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Glivec 100mg. 120 tablets

Brand: NOVARTIS
Product Code: Glivec 100mg. 120 tablets
Availability: In Stock
Product viewed: 712

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What Glivec is and what it is used for
Glivec is a medicine that contains an active substance called imatinib. This drug works by suppressing the growth of abnormal cells in the following diseases involving several types of cancer.

Glivec is used to treat children and adults in:
Chronic Myeloid Leukemia (CML). Leukemia is a white blood cell cancer. Usually, these white cells help the body fight infections. Chronic myeloid leukemia is a type of leukemia in which certain, other than normal, white blood cells (called myeloid cells) begin to proliferate uncontrollably;
Positive Philadelphia chromosome acute lymphoblastic leukemia (Ph-positive ALL). Leukemia is a white blood cell cancer. Usually, these white cells help the body fight infections. Acute lymphoblastic leukemia is a type of leukemia in which certain non-normal white blood cells (called lymphoblasts) begin to proliferate uncontrollably. Glivec suppresses the growth of these cells.
Glivec is also used to treat adults when:
Myelodysplastic syndrome / myeloproliferative diseases (MDS / MIP). These are a group of blood disorders in which some blood cells begin to multiply uncontrollably. Glivec suppresses the growth of these cells in some subtypes of these diseases;
Hyperreosinophilic syndrome (HES) and / or chronic eosinophilic leukemia (HEL). These are diseases of the blood where some cells (called eosinophils) begin to multiply uncontrollably. Glivec suppresses the growth of these cells in some subtypes of these diseases;
Gastrointestinal stromal tumors (GIST). GIST is a cancer of the stomach and intestine. It stems from the uncontrolled cell growth of the supporting tissues of these organs;
Dermatofibrosarcoma protruberans (DFSP). DFSP is a cancer of the tissues under the skin, in which some cells start uncontrollable growth. Glivec suppresses the growth of these cells.
In the rest of this leaflet, we will use the abbreviations when talking about the diseases involved.

If you have any questions about how Glivec works or why you are prescribed this medicine, ask your doctor.

2. What you need to know before you take Glivec
Glivec will be prescribed by a doctor who has experience in the treatment of cancer of the blood or solid tumors.
Carefully follow all the instructions of the physician, even if they differ from the information contained in this leaflet.

Do not take Glivec:
if you are allergic to imatinib or any of the other ingredients of this medicine (listed in section 6).
If the above applies to you, tell your doctor without taking Glivec.
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 Glivec:
if you have or have ever had problems with the liver, kidneys or heart;
if you take the medicine levothyroxine due to thyroid removal.
If any of the above applies to you, tell your doctor before taking Glivec.

During treatment with Glivec, tell your doctor immediately if you start to gain weight quickly. Glivec may cause water retention in the body (severe fluid retention).
While you are taking Glivec, your doctor will check your condition regularly to see if the medicine works. In addition, you will be given blood tests and your bodyweight will be measured regularly.

Children and adolescents
Glivec is also a medicine for the treatment of children with CML. There is no experience in children with CML less than 2 years of age. There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS / MPH, DFSP, GIST and HES / HEL.
Some growth hormone deficiency may occur in some children and adolescents taking Glivec. The treating physician will monitor the growth during regular visits.
Other medicines and Glivec
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), including herbal medicines (such as St. John's Wort). Some medicines may affect the effect of Glivec when taken at the same time. They may increase or decrease the effect of Glivec by increasing the side effects or making Glivec less effective. Glivec may have the same effect on some other medicinal products.

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

Pregnancy, breastfeeding and fertility
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, talk to your doctor before taking this medicine;
Glivec is not recommended during pregnancy unless clearly necessary because it may harm your baby. Your doctor will discuss with you the potential risks of taking Glivec during pregnancy;
Women who are likely to become pregnant are advised to use effective methods to prevent pregnancy during treatment;
Do not breast-feed during treatment with Glivec;
Patients who worry about their fertility when taking Glivec are advised to consult with their treating physician.
Driving and using machines
You may experience dizziness or drowsiness or blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines until you feel good again.

3. How to take Glivec
Your doctor has prescribed Glivec because you suffer from a serious illness. Glivec can help you fight this disease.
Therefore, always take this medicine exactly as your doctor or pharmacist has told you. It is important to do so for as long as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Do not stop taking Glivec until your doctor tells you to. If you are unable to take your medicine as your doctor has told you or you feel you no longer need it, contact your doctor immediately.

How much to take Glivec
Use in adults
Your doctor will tell you exactly how many Glivec capsules to take.
If you are being treated for CML:
Depending on your condition, the usual starting dose is 400 mg or 600 mg:
400 mg, which are taken as 4 capsules once a day;
600 mg, which is taken as 6 capsules once a day.
If you are being treated for GIST:
The starting dose is 400 mg, which is taken as 4 capsules once a day.
For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to treatment. If your dose is 800 mg (8 capsules), you should take 4 capsules in the morning and 4 capsules in the evening.

If you are being treated for Ph-positive ALL:
The starting dose is 600 mg, which is taken as 6 capsules once a day.
If you are being treated for MDS / MRL:
The starting dose is 400 mg, which is taken as 4 capsules once a day.
If you are being treated for HES / HEL:
The starting dose is 100 mg, which is taken as one capsule once a day. Your doctor may decide to increase the dose of 400 mg, which is taken as 4 capsules once a day, depending on how you respond to treatment.
If you are being treated for a DFSP:
The 800 mg dose (8 capsules) should be taken as 4 capsules in the morning and 4 capsules in the evening.
Use in children and adolescents
Your doctor will tell you how many Glivec capsules you should give your child. The amount of Glivec will depend on your child's condition, weight and height. The total daily dose in children should not exceed 800 mg for CML and 600 mg for Ph-positive ALL. Treatment may be given as a single daily dose or, alternatively, the daily dose may be divided into two intakes (half the dose in the morning and half in the evening).

When and how to take Glivec
Take Glivec while on meals. This will help you protect yourself from stomach problems while taking Glivec;
Swallow the capsules whole with a full glass of water. Do not open or crush the capsules unless you have difficulty swallowing them (eg in children);
If you can not swallow the capsules, you can open them and pour their contents into a glass of non-carbonated water or apple juice;
If you are a woman who is pregnant or can become pregnant and trying to open the capsules, you should do so with caution to avoid skin and eye contact or inhalation. You should immediately wash your hands after opening the capsules.
How long to take Glivec
Take Glivec every day for as long as your doctor tells you.

If you take more Glivec than you should
If you accidentally take more capsules, tell your doctor straight away. Medical intervention may be necessary. Take the medicine pack with you.
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 everyone gets them. They are usually mild to moderate.

Some side effects can be serious. Tell your doctor immediately if you experience 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. Glivec may cause water retention in the body (severe fluid retention);
Signs of infection such as fever, severe chills, sore throat or mouth sores. Glivec may lead to a decrease in white blood cell count and thus make you more susceptible to infections;
Unexpected bleeding or bruising (without hurting).
Uncommon (may affect up to 1 in 100 people) or rare (may affect up to 1 in 1,000 people):
Chest pain, abnormal heart rhythm (signs of heart problems);
Cough, difficulty breathing or breathing pain (signs of lung problems);
Feeling dizzy, dizzy or faint (signs of low blood pressure);
Nausea (feeling sick), loss of appetite, dark coloration of the urine, yellowing of the skin or eyes (signs of liver problems);
Rash, blistering of the lips, eyes, skin or mouth, scaling, fever, raised red or purple skin patches, itching, burning sensation, purulent eruption (signs of skin problems);
Stomach pain in the abdomen, blood in your poisoned fabrics, stools or urine, black stools (signs of gastrointestinal disorders);
Severe decrease in urine output, feeling thirsty (signs of kidney problems);
Nausea (vomiting) with diarrhea and vomiting, abdominal pain or fever (signs of intestinal problems);
Severe headache, weakness or paralysis of the limbs or face, difficulty in speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or intracranial / cerebral edema);
Pale skin, tiredness and difficulty in breathing, darkening of the urine (signs of decreased red blood cell count);
Pain in the eyes or worsening of eyesight, bleeding in the eyes;
Hip pain or difficulty walking;
Numb or cold toes and hands (signs of Raynaud's syndrome);
Sudden swelling and redness of the skin (signs of a skin infection called cellulitis);
Decreased hearing;
Muscle weakness and cramps with impaired heart rhythm (signs of change in the amount of potassium in the blood);
Bruising;
Stomach pain with nausea (elevation);
Muscle spasms with fever, red-brown urine coloring, muscle pain or weakness (signs of muscle problems);
Pelvic pain, sometimes accompanied by nausea and vomiting, unexplained bleeding from the vagina, feeling dizzy or faint due to a fall in blood pressure (signs of ovarian or uterine problems);
Nausea, shortness of breath, irregular heart rhythm, urinary incontinence, fatigue and / or discomfort in joints associated with laboratory abnormalities (eg high levels of potassium, uric acid and calcium and low levels of phosphorus in the blood).
Not known (frequency can not be estimated from the available data):
Combination of widespread severe rash, nausea, fever, increased number of white blood cells or yellowing of the skin or eyes (signs of jaundice) with shortness of breath, chest pain / discomfort, severe decrease in urine output, thirst, n. (signs of a treatment-related allergic reaction).
If you get any of the side effects listed above, tell your doctor immediately.

Other side effects may include:
Very common (may affect more than 1 in 10 people):
Headache or feeling tired;
Nausea (vomiting), vomiting, diarrhea or indigestion;
Rash;
Muscle spasms or pains in the joints, muscles or bones;
Ankle rush or puffiness of the eyelids;
Weight gain.
If any of these reactions affect you seriously, tell your doctor.

Common (may affect up to 1 in 10 people):
Anorexia, weight loss or taste disturbances;
Feeling dizzy or weak;
Sleep disorder (insomnia);
Wrinkles from the eye with itching, redness and edema (conjunctivitis), eye irritation or blurred vision;
Bleeding from the nose;
Pain or swelling of the abdomen, gas, heartburn or constipation;
Pruritus
Unclear hair loss or thinning of hair;
Tingling of the hands from the wrist down or the feet;
Mouthwashes in the mouth;
Pain and swelling of the joints;
Dry mouth, dry skin, dry eyes;
Reduced or increased sensitivity of the skin;
Hot waves, chills or night sweats.
If any of these reactions affect you seriously
Not known (frequency can not be estimated from the available data):
Flushing and / or swelling of the palms of the hands and the lower part of the foot, which may be accompanied by tingling or burning pain;
Growth retardation in children and adolescents.
If any of these reactions affect you seriously, tell your doctor.
Reporting of side effects
If any of the side effects gets serious, tell your doctor, pharmacist or nurse. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information on the safety of this medicine.

5. How to store Glivec
Keep out of the reach and sight 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 packages that are damaged or have signs of tampering.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information
What Glivec contains
The active substance is imatinib mesylate. Each Glivec capsule contains 100 mg imatinib mesylate.
The other ingredients are: microcrystalline cellulose, crospovidone, magnesium stearate and colloidal anhydrous silica. The capsule is composed of gelatin, red iron oxide (E172), yellow iron oxide (E172) and titanium dioxide (E171). The ink is composed of red iron oxide (E172) and shellac.

What Glivec looks like and contents of the pack
Glivec 100 mg capsules are orange to gray-orange and marked with "NVR SI". They contain white to yellow powder.
Available in packs containing 24, 48, 96, 120 or 180 capsules, but they may not be available in your country.

 

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