmark may help patients complete a full course of antiviral therapy (peginterferon and ribavirin).

2. Important information before using Eltrombopag Glenmark

When not to use Eltrombopag Glenmark

• if the patient is allergic to eltrombopag or any of the other ingredients of this medicine (listed in section 6, “Contents of the Eltrombopag Glenmark”). Please consult your doctor if you think the situation described above applies to you.

Warnings and precautions
Before starting treatment with Eltrombopag Glenmark, discuss the following with your doctor:

• if the patient has liver disease. In patients with low platelet counts and also with advanced (chronic) liver disease, there is an increased risk of adverse reactions, including life-threatening liver damage and blood clots. If the doctor considers that the benefits of treatment with Eltrombopag Glenmark outweigh the risks, the patient will be closely monitored during treatment,
• if the patient is at risk of blood clots in veins or arteries, or if there is a family history of blood clots. The risk of blood clots may be increased:
  • if the patient is elderly
  • if the patient has been immobile for a prolonged period
  • if the patient has malignant cancer
  • if the patient is taking oral contraceptives or hormone replacement therapy
  • if the patient has recently undergone surgery or suffered trauma
  • if the patient is overweight
  • if the patient smokes
  • if the patient has advanced chronic liver disease
    Inform your doctor before starting treatment if any of the above situations apply to you. Do not use Eltrombopag Glenmark unless your doctor considers that the expected benefits outweigh the risk of blood clots.
• if the patient has cataracts (clouding of the eye lens)
• if the patient has other blood disorders, such as myelodysplastic syndrome (MDS). Before starting treatment with Eltrombopag Glenmark, the doctor will perform tests to rule out this condition. If the patient has MDS and is taking Eltrombopag Glenmark, the MDS may worsen. Inform your doctor if any of the above situations apply to you.

Ophthalmological examination
Your doctor will recommend regular eye examinations to detect cataracts. If the patient does not undergo routine eye examinations, the doctor should order regular checks. Examination may also include detection of any bleeding in the retina (the light-sensitive layer located at the back of the eye) or nearby areas.
Regular tests will be necessary
Before starting treatment with Eltrombopag Glenmark, the doctor will perform blood tests to evaluate blood cells, including platelets. These tests will be repeated periodically during treatment.
Blood tests to assess liver function
Eltrombopag Glenmark may cause blood test results indicating liver damage—increased activity of certain liver enzymes, particularly bilirubin and alanine or aspartate aminotransferase. If the patient is receiving interferon-based treatment concurrently with Eltrombopag Glenmark for low platelet count associated with hepatitis C, certain liver conditions may worsen.
Before starting treatment with Eltrombopag Glenmark and periodically during treatment, blood tests will be performed to assess liver function. It may be necessary to discontinue Eltrombopag Glenmark if levels of these substances increase significantly or if other signs of liver damage occur.
Please refer to the information in section 4 of this leaflet, “Liver disorders”.
Blood tests to monitor platelet count
If the patient stops taking Eltrombopag Glenmark, platelet count may decrease again within a few days. Platelet count will be monitored, and the doctor will discuss appropriate precautions with the patient.
A very high platelet count may increase the risk of blood clots. However, blood clots may also occur when platelet count is normal or low. The doctor will adjust the dose of Eltrombopag Glenmark to ensure that platelet count does not become too high.
Seek immediate medical help if the patient experiences any of the following symptoms of blood clots:

• swelling, pain, or tenderness in one leg
• sudden shortness of breath, especially with sharp chest pain or rapid breathing
• abdominal pain, abdominal swelling, or blood in stool

Tests to assess bone marrow
In patients with bone marrow disorders, medicines such as Eltrombopag Glenmark may worsen these conditions. Changes in bone marrow may manifest as abnormal blood test results. The doctor may order direct bone marrow examinations during treatment with Eltrombopag Glenmark.
Tests to detect gastrointestinal bleeding
If the patient is receiving interferon therapy concurrently with Eltrombopag Glenmark, monitoring for signs of stomach or intestinal bleeding will continue after stopping Eltrombopag Glenmark.
Heart examinations
The doctor may consider performing heart examinations during treatment with Eltrombopag Glenmark, including electrocardiography (ECG).
Elderly patients (65 years and older)
There is limited data on the use of Eltrombopag Glenmark in patients aged 65 years and older.
Caution should be exercised when using Eltrombopag Glenmark in patients aged 65 years and older.
Children and adolescents
Eltrombopag Glenmark is not recommended for children under 1 year of age with immune thrombocytopenia.
The medicine is also not recommended for patients under 18 years of age with low platelet count due to hepatitis C virus.
Eltrombopag Glenmark and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use. This includes over-the-counter medicines and vitamins.
Some commonly used medicines interact with eltrombopag—including both prescription and non-prescription medicines, as well as mineral products. These include:

• antacids used to treat indigestion, heartburn, or stomach ulcers (see also “When to take the medicine” in section 3)
• statins, which lower cholesterol levels
• certain medicines used to treat HIV infection, such as lopinavir and (or) ritonavir
• cyclosporine, used in transplant patients or in immune system disorders
• mineral products such as iron, calcium, magnesium, aluminium, selenium, and zinc, which may be components of vitamin-mineral supplements (see also “When to take the medicine” in section 3)
• medicines such as methotrexate and topotecan, used in cancer treatment.

Inform your doctor if you are taking any of the listed medicines. Some of them should not be used during treatment with Eltrombopag Glenmark, or dose adjustments or changes in timing of administration may be required. Your doctor will review all medicines you are taking and recommend changes if necessary.
If the patient is taking anticoagulant medicines to prevent blood clots, the risk of bleeding may be increased. Your doctor will discuss this with you.
If the patient is taking corticosteroids, danazol, and (or) azathioprine, it may be necessary to reduce the doses of these medicines or discontinue them during concomitant use of Eltrombopag Glenmark.
Taking Eltrombopag Glenmark with food and drink
Eltrombopag Glenmark must not be taken with dairy products or dairy-based beverages, as the calcium in dairy products affects the absorption of the medicine. For further information, please refer to “When to take the medicine” in section 3.
Pregnancy and breastfeeding
Do not use Eltrombopag Glenmark during pregnancy unless your doctor specifically advises it. The effect of eltrombopag use during pregnancy is unknown.

• Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning to become pregnant.
• While taking Eltrombopag Glenmark, use an appropriate method of contraception to prevent pregnancy.
• Inform your doctor if you become pregnant while taking Eltrombopag Glenmark.

Do not breastfeed while taking Eltrombopag Glenmark. It is not known whether eltrombopag passes into breast milk.
Inform your doctor if you are breastfeeding or plan to breastfeed.
Driving and operating machinery
Eltrombopag Glenmark may cause dizziness and other adverse effects that may impair attention and concentration.
Do not drive or operate machinery unless the patient is certain that these symptoms do not occur.
Eltrombopag Glenmark contains isomalt and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered “sodium-free”.

3. How to take Eltrombopag Glenmark

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist. Do not change the dose or dosing schedule of Eltrombopag Glenmark unless
your doctor or pharmacist advises you to do so. While taking Eltrombopag Glenmark, the patient
will remain under the care of a doctor experienced in treating the condition affecting the patient.

How much medicine to take

Immune thrombocytopenia

Adults and children (aged 6 to 17 years) – the usual starting dose in immune thrombocytopenia is one 50 mg tablet of Eltrombopag Glenmark once daily. In patients of East Asian or Southeast Asian origin, it may be necessary to start treatment with a lower dose of 25 mg.

Children (aged 1 to 5 years) – the usual starting dose in immune thrombocytopenia is one 25 mg tablet of Eltrombopag Glenmark once daily.

Chronic hepatitis C

Adults – the usual starting dose in chronic hepatitis C is one 25 mg tablet of Eltrombopag Glenmark once daily. In patients of East Asian or Southeast Asian origin, treatment should also be initiated at this 25 mg dose.

How to take the tablets

Swallow the tablets whole with water.

When to take the medicine

Make sure that

• for 4 hours before taking Eltrombopag Glenmark
• and for 2 hours after taking Eltrombopag Glenmark

the patient does not consume the following foods:

• dairy products such as cheese, butter, yoghurt, ice cream
• milk or drinks containing milk, yoghurt or cream
• antacids used to treat indigestion and heartburn
• vitamin and mineral supplements containing iron, calcium, magnesium, aluminium, selenium, zinc

Failure to follow these instructions may result in Eltrombopag Glenmark not being properly absorbed by the body.

For 4 hours ... and for 2 hours
before after taking
taking this medicine
this medicine…
DO NOT consume dairy products,
antacids,
or mineral supplements

Talk to your doctor for more information about suitable foods and drinks.

Taking more Eltrombopag Glenmark than prescribed

If you take more Eltrombopag Glenmark than prescribed, contact your doctor immediately.

Missing a dose of Eltrombopag Glenmark

Take the next dose at your usual time. Do not take more than one dose of Eltrombopag Glenmark per day.

Stopping Eltrombopag Glenmark

Do not stop taking Eltrombopag Glenmark without first consulting your doctor. If your doctor advises stopping treatment, your platelet count will be monitored weekly for four weeks. See also "Bleeding or bruising after stopping treatment" in section 4.

If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
Symptoms to be aware of: seek medical advice
In patients treated with Eltrombopag Glenmark for primary immune thrombocytopenia or low platelet count associated with hepatitis C, symptoms of severe adverse reactions may occur. It is important to inform your doctor if any of these symptoms appear.
Increased risk of thrombosis
Some people may have an increased risk of blood clots, and medicines such as Eltrombopag Glenmark may increase this risk. Sudden blockage of a blood vessel by a clot is an uncommon adverse reaction and may occur in no more than 1 in 100 people.
Seek immediate medical help if the patient experiences any of the following symptoms of thrombosis:

• swelling, pain, warmth sensation, redness or tenderness in one leg
• sudden shortness of breath, especially with acute chest pain or rapid breathing
• abdominal pain (stomach pain), abdominal swelling, blood in stool.

Liver disorders
Eltrombopag Glenmark may cause changes detectable in blood tests, which could indicate liver damage. Liver disorders (increased liver enzyme activity in blood tests) are common and may occur in up to 1 in 10 patients. Other liver problems are uncommon and may occur in no more than 1 in 100 patients.
If any of the following symptoms of liver disorders occur:

• yellowing of the skin or whites of the eyes (jaundice)
• abnormally dark urine, inform your doctor immediately.

Bleeding or bruising after stopping treatment
Usually within two weeks after stopping Eltrombopag Glenmark, the patient's platelet count decreases to the level observed before starting treatment with Eltrombopag Glenmark. Low platelet count may increase the risk of bleeding or bruising. Your doctor will monitor your platelet count for at least four weeks after stopping this medicine.
Inform your doctor if bleeding or bruising occurs after stopping Eltrombopag Glenmark.
Some patients may experience gastrointestinal bleeding after discontinuation of peginterferon, ribavirin, and eltrombopag. Symptoms include:

• black, tarry stools (change in stool color is an uncommon adverse reaction, occurring in no more than 1 in 100 patients)
• blood in stool
• vomiting blood or coffee-ground-like material
  Inform your doctor immediately if any of these symptoms occur.

The following adverse reactions have been reported in association with eltrombopag treatment in adult patients with primary immune thrombocytopenia:
Very common adverse reactions (may occur in more than 1 in 10 people):

• infection of nose, sinuses, throat and upper respiratory tract (upper respiratory tract infection)
• cough, common cold
• nausea, diarrhoea
• back pain

Very common adverse reactions detectable in blood tests:

• increased liver enzyme activity (alanine aminotransferase (AlAT))

Common adverse reactions (may occur in no more than 1 in 10 people):

• influenza, cold sores, pneumonia, irritation and inflammation (swelling) of sinuses, inflammation (swelling) and infection of tonsils, lung, sinus, nose and throat infections, gingivitis, sore throat and discomfort when swallowing
• loss of appetite
• sleep disturbances, depression
• reduced skin sensation, tingling, pricking or numbness, drowsiness, migraine
• eye disorders, including abnormal eye test results, dry eyes, eye pain and blurred vision, impaired vision
• ear pain, sensation of spinning (dizziness)
• pain, swelling and tenderness in one leg (usually calf) with warm skin sensation at the affected site (symptoms of deep vein thrombosis), localized swelling filled with blood from a damaged blood vessel (haematoma), hot flushes
• watery nasal discharge
• oral disorders, including dry mouth, mouth pain, tongue sensitivity, gum bleeding, mouth ulcers, toothache, vomiting, abdominal pain, flatulence
• abnormal liver function
• skin changes, including excessive sweating, itchy raised rash, red spots, skin appearance changes, hair loss
• muscle pain, muscle cramps, muscle weakness, bone pain
• foamy urine with presence of air bubbles (symptoms indicating protein in urine)
• heavy menstrual bleeding
• high body temperature, feeling of warmth, chest pain, feeling of weakness

Common adverse reactions detectable in blood tests:

• decreased number of red blood cells (anaemia), decreased platelet count (thrombocytopenia), decreased number of white blood cells, decreased haemoglobin concentration, increased eosinophil count, increased white blood cell count (leukocytosis)
• increased uric acid concentration, decreased potassium concentration
• increased liver enzyme activity (aspartate aminotransferase (AspAT)), increased blood bilirubin concentration (a substance produced by the liver)
• increased concentration of certain proteins, increased creatinine concentration
• increased alkaline phosphatase activity

Uncommon adverse reactions (may occur in no more than 1 in 100 people):

• skin infection
• rectal and colon cancer
• allergic reaction
• loss of appetite, painful joint swelling due to uric acid (gout)
• lack of interest, mood changes, uncontrollable or unexpected crying
• balance disorders, speech and nerve function disorders, tremors, paralysis on one side of the body, migraine with aura, nerve damage, dilation or swelling of blood vessels causing headache
• eye disorders, including excessive tearing, clouding of the eye lens (cataract), retinal haemorrhage, dry eyes
• rapid heartbeat, irregular heartbeat, bluish skin discoloration, cardiac rhythm disorders (QT interval prolongation), which may indicate heart and blood vessel disorders, interruption of blood flow to part of the heart
• possible pain, swelling and (or) redness around a vein, which may indicate venous thrombosis, blood clot, sudden redness
• sudden shortness of breath, especially combined with acute chest pain and (or) rapid breathing, which may indicate pulmonary embolism (see "Increased risk of thrombosis" above in section 4), loss of function in part of the lung due to blockage of the pulmonary artery, nose, throat and sinus disorders, sleep-related breathing disorders
• oral disorders, including dry or painful mouth, tongue pain, gum bleeding, oral discomfort, blisters or ulcers in mouth and throat, gastrointestinal disorders, including frequent bowel movements, food poisoning, blood in stool, bloody vomiting, rectal bleeding, change in stool color, abdominal distension, constipation
• yellowing of the skin and (or) abdominal pain, which may indicate biliary obstruction, liver disease, liver damage due to inflammation (see "Liver disorders" above in section 4), drug-induced liver damage
• painful or abnormal skin sensations, skin changes, including skin discoloration, peeling, redness, itching and sweating, cold sweats
• muscle weakness
• kidney disorders, including nephritis, excessive urination at night, kidney failure, presence of white blood cells in urine
• feeling of warmth, restlessness, bleeding around a catheter (if present) into the skin, redness or swelling at wound site, general malaise, sensation of a foreign body
• sunburn

Uncommon adverse reactions detectable in laboratory tests:

• changes in red blood cell shape, decreased number of red blood cells (anaemia) due to excessive red blood cell breakdown (haemolytic anaemia), increased myelocyte count, increased band neutrophil count, presence of developing white blood cells which may indicate certain diseases, increased platelet count, increased haemoglobin concentration
• decreased calcium concentration
• increased blood urea concentration, increased protein in urine
• increased albumin concentration in blood, increased total protein concentration, decreased albumin concentration in blood, increased urine pH

The following additional adverse reactions have been reported in association with eltrombopag treatment in children (aged 1 to 17 years) with ITP:
If these adverse reactions worsen, inform your doctor, pharmacist or nurse.
Very common adverse reactions (may occur in more than 1 in 10 children):

• infection of nose, sinuses, throat and upper respiratory tract, common cold (upper respiratory tract infection)
• cough
• nausea, diarrhoea, abdominal pain
• high body temperature

Common adverse reactions (may occur in no more than 1 in 10 children):

• difficulty falling asleep (insomnia)
• itchy nose, runny or blocked nose, sore throat, cold, nasal mucosa congestion and sneezing, nasal and throat pain
• toothache, oral disorders, including dry mouth, oral pain, tongue sensitivity, gum bleeding, mouth ulcers

The following adverse reactions have been reported in association with eltrombopag treatment in combination with peginterferon and ribavirin in patients with hepatitis C:
Very common adverse reactions (may occur in more than 1 in 10 people):

• loss of appetite
• headache
• cough
• nausea, diarrhoea
• itching, swelling of hands or feet, unusual hair loss
• muscle pain, muscle weakness
• fever, feeling of fatigue, flu-like illness, weakness, chills

Very common adverse reactions detectable in blood tests:

• decreased number of red blood cells (anaemia)

Common adverse reactions (may occur in no more than 1 in 10 people):

• urinary tract infections, infection of nose, sinuses, throat and upper respiratory tract, common cold (upper respiratory tract infection), inflammation of the mucous membrane lining the bronchi, nasal passage, throat and oral cavity, flu-like symptoms, dry mouth, pain or inflammation of the oral cavity, toothache, influenza, cold sores
• weight loss
• sleep disorders, abnormal drowsiness, depression, anxiety
• dizziness, concentration and memory disturbances, mood changes, brain dysfunction due to liver damage, tingling or numbness in hands or feet
• vision disorders, including: clouding of the eye lens (cataract), dry eye syndrome, small yellow deposits on the retina, yellowing of the whites of the eyes, retinal haemorrhage
• sensation of spinning (dizziness)
• rapid or irregular heartbeat (palpitations)
• shortness of breath, cough with sputum, runny nose, sore throat and discomfort when swallowing
• gastrointestinal disorders, including vomiting, abdominal pain, indigestion, constipation, abdominal distension, taste disturbances, haemorrhoids, stomach pain or discomfort, swelling and bleeding of blood vessels in the oesophagus, toothache
• liver disorders, including liver tumour, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver damage (see above "Liver disorders" in section 4)
• skin changes, including rash, dry skin, skin eruptions, skin redness, itching, excessive sweating, unusual skin growths, hair loss
• joint pain, back pain, bone pain, limb pain (legs, arms, hands or feet), muscle cramps
• irritability, general malaise, skin reaction such as redness, swelling and pain at injection site, chest pain and discomfort, fluid accumulation in the body or limbs causing swelling
• depression, anxiety, sleep disorders, nervousness
• fever, headache

Common adverse reactions detectable in blood tests:

• increased blood glucose concentration, decreased white blood cell count, decreased neutrophil count, decreased blood albumin concentration, decreased haemoglobin concentration, increased blood bilirubin concentration (a substance produced in the liver), changes in enzymes controlling blood coagulation

Uncommon adverse reactions (may occur in no more than 1 in 100 people):

• gastroenteritis (stomach flu), sore throat
• decreased number of red blood cells (anaemia) due to excessive red blood cell breakdown (haemolytic anaemia)
• confusion, agitation
• mouth blisters or ulcers, gastritis
• blood clots in the vein carrying blood to the liver (possible liver and/or gastrointestinal damage), impaired liver function
• skin changes, including discoloration, peeling, redness, itching, skin lesions and night sweats
• abnormal blood clotting in small blood vessels with kidney failure, pain during urination
• rash, bruising at injection site, chest discomfort
• cardiac rhythm disorders (QT interval prolongation)

Reporting of adverse reactions
If any adverse reactions occur, including any unlisted symptoms not mentioned in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Eltrombopag Glenmark

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack following the abbreviation EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Eltrombopag Glenmark contains:

• The active substance is eltrombopag olamine. Eltrombopag Glenmark 25 mg: each coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.

Eltrombopag Glenmark 50 mg: each coated tablet contains eltrombopag olamine equivalent to 50 mg of eltrombopag.

• The other ingredients are: microcrystalline cellulose, polyethylene glycol, povidone, isomalt (E 953), calcium silicate, sodium carboxymethyl starch (type A), magnesium stearate (tablet core), hypromellose, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), triacetin (tablet coating).

What Eltrombopag Glenmark looks like and contents of the pack
Eltrombopag Glenmark 25 mg are dark pink, coated, round, biconvex tablets with the imprint “II” on one side and a diameter of approximately 8 mm.
Eltrombopag Glenmark 50 mg are pink, coated, round, biconvex tablets with the imprint “III” on one side and a diameter of approximately 10 mm.
Pack sizes available:
Blister packs in cardboard cartons containing 10, 14, 28, 30 or 84 coated tablets; unit-dose blister packs in cardboard cartons containing 10x1, 14x1, 28x1, 30x1 or 84x1 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic
Manufacturer
Synthon Hispania S.L.
Calle De Castelló 1
Sant Boi De Llobregat
08830 Barcelona
Spain
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 Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekonskiego 3
00-728 Warsaw
Tel: +48 22 35 12 500
Email: [email protected]
This medicinal product is authorised in the Member States of the European Economic Area under the following names: