What should I know before I use CRESEMBA?
What if I am taking other medicines?
How do I use CRESEMBA?
What should I know while using CRESEMBA?
Are there any side effects?
Why am I using CRESEMBA?
What should I know before I use CRESEMBA?
What if I am taking other medicines?
How do I use CRESEMBA?
What should I know while using CRESEMBA?
Are there any side effects?
Product details
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Audio under revision, check back soon
For more information, see Section 1. Why am I using CRESEMBA? in the full CMI.
Do not use CRESEMBA if you are taking any of the medicines listed in section 3. What if I am taking other medicines?
Do not take this medicine if you have familial short QT syndrome (Disorder of the heart).
CRESEMBA should not be taken during pregnancy or breastfeeding, unless indicated by your doctor. Effective contraception should be used in women of childbearing potential.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use CRESEMBA? in the full CMI.
Things you should do
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Remind any doctor or dentist you visit that you are using CRESEMBA.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
If you become pregnant while taking this medicine, tell your doctor immediately.
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Things you should not do
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Do not stop using this medicine suddenly or lower the dosage without checking with your doctor.
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Driving or using machines
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This medicine may cause confusion, tiredness and sleepiness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
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Looking after your medicine
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Capsules
: Keep your capsules in the original pack until it is time to take them and store in a cool dry place where the temperature stays below 25°C.
Powder for injection
: This will be stored correctly in the pharmacy or on the hospital ward.
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What should I know before I use CRESEMBA?
What if I am taking other medicines?
How do I use CRESEMBA?
What should I know while using CRESEMBA?
Are there any side effects?
Why am I using CRESEMBA?
What should I know before I use CRESEMBA?
What if I am taking other medicines?
How do I use CRESEMBA?
What should I know while using CRESEMBA?
Are there any side effects?
Product details
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- Download PDF Large Print
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Audio under revision, check back soon
Do not use CRESEMBA if:
1. You are allergic to isavuconazole, or any of the ingredients listed at the end of this leaflet.
2. You are allergic to any other similar medicines such as ketoconazole, fluconazole, itraconazole, voriconazole or posaconazole.
3. You are taking any of the medicine listed in section 3. What if I am taking other medicines?
Check with your doctor if you:
Pregnancy and breastfeeding
How much to use
When to use CRESEMBA and for how long
If you forget to use CRESEMBA
If you use too much CRESEMBA
( by calling 13 11 26), or
Things you should do
Call your doctor straight away if:
Things you should not do
Driving or using machines
Looking after your medicine
Getting rid of any unwanted medicine
Side effects
Side effects
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What to do
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Gastrointestinal related problems:
feeling sick (nausea)
being sick (vomiting)
diarrhoea
stomach pain
decreased appetite
feeling bloated (abdominal distension)
indigestion
constipation
changes in taste (dysgeusia)
Aches and pains:
headache
back pain
Heart and related effects:
heartbeat problems - may be too fast or uneven, or extra heart beats – this may show in your heart tracing (electrocardiogram or ECG)
inflamed veins that could lead to blood clots
Altered mental state:
confusion, agitation and/or disorientation, changes to behavior/mood
depression
difficulty sleeping
fainting or feeling faint, dizziness
sensation of tingling, tickling, or prickling of the skin
feeling of ‘spinning’ or being dizzy (vertigo)
feeling weak, very tired, or sleepy or generally out of sorts (malaise)
Skin and hair effects:
rash, itching
problems with the skin, red or purple spots on the skin
inflamed skin (dermatitis)
hair loss
Changes in body detected in blood tests or other medical exams:
low blood levels of potassium and magnesium
changes in blood tests of liver function
reduced white blood cells - can increase your risk of infection and fever
reduced blood cells - can increase your risk for bleeding or bruising and can make you feel weak or short of breath or make your skin pale or make infections more likely
low blood sugar levels-sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having fast, pounding heart beat
low levels in the blood of a protein called ‘albumin', which may cause water retention, leading to swelling in some parts of the body
inflammation or enlargement of the liver - may cause yellowing of skin and eyes, pale colored stool and or dark colored urine
not getting the right nutrition from your diet (malnutrition)
low blood pressure- may cause dizziness, lightheadedness
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Speak to your doctor if you have any of these side effects and they worry you.
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Serious side effects
Serious side effects
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What to do
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Hypersensitivity reactions:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
sudden and severe difficulty breathing
fainting, confusion, seizures or fits
sudden or severe itching, skin rash, hives or blisters
signs of kidney failure such as tiredness, lack of appetite and reduced or greatly increased amount of urine
chest pain
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Go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
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Reporting side effects
What CRESEMBA contains
Active ingredient
(main ingredient)
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CRESEMBA capsules:
CRESEMBA Capsules contain 100 mg of isavuconazole (as 186.3 mg isavuconazonium sulfate)
CRESEMBA Powder for Injection:
CRESEMBA Powder for Injection contains 200 mg of isavuconazole (as 372.6 mg isavuconazonium sulfate)
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Other ingredients
(inactive ingredients)
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CRESEMBA capsules:
Contain the following other ingredients:
Capsule Contents
magnesium citrate
microcrystalline cellulose
purified talc
colloidal anhydrous silica
stearic acid
Capsule Shell
hypromellose
iron oxide red (E172) (capsule body only)
titanium dioxide (E171)
gellan gum
potassium acetate
disodium edetate
sodium lauryl sulfate
Printing Ink
shellac
propylene glycol
potassium hydroxide
iron oxide black (E172)
CRESEMBA Powder for Injection:
Contains the following other ingredients:
mannitol
sulfuric acid (for pH-adjustment)
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What CRESEMBA looks like
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