Synacthen Depot Ampoules 1mg/ml
tetracosactide acetate
Read all of this leaflet carefully before you are given this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor.
The information in this leaflet has been divided into the following sections:
- 1. What Synacthen Depot is and what it is used for
- 2. Check before you receive Synacthen Depot
- 3. How Synacthen Depot is given to you
- 4. Possible side effects
- 5. How to store Synacthen Depot
- 6. Further information
What Synacthen Depot is and what it is used for
Synacthen Depot belongs to a group of medicines called pituitary hormones.
The pituitary gland is a small gland inside the brain which controls many other glands in the body, including the thyroid and adrenal glands. The pituitary gland produces hormones which send chemical messages to various parts of the body and affect many bodily functions such as blood pressure, blood sugar levels, growth and menstrual cycle.
The adrenal glands are found on top of the kidneys and make the body’s natural steroids which can affect blood pressure and the way the body handles the sugars, protein and fats absorbed from food. They also make adrenaline which controls the body’s response to different types of stress.
Synacthen Depot is similar to the hormone that the pituitary gland normally produces (called ACTH) to make the adrenal glands produce certain steroids. When Synacthen depot is injected it works on the adrenal glands by ‘telling’ them to produce more steroids.
Synacthen Depot is used in place of medicines like prednisolone or cortisone (types of steroids) to treat a number of different conditions, including ulcerative colitis, Crohn's disease and rheumatoid arthritis. It is usually only given for a
short time.
Synacthen Depot is also used as a test to find out if the pituitary and adrenal glands are working normally.
Check before you receive Synacthen Depot
You should not be given Synacthen Depot if:
- you are allergic (hypersensitive) to adrenocorticotropic hormone (ACTH), tetracosactide acetate or any of the ingredients of Synacthen Depot (see Section 6 Further information)
- you suffer from any allergies, including allergies to any medicines
- you suffer from any serious mood or mental health disorders
- you have or have you ever had TB (tuberculosis)
- you have currently got any infections
- you suffer from any known hormone problems, e.g. Cushing’s syndrome or Addison’s disease (over or under active adrenal glands)
- you have an ulcer in your stomach or small intestine
- you suffer from any serious heart disease
- you suffer from asthma
- you are pregnant, trying to become pregnant, or breast-feeding.
Synacthen Depot is not for use in children under 3 years of age.
If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you are given Synacthen Depot.
Take special care with Synacthen Depot
Before you are given Synacthen Depot tell your doctor if:
- you have been vaccinated recently or are planning to have a vaccination
- your immune system is not working properly
- you have any disorder of the intestines, e.g. ulcerative colitis, diverticulitis
- you have recently had surgery on your intestines (bowel)
- you suffer from high blood pressure
- you have suffered from a blood clot in the past
- you suffer from any serious liver or kidney disease
- you suffer from osteoporosis (thinning of the bones)
- you suffer from myasthenia gravis (an illness causing muscle weakness)
- you have an under active thyroid gland which can cause tiredness or weight gain.
If any of the above applies to you, or if you are not sure, speak to your doctor before you are given Synacthen Depot.
Taking other medicines
Tell your doctor or pharmacist if you are taking/using or have recently taken/used any of the following medicines as they may interfere with Synacthen Depot:
- medicines to control high blood pressure
- medicines to control diabetes.
Please tell your doctor or pharmacist if you are taking or have recently taken/used any other medicines, including medicines obtained without a prescription.
Taking with food and drink
Since Synacthen Depot can cause salt and water retention, your doctor may advise a low-salt diet during treatment.
Pregnancy and breast-feeding
You should not receive Synacthen Depot if you are pregnant, trying to become pregnant or breast-feeding.
Driving and using machines
If you feel dizzy or get blurred vision after you have been given Synacthen Depot, do not drive or operate machinery until these effects have worn off.
Important information about some of the ingredients of Synacthen Depot
Synacthen Depot contains benzyl alcohol. Benzyl alcohol can cause toxic reactions and allergic reactions in children less than 3 years old.
Synacthen Depot is essentially ‘sodium-free’ - it contains less than 1 mmol sodium (23 mg) per 1mg.
How Synacthen Depot is given to you
Your treatment with Synacthen Depot will take place in a hospital, under the supervision of a doctor. The doctor will be monitoring your progress carefully during your treatment with Synacthen Depot.
Treatment with Synacthen Depot
Your doctor will decide on a suitable dose of Synacthen Depot depending on your condition. The liquid in the ampoule will be drawn up into a syringe and injected into a muscle by your doctor or nurse.
Adults including elderly patients will usually start treatment with 1mg once or twice daily for about three days. As your condition improves, this dose will then be reduced over a period of several weeks, to 0.5mg every two to three days or 1mg once a week.
Children aged 3 -12 years will be given a lower dose based on their age and weight. They will start with an injection every day. This will then be reduced to once every 2 to 8 days.
Your doctor may monitor growth or organise heart scans in children who are given this medicine for a long period of time.
Synacthen Depot is not suitable for children under three years of age.
Diagnostic Tests with Synacthen Depot
You will be given one, two or three injections followed by a number of blood tests.
What to do if you think you have received more Synacthen Depot than you should
As this medicine is given to you in hospital, it is very unlikely that an overdose will happen. If anyone receives this medicine by accident, tell the hospital accident and emergency department or a doctor immediately. Show any left over medicines or the empty packet to the doctor.
If you forget to take Synacthen Depot
As a doctor or nurse is giving you this medicine, you are unlikely to miss a dose.
If you have any worries, tell a doctor or nurse.
Synacthen Depot Side Effects
Do not worry. Like all medicines, Synacthen Depot can cause side effects, although not everyone gets them.
Very rarely, Synacthen Depot can cause an allergic reaction with skin irritation and swelling, faintness, wheezing or flushing. For this reason, you should be monitored carefully for 30 minutes after each injection. If you get a reaction like this when you are not under medical supervision, contact your doctor or nearest
hospital accident and emergency department immediately. Once you have had an allergic reaction like this, you should never be treated with Synacthen Depot or similar medicines again.
You are unlikely to get any of the following rare side effects but if you do, tell your doctor as soon as possible.
- menstrual (period) problems
- swelling of the face (moon face)
- increased thirst
- mood changes or fits
- decreased or blurred vision
- high blood pressure
- inflammation of the pancreas which causes severe stomach and back pain
- acne, other skin problems or unusual bruising
- muscle cramps or pain, muscle weakness
- pain in back, hips, arms, shoulders or legs
- heart problems which can cause shortness of breath or ankle swelling
- inflammation of the blood vessels (sometimes with a rash, arthritis or kidney failure)
- poor healing of wounds
- bleeding into the adrenal gland (small glands above the kidneys) which may result in sudden stomach or back pain, weakness, fainting, loss of appetite and feeling or actually being sick.
Other common side effects (that affect less than 1 person in 10) that may occur include:
- increased chance of infection
- abscess
- increase in the number of white blood cells which can cause bleeding, fever, infection or inflammation
- unusual increase in hair growth on body or face
- diabetes mellitus (increased sugar levels in your urine)
- fluid retention
- low levels of potassium which can cause muscle weakness, muscle twitching or abnormal heart beat or low levels of calcium which can cause muscle cramps, stomach cramps or spasms. Your doctor may want to take a blood test to measure your blood levels of potassium or calcium
- increased appetite
- headache
- protrusion of the eye-balls in their sockets
- glaucoma/blurred vision
- a feeling of dizziness or “spinning”
- blood clot
- blood in your stools
- blood in your urine
- blood in your vomit
- stomach pain or a bloated stomach
- inflammation of the gullet (food pipe)
- small, round, dark red spots on the skin
- bruising
- facial flushing
- darkening or lightening of skin colour
- increased sweating
- bone thinning and fractures of the bones
- ruptured tendon, the symptoms of which include severe pain, inability to use the affected arm or leg and rapid bruising at the site
- slowing of the rate of growth in children
- weight increase.
Very rare side effects include (that affect less than 1 person in 1000):
- long term use in children up to 5 years may cause changes to the heart.
If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor.
How to store Synacthen Depot
Synacthen Depot will be stored in the hospital pharmacy.
Keep out of the reach and sight of children.
Do not use Synacthen Depot after the expiry date which is stated on the ampoule. The expiry date refers to the last day of that month after Exp/Lot.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required. These measures will help protect the environment.
Further information
What is in Synacthen Depot?
The active ingredient in this medicine is tetracosactide acetate.
The other ingredients are zinc chloride, sodium phosphate, benzyl alcohol (50 mg/5 ml), sodium chloride, sodium hydroxide and water.
What Synacthen Depot looks like and contents of the pack
Synacthen Depot comes in packs of 10 ampoules.
Marketing Authorisation Holder and Manufacturer
The product licence holder is:
Synacthen Depot is manufactured by
The information in this leaflet applies only to Synacthen Depot. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.
This leaflet was last approved in:
26th November 2008
Alliance, Alliance Pharmaceuticals and associated devices are registered Trademarks.
© Alliance Pharmaceuticals Ltd 2008.
SYNACTHEN is a registered trademark of Novartis Pharmaceuticals Limited and is used under licence by Alliance Pharmaceuticals Limited.
UK PIL 006 v5a
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