Temozolomide Glenmark

Leaflet accompanying the packaging: information for the user

Temozolomide Glenmark, 5 mg, hard capsules

Temozolomide Glenmark, 20 mg, hard capsules

Temozolomide Glenmark, 100 mg, hard capsules

Temozolomide Glenmark, 140 mg, hard capsules

Temozolomide Glenmark, 180 mg, hard capsules

Temozolomide Glenmark, 250 mg, hard capsules

Temozolomide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. 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 side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Temozolomide Glenmark contains the active substance temozolomide. This medicine is an anticancer medicine.
Temozolomide Glenmark is used to treat certain types of brain tumors:

• in adults with newly diagnosed glioblastoma multiforme. Temozolomide Glenmark is first given in combination with radiotherapy (concomitant phase), and then as the only medicine (monotherapy phase).
• in children aged 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temozolomide Glenmark is used to treat these tumors when they recur or progress after standard treatment.

2. Important information before taking Temozolomide Glenmark

When not to take Temozolomide Glenmark

• if the patient is allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
• if the patient has been diagnosed with hypersensitivity to dacarbazine (an anticancer medicine, sometimes called DTIC). Symptoms of an allergic reaction include itching, shortness of breath or other breathing difficulties, swelling of the face, lips, tongue, or throat.
• if there is a significantly reduced number of certain blood cells (due to bone marrow suppression), such as white blood cells or platelets. These cells play an

important role in fighting infections and the blood clotting process. The doctor will examine the blood before starting treatment to ensure that the number of these cells is sufficient.

Warnings and precautions

Before starting treatment with Temozolomide Glenmark, the patient should discuss the following with their doctor, pharmacist, or nurse:

• if the patient has a history of severe pneumonia caused by the microorganism Pneumocystis jirovecii (PCP). Patients with newly diagnosed glioblastoma multiforme will receive Temozolomide Glenmark in a 42-day treatment schedule in combination with radiotherapy. In this case, the doctor will also prescribe medicines to prevent the development of this type of pneumonia (PCP).
• if the patient has ever had or may currently have a hepatitis B virus infection. This is necessary because Temozolomide Glenmark may cause the hepatitis B virus infection to recur, which can lead to death in some cases. Before starting treatment, patients will be carefully examined by the doctor for signs of this infection.
• if the patient has a reduced number of red blood cells (anemia), white blood cells, and platelets, or has bleeding or blood clotting problems. In this case, the doctor may reduce the dose of Temozolomide Glenmark, interrupt, discontinue, or change the treatment. Other treatments may also be necessary. In some cases, it may be necessary to discontinue Temozolomide Glenmark treatment. During treatment, the doctor will regularly perform blood tests to monitor the adverse effects of Temozolomide Glenmark on blood cells.
• if there is a small risk of other changes in blood cells, including the development of leukemia.
• if the patient experiences nausea and/or vomiting, which are very common side effects associated with Temozolomide Glenmark (see section 4), the doctor may prescribe anti-emetic medicines. If the patient experiences frequent vomiting before or during treatment, they should ask their doctor for advice on the best time to take Temozolomide Glenmark, when vomiting is less likely to occur. If vomiting occurs after taking the medicine, the patient should not take a second dose on the same day.
• if the patient has a fever or signs of infection, they should contact their doctor immediately.
• if the patient is over 70 years old, they may be more prone to infections, have an increased tendency to bruise or bleed.
• if the patient has liver or kidney disease, it may be necessary to adjust the dose of Temozolomide Glenmark.

Children and adolescents

Temozolomide Glenmark should not be given to children under 3 years of age, as there are no data available for this age group. The amount of data on patients over 3 years of age who have taken Temozolomide Glenmark is limited.

Temozolomide 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.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Temozolomide Glenmark should not be taken during pregnancy, unless the doctor has explicitly recommended it.
During treatment with Temozolomide Glenmark and for at least 6 months after the end of treatment, women who may become pregnant should use effective contraceptive measures.
Breastfeeding should be discontinued during treatment with Temozolomide Glenmark.

Male fertility

Temozolomide Glenmark may cause permanent infertility. Men taking Temozolomide Glenmark should use effective contraceptive measures and not father a child during treatment and for at least 3 months after the end of treatment. It is recommended that the patient consult their doctor to consider sperm preservation before starting treatment.

Driving and using machines

During treatment with Temozolomide Glenmark, the patient may experience fatigue or drowsiness. The patient should not drive or operate machinery until they know how the medicine affects them (see section 4).

Temozolomide Glenmark contains lactose

Temozolomide Glenmark contains lactose (a type of sugar). If the doctor has previously determined that the patient has an intolerance to some sugars, the patient should contact their doctor before taking this medicine.

Temozolomide Glenmark contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Temozolomide Glenmark

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Dosage and duration of treatment
The doctor will prescribe the appropriate dose of Temozolomide Glenmark for the patient.
The dose is determined based on the patient's body size (height and weight) and whether the tumor has recurred and whether the patient has previously received chemotherapy. To prevent nausea and vomiting or reduce them, the doctor may prescribe other medicines (anti-emetic medicines) to be taken before and/or after Temozolomide Glenmark.
Patients with newly diagnosed glioblastoma multiforme:
Treatment is given in two phases:

• first, Temozolomide Glenmark is given in combination with radiotherapy (concomitant phase)
• then, only Temozolomide Glenmark is given (monotherapy phase).

During the concomitant phase, the doctor will start giving Temozolomide Glenmark at a dose of 75 mg/m² body surface area (the usual dose). The prescribed dose will be taken daily for 42 days (up to 49 days) in combination with radiotherapy. Depending on the results of blood tests and the patient's tolerance to the medicine during the concomitant phase, the doctor may delay or interrupt Temozolomide Glenmark treatment. After the end of radiotherapy, there will be a 4-week break in treatment to allow the patient to recover. Then, the monotherapy phase will begin.
During the monotherapy phase, Temozolomide Glenmark is given at a different dose and in a different way. The doctor will determine the appropriate dose for the patient. The patient may receive up to 6 cycles of treatment. Each cycle lasts 28 days. The patient will take only Temozolomide Glenmark once a day for the first 5 days of each cycle ("days of taking the medicine").
The initial dose is 150 mg/m² body surface area. Then, for 23 days, the patient will not take Temozolomide Glenmark. This gives a 28-day treatment cycle. After

• 28 days, the next cycle of treatment will begin. The patient will again take Temozolomide Glenmark once a day for 5 days, and then not take the medicine for 23 days. Depending on the results of blood tests and the patient's tolerance to the medicine in each treatment cycle, the doctor may adjust the dose, delay, or interrupt Temozolomide Glenmark treatment.

How to take Temozolomide Glenmark
The recommended dose of Temozolomide Glenmark should be taken once a day, preferably at the same time every day.
The capsules should be taken on an empty stomach; for example, at least one hour before planned breakfast. The capsule(s) should be swallowed whole, with a glass of water. The capsules should not be opened, crushed, or chewed. If a capsule is damaged, contact with its contents should be avoided, especially with the skin, eyes, or nose. If the medicine accidentally comes into contact with the eyes or nose, the affected area should be rinsed thoroughly with water.
Depending on the prescribed dose, the patient may take more than one capsule at the same time or may take capsules of different strengths (with different amounts of active substance expressed in milligrams). The color of the capsule cap varies depending on the strength (see the table below).

The patient must be sure to understand and remember the following information:

• how many capsules to take each day of taking the medicine. The patient should ask their doctor or pharmacist to write down this information (including the color of the capsule cap).
• which days are the days of taking the medicine.

Before starting each new cycle, the patient should again receive information from their doctor about how to take the medicine, as it may differ from the previous cycle.
Temozolomide Glenmark should always be taken exactly as prescribed by the doctor. It is very important to consult a doctor or pharmacist if the patient has any doubts. Errors in taking the medicine can have serious consequences for the patient's health.

Taking a higher dose of Temozolomide Glenmark than recommended

If the patient accidentally takes more Temozolomide Glenmark capsules than prescribed by the doctor, they should immediately consult their doctor, pharmacist, or nurse.

Missing a dose of Temozolomide Glenmark

A missed dose of the medicine should be taken as soon as possible on the same day. If the missed dose is not taken until the next day, the patient should contact their doctor. A double dose should not be taken to make up for a missed dose, unless the doctor recommends it.
If the patient has any further doubts about taking this medicine, they should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Temozolomide Glenmark can cause side effects, although not everybody gets them.
The patient should immediatelycontact their doctor if they experience any of the following symptoms:

• severe allergic reaction (hypersensitivity) (hives, wheezing or other breathing difficulties)
• uncontrolled bleeding
• seizures (convulsions)
• fever
• chills
• severe, persistent headaches

Taking Temozolomide Glenmark may cause a decrease in the number of a certain type of blood cell. This can lead to more frequent bruising or bleeding, anemia (reduced number of red blood cells), fever, and reduced resistance to infections.
The decrease in blood cells is usually temporary. In some cases, it may be prolonged and lead to a very severe form of anemia (aplastic anemia).
The doctor will regularly perform blood tests and, based on the results, decide whether any appropriate treatment is needed. In some patients, it may be necessary to reduce the dose or interrupt treatment.
Other reported side effects are listed below:

Very common side effects (may affect more than 1 in 10 people) include:

• loss of appetite, speech difficulties, headache
• constipation, nausea, vomiting, diarrhea
• rash, hair loss
• fatigue.

Common side effects (may affect up to 1 in 10 people) include:

• infections, oral infections
• reduced number of blood cells (neutropenia, lymphopenia, thrombocytopenia)
• allergic reaction
• increased blood sugar levels
• memory disorders, depression, anxiety, confusion, insomnia or sleep disturbances
• coordination and balance disorders
• concentration disorders, changes in mental state or alertness, forgetfulness
• dizziness, sensation disorders, tingling, tremors, taste disorders
• partial loss of vision, abnormal vision, double vision, eye pain
• hearing loss, ear infection
• blood clots in the lungs or legs, high blood pressure
• pneumonia, shortness of breath, bronchitis, cough, sinusitis
• abdominal or stomach pain, stomach upset/heartburn, swallowing difficulties
• dry skin, itching
• muscle damage, muscle weakness, muscle pain
• joint pain, back pain
• frequent urination, difficulties in controlling urination
• fever, flu-like symptoms, pain, malaise, cold or flu
• fluid retention, swelling of the legs
• increased liver enzyme activity
• weight loss, weight gain
• radiation injuries

Uncommon side effects (may affect up to 1 in 100 people) include:

• brain infections (herpes simplex encephalitis), including fatal cases
• wound infections
• new or reactivated cytomegalovirus infection
• reactivation of hepatitis B virus infection
• secondary tumors, including leukemia
• reduced number of blood cells (pancytopenia, anemia, leukopenia)
• red spots under the skin
• diabetes insipidus (symptoms include frequent urination and thirst), low potassium levels in the blood
• mood changes, hallucinations
• partial paralysis, changes in smell perception
• hearing disorders, middle ear infection
• palpitations (feeling of heartbeat), hot flashes
• stomach swelling, difficulties in controlling bowel movements, hemorrhoids, dry mouth
• liver inflammation and liver damage (including fatal liver failure), cholestasis, increased bilirubin levels
• blisters on the body or in the mouth, skin peeling, skin rashes, painful skin redness (including on the hands and feet)
• increased sensitivity to sunlight, hives, increased sweating, skin color changes
• difficulties in urinating
• vaginal bleeding, vaginal irritation, absence or heavy menstrual periods, breast pain, sexual impotence
• chills, facial swelling, tongue discoloration, thirst, dental problems
• dry eyes

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Temozolomide Glenmark

The medicine should be stored out of sight and reach of children, preferably in a locked cabinet.
Accidental ingestion of the medicine can be fatal for a child.
Do not take this medicine after the expiry date stated on the sachet label after "EXP" and on the carton after "Expiry date". The expiry date refers to the last day of the month stated.
Sachet
Temozolomide Glenmark, 5 mg and 20 mg: Store below 25°C.
Temozolomide Glenmark, 100 mg, 140 mg, 180 mg, 250 mg: Store below 30°C.
The patient should inform their pharmacist about any changes in the appearance of the capsules.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Temozolomide Glenmark contains

The active substance of the medicine is temozolomide.

• Temozolomide Glenmark, 5 mg: each hard capsule contains 5 mg of temozolomide.
• Temozolomide Glenmark, 20 mg: each hard capsule contains 20 mg of temozolomide.
• Temozolomide Glenmark, 100 mg: each hard capsule contains 100 mg of temozolomide.
• Temozolomide Glenmark, 140 mg: each hard capsule contains 140 mg of temozolomide.
• Temozolomide Glenmark, 180 mg: each hard capsule contains 180 mg of temozolomide.
• Temozolomide Glenmark, 250 mg: each hard capsule contains 250 mg of temozolomide.

Other ingredients are:
capsule contents: lactose, colloidal anhydrous silica, sodium carboxymethyl cellulose (Type A), tartaric acid, stearic acid
capsule shell, size 0
Temozolomide Glenmark, 5 mg: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132)
Temozolomide Glenmark, 20 mg: gelatin, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172)
Temozolomide Glenmark, 100 mg: gelatin, titanium dioxide (E 171), red iron oxide (E 172), indigo carmine (E 132)
Temozolomide Glenmark, 140 mg: gelatin, titanium dioxide (E 171), indigo carmine (E 132)
Temozolomide Glenmark, 180 mg: gelatin, titanium dioxide (E 171), red iron oxide (E 172), black iron oxide (E 172), yellow iron oxide (E 172)
Temozolomide Glenmark, 250 mg: gelatin, titanium dioxide (E 171)
Printing ink
Black ink: shellac, macrogol, concentrated ammonia solution, potassium hydroxide, iron oxide black (E172)

What Temozolomide Glenmark looks like and contents of the pack

Temozolomide Glenmark, 5 mg: hard gelatin capsules, size 0, with a green cap and white body. The body is printed with the number 5 in black ink.
Temozolomide Glenmark, 20 mg: hard gelatin capsules, size 0, with an orange cap and white body. The body is printed with the number 20 in black ink.
Temozolomide Glenmark, 100 mg: hard gelatin capsules, size 0, with a purple cap and white body. The body is printed with the number 100 in black ink.
Temozolomide Glenmark, 140 mg: hard gelatin capsules, size 0, with a blue cap and white body. The body is printed with the number 140 in black ink.
Temozolomide Glenmark, 180 mg: hard gelatin capsules, size 0, with a chocolate-brown cap and white body. The body is printed with the number 180 in black ink.
Temozolomide Glenmark, 250 mg: hard gelatin capsules, size 0, with a white cap and white body. The body is printed with the number 250 in black ink.
Sachet
The sachet is made of paper/LDPE/aluminum/ethylene and acrylic acid copolymer. Each sachet contains 1 hard capsule. The sachets are packed in a carton. The carton contains 5 hard capsules, each packed in a separate sachet.

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer

EirGen Pharma Ltd.
Westside Business Park, Old Kilmeaden Road
Waterford, X91 YV67
Ireland
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

For more information about the medicine, please contact the marketing authorization holder's representative:

Glenmark Pharmaceuticals Sp. z o.o.
Osmańska 14 Street
02-823 Warsaw
Date of last revision of the leaflet:February 2022