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 further questions, you should ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, you should tell your 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 a single 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 have recurred or progressed after standard treatment.

2. Important information before taking Temozolomide Glenmark

When not to take Temozolomide Glenmark

• if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
• if you have previously been treated with dacarbazine (an anticancer medicine, also known as DTIC). Symptoms of an allergic reaction include itching, shortness of breath or wheezing, swelling of the face, lips, tongue, or throat.
• if you have a severely 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 blood clotting. Your doctor will check your blood before starting treatment to make sure you have enough of these cells.

Warnings and precautions

Before taking Temozolomide Glenmark, you should discuss with your doctor, pharmacist, or nurse:

• if you have a history of a severe lung infection 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, your doctor will also prescribe medicines to help prevent the development of this type of pneumonia (PCP).
• if you have ever had or currently have a hepatitis B virus infection. This is necessary because Temozolomide Glenmark may cause the hepatitis B virus infection to recur, which in some cases can be fatal. Before starting treatment, patients will be carefully examined by their doctor for signs of this infection.
• if you have a reduced number of red blood cells (anemia), white blood cells, or platelets, or if you have bleeding or blood clotting problems. In this case, your 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, your doctor will regularly check your blood to monitor the undesirable 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 you experience nausea and/or vomiting, which are very common side effects associated with Temozolomide Glenmark (see section 4), your doctor may prescribe anti-emetic medicines. If you experience frequent vomiting before or during treatment, you should ask your doctor to indicate the most convenient time to take Temozolomide Glenmark, when vomiting does not occur. If vomiting occurs after taking the medicine, you should not take a second dose on the same day.
• if you have a fever or signs of infection, you should immediately contact your doctor.
• if you are over 70 years old, you may be more prone to infections, have an increased tendency to bruise or bleed.
• if you have 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 is limited experience in children.

Temozolomide Glenmark and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine. You should not take Temozolomide Glenmark during pregnancy, unless your doctor has clearly indicated that you should.
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.
You should not breastfeed while taking 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

While taking Temozolomide Glenmark, you may feel tired or sleepy. You should not drive or operate machinery until you know how this medicine affects you (see section 4).

Temozolomide Glenmark contains lactose

Temozolomide Glenmark contains lactose (a type of sugar). If your doctor has previously determined that you have an intolerance to some sugars, you should contact your 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 essentially 'sodium-free'.

3. How to take Temozolomide Glenmark

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
Dosage and duration of treatment
Your doctor will decide the correct dose of Temozolomide Glenmark for you. The dose will be calculated based on your body size (height and weight) and whether the tumor has recurred and whether you have previously received chemotherapy. To prevent nausea and vomiting or reduce them, your 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, your doctor will start 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 your blood tests and your tolerance to the medicine during the concomitant phase, your doctor may delay or interrupt Temozolomide Glenmark treatment. After completing radiotherapy, there will be a 4-week break in treatment to allow you to recover. Then, the monotherapy phase will begin.
During the monotherapy phase, Temozolomide Glenmark will be given at a different dose and in a different way. Your doctor will decide the correct dose for you. You may receive up to 6 cycles of treatment. Each cycle lasts 28 days. You will take 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 the next 23 days, you will not take Temozolomide Glenmark. This gives a 28-day treatment cycle. After

• day 28, the next cycle will begin. You will take Temozolomide Glenmark once a day for 5 days, and then not take it for the next 23 days. Depending on the results of your blood tests and your tolerance to the medicine during each treatment cycle, your 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. Do not open, crush, or chew the capsules. If a capsule is damaged, you should avoid contact with its contents with your skin, eyes, or nose. If the medicine accidentally comes into contact with your eyes or nose, you should rinse the affected area with water.
Depending on the prescribed dose, you may take more than one capsule at the same time or 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).

You must be sure that you have understood and remembered the following information:

• how many capsules to take each day you take the medicine. You should ask your 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, you should receive information from your doctor about how to take the medicine, as it may be different from the previous cycle.
Temozolomide Glenmark should always be taken exactly as your doctor has told you. It is very important that you contact your doctor or pharmacist if you are unsure. Mistakes in the way you take the medicine can have serious consequences for your health.

Taking a higher dose of Temozolomide Glenmark than prescribed

If you accidentally take more Temozolomide Glenmark capsules than your doctor has prescribed, you should immediately contact your doctor, pharmacist, or nurse.

Missing a dose of Temozolomide Glenmark

Missed doses should be taken as soon as possible on the same day. If a full day has passed since the missed dose, you should contact your doctor. Do not take a double dose to make up for a missed dose, unless your doctor has told you to do so.
If you have any further questions about taking this medicine, you should ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should immediatelycontact your doctor if you 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 reduction in the number of a certain type of blood cell. This can lead to more frequent bruising or bleeding, anemia (reduced red blood cell count), fever, and reduced resistance to infections.
The reduction in blood cells is usually temporary. In some cases, it may be prolonged and lead to a very severe form of anemia (aplastic anemia).
Your doctor will regularly check your blood and, based on the results, decide if 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 difficulties, changes in mental state or alertness, forgetfulness
• dizziness, sensory disturbances, tingling, tremors, taste disorders
• partial loss of vision, abnormal vision, double vision, eye pain
• hearing loss, ringing in the ears, ear pain
• 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, difficulty 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 sense of smell
• hearing disorders, middle ear infection
• palpitations (feeling your heartbeat), hot flashes
• stomach swelling, difficulty 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 redness of the skin, severe skin rash with skin swelling (including on the hands and feet)
• increased sensitivity to sunlight, hives, increased sweating, skin color changes
• difficulty 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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor or 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Temozolomide Glenmark

The medicine should be stored out of the sight and reach of children, preferably in a locked cabinet.
Accidental ingestion of the medicine may cause death in a child.
Do not take this medicine after the expiry date stated on the blister pack label after 'EXP' and on the carton after 'Expiry date'. The expiry date refers to the last day of the month stated.
Blister pack
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.
You should inform your pharmacist of any changes in the appearance of the capsules.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 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 carboxymethylcellulose (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.
Blister pack
Blister pack of paper/PVDC/Aluminum/ethylene-acrylic acid copolymer. Each blister pack contains 1 hard capsule. The blister packs are packaged in a carton. The carton contains 5 hard capsules, each packaged in a separate blister pack.

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 further information about this medicine, you should contact the marketing authorization holder:

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