SYNACTHEN DEPOT®

1mg/ml Suspension for Injection

Tetracosactrin Zinc Phosphate Complex

What is in this leaflet

This leaflet answers some common questions about Synacthen Depot.

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 Depot 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 Depot is used for

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

This medicine is not suitable for newborn babies, especially if they are
premature, because it contains benzyl alcohol, which can cause severe side
effects in very young babies.

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

Your doctor may have prescribed it for another reason.

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

Before you have Synacthen Depot

When you must not have it

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

• tetracosactrin, the active ingredient in Synacthen Depot 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 Depot 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 Depot 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 Depot.

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

Do not have Synacthen Depot 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 Depot 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 Depot 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 Depot.

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

How Synacthen Depot is given

How much is given

Adults: the starting dose is usually a single daily injection of 1 mg but it
may be given twice a day in severe cases. Once the condition has improved, the
number of injections can usually be reduced to one every 2 or 3 days or even
once weekly.

Children: the starting dose is usually a single daily injection ranging from
0.25 to 1 mg, depending on the age of the child. Once the condition has
improved, the number of injections can usually be reduced to one every 2 to 8
days.

How long treatment lasts

Synacthen Depot 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 Depot

Things you must do

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

This medicine must not be used during pregnancy.

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

Your doctor will check for unwanted side effects. Some side effects such as
changes in blood pressure and in the levels of sugar and other elements in the
blood may only be found by doing regular tests. Children may need to have their
heart checked and their growth monitored during long-term treatment.

If you suffer an injury requiring medical attention or you are about to
undergo surgery, either during treatment with Synacthen Depot or within 1 year
after treatment has stopped, be sure to tell the doctor who treats you about
this medicine.

Prolonged treatment with Synacthen Depot may make your adrenal glands less able
to cope with the stress to your body caused by an injury or surgery.

If you are about to be started on any new medicine, remind your doctor and
pharmacist that you are having Synacthen Depot.

Tell any other doctor, dentist or pharmacist who treats you that you are having
Synacthen Depot.

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 Depot 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 Depot 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 Depot 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 Depot.

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 Depot, 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 Depot

Storage

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

Disposal

If your doctor stops your treatment with Synacthen Depot 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 Depot is available in a glass ampoule containing 1 mL of milky
white liquid; one ampoule per carton.

Ingredients

Each ampoule of Synacthen Depot contains 1 mg of the active ingredient,
tetracosactrin (in a zinc phosphate complex). It also contains:

• benzyl alcohol
• hydrochloric acid
• sodium chloride
• sodium hydroxide
• sodium phosphate dibasic
• zinc chloride
• water for injections