Imatinib SPC 100 mg - 60 Tablets

1. What Imatinib SPC is and what is used for
Imatinib SPC tablets are 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 SPC is a treatment for:
- Chronic myeloid leukemia (CML). Leukemia is a cancer of white blood cells. These white
cells usually help the body to fight infection. Chronic myeloid leukemia is a form of
leukemia in which certain abnormal white cells (named myeloid cells) start growing out of
control.
- Philadelphia chromosome positive acute lymphoblastic leukemia (Ph-positive ALL).
Leukemia is a cancer of white blood cells. These white cells usually help the body to fight
infection. Acute lymphoblastic leukemia is a form of leukemia in which certain abnormal
white cells (named lymphoblasts) start growing out of control. Imatinib SPC inhibits the
growth of these cells
Imatinib SPC 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 SPC 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 SPC 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 SPC 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 SPC works or why this medicine has been
prescribed for you, ask your doctor.
2. What you need to know before you take Imatinib SPC
Imatinib SPC will only be prescribed to you by a doctor with experience in medicines to treat
blood cancers or solid tumors.
Follow all your doctor’s instructions carefully, even if they differ from the general information
contained in this leaflet.
The tablets contain lactose and should not be administered in patients with rare hereditary
problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose
malabsorption
Do not take Imatinib SPC:
- if you are allergic to Imatinib SPC or any of the other ingredients of this medicine (listed in
section 6).
- If this applies to you, tell your doctor without taking Imatinib SPC.
- 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 SPC:
- 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 SPC
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 Sensitive to the sun –cover sun-exposed areas of skin.
- if you experience bruising, bleeding, fever, fatigue and confusion when taking Glivec, 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 SPC.
You may become more sensitive to the sun while taking Glivec. It is important to cover sunexposed areas of skin and use sunscreen with high sun protection factor (SPF). These precautions
are also applicable to children.
During treatment with Imatinib SPC, tell your doctor straight away if you put on weight very
quickly. Imatinib SPC may cause your body to retain water (severe fluid retention).
While you are taking Imatinib SPC, your doctor will regularly check whether the medicine is
working. You will also have blood tests and be weighed regularly.
Children and adolescents
Imatinib SPC 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 and
adolescents with Ph-positive ALL and very limited experience in children and adolescents with
MDS/MPD, DFSP and HES/CEL.
To add the total dose must not exceed 600mg with Ph+ ALL.
Some children and adolescents taking Imatinib SPC may have slower than normal growth. The
doctor will monitor the growth at regular visits.
Other medicines and Imatinib SPC
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 SPC when taken together. They may increase or decrease the effect of Imatinib
SPC, either leading to increased side effects or making Imatinib SPC less effective. Imatinib SPC
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 SPC 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 SPC during
pregnancy.
- Women who might become pregnant are advised to use effective contraception during
treatment.
- Do not breast-feed during the treatment Imatinib SPC.
- Patients who are concerned about their fertility while taking Imatinib SPC 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.
3. How to take Imatinib SPC
Your doctor has prescribed Imatinib SPC because you suffer from a serious condition. Imatinib
SPC can help you to fight this condition.
However, always take this medicine exactly as your doctor or pharmacist has told you. It is
important that you do this as long as your doctor or pharmacist tells you to. Check with your
doctor or pharmacist if you are not sure.
Do not stop taking Imatinib SPC 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 SPC to take
Use in adults
Your doctor will tell you exactly how many tablets of Imatinib SPC 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 one tablet once a day.
- 600 mg to be taken as one tablet of 400 mg plus 2 tablets of 100 mg once a day.
- If you are being treated for GIST:
- The starting dose is 400 mg, to be taken as one tablet 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 (2 tablets), you should take one tablet in the
morning and a second tablet in the evening.
- If you are being treated for Ph-positive ALL:
The starting dose is 600 mg to be taken as e.g. 1 tablet of 400 mg plus 2 tablets of 100 mg
once a day.
The total dose must not exceed 600mg with Ph+ ALL..
- If you are being treated for MDS/MPD:
The starting dose is 400 mg to be taken as e.g. 1 tablet of 400 mg once a day.
- If you are being treated for HES/CEL:
The starting dose is 100 mg, to be taken as 1 tablet of 100 mg once a day. Your doctor may
decide to increase the dose to 400 mg, to be taken as e.g. 1 tablet of 400 mg once a day,
depending on how you respond to treatment.
- If you are being treated for DFSP:
The dose is 800 mg per day, to be taken as a half dose (e.g. 1 tablet of 400 mg) in the morning
and a half dose (e.g. 1 tablet of 400 mg) in the evening.
Use in children and adolescents
The doctor will tell you how many tablets of Imatinib SPC to give to your child. The amount of
Imatinib SPC 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 SPC
- Take Imatinib SPC with a meal. This will help protect you from stomach problems when
taking Imatinib SPC.
- 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 and 200 ml for each 400 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.
How long to take Imatinib SPC
Keep taking Imatinib SPC every day for as long as your doctor tells you.
If you take more Imatinib SPC 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 SPC
- 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.
4. Possible side effects
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) side effects:
- rapid weight gain. Imatinib SPC may cause your body to retain water (severe fluidretention).
- signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib SPC 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)
side effects:
- 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 your hips or difficulty walking
- 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 side effects (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 Imatinib tablets treatment or after
you have stopped taking Imatinib tablets.
- swelling such as round your ankles or puffy eyes
- weight gain
- If any of these affect you severely, tell your doctor. Common side effects (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 affect 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.
- slowing of growth in children and adolescents.
If any of these affect you severely, tell your doctor.
Common side effects (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 affect 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
- slowing of growth in children and adolescents
If any of these affect 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.
5. How to store Imatinib SPC
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.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
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.
6. Contents of the pack and other information
What Imatinib SPC film coated tablets contain
- The active substance is Imatinib mesilate. Each tablet of Imatinib SPC contains either 100
mg imatinib (as mesilate) for 100 mg film-coated tablets or 400 mg imatinib (as mesilate) for
400 mg film-coated tablets.
- The other ingredients are sodium stearyl fumarate, anhydrous colloidal silica, crospovidone,
microcrystalline cellulose, anhydrous lactose and magnesium stearate.
- The tablet coating is made of red iron oxide (E172), yellow iron oxide (E172), titanium
dioxide (E171), macrogol, sodium laurilsulfate and hypromellose.
What Imatinib SPC tablets look like and contents of the pack
Imatinib SPC 100 mg Film-Coated Tablets are yellow to brownish orange, round film coated
tablets debossed with "1" on one side and score line on the other side.
They are supplied in blister packs.
Imatinib SPC 400 mg Film-Coated Tablets are yellow to brownish orange, ovaloid film coated
tablets debossed with "4" on one side and score line on the other side.
They are supplied in blister packs.