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

Active substance: OCTREOTIDE ACETATE

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Octreotide 0.2mg/ml Solution for Injection or Concentrate for Solution for Infusion
PL 00289/1140
UK/H/2340/01/DC

Version 1
Draft 1

PACKAGE LEAFLET: INFORMATION FOR THE USER
Octreotide 0.2 mg/ml Solution for injection or Concentrate for solution for infusion
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.

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


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


To prevent complications following pancreatic surgery

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Octreotide 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.

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
you 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.
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.
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).

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.
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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 0.2 mg/ml solution for injection or concentrate for solution for infusion contains less than 1
mmol sodium per dose, i.e. essentially “sodium-free”.
Other Special Warnings




3.

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 effective contraceptive method during
treatment with Octreotide

HOW TO USE OCTREOTIDE

Always use Octreotide exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are unsure of anything.
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.
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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To prevent complications following pancreatic surgery
• 0.1 mg three times a day for seven days starting on the day of the operation.
People with liver or kidney problems may be given a smaller dose.
There is very little experience of using octreotide in children
If you receive more Octreotide than you should
If you are concerned that you may have been given too much Octreotide, tell your doctor or nurse
immediately.
If you miss a dose of Octreotide
As you will be given this medicine under close supervision, it is very unlikely that you will miss a
dose. If you think that you have missed a dose of treatment, tell a doctor or nurse at once.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Octreotide can cause side effects, although not everybody gets them.
Most people who are prescribed Octreotide benefit from taking it, but a few people 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 for more than 15 minutes and will be less if you let your medicine reach room
temperature before injecting.
Some side effects can be serious. Stop taking Octreotide 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.
These might be a result of an allergic reaction.
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.
The following side effects have also been reported and the approximate frequencies shown:
Very common (≥1/10)
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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
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.
Uncommon:
• Dehydration
• Fast heart beat
Frequency not known:
• 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
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Liver dysfunction.

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.

5.

HOW TO STORE OCTREOTIDE

Keep out of the reach and sight of children.
Do not use Octreotide 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 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: 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.
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.

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 0.2 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.
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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 00289/1140
<---------------------------------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
Instructions for use, handling and disposal:
Octreotide Teva is an injection and a concentrate for solution for infusion. This must be handled with
caution. The dilution must be done under aseptic conditions, by trained staff and in a specific area.
The contact of Octreotide Teva with skin and membranes should be avoided. If the solution comes
into contact with the skin: wash with water and soap. If the solution comes into contact with
membranes, wash (irrigate) the affected area with water.
To reduce local discomfort, let the solution reach room temperature before injecting. Avoid multiple
injections at short intervals at the same time.
To prevent contamination, it is recommended to puncture the cap of the vial not more than 10 times.
Storage:
Storage conditions:
Before opening: Store in a refrigerator 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: The chemical and physical stability of Octreotide Teva 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.
Disposal:
Any unused product or waste material should be disposed of in accordance with local requirements.

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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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