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 You Start Taking This Medicine Because It Contains Important Information for You.

• You should 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 in combination with radiotherapy (concomitant phase), and then as monotherapy (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 a severe infection, with or without a low white blood cell count, and/or fever.
• you have had a previous severe allergic reaction to dacarbazine (DTIC).
• you have a history of radiation therapy to the brain.
• you have a history of a brain infection.
• you have kidney or liver problems.
• you have a low number of red blood cells (anemia), white blood cells (leukopenia), or platelets (thrombocytopenia), or have had these conditions in the past.
• you have a history of a disease affecting the bone marrow or have undergone a bone marrow transplant.
• you have a history of seizures or are taking anticonvulsant medications.

Children and Adolescents

Temozolomide Glenmark should not be given to children under 3 years of age. There is limited information on the use of Temozolomide Glenmark in children, particularly in children under 3 years of age.

Temozolomide Glenmark with Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including medicines obtained without a prescription.

Pregnancy, Breast-Feeding, and Fertility

Women of childbearing potential must use effective contraception during treatment with Temozolomide Glenmark and for at least 6 months after treatment. If you become pregnant during treatment, you must immediately inform your doctor. You should not breast-feed while taking Temozolomide Glenmark.

Male Fertility

Temozolomide Glenmark may cause permanent infertility. Male patients should use effective contraception during and for up to 3 months after treatment. It is recommended that male patients consider sperm preservation before starting treatment.

Driving and Using Machines

Temozolomide Glenmark may cause fatigue, dizziness, or other side effects that could affect your ability to drive or operate machinery. Do not drive or operate machinery unless you are sure that Temozolomide Glenmark does not affect you.

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, 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

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Dosage and Duration of Treatment
Your doctor will decide the correct dose of Temozolomide Glenmark for you based on your body size and whether you have had chemotherapy before. To prevent nausea and vomiting, your doctor may prescribe other medicines (anti-emetics) to be taken before and/or after taking 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 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) together with radiotherapy. Depending on your blood test results and how you tolerate the medicine during the concomitant phase, your doctor may delay or stop your treatment. 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 in a different way. Your doctor will work out the correct dose for you. You may receive up to 6 treatment cycles. Each cycle lasts 28 days. You will take Temozolomide Glenmark alone once a day for the first 5 days of each cycle ("dosing days").

• on the 28th day, the next cycle will begin. You will again take Temozolomide Glenmark once a day for 5 days, and then not take it for the next 23 days.

Before each new cycle, your doctor will check your blood to see if your dose of Temozolomide Glenmark needs to be adjusted. Depending on your blood test results, your doctor may adjust your dose for the next cycle.
Patients with Recurrent or Progressive Glioma:
The treatment cycle lasts 28 days. You will take Temozolomide Glenmark alone once a day for the first 5 days. The daily dose depends on whether you have had chemotherapy before. If you have not had chemotherapy before, the initial dose will be 200 mg/m² body surface area once a day for the first 5 days. If you have had chemotherapy before, the initial dose will be 150 mg/m² body surface area once a day for the first 5 days. For the next 23 days, you will not take Temozolomide Glenmark. This will be one 28-day treatment cycle. After 28 days, the next cycle will begin. You will again take Temozolomide Glenmark once a day for 5 days, and then not take it for the next 23 days.
Before each new cycle, your doctor will check your blood to see if your dose of Temozolomide Glenmark needs to be adjusted. Depending on your blood test results, your doctor may adjust your dose for the next cycle.
How to Take Temozolomide Glenmark
Take the recommended dose 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 come into contact with your skin, eyes, or nose, wash the affected 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 capsule).
• which days are your dosing days.

Before each new cycle, you should again receive information from your doctor about how to take your medicine, as it may be different from the previous cycle.
Temozolomide Glenmark should always be taken following the instructions of your doctor. It is very important to ask your doctor or pharmacist if you are unsure about anything.

Take a Higher Dose of Temozolomide Glenmark Than Prescribed

If you accidentally take more capsules than prescribed by your doctor, contact your doctor, pharmacist, or nurse immediately.

Miss a Dose of Temozolomide Glenmark

Take the missed dose as soon as possible on the same day. If the missed dose is not taken on the same 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 must 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 can cause a reduction in the number of certain types of blood cells. This may cause you to bruise or bleed more easily, get infections, or feel tired and weak. Your doctor will regularly check your blood to see if you have any of these problems. In some cases, your doctor may need to reduce or delay your dose of Temozolomide Glenmark or stop treatment altogether.

Very Common Side Effects (May Affect More Than 1 in 10 People) Include:

• loss of appetite, difficulty speaking, headache
• constipation, nausea, vomiting, diarrhea
• rash, hair loss
• fatigue.

Common Side Effects (May Affect Up to 1 in 10 People) Include:

• infections, mouth 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
• difficulty concentrating, changes in mental status or alertness, memory loss
• dizziness, sensation changes, tingling, tremors, taste changes
• 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
• stomach or abdominal pain, indigestion/heartburn, difficulty swallowing
• dry skin, itching
• muscle damage, muscle weakness, muscle pain
• joint pain, back pain
• urinary frequency, difficulty controlling urination
• 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 hepatitis B virus
• secondary tumors, including leukemia
• reduced number of blood cells (pancytopenia, anemia, leukopenia)
• red spots under the skin
• diabetes insipidus (symptoms include excessive thirst and urination), low potassium levels in the blood
• mood changes, hallucinations
• partial paralysis, changes in sense of smell
• hearing loss, middle ear infection
• palpitations (feeling of heartbeat), hot flashes
• stomach bloating, 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 discoloration
• difficulty urinating
• vaginal bleeding, vaginal irritation, absence or excess of menstrual periods, breast pain, sexual impotence
• chills, facial swelling, tongue discoloration, thirst, dental 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 below.
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 may be fatal to a child.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. 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 visible signs of deterioration, such as damage to the capsules or blisters.
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.

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, ammonium hydroxide, potassium hydroxide, iron oxide black (E172)

What Temozolomide Glenmark Looks Like and Contents of the Pack

Temozolomide Glenmark, 5 mg: green and white, size 0, hard gelatin capsules. The capsule is imprinted with the number 5 in black ink.
Temozolomide Glenmark, 20 mg: orange and white, size 0, hard gelatin capsules. The capsule is imprinted with the number 20 in black ink.
Temozolomide Glenmark, 100 mg: purple and white, size 0, hard gelatin capsules. The capsule is imprinted with the number 100 in black ink.
Temozolomide Glenmark, 140 mg: blue and white, size 0, hard gelatin capsules. The capsule is imprinted with the number 140 in black ink.
Temozolomide Glenmark, 180 mg: brown and white, size 0, hard gelatin capsules. The capsule is imprinted with the number 180 in black ink.
Temozolomide Glenmark, 250 mg: white, size 0, hard gelatin capsules. The capsule is imprinted with the number 250 in black ink.
Blister pack
Aluminum/PVC blisters. Each blister contains 1 hard capsule. The blisters are packed in a cardboard box. The cardboard box contains 5 hard capsules, each in a separate blister.

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 on This Medicine, 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