Consumer Medicine Information

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.

Sponsor

Synacthen is supplied in New Zealand by:
Novartis New Zealand Limited
Private Bag 47909
Ponsonby
6-8 Mackelvie Street
Grey Lynn
AUCKLAND

Telephone: 0800 652 422

® = registered trademark

This leaflet was prepared on the 16 May 2006 based on the currently
approved data sheet for this product.