SANDOSTATIN® LAR®

10mg, 20mg and 30mg Injection

Octreotide

What is in this leaflet

This leaflet answers some common questions about Sandostatin LAR.

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 having Sandostatin LAR against the benefits they expect it will
give you.

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

Keep this leaflet. You may need to read it again.

What Sandostatin LAR is used for

Sandostatin LAR is a long acting form of Sandostatin injection. It is
injected into the buttocks once every 4 weeks, instead of having frequent
injections of the short-acting Sandostatin under the skin.

• Sandostatin LAR 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. Too much growth hormone
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 LAR can relieve many of
these symptoms.

• Sandostatin LAR is used to relieve symptoms of certain types of cancer
  such as carcinoid syndrome, VIPomas, glucagonomas, gastinomas, insulinomas
  and GRFomas.

By blocking hormones that are over-produced in these conditions,

Sandostatin LAR can relieve symptoms such as flushing of the skin and
severe diarrhoea.

Sandostatin LAR contains octreotide, a man-made medicine derived from
somatostatin. Somatostatin is a substance found in the human body which
controls the effects of certain hormones such as insulin and growth hormone.
Sandostatin LAR is used instead of somatostatin because its effects are
stronger and last longer.

Ask your doctor if you have any questions about why Sandostatin LAR 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 have Sandostatin LAR

When you must not have it

Do not have Sandostatin LAR if you have an allergy to:

• octreotide (the active ingredient in Sandostatin LAR) 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 have Sandostatin LAR 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 have it

Tell your doctor if you have 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 you B₁₂ levels periodically)
• if you receive long treatment of Sandostatin LAR your doctor may wish to
  check your thyroid function periodically.

Your doctor may want to take special precautions if you have any of these
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 LAR during pregnancy
or breast-feeding. If it is necessary for you to have 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 have Sandostatin LAR.

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 LAR 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 electrolye 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 having Sandostatin LAR.

How Sandostatin LAR is given

Your doctor or nurse will inject Sandostatin LAR into your buttocks.

How much is given

The usual starting dose of Sandostatin LAR is 20 mg, injected every 4
weeks. After about 3 months, the dose may be lowered to 10 mg or increased to
30 mg depending on how you respond to it.

Depending on your condition you may also need to continue injecting
short-acting Sandostatin under the skin for about 2 weeks after your first
injection of Sandostatin LAR. Your doctor will tell you if this is the case.

If you forget to have it

If you forget to have your injection, have it as soon as you remember
and then go back to your normal schedule.

It will not do any harm if your dose is a few days late but some of your
symptoms may come back temporarily until you get back on schedule.

If you are given too much (Overdose)

Tell your doctor if you notice any of the following signs that the dose
of Sandostatin LAR is too high.

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, weight loss, lack of
energy and tiredness, yellow skin and eyes.

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

While you are having Sandostatin LAR

Things you must do

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

If you must have 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 having Sandostatin LAR.

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

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 LAR 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 having Sandostatin LAR.

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 if you notice:

• signs of allergy such as rash, itching or hives on the skin; swelling of
  the face, lips, tongue or other part 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
• changes in the activity of the thyroid gland (hyper - or hypothyroidism)
  causing changes in heart rate, appetite, weigh; tiredness, feeling cold or
  sweating too much anxiety or swelling at the front of the neck
• change in liver function tests

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

• pain, rash or swelling at the injection site
• loss of appetite
• nausea or vomiting
• cramps
• feeling of bloating or wind
• diarrhoea or other change in bowel motions
• 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 LAR

Storage

If you have to store Sandostatin LAR at home:

• Keep the vials in the original container until it is time to use them.
• If you are storing the vials for longer than one day, keep them in the
  refrigerator. Do not freeze them.
• You can keep the vials at room temperature on the day of injection.

If any vials have been left out of the fridge for longer than one day,
do not use them.

Keep the medicine where children cannot reach it.

Disposal

If your doctor stops your treatment with this medicine or you find that
the expiry date has passed or the vials 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 LAR is a white powder packed in a glass vial. Each box of
Sandostatin LAR contains one vial of powder, a glass prefilled syringe of
liquid to mix with the powder and 2 needles.

Ingredients

Sandostatin LAR vials contain 10 mg, 20 mg or 30 mg of the active
ingredient, octreotide (as octreotide acetate). They also contain:

• mannitol
• polyglactin

The rubber stopper in the vial contains latex.

The prefilled syringe solution contains:

• mannitol
• sodium carboxymethylcellulose
• water for injections