Temozolomide Glenmark

Package Leaflet: 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

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, 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Temozolomide Glenmark is and what it is used for
• 2. Before you take 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 Temozolomide Glenmark is and what it is used for

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

• in adults with newly diagnosed glioblastoma multiforme. Temozolomide Glenmark is first given with radiotherapy (concomitant phase), and then alone (monotherapy phase).
• in children aged 3 years and older and adults with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temozolomide Glenmark is used to treat these tumors when they have returned or worsened after standard treatment.

2. Before you take 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 anti-cancer medicine, also known as DTIC). Signs of an allergic reaction include itching, difficulty breathing 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 are important for fighting infections and for blood clotting. Your doctor will check your blood before starting treatment to make sure that you have a sufficient number of these cells.

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 are important for fighting infections and for blood clotting. Your doctor will check your blood before starting treatment to make sure that you have a sufficient number of these cells.

Warnings and precautions

Before taking Temozolomide Glenmark, talk to your doctor, pharmacist, or nurse if:

• you have had a severe allergic reaction to DTIC (dacarbazine) in the past.
• you have, or have had, a severe infection, such as Pneumocystis jirovecii pneumonia (PCP). Patients with newly diagnosed glioblastoma multiforme will be given Temozolomide Glenmark in a 42-day cycle with radiotherapy. In this case, your doctor will also prescribe medicines to help prevent the development of PCP.
• you have, or have had, hepatitis B infection. This is because Temozolomide Glenmark may cause the hepatitis B virus to become active again, which can be fatal in some cases. Before starting treatment, patients will be carefully checked by their doctor for signs of this infection.
• you have a low number of red blood cells (anemia), white blood cells, or platelets, or have bleeding or clotting problems. In this case, your doctor may reduce the dose, interrupt, or stop treatment. Other treatments may also be necessary. In some cases, it may be necessary to stop treatment with Temozolomide Glenmark. During treatment, your doctor will regularly check your blood to monitor the undesirable effects of Temozolomide Glenmark on your blood cells.
• you have a small risk of other changes in your blood cells, including the development of leukemia.
• you have nausea and/or vomiting, which are very common side effects of Temozolomide Glenmark (see section 4). Your doctor may prescribe anti-emetic medicines to prevent or reduce nausea and vomiting. If you have frequent vomiting before or during treatment, you should ask your 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, you should not take a second dose on the same day.
• you have a fever or signs of infection, you should contact your doctor immediately.
• you are over 70 years old, as you may be more prone to infections, bruising, or bleeding.
• you have liver or kidney problems, as your doctor may need 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 with the use of this medicine in this age group.

Temozolomide Glenmark and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or think you may be pregnant, consult your doctor or pharmacist before taking this medicine. You should not take Temozolomide Glenmark during pregnancy unless your doctor has specifically advised you to do so.
Women who are able to become pregnant should use effective contraception during treatment with Temozolomide Glenmark and for at least 6 months after the end of treatment. You should stop breastfeeding while taking Temozolomide Glenmark.

Male fertility

Temozolomide Glenmark may cause permanent infertility. Male patients taking Temozolomide Glenmark should use effective contraception and not father a child during treatment and for at least 3 months after the end of treatment. It is recommended that patients consult their doctor to discuss the preservation of sperm 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 you have been told by your doctor 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 is essentially sodium-free.

3. How to take Temozolomide Glenmark

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.
Dose and duration of treatment
Your doctor will prescribe the dose of Temozolomide Glenmark that is right for you. The dose will be based on your body size (height and weight) and whether you have had chemotherapy before. To prevent or reduce nausea and vomiting, your doctor may prescribe other medicines (anti-emetic medicines) to be taken before and/or after taking Temozolomide Glenmark.
Patient with newly diagnosed glioblastoma multiforme:
Treatment is given in two phases:

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

During the concomitant phase, your doctor will start you on a dose of 75 mg/m² body surface area (the usual dose) of Temozolomide Glenmark. You will take this dose every day for 42 days (up to 49 days) with radiotherapy. Depending on your blood test results and how you tolerate the medicine during the concomitant phase, your doctor may delay or stop treatment with Temozolomide Glenmark. After radiotherapy is completed, there will be a 4-week break to allow you to recover. Then, the monotherapy phase will begin.
During the monotherapy phase, Temozolomide Glenmark is given at a different dose and schedule. Your doctor will determine the right 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 ("dosing days").

• on day 28, the next cycle will begin. You will again take Temozolomide Glenmark once a day for 5 days, and then not take it for 23 days. Depending on your blood test results and how you tolerate the medicine during each cycle, your doctor may adjust the dose, delay, or stop treatment with Temozolomide Glenmark.

How to take Temozolomide Glenmark
Take the prescribed dose of Temozolomide Glenmark once a day, at the same time each day.
Take the capsules on an empty stomach; for example, at least one hour before you plan to eat breakfast. Swallow the capsules whole with a glass of water. Do not open, crush, or chew the capsules. If a capsule is damaged, avoid contact with the contents and wash your hands thoroughly. If the contents of the capsule come into contact with your eyes, nose, or mouth, wash the area with water.

You must be sure that you understand and remember the following information:

• how many capsules to take each day you take the medicine. Ask your doctor or pharmacist to write this information down for you (including the color of the cap).
• which days are your "dosing days".

Before each new cycle, you should receive information from your doctor about how to take the medicine, as the dose may be different from the previous cycle.
Temozolomide Glenmark should always be taken as directed by your doctor. It is very important to contact your doctor or pharmacist if you have any doubts. Mistakes in the way you take the medicine can have serious consequences for your health.

What to do if you take more Temozolomide Glenmark than you should

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

What to do if you miss a dose of Temozolomide Glenmark

Take the missed dose as soon as you remember on the same day. If the missed dose is not taken until the next day, consult your doctor. Do not take a double dose to make up for a missed dose unless your doctor tells you to do so.
If you have any further questions on the use of this medicine, 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

Temozolomide Glenmark may cause a reduction in the number of certain types of blood cells. This can lead to an increased risk of bleeding or bruising, anemia (reduced number of red blood cells), fever, and a reduced ability to fight 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 decide if any treatment is needed. In some cases, it may be necessary to reduce the dose or stop treatment.

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
• mood changes, depression, anxiety, confusion, insomnia or sleep disturbances
• coordination and balance problems
• concentration problems, changes in mental status or alertness, memory problems
• dizziness, sensory disturbances, tingling, tremors, taste disturbances
• partial loss of vision, abnormal vision, double vision, eye pain
• hearing loss, ear infections, ear pain
• blood clots in the lungs or legs, high blood pressure
• pneumonia, shortness of breath, bronchitis, cough, sinusitis
• abdominal pain or stomach discomfort, indigestion/heartburn, difficulty swallowing
• dry skin, itching
• muscle damage, muscle weakness, muscle pain
• joint pain, back pain
• urinary frequency, difficulty urinating
• fever, flu-like symptoms, pain, malaise, cold or flu
• fluid retention, swelling of the feet
• increased liver enzyme activity
• weight loss, weight gain
• radiation injury

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

• brain infections (including potentially fatal cases of herpes simplex encephalitis)
• wound infections
• reactivation of cytomegalovirus infection
• reactivation of hepatitis B 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 disturbances, ear infections
• heart palpitations (feeling of heartbeat), hot flashes
• stomach swelling, difficulty controlling bowel movements, hemorrhoids, dry mouth
• liver inflammation and damage (including potentially fatal liver failure), cholestasis, increased bilirubin levels
• blisters on the skin or in the mouth, skin peeling, skin rashes, painful redness of the skin, severe skin rash with skin peeling (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, impotence
• chills, facial swelling, tongue discoloration, thirst, tooth problems
• dry eyes

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.
Side effects can be reported to the national reporting system listed in the "Further information" section.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Temozolomide Glenmark

Keep this medicine out of the sight and reach of children, preferably in a locked cupboard.
Accidental ingestion of the medicine can be fatal to a child.
Do not take this medicine after the expiry date which is stated on the blister and the carton after "EXP" and on the carton after "Expiry Date". The expiry date refers to the last day of that month.
Blister
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.
Tell your pharmacist about any changes in the appearance of the capsules.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What 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.

The other ingredients are:
capsule contents: lactose, colloidal anhydrous silica, sodium starch glycolate (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 and ethylene-acrylic acid copolymer. Each blister pack contains 1 hard capsule. The blister packs are packed in a cardboard box. The cardboard box contains 5 hard capsules, each in a separate blister pack.

Marketing Authorisation 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, please contact the Marketing Authorisation Holder:

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