Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - imatinib

Document Subject

Generated Narrative: MedicinalProductDefinition mp47a63fc97978537204b7a7371de13662

identifier: http://ema.europa.eu/identifier/EU/1/12/808/001-020

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Imatinib Teva 100 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-47a63fc97978537204b7a7371de13662

identifier: http://ema.europa.eu/identifier/EU/1/12/808/001-020

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - imatinib

Attesters

What is in this leaflet

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

Imatinib Teva is a medicine containing an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include some types of cancer.

Imatinib Teva is a treatment for adults and children for:

• Chronic myeloid leukaemia (CML). Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Chronic myeloid leukaemia is a form of leukaemia in which certain abnormal white cells (named myeloid cells) start growing out of control.
• Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph-positive ALL). Leukaemia is a cancer of white blood cells. These white cells usually help the body to fight infection. Acute lymphoblastic leukaemia is a form of leukaemia in which certain abnormal white cells (named lymphoblasts) start growing out of control. Imatinib Teva inhibits the growth of these cells.

Imatinib Teva is also a treatment for adults for:

• Myelodysplastic/myeloproliferative diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.
• Hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). These are blood diseases in which some blood cells (named eosinophils) start growing out of control. Imatinib Teva inhibits the growth of these cells in a certain subtype of these diseases.
• Gastrointestinal stromal tumours (GIST). GIST is a cancer of the stomach and bowels. It arises from uncontrolled cell growth of the supporting tissues of these organs.
• Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control. Imatinib Teva inhibits the growth of these cells.

In the rest of this leaflet, we will use the abbreviations when talking about these diseases.

If you have any questions about how Imatinib Teva works or why this medicine has been prescribed for you, ask your doctor.

Imatinib Teva will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.

Follow all your doctor s instructions carefully, even if they differ from the general information contained in this leaflet.

Do not take Imatinib Teva

• if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).

If this applies to you, tell your doctor without taking Imatinib Teva.

If you think you may be allergic but are not sure, ask your doctor for advice.

Warnings and precautions Talk to your doctor before taking Imatinib Teva:

• if you have or have ever had a liver, kidney or heart problem.
• if you are taking the medicine levothyroxine because your thyroid has been removed.
• if you have ever had or might now have a hepatitis B infection. This is because Imatinib Teva 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 experience bruising, bleeding, fever, fatigue and confusion when taking Imatinib Teva, contact your doctor. This may be a sign of damage to blood vessels known as thrombotic microangiopathy (TMA).

If any of these apply to you, tell your doctor before taking Imatinib Teva.

You may become more sensitive to the sun while taking Imatinib Teva. It is important to cover sun- exposed areas of skin and use sunscreen with high sun protection factor (SPF). These precautions are also applicable to children.

During treatment with Imatinib Teva, tell your doctor straight away if you put on weight very quickly. Imatinib Teva may cause your body to retain water (severe fluid retention).

While you are taking Imatinib Teva your doctor will regularly check whether the medicine is working. You will also have blood tests and be weighed regularly.

Children and adolescents Imatinib Teva is also a treatment for children and adolescents with CML. There is no experience in children with CML below 2 years of age. There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP, GIST and HES/CEL.

Some children and adolescents taking Imatinib Teva may have slower than normal growth. The doctor will monitor the growth at regular visits.

Other medicines and Imatinib Teva Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription (such as paracetamol) and including herbal medicines (such as St. John s Wort). Some medicines can interfere with the effect of Imatinib Teva when taken together. They may increase or decrease the effect of Imatinib Teva, either leading to increased side effects or making Imatinib Teva less effective. Imatinib Teva may do the same to some other medicines.

Tell your doctor if you are using medicines that prevent the formation of blood clots.

Pregnancy, breast-feeding and fertility

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
• Imatinib Teva is not recommended during pregnancy unless clearly necessary as it may harm your baby. Your doctor will discuss with you the possible risks of taking Imatinib Teva during pregnancy.
• Women who might become pregnant are advised to use effective contraception during treatment and for 15 days after ending treatment.
• Do not breast-feed during the treatment with Imatinib Teva and for 15 days after ending treatment, as it may harm your baby.
• Patients who are concerned about their fertility while taking Imatinib Teva are advised to consult with their doctor.

Driving and using machines You may feel dizzy or drowsy or get blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines until you are feeling well again.

Your doctor has prescribed Imatinib Teva because you suffer from a serious condition. Imatinib Teva can help you to fight this condition.

However, always take this medicine exactly as your doctor, pharmacist or nurse has told you. It is important that you do this as long as your doctor, pharmacist or nurse tells you to. Check with your doctor, pharmacist or nurse if you are not sure.

Do not stop taking Imatinib Teva unless your doctor tells you to. If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight away.

How much Imatinib Teva to take

Use in adults
Your doctor will tell you exactly how many tablets of Imatinib Teva to take.

• If you are being treated for CML: Depending on your condition the usual starting dose is either 400 mg or 600 mg:

• 400 mg to be taken as 4 tablets once a day,

• 600 mg to be taken as 6 tablets once a day.

• If you are being treated for GIST: The starting dose is 400 mg, to be taken as 4 tablets once a day.

For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment. If your daily dose is 800 mg (8 tablets), you should take 4 tablets in the morning and 4 tablets in the evening.

• If you are being treated for Ph-positive ALL: The starting dose is 600 mg to be taken as 6 tablets once a day.

• If you are being treated for MDS/MPD: The starting dose is 400 mg, to be taken as 4 tablets once a day.

• If you are being treated for HES/CEL: The starting dose is 100 mg, to be taken as 1 tablet once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as 4 tablets once a day, depending on how you respond to treatment.

• If you are being treated for DFSP: The dose is 800 mg per day (8 tablets), to be taken as 4 tablets in the morning and 4 tablets in the evening.

Use in children and adolescents The doctor will tell you how many tablets of Imatinib Teva to give to your child. The amount of Imatinib Teva given will depend on your child s condition, body weight and height. The total daily dose in children and adolescents must not exceed 800 mg with CML and 600 mg with Ph+ALL. The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).

When and how to take Imatinib Teva

• Take Imatinib Teva with a meal. This will help protect you from stomach problems when taking Imatinib Teva.
• Swallow the tablets whole with a large glass of water.

If you are unable to swallow the tablets, you can dissolve them in a glass of still water or apple juice:

• Use about 50 ml for each 100 mg tablet.
• Stir with a spoon until the tablets have completely dissolved.
• Once the tablet has dissolved, drink everything in the glass straight away. Traces of the dissolved tablets may be left behind in the glass.

The tablet can be divided into equal doses.

How long to take Imatinib Teva Keep taking Imatinib Teva every day for as long as your doctor tells you.

If you take more Imatinib Teva than you should If you have accidentally taken too many tablets, talk to your doctor straight away. You may require medical attention. Take the medicine pack with you.

If you forget to take Imatinib Teva

• If you forget a dose, take it as soon as you remember. However if it is nearly time for the next dose, skip the missed dose.
• Then continue with your normal schedule.
• Do not take a double dose to make up a forgotten dose.

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. They are usually mild to moderate.

Some side effects may be serious. Tell your doctor straight away if you get any of the following:

Very common (may affect more than 1 in 10 people) or common (may affect up to 1 in 10 people):

• Rapid weight gain. Imatinib Teva may cause your body to retain water (severe fluid retention).
• Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib Teva can reduce the number of white blood cells, so you might get infections more easily.
• Unexpected bleeding or bruising (when you have not hurt yourself).

Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):

• Chest pain, irregular heart rhythm (signs of heart problems).
• Cough, having difficulty breathing or painful breathing (signs of lung problems).
• Feeling light-headed, dizzy or fainting (signs of low blood pressure).
• Feeling sick (nausea), with loss of appetite, dark-coloured urine, yellow skin or eyes (signs of liver problems).
• Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
• Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
• Severely decreased urine output, feeling thirsty (signs of kidney problems).
• Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).
• Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).
• Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
• Eye pain or deterioration in vision, bleeding in the eyes.
• Pain in bones or joints (signs of osteonecrosis).
• Blisters on skin or mucous membranes (signs of pemphigus).
• Numb or cold toes and fingers (signs of Raynaud s syndrome).
• Sudden swelling and redness of the skin (signs of a skin infection called cellulitis).
• Difficulty hearing.
• Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
• Bruising.
• Stomach pain with feeling sick (nausea).
• Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
• Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
• Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and calcium levels and low phosphorous levels in the blood).
• Blood clots in small blood vessels (thrombotic microangiopathy).

Not known (frequency cannot be estimated from the available data):

• Combination of a widespread severe rash, feeling sick, fever, high level of certain white blood cells or yellow skin or eyes (signs of jaundice) with breathlessness, chest pain/discomfort, severely decreased urine output and feeling thirsty etc. (signs of a treatment-related allergic reaction).
• Chronic renal failure.
• Recurrence (reactivation) of hepatitis B infection when you have had hepatitis B in the past (a liver infection).

If you get any of the above, tell your doctor straight away.

Other side effects may include:

Very common (may affect more than 1 in 10 people):

• Headache or feeling tired.
• Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
• Rash.
• Muscle cramps or joint, muscle or bone pain, during treatment with Imatinib Teva or after you have stopped taking Imatinib Teva.
• Swelling such as round your ankles or puffy eyes.
• Weight gain. If any of these affects you severely, tell your doctor.

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

• Anorexia, weight loss or a disturbed sense of taste.
• Feeling dizzy or weak.
• Difficulty in sleeping (insomnia).
• Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
• Nose bleeds.
• Pain or swelling in your abdomen, flatulence, heartburn or constipation.
• Itching.
• Unusual hair loss or thinning.
• Numbness of the hands or feet.
• Mouth ulcers.
• Joint pain with swelling.
• Dry mouth, dry skin or dry eye.
• Decreased or increased skin sensitivity.
• Hot flushes, chills or night sweats. If any of these affects you severely, tell your doctor.

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

• Cough, runny or stuffy nose, feeling of heaviness or pain on pressing the area above the eyes or on the sides of the nose, nasal congestion, sneezing, sore throat, with or without headache (signs of upper respiratory tract infection).
• Severe headache felt as a throbbing pain or pulsing sensation, usually on one side of the head and often accompanied by nausea, vomiting and sensitivity to light or sound (signs of migraine).
• Flu-like symptoms (influenza).
• Pain or burning sensation while passing urine, increased body temperature, pain in groin or pelvic area, red- or brown-coloured or cloudy urine (signs of urinary tract infection).
• Pain and swelling of your joints (signs of arthralgia).
• A constant feeling of sadness and loss of interest, which stops you carrying out your normal activities (signs of depression).
• A feeling of apprehension and worry along with physical symptoms such as pounding heart, sweating, trembling, dry mouth (signs of anxiety).
• Sleepiness/drowsiness/excessive sleep.
• Trembling or shaky movements (tremor).
• Memory impairment.
• Overwhelming urge to move the legs (restless leg syndrome).
• Hearing noises (e.g. ringing, humming) in the ears that have no external source (tinnitus).
• High blood pressure (hypertension).
• Burping/belching.
• Inflammation of the lips.
• Difficulty swallowing.
• Increased sweating.
• Skin discolouration.
• Brittle nails.
• Red bumps or white-headed pimples around the roots of the hair, possibly with pain, itching or burning sensation (signs of inflammation of the hair follicles, also called folliculitis).
• Skin rash with flaking or peeling (exfoliative dermatitis).
• Breast enlargement (may occur in men or women).
• Dull pain and/or feeling of heaviness in the testicles or lower abdomen, pain during urination, sexual intercourse or ejaculation, blood in urine (signs of oedema of the testicles).
• Inability to get or keep an erection (erectile dysfunction).
• Heavy or irregular menstrual periods.
• Difficulty achieving/maintaining sexual arousal.
• Decreased sexual desire.
• Nipple pain.
• Generally feeling unwell (malaise).
• Viral infection such as cold sore.
• Lower back pain resulting from kidney disorder.
• Increased frequency of passing urine.
• Increase in appetite.
• Pain or burning sensation in upper abdomen and/or chest (heartburn), nausea, vomiting, acid reflux, feeling of fullness and bloating, black-coloured stools (signs of stomach ulcer).
• Joint and muscle stiffness.
• Abnormal laboratory test results.
• Painful red lumps on the skin, skin pain, skin reddening (inflammation of fatty tissue under the skin). If any of these affects you severely, tell your doctor.

Rare (may affect up to 1 in 1,000 people):

• Confusion.
• Nail discolouration. If any of these affects you severely, tell your doctor.

Not known (frequency cannot be estimated from the available data):

• Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.
• Painful and/or blistering skin lesions.
• Slowing of growth in children and adolescents. If any of these affects you severely, tell your doctor.

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.

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 the month.

This medicine does not require any special storage conditions.

Do not use any pack that is damaged or shows signs of tampering.

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 Imatinib Teva contains

• The active substance is imatinib (as mesilate).
• Each film-coated tablet of Imatinib Teva contains 100 mg imatinib (as mesilate).
• The other ingredients are calcium hydrogen phosphate, crospovidone and magnesium stearate.
• The tablet coating is made of polyvinyl alcohol partially hydrolysed, macrogol, iron oxide yellow (E172), talc, titanium dioxide (E171) and iron oxide red (E172).

What Imatinib Teva looks like and contents of the pack Imatinib Teva 100 mg film-coated tablets are dark yellow to brownish orange round film-coated tablets with a score line on one side. The tablet is debossed with IT and 1 at each side of the score line. The tablets are approximately 9 mm in diameter.

Imatinib Teva 100 mg film-coated tablets are available in pack sizes of 60 or 120 film-coated tablets in blisters. Imatinib Teva 100 mg film-coated tablets are available in pack sizes of 20x1, 60x1, 120x1 or 180x1 film-coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Teva B.V. Swensweg 5 2031 GA Haarlem The Netherlands

Manufacturer Teva Pharmaceutical Works Private Limited Company Pallagi t Debrecen H-4Hungary

Teva Czech Industries s.r.o. Ostravska 29, c.p. 74770 Opava-Komarov Czech Republic

TEVA PHARMA, S.L.U. C/C, n. 4, Poligono Industrial Malpica 50016 Zaragoza Spain

Merckle GmbH Graf-Arco-Str. 3, 89079 Ulm Germany

Teva Operations Poland Sp. z o.o. ul. Mogilska 80, 31-546 Krakow Poland

Teva Pharma B.V. Swensweg 5,
2031 GA Haarlem The Netherlands

PLIVA Croatia Ltd. Prilaz baruna Filipovica 10000 Zagreb Croatia

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG T l/Tel: +32 38207Lietuva UAB Teva Baltics Tel: +370 52660

Te : +359 24899Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien T l/Tel: +32 38207 esk republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007Magyarorsz g Teva Gy gyszergy r Zrt. Tel: +36 12886Danmark Teva Denmark A/S Tlf: +45 44985Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407Deutschland AbZ-Pharma GmbH Tel: +49 73140Nederland Teva Nederland B.V. Tel: +31 8000228Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610Norge Teva Norway AS Tlf: +47 66775
TEVA HELLAS . . : +30 2118805 sterreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970Espa a Teva Pharma, S.L.U. Tel: +34 913873Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459France Teva Sant
T l: +33 155917Portugal Teva Pharma - Produtos Farmac uticos, Lda. Tel: +351 214767Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720Rom nia Teva Pharmaceuticals S.R.L. Tel: +40 212306Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890 sland Teva Pharma Iceland ehf. S mi: +354 5503Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267Italia Teva Italia S.r.l. Tel: +39 028917Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805
TEVA HELLAS . .

: +30 2118805Sverige Teva Sweden AB Tel: +46 42121Latvija UAB Teva Baltics fili le Latvij
Tel: +371 67323United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407This 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 Package leaflet: Information for the patient

Imatinib Teva 400 mg film-coated tablets imatinib

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.