Temozolomide Hospira 250 mg hard capsules

Temozolomide is an anti-cancer medicine that is used in combination with radiotherapy or on its own.

Temozolomide Hospira capsules are taken to treat:

• newly diagnosed specific form of brain tumour (glioblastoma multiforme).
• specific forms of brain tumour (e.g. glioblastoma multiforme or anaplastic. astrocytoma) that has returned or where the cancer has spread after standard therapy.

Do not take Temozolomide Hospira

• if you are allergic (hypersensitive) to temozolomide or any of the other ingredients of Temozolomide Hospira.
• if you have had an allergic reaction to another anti-cancer medicine called dacarbazine.
• if you have a reduced number of blood cells.

Take special care with Temozolomide Hospira capsules

• if you are taking temozolomide for 42 days, in combination with radiation treatment. Your doctor will also prescribe a medicine to help prevent a serious form of pneumonia called Pneumocystis carinii pneumonia (PCP). There may be a higher risk of pneumonia when you are taking temozolomide for a longer time. However, your doctor will be checking for signs of pneumonia in all patients receiving temozolomide, especially if you are also taking steroids.
• if you have anaemia, low blood count (such as white blood cell count and platelet count), or blood clotting problems before treatment, or develop them during treatment. Your doctor may need to reduce the dose of your medicine or interrupt your treatment, or you may need other treatment. Your doctor will decide whether any change in your treatment is needed. In some cases, it may be necessary to stop treatment with temozolomide. Your blood will be tested regularly to monitor your condition. If you develop fever or symptoms of an infection contact your doctor immediately.
• if you feel sick or vomit. If you vomit frequently before or during treatment, ask your doctor about medicines to help prevent vomiting or control the vomiting and the best time to take temozolomide until the vomiting is under control. If you vomit after your dose, do not take a second dose on the same day.
• in children younger than three years old as there is no experience with the use of temozolomide. Therefore, treatment in children under three years of age is not recommended.
• if you are male because of the possibility of irreversible infertility due to treatment with temozolomide. You are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment.
• if you are older than 70 years of age. Older patients are more prone to infections, increased bruising or bleeding.
• if you have liver or kidney problems as your dose of temozolomide may need to be adjusted.
• if you have any sort of lactose (sugar) intolerance.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Temozolomide Hospira must not be taken if you are pregnant unless clearly indicated by your doctor. You must not become pregnant during treatment with this medicine and must use an effective method of contraception during treatment. If pregnancy occurs during your treatment, you must tell your doctor immediately.

You must not breast-feed whilst you are being treated with Temozolomide Hospira.

Ask your doctor for advice before taking any medicine.

Driving and using machines

When you take temozolomide you may feel tired or sleepy. In this case, do not drive or use any tools or machines.

Important information about some of the ingredients of Temozolomide Hospira

Each capsule contains a small amount of lactose. Thus, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Temozolomide should only be prescribed by specialists experienced in brain tumours.

Your doctor will decide the correct dose of temozolomide for you to take, based on your size (height and weight) and whether you have had chemotherapy treatment. You may be given other medicines to take before and/or after temozolomide to avoid or control vomiting.

Take your prescribed dose of Temozolomide Hospira once a day. Take the dose 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 or chew the capsules.

If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose. Avoid inhaling the powder. If you accidentally get some in your eyes or nose, flush the area with water.

If you are taking Temozolomide Hospira in combination with radiotherapy (newly diagnosed patients):

While the radiotherapy is ongoing your doctor will start temozolomide at a dose of 75 mg/m² and the actual daily dose you take will depend on your height and weight. You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy. Based on your blood counts and how you tolerate temozolomide, the dose may be delayed or stopped.

Once the radiotherapy is completed, you will interrupt treatment for 4 weeks to give your body a chance to recover.

Then there may be up to 6 treatment cycles, and each one lasts 28 days. You will take your new dose of temozolomide capsules initially at 150 mg/m² once daily for the first five days (?dosing days?) of each cycle, followed by 23 days without temozolomide; this adds up to a 28 day treatment cycle.

After day 28, the next cycle will begin, in which you will again take this medicine once daily for five days followed by 23 days without temozolomide. Based on your blood counts and how you tolerate temozolomide during each treatment cycle, the dose may be adjusted, delayed or stopped.

If you are taking Temozolomide Hospira capsules alone (without radiotherapy):

A treatment cycle with Temozolomide Hospira comprises 28 days. You will take the capsules once daily for the first five days (?dosing days?) followed by 23 days without temozolomide, adding up to the 28 day treatment cycle.

After day 28, the next cycle will begin, in which you will again take this medicine once daily for five days followed by 23 days without temozolomide. Before each new treatment cycle, your blood will be tested to see if the temozolomide dose needs to be adjusted.

If you have not been treated before with chemotherapy, you will take your first dose of temozolomide at 200 mg/m² once daily for the first five days (?dosing days?) followed by 23 days without temozolomide. If you have been treated before with chemotherapy, you will take your first dose of temozolomide at 150 mg/m² once daily for the first five days (?dosing days?) followed by 23 days without temozolomide.

Depending on your blood test results, your doctor may adjust your dose for the next cycle. Each time you start a new treatment cycle, be sure you understand exactly how many capsules of each strength you need to take each day and how many days you will receive this dose.

All patients

Temozolomide comes in different strength capsules (shown on the outer label in mg). Each strength has a different colour cap. Depending on the dose of temozolomide that your doctor prescribes, you may have to take several capsules on each dosing day of the treatment cycle.

• Be sure you understand exactly how many capsules you need to take of each strength. Ask your doctor or pharmacist to write down the number of each strength (including colour) that you need to take each dosing day.
• Be sure you know exactly which days are your dosing days.
• Be sure you review the dose with your health care provider each time you start a new cycle. Sometimes the dose or the mix of capsules you need to take will be different from the last cycle.
• Once you take the medicine home, if you are confused or unsure about how to take your dose, call for re-instruction before beginning the treatment cycle. Errors in how you take this medicine may have serious health consequences.

If you take more Temozolomide Hospira than you should

Take Temozolomide Hospira only as it is prescribed for you. If you accidentally take more temozolomide than you were told to, contact your doctor or pharmacist immediately.

If you forget to take Temozolomide Hospira

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 double the next dose unless your doctor tells you to do so.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Temozolomide Hospira can cause side effects, although not everybody gets them.

Patients taking temozolomide in combination with radiation therapy may experience different side effects than patients taking temozolomide alone.

Contact your doctor immediately if you have a severe allergic reaction (rash which might be itchy, wheezing or other breathing difficulty), uncontrolled fits, fever or a severe headache that does not go away.

Temozolomide treatment can cause a reduction in certain kinds of blood cells. This may cause you to have increased bruising or bleeding, anaemia, fever, and/or a reduced resistance to infections. The reduction of blood cells is usually temporary, but in some cases may be for longer 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 dose will be reduced or discontinued.

The following side effects may occur if you are a newly diagnosed patient taking Temozolomide Hospira for a specific brain tumour (glioblastoma multiforme) in combination treatment with radiotherapy and then later taking temozolomide on its own. Medical attention may be required.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data).

Very common side effects:

Headache constipation feeling andor being sick rash hair loss loss of appetite tiredness

Common side effects:

Abnormal liver function tests, changes in blood cells, fits, change in mental status or alertness, sleepiness, difficulty with your balance, dizziness, confusion, forgetfulness, difficulty concentrating, tingling sensation, pins and needles, difficulty speaking or understanding language, shaking, stroke. abnormal or blurred vision, double-vision loss of hearing, ringing noise in the ear shortness of breath, cough sores or ulcers in the mouth, diarrhoea, stomach pain, heartburn, difficulty swallowing, dry mouth frequent urination, difficulty with holding your urine or urine leakage skin irritation or redness, dry skin, itching muscle weakness, painful joints, muscle aches and pains increased sugar in the blood, loss of weight infections, wound infection, sore throat, fungal infections in the mouth, cold sores bleeding, fluid retention, swollen legs, blood clots allergic reaction, fever, radiation injury, facial swelling, pain, changes in sense of taste anxiety, depression, changing emotions, inability to fall asleep or stay asleep,

Uncommon side-effects:

raised liver enzymes your doctor will check this palpitations abnormal heart beats flu-like symptoms, red spots under the skin long or repeated fits, tremors or jerking movement, partial paralysis, difficulty with your coordination and balance, difficulty swallowing, changes in sensation of touch partial loss of vision, dry or painful eyes infection of the middle ear, pain or discomfort in the ears from loud noises, earache, deafness, feeling that ones surroundings are spinning pneumonia, inflammation of your sinuses, bronchitis, blocked nose, a cold or the flu

bloated stomach, difficulty controlling your bowel movements, haemorrhoids piles pain with urination peeling skin, increased skin sensitivity to sunlight, change in skin colour, increased sweating muscle damage, back pain appearance of a swollen or moon face low potassium level in the blood, weight gain shingles, flu-like symptoms bleeding within the brain, high blood pressure, blood clot in the lung, swelling weakness, swollen face, shivering, change in your sense of taste, tooth disorder sexual impotence, vaginal bleeding, absent or heavy menstrual periods, vaginal irritation, breast pain, mood swings, depression, hallucination and memory loss discolouration of your tongue change in your sense of smell thirst

The following side effects may occur if you are taking only temozolomide (patients treated for
brain tumours that have come back or that have spread)

Very common:

Abnormal blood values, headache, feeling or being sick, constipation, loss of appetite, tiredness

Common:

Sleepiness, dizziness, tingling sensation, diarrhoea, stomach pain, indigestion, rash, itching, hair loss, weight loss, fever, weakness, shivering, feeling unwell, pain, change in taste, shortness of breath

Uncommon:

Changes in blood cells

Rare:

Infections including agents causing pneumonia.

Very rare:

Skin redness, an itchy rash with raised yellow or white lumps that are surrounded by red inflammation, skin eruption, allergic reactions.

Very rare cases of lung side effects have been observed with temozolomide. Patients usually present with shortness of breath and cough. Tell your doctor if you notice any of these symptoms.

Very rare cases of rash with skin swelling, including on the palms of the hands and soles of the feet, 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 occurs.

Very rarely, patients taking temozolomide and medicines like it may have a small risk of other changes in blood cells, including leukaemia.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children, preferably in a locked cupboard. Accidentally taking the capsules can be fatal.

Do not use Temozolomide Hospira 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.
Store in the original bottle.
Keep the bottle tightly closed in order to protect from moisture.

Tell your pharmacist if you notice any change 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 to protect the environment.

What Temozolomide Hospira contains

• The active substance is temozolomide. Each capsule contains 250 mg of temozolomide.
• The other ingredients of the capsule are anhydrous lactose, colloidal anhydrous silica,sodium starch glycolate type A, tartaric acid, stearic acid. The capsule shells contain gelatine and water. Colourants used in the capsule shells are titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) and indigo carmine (E132).

[250mg] Capsule shells contain gelatine, water and sodium laurilsulfate. Colourants used in the capsule shells are titanium dioxide (E171).

The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide (E172), potassium hydroxide and purified water.

What Temozolomide Hospira looks like and contents of the pack

Temozolomide Hospira 250 mg hard capsules have a white body, a white cap, and are imprinted ?TMZ? on cap and ?250? on body with black ink.

The hard capsules are dispensed in amber glass or plastic bottles containing 5 or 20 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW, United Kingdom

This leaflet was last approved in {MM/YYYY}