100 mg hard capsules
imatinib

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask <doctor> <,> <or> <pharmacy staff> <or nurse>.

– <This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours

– If you get any side effects , talk to <doctor> <,> <or> <pharmacist> <or nurse>. This also applies to any side effects not mentioned in this information. See section 4

In this leaflet you will find information about:
1. What Imatinib Cipla is and what it is used for
2. What you need to know before you use Imatinib Cipla
3. How to use Imatinib Cipla
4. Possible side effects
5. How to store Imatinib Cipla 6. Contents of the pack
and other information

What Imatinib Cipla is and what it is used for

Imatinib Cipla is a medicine that contains an active substance called imatinib. The drug acts by inhibiting the growth of abnormal cells in the diseases listed below. These include certain types of cancer.

Imatinib Cipla is a medicine that contains an active substance called imatinib. The drug acts by inhibiting the growth of abnormal cells in the diseases listed below. These include certain types of cancer.

Imatinib Cipla is a treatment for adults and children for:

  • Chronic myeloid 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, immature white blood cells (so-called lymphoblasts ) begin to grow out of control. Imatinib Cipla inhibits the growth of these cells.

Imatinib Cipla 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 Cipla inhibits the growth of these cells in a certain subset of these diseases.

  • Hypereosinophilic 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 Cipla inhibits the growth of these cells in a certain subset of these diseases.
  • Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue under the skin in which certain cells begin to grow out of control. Imatinib Cipla 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 Cipla may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions and always follow their instructions

What you need to know before you use Imatinib Cipla

Do not use Imatinib Cipla

Imatinib Cipla will only be prescribed to you by a doctor with medical experience in treating different types of blood cancers or solid tumors.

Follow all of your doctor’s instructions carefully, although these may differ from the general information in this leaflet.

Do not take Imatinib Cipla:

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

If this applies to you, do not take Imatinib Cipla but tell your doctor.

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

Warnings and cautions

Talk to your doctor before taking Imatinib Cipla:

  • if you have or have had a liver, kidney or heart disease.
  • if you are taking the medicine levothyroxine because your thyroid has been removed.
  • if you have ever had or may now have a hepatitis B infection . The reason for this is that Imatinib Cipla can cause your hepatitis B to become active again, which in some cases can be fatal. Patients will be closely monitored by their physician for signs of this infection before starting treatment.

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

When taking Imatinib Cipla, tell your doctor immediately if you gain weight quickly. Imatinib Cipla can cause your body to bind fluid (severe fluid retention ).

When you take Imatinib Cipla, 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 Cipla is also a treatment for children with CML. There is no experience in children with CML under 2 years of age and in children under 1 year of age with Ph-positive ALL. Experience is very limited for children with MDS / MPD, DFSP, and HES / CEL.

Some children and adolescents taking Imatinib Cipla may grow more slowly than usual. Your doctor will regularly check your growth.

Other medicines and Imatinib Cipla

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 Cipla when taken together.

They may increase or decrease the effect of Imatinib Cipla and either leads to more side effects or make Imatinib Cipla less effective. Imatinib Cipla can do the same for some other medicines.

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

Pregnancy, breastfeeding and fertility

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 Cipla 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 Cipla during pregnancy.
  • Women who may become pregnant are advised to use effective contraception during treatment.
  • Do not breast-feed during treatment with Imatinib Cipla.
  • Patients who are concerned about their fertility when taking Imatinib Cipla 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.

Imatinib Cipla contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine

Imatinib Cipla contains This medicine is subject to extended monitoring. This will make it possible to quickly identify new security information. You can help by reporting any side effects you may have. Information on how to report side effects can be found at the end of section 4.

How to use Imatinib Cipla

Your doctor has prescribed Imatinib Cipla because you are suffering from a serious illness. Imatinib Cipla can help you fight this condition.

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. Ask your doctor or pharmacist if you are unsure.

Do not stop taking Imatinib Cipla 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 Cipla to take?

The recommended dose is:

Use for adults

If you are being treated for CML:
Depending on your condition, the usual starting dose is either 400 mg or 600 mg:
– 400 mg taken as 4 capsules once a day.
– 600 mg taken as 6 capsules once a day.

– If you are being treated for Ph-positive ALL: The
the starting dose is 600 mg taken as 6 capsules once daily.

– If you are being treated for MDS / MPD: The
the starting dose is 400 mg taken as 4 capsules once a day.

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

– If you are being treated for DFSP:
Dose one is 800 mg per day (8 capsules), to be taken as 4 capsules in the morning and 4 capsules in the evening.

Use for children and adolescents

Your doctor will tell you how many Imatinib Cipla capsules to give to your child. The amount of Imatinib Cipla given depends on your baby’s condition, body weight, and height. The total 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 or alternatively the daily dose can be given on two different occasions (half in the morning and a half in the evening).

When and how to take Imatinib Cipla

  • Take Imatinib Cipla with a meal. It helps to protect against stomach problems when you take Imatinib Cipla.
  • Swallow the capsules whole with a large glass of water. Do not open or crush the capsules, unless you have difficulty swallowing (eg in children).
  • If you can not swallow the capsules, you can open them and pour the powder into a glass of non-carbonated water or apple juice.
  • If you are a woman of childbearing potential trying to open the capsules, be careful to handle the contents carefully and avoid skin or eye contact or inhalation. Hands should be washed immediately after handling opened capsules.

How long to take Imatinib Cipla?

Continue to take Imatinib Cipla every day for as long as your doctor tells you to.

If you take more Imatinib Cipla then you should

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Contact your doctor immediately if you have accidentally taken too many capsules. You may need medical attention. Take the medicine pack with you.

If you use more Imatinib Cipla than you should  

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Contact your doctor immediately if you have accidentally taken too many capsules. You may need medical attention. Take the medicine pack with you.

If you forget to use Imatinib Cipla

  • 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.

Some side effects can be serious. Tell your doctor immediately 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 Cipla can make your body bind water (severe fluid retention ).
  • Signs of infection , e.g. fever, frostbite, sore throat or sore mouth. Imatinib Cipla can reduce the number of white blood cells so that you can get infected more easily .
  • Sudden bleeding or sores (when you have not injured yourself).

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

  • Chest pain, irregular heartbeat (signs of heart problems).
  • Cough, difficulty breathing or painful breathing (signs of lung problems).
  • Feeling dizzy, dizzy or fainting (signs of low blood pressure ).
  • Nausea, with 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, blood in vomit, stool or urine, black stools (signs of gastrointestinal disease).
  • Severe decreased urine output, 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 legs or face, difficulty speaking, sudden unconsciousness (signs of nervous system problems such as bleeding or swelling of the skull / brain).
  • Paleness, 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 ).
  • Hearing difficulties.
  • Muscle weakness and muscle cramps with abnormal heart rhythm (signs that indicate changes in the amount of potassium in your blood).
  • Bruises.
  • Stomach 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 / low potassium levels, high uric acid and calcium levels, and low phosphorus levels in the blood).

Has been reported (occurs in 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
  • Inflammation of the pericardium (pericarditis). This can manifest itself as chest pain that varies with each breath. The pain often increases when you lie down and decreases when you sit up. Fever, cough and palpitations are also common symptoms. The condition can be serious and require medical intervention.
  • Cardiac perforation is caused by the accumulation of blood, fluid, warts, clots or gas in the pericardium, which leads to reduced ventricular filling and subsequent effects on blood circulation. Cardiac tamponade is a medical emergency.
  • Extensive skin peeling ( toxic epidermal necrolysis ) or widespread rash affecting blood, liver and other organs (drug- related rash with eosinophilia and systemic symptoms)
  • Recurrence (reactivation) of hepatitis B infection when you have previously had hepatitis B (a liver infection).
  • Bleeding in the eye (vitreous hemorrhage)
  • Blood clots, usually in the bone, which cause pain, swelling and redness ( thrombosis )
  • Respiratory failure, occurs when oxygenation in the respiratory system does not work ( acute respiratory failure).
  • Pneumonia that can cause shortness of breath and difficulty breathing (interstitial lung disease).
  • Tissue death (avascular necrosis )
  • Bleeding in the gastrointestinal tract ( antral love eczema)

Tell your doctor immediately if you get any of the above.

Other side effects may include:

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

  • Headache or fatigue.
  • Nausea, vomiting, diarrhea or indigestion.
  • Rash.
  • Muscle cramps or pain in joints, muscles or bones during treatment or after stopping Imatinib Cipla.
  • Swelling around joints or swollen eyes.
  • Weight gain.

Tell your doctor if any of these affect you seriously.

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

  • Decreased appetite, weight loss or taste disorders.
  • Dizziness or weakness.
  • Sleep problems ( insomnia ).
  • Runny 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 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.

Has been reported (occurs in an 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.
  • Slow growth in children and adolescents.

Tell your doctor if any of these affect you seriously.

Reporting of side effects ar

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 via

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

By reporting side effects, you can help increase the safety of medicines.

5. How to store Imatinib Cipla

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 expiration date is the last day of the specified month.

Do not store above 25 ° C. Store in the original package. Moisture sensitive.

Do not use if any packaging is damaged or shows signs of having been opened or otherwise handled improperly.

Medicines should 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

Contents of the packaging and other information

Content declaration

  • The active substance is imatinib. Each capsule contains 100 mg of imatinib (as mesilate).
  • The other ingredients are anhydrous lactose , crospovidone (type B), colloidal anhydrous silica and magnesium stearate.
  • The capsule shell contains gelatin, red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171) and sodium lauryl sulphate.

What the medicine looks like and the contents of the pack

Imatinib Cipla 100 mg size 3 hard gelatin capsules filled with light yellow granules, brown top, and white body.

Capsule length: 15.8 mm.

Blisters of PVC / PE / PVDC aluminum

Packed in 20, 60, 120, or 180 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Cipla Europe NV

De Keyserlei 58-60, Box-19,

2018 Antwerp,

Belgium

Manufacturer:

S&D Pharma CZ, spol. s ro

Theodor 28

273 08 Pchery (Pharmos as a facility)

Czech Republic

Cipla (EU) Limited

Dixcart House, Addlestone Road,

Bourne Business Park, Addlestone,

Surrey, KT15 2LE,

UK

Cipla Europe NV

De Keyserlei 58-60, Box-19,

2018 Antwerp,

Belgium

Pharmadox Healthcare Limited

KW20A Corradino Industrial Estate

Paola PLA 3000

Malta

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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