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SANDOSTATIN®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
SANDOSTATIN contains the active ingredient octreotide. SANDOSTATIN is used to block
the production of excessive growth hormone and acts to reduce the amount of other
chemicals and proteins that occur naturally in your body. This may be useful in treating
certain types of cancers, excessive body part growth (acromegaly) and following surgery
on your pancreas. For more information, see Section 1. Why am I using SANDOSTATIN? in the full CMI.
Do not use if you have ever had an allergic reaction to SANDOSTATIN or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions such as problems with your liver, gall bladder, heart, or blood sugar. Tell your doctor if you 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 SANDOSTATIN? in the full CMI.
Talk to your doctor if you have any other medical conditions such as problems with your liver, gall bladder, heart, or blood sugar. Tell your doctor if you 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 SANDOSTATIN? in the full CMI.
Some medicines may interfere with SANDOSTATIN and affect how it works. A list of these
medicines is in Section 3. What if I am taking other medicines? in the full CMI.
SANDOSTATIN is given by injection under the skin using special equipment designed
to use the glass capsule (ampoule)
You may be able to take SANDOSTATIN at home, your doctor or nurse will show you how
to do this and provide you with this equipment.
More instructions can be found in Section 4. How do I use SANDOSTATIN? in the full CMI.
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Things you should do
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Remind any doctor, dentist, surgeon, pharmacist, or anesthetist that you are using
SANDOSTATIN.
Attend any follow-up appointments to check how you are responding to treatment.
Take contraception (birth control) if your doctor tells you to in order to avoid becoming
pregnant.
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Things you should not do
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Do not stop using this medicine suddenly.
Do not give this medicine to someone else.
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Driving or using machines
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SANDOSTATIN may make you feel dizzy, light-headed, or weak. Do not drive or do anything
else that would require your attention.
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Drinking alcohol
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SANDOSTATIN may make you feel dizzy, light-headed, or weak. You should avoid alcohol
while on treatment with SANDOSTATIN.
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Looking after your medicine
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SANDOSTATIN should generally be kept in the fridge (set between 2 - 8°C). Do NOT freeze
it.
SANDOSTATIN can also be stored for up to 2 weeks at room temperature (below 30°C)
for daily use. If the ampoules have not been kept in the fridge for more than 2 weeks,
throw them away.
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For more information, see Section 5. What should I know while using SANDOSTATIN? in the full CMI.
Some common side effects include diarrhoea, constipation, feeling gassy, stomach pain/discomfort
or cramps, feeling or being sick, headaches, dizziness, gall stones, weight changes,
high blood sugar, redness, itchiness, swelling or rash at injection site, redness
elsewhere on the skin, hair loss, feeling tired, weak, anxious, or cold. Serious side
effects include signs of an allergic reaction including 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; severe stomach pain, tenderness or swelling;
signs of liver disease including yellowing of skin or whites around eyes; changes
to vision; passing much less urine or unable to pass urine when going to the toilet;
trembling hands or balance problems; sweating more than normal; feeling faint/rapid
heartbeat; bruising more than normal.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
SANDOSTATIN®
(San-do-statin)
Active ingredient(s):
Octreotide (ok-TREE-oh-tide)
Consumer Medicine Information (CMI)
This leaflet provides important information about using SANDOSTATIN. 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 SANDOSTATIN.
Where to find information in this leaflet:
SANDOSTATIN contains the active ingredient octreotide. SANDOSTATIN is an anti-growth hormone, meaning that it is used to block the production
of excessive growth hormone that occurs naturally in your body. It also works to reduce
the amount of other chemicals and proteins in your body that may be making you unwell.
SANDOSTATIN has three main uses.
1. Treatment of acromegaly. This is a condition where the body produces too much hormone
that controls the growth of your bones, organs, and tissues. SANDOSTATIN helps reduce
the amount of this chemical in your body to relieve the effects of this condition
which may include stiffness or pain in your joints and larger than normal bones in
your hand and feet.
2. Relieve the effects of some types of cancer (uncontrolled cell growth) including
carcinoid syndrome (tumour of the gut/lungs) and VIPoma (tumour of the gut) such as
diarrhoea.
3. In people who are having surgery on their pancreas to help reduce the chance of
having problems after the surgery.
Do not use SANDOSTATIN if:
you are allergic to octreotide, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have previously had or currently have gallstones
have previously had or currently have diabetes
have previously had or currently have liver problems
have previously had or currently have low vitamin B12
are taking medication to treat high blood pressure
are taking medication to manage fluid retention/electrolytes
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?
Monitoring
Before commencing treatment, your doctor may send you for blood/urine tests. They
may refer you to specialist appointments to check on your gall bladder, thyroid,
or liver function. They may also monitor you throughout treatment to see how your
body is responding and whether your dose may need to change.
Some tests, such as blood sugar, you may also be required to do which can be done
from home.
Gallstones
Using SANDOSTATIN, especially if you must use it for a long time may cause gallstones.
Your doctor will want to know if you have gallstones currently or have experienced
things like fever, chills, stomach pain, or a yellowing of the skin/eyes because of
gallstones in the past. Your doctor will likely send you for an ultrasound of the
gallbladder before treatment and throughout treatment.
Diabetes
SANDOSTATIN can affect your blood sugar. If you are a diabetic or may be at risk of
developing diabetes, your doctor may want to closely monitor your blood sugar levels
using special equipment. If you are currently taking insulin, your doctor may alter
your dose.
Liver function
If you have liver scarring or problems with your liver, your doctor may adjust your
dose. Your body may take more time than expected to handle the medicine for each dose.
Nutrition
Your doctor may want to check your vitamin B12 levels in your blood. SANDOSTATIN may
also change how your body handles fat in your diet. Your doctor may refer you to a
dietician.
Heart function and blood pressure
Your doctor may change your dose of SANDOSTATIN if you are taking medicines to control
blood pressure or electrolytes.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant, think you may be pregnant or intend to
become pregnant. There is limited information on using SANDOSTATIN while pregnant
or when trying to have a baby.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known
whether SANDOSTATIN passes through breast milk and may harm your baby.
Contraception
Your doctor may request that you take an effective contraception (birth control) to
prevent pregnancy.
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 SANDOSTATIN and affect how it works. These can include:
Medicines to control your blood pressure (e.g., beta-blockers)
Medicines to control fluid retention or electrolytes (e.g., calcium blockers)
Medicines to treat heartburn/stomach ulcer (e.g., cimetidine)
Medicines used following transplant (e.g., cyclosporin)
Medicines used to treat pituitary gland tumours (e.g., bromocriptine)
Medicines used to treat irregular heartbeat (e.g., quinidine)
Medicines used to manage blood sugar (e.g., Insulin)
For you to more safely use SANDOSTATIN, your doctor may alter your dose of SANDOSTATIN
or your other medications depending on what you are taking.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SANDOSTATIN.
How to use SANDOSTATIN
SANDOSTATIN is injected just under the skin. See section "How to inject SANDOSTATIN"
Your doctor will tell you how much SANDOSTATIN to take based on your condition and
whether you may be taking other medications/have any other health conditions.
Follow the instructions provided and use SANDOSTATIN until your doctor tells you to
stop.
If you do not understand how to use it properly and you are injecting it at home,
ask your doctor for help.
How much to use
If you have acromegaly
Your doctor will usually start you on injections of between 0.05 to 0.1 mg taken every
8 or 12 hours.
Your doctor may adjust your dose depending on how well your body responds to treatment.
If you have Carcinoid syndrome and VIPoma
Your doctor will usually start you on injections of 0.05 mg once or twice a day.
Your doctor may adjust your dose depending on how well your body responds to treatment.
If you have recently had surgery on your pancreas
Your doctor will usually start you on injections of 0.1 mg usually given three times
a day for one week, starting about an hour before the operation.
Your doctor may adjust your dose depending on how well your body responds to treatment.
When to use SANDOSTATIN
SANDOSTATIN should be injected in between meals or at bedtime. Avoid having a meal
close to when you are injecting as it may upset your stomach.
Before you inject SANDOSTATIN at home
Your doctor or nurse will show you how to do this. It is important that you can do
this when they send you home with it.
Make sure the ampoule is at room temperature before you use it. If it has been in
the fridge, take it out half an hour before using it. You can warm it up in your hand
but don't try to heat it in the microwave.
Check the liquid in the glass capsule (ampoule) - it should be clear and colourless.
You must not take SANDOSTATIN if the capsules show floating pieces (particles), or
the liquid is discoloured (see section "Getting rid of unwanted medicine").
Injecting SANDOSTATIN at home
Inject SANDOSTATIN the same way your doctor or nurse has shown you with the equipment
they provide you.
Choose a new site each time you need to inject (avoid injecting in the same place
during back-to-back treatments).
The upper arms, thighs and abdomen are good areas for injection.
After you receive your injection of SANDOSTATIN
Throw away the glass capsule (ampoule) that was used. Each capsule may only be used
once.
If you notice pain, stinging, tingling, burning, redness or swelling at the injection
site after the injection, gently rub the site for a few seconds. If it persists into
the day and it worries you, talk to your doctor.
If you forget to use SANDOSTATIN
Inject the dose as soon as you remember, and then go back to using it as you would
normally.
Do not take a double dose to make up for the dose you missed. This may increase the
chance of you getting an unwanted effect.
If you use too much SANDOSTATIN
If you think that you have used too much SANDOSTATIN, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
(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.
Some of the symptoms of taking too much SANDOSTATIN may include irregular heartbeat,
low blood pressure, cardiac arrest, brain hypoxia (lower level of oxygen than normal
going to your brain), severe upper stomach pain, yellow skin, and eyes, feeling sick/vomiting,
loss of appetite, diarrhoea, weakness, tiredness, lack of energy, weight loss, abdominal
swelling, discomfort, painful muscle cramps and changes to heart rhythm.
Things you should do
Keep all your appointments, including those for specialists so that your overall health
and response to treatment can be monitored.
Complete blood/urine tests requested by your doctor promptly.
Ensure you take an effective form of contraception if your doctor asks you to.
Call your doctor straight away if you:
You are pregnant or think you may be pregnant.
Remind any doctor, dentist, surgeon, anaesthetist, or pharmacist you visit that you
are using SANDOSTATIN.
Things you should not do
Do not stop using this medicine suddenly.
Do not give this medicine to someone else.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how SANDOSTATIN
affects you.
SANDOSTATIN may make you feel dizzy, light-headed, or weak. Do not drive or do anything
else that would require your attention.
Drinking alcohol
Tell your doctor if you drink alcohol.
SANDOSTATIN may make you feel dizzy, light-headed, or weak. You should avoid alcohol
while on treatment with SANDOSTATIN.
Looking after your medicine
Keep the ampoules (glass capsules) in their original container inside the carton until
it is time to use them. Follow the instructions in the carton on how to take care
of your medicine properly.
You should store SANDOSTATIN in the fridge (set between 2 - 8°C). Do NOT freeze it.
SANDOSTATIN can also be stored for up to 2 weeks at room temperature (below 30°C)
for day-to-day use. Any ampoules that have not been used within this time must be
thrown away if they have not been kept in the fridge.
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 windowsills.
Keep it where young children cannot reach it.
When to discard your medicine
if the pack has been out of the fridge for more than 2 weeks, take it to a pharmacy
for disposal.
if there is any leftover from the glass capsule after you have opened it and taken
the injection, it can be thrown away.
Getting rid of any unwanted medicine
If your glass capsules (ampoules) are discolored or have floating pieces (particles)
in it, take it to your pharmacist to exchange it.
If your doctor tells you that you no longer need to use this medicine or it is out
of date, damaged or shows signs of tampering, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date or if you have not kept it in the fridge
for more than 2 weeks. Take it to a pharmacy for safe disposal.
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
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Less serious side effects
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What to do
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Skin problems
Swelling, redness, rash, swelling or itching at the site of injection.
Flushing (redness) of the skin elsewhere.
Stomach problems
Indigestion, cramps, discomfort
Bloating, wind
Constipation/diarrhoea
Loss of appetite
General wellbeing
Feeling sick, vomiting
Headache
Feeling dizzy or lightheaded
Feeling tired or weak
Mood and body changes
Faster heart rate
Change in weight
Feeling cold
Increased sweating
Feeling anxious
Swelling of hands or feet from fluid.
Thyroid changes
Temporary hair loss
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
Tell your doctor if anything is making you feel unwell.
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Serious side effects
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Serious side effects
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What to do
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Signs of an allergic reaction
Sudden onset of rash, hives, itching, blisters that are spreading
Swelling of the face, lips and tongue or other parts of the body
Wheezing, difficulty breathing, unable to catch your breath.
Stomach problems
Severe stomach pain, swelling, tenderness.
Liver problems
Yellow skin and eyes, feeling generally unwell
Fever accompanied by feeling sick or vomiting
Kidney problems
Yellow skin and eyes, feeling generally unwell
Blood sugar/pancreas problems
Sweating more than normal, feeling weak, tired, or trembling.
Feeling dizzy, weak, hungry
Fast or irregular heartbeat
Passing large amounts of urine that is discolored/feeling very thirsty.
Changes to vision
Blood problems
Bruising more easily than normal
Increased bleeding from wound
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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.
You may require medical treatment.
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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.
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.
This medicine is only available with a doctor's prescription. SANDOSTATIN ampoules
contain 0.05 mg, 0.1 mg or 0.5 mg of the active ingredient, octreotide (as octreotide
acetate).
What SANDOSTATIN contains
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Active ingredient
(main ingredient)
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Octreotide (as octreotide acetate)
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Other ingredients
(inactive ingredients)
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• lactic acid
• mannitol
• sodium bicarbonate
• water for injections
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Potential allergens
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-
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Do not take this medicine if you are allergic to any of these ingredients.
What SANDOSTATIN looks like
SANDOSTATIN solution for injection is a clear and colourless liquid. The solution
is filled into a 1 mL colourless glass ampoule (glass capsule) with two colour coded
rings and a one-point cut.
SANDOSTATIN solution for injection is available in three strengths in boxes that contain
5 ampoules:
0.05 mg ampoules, box of 5 (AUST R 42192)
0.1 mg ampoules, box of 5 (AUST R 42193)
0.5 mg ampoules, box of 5 (AUST R 42191)
