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The product code(s) for this leaflet is: PLGB 31750/0169.
Temozolomide 100 mg hard capsules
Temozolomide SUN 100 mg hard capsules
temozolomide
1. What Temozolomide SUN is and what it is used for
2. What you need to know before you take Temozolomide SUN
3. How to take Temozolomide SUN
4. Possible side effects
5. How to store Temozolomide SUN
6. Contents of the pack and other information
Temozolomide SUN contains a medicine called temozolomide. This medicine is an antitumour agent.
Temozolomide SUN is used for the treatment of specific forms of brain tumours:
Talk to your doctor, pharmacist or nurse before taking Temozolomide SUN,
Do not give this medicine to children under the age of 3 years because it has not been studied. There is limited information in patients over 3 years of age who have taken Temozolomide SUN.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This is because you must not be treated with Temozolomide SUN during pregnancy unless clearly indicated by your doctor.
Effective contraceptive precautions must be taken by female patients who are able to become pregnant during treatment with Temozolomide SUN, and for at least 6 months following completion of treatment.
You should stop breast-feeding while receiving treatment with Temozolomide SUN.
Temozolomide SUN may cause permanent infertility. Male patients should use effective contraception and not father a child for at least 3 months after stopping treatment. It is recommended to seek advice on conservation of sperm prior to treatment.
Temozolomide SUN may make you feel tired or sleepy. In this case, do not drive or use any tools or machines or cycle until you see how this medicine affects you (see section 4).
Temozolomide SUN contains lactose (a kind 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.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Dosage and duration of treatment
Your doctor will work out your dose of Temozolomide SUN. This is based on your size (height and weight) and whether you have a recurrent tumour and have had chemotherapy treatment in the past. You may be given other medicines (anti-emetics) to take before and/or after taking Temozolomide SUN to prevent or control nausea and vomiting.
Patients with newly-diagnosed glioblastoma multiforme
If you are a newly-diagnosed patient, treatment will occur in two phases:
During the concomitant phase, your doctor will start Temozolomide SUN at a dose of 75 mg/m2 (usual dose). You will take this dose every day for 42 to 49 days in combination with radiotherapy. The Temozolomide SUN dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Once the radiotherapy is completed, you will have no treatment for 4 weeks. This will give your body a chance to recover.
Then, you will start the monotherapy phase.
During the monotherapy phase, the dose and way you take Temozolomide SUN can vary. Your doctor will work out your exact dose. There may be up to 6 treatment periods (cycles). Each one lasts 28 days. The first dose will be 150 mg/m2. You will take your new dose of Temozolomide SUN once daily for the first 5 days (“dosing days”) of each cycle. Then you will have 23 days without Temozolomide SUN. This adds up to a 28-day treatment cycle.
After day 28, the next cycle will begin. You will again take Temozolomide SUN once daily for 5 days followed by 23 days without Temozolomide SUN. The Temozolomide SUN dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.
Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temozolomide SUN only
A treatment cycle with Temozolomide SUN lasts 28 days.
You will take Temozolomide SUN only once daily for the first 5 days. This daily dose depends on whether or not you have received chemotherapy before.
If you have not been previously treated with chemotherapy, your first dose of Temozolomide SUN will be 200 mg/m2 once daily for the first 5 days. If you have been previously treated with chemotherapy, your first dose of Temozolomide SUN will be 150 mg/m2 once daily for the first 5 days. Then, you will have 23 days without Temozolomide SUN. This adds up to a 28-day treatment cycle.
After day 28, the next cycle will begin. You will again receive Temozolomide SUN once daily for 5 days, followed by 23 days without Temozolomide SUN.
Before each new treatment cycle, your blood will be tested to see if the Temozolomide SUN dose needs to be adjusted. Depending on your blood test results, your doctor may adjust your dose for the next cycle.
How to take Temozolomide SUN
Take your prescribed dose of Temozolomide SUN once a day, preferably 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 capsule(s) whole with a glass of water. Do not open, crush or chew the capsules. If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose. If you accidentally get some in your eyes or nose, flush the area with water.
1. Tear off the individual capsule pocket at the perforation
2. Peel off the foil using the unsealed edge
3. Using dry hands, remove the capsule from the blister
4. Put the capsule in your mouth
Depending on the prescribed dose, you may have to take more than one capsule at the same time. You may have to take different strengths to make up the dose. The marking on the capsule is different for each strength (see list below).
Strength Imprint
Temozolomide SUN 5 mg hard capsules: 890 & 5 mg
Temozolomide SUN 20 mg hard capsules: 891 & 20 mg
Temozolomide SUN 100 mg hard capsules: 892 & 100 mg
Temozolomide SUN 140 mg hard capsules: 929 & 140 mg
Temozolomide SUN 180 mg hard capsules: 930 & 180 mg
Temozolomide SUN 250 mg hard capsules: 893 & 250 mg
You should make sure you fully understand and remember the following:
Review the dose with your doctor each time you start a new cycle, since it may be different from the last cycle.
Always take Temozolomide SUN exactly as your doctor has told you. It is very important to check with your doctor or pharmacist if you are not sure. Making a mistake in how you take this medicine may have serious health consequences.
If you accidentally take more Temozolomide SUN capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Take the missed dose as soon as possible during the same day. If a full day has gone by, check with your doctor. Do not take a double dose to make up for a forgotten 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you have any of the following:
Temozolomide SUN treatment can cause a reduction in certain kinds of blood cells. This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and reduced resistance to infections. The reduction in blood cell counts is usually short-lived. In some cases, it may be prolonged and may lead to a very severe form of anaemia (aplastic anaemia). Your doctor will monitor your blood regularly for any changes, and will decide if any specific treatment is needed. In some cases, your Temozolomide SUN dose will be reduced or treatment stopped.
Other side effects that have been reported are listed below:
Very common side effects (may affect more than 1 in 10 people) are:
Common side effects (may affect up to 1 in 10 people) are:
Uncommon side effects (may affect up to 1 in 100 people) are:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children, preferably in a locked cupboard. Accidental ingestion can be lethal for children.
Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
Tell your pharmacist if you notice any change in the appearance of the capsules.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Temozolomide SUN 100 mg hard capsules have a white opaque body and cap, imprinted in pink ink. The cap is imprinted with ‘892’. The body is imprinted with ‘100 mg’ and two stripes.
The hard capsules are available in blister packs containing 5 capsules. For the 20 capsules packs, 4 blisters of 5 capsules will be included in a carton.
Not all pack sizes may be marketed.
This leaflet was last revised in 02/2022.