tetracosactrin zinc phosphate complex
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about . It does not contain all the information that is known about . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
What Synacthen Depot is used for
Synacthen Depot has two very different uses:
It is used in people with multiple sclerosis who are experiencing a worsening of their symptoms.
It is used in young children to treat some types of seizure (fit), such as infantile spasms.
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. It must also be used with caution in children up to 3 years of age.
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
For multiple sclerosis: 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.
For seizures in 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
difficulty urinating or passing little or no urine
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
Sponsor
Synacthen Depot is supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty Limited
ACN 004 244 160
54 Waterloo Road
North Ryde NSW 2113
Telephone: 1 800 671 203
®= Registered Trademark
This leaflet was prepared in June 2005
(synd150605c.doc) based on PI (synd150605i.doc)
Australian Registration Number
Synacthen Depot AUST R 11060
