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SANDOSTATIN AMPOULES 100 MICROGRAMS IN 1ML CONCENTRATE FOR SOLUTION FOR INFUSION

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PATIENT INFORMATION LEAFLET

Sandostatin® Ampoules
100 micrograms in 1ml solution for
injection or concentrate for solution
for infusion
(octreotide acetate)
The name of your medicine is Sandostatin® Ampoules
100 micrograms in 1ml solution for injection or concentrate for
solution for infusion but will be referred to as Sandostatin
throughout the remainder of this leaflet.
What you need to know about Sandostatin
Your doctor has decided that you need this medicine to help treat your
condition.
Please read this leaflet carefully before you start to have your
medicine. It contains important information. Keep the leaflet in a
safe place because you may want to read it again.
If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist. This medicine has
been prescribed for you. Never give it to someone else. It may not be
the right medicine for them even if their symptoms seem to be the
same as yours.
If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

You should also ask yourself these questions before having
Sandostatin:
 Are you pregnant?
 Do you have diabetes?
 Do you have any thyroid problems, or have you had a disease
which may have affected your thyroid?
 Do you have any problems with your liver, or have you had a
disease which may have affected your liver?
 Have you ever suffered from gallstones or other stomach problems?
 Do you have a history of Vitamin B12 deficiency?
If the answer to any of these questions is YES, tell your doctor or
nurse because Sandostatin might not be the right medicine for you.

Are you taking other medicines?
Sandostatin interacts with a large number of other medicines. Tell your
doctor or nurse if you are taking any of the following:
Insulin, or other drugs for diabetes
Ciclosporin
Cimetidine
Bromocriptine
Medicines to control blood pressure (beta-blockers or calcium channel
blockers) or agents to control fluid and electrolyte balance (diuretics)
Medicines metabolised by the liver for example carbamazepine,digoxin
and warfarin and terfenadine. Always tell your doctor or pharmacist
about all the medicines you are taking. This means medicines you
have bought yourself as well as medicines on prescription from your
doctor.

Will there be any problems with driving or using machinery?

In this leaflet:

No problems have been reported.

1. What Sandostatin is and what it’s used for
2. Things to consider before you start to take Sandostatin
3. How to take Sandostatin
4. Possible side effects
5. How to store Sandostatin
6. Further information

Other special warnings

1. WHAT SANDOSTATIN IS AND WHAT IT’S USED FOR





Sandostatin is an injection. Sandostatin injections contain the active
ingredient octreotide (as the acetate). Octreotide is a synthetic form of
a hormone called somatostatin which occurs naturally in the body. It
helps stop the release of some hormones, including growth hormone,
in the body.
Sandostatin can be used:

 Your doctor may want to give you a check up from time to time while

you are being treated with Sandostatin.
 Growth hormone secreting pituitary tumours may sometimes



expand and cause problems. Tell your doctor if you experience any
problems with your eyes or sight.
Tell your doctor if your stomach or bowel problems get worse.
There is very little experience of using Sandostatin in children.
Sandostatin should only be used during pregnancy if clearly
needed. Tell your doctor if you are preganant or wanting to become
pregnant.
Women of child bearing potential must use an effective
contraceptive method during treatment with Sandostatin.

3. HOW TO TAKE SANDOSTATIN

1. To treat acromegaly
Acromegaly is a condition where the body produces too much growth
hormone. The level of growth hormone controls the growth of tissues,
organs and bones. Too much hormone means the size of bones and
tissues, especially in the hands and feet, is larger than normal. The
symptoms of acromegaly include headache, excessive perspiration,
numb hands and feet, tiredness, and joint pain. In most cases, the
overproduction of growth hormone is caused by an enlargement in the
pituitary gland (a pituitary adenoma).
Sandostatin is used to treat people with acromegaly;
 when other types of treatment for acromegaly (surgery or
radiotherapy) are not suitable or haven’t worked;
 after radiotherapy, to cover the interim period until the radiotherapy
becomes fully effective;
 before surgery on the pituitary gland.

Follow the instructions given you by your doctor. He/she will tell you
the correct dose and how often to inject your medicine. Follow your
doctor's instructions exactly and never change the dose yourself. Ask
your doctor or pharmacist if you are unsure about how much medicine
to have or when to have it.

2.To relieve stomach or bowel symptoms associated with
certain tumours known as ‘gastroenteropancreatic’ tumours
(rare tumours of the stomach, bowels or pancreas)

To avoid side effects like stomach ache, wind, diarrhoea and
constipation do not inject at mealtimes. Inject between meals or before
going to bed.

Overproduction of specific hormones and other related natural
substances can be caused by some rare conditions of the stomach,
bowels or pancreas. This upsets the natural hormonal balance of the
body, and results in a variety of symptoms, such as flushing,
diarrhoea, low blood pressure, rash and weight loss. Treatment with
Sandostatin helps to control these symptoms.

In rare cases Sandostatin will have to be injected intravenously (into a
vein). If this is necessary the doctor or nurse will do it and monitor you
closely. You must NOT inject Sandostatin into your veins yourself.

3. To prevent complications following pancreatic surgery
Sandostatin can be used in some patients when they have an
operation on the pancreas. It may help reduce some of the problems
which can occur in the abdomen after the operation, such as
inflammation (swelling) and infection.

2. THINGS TO CONSIDER BEFORE YOU START TO TAKE
SANDOSTATIN
Some people MUST NOT be given Sandostatin. Talk to your
doctor if:
 you think you may be allergic to octreotide or to any of the other

ingredients of the Sandostatin preparations. (These are listed at the
end of the leaflet.)
 you are breastfeeding.
S0409-5-SP-PIL-08.03.2013

Your medicine must be injected subcutaneously i.e. into the tissue
under the skin. Your doctor or nurse will show you how to do this. If
you are unsure, go back and ask for advice. You must use a clean,
sterile syringe and needle every time.
The upper arms, thighs and stomach are good areas for subcutaneous
injection. Choose a different place each time so that you don’t irritate a
particular area. Keep changing the injection site. Don’t inject into the
same place too frequently.

How to open the ampoule
The ampoules have a small etched mark at the breaking point, and a
blue spot on the top. To snap open an ampoule, push carefully with the
thumb of one hand on the blue spot at the top of the ampoule while
holding the lower half of the ampoule with your other hand. The
ampoule should snap open at the break point without shattering. If you
have any problems opening the ampoules, ask your doctor or
pharmacist.
Do not open the ampoule until it is time to have your injection. If you
keep the injection in the fridge, warm it up to room temperature in your
hand before using it. This will reduce any pain at the site of injection.
Do not heat the ampoules or vials any other way.

Doses
For the treatment of acromegaly
The usual dose is 0.1 to 0.2 mg three times a day by subcutaneous
injection. Depending on how you respond, your doctor will adjust the
dose until he/she finds the right dose.

To relieve symptoms caused by over-production of some
hormones
 Your doctor will usually start your treatment with 0.05 mg once or

twice daily by subcutaneous injection. Depending on how you
respond, your doctor may gradually increase the dose until he/she
finds your ideal dose.

To prevent complications following pancreatic surgery
 0.1mg three times a day for seven days starting on the day of the

operation.
People with liver problems may be given a smaller dose.

What if you forget to take a dose?
If you forget to take a dose have the injection as soon as you
remember unless it is almost time for your next dose, then go on as
before. DO NOT take a double dose.

What if you take too much?
If you accidentally take too much, tell your doctor at once or contact
your nearest hospital casualty department. Take your medicine with
you.

4. POSSIBLE SIDE EFFECTS
Most people who are prescribed Sandostatin benefit from taking it, but
a few can be upset by it. If you are receiving this medicine on a long
term basis then you will go to hospital from time to time to have regular
check-ups. There is no need to worry if you suffer from any of the
following common reactions at the site of injection:
 Pain, stinging, tingling, burning, redness and swelling.

These rarely last more than 15 minutes and will be less if you let your
medicine reach room temperature before injection.

Some side effects can be serious
Stop taking Sandostatin and tell your doctor straight away if you
notice that:
 Your face becomes flushed or swollen or you develop spots or a
rash
 Your chest feels tight, you become short of breath or wheezy
 You feel faint, possibly as a result of a fall in blood pressure.

Patients taking Sandostatin have reported experiencing the following
additional side effects:
 Anaphylaxis (a type of allergic reaction which causes difficulty in
breathing or dizziness), allergy/hypersensitivity reactions
 Itchy rash
 Inflammation of the pancreas
 Liver inflammation (hepatitis); symptoms may include yellowing of
the skin and eyes (jaundice), nausea, vomiting, loss of appetite,
generally feeling unwell, itching, light-coloured urine
 Irregular heart beat
 Liver dysfunction.
If any of the symptoms become troublesome, or if you notice
anything else not mentioned here, please go and see your doctor.
He/she may want to give you a different medicine.

5. HOW TO STORE SANDOSTATIN










Keep out of the sight and reach of children.
Store in refrigerator (between 2°C and 8°C).
Keep in the original packaging to protect them from light.
For day-to-day use they may be stored at room temperature for up
to two weeks.
If you do not use a whole ampoule return what is left to your
pharmacist.
Do not take Sandostatin after the expiry date which is printed on the
outside of the pack.
If your doctor tells you to stop taking Sandostatin, please take any
which is left back to your pharmacist to be destroyed. Only keep it if
the doctor tells you to.
Do not throw it away with your normal household water or waste.
This will help to protect the environment.

6. FURTHER INFORMATION
What Sadostatin contains
Each 1ml ampoule contains octreotide acetate equivalent to 100
micrograms octreotide.
The other ingredients are: lactic acid, mannitol, sodium hydrogen
carbonate and water for injection.
Sandostatin contains less than 1mmol (23mg) sodium per dose i.e
essentially sodium free.

These might be the result of an allergic reaction.

What Sandostatin looks like and contents of the pack

If you develop any of the following see your doctor immediately:
 Prolonged/troublesome bloating of the stomach with pain
 Nausea/vomiting associated with drowsiness
 Feeling restless or giddy
 Yellowing of skin or the whites of your eyes
 Acute pancreatitis (sudden, severe, burning pains in the stomach).
This may happen within the first few hours or days of treatment and
resolves itself upon drug withdrawal.

Sandostatin Ampoules come in packs containing 5 ampoules.
It is a clear, colourless solution, and is available in ampoules
containing 100 micrograms in 1 ml.

These other side effects have been reported in clinical trials:
Up to 1 in 10 people have experienced:
 Stomach ache, nausea, wind, diarrhoea or constipation. (These will





be less if you inject between meals or before going to bed.)
Changes in blood sugar levels (hyperglycaemia)
Headache
Gallstones
Local pain at the site of injection.

Manufacturer
Novartis Farmacéutica, S.A.
Gran Vía de les Corts Castalanes, 764
08013 Barcelona, Spain.

Procured from within the EU and repackaged by: Amimed
Direct Ltd, Hendon London, NW9 6AQ.
Product Licence holder: Sam Pharma Ltd, Unit 20 Garrick
Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.
POM

PL No: 33902/0409

Leaflet revision date: 08/03/2013
Sandostatin ® is a registered trademark of Novartis AG.

Up to 1 in 100 people have experienced:





















Slow heart beat
Hair loss.
Itching
Rash
Shortness of breath
Dizziness
Loss of appetite
Changes in blood sugar levels (hypoglycaemia)
Impaired glucose tolerance
Stomach discomfort after a meal
Vomiting
Bloated stomach
Loose faeces (stools)
Discolouration of faeces
Fat in your faeces (pale and fatty loose stools)
Inflammation of the gallbladder
Biliary sludge
Yellow skin and eyes
Abnormal liver function test results
Changes in activity of the thyroid gland (hypothyroidism) causing
changes in heart rate, appetite or weight, tiredness, feeling cold or
sweating too much, anxiety or swelling at the front of the neck.

Up to 1 in 1,000 people have experienced:
 Dehydration
 Fast heart beat

S0409-5-SP-PIL-08.03.2013

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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