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NIBIX 400 MG HARD CAPSULES

Active substance(s): IMATINIB MESILATE / IMATINIB MESILATE / IMATINIB MESILATE

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Package leaflet: Information for the patient
Nibix 400 mg capsule, hard
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.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Nibix is and what it is used for
What you need to know before you take Nibix
How to take Nibix
Possible side effects
How to store Nibix
Contents of the pack and other information

1. WHAT NIBIX IS AND WHAT IT IS USED FOR
Nibix 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.
Nibix 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.
In adult patients, Nibix is used to treat a late stage of chronic myeloid
leukaemia called “blast crisis”. In children and adolescents it may be used to
treat all stages of the illness.
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. Nibix inhibits the growth of these cells.

Nibix 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. Nibix 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. Nibix inhibits the growth of these cells in a
certain subtype of these diseases.

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 and HES/CEL.
Some children and adolescents taking Nibix may have slower than normal growth.
The doctor will monitor the growth at regular visits.
Other medicines and Nibix
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 Nibix when taken together. They may
increase or decrease the effect of Nibix, either leading to increased side effects or
making Nibix less effective. Nibix 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.
Pregnancy
Nibix 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
Nibix during pregnancy.
Women who might become pregnant are advised to use effective contraception
during treatment.
Breast-feeding
Do not breast-feed during the treatment with Nibix.
Fertility
Patients who are concerned about their fertility while taking Nibix 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.
Nibix contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
3. HOW TO TAKE NIBIX
Your doctor has prescribed Nibix because you suffer from a serious condition.
Nibix 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 Nibix 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 Nibix to take
Use in adults
Your doctor will tell you exactly how many capsules of Nibix to take.

Dermatofibrosarcoma protuberans (DFSP).
DFSP is a cancer of the tissue beneath the skin in which some cells start
growing out of control. Nibix inhibits the growth of these cells.

-

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

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 capsules), you should take one
capsule in the morning and a second capsule in the evening.

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

If you are being treated for CML:
The usual starting dose is 600 mg to be taken as one capsule of 400 mg plus 2
capsules of 100 mg capsules once a day.

-

If you are being treated for Ph-positive ALL:
The starting dose is 600 mg to be taken as one capsule of 400 mg plus 2 capsules
of 100 mg capsules once a day.

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

-

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

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

-

If you are being treated for HES/CEL:
The starting dose is 100 mg, to be taken as one capsule of 100 mg once a day.
Your doctor may decide to increase the dose to 400 mg, to be taken as one
capsule 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 (2 capsules), to be taken as one capsule in the
morning and one capsule in the evening.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NIBIX

Do not take Nibix:
- 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 Nibix.
If you think you may be allergic but are not sure, ask your doctor for advice.
Warning and precautions
Talk to your doctor before taking Nibix:
- 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 Nibix
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 any of these apply to you, tell your doctor before taking Nibix.
During treatment with Nibix, tell your doctor straight away if you put on weight
very quickly. Nibix may cause your body to retain water (severe fluid retention).
While you are taking Nibix, your doctor will regularly check whether the medicine
is working. You will also have blood tests and be weighed regularly.
Children and adolescents
Nibix is also a treatment for children and adolescents with CML.

Use in children and adolescents
The doctor will tell you how many capsules of Nibix to give to your child. The
amount of Nibix 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. 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 Nibix
- Take Nibix with a meal. This will help protect you from stomach problems
when taking Nibix.
- Swallow the capsules whole with a large glass of water. Do not open or
crush the capsules unless you have difficulty in swallowing (e.g. in children).
- If you are unable to swallow the capsules, you can open them and pour the
powder into a glass of still water or apple juice.
- If you are a woman who is pregnant or might get pregnant and are trying to
open the capsules, you should handle the contents with caution in order to
avoid skin-eye contact or inhalation. You should wash your hands

immediately after opening the capsules.
How long to take Nibix
Keep taking Nibix every day for as long as your doctor tells you.
If you take more Nibix than you should
If you have accidentally taken too many capsules, talk to your doctor straight
away. You may require medical attention. Take the medicine pack with you.
If you forget to take Nibix
- 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 or
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 side effects
(may affect up to 1 in 10 people):
- Rapid weight gain. Nibix may cause your body to retain water (severe fluid
retention).
- Signs of infection such as fever, severe chills, sore throat or mouth ulcers.
Nibix 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 side effects (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 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 phosphorous levels and low calcium levels in
the blood).
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), renal failure
chronic.
- 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.
- Swelling such as round your ankles or puffy eyes.
- Weight gain
If any of these affects 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 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.
- 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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of
this medicine.
5. HOW TO STORE NIBIX
-

Store below 30°C
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.
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 Nibix contains
- The active substance is imatinibe mesilate. Each capsule of Nibix contains
400 mg of imatinib (as mesilate).
- The other ingredients are crospovidone (type A), lactose monohydrate and
magnesium stearate
- The capsule shell is made of gelatine, yellow iron oxide (E172), titanium
dioxide (E171), red iron oxide (E172) and black iron oxide (E172).
What Nibix looks like and contents of the pack
Nibix, 400 mg, hard capsule are gelatin capsules of size “00” with caramel body
and cap. They are supplied in packs containing 10, 30, 90 or 100 capsules, but
these may not all be available in your country.

Marketing Authorisation Holder
Rivopharm UK Ltd
30th Floor
40 Bank Street
Canary Wharf
London, E14 5NR
United Kingdom

Manufacturer
Pabianickie Zakłady Farmaceutyczne Polfa S.A.
ul. Marsz. J. Piłsudskiego 5
95-200 Pabianice
Poland
UAB Norameda
Meistrų 8a, Vilnius LT-02189
Lithuania

This leaflet was last revised in 12/2016

R/MA/0069/PIL/002

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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