Consumer medicine information

Imatinib GH

Imatinib GH

Active ingredient(s): Imatinib mesilate


Consumer Medicine Information (CMI)

This leaflet provides important information about using Imatinib GH. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Imatinib GH.

Where to find information in this leaflet:

1. Why am I using Imatinib GH?
2. What should I know before I use Imatinib GH?
3. What if I am taking other medicines?
4. How do I use Imatinib GH?
5. What should I know while using Imatinib GH?
6. Are there any side effects?
7. Product details

1. Why am I using Imatinib GH?

Imatinib GH contains the active ingredient Imatinib mesilate. Imatinib GH belongs to a group of anti-cancer medicines known as tyrosine kinase inhibitors.

Imatinib GH is used to treat adults who have certain types of cancer and leukemia, including chronic myeloid leukemia (CML) and acute lymphoblastic leukemia with Philadelphia chromosome positive (Ph-positive ALL).

Imatinib GH is also used to treat adults for:

  • Myelodysplastic / myeloproliferative diseases (MDS/MPD). These are a group of blood diseases in which some blood cells start growing out of control.
  • Aggressive systemic mastocytosis (ASM). It is a cancer in which certain blood cells, called “mast” cells, grow out of control.
  • 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.
  • Gastro-intestinal stromal tumours (GIST). This is a type of cancer of the stomach and bowels. This cancer affects the tissue that surrounds the stomach and bowels and the cells grow uncontrollably.
  • Dermatofibrosarcoma protuberans (DFSP). DFSP is a cancer of the tissue beneath the skin in which some cells start growing out of control.

Imatinib GH works by slowing the growth of and killing cancer cells while leaving normal cells alone.

2. What should I know before I use Imatinib GH?

Warnings

Do not use Imatinib GH if:

  • you are allergic to imatinib, or any of the ingredients listed at the end of this leaflet.

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

If you experience an allergic reaction, stop using the medicine and inform your doctor or pharmacist immediately.

  • Some of the symptoms of an allergic reaction may include
    – shortness of breath, wheezing or difficulty breathing;
    – swelling of the face, lips, tongue or other parts of the body;
    – rash, itching or hives on the skin.
  • you have the rare hereditary problems of glucose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption as Imatinib GH contains lactose

Check with your doctor if you:

  • have any other medical conditions
  • take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

This medicine may be harmful to your unborn baby. If it is necessary for you to take it during pregnancy, your doctor will let you know.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

It is not known if the active ingredient, imatinib, passes into the breast milk. Breastfeeding is not recommended because this medicine could affect your baby.

Tell your doctor if you have ever had any of the following medical problems or procedures:

  • kidney or liver problems
  • problems with your heart
  • you have had your thyroid gland removed
  • hepatitis B infection. As during treatment with Imatinib GH, hepatitis B may become active again.

Your doctor may want to take special precautions in this case.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Imatinib GH and affect how it works. These include many medicines that are eliminated from the body through the liver e.g.

  • St. John’s wort, a herbal medicine found in many products that you can buy without a prescription
  • paracetamol, a medicine found in many common pain relievers and cold remedies (e.g. Panadol®, Panadeine®, Codral®, Tylenol®) which are known to be associated with liver toxicity.
  • antibiotic medicines such as rifampicin, ketoconazole, erythromycin, clarithromycin, itraconazole
  • antiviral medicines used to treat HIV/AIDS
  • dexamethasone, a steroid medicine
  • medicines for high cholesterol, such as simvastatin
  • medicines used to treat epilepsy, such as phenytoin, carbamazepine, phenobarbitone
  • warfarin, a medicine used to prevent blood clots
  • some medicines used to treat mental disorders and depression
  • some medicines used to treat high blood pressure and heart problems
  • cyclosporine

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Imatinib GH.

4. How do I use Imatinib GH?

How much to take

  • Your doctor will tell you exactly how many tablets of Imatinib GH to take
  • Do not exceed the recommended dose prescribed by your doctor
  • Follow the instructions provided and use Imatinib GH until your doctor tells you to stop
  • Your doctor may direct you to take a higher or lower dose or stop treatment depending on how your body responds to Imatinib GH.
  • Imatinib GH is usually taken as a single dose each day.
    However, your doctor may want you to take them in two doses, one in the morning and one in the evening

When to take Imatinib GH

Take Imatinib GH every day; at the same time, with water and food for as long as your doctor recommends.

How to take Imatinib GH

  • Take the medicine with a large glass of water and food. This will help avoid stomach irritation
  • If you are unable to swallow the capsules
    – you can open the capsule and pour the powder capsule contents into a glass of still water or apple juice (approximately 50 mL for 100 mg capsule or 200 mL for 400 mg capsule)
    – Stir with a spoon to complete mixing of the capsule
    – Drink immediately

If you forget to use Imatinib GH

Imatinib GH should be taken regularly at the same time each day. If you miss your dose at the usual time, take the missed dose as soon as you remember, then continue with your normal schedule

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you take too much Imatinib GH

If you think that you have taken too much Imatinib GH, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Imatinib GH?

Things you should do

Make sure you follow your doctor’s instructions carefully and keep all appointments.

You will need regular check-up to make sure the treatment is working. Regular blood tests, weight checks and urine tests can also find side effects before they become serious.

Use a method of contraception to prevent pregnancy during treatment and for 15 days after ending treatment.

Some children taking Imatinib GH may have slower than normal growth. Growth will be monitored at regular visits by your doctor

Call your doctor straight away if you:

  • become pregnant or think you might be pregnant while you are taking this medicine.
  • Think you might be having an allergic reaction to Imatinib GH treatment

Remind any doctor, dentist or pharmacist you visit that you are using Imatinib GH.

Things you should not do

  • Do not stop using this medicine suddenly unless your doctor tells you to.
  • Do not give this medicine to anyone else even if they have the same condition as you.

Drinking grapefruit juice

Avoid drinking grapefruit juice while you are being treated with Imatinib GH. Grapefruit juice may interact with Imatinib GH and affect how your body uses this medicine.

Treating a headache, cold or other minor aches and Pains

Try to avoid taking medicines containing paracetamol (e.g. Panadol®, Panadeine®, Codral®, Tylenol®) to treat minor aches and pains. Ask your pharmacist to suggest an alternative medicine.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Imatinib GH affects you.

This medicine may cause dizziness, light-headedness or drowsiness in some people.

Wear sun protection when outdoors

When you are outdoors, wear protective clothing and use at least a 15+ sunscreen. Do not use a sunlamp or tanning beds.

This medicine may cause your skin to be much more sensitive to sunlight than it normally is.

Exposure to sunlight may cause a skin rash, itching, redness or severe sunburn. If your skin does appear to be burning, tell your doctor.

Drinking alcohol

Tell your doctor if you drink alcohol.

There are no known interactions of Imatinib GH with alcohol.

Looking after your medicine

  • Keep your medicine in the original container until it is time to take it.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary.

However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects What to do
Stomach problems:

  • indigestion, upset stomach, wind, feeling of bloating
  • nausea (feeling sick) or vomiting
  • diarrhoea, constipation

Skin problems:

  • rash, eczema, itching, dry skin, darkening or lightening of skin
  • symptoms of sunburn which happens more quickly than normal

General problems:

  • swelling of fingers, eyelids, face or lower legs due to fluid build up
  • dry mouth
  • swelling, aching, cramping or stiffness in joints or muscles
  • pain after stopping imatinib (including muscle, limb, joint, bone and back pain)
  • pain in the bones or along veins
  • headache, dizziness, light-headedness or vertigo (spinning sensation)
  • tiredness, weakness, feeling generally unwell
  • numbness, coldness or tingling in fingers and toes
  • difficulty sleeping, feeling anxious, depressed, confused or forgetful
  • change in sense of taste
  • irritated, red, runny or itchy eyes, blurred vision
  • ringing in the ears
  • changes in appetite and weight
  • hair loss
  • sweating during the night
  • throat pain
  • cough or cold symptoms
  • loss of interest in sex, problems with sexual function
  • breast enlargement, nipple pain, painful periods
  • 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
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects What to do
Chest problems:

  • severe allergic reaction that can result in difficulty breathing, dizziness.
  • cough, wheezing, pain in chest when breathing/difficult or painful breathing
  • muscle weakness, muscle spasms, abnormal heart rhythm
  • fever, tiredness, irregular heart beat
  • nausea, shortness of breath, clouding of urine, joint discomfort
  • crushing chest pain with fever. Tiredness

Stomach problems

  • severe abdominal pain, vomiting blood, black or bloody stools, swelling of the abdomen/fluid within the abdomen, constipation, stomach pain
  • nausea, diarrhoea, vomiting,

Skin problems:

  • weakness, spontaneous bleeding or bruising, frequent infections with signs such as fever, chills, swollen glands, sore throat or mouth ulcers
  • pale skin, tiredness, breathlessness, dark urine, yellowing of your skin or eyes.
  • severe rash, red skin, skin/lip/eye/mouth blisters, skin peeling, fever, red raised or purple skin patches, itching, burning, pustular eruption
  • inflammation of the skin caused by an infection
  • blisters on skin or mouth/nose/genitals

General problems:

  • rapid weight gain, noticeable swelling (legs, face)
  • pain in bone and joints
  • thirst, weight loss and severely decreased urine output
  • blood in the urine
  • nosebleeds or any other unusual bleeding
  • vision impairment, blurred vision, blood in eye
  • seizures (fits)
  • pelvic pain sometimes accompanied by nausea and vomiting, unexpected vaginal bleeding
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
  • muscle spasms, fever, red-brown urine, kidney disorders, pain or weakness in muscles
  • nausea, loss of appetite, dark-coloured urine or yellowing of your skin or eyes
  • Changes in urine or blood in urine, pain in the kidney area, tiredness, loss of appetite, nausea/vomiting, lack of concentration, headache, cramping, itching
  • nausea, diarrhoea, vomiting, abdominal pain, fever
  • severe skin rash, itching, hives, blisters or peeling skin, which may be accompanied by fever, chills, headache, swollen glands, stomach pain or aching joints and muscles
  • severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness
  • swelling and pain in one part of the body
  • severe headache, dizziness, blurred vision
  • fever, skin rash, joint pain and swelling as well as tiredness, loss of appetite, nausea, jaundice (yellowing of the skin), pain in the upper right abdomen, pale stools and dark urine
  • fatigue, dizziness, shortness of breath, bruises, gum/nose bleeds, minor cuts that bleed a lot, confusion, sleepiness, seizures, decreased urine, swollen legs, fever
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Some of these side effects can only be found by laboratory testing.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Imatinib GH contains

Active ingredient
(main ingredient)
imatinib mesilate
Other ingredients
(inactive ingredients)
The other ingredients are:

  • lactose,
  • crospovidone,
  • colloidal anhydrous silica,
  • magnesium stearate.

The capsule shells (cap and body) contain:

  • gelatin,
  • purified water,
  • iron oxide red
  • iron oxide yellow
  • titanium dioxide.
  • sodium lauryl sulfate

Do not take this medicine if you are allergic to any of these ingredients.

What Imatinib GH looks like

Imatinib GH 100 mg capsules are light yellow granules filled in size 3 hard gelatin capsule with brown cap and white body (AUST R 281535).

Imatinib GH 400 mg capsules are light yellow granules filled in size 00EL hard gelatin capsules with brown cap and brown body (AUST R 281536).

Who distributes Imatinib GH

Generic Health Pty Ltd
Level 1, 1102 Toorak Road
CAMBERWELL VIC 3124
drugsafety@cipla.com
Phone no: 1 800 569 074

This leaflet was prepared in March 2022.