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OCTREOTIDE 0.2 MG/ML SOLUTION FOR INJECTION OR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): OCTREOTIDE ACETATE

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Package leaflet: Information for the patient
Octreotide 0.2 mg/ml solution for injection or concentrate for solution for 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 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 Teva 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 Octreotide
helps to lower the risk of complications (e.g. abscess in the abdomen, inflammation of the
pancreas gland) after 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 thyroidstimulating 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
Do not use Octreotide:
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 Octreotide:
-

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

-

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.

-

if you have a history of vitamin B12 derivation 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 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 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 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.
If you use more Octreotide than you should
No life-threatening reactions have been reported after overdose of Octreotide.
The symptoms of overdose are: irregular heartbeat, 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 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 can 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 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 heartbeat.
Uncommon (may affect up to 1 in 100 people):

Thirst, low urine output, dark urine, dry flushed skin.

Fast heartbeat.
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 injection site.
Common (may affect up to 1 in 10 people):

Stomach discomfort after a meal (dyspepsia).

Vomiting.

Feeling of fullness in the stomach.











Fatty stools.
Loose stools.
Discolouration of faeces.
Dizziness.
Loss of appetite.
Changes 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 the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store Octreotide
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 label after EXP. The expiry date
refers to the last day of that month.
Storage conditions:
Before opening: Store in a refrigerator between 2-8°C, protected from light. Do not freeze.
After opening: Opened vials may be stored for 2 weeks at room temperature for day to day use.
After dilution: Octreotide (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
Octreotide 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 preferably be
used immediately. If the solution is not used immediately, storage prior to use is the responsibility of
the user and should be at 2 to 8°C. Before administration the solution has to be brought to room
temperature again. The total time between reconstitution, dilution with infusion media, storage in a
refrigerator, and end of administration must not be longer than 24 hours.
Do not use this medicine unless the solution is clear and free from visible particles.
Do no 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 Octreotide contains
-

The active substance is octreotide (as the acetate).

Each ml of solution for injection or concentrate for solution for infusion contains 0.2 mg
octreotide.
-

The other ingredients are glacial acetic acid, sodium acetate trihydrate (E262), mannitol (E421),
phenol and water for injections.

What Octreotide looks like and contents of the pack
Octreotide 0.2 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 0.2 mg/ml solution for injection or concentrate for solution for infusion is available in pack
sizes of 1, 5, and 10 vials.
Not all pack sizes may be marketed.
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 2014.
PL 00289/1140
<---------------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:


Intravenous infusion (for health-care professionals)

Octreotide (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 Octreotide
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 preferably be used
immediately. If the solution is not used immediately, storage prior to use is the responsibility of the
user and should be at 2 to 8°C. Before administration the solution has to be brought to room
temperature again.
The total time between reconstitution, dilution with infusion media, storage in a refrigerator, and end
of administration must not be longer than 24 hours.
When Octreotide is to be administered as intravenous infusion, the contents of one 0.5 mg 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.

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.

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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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