Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - temomedac

Document Subject

Generated Narrative: MedicinalProductDefinition mp065d110b327b470e1ddc262836549605

identifier: http://ema.europa.eu/identifier/EU/1/09/605/001-012

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Temomedac 5 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-065d110b327b470e1ddc262836549605

identifier: http://ema.europa.eu/identifier/EU/1/09/605/001-012

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - temomedac

Attesters

What is in this leaflet

1. What Temomedac is and what it is used for
2. What you need to know before you take Temomedac
3. How to take Temomedac
4. Possible side effects
5. How to store Temomedac
6. Contents of the pack and other information

Temomedac contains a medicine called temozolomide. This medicine is an antitumour agent.

Temomedac is used for the treatment of specific forms of brain tumours:

• in adults with newly-diagnosed glioblastoma multiforme. Temomedac is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
• in children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Temomedac is used in these tumours if they return or get worse after standard treatment.

Do not take Temomedac

• 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 anticancer medicine sometimes called DTIC). Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.
• if certain kinds of blood cells are severely reduced (myelosuppression), such as your white blood cell count and platelet count. These blood cells are important for fighting infection and for proper blood clotting. Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.

Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Temomedac,

• as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP). If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temomedac for 42 days in combination with radiotherapy. In this case, your doctor will also prescribe medicine to help you prevent this type of pneumonia (PCP).
• if you have ever had or might now have a hepatitis B infection. This is because Temomedac could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
• if you have low counts of red blood cells (anaemia), white blood cells and platelets, or blood clotting problems before starting the treatment, or if you develop them during treatment. Your doctor may decide to reduce the dose, interrupt, stop or change your treatment. You may also need other treatments. In some cases, it may be necessary to stop treatment with Temomedac. Your blood will be tested frequently during treatment to monitor the side effects of Temomedac on your blood cells.
• as you may have a small risk of other changes in blood cells, including leukaemia.
• if you have nausea (feeling sick in your stomach) and/or vomiting which are very common side effects of Temomedac (see section 4), your doctor may prescribe you a medicine (an anti- emetic) to help prevent vomiting.
• if you vomit frequently before or during treatment, ask your doctor about the best time to take Temomedac 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 fever or symptoms of an infection, contact your doctor immediately.
• if you are older than 70 years of age, you might be more prone to infections, bruising or bleeding.
• if you have liver or kidney problems, your dose of Temomedac may need to be adjusted.

Children and adolescents 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 Temomedac.

Other medicines and Temomedac Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility 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 Temomedac 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 Temomedac, and for at least 6 months following completion of treatment.

You should stop breast-feeding while receiving treatment with Temomedac.

Male fertility Temomedac 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.

Driving and using machines Temomedac 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).

Temomedac contains lactose Temomedac 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.

Temomedac contains sodium This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially sodium-free .

Additional information for Temomedac 20 mg hard capsules The excipient sunset yellow FCF (E110) included in the capsules shell may cause allergic reactions.

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 Temomedac. This is based on your size (height and weight) and if 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 Temomedac 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:

• treatment together with radiotherapy (concomitant phase) first
• followed by treatment with only Temomedac (monotherapy phase).

During the concomitant phase, your doctor will start Temomedac at a dose of 75 mg/m (usual dose). You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy. The Temomedac 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 interrupt 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 Temomedac will be different. Your doctor will work out your exact dose. There may be up to 6 treatment periods (cycles). Each one lasts 28 days. You will take your new dose of Temomedac alone once daily for the first 5 days ( dosing days ) of each cycle. The first dose will be 150 mg/m . Then you will have 23 days without Temomedac. This adds up to a 28 day treatment cycle. After Day 28, the next cycle will begin. You will again take Temomedac once daily for 5 days followed by 23 days without Temomedac. The Temomedac 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 Temomedac only

A treatment cycle with Temomedac lasts 28 days. You will take Temomedac alone 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 Temomedac will be 200 mg/m once daily for the first 5 days. If you have been previously treated with chemotherapy, your first dose of Temomedac will be 150 mg/m once daily for the first 5 days. Then, you will have 23 days without Temomedac. This adds up to a 28 day treatment cycle.

After Day 28, the next cycle will begin. You will again receive Temomedac once daily for 5 days, followed by 23 days without Temomedac.

Before each new treatment cycle, your blood will be tested to see if the Temomedac dose needs to be adjusted. Depending on your blood test results, your doctor may adjust your dose for the next cycle.

How to take Temomedac

Take your prescribed dose of Temomedac 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.
Depending on the prescribed dose, you may have to take more than one capsule together, eventually with different strengths (content of active substance, in mg). The colour and marking of the capsule is different for each strength (see table below).

Strength Colour/marking Temomedac 5 mg two stripes in green ink on the cap and T 5 mg in green ink on the body Temomedac 20 mg two stripes in orange ink on the cap and T 20 mg in orange ink on the body Temomedac 100 mg two stripes in pink ink on the cap and T 100 mg in pink ink on the body Temomedac 140 mg two stripes in blue ink on the cap and T 140 mg in blue ink on the body Temomedac 180 mg two stripes in red ink on the cap and T 180 mg in red ink on the body Temomedac 250 mg two stripes in black ink on the cap and T 250 mg in black ink on the body

You should make sure you fully understand and remember the following:

• how many capsules you need to take every dosing day. Ask your doctor or pharmacist to write it down (including the colour).
• which days are your dosing days. Review the dose with your doctor each time you start a new cycle, since it may be different from the last cycle.

Always take Temomedac exactly as your doctor has told you. It is very important to check with your doctor or pharmacist if you are not sure. Errors in how you take this medicine may have serious health consequences.

If you take more Temomedac than you should If you accidentally take more Temomedac capsules than you were told to, contact your doctor, pharmacist or nurse immediately.

If you forget to take Temomedac 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:

• a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty),
• uncontrolled bleeding,
• seizures (convulsions),
• fever,
• chills,
• severe headache that does not go away.

Temomedac 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 Temomedac 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:

• loss of appetite, difficulty speaking, headache
• vomiting, nausea, diarrhoea, constipation
• rash, hair loss
• tiredness

Common side effects (may affect up to 1 in 10 people) are:

• infections, oral infections,
• reduced number of blood cells (neutropenia, lymphopenia, thrombocytopenia)
• allergic reaction
• increased blood sugar
• memory impairment, depression, anxiety, confusion, inability to fall asleep or stay asleep
• impaired coordination and balance
• difficulty concentrating, change in mental status or alertness, forgetfulness
• dizziness, impaired sensations, tingling sensations, shaking, abnormal taste
• partial loss of vision, abnormal vision, double vision, painful eyes
• deafness, ringing in the ears, earache
• blood clot in lung or legs, high blood pressure
• pneumonia, shortness of breath, bronchitis, cough, inflammation of your sinuses
• stomach or abdominal pain, upset stomach/heartburn, difficulty swallowing
• dry skin, itching
• muscle damage, muscle weakness, muscle aches and pain
• painful joint, back pain
• frequent urination, difficulty withholding your urine
• fever, flu-like symptoms, pain, feeling unwell, a cold or the flu
• fluid retention, swollen legs
• liver enzyme elevations
• loss of weight, weight gain
• radiation injury

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

• brain infections (meningoencephalitis herpetic) including fatal cases
• new or reactivated cytomegalovirus infections
• wound infections
• reactivated hepatitis B virus infections
• secondary cancers including leukaemia
• reduced blood cell counts (pancytopenia, anaemia, leukopenia)
• red spots under the skin
• diabetes insipidus (symptoms include increased urination and feeling thirsty), low potassium level in the blood
• mood swings, hallucination
• partial paralysis, change in your sense of smell
• dry eyes
• hearing impairment, infection of the middle ear
• palpitations (when you can feel your heart beat), hot flushes
• swollen stomach, difficulty controlling your bowel movements, haemorrhoids, dry mouth
• hepatitis and injury to the liver (including fatal liver failure), cholestasis, increased bilirubin
• blisters on body or in mouth, skin peeling, skin eruption, painful reddening of the skin, severe rash with skin swelling (including palms and soles)
• increased sensitivity to sunlight, urticaria (hives), increased sweating, change in skin colour
• difficulty in urinating
• vaginal bleeding, vaginal irritation, absent or heavy menstrual periods, breast pain, sexual impotence
• shivering, face swelling, discolouration of the tongue, thirst, tooth disorder

Reporting of side effects 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 national reporting system listed in Appendix V. 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 30 C. Store in the original package in order to protect from moisture.
Keep the bottle tightly closed.

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.

What Temomedac contains

• The active substance is temozolomide. Temomedac 5 mg hard capsules: Each capsule contains 5 mg temozolomide. Temomedac 20 mg hard capsules: Each capsule contains 20 mg temozolomide. Temomedac 100 mg hard capsules: Each capsule contains 100 mg temozolomide. Temomedac 140 mg hard capsules: Each capsule contains 140 mg temozolomide. Temomedac 180 mg hard capsules: Each capsule contains 180 mg temozolomide. Temomedac 250 mg hard capsules: Each capsule contains 250 mg temozolomide.

• The other ingredients are: capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid (see section 2 Temomedac contains lactose ). capsule shell (including printing ink): Temomedac 5 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, indigo carmine (E 132) aluminium lake, yellow iron oxide (E 172)
  Temomedac 20 mg hard capsules: gelatine, titanium dioxide (E 171), shellac, propylene glycol, sunset yellow FCF aluminium Lake (E 110). Temomedac 100 mg hard capsules: gelatin, titanium dioxide (E 171), red iron oxide (E 172), shellac, propylene glycol and yellow iron oxide (E 172). Temomedac 140 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, indigo carmine (E 132) aluminium lake. Temomedac 180 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, red iron oxide (E 172) Temomedac 250 mg hard capsules: gelatin, titanium dioxide (E 171), shellac, propylene glycol, black iron oxide (E 172).

What Temomedac looks like and contents of the pack

Temomedac 5 mg hard capsules have a white opaque body and cap with two stripes in green ink on the cap and with T 5 mg in green ink on the body.

Temomedac 20 mg hard capsules have a white opaque body and cap with two stripes in orange ink on the cap and with T 20 mg in orange ink on the body.

Temomedac 100 mg hard capsules have a white opaque body and cap with two stripes in pink ink on the cap and with T 100 mg in pink ink on the body.

Temomedac 140 mg hard capsules have a white opaque body and cap with two stripes in blue ink on the cap and with T 140 mg in blue ink on the body.

Temomedac 180 mg hard capsules have a white opaque body and cap with two stripes in red ink on the cap and with T 180 mg in red ink on the body.

Temomedac 250 mg hard capsules have a white opaque body and cap with two stripes in black ink on the cap and with T 250 mg in black ink on the body.

The hard capsules for oral use are dispensed in amber glass bottles containing 5 or 20 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

medac Gesellschaft f r klinische Spezialpr parate mbH Theaterstr. 6 22880 Wedel Germany

This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.