SANDOSTATIN®

0.05, 0.1 and 0.5mg/ml Injection

Octreotide

What is in this leaflet

This leaflet answers some common questions about Sandostatin.

It does not contain all the available information. It does not take the
place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of
you using Sandostatin against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or
pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Sandostatin is used for

Sandostatin has 4 uses:

1. Sandostatin is used to treat acromegaly
   
   
   
   In people with acromegaly the body makes too much growth hormone, which
   controls the growth of tissues, organs and bones. This leads to enlargement
   of the bones, especially of the hands and feet. Other symptoms include
   headaches, increased sweating, tiredness, numbness of the hands and feet,
   pain and stiffness in the joints and loss of sexual function. By blocking
   the excess growth hormone, Sandostatin can relieve many of these symptoms.
2. Sandostatin is used to relieve symptoms of certain types of cancer such
   as carcinoid syndrome, VIPomas, glucagonomas, gastrinomas, insulinomas and
   GRFomas.
   

   
   
   By blocking hormones that are over-produced in these conditions, Sandostatin
   can relieve symptoms such as flushing of the skin and severe diarrhoea.

3. Sandostatin is used for people who are having surgery on the pancreas.
   This medicine helps to lower the chance of complications after the surgery.
   
   
   
   Sandostatin is used in the emergency management of oesophageal varices. This
   medicine helps to stop bleeding and to protect from rebleeding from
   oesophageal varices.

Sandostatin contains octreotide, a man-made medicine derived from
somatostatin, a substance found in the human body. Octreotide is used instead
of somatostatin because its effects are stronger and last longer so that it
needs to be given only 2 or 3 times a day.

Ask your doctor if you have any questions about why Sandostatin has been
prescribed for you.

Your doctor may have prescribed this medicine for another reason.

This medicine is only available with a doctor's prescription. It is not
addictive.

There is very little information on the use of this medicine in children.

Before you use Sandostatin

When you must not use it

Do not use Sandostatin if you have an allergy to:

• octreotide (the active ingredient in Sandostatin) or any of the other
  ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include shortness of
breath, wheezing or difficulty breathing; swelling of the face, lips, tongue
or other parts of the body; rash, itching or hives on the skin.

Do not use Sandostatin after the expiry date printed on the pack or if
the packaging is torn or shows signs of tampering.

In that case, return it to your pharmacist.

Before you start to use it

Tell your doctor if you have, or have had, any of the following medical
conditions:

• gallstones (your doctor may wish to check your gallbladder periodically)
• problems with your blood sugar levels, either too high (diabetes) or too
  low (hypoglycaemia)
• problems with your liver
• history of vitamin B₁₂ deprivation (your doctor may wish to
  check your B₁₂ levels periodically)
• if you receive long term treatment with Sandostatin your doctor may wish
  to check your thyroid periodically

Your doctor may want to take special precautions if you have any of the
above conditions.

Tell your doctor if you are pregnant or intend to become pregnant or
wish to breast-feed your baby.

There is not much information on the use of Sandostatin during pregnancy or
breast-feeding. If it is necessary for you to use this medicine, your doctor
will discuss with you the benefits and risks involved.

If you have not told your doctor about any of these things, tell him/her
before you use Sandostatin.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any
that you buy without a prescription from a pharmacy, supermarket or health
food shop.

Some medicines and Sandostatin may interfere with each other. Some of these
medicines include:

• bromocriptine, a medicine which is also used to treat acromegaly
• medicines for diabetes
• cimetidine, a medicine for ulcers
• cyclosporin, a medicine used to suppress the immune system
• quinidine, a medicine used to prevent irregular heartbeats
• terfenadine, a medicine used to relieve the symptoms of allergies
• medicines to control blood pressure (beta-blockers or calcium channel
  blockers)
• agents to control fluid and electrolyte balance

You may need to take different amounts of your medicines or you may need to
take different medicines.

Your doctor and pharmacist have more information on medicines to be careful
with or avoid while using Sandostatin.

How to use Sandostatin

Follow all directions given to you by your doctor and pharmacist
carefully.

These directions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor
or pharmacist for help.

How it is given

Sandostatin cannot be taken by mouth because it is rapidly broken down in
the stomach. Instead it is given as a subcutaneous injection. That means that
it is injected into the fat layer just under the skin.

How much is given

The dose of Sandostatin depends on the condition being treated.

1. Acromegaly: treatment is usually started with injections of 0.05 to 0.1
   mg every 8 or 12 hours. The dose can then be adjusted depending on how well
   it blocks growth hormone and relieves symptoms such as tiredness, sweating
   and headache.
2. Carcinoid syndrome and VIPoma: treatment is usually started with
   injections of 0.05 mg once or twice a day. The dose can be increased if
   symptoms such as diarrhoea are not relieved.
3. Surgery on the pancreas: injections of 0.1 mg are usually given three
   times a day for one week, starting about an hour before the operation.

If you are giving the injections yourself

If you will be giving the injections yourself, your doctor or nurse will
teach you how to do it properly.

Before using a Sandostatin ampoule, check the liquid for particles or a
change in colour. If you notice anything unusual, do not use the ampoule.

Once an ampoule is opened, use it immediately and throw out any liquid
that remains.

The ampoule does not contain any preservative.

Give the injections between meals or at bedtime. Avoid having meals
around the time of the injections.

This will help to reduce the chance of stomach upset.

To help prevent irritation or pain at the injection site:

• Choose a new site for each injection. The upper arms, thighs and abdomen
  are good areas for injection.
• Make sure the ampoule is at room temperature before you use it. If it
  has been in the fridge, take it out half an hour before using it. You can
  warm it up in your hand but don't try to heat it.

If you notice pain, stinging, tingling, burning, redness or swelling at
the injection site after the injection, gently rub the site for a few seconds.

These side effects rarely last more than 15 minutes after an injection.

If you forget to use it

Inject the dose as soon as you remember, and then go back to using it as
you would normally.

It won't do any harm if you miss a dose but some of your symptoms may come
back temporarily until you get back on schedule.

Do not use a double dose to make up for the one that you missed.

This may increase the chance of you getting an unwanted side effect.

If you have trouble remembering when to use your medicine, ask your
pharmacist for some hints.

If you use too much (Overdose)

Immediately telephone your doctor or Poisons Information Centre
[telephone 0800 POISON (0800 764 766)], or go to Accident and Emergency at
your nearest hospital if you think that an overdose has happened. Do this even
if there are no signs of discomfort or poisoning.

Some of the symptoms of an overdose may include irregular heartbeat,
flushing of the face, cramps in the abdomen, diarrhoea, an empty feeling in
the stomach and nausea (feeling sick), loss of appetite, weakness, tiredness,
lack of energy, weight loss.

No life-threatening reactions have been reported after an overdose of this
medicine.

While you are using Sandostatin

Things you must do

Keep all of your doctor's appointments so that your progress can be
checked.

If you must use this medicine for a long time, your doctor may want to check
your blood sugar, gallbladder and liver function from time to time to prevent
unwanted side effects from happening.

If you are about to be started on any new medicine, remind your doctor
and pharmacist that you are using Sandostatin.

Tell any other doctor, dentist or pharmacist who treats you that you are
using Sandostatin.

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem to
be the same as yours.

Do not use it to treat any other complaints unless your doctor tells you
to.

Things to be careful of

Be careful driving, operating machinery or doing jobs that require you
to be alert until you know how Sandostatin affects you.

This medicine may cause dizziness, lightheadedness or weakness in some people.
If you have any of these symptoms, do not drive or do anything else that could
be dangerous.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel
well while you are using Sandostatin.

All medicines can have side effects. Sometimes they are serious, but most of
the time they are not. You may need medical treatment if you get some of the
side effects.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor immediately or go to Accident and Emergency at your
nearest hospital if you notice:

• signs of allergy such as rash, itching or hives on the skin; swelling of
  the face, lips, tongue or other parts of the body; shortness of breath,
  wheezing or troubled breathing
• severe pain, tenderness or swelling in the stomach or abdomen, which may
  be accompanied by fever, nausea and vomiting (symptoms of a possible problem
  with your liver, pancreas or gall bladder)
• symptoms of low blood glucose (hypoglycaemia), including sweating,
  trembling, dizziness, weakness, hunger, palpitations (feeling of fast or
  irregular heartbeat) and fatigue
• symptoms of high blood glucose (hyperglycaemia), including lethargy or
  tiredness, headache, thirst, passing large amounts of urine, and blurred
  vision
• unusually slow heartbeat
• changes in the activity of thyroid gland (hyper- or hypothyroidism)
  causing changes in heart rate, appetite, weight, tiredness, feeling cold or
  sweating too much anxiety or swelling at the front of the neck
• changes in liver function tests
• back pain from gall stones

Tell your doctor if you notice any of the following side effects and
they worry you:

• irritation or pain at the injection site
• loss of appetite
• nausea or vomiting
• cramps
• feeling of bloating or wind
• diarrhoea or other change in bowel motions
• headache
• dizziness or light headedness
• swelling of hands or feet due to excess fluid
• tiredness or weakness
• flushing of the skin
• temporary hair loss
• dizziness

Tell your doctor if you notice anything else that is making you feel
unwell.

Other side effects not listed above may happen in some people.

After using Sandostatin

Storage

• Keep the ampoules in the original container until it is time to use
  them.
• You can store the ampoules for up to 2 weeks at room temperature.
• If you are storing the ampoules for longer than 2 weeks, keep them in
  the refrigerator. Do not freeze them.
• Do not store Sandostatin or any other medicine in the bathroom or near a
  sink.
• Do not leave them in the car or on window sills.

Keep the medicine where children cannot reach it.

Disposal

If any ampoules have been left out of the fridge for longer than 2
weeks, do not use them.

If your doctor tells you to stop using this medicine or you find that
the expiry date has passed or the ampoules have been left out of the fridge
for too long, ask your pharmacist what to do with any medicine you have left
over.

Product description

What it looks like

Sandostatin comes in 1mL glass ampoules containing a clear, colourless
liquid; boxes of 5.

Ingredients

Sandostatin ampoules contain 0.05 mg, 0.1 mg or 0.5 mg of the active
ingredient, octreotide (as octreotide acetate). They also contain:

• lactic acid
• mannitol
• sodium hydrogen carbonate
• water for injections