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SANDOSTATIN AMPOULES 50 MCG/ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): OCTREOTIDE

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Package leaflet: Information for the patient

SANDOSTATIN® 50 microgram/1 mL,
solution for injection/infusion
SANDOSTATIN® 100 microgram/1 mL,
solution for injection/infusion
SANDOSTATIN® 500 microgram/1 mL,
solution for injection/infusion
SANDOSTATIN® 1000 microgram/5 mL,
solution for injection/infusion
octreotide
Read all of this leaflet carefully before you start using this
medicine because it contains important information
for you.
–– Keep this leaflet. You may need to read it again.
–– If you have any further questions, ask your doctor,
pharmacist or nurse.
–– This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
–– If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Sandostatin is and what it is used for
2. What you need to know before you use Sandostatin
3. How to use Sandostatin
4. Possible side effects
5. How to store Sandostatin
6. Contents of the pack and other information
1. W
hat Sandostatin is and what it is used for
Sandostatin is a synthetic compound derived from
somatostatin, a substance normally found in the human
body which inhibits the effects of certain hormones such as
growth hormone. The advantages of Sandostatin over
somatostatin are that it is stronger and its effects last longer.
Sandostatin is used
• in acromegaly, a condition where the body produces too
much growth hormone. Normally, growth hormone
controls growth of tissues, organs, and bones. Too much
growth hormone leads to an increase in the size of bones
and tissues, especially in the hands and feet.
Sandostatin markedly reduces the symptoms of
acromegaly, which include headache, excessive
perspiration, numbness of the hands and feet, tiredness,
and joint pain.
• to relieve symptoms associated with some tumours of
the gastrointestinal tract (e.g. carcinoid tumours,
VIPomas, glucagonomas, gastrinomas, insulinomas). In
these conditions, there is overproduction of some specific
hormones and other related substances by the stomach,
bowels, or pancreas. This overproduction upsets the
natural hormonal balance of the body and results in a
variety of symptoms, such as flushing, diarrhoea, low

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2. What you need to know before you use Sandostatin
Do not use Sandostatin:
–– if you are allergic to octreotide or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before using Sandostatin:
–– if you know that you have gallstones now, or have had
them in the past; tell your doctor, as prolonged use of

Sandostatin may result in gallstone formation. Your
doctor may wish to check your gallbladder periodically.

If you are diabetic, your doctor may need to adjust your
insulin dosage.

–– if you have problems with your blood sugar levels, either
too high (diabetes) or too low (hypoglycaemia). When
Sandostatin is used to treat bleeding from
gastro‑oesophageal varices; monitoring of blood sugar
level is mandatory.

Pregnancy and breast‑feeding
If you are pregnant or breast‑feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine.

–– if you have a history of vitamin B12 deprivation your doctor
may wish to check your vitamin B12 level periodically.
Test and checks
If you receive treatment with Sandostatin over a long
period of time, your doctor may wish to check your thyroid
function periodically.
Your doctor will check your liver function.
Children
There is little experience with the use of Sandostatin in children.
Other medicines and Sandostatin
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
You can generally continue taking other medicines while on
Sandostatin. However, certain medicines, such as
cimetidine, ciclosporin, bromocriptine, quinidine and
terfenadine have been reported to be affected by Sandostatin.
If you are taking a medicine to control your blood pressure
(e.g. a beta blocker or a calcium channel blocker) or an
agent to control your fluid and electrolyte balance, your
doctor may need to adjust the dosage.

Sandostatin should only be used during pregnancy if clearly
needed.
Women of child‑bearing age should use an effective
contraceptive method during treatment.
Do not breast-feed while using Sandostatin. It is not known
whether Sandostatin passes into breast milk.
Driving and using machines
Sandostatin has no or negligible effects on the ability to
drive and use machines. However, some of the side effects
you may experience while using Sandostatin, such as
headache and tiredness, may reduce your ability to drive
and use machines safely.
Sandostatin contains sodium
Sandostatin contains less than 1 mmol sodium (23 mg)
per dose, which means it is essentially “sodium-free”.
3. How to use Sandostatin
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Depending on the condition being treated, Sandostatin is
given by:
• subcutaneous (under the skin) injection or

• intravenous (into a vein) infusion.
If you have liver cirrhosis (chronic liver disease), your
doctor may need to adjust your maintenance dose.
Your doctor or nurse will explain to you how to inject
Sandostatin under the skin, but infusion into a vein must
always be performed by a health care professional.
• Subcutaneous injection
The upper arms, thighs, and abdomen are good areas for
subcutaneous injection.
Choose a new site for each subcutaneous injection so that
you do not irritate a particular area. Patients who will be
injecting themselves must receive precise instructions from
the doctor or nurse.
If you store the medicine in the refrigerator, it is
recommended that you allow it to reach room temperature
before using it. This will reduce the risk of pain at the site
of injection. You can warm it up in your hand but do not
heat it.
A few people experience pain at the site of the
subcutaneous injection. This pain usually only lasts a short
time. If this happens to you, you can relieve this by gently
rubbing the site of injection for a few seconds afterwards.
Before using a Sandostatin ampoule, check the solution for
particles or a change of colour. Do not use it if you see
anything unusual.
To prevent contamination the cap of the multidose vials
should be punctured not more than 10 times.

If you use more Sandostatin than you should
No life‑threatening reactions have been reported after
overdose of Sandostatin.
The symptoms of overdose are: irregular heart beat, low
blood pressure, cardiac arrest, reduced supply of oxygen to
the brain, severe upper stomach pain, yellow skin and
eyes, nausea, loss of appetite, diarrhoea, weakness,
tiredness, lack of energy, weight loss, abdominal swelling,
discomfort and high level of lactic acid in the blood.
If you think that an overdose has happened and you
experience such symptoms, tell your doctor straight away.
If you forget to use Sandostatin
Administer one dose as soon as you remember, and then
continue as usual. It will not do any harm if you miss a
dose, but you could get some temporary re‑appearance of
symptoms until you get back on schedule.
Do not inject a double dose of Sandostatin to make up for
forgotten individual doses.
If you stop using Sandostatin
If you interrupt your treatment with Sandostatin your
symptoms may come back. Therefore, do not stop using
Sandostatin unless your doctor tells you to.
If you have any further questions on the use of this
medicine, ask your doctor, nurse or pharmacist.
4. Possible side effects
Like all medicines this medicine can cause side effects,
although not everybody gets them.

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Tech. Drawing No.: 799.4.9166/07

blood pressure, rash, and weight loss. Treatment with
Sandostatin helps to control these symptoms.
• to prevent complications following surgery of the
pancreas gland. Treatment with Sandostatin helps to
lower the risk of complications (e.g. abscess in the
abdomen, inflammation of the pancreas gland) after the
surgery.
• to stop bleeding and to protect from re‑bleeding from
ruptured gastro‑oesophageal varices in patients suffering
from cirrhosis (chronic liver disease). Treatment with
Sandostatin helps to control bleeding and reduce
transfusion requirements.
• to treat pituitary tumours that produce too much
thyroid‑stimulating hormone (TSH). Too much
thyroid‑stimulating hormone (TSH) leads to
hyperthyroidism.
Sandostatin is used to treat people with pituitary tumours
that produce too much thyroid‑stimulating hormone (TSH):
–– when other types of treatment (surgery or
radiotherapy) are not suitable or have not worked;
–– after radiotherapy, to cover the interim period until the
radiotherapy becomes fully effective.

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Some side effects could be serious. Tell your doctor
straight away if you get any of the following:

Tell your doctor straight away if you notice any of the side
effects above.

Very common (may affect more than 1 in 10 people):
• Gallstones, leading to sudden back pain.
• Too much sugar in the blood.

Other side effects:
Tell your doctor, pharmacist or nurse if you notice any of
the side effects listed below. They are usually mild and
tend to disappear as treatment progresses.

Common (may affect up to 1 in 10 people):
• Underactive thyroid gland (hypothyroidism) causing
changes in heart rate, appetite or weight; tiredness,
feeling cold, or swelling at the front of the neck.
• Changes in thyroid function tests.
• Inflammation of the gallbladder (cholecystitis);
symptoms may include pain in the upper right abdomen,
fever, nausea, yellowing of the skin and eyes (jaundice).
• Too little sugar in the blood.
• Impaired glucose tolerance.
• Slow heart beat.
Uncommon (may affect up to 1 in 100 people):
• Thirst, low urine output, dark urine, dry flushed skin.
• Fast heart beat.
Other serious side effects
• Hypersensitivity (allergic) reactions including skin rash.
• A type of an allergic reaction (anaphylaxis) which causes
difficulty in breathing or dizziness.
• An inflammation of the pancreas gland (pancreatitis);
symptoms may include sudden pain in the upper
abdomen, nausea, vomiting, diarrhoea.
• 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.

Very common (may affect more than 1 in 10 people):
• Diarrhoea.
• Abdominal pain.
• Nausea.
• Constipation.
• Flatulence (wind).
• Headache.
• Local pain at the injection site.
Common (may affect up to 1 in 10 people):
• Stomach discomfort after meal (dyspepsia).
• Vomiting.
• Feeling of fullness in the stomach.
• Fatty stools.
• Loose stools.
• Discolouration of faeces.
• Dizziness.
• Loss of appetite.
• Change in liver function tests.
• Hair loss.
• Shortness of breath.
• Weakness.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly
(see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Store in the original package in order to protect from light.
Store in a refrigerator (2°C to 8°C). Do not freeze.
The ampoules (50, 100 and 500 micrograms/1 ml) may
be stored below 30°C for up to two weeks.
The ampoules should be used immediately after opening.
The multidose vials of 1000 micrograms/5 ml
(200 micrograms/1 ml) may be stored below 25°C for up
to two weeks.

If you get any side effects, please tell your doctor, nurse or
pharmacist.

The multidose vials may be stored below 25°C for two
weeks after first opening.

Diluted solutions should be used immediately after
preparation.

What Sandostatin looks like and contents of the pack
Ampoules:

Belgium, France, Luxemburg,
Netherlands

Sandostatine

necessary until the prescribed duration of treatment is
reached.

Do not use this medicine after the expiry date which is
stated on the label and carton after EXP. The expiry date
refers to the last day of that month.

Colourless glass containing clear, colourless solution

Italy, Portugal

Sandostatina

How much Sandostatin to use
The dose of Sandostatin depends on the condition being
treated.
• Acromegaly
Treatment is usually started at 0.05 to 0.1 mg
every 8 or 12 hours by subcutaneous injection. It is then
changed according to its effect and relief of symptoms
(such as tiredness, sweating and headache). In most
patients the optimal daily dose will be 0.1 mg 3 times/day.
A maximum dose of 1.5 mg/day should not be exceeded.
• Tumours of the gastrointestinal tract
Treatment is usually started at 0.05 mg once or twice a
day by subcutaneous injection. Depending on response and
tolerability, the dosage can be gradually increased
to 0.1 mg to 0.2 mg 3 times/day. In carcinoid tumours,
therapy should be discontinued if there is no improvement
after 1 week of treatment at the maximum tolerated dose.
• Complications following pancreatic surgery
The usual dosage is 0.1 mg 3 times/day by subcutaneous
injection for 1 week, starting at least 1 hour before surgery.
• Bleeding gastro‑oesophageal varices
The recommended dosage is 25 micrograms/hour
for 5 days by continuous intravenous infusion. Monitoring
of blood sugar level is necessary during treatment.
• TSH‑secreting pituitary adenomas
The dosage most generally effective is 100 micrograms
three times a day by subcutaneous injection. The dose can
be adjusted according to the responses of TSH and thyroid
hormones. At least 5 days of treatment will be needed to
judge the efficacy.

Do not use this medicine if you notice particles or a change
of colour.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.
6. Contents of the pack and other information
What Sandostatin contains
–– The active substance is octreotide.
Sandostatin 50 microgram: 1 ml solution
contains 50 microgram octreotide.
Sandostatin 100 microgram: 1 ml solution
contains 100 microgram octreotide.
Sandostatin 500 microgram: 1 ml solution
contains 500 microgram octreotide.
Sandostatin 1000 microgram: one multidose vial of 5 ml
solution contains 1000 microgram octreotide
(200 microgram/1 ml).
–– The other ingredients are
in ampoules: lactic acid, mannitol (E421), sodium
hydrogen carbonate, water for injections in multidose
vials: lactic acid, phenol, mannitol (E421), sodium
hydrogen carbonate, water for injections

Packs of three, five, six, ten, twenty and fifty ampoules.
Multipacks of ten packs, each containing three ampoules.
Multidose vials:
Colourless glass with latex free rubber closure
(isobutylene-isoprene rubber) containing clear, colourless
solution.
Packs of one and five vials.
Multipacks of ten and twenty packs, each containing
one vial.
Not all strengths or pack sizes may be marketed in your
country.
Marketing Authorisation Holder and Manufacturer
Novartis Pharmaceuticals UK Limited, Frimley Business
Park, Frimley, Camberley, Surrey, GU16 7SR, England.
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria, Bulgaria, Croatia,
Sandostatin
Cyprus, Czech Republic,
Denmark, Estonia, Finland,
Germany, Greece, Hungary,
Ireland, Iceland, Latvia,
Lithuania, Malta,Norway,
Poland, Romania, Slovakia,
Slovenia, Spain, Sweden, United
Kingdom

This leaflet was last revised in 03/2016.
If you would like any more information, or would like the
leaflet in a different format, please contact Medical
Information at Novartis Pharmaceuticals UK Ltd, telephone
number 01276 698370.
SANDOSTATIN is a registered trade mark.
Copyright Novartis Pharmaceuticals UK Limited.
The following information is intended for healthcare
professionals only:
• Intravenous infusion (for health‑care professionals)
Inspect the medicinal product visually for discoloration and
particulate matter prior to administration. Do not use it if
you see anything unusual. For intravenous infusion dilute
the product prior to administration. Sandostatin (octreotide
acetate) is physically and chemically stable for 24 hours in
sterile physiological saline solutions or sterile solutions of
dextrose (glucose) 5% in water. However, because
Sandostatin can affect glucose homeostasis, it is
recommended that physiological saline solutions be used
rather than dextrose. The diluted solutions are physically
and chemically stable for at least 24 hours below 25°C.
From a microbiological point of view, the diluted solution
should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are the
responsibility of the user.
The contents of one 500 microgram ampoule should
normally be dissolved in 60 mL physiological saline, and
the resulting solution should be infused by means of an
infusion pump. This should be repeated as often as

2184074 GB

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The Maltings

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
/
WO:
1484895
Comp. Description: Leaflet SANDOSTATIN LIVI/LIAM GB
Comp. Number New: 2184074 GB
Comp. Number Old: 2162780 GB
Format/Dimension: 594 x 148mm
Tech. Drawing No.: 799.4.9166/07

Both

Production Site:
CTM:
Printing Colours:

Stein
Price, Neil
Black

Technical Colours: Cutting
Dimensions

Minimum Font Size: 9.0pt
Font Type: News Gothic
02/03/2016

If you are administering Sandostatin by subcutaneous
injection, it may help to reduce the risk of gastrointestinal
side effects if you avoid eating meals around the time of
injection. It is therefore recommended that you inject
Sandostatin between meals or when you go to bed.

5. How to store Sandostatin
Keep this medicine out of the sight and reach of children.

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A few people experience pain at the site of the
subcutaneous injection. This pain usually only lasts a short
time. If this happens to you, you can relieve this by gently
rubbing the site of injection for a few seconds afterwards.

Rachel Bryan

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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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