OCTREOTIDE 0.05 MG/ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance: OCTREOTIDE ACETATE

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Growth hormone secreting pituitary tumours may
sometimes expand and cause problems. Tell your doctor
if you experience any problems with your eyes or sight.
PACKAGE LEAFLET:
INFORMATION FOR THE USER

IN THIS LEAFLET:

1. What Octreotide is and what it is used for
2. Before Octreotide is used
3. How to use Octreotide
4. Possible side effects
5. How to store Octreotide
6. Further information

1

WHAT OCTREOTIDE IS AND WHAT IT IS
USED FOR

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.
Octreotide is used:
• 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).
Octreotide is used to treat people with acromegaly;
• when other types of treatment for acromegaly
(surgery or radiotherapy) are not suitable or
have not worked;
• after radiotherapy, to cover the interim period
until the radiotherapy becomes fully effective;
• before surgery on the pituitary gland

Frequency not known:
• Anaphylaxis (a type of allergic reaction which
causes difficulty in breathing or dizziness),
There is very little experience of using octreotide in
allergy/hypersensitivity reactions
children
• Itchy rash
• Inflammation of the pancreas
If you receive more Octreotide than you should
If you are concerned that you may have been given too • Liver inflammation (hepatitis); symptoms may
include yellowing of the skin and eyes (jaundice),
much Octreotide, tell your doctor or nurse immediately.
nausea, vomiting, loss of appetite, generally
feeling unwell, itching, light-coloured urine
If you miss a dose of Octreotide
• Irregular heart beat
As you will be given this medicine under close
• Liver dysfunction.
supervision, it is very unlikely that you will miss a
dose. If you think that you have missed a dose of
If any of the side effects gets serious, or if you notice
treatment, tell a doctor or nurse at once.
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
5 HOW TO STORE OCTREOTIDE
4 POSSIBLE SIDE EFFECTS
Keep out of the reach and sight of children.
Like all medicines, Octreotide can cause side effects,
Do not use Octreotide after the expiry date which is
although not everybody gets them.
stated on the label after EXP. The expiry date refers
Most people who are prescribed Octreotide benefit from to the last day of that month.
taking it, but a few people can be upset by it. If you
are receiving this medicine on a long term basis then Storage conditions:
Before opening: Store in a refrigerator 2-8°C,
you will go to hospital from time to time to have
protected from light. Do not freeze.
regular check-ups.
There is no need to worry if you suffer from any of the After opening: The product must be used immediately
and any unused drug-product must be discarded.
following common reactions at the site of injection:
• Pain, stinging, tingling, burning, redness and swelling. After dilution: The chemical and physical stability of
These rarely last for more than 15 minutes and will be Octreotide solution diluted in 9 mg/ml (0.9%)
less if you let your medicine reach room temperature sodium chloride solution for infusion has been
before injecting.
demonstrated for 24 hours when stored below 25°C.
Some side effects can be serious. Stop taking Octreotide From a microbiological point of view, the product
and tell your doctor straight away if you notice that: should be used immediately, if not used immediately,
storage times and conditions are the responsibility of
• Your face becomes flushed or swollen or you
the user, unless dilution has taken place in controlled
develop spots or a rash
• Your chest feels tight, you become short of breath and validated aseptic conditions.
or wheezy
Do not use unless the solution is clear and free from
• You feel faint, possibly as a result of a fall in blood visible particles.
pressure.
For single use only.
These might be a result of an allergic reaction.

Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any of the following medicines,
including medicines obtained without a prescription.
• Insulin or other drugs for diabetes
• Ciclosporin (a drug used after a transplant)
• Cimetidine (a drug used to reduce stomach acid)
• Bromocriptine (a drug used in Parkinson’s disease
or in acromegaly or to suppress breast milk)
• 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 (a drug used in psychiatric disorders,
epilepsy, trigeminal neuralgia and neuropathy),
digoxin (medicine for certain heart problems) and
warfarin (a drug used to thin the blood) and
terfenadine (to relieve allergic symptoms).

People with liver or kidney problems may be given a
smaller dose.

Please tell your doctor or hospital pharmacist if you
are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicines. You should not use Octreotide
if you are pregnant unless you have been told by your
doctor that it is absolutely necessary for you to do so.
You should not breast-feed your infant whilst
receiving treatment with octreotide, unless you have
been told to do so.
Driving and using machines
Octreotide may make you feel dizzy. If this happens,
do not drive or operate machinery. Remember that if
you are unwell your ability to operate machinery
may be affected.
Important information about some of the
ingredients of Octreotide
Octreotide 0.05 mg/ml, 0.1 mg/ml and 0.5 mg/ml
solution for injection or concentrate for solution for
infusion contains less than 1 mmol sodium per dose,
i.e. essentially “sodium-free”.

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 the skin or 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.

Other Special Warnings
• Tell your doctor if your stomach or bowel
symptoms get worse
• Octreotide should only be used in pregnancy if
clearly needed. Tell your doctor if you are pregnant
or want to become pregnant
• Women of child bearing potential must use an
• To relieve stomach or bowel symptoms associated
effective contraceptive method during treatment
with certain tumours known as
with Octreotide.
‘gastroenteropancreatic’ tumours (rare tumours of
the stomach, bowels or pancreas)
3 HOW TO USE OCTREOTIDE
Overproduction of specific hormones and other
related natural substances can be caused by some Always use Octreotide exactly as your doctor has
rare conditions of the stomach, bowels or
told you. You should check with your doctor or
pancreas. This upsets the natural hormonal
pharmacist if you are unsure of anything.
balance of the body, and results in a variety of
symptoms, such as flushing, diarrhoea, low blood Your medicine must be injected subcutaneously i.e.
into the tissue under the skin. Your doctor or nurse
pressure, rash and weight loss. Treatment with
will show you how to do this. If you are unsure, go
Octreotide helps to control these symptoms.
back and ask for advice. You must use a clean, sterile
• To prevent complications following pancreatic
syringe and needle every time.
surgery
The upper arms, thighs and stomach are good areas
Octreotide can be used in some patients when
for subcutaneous injection. Choose a different place
they have an operation on the pancreas. It may
help reduce some of the problems which can occur each time so that you don’t irritate a particular area.
Keep changing the injection site. Don’t inject into the
in the abdomen after the operation, such as
same place too frequently.
inflammation (swelling) and infection.

2

BEFORE OCTREOTIDE IS USED

You should NOT be given Octreotide
• if you are allergic (hypersensitive) to octreotide
acetate or any of the other ingredients of
Octreotide (see section 6)
• if you are breast-feeding.
Take special care with Octreotide
• if you are pregnant
• as octreotide may affect your blood sugar levels.
You or your doctor should closely monitor your
blood sugar levels
• if you have any thyroid problems, or have had a
disease which may have affected your thyroid
• if you have any problems with your liver, or have you
had a disease which may have affected your liver
• if you have ever suffered from gallstones or other
stomach problems
• if you have a history of Vitamin B12 deficiency.
Your doctor may need to monitor your vitamin B12
levels during therapy with octreotide.
Your doctor may want to give you a check up from time
to time while you are being treated with Octreotide.

The following side effects have also been reported
and the approximate frequencies shown:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)
Very common:
• 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.

To avoid side effects like stomach ache, wind,
diarrhoea and constipation do not inject at mealtimes.
Inject between meals or before going to bed.
In rare cases Octreotide 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 Octreotide into your veins yourself.
The usual dosages are given below; however your
doctor will decide what dosage to give to you, as this
depends on the nature of your treatment, your age
and your medical condition:
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
they find 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 they
find your ideal dose.

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6

FURTHER INFORMATION

What Octreotide contains
• The active substance is octreotide (as the acetate).
Each ml of solution for injection or concentrate for
solution for infusion contains 0.05 mg, 0.1 mg and
0.5 mg octreotide.
• The other ingredients are glacial acetic acid,
sodium acetate trihydrate (E262), mannitol (E421)
and water for injections.
What Octreotide looks like and contents of the pack
Octreotide 0.05 mg/ml, 0.1 mg/ml and 0.5 mg/ml
solution for injection or concentrate for solution for
infusion is a clear and colourless solution. The
solution is supplied in colourless glass vials closed
with serum rubber stoppers and sealed with
aluminium flip-off caps fitted with plastic flip-off
discs. The product is packed in cardboard boxes.
Octreotide 0.05 mg/ml, 0.1 mg/ml and 0.5 mg/ml
solution for injection or concentrate for solution for
infusion is available in pack sizes of 1, 3, 5, 6, 10, 20
and 30 vials.
Not all pack sizes may be marketed.

After dilution: The chemical and physical stability of
Octreotide solution diluted in 9 mg/ml (0.9%)
sodium chloride solution for infusion has been
demonstrated for 24 hours when stored below 25°C.
From a microbiological point of view, the product
should be used immediately, if not used immediately,
storage times and conditions are the responsibility of
the user, unless dilution has taken place in controlled
and validated aseptic conditions.

Do not use unless the solution is clear and free from
visible particles.



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The following information is intended for medical or with water and soap. If the solution comes into contact
with membranes, wash (irrigate) the affected area
healthcare professionals only:
with water.
Instructions for use, handling and disposal:
To reduce local discomfort, let the solution reach
room temperature before injecting. Avoid multiple
For single use only.
injections at short intervals at the same time.
Octreotide is an injection and a concentrate for solution Storage:
for infusion. This must be handled with caution. The Storage conditions:
dilution must be done under aseptic conditions, by
Before opening: Store in a refrigerator 2-8°C,
trained staff and in a specific area. The contact of
protected from light. Do not freeze.
Octreotide with skin and membranes should be avoided. After opening: The product must be used immediately
If the solution comes into contact with the skin: wash and any unused drug-product must be discarded.

Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

Common:
• 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.



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Uncommon:
• Dehydration
• Fast heart beat.

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Read all of this leaflet carefully before you start
using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Tell your doctor if your stomach or bowel problems
get worse.

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OCTREOTIDE 0.05 mg/ml, 0.1 mg/ml
and 0.5 mg/ml SOLUTION FOR
INJECTION OR CONCENTRATE FOR
SOLUTION FOR INFUSION

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG,
United Kingdom
Manufacturer
Teva Pharmaceutical Works Private Limited Company
H-2100 Gödöllö
Táncsics Mihály út 82
Hungary
This leaflet was last revised in November 2011
PL 00289/1257
PL 00289/1264-5

61204-A

Disposal:
Any unused product or waste material should be
disposed of in accordance with local requirements.

61204-A

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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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