SYNACTHEN®

250 mcg/ml Solution for Injection or infusion

Tetracosactrin

What is in this leaflet

This leaflet answers some common questions about Synacthen.

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 or your child having Synacthen against the benefits they expect it will
provide.

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

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

What Synacthen is used for

Synacthen is used as a diagnostic test to find out if the adrenal glands,
small glands next to the kidneys, are working as well as they should.

Synacthen may also be used instead of steroids (medicines such as cortisone)
to treat a number of different conditions:

• acute exacerbations of multiple sclerosis.
• some types of seizures in children.
• rheumatic diseases as a short-term therapy in conditions for which
  corticoids are normally used.
• skin diseases responsive to corticoids.
• ulcerative colitis and Crohn's disease.
• additional therapy in cancer patients to improve the tolerability of
  chemotherapy.

Synacthen works by causing the adrenal glands to increase the production of
natural "steroid" hormones that can help to reduce the symptoms of certain
diseases.

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

Your doctor may have prescribed it for another reason.

Synacthen is only available with a doctor's prescription. It is not
habit-forming.

Before you have Synacthen

When you must not have it

Do not have Synacthen if you have ever had an allergic reaction to:

• tetracosactrin, the active ingredient in Synacthen or any of the other
  ingredients listed at the end of this leaflet
• a similar medicine called ACTH or corticotrophin

Symptoms of an allergic reaction may include redness or pain at the injection
site, rash, itching, hives or flushing of the skin, dizziness, nausea (feeling
sick) or vomiting, difficulty breathing, swelling of the face, lips, tongue or
other parts of the body.

Do not have Synacthen if you have any of the following health
problems/medical conditions:

• a viral illness or you have recently been vaccinated with a live virus
  vaccine
• an infection, unless you are taking antibiotics for it
• a stomach ulcer
• severe heart disease
• abnormal functioning of your adrenal glands
• a mental illness with disturbances in thinking, feelings and behaviour

If you are unsure whether any of the above conditions apply to you, your
doctor can provide more information.

Do not have Synacthen if you are pregnant.

This medicine may affect your developing baby or cause a miscarriage if you have
it while you are pregnant.

Do not breast-feed while you are having Synacthen.

There is not enough information to recommend breast-feeding while you are having
this medicine.

Do not have Synacthen if the expiry date printed on the pack has passed or
if the packaging is torn or shows signs of tampering.

In that case, return it to your pharmacist.

Before you start to have it

Tell your doctor if you have asthma or allergies, including any allergies
to other medicines, foods, dyes or preservatives.

Your chance of having an allergic reaction to Synacthen may be greater than
normal.

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

• diabetes
• high blood pressure
• kidney problems
• an inflammation of the bowel (e.g. ulcerative colitis or diverticulitis)
• recent bowel surgery
• blockage of a blood vessel by a clot (thromboembolism)
• weak brittle bones (osteoporosis)
• myasthenia gravis, a condition which causes extreme muscle weakness
• an underactive thyroid gland
• cirrhosis of the liver
• tuberculosis
• an eye infection caused by herpes simplex virus
• an infection caused by an amoeba

If you are unsure about any of the above conditions, your doctor can provide
more information.

Taking other medicines

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

Some medicines and Synacthen may interfere with each other. These include:

• medicines for diabetes
• medicines for high blood pressure

Your doctor may need to adjust the dose of these medicines while you are
being treated with Synacthen.

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

How Synacthen is given

How much is given

For diagnosis of hormonal problem only one dose of Synacthen is needed. For
therapeutic use, your doctor will decide on a suitable dose of Synacthen
depending on your condition.

Adults, including elderly patients will be given 250mcg (one ampoule).

How long treatment lasts

You will be given a single injection of Synacthen into the muscle. You will
have two blood samples taken, one before the dose of Synacthen and the other 30
minutes after the dose. These blood samples will show whether your adrenal
glands are functioning as well as they should

In the case of therapeutic use Synacthen will not cure your condition but it
may relieve some of the symptoms. The injections can be continued for as long as
they provide a benefit. When treatment is stopped, it will usually be done
gradually to help maintain the normal function of your adrenal glands.

While you are having Synacthen

Things you must do

If you become pregnant while having Synacthen, tell your doctor
immediately.

This medicine must not be used during pregnancy.

Things you must not do

Do not have any vaccinations without first checking with your doctor.

This medicine can change your response to vaccines and may prevent you from
being successfully vaccinated against some diseases.

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

Do not give this medicine to anyone else, even if they seem to have the
same condition as you.

Things to be careful of

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

This medicine may cause headache and vertigo (spinning sensation) in some
people. Make sure you know how it affects you before you drive or do anything
else that could be dangerous.

If you are being treated for diabetes, be careful to check your blood
sugar regularly and report any problems to your doctor.

Synacthen may change how well your diabetes is controlled. The dose of your
diabetes medicines may need to be changed.

Be careful to avoid close contact with anyone who has an infectious
disease.

This medicine may make you more susceptible to infections than usual and these
infections may be more serious.

Side effects

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

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

Side effects can often be relieved by reducing the dose given at each
injection or increasing the time between injections.

Do not be alarmed by the following lists of possible side effects. You may
not experience any of them.

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

During the injection of Synacthen, tell your doctor immediately if you
notice any of the following signs of a possible allergic reaction:

• redness or pain at the injection site
• rash, itching, hives or flushing of the skin
• dizziness
• nausea (feeling sick) or vomiting
• difficulty breathing
• swelling of the face, lips, tongue or other parts of the body

Allergic reactions can happen rarely, usually within 30 minutes after the
injection. During this period, your doctor or nurse will watch you closely for
signs of allergy and will have medicines to treat this type of reaction near at
hand.

Tell your doctor immediately if you notice any of the following symptoms
at any time during treatment:

• severe pain or tenderness in the stomach, which may be accompanied by
  nausea (feeling sick) and vomiting
• vomiting blood or material that looks like coffee grounds
• pain and ulceration along the food pipe leading from the throat to the
  stomach
• convulsions (fits)
• pain in the eye or difficulty seeing
• sudden severe headache, sudden loss of coordination, slurred speech,
  numbness in an arm or leg, pain in the calves, thighs or chest
• shortness of breath and swelling of legs or ankles due to fluid build-up
• rapid changes in mood from extreme happiness to depression, personality
  changes or other disturbances in thinking, feelings and behaviour
• any infections, abscesses or wounds other than of a very minor nature

Tell your doctor if any of the following happen and they worry you:

• headache
• spinning sensation (vertigo)
• difficulty sleeping
• muscle weakness
• feeling of bloating in the abdomen
• changes to the skin such as thinning, darkening in colour, acne, stretch
  marks, red or purple pinhead spots or bruising
• red or moon- shaped face
• increased sweating
• excessive hair growth
• changes in menstrual period
• increased appetite
• weight gain

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 Synacthen

Storage

If you are storing Synacthen at home, keep it in the fridge. Make sure
that young children cannot reach it.

Disposal

If your doctor stops your treatment with Synacthen or you find that the
expiry date has passed, ask your pharmacist what to do with any medicine that
you have left over.

Product description

What it looks like

Synacthen is available in a glass ampoule containing 1 mL of clear colourless
liquid; 10 ampoules per pack.

Ingredients

Each ampoule of Synacthen contains 250mcg of the active ingredient,
tetracosactrin (as in hexa-acetate salt). It also contains:

• acetic acid
• sodium acetate
• sodium chloride
• water for injections

This medicine does not contain any preservative.