20 mg, 100 mg, 140 mg, 180 mg and 250 mg hard capsules
Temozolomide
What Temozolomide STADA is and what it is used for
Temozolomide Stada contains the medicine temozolomide. This medicine is used to treat tumors.
Temozolomide Stada is used to treat certain types of brain tumors:
- in adults, newly diagnosed glioblastoma multiforme. Temozolomide Stada is first used together with radiation (concomitant treatment phase) and then alone (monotherapy phase of treatment)
- in children older than 3 years and adult patients with malignant gliomas, such as glioblastoma multiforme or anaplastic astrocytoma. Temozolomide Stada is used for these tumors if they return or worsen after standard treatment.
Temozolomide contained in Temozolomide Stada may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What you need to know before you use Temozolomide STADA
Do not use Temozolomide STADA
- if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6)
- if you have had an allergic reaction to dacarbazine (an anti-cancer medicine, sometimes called DTIC). Signs of an allergic reaction include feeling itchy, shortness of breath or wheezing, and swelling of the face, lips, tongue, or throat
- if certain types of blood cells are greatly reduced (myelosuppression), such as the white blood cells or platelets. These blood cells are important when it comes to fighting infection and for functioning blood coagulation. Your doctor will check your blood to make sure you have enough of these blood cells before you start treatment.
Warnings and precautions
Talk to your doctor or pharmacist before taking Temozolomide Stada.
- because you should be closely monitored for the development of a serious form of pneumonia called Pneumocystis jirovecii pneumonia (PCP). If you have recently received your diagnosis ( glioblastoma multiforme ), you can receive Temozolomide Stada for 42 days in combination with radiation. In that case, your doctor will also prescribe medication to help you prevent this type of pneumonia.
- if you have ever had or possibly now have a hepatitis B infection. Temozolomide Stada can cause hepatitis B to become active again and in some cases, this can lead to death. You will be carefully examined by your doctor for signs of this infection before starting treatment.
- if you have low numbers of red blood cells ( anemia ), white blood cells and platelets ( thrombocytes ), or problems with blood clotting before starting treatment, or if you develop such problems during treatment. Your doctor may decide to lower the dose, stop, stop or change the treatment. You may also need other treatment. In some cases, it may be necessary to stop treatment with Temozolomide Stada. Your blood will be tested regularly during treatment to monitor the side effects of Temozolomide Stada on your blood cells.
- because you may have a small risk of other blood cell changes, including leukemia.
- if you experience nausea and/or vomiting, which are very common side effects of Temozolomide Stada (see section 4), your doctor may prescribe medicine (an antiemetic ) to prevent vomiting.
- If you vomit frequently before and during treatment, ask your doctor at what time it is best to take Temozolomide Stada until the vomiting is under control. If you vomit after taking your dose, do not take a second dose on the same day.
- if you develop a fever or symptoms of an infection, contact your doctor immediately.
- if you are over 70, you may be more susceptible to infection and bruise or bleeding more easily.
- if you have liver or kidney problems, your Temozolomide Stada dose may need to be adjusted.
Children and young people
Do not give this medicine to children younger than 3 years because there is no experience. There is only limited information on patients older than 3 years who have taken temozolomide.
Other medicines and Temozolomide STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. You should not be treated with Temozolomide Stada if you are pregnant unless your doctor tells you so.
Effective contraception must be used by both male and female patients taking Temozolomide Stada (see also below “Male fertility”).
You must stop breastfeeding while you are receiving treatment with Temozolomide Stada.
Male fertility
Temozolomide Stada can cause permanent infertility . Male patients should use an effective method of contraception and not have children up to 6 months after finishing treatment. It is recommended to consult about sperm freezing before starting treatment.
Driving ability and use of machinery
Temozolomide Stada can make you feel tired or sleepy. If this is the case, do not drive, use machinery, or cycle until you know how this medicine affects you (see section 4).
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure
Temozolomide STADA contains lactose, sodium, and dye
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicinal product contains less than 1 mmol sodium (23 mg) per hard capsule, i.e. essentially “sodium-free”.
Temozolomide Stada 20 mg: The ingredient para-orange (E110) is in the capsule shell and can cause allergic reactions.
How to use Temozolomide STADA
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Dosage and duration of treatment
Your doctor will determine the Temozolomide Stada dose. The dose is based on your body size (height and weight) and whether you have a recurrent tumor and have previously received chemotherapy.
You may be prescribed other medicines (antiemetics) to be taken before and/or after you take Temozolomide Stada to prevent or control nausea or vomiting.
Patients with newly diagnosed glioblastoma multiforme
If you have recently been diagnosed, treatment will be in two phases:
- first treatment together with radiation (concurrent phase)
- followed by treatment with Temozolomide Stada alone (monotherapy phase)
During the concurrent phase, your doctor will start you with Temozolomide Stada at a dose of 75 mg/m 2 (usual dose ). You will take this dose every day for 42 days (up to 49 days) in combination with radiation. Temozolomide Stadadose can be postponed or the treatment interrupted depending on your blood values and on how you tolerate the drug during the simultaneous phase.
When the radiation treatment is finished, you will have a treatment break of 4 weeks. It will give your body a chance to recover.
You will then begin the monotherapy phase.
During the monotherapy phase, the dose and the way you take Temozolomide Stada will be different. Your doctor will work out exactly what amount you should have. You can have up to 6 treatment periods (cycles). Each of these lasts for 28 days. You will take only the new Temozolomide Stada dose once a day for the first 5 days (“dosing days”) of each cycle. The first dose will be 150 mg/m 2. You will then have 23 days without Temozolomide Stada. In total, there will be a treatment cycle of 28 days.
After day 28, the next cycle begins. You will again take Temozolomide Stada once a day for 5 days followed by 23 days without Temozolomide Stada. The Temozolomide Stada dose can be adjusted, postponed, or discontinued depending on your blood levels and how well you tolerate the medicine during each treatment cycle.
Patients with tumors that have come back or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma ) receiving only Temozolomide Stada
A treatment cycle with Temozolomide Stada lasts 28 days.
You will take only Temozolomide Stada once daily for the first 5 days. The daily dose depends on whether you have previously received chemotherapy or not.
If you have not previously been treated with chemotherapy, the first dose of Temozolomide Stada will be 200 mg/m 2 once daily for the first 5 days. If you have previously been treated with chemotherapy, the first dose of Temozolomide Stada will be 150 mg/m 2 once daily for the first 5 days. You will then have 23 days without Temozolomide Stada. In total, there will be a treatment cycle of 28 days.
After day 28, the next treatment cycle begins. You will again receive Temozolomide Stada once daily for 5 days, followed by 23 days without Temozolomide Stada.
Before each new treatment cycle, your blood will be tested to see if the Temozolomide Stada dose needs to be adjusted. Depending on the results of your blood tests, your doctor may adjust the dose from one to the next cycle.
How to take Temozolomide Stada
Take the prescribed dose of Temozolomide Stada once daily, preferably at the same time each day.
Take the capsules on an empty stomach; for example, at least one hour before you intend 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 broken, avoid the powder coming into contact with the skin, eyes, or nose. If you accidentally get something in your eyes or nose, rinse with water.
Depending on the dose you have been prescribed, you may need to take several capsules at the same time, possibly in different strengths (the active substance in mg). The color and markings on the capsule are different for the different strengths (see table).
| Strength | Color marking |
|---|---|
| Temozolomide Stada 20 mg | Two orange stripes on the top half and “T 20 mg” in orange on the bottom half |
| Temozolomide Stada 100 mg | Two pink stripes on the top half and “T 100” in pink on the bottom half |
| Temozolomide Stada 140 mg | Two blue stripes on the top half and “T 140” in blue on the bottom half |
| Temozolomide Stada 180 mg | Two red stripes on the top half and “T 180 mg” in red on the bottom half |
| Temozolomide Stada 250 mg | Two black stripes on the top half and “T 250 mg” in black on the bottom half |
Make sure you understand exactly and remember the following:
- how many capsules do you need to take each dosing day? Ask your doctor or pharmacist to write it down for you (including the color).
- which days are your dosing days?
Be sure to review dosage one with your doctor each time you start a new treatment cycle, as it may differ from dosage one in the previous cycle.
Always take Temozolomide Stada as directed by your doctor. Ask your doctor or pharmacist if you are unsure. Mistakes in how you take your medication can have serious consequences on your health.
If you have used too much Temozolomide STADA
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice
If you forget to use Temozolomide STADA
Take the missed dose as soon as possible on the same day. If a day has already passed, 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 further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following:
- a severe allergic (hypersensitivity) reaction ( hives, wheezing, or other breathing difficulties)
- uncontrolled bleeding
- convulsions
- fever
- chills
- severe headache that does not go away.
The treatment with Temozolomide Stada can cause a reduction in certain types of blood cells. This can mean that you bruise or bleed more easily, have anemia (lack of red blood cells ), fever, and reduced resistance to infection. The reduced number of blood cells is usually transient. In some cases, it can be more prolonged and lead to a very severe form of anemia ( aplastic anemia ). Your doctor will measure your blood levels regularly to detect any changes and determine if any special treatment is required. In some cases, your dose mayTemozolomide Stada need to be reduced or treatment stopped.
Side effects in clinical studies
Temozolomide Stada in combination with radiotherapy in newly diagnosed glioblastoma
Patients receiving Temozolomide Stada in combination with radiation may have different side effects than patients receiving Temozolomide Stada alone. The following side effects may occur and may require medical attention.
Very common (may affect more than 1 in 10 people): loss of appetite, headache, constipation, nausea, vomiting, rash, hair loss, and tiredness.
Common (may affect up to 1 in 10 people): oral infection, wound infections, decreased blood cell count ( neutropenia, thrombocytopenia, lymphopenia, leukopenia ), increased blood sugar, weight loss, changes in mood or attention, anxiety/depression, sleepiness, difficulty speaking, impaired balance, dizziness, confusion, forgetfulness, difficulty concentrating, inability to fall asleep or stay asleep, tingling, bruising, tremors, abnormal or blurred vision, double vision, hearing loss, shortness of breath, cough, blood clots in the legs, fluid retention, swollen legs, diarrhea, stomach or abdominal pain, heartburn, upset stomach, difficulty swallowing, dry mouth, irritated or red skin, dry skin, itching, muscle weakness, pain in the joints, muscle aches and pains, frequent urination, difficulty keeping a tight seal, allergic reactions, fever, radiation damage, facial swelling, pain, taste changes, abnormal liver function values.
Uncommon (may affect up to 1 in 100 people): flu-like symptoms, red spots under the skin, low potassium levels in the blood, weight gain, mood swings, hallucinations and impaired memory, partial paralysis, impaired coordination, decreased sensation, partial loss of vision, dry or painful eyes, deafness, middle ear infection, ringing in the ears, earache, palpitations, blood clots in the lungs, high blood pressure, pneumonia, sinusitis, bronchitis, cold or flu, stomach bloating, difficulty controlling bowel movements, hemorrhoids, flaky skin, increased sensitivity of the skin to sunlight, changed skin color, increased sweating, muscle damage, back pain, difficulty urinating, vaginal bleeding, sexual impotence, missed or heavy periods, vaginal irritation, breast pain, hot flushes, chills, discoloration of the tongue, changes in smell, thirst, toothache.
Temozolomide Stada monotherapy in recurrent or worsening glioma.
The following side effects may occur and may require medical attention
Very common (may affect more than 1 in 10 people): decreased number of blood cells ( neutropenia or lymphopenia, thrombocytopenia ), loss of appetite, headache, vomiting, nausea, constipation, tiredness.
Common (may affect up to 1 in 10 people): weight loss, sleepiness, dizziness, tingling, shortness of breath, diarrhea, abdominal pain, upset stomach, rash, itching, hair loss, fever, weakness, chills, feeling unwell, pain, taste changes.
Uncommon (may affect up to 1 in 100 people): decreased number of blood cells (pancytopenia, anemia, leukopenia )
Rare (may affect up to 1 in 1,000 people): cough, infection including pneumonia
Very rare (may affect up to 1 in 10,000 users): skin redness, urticaria ( hives ), skin rash, allergic reactions.
Other side effects ar
Carees of increased liver enzymes have been reported as common. Cases of increased bilirubin levels, problems with the flow of bile (cholestasis), inflammation of the liver, and liver damage, including liver failure with a fatal outcome, have been reported less commonly.
Very rare cases of severe skin rash with swelling of the skin, including the palms and soles, or painful reddening of the skin and/or blisters on the body or in the mouth have been observed. Tell your doctor immediately if this happens.
Very rare cases of pulmonary side effects have been observed with Temozolomide Stada. Patients usually present with shortness of breath and cough. Tell your doctor if you notice any of these symptoms.
In very rare cases, patients taking Temozolomide Stada and similar medicines may be at a small risk of developing other cancers including leukemia.
New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have been reported less commonly. Cases of brain infections caused by herpes viruses (meningoencephalitis caused by herpes viruses), including fatal cases, have been reported uncommonly. Cases of sepsis (blood poisoning: when bacteria and their toxin circulate in the blood and start to damage organs) have been reported less commonly.
Cases of diabetes insipidus have been reported less commonly. Symptoms of diabetes insipidus are large amounts of urine and thirst.
How Temozolomide STADA should be stored
Keep this medicine out of the sight and reach of children, preferably in a locked cabinet. Accidental ingestion can be fatal for children.
Use before the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Store in the original packaging. Light sensitive. Close the jar well. Moisture sensitive.
Store at a maximum of 30 ºC.
Tell the pharmacist if you notice any change in the appearance of the capsules.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is temozolomide. Each capsule contains 20, 100, 140, 180, and 250 mg of temozolomide, respectively.
- Other ingredients are:
Capsule contents: lactose, colloidal anhydrous silicon dioxide, sodium starch glycolate type A, tartaric acid, stearic acid.
Temozolomide Stada 20 mg
Capsule shell: gelatin, titanium dioxide (E171), shellac, propylene glycol, para orange (E110).
Temozolomide Stada 100 mg
Capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), shellac, propylene glycol, and yellow iron oxide (E172).
Temozolomide Stada 140 mg
Capsule shell: gelatin, titanium dioxide (E171), shellac, propylene glycol, indigo carmine (E132).
Temozolomide Stada 180 mg
Capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), shellac, propylene glycol.
Temozolomide Stada 250 mg
Capsule shell: gelatin, titanium dioxide (E171), shellac, propylene glycol, black iron oxide (E172).
Appearance and package sizes of the medicine
Temozolomide Stada 20 mg:
The hard capsule is white and opaque with two orange lines on the top and “T 20 mg” in orange on the bottom with a diameter of about 6.2 mm and a length of about 18.0 mm.
Temozolomide Stada 100 mg
The hard capsule is white and opaque with two pink lines on the top and “T 100 mg” in pink on the bottom with a diameter of about 6.8 mm and a length of about 19.4 mm.
Temozolomide Stada 140 mg
The hard capsule is white and opaque with two blue lines on the top and “T 140 mg” in blue on the bottom with a diameter of about 7.5 mm and a length of about 21.7 mm.
Temozolomide Stada 180 mg
The hard capsule is white and opaque with two red lines on the top and “T 180 mg” in red on the bottom with a diameter of about 7.5 mm and a length of about 21.7 mm.
Temozolomide Stada 250 mg
The hard capsule is white and opaque with two black lines on the top and “T 250 mg” in black on the bottom with a diameter of about 7.5 mm and a length of about 21.7 mm.
The hard capsules for oral use are packaged in brown glass jars containing 5 or 20 capsules.
Not all pack sizes may be marketed.
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer
NERPHARMA SRL
Viale Pasteur, 10
20014 Nerviano
Italy
STADAPHARM GmbH
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Haupt Pharma Amareg GmbH
Donaustaufer Straße 378
93055 Regensburg
Germany
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark