100 mg, 400 mg film-coated tablets
imatinib
What Imatinib Sandoz is and what it is used for
Imatinib Sandoz is a medicine that contains an active substance called imatinib. The drug acts by inhibiting the growth of abnormal cells in diseases listed below. These include certain types of cancer.
Imatinib Sandoz is a treatment for adults and children for:
- K ronisk myelogenous leukemia (CML). Leukemia is a cancer of the white blood cells . These white blood cells usually help the body fight infection . Chronic myeloid leukemia is a form of leukemia in which certain abnormal white blood cells (so-called myeloid cells) begin to grow out of control.
- Philadelphia chromosome-positive acute lymphoblastic leukemia ( Ph- positive ALL). Leukemia is a cancer of the white blood cells . These white blood cells normally help the body fight infection . Acute lymphoblastic leukemia is a form of leukemia in which certain abnormal white blood cells (so-called lymphoblasts ) begin to grow out of control. Imatinib Sandoz inhibits the growth of these cells.
Imatinib Sandoz is also a treatment for adults for:
- Myelodysplastic / myeloproliferative disorders (MDS / MPD). These are a group of blood diseases in which certain blood cells begin to grow out of control. Imatinib Sandoz inhibits the growth of these cells in a certain subset of these diseases.
- H ypereosinofilt syndrome (HES) and / or chronic eosinophilic leukemia (CEL). These are blood diseases in which certain blood cells (so-called eosinophils) begin to grow out of control. Imatinib Sandoz inhibits the growth of these cells in a certain subset of these diseases.
- D ermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue under the skin in which certain cells begin to grow out of control. Imatinib Sandoz inhibits the growth of these cells.
In the rest of this leaflet, abbreviations will be used when talking about these diseases.
Ask your doctor if you have any questions about how this medicine works or why this medicine has been prescribed for you.
Imatinib contained in Imatinib Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Imatinib Sandoz
Imatinib Sandoz will only be prescribed to you by a doctor who has medical experience in treating different types of blood cancer or solid tumors.
Follow your doctor’s instructions carefully, even if they differ from the general information in this leaflet.
Do not take Imatinib Sandoz:
- if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
If this applies to you, for a not Imatinib Sandoz but notify your doctor.
If you think you may be allergic but are not sure, ask your doctor for advice.
Warnings and cautions
Talk to your doctor before taking Imatinib Sandoz:
- if you have or have had a liver, kidney or heart disease
- if you are taking the medicine levothyroxine due to that your thyroid gland has been removed
- if you have ever had or may have a hepatitis B infection . The reason for this is that Imatinib Sandoz can cause your hepatitis B to become active again, which in some cases can be fatal. Patients will be closely monitored by their doctor for signs of this infection before starting treatment
- if you get bruises, bleeding, fever, get very tired and confused when taking Imatinib Sandoz, contact your doctor. This may be a sign of a damage to the blood vessels called thrombotic microangiopathy (TMA).
If any of these apply to you, tell your doctor before taking Imatinib Sandoz.
You may become more sensitive to the sun while taking Imatinib Sandoz. It is important to cover exposed areas of the skin and use sunscreen with a high sun protection factor (SPF). These precautions also apply to children.
V in d treatment with Imatinib Sandoz m eddela your doctor immediately if you are rapidly gaining weight. Imatinib Sandoz can cause your body to bind fluid (severe fluid retention ).
When you are taking Imatinib Sandoz, your doctor will regularly check that the medicine is working. You will also be given blood samples and weighed regularly.
Children and young people
Imatinib Sandoz is also a treatment for children with CML. There is no experience from children with CML under 2 years. There is limited experience from children with Ph-positive ALL and very limited experience from children with MDS / MPD, DFSP, and HES / CEL.
Some children and adolescents taking Imatinib Sandoz may grow more slowly than usual. The doctor will regularly check the growth.
Other medicines and Imatinib Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription (eg paracetamol ) and herbal medicines (eg St. John’s wort ). Some medicines may affect the effect of Imatinib Sandoz when taken together. They may increase or decrease the effect of Imatinib Sandoz and either leads to more side effects or make Imatinib Sandoz less effective. Imatinib Sandoz can do the same for some other medicines.
Tell your doctor if you are taking medicines that prevent blood clots from forming.
Pregnancy, breastfeeding 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 using this medicine.
- Imatinib Sandoz is not recommended during pregnancy unless it is necessary as it may harm your baby. Your doctor will discuss the possible risks of taking Imatinib Sandoz during pregnancy.
- Women who may become pregnant are advised to use effective contraception during treatment and for 15 days after stopping treatment.
- Do not breast-feed during treatment with Imatinib Sandoz and for 15 days after stopping treatment as it may be harmful to your baby.
- Patients who are concerned about their fertility when taking Imatinib Sandoz are advised to consult their doctor.
Driving and using machines
You may feel dizzy or tired or have blurred vision when using this medicine. If this happens, do not drive or use any tools or machines until you feel well again.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to take Imatinib Sandoz
Your doctor has prescribed Imatinib Sandoz because you are suffering from a serious illness. Imatinib Sandoz can help you fight this condition.
Always take this medicine exactly as your doctor or pharmacist has told you. You must do this as long as your doctor or pharmacist tells you to. Ask your doctor or pharmacist if you are unsure.
Do not stop taking Imatinib Sandoz unless your doctor tells you to. If you can not take the medicine according to your doctor’s prescription or if you feel that you do not need it anymore, contact your doctor immediately.
How much Imatinib Sandoz to take?
A U SE adult
Your doctor will tell you exactly how many Imatinib Sandoz tablets to take.
- If you are being treated for KML:Depending on your condition, the usual starting dose is either 400 mg or 600 mg:Imatinib Sandoz 100 mg :
- 400 mg to be taken as 4 tablets a once a day
- 600 mg taken as 6 tablets once a day
- 400 mg taken as a tablet once a day
- 600 mg taken as a tablet of 400 mg plus half a tablet of 400 mg (or 2 tablets of 100 mg) a go ng day
When treating CML, your doctor may prescribe a higher or lower dose depending on how you respond to the treatment.
Imatinib Sandoz 100 mg: If your daily dose is 800 mg (8 tablets), take 4 tablets in the morning and 4 tablets in the evening.
Imatinib Sandoz 400 mg: If your daily dose is 800 mg (2 tablets), take one tablet in the morning and one tablet in the evening.
- If you are being treated for Ph -positive ALL:Imatinib Sandoz 100 mg : The starting dose is 600 mg taken as 6 tablets once a day.Imatinib Sandoz 400 mg : The starting dose is 600 mg administered as one tablet of 400 mg plus half a tablet of 400 mg (or 2 tablets of 100 mg) a g steam day.
- If you are being treated for MDS / MPD:Imatinib Sandoz 100 mg : The starting dose is 400 mg to be taken as 4 tablets a once a day.Imatinib Sandoz 400 mg : The starting dose is 400 mg taken as a tablet ag steam per day.
- O m you Behan training covers f ear HE S / CEL :Imatinib Sandoz 100 mg : The starting dose is 100 mg taken as a tablet a g steam day. Your doctor may decide to increase the dose of one 400 mg to be taken as 4 tablets a g steam daily, depending on how you respond to treatment.Imatinib Sandoz 400 mg : The starting dose is 100 mg taken as a 1 tablet of 100 mg, a g steam day. Your doctor may decide to increase the dose of one 400 mg taken as one 400 mg tablet a g steam daily, depending on how you respond to treatment.
- O m you behan training covers f ear DF SP :Imatinib Sandoz 100 mg : The dose is 800 mg a day (8 tablets) taken as 4 tablets in the morning and 4 tablets in the evening.Imatinib Sandoz 400 mg : The dose is 800 mg a day (2 tablets) taken as one tablet in the morning and one tablet in the evening.
Use for children and adolescents
Your doctor will tell you how many Imatinib Sandoz tablets to give to your child. The amount of Imatinib Sandoz given depends on your baby’s condition, body weight, and height. The total daily dose for children should not exceed 800 mg for CML and 600 mg for Ph-positive ALL. The treatment can either be given to your child as a single dose per day or the daily dose can be given on two different occasions (half in the morning and a half in the evening).
The tablets can be divided into two equal doses.
N is and how to take Imatinib Sandoz?
- Take Imatinib Sandoz with a meal. It helps to protect against stomach problems when you take Imatinib Sandoz.
- Swallow the tablets whole with a large glass of water.
If you can not swallow the tablets, you can dissolve them in a glass of non-carbonated water or apple juice:
- Imatinib Sandoz 100 mg : Use approximately 50 ml of liquid for each 100 mg tablet.
- Imatinib Sandoz 400 mg : Use approximately 200 ml of liquid for each 400 mg tablet or 100 ml of liquid for half a 400 mg tablet.
- Stir with a spoon until the tablets have completely dissolved.
- Once the tablet has dissolved, immediately drink the entire contents of the glass. Residues of the dissolved tablets may remain in the glass.
How long to take Imatinib Sandoz?
Continue to take Imatinib Sandoz every day for as long as your doctor tells you to.
If you take more Imatinib Sandoz than you should
If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for assessment of the risk and advice. Take the medicine pack with you.
If you forget to take Imatinib Sandoz
- If you forget to take a dose , take it as soon as you remember. However, skip the missed dose if it is soon time to take the next dose .
- Then continue with your normal schedule.
- Do not take a double dose to make up for a forgotten dose .
If you have any further questions on the use of this product, 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 of mild to moderate severity.
V in ssa side effect is potentially serious. Tell your doctor immediately if you get any of the following:
Very common (may affect more than 1 user in 10) or common (may affect up to 1 user in 10):
- rapid weight gain. Imatinib Sandoz can cause your body to bind water (severe fluid retention ).
- signs of infection , e.g. fever, severe chills, sore throat or sore mouth. Imatinib Sandoz can reduce the number of white blood cells so that you can get infected more easily .
- sudden bleeding or bruising (when you have not injured yourself).
Uncommon (may affect up to 1 in 100 users) or rare (may affect up to 1 in 1,000 users):
- chest pain, irregular heartbeat (signs of heart problems)
- cough, difficulty breathing or painful breathing (signs of lung problems)
- feel dizzy, dizzy or fainting (signs of low blood pressure )
- nausea, decreased appetite, dark urine, yellowing of the skin or eyes (signs of liver problems)
- skin rash, redness with blisters on lips, eyes, skin or mouth, flaking of the skin, fever, raised red or purple skin areas, itching , burning sensation, rash with small blisters (signs of skin problems)
- severe abdominal pain, vomiting blood, stools or urine, black stools (signs of gastrointestinal disease)
- severe urinary incontinence, thirst (signs of kidney problems)
- nausea, with diarrhea and vomiting, abdominal pain or fever (signs of intestinal problems)
- severe headache, weakness or paralysis of the arms, legs or face, difficulty speaking, sudden unconsciousness (signs of nervous system problems such as bleeding or swelling of the skull / brain)
- pallor, fatigue and shortness of breath with dark urine (signs of low level of red blood cells )
- eye pain or impaired vision, bleeding in the eyes
- pain in the 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 cellulite )
- impaired hearing
- muscle weakness and muscle cramps with abnormal heart rhythm (signs that indicate changes in the amount of potassium in your blood)
- bruises
- abdominal pain, with nausea
- muscle cramps, with 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, dizziness or fainting due to low blood pressure (signs of ovarian or uterine problems)
- nausea, shortness of breath, irregular heartbeat, cloudy urine, fatigue and / or joint problems associated with abnormal laboratory values (eg high potassium , uric acid and calcium levels, and low phosphate levels in the blood)
- blood clots in small blood vessels (thrombotic microangiopathy).
H is reported (affecting an unknown number of users):
- combination of severe skin rash, nausea, fever, high levels of certain white blood cells or yellow skin or eyes (signs of jaundice) with shortness of breath, chest pain / discomfort, greatly reduced urine production and feeling of thirst, etc. (signs of treatment-related allergic reaction)
- chronic renal failure
- recurrence (reactivation) of hepatitis B infection when you have previously had hepatitis B (a liver infection).
Tell your doctor immediately if you get any of the above.
A change side effects may include:
Very common (may affect more than 1 user in 10):
- headache or fatigue
- nausea, vomiting, diarrhea or indigestion
- rash
- muscle cramps or pain in joints, muscles or bones during treatment with Imatinib Sandoz or after stopping Imatinib Sandoz
- swelling around joints or swollen eyes
- weight gain.
Tell your doctor if any of these affect you seriously.
V anliga (may affect up to 1 in 10):
- decreased appetite, weight loss or taste disorders
- dizziness or weakness
- sleep problems ( insomnia )
- watery eyes with itching , redness and swelling (conjunctivitis), watery eyes or blurred vision
- nosebleed
- abdominal pain or distended abdomen, flatulence, heartburn, constipation
- itching
- unexpectedly heavy hair loss or thinning of the hair
- numbness in the hands and feet
- sores in the mouth
- joint pain with swelling
- dry mouth , dry skin or dry eyes
- decreased or increased sensitivity of the skin
- hot flashes, chills or night sweats.
Tell your doctor if any of these affect you seriously.
H is reported (affecting the unknown number of users):
- redness and / or swelling in the palms and soles of the feet which may be accompanied by a stinging sensation or burning pain
- painful changes in the skin with or without blisters
- slow growth in children and adolescents.
Tell your doctor if any of these affect you seriously.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Imatinib Sandoz
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 blister or carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C. Store in the original package. Moisture sensitive.
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.
6. Contents of the packaging and other information
Content declaration
- The active substance is imatinib mesilate.
Each film-coated tablet contains 100 mg imatinib (as mesilate).
Each film-coated tablet contains 400 mg imatinib (as mesilate).
- Other excipients in the tablet core are microcrystalline cellulose, crospovidone (type A), hypromellose, magnesium stearate, anhydrous colloidal silica.
- Other excipients in the film coating of the tablet are red iron oxide (E 172), yellow iron oxide (E 172), macrogol 4000, talc, hypromellose.
What the medicine looks like and contents of the pack
Imatinib Sandoz 100 mg: Very dark yellow or brown-orange, round, biconvex film-coated tablet with bevelled edges, diameter approximately 9.2 mm. The tablet is marked with “NVR” on one side and the other side with the letters “S” and “A” on each side of the breaker notch.
Imatinib Sandoz 400 mg: Very dark yellow or brown-orange, oval, biconvex film-coated tablet with bevelled edges, approximately 19.2 mm long and approximately 7.7 mm wide. The tablet is marked with “400” on one side and the other side with the letters “S” and “L” on each side of the notch.
Imatinib Sandoz 100 mg: The tablets are packaged in PVC / aluminum or PVC / PE / PVDC / aluminum blisters and placed in a carton, in pack sizes of 20, 30, 50, 60, 80, 90, and 120 film-coated tablets.
Imatinib Sandoz 400 mg: The tablets are packaged in PVC / PE / PVDC / aluminum blisters and placed in a carton, in pack sizes of 10, 30, 50, 60, 80, and 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Lek Pharmaceuticals dd, Verovškova ulica 57, 1526 Ljubljana, Slovenia
or
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
Lek Pharmaceuticals dd, Trimlini 2D, 9220 Lendava, Slovenia