Eltrombopag glenmark

Package leaflet: Information for the user

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 you.

• Keep this leaflet. 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 you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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. Important information 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 your blood. Platelets are blood components that help reduce or prevent the risk of bleeding.

Eltrombopag Glenmark is used to treat a blood clotting disorder called immune (idiopathic) 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 (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 chronic hepatitis C virus (HCV) infection who have difficulties due to side effects during interferon-based therapy. 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, "What Eltrombopag Glenmark contains"). The patient should consult a doctor if they think the situation described above applies to them.

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 venous or arterial blood clots, 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 experienced trauma
  • if the patient is overweight
  • if the patient smokes
  • if the patient has advanced chronic liver disease
    The patient should inform the doctor before starting treatment if any of the above situations apply. Eltrombopag Glenmark should not be used unless the 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 Eltrombopag Glenmark, the doctor will perform tests to rule out this condition. If the patient has MDS and is taking Eltrombopag Glenmark, MDS may worsen. The patient should inform the doctor if any of the above situations apply.

Ophthalmological examination
The doctor will recommend regular eye examinations to detect cataracts. If the patient does not routinely undergo eye examinations, the doctor should arrange for regular check-ups. Examinations may also include assessment for any bleeding in the retina (the light-sensitive layer at the back of the eye) or nearby areas.
Regular monitoring will be required
Before starting 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 therapy together with Eltrombopag Glenmark for low platelet count associated with hepatitis C, certain liver conditions may worsen.
Blood tests to assess liver function will be performed before starting Eltrombopag Glenmark and periodically during treatment. 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 section 4 of this leaflet, "Liver disorders".
Blood tests to monitor platelet count
If the patient stops taking Eltrombopag Glenmark, platelet counts may decrease again within a few days. Platelet counts will be monitored, and the doctor will discuss appropriate precautions with the patient.
Very high platelet counts may increase the risk of blood clots. However, blood clots may also occur when platelet counts are normal or low. The doctor will adjust the dose of Eltrombopag Glenmark to ensure platelet counts do not become too high.
Seek immediate medical attention 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 the stool

Bone marrow assessment
In patients with bone marrow disorders, medicines such as Eltrombopag Glenmark may worsen these conditions. Changes in the bone marrow may manifest as abnormal blood test results. The doctor may recommend direct bone marrow examinations during treatment with Eltrombopag Glenmark.
Tests to detect gastrointestinal bleeding
If the patient is receiving interferon therapy together with Eltrombopag Glenmark, they will be monitored for signs of bleeding from the stomach or intestines after stopping Eltrombopag Glenmark treatment.
Heart examinations
The doctor may consider performing heart assessments during treatment with Eltrombopag Glenmark, including electrocardiograms (ECG).
Elderly patients (aged 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 infection.
Eltrombopag Glenmark and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. 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 autoimmune diseases
• mineral products such as iron, calcium, magnesium, aluminium, selenium, and zinc, which may be components of vitamin and mineral supplements (see also "When to take the medicine" in section 3)
• medicines such as methotrexate and topotecan, used in cancer treatment.

The patient should inform the doctor if they are taking any of these 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. The doctor will review the patient's medications and recommend changes if necessary.
If the patient is taking anticoagulant medicines to prevent blood clots, there is an increased risk of bleeding. The doctor will discuss this with the patient.
If the patient is taking corticosteroids, danazol, and/or azathioprine, it may be necessary to reduce the doses or discontinue these medicines 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 drinks, 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 advised by a doctor. The effect of eltrombopag use during pregnancy is unknown.

• Inform the doctor if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant.
• The patient should use an appropriate method of contraception during treatment with Eltrombopag Glenmark to prevent pregnancy.
• Inform the doctor if the patient becomes pregnant while taking Eltrombopag Glenmark.

Breastfeeding is not recommended during treatment with Eltrombopag Glenmark. It is not known whether eltrombopag passes into breast milk.
Inform the doctor if the patient is breastfeeding or planning 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 affect them.
Eltrombopag Glenmark contains isomalt and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their 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 managing the disease affecting the patient.

How much medicine to take

Immune thrombocytopenic purpura (ITP)
Adults and children (aged 6 to 17 years): the usual starting dose in immune thrombocytopenic purpura is one 50 mg tablet of Eltrombopag Glenmark daily. In patients of East or South-East Asian origin, a lower starting dose of 25 mg may be required.
Children (aged 1 to 5 years): the usual starting dose in immune thrombocytopenic purpura is one 25 mg tablet of Eltrombopag Glenmark daily.

Chronic hepatitis C
Adults: the usual starting dose in chronic hepatitis C is one 25 mg tablet of Eltrombopag Glenmark daily. In patients of East or South-East Asian origin, treatment should be initiated at the same 25 mg dose.

How to take the tablets
The tablets should be swallowed 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, or 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 more Eltrombopag Glenmark has been taken than prescribed, contact your doctor immediately.

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

Stopping treatment with Eltrombopag Glenmark
Do not stop taking Eltrombopag Glenmark without first consulting your doctor. If your doctor decides to discontinue 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Symptoms to watch for: consult a doctor
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. Immediate medical attention is required if any of the following signs of thrombosis occur:

• swelling, pain, warmth, redness, or tenderness in one leg
• sudden shortness of breath, especially with sharp 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 that may 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-related 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
  you should immediately inform your doctor.

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 the treatment. Low platelet count may increase the risk of bleeding or bruising. Your doctor will monitor your platelet count for at least 4 weeks after stopping this medicine.
Inform your doctor immediately 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 (stool discoloration is an uncommon adverse reaction, occurring in no more than 1 in 100 patients)
• blood in stool
• vomiting blood or coffee-ground-like material
  Seek immediate medical advice 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):

• nasal, sinus, throat, and upper respiratory tract infections (upper respiratory tract infection)
• cough, common cold
• nausea, diarrhea
• 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, sinus irritation and inflammation (sinus swelling), tonsillar inflammation (swelling) and infection, 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, blurred vision, visual impairment
• ear pain, sensation of spinning (dizziness)
• pain, swelling, and tenderness in one leg (usually calf), with a feeling of warmth in the affected area (symptoms of deep vein thrombosis), localized blood-filled swelling due to damaged blood vessel (hematoma), 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 disorders, including excessive sweating, raised itchy rash, red spots, skin appearance changes, hair loss
• muscle pain, muscle cramps, muscle weakness, bone pain
• foamy urine with presence of air bubbles (symptoms of 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 (anemia), decreased platelet count (thrombocytopenia), decreased white blood cell count, decreased hemoglobin 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
• colorectal 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, one-sided paralysis, migraine with aura, nerve damage, blood vessel dilation or swelling causing headache
• eye disorders, including excessive tearing, lens clouding (cataract), retinal hemorrhage, 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 pulmonary artery blockage, nose, throat, and sinus disorders, sleep-related breathing disorders
• oral disorders, including dryness or pain in the mouth, tongue pain, gum bleeding, oral discomfort, blisters or ulcers in the mouth and throat, gastrointestinal disorders, including frequent defecation, food poisoning, blood in stool, bloody vomiting, rectal bleeding, stool color change, abdominal distension, constipation
• yellowing of the skin and/or abdominal pain, which may indicate bile duct obstruction, liver disease, liver damage due to inflammation (see "Liver disorders" above in section 4), drug-induced liver injury
• painful or abnormal skin sensations, skin disorders, including skin discoloration, peeling, redness, itching, and sweating, cold sweats
• muscle weakness
• kidney disorders, including kidney inflammation, excessive urination at night, kidney failure, presence of white blood cells in urine
• feeling of warmth, restlessness, bleeding around the catheter (if present) into the skin, redness or swelling at the wound site, general malaise, sensation of foreign body
• sunburn

Uncommon adverse reactions detectable in laboratory tests:

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

• nasal, sinus, throat, and upper respiratory tract infections, common cold (upper respiratory tract infection)
• cough
• nausea, diarrhea, 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, nasal catarrh, nasal mucosal 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, diarrhea
• 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 (anemia)

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

• urinary tract infections, nasal, sinus, throat, and upper respiratory tract infections, common cold (upper respiratory tract infection), bronchial mucosal inflammation, nasal passage, throat, and oral cavity inflammation, 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: lens clouding (cataract), dry eye syndrome, small yellow eye retinal deposits, yellowing of the whites of the eyes, retinal hemorrhage
• sensation of spinning (dizziness)
• rapid or irregular heartbeat (palpitations)
• shortness of breath, cough with sputum, nasal catarrh, sore throat, and discomfort when swallowing
• gastrointestinal disorders, including vomiting, abdominal pain, indigestion, constipation, abdominal distension, taste disturbances, hemorrhoids, stomach pain or discomfort, blood vessel swelling and bleeding in the esophagus, toothache
• liver disorders, including liver tumor, yellowing of the whites of the eyes or skin (jaundice), drug-induced liver injury (see above "Liver disorders" in section 4)
• skin disorders, 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 sugar (glucose) concentration, decreased white blood cell count, decreased neutrophil count, decreased blood albumin concentration, decreased hemoglobin 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 (anemia) due to excessive red blood cell breakdown (hemolytic anemia)
• confusion, agitation
• mouth blisters or ulcers, gastritis
• blood clots in the vein carrying blood to the liver (possible liver and/or gastrointestinal damage), liver function disorders
• skin disorders, including color changes, 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 symptoms not listed 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 this medicine.

5. How to store Eltrombopag Glenmark

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
blister after the abbreviation EXP, which refers to the expiry date. 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such 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 film-coated tablet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.

Eltrombopag Glenmark 50 mg: each film-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, film-coated, round, biconvex tablets with the engraved mark “II” on one side and a diameter of approximately 8 mm.
Eltrombopag Glenmark 50 mg are pink, film-coated, round, biconvex tablets with the engraved mark “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 film-coated tablets; unit dose blisters in cardboard cartons containing 10x1, 14x1, 28x1, 30x1 or 84x1 film-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 more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekońskiego 3
00-728 Warsaw
Tel: +48 22 35 12 500
Email: [email protected]
This medicine is authorised in the European Economic Area countries under the following names: