Eltrombopag Glenmark

Leaflet accompanying the packaging: patient information

Eltrombopag Glenmark, 25 mg, film-coated tablets

Eltrombopag Glenmark, 50 mg, film-coated tablets

Eltrombopag

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Eltrombopag Glenmark and what is it 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 packaging and other information

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

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

Eltrombopag Glenmark is used to treat a bleeding disorder called primary immune thrombocytopenia (ITP) in patients over 1 year of age who have been previously treated with other medicines (corticosteroids or immunoglobulins) and have not responded to them.

Primary immune thrombocytopenia is caused by a low platelet count (thrombocytopenia). People with primary immune thrombocytopenia are more prone to bleeding. Symptoms that patients with primary immune thrombocytopenia may notice include petechiae (small, flat, red spots under the skin), purpura, nosebleeds, gum bleeding, and difficulty stopping bleeding in case of injury or trauma.

Eltrombopag Glenmark may also be used to treat low platelet count (thrombocytopenia) in adults with hepatitis C virus (HCV) infection who have had difficulty with side effects during treatment with interferon. Many people with hepatitis C have a low platelet count, not only due to the disease but also as a result of the action of certain antiviral medicines used to treat it.

Taking Eltrombopag Glenmark may help patients complete their full antiviral treatment (peginterferon and ribavirin).

2. Important information before taking Eltrombopag Glenmark

When not to take 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 this situation applies to them.

Warnings and precautions

Before starting treatment with Eltrombopag Glenmark, the patient should discuss the following with their doctor:

• if the patient has liver disease. People with low platelet count and advanced (long-standing) liver disease are at increased risk of side effects, including life-threatening liver damage and blood clots. If the doctor considers that the benefits of taking Eltrombopag Glenmark outweigh the risks, the patient will be closely monitored during treatment.
• if the patient is at risk of blood clots in the 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 long time
• if the patient has cancer
• if the patient is taking oral contraceptives or hormone replacement therapy
• if the patient has recently undergone surgery or trauma
• if the patient is overweight
• if the patient smokes
• if the patient has advanced chronic liver disease. The patient should inform their doctor before starting treatment if any of these situations apply to them. Eltrombopag Glenmark should not be taken unless the doctor considers that the expected benefits outweigh the risk of blood clots.
• if the patient has cataracts (clouding of the lens in the eye)
• 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 takes Eltrombopag Glenmark, MDS may worsen. The patient should inform their doctor if any of these situations apply to them.

Eye examination

The doctor will recommend an eye examination to detect cataracts. If the patient does not undergo regular eye examinations, the doctor should recommend regular examinations. The occurrence of any bleeding in the retina (the light-sensitive layer at the back of the eye) or near it may also be examined.

Regular blood tests will be necessary

Before starting treatment with Eltrombopag Glenmark, the doctor will perform blood tests to assess the patient's blood cells, including platelets. During treatment, these tests will be repeated at regular intervals.

Blood tests to assess liver function

Eltrombopag Glenmark may cause changes in blood test results that may indicate liver damage - increased activity of certain liver enzymes, particularly bilirubin and alanine or aspartate transaminase. If the patient is taking interferon-based treatment with Eltrombopag Glenmark for low platelet count associated with hepatitis C, some liver diseases may worsen.

Blood tests to assess liver function will be performed before starting treatment with Eltrombopag Glenmark and at regular intervals during treatment. It may be necessary to stop taking Eltrombopag Glenmark if the levels of these substances increase significantly or if other symptoms of liver damage occur.

The patient should read the information in section 4 of this leaflet "Liver disorders".

Blood tests to assess platelet count

If the patient stops taking Eltrombopag Glenmark, it is likely that the platelet count will decrease again within a few days. The 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 can also occur when the platelet count is normal or too low. The doctor will adjust the dose of Eltrombopag Glenmark to prevent the platelet count from becoming too high.

The patient should seek medical attention immediately if they experience any of the following symptoms of a blood clot:

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

Bone marrow examinations

In people with bone marrow disorders, medicines like Eltrombopag Glenmark may worsen these disorders. Changes in the bone marrow may be indicated by abnormal blood test results. The doctor may order direct bone marrow examinations during treatment with Eltrombopag Glenmark.

Examinations to detect gastrointestinal bleeding

If the patient is taking interferon-based treatment with Eltrombopag Glenmark for low platelet count associated with hepatitis C, they will be monitored for symptoms of gastrointestinal bleeding after stopping treatment with Eltrombopag Glenmark.

Heart examinations

The doctor may consider examining the patient's heart during treatment with Eltrombopag Glenmark and performing an electrocardiogram (ECG).

Elderly patients (65 years and older)

There is limited data on the use of Eltrombopag Glenmark in patients aged 65 and older.

Care should be taken when using Eltrombopag Glenmark in patients aged 65 and older.

Children and adolescents

Eltrombopag Glenmark is not recommended for children under 1 year of age with primary immune thrombocytopenia.

The medicine is also not recommended for patients under 18 years of age with low platelet count associated with hepatitis C virus infection.

Eltrombopag Glenmark and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines available without a prescription and vitamins.

Certain commonly used medicines interact with eltrombopag - including prescription and non-prescription medicines and mineral products. These include:

• antacids used to treat heartburn, acid reflux, and 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 ritonavir
• cyclosporin used in transplants or immune system disorders
• mineral products, such as iron, calcium, magnesium, aluminum, 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 to treat cancer.

The patient should tell their doctor if they are taking any of these medicines. Some of them should not be taken while taking Eltrombopag Glenmark, or the dose or timing of the medicines may need to be adjusted. The doctor will review the patient's medicines and recommend changes if necessary.

If the patient is taking 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 dose of these medicines or stop taking them while taking Eltrombopag Glenmark.

Taking Eltrombopag Glenmark with food and drink

Eltrombopag Glenmark should not be taken with dairy products or drinks, as the calcium in these products affects the absorption of the medicine. For more information, the patient should read "When to take the medicine" in section 3.

Pregnancy and breastfeeding

Eltrombopag Glenmark should not be taken during pregnancy unless the doctor recommends it. The effect of taking eltrombopag during pregnancy is unknown.

• The patient should inform their doctor if they are pregnant, think they may be pregnant, or plan to have a baby.
• While taking Eltrombopag Glenmark, the patient should use appropriate contraception to prevent pregnancy.
• The patient should inform their doctor if they become pregnant while taking Eltrombopag Glenmark.

The patient should not breastfeed while taking Eltrombopag Glenmark. It is not known whether eltrombopag passes into breast milk.

The patient should inform their doctor if they are breastfeeding or plan to breastfeed.

Driving and using machines

Eltrombopag Glenmark may cause dizziness and other side effects that reduce attention.

The patient should not drive or operate machinery unless they are sure that these symptoms do not occur.

Eltrombopag Glenmark contains isomalt and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

3. How to take Eltrombopag Glenmark

This medicine should always be taken exactly as the doctor has instructed. If the patient is unsure, they should ask their doctor or pharmacist. The patient should not change the dose or dosing schedule of Eltrombopag Glenmark unless their doctor or pharmacist tells them to do so. While taking Eltrombopag Glenmark, the patient will remain under the care of a doctor experienced in treating the patient's condition.

How much to take

Primary immune thrombocytopenia

Adults and children (aged 6 to 17 years) - the usual starting dose for primary immune thrombocytopenia is one 50 mg tablet of Eltrombopag Glenmark per day. In patients of East Asian/South East 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 for primary immune thrombocytopenia is one 25 mg tablet of Eltrombopag Glenmark per day.

Hepatitis C

Adults - the usual starting dose for hepatitis C is one 25 mg tablet of Eltrombopag Glenmark per day. In patients of East Asian/South East Asian origin, treatment should be started with the same dose of 25 mg.

How to take the tablets

The tablets should be swallowed whole with water.

When to take the medicine

The patient should make sure that:

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

they do not eat the following foods:

• dairy products, such as cheese, butter, yogurt, ice cream
• milk or drinks containing milk, yogurt, or cream
• antacids used to treat heartburn and acid reflux
• mineral supplements containing iron, calcium, magnesium, aluminum, selenium, or zinc

If the patient does not follow these instructions, Eltrombopag Glenmark may not be properly absorbed by the body.

The patient should talk to their doctor to get more information about the foods and drinks to avoid.

What to do if too much Eltrombopag Glenmark is taken

If the patient takes more Eltrombopag Glenmark than they should, they should contact their doctor immediately.

What to do if a dose of Eltrombopag Glenmark is missed

The patient should take the next dose at the usual time. They should not take more than one dose of Eltrombopag Glenmark per day.

What to do if treatment with Eltrombopag Glenmark is stopped

The patient should not stop taking Eltrombopag Glenmark without consulting their doctor first. If the doctor recommends stopping treatment, the patient's platelet count will be monitored.

For 4 hours before taking

this medicine…

... and for 2 hours

after taking

this medicine

DO NOT eat dairy products, antacids

or mineral supplements

See also "Bleeding or bruising after stopping treatment" in section 4.

If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Eltrombopag Glenmark can cause side effects, although not everybody gets them.

Symptoms to look out for: the patient should see a doctor

In patients taking Eltrombopag Glenmark for primary immune thrombocytopenia or low platelet count associated with hepatitis C, symptoms of serious side effects may occur. It is essential to inform the doctor about these symptoms.

Increased risk of blood clots

In some people, the risk of blood clots may increase, and medicines like Eltrombopag Glenmark may worsen this condition. Sudden blockage of a blood vessel by a blood clot is an uncommon side effect and may occur in less than 1 in 100 people.

The patient should seek medical attention immediately if they experience any symptoms of a blood clot, such as:

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

Liver disorders

Eltrombopag Glenmark may cause changes in blood test results that may indicate liver damage. Liver disorders (increased activity of enzymes in blood test results) are common and may occur in less than 1 in 10 people. Other liver problems are uncommon and may occur in less than 1 in 100 people.

If the patient experiences any of the following symptoms of liver disorders:

• yellowing of the skin or whites of the eyes (jaundice)
• darkening of the urine

they should tell their doctor immediately.

Bleeding or bruising after stopping treatment

Usually, within two weeks after stopping treatment with Eltrombopag Glenmark, the patient's platelet count will decrease to the level before starting treatment with Eltrombopag Glenmark. A low platelet count may increase the risk of bleeding or bruising. The doctor will monitor the patient's platelet count for at least 4 weeks after stopping treatment with this medicine.

The patient should inform their doctor if they experience any bleeding or bruising after stopping treatment with Eltrombopag Glenmark.

In some patients, gastrointestinal bleeding may occur after stopping treatment with peginterferon, ribavirin, and eltrombopag. Symptoms include:

• black, tarry stools (a change in stool color, which is an uncommon side effect that may occur in less than 1 in 100 people)
• blood in the stool
• vomiting blood or coffee-ground-like material

The patient should tell their doctor immediately if they experience any of these symptoms.

The following side effects have been reported in adults with primary immune thrombocytopenia taking eltrombopag:

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

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

Very commonside effects that may be seen in blood tests:

• increased activity of liver enzymes (alanine transaminase (ALT))

Commonside effects (may affect up to 1 in 10 people):

• flu, herpes simplex, pneumonia, sinusitis, tonsillitis, bronchitis, pharyngitis, toothache, headache, fatigue, dizziness, insomnia, depression, numbness, tingling, or burning sensation, somnolence, migraine
• eye disorders, including abnormal vision test results, dry eyes, eye pain, and blurred vision, visual impairment
• ear pain, sensation of spinning (vertigo)
• swelling, pain, or tenderness in one leg (usually the calf) with a feeling of warmth in the affected area (symptoms of deep vein thrombosis), localized swelling filled with blood from a damaged blood vessel (hematoma), hot flashes
• runny nose
• mouth disorders, including dry mouth, mouth pain, tongue sensitivity, gum bleeding, mouth ulceration, toothache, vomiting, abdominal pain
• abnormal liver function
• skin changes, including excessive sweating, pruritic rash, red spots, skin changes, hair loss
• muscle pain, muscle spasms, muscle weakness, bone pain
• urinary disorders, including kidney disease, nocturia, kidney failure, presence of white blood cells in the urine
• fever, feeling hot, bleeding at the catheter site (if present) to the skin, redness or swelling at the wound site, general malaise, feeling of a foreign body
• sunburn

Commonside effects that may be seen in blood tests:

• decreased red blood cell count (anemia), decreased platelet count (thrombocytopenia), decreased white blood cell count, decreased hemoglobin level, increased eosinophil count, increased white blood cell count (leukocytosis)
• increased uric acid level, decreased potassium level
• increased liver enzyme activity (aspartate transaminase (AST)), increased bilirubin level in the blood
• increased levels of certain proteins, increased creatinine level
• increased alkaline phosphatase activity

Uncommonside effects (may affect up to 1 in 100 people):

• skin infection
• rectal or colon cancer
• allergic reaction
• loss of appetite, painful joint swelling caused by uric acid (gout)
• lack of interest, mood changes, crying that is hard to control or occurs unexpectedly
• balance disorders, speech and nerve disorders, tremors, paralysis of one side of the body, migraine with accompanying aura, nerve damage, vasodilation causing headache
• eye disorders, including increased tearing, cataracts, retinal hemorrhage, dry eyes
• rapid heartbeat, irregular heartbeat, cyanosis, cardiac arrhythmias (QT prolongation), which may be symptoms of heart and blood vessel disorders, interruption of blood flow to a part of the heart
• possible pain, swelling, and/or redness in or around a vein, which may be symptoms of a blood clot, blood clot, sudden redness
• sudden shortness of breath, especially with sudden chest pain and/or rapid breathing, which may be a symptom of a pulmonary embolism (see "Increased risk of blood clots" above in section 4), loss of lung function due to blockage of a pulmonary artery, respiratory disorders, sleep apnea
• mouth disorders, including dryness or pain in the mouth, tongue sensitivity, gum bleeding, mouth discomfort, blisters or ulcers in the mouth and throat, gastrointestinal disorders, including frequent bowel movements, food poisoning, blood in the stool, vomiting blood, rectal bleeding, change in stool color, abdominal bloating, constipation
• liver disorders, including liver tumor, yellowing of the whites of the eyes or skin (jaundice), liver damage caused by taking the medicine (see "Liver disorders" above in section 4)
• skin changes, including discoloration, peeling, redness, itching, excessive sweating, unusual skin growths, hair loss
• joint pain, back pain, bone pain, limb pain (arms, legs, hands, or feet), muscle spasms
• irritability, general malaise, skin reaction, such as redness or swelling and pain at the injection site, chest pain and discomfort, fluid accumulation in the body or limbs causing swelling
• depression, anxiety, sleep disorders, nervousness
• fever, headache

Uncommonside effects that may be seen in blood tests:

• changes in red blood cell shape, decreased red blood cell count (anemia) caused by excessive breakdown of red blood cells (hemolytic anemia), increased neutrophil count, presence of developing white blood cells, which may indicate certain diseases, increased platelet count, increased hemoglobin level
• decreased calcium level
• increased urea level in the blood, increased protein level in the urine
• increased albumin level in the blood, increased total protein level, decreased albumin level in the blood, increased urine pH

The following additional side effects have been reported in children (aged 1 to 17 years) with ITP taking eltrombopag:

If these side effects worsen, the patient should tell their doctor, pharmacist, or nurse.

Very commonside effects (may affect more than 1 in 10 children):

• infection of the nose, sinuses, throat, and upper respiratory tract, common cold (upper respiratory tract infection)
• cough
• nausea, diarrhea, abdominal pain
• fever

Commonside effects (may affect up to 1 in 10 children):

• difficulty sleeping (insomnia)
• nasal congestion or runny nose, sore throat, nasal congestion and sneezing
• toothache, mouth disorders, including dry mouth, mouth pain, tongue sensitivity, gum bleeding, mouth ulceration

The following side effects have been reported in patients with HCV taking eltrombopag in combination with peginterferon and ribavirin:

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

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

Very commonside effects that may be seen in blood tests:

• decreased red blood cell count (anemia)

Commonside effects (may affect up to 1 in 10 people):

• urinary tract infections, infection of the nose, sinuses, throat, and upper respiratory tract, common cold (upper respiratory tract infection), sinusitis, pharyngitis, tonsillitis, flu-like illness, dry mouth, mouth pain or discomfort
• weight loss
• sleep disorders, somnolence, depression, anxiety
• dizziness, balance disorders, speech and nerve disorders, mood changes, brain dysfunction caused by liver damage, tingling or numbness of the hands or feet
• eye disorders, including cataracts, dry eyes, retinal hemorrhage
• vertigo
• rapid or irregular heartbeat, shortness of breath, coughing up mucus, sore throat, and discomfort when swallowing
• gastrointestinal disorders, including vomiting, abdominal pain, nausea, constipation, bloating, taste disorders, hemorrhoids, stomach pain or discomfort
• liver disorders, including liver tumor, yellowing of the whites of the eyes or skin (jaundice), liver damage caused by taking the medicine (see "Liver disorders" above in section 4)
• skin changes, including rash, dry skin, eczema, redness, itching, excessive sweating, unusual skin growths, hair loss
• joint pain, back pain, bone pain, limb pain (arms, legs, hands, or feet), muscle spasms
• irritability, general malaise, skin reaction, such as redness or swelling and pain at the injection site, chest pain and discomfort, fluid accumulation in the body or limbs causing swelling
• depression, anxiety, sleep disorders, nervousness
• fever, headache

Commonside effects that may be seen in blood tests:

• increased blood sugar (glucose) level, decreased white blood cell count, decreased neutrophil count, decreased albumin level in the blood, decreased hemoglobin level, increased bilirubin level in the blood, changes in blood clotting enzymes

Uncommonside effects (may affect up to 1 in 100 people):

• gastroenteritis, sore throat
• decreased red blood cell count (anemia) caused by excessive breakdown of red blood cells (hemolytic anemia)
• confusion, agitation
• mouth blisters or ulcers, gastritis
• blood clots in the vein that carries blood to the liver (possible liver damage and/or gastrointestinal disorders), liver function disorders
• skin changes, including discoloration, peeling, redness, itching, excessive sweating, unusual skin growths, and night sweats
• disorders of blood clotting in small blood vessels with kidney failure, pain when urinating
• rash, bruising at the injection site, chest discomfort
• heart rhythm disorders (QT prolongation)

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Eltrombopag Glenmark

The medicine should be stored out of sight and reach of children.

The patient should not take this medicine after the expiry date stated on the carton and blister after the "EXP" abbreviation, which indicates the expiry date. The expiry date refers to the last day of the month stated.

There are no special storage requirements.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Eltrombopag Glenmark contains:

• The active substance of the medicine 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, macrogol, povidone, isomalt (E 953), calcium silicate, sodium carboxymethylcellulose (type A), magnesium stearate (tablet core), hypromellose, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172), triacetin (tablet coating).

What Eltrombopag Glenmark looks like and contents of the pack:

Eltrombopag Glenmark, 25 mg are dark pink, round, biconvex film-coated tablets with a diameter of about 8 mm, with the symbol "II" embossed on one side.

Eltrombopag Glenmark, 50 mg are pink, round, biconvex film-coated tablets with a diameter of about 10 mm, with the symbol "III" embossed on one side.

Available pack sizes:

Blisters in cardboard boxes containing 10, 14, 28, 30, or 84 film-coated tablets, single-dose blisters in cardboard boxes containing 10x1, 14x1, 28x1, 30x1, or 84x1 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization 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

Netherlands

For more information about the medicine, the patient should contact the local representative of the marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: