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OCTREOTIDE 100 MICROGRAMS/1 ML SOLUTION FOR INJECTION

Active substance(s): OCTREOTIDE ACETATE / OCTREOTIDE ACETATE

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

6166-01

Package leaflet: Information for the patient
Octreotide 50 micrograms/1 ml solution for injection
Octreotide 100 micrograms/1 ml solution for injection
Octreotide 200 micrograms/ml solution for injection
Octreotide 500 micrograms/1 ml solution for injection
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 Octreotide is and what it is used for
2. What you need to know before you use Octreotide
3. How to use Octreotide
4. Possible side effects
5. How to store Octreotide
6. Contents of the pack and other information

1. What Octreotide is and what it is used for
Octreotide 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 Octreotide over somatostatin are that it is stronger and its
effects last longer.
Octreotide 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.
Octreotide 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 blood pressure, rash, and weight loss. Treatment with
Octreotide helps to control these symptoms.
• to prevent complications following surgery of the pancreas gland. Treatment
with Octroetide 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
Octreotide 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. Octreotide 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

2. What you need to know before you use Octreotide

• 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 Octreotide 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 Octreotide in children.

Other medicines and octreotide:
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 Octreotide. However, certain
medicines, such as cimetidine, ciclosporin, bromocriptine, quinidine and terfenadine have
been reported to be affected by Octreotide.
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.
If you are diabetic, your doctor may need to adjust your insulin dosage.

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.
Octreotide 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 Octreotide. It is not known whether Octreotide passes into
breast milk.

Driving and using machines
Octreotide has no or negligible effects on the ability to drive and use machines. However,
some of the side effects you may experience while using Octreotide, such as headache
and tiredness, may reduce your ability to drive and use machines safely.

3. How to use Octreotide
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, Octreotide 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 Octreotide under the skin, but
infusion into a vein must always be performed by a healthcare 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 Octreotide, 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 no more
than 10 times.

Do not use octreotide:

If you use more octreotide than you should

• if you are allergic to octreotide or any of the ingredients of this medicine (listed in
section 6).

No life-threatening reactions have been reported after overdose of Octreotide.

Warnings and precautions
Talk to your doctor before using Octreotide.
• if you know that you have gallstones now, or have had them in the past; tell your doctor,
as prolonged use of Octroetide may result in gallstone formation. Your doctor may wish
to check your gallbladder periodically.

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.

The following information is intended for
healthcare professionals only:

Intravenous infusion (for health-care
professionals)
The diluted solutions of Octreotide Hospira
(octreotide acetate) in 0.9% sodium
chloride solution for injection and stored
in PVC bags or in polypropylene syringes
are physically and chemically stable for
seven days when stored at below 25°C.
From a microbiological point of view,
the diluted solution should preferable
by used immediately. If the solution
is not used immediately, storage prior
to use is the responsibility of the user
and noramlyl should not be longer than
24 hours at 2 to 8°C, unless dilution has
taken place in controlled and validated
aseptic conditions. Before administration
the solution has to be brought to room
temperature again.
When Octreotide is to be administered as
intravenous infusion, the contents of one
500 micrograms vial 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
necessary until the prescribed duration of
treatment is reached.
Before using an Octreotide vial, 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.

How much Octreotide to use
The dose of Octreotide 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.

Component Specification

Requester

Item number:

6166-01

Request number:

PAR-2016-0006166

Country:

UK & Ireland

OI template:
Amalia version:

OMI001
7

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

360 x 305 mm
1 ml & 5 ml vials
Omega
N/A
72 x 39 mm
Yes
No

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed to
the printing stage.

Pharma code:
Pharma code length:
Supplier Code:

N/A
N/A

Colours
Black:

TBC

Previous Item Number: Q79776
Signed:
Date:
Version 1
Technician:
Date:

CS
18/Aug/16

Version 2
Technician:
Date:

KM
23/Aug/16

Version 3
Technician:
Date:

CS
25/Aug/16

Version 4
Technician:
Date:

KM
19/Sep/16

Version 5
Technician:
Date:

CS
06/Oct/16

Version 6
Technician:
Date:

CS
10/Oct/16

Version 7
Technician:
Date:

XX
dd/mmm/yy

Version 8
Technician:
Date:

XX
dd/mmm/yy

Version 9
Technician:
Date:

XX
dd/mmm/yy

Version 10
Technician:
Date:

XX
dd/mmm/yy

6166-01

• 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.

If you forget to use Octreotide
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 Octreotide to make up for forgotten individual doses.

If you stop using Octreotide
If you interrupt your treatment with Octreotide, your symptoms may come back. Therefore,
do not stop using Octreotide 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.

Some side effects could be serious. Tell your doctor straight away if you get any of
the following:
Very common (may affect more than 1 in 10 people):
• Gallstones, leading to sudden back pain
• Too much sugar in the blood
Common (may affect up to 1 in 10 people):
• Underactive thyroid gland (hypothyroidism) causing change 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 heartbeat
Tell your doctor straight away if you notice any of the side effects above.

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

If you are administering Octreotide 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 Octreotide between meals or when you go to
bed.

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 via
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this
medicine

5. How to store Octreotide

Component Specification

Requester

Item number:

6166-01

Request number:

PAR-2016-0006166

Country:

UK & Ireland

The multidose vials of 200 micrograms/ml solution for injection for daily use may be stored
for two weeks below 25ºC.

OI template:
Amalia version:

OMI001
7

Octreotide, diluted in 0.9% sodium chloride would not normally be stored for longer than
24 hours in a refrigerator.

The injection should only be used if it is clear and free of particles.

Dimensions:
Container(s):
Supplier:
Stock:
Folded dimensions:
Printed both sides:
Perforated:

360 x 305 mm
1 ml & 5 ml vials
Omega
N/A
72 x 39 mm
Yes
No

I have checked this artwork against the
registered text including spelling, layout, size,
colours, registration numbers and scientific
equations, the name and address and
trademarks. Also for any possible changes to
related items.
This artwork is in conformance with the
Marketing Authorisation and can now proceed to
the printing stage.

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.

Pharma code:
Pharma code length:
Supplier Code:

N/A
N/A

Keep the vial in the outer carton in order to protect the product from light.
Medicinal product as packaged for sale: Store in a refrigerator (2ºC-8ºC). Do not freeze.
Shelf-life after first opening: The product must be used immediately and any unused
drug-product must be discarded.

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

6. Contents of the pack and other information
What Octreotide Solution for Injection contains
• The active substance is octreotide;
• The other excipients are glacial acetic acid, sodium acetate trihydrate, sodium
chloride and water for injections. The multi-dose vials additionally contain phenol
(a preservative).
This medicinal product contains less than 1 mmol (23 mg) of sodium (i.e., essentially
sodium free) per ml of solution.

What Octreotide Solution for Injection looks like and contents of the pack
Octreotide Solution for Injection is available as vials containing a clear, colourless solution
for injection.

Octreotide Solution for Injection is available in the following pack sizes:

Octreotide solution for injection 50 micrograms/1 ml (packs of 5, or 30 vials)
Octreotide solution for injection 100 micrograms/1 ml (packs of 5, or 30 vials)
Octreotide solution for injection 500 micrograms/1 ml (packs of 5, or 30 vials)
Octreotide solution for injection 200 micrograms/ ml (packs of 1 or 10 multidose vials)
The vials may be overwrapped with a protective plastic to minimise the risk of spillage if
the vials break; these vials are referred to as ONCO-TAIN®.
Not all pack sizes may be marketed.
Octreotide is an injectable solution that depending on the condition being treated, it is
administered by subcutaneous injection (s.c.) or by intravenous infusion (i.v.).

Marketing authorisation holder and manufacturer:
Hospira UK Limited
Horizon
Honey Lane
Hurley, Maidenhead
SL6 6RJ
UK

This leaflet was last revised in 04/2016.

Colours
Black:

TBC

Previous Item Number: Q79776
Signed:
Date:
Version 1
Technician:
Date:

CS
18/Aug/16

Version 2
Technician:
Date:

KM
23/Aug/16

Version 3
Technician:
Date:

CS
25/Aug/16

Version 4
Technician:
Date:

KM
19/Sep/16

Version 5
Technician:
Date:

CS
06/Oct/16

Version 6
Technician:
Date:

CS
10/Oct/16

Version 7
Technician:
Date:

XX
dd/mmm/yy

Version 8
Technician:
Date:

XX
dd/mmm/yy

Version 9
Technician:
Date:

XX
dd/mmm/yy

Version 10
Technician:
Date:

XX
dd/mmm/yy

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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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