PACKAGE LEAFLET: INFORMATION FOR THE USER
Synacthen 250 micrograms/ml, solution for injection
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
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 or pharmacist . See section 4.
What is in this leaflet
What Synacthen 250 micrograms/ml is and what it is used for
What you need to know before you use Synacthen 250 micrograms/ml
How to use Synacthen 250 micrograms/ml
Possible side effects
How to store Synacthen 250 micrograms/ml
Contents of the pack and other information
WHAT SYNACTHEN 250 MICROGRAMS/ML IS AND WHAT IT IS USED FOR
Synacthen ampoules contains tetracosactide. This is a substance which stimulates the adrenal glands
to produce certain hormones.
Synacthen (tetracosactide) is used as a test to find out the cause of certain hormonal problems e.g.,
low levels of the hormone cortisol as in Addison’s disease. Two blood samples will be taken, one
before the injection of Synacthen and the other 30 minutes after injection. These blood samples will
show whether your adrenal glands are functioning as well as they should by measuring the hormone
WHAT YOU NEED TO KNOW BEFORE YOU USE SYNACTHEN 250
Do not take Synacthen:
if you have:
hormone) or any of the other ingredients of this medicine (listed in section 6).
Acute psychosis (loss of sense of reality).
An Infectious disease.
Peptic ulcer (sore in mucosa of the stomach and/or intestinal tract).
Refractory heart failure (severe cardiac condition).
Cushing’s syndrome (hormonal disorder).
Primary adrenocortical insufficiency (adrenal gland does not produce enough steroid hormone).
Adrenogenital syndrome (overproduction of a hormone resulting in increased testosterone given
to the baby).
Allergic disorders (e.g. asthma).
Pregnancy and breast-feeding.
Warnings and precautions
Talk to your doctor or nurse before using Synacthen if you have previously experienced adverse
reactions to ACTH, Synacthen or other drugs.
Take special care with Synacthen 250 micrograms/ml
Synacthen may interact with routine drug testing in athletes.
Other medicines and Synacthen
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Synacthen brings about an increase in adrenocortical production of glucocorticoids (a steroid
hormone) and mineralocorticoids, drug interactions of the type seen with these corticosteroids
(steroid hormone) may occur.
Patients receiving medication for diabetes mellitus or for moderate to severe hypertension (high
blood pressure) must have their dosage adjusted if treatment with Synacthen is started.
Synacthen 250 micrograms/ml with food and drink
No information available.
Pregnancy and breast-feeding
Synacthen must not be used during pregnancy.
Synacthen must not be used while breast-feeding.
Driving and using machines
Since Synacthen may have an effect on the central nervous system, patients should be very cautious
when driving vehicles or using machines.
Synacthen 250 micrograms/ml contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially “sodium-
HOW TO USE SYNACTHEN 250 MICROGRAMS/ML
Always use Synacthen 250 micrograms/ml exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
This preparation of Synacthen is intended for administration for diagnostic purposes only. It may be
administered as a single dose into a vein or muscle.
The 30-minute Synacthen diagnostic test is based on measurement of the concentration of cortisol in
the plasma (the liquid in your blood excluding the blood cells) immediately before and exactly 30
minutes after a dose of 1 ml (250 micrograms) Synacthen has been administered into a vein or
muscle. Adrenocortical function can be regarded as normal if the concentration of cortisol in the
plasma after dose injection (administration with Synacthen) amounts to at least 200 nmol/litre (70
Use in the elderly
There is no evidence to suggest that dosage should be different in the elderly.
Use in children
The dosage will be administered into a vein. The concentration is decided by the physician and will be
around 1 ml (250 micrograms) per 1.73 m
body surface area. For children aged 5-7 years,
approximately half the adult dose will be adequate.
If you use more Synacthen 250 micrograms/ml than you should
Overdosage is unlikely to be a problem when the product is used as a single dose for diagnostic
POSSIBLE SIDE EFFECTS
Like all medicines, Synacthen can cause side effects, although not everybody gets them.
Undesirable effects related to Synacthen
Synacthencan provoke hypersensitivity reactions, which tend to be more
severe (anaphylactic shock) in patients susceptible to allergies (especially asthma). Hypersensitivity
reactions may include skin reactions at the injection site, dizziness, nausea, vomiting, hives, itching,
flushing, general feeling of being unwell, , shortness of breath and/or a rapid swelling of the skin and
mucous membranes (angioneurotic oedema or Quincke's oedema). If you experiencing any of these
reactions you should tell a doctor
Infections and infestations
Increased susceptibility to infection, abscess
Blood and the lymphatic system
An increase in white blood cells (leukocytosis)
Irregular menstruation, Cushing’s syndrome (a hormone
disorder caused by high levels of cortisol in the blood) and a
state when the pituitary does not produces enough hormone
which may lead to a secondary adrenocortical insufficiency
(when the adrenal glands are not working properly).
Particularly in times of stress, e.g. after trauma, surgery or
illness there may be a decreased carbohydrate tolerance,
high blood sugars, manifestations of latent (dormant)
diabetes mellitus andexcessive hair growth.
Metabolism and nutrition disorders
Increased appetite, low blood potassium, calcium
deficiency, retention of sodium and fluid in the body
Nervous system disorders
Headache, vertigo, convulsions
Optic disc swelling as a result of an increased preassure
within the skull, usually after treatment
Cataracts, increased pressure within the eyeball, glaucoma,
bulging of the eye ball (exophthalmose)
Congestive heart failure (heart failure in which the heart is
unable to adequately pump out the blood), increased blood
Thickening of the heart muscle may occur in single cases in
infants and small children treated over a prolonged period
with high doses. This symptom will return to normal after
end of treatment.
Blood clot (thromboembolism), inflammation of the blood
vessel walls (necrotising vasculitis)
Peptic ulcer with possible perforation and bleeding,
inflammation of the pancrease, abdominal distension,
inflammation of the lining of the gullet
Skin and subcutaneous tissue
Skin atrophy (cells of the skin wither away), red spots under
the skin and brusing , erythema, increased perspiration,
acne and skin hyper pigmentation
Musculoskeletal, connective tissue and
Osteoporosis, muscular weakness, loss of muscle mass,
compression fractures of the bones in the spine, bone death
in the femoral and humeral heads (specific bones in the
body), pathological fracture of long bones, tendon rupture
General disorders and administration
healing, retarded growth
Negative nitrogen balance due to protein degradation,
suppression of skin test reactions
Isolated cases of adrenal haemorrhage (an internal bleeding from part of the suprarenal glands) have
been reported with Synacthen.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via HPRA
Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: firstname.lastname@example.org.
By reporting side effects you can help provide more information on the safety of this medicine
HOW TO STORE SYNACTHEN 250 MICROGRAMS/ML
Your medicine should be stored in the fridge (2–8°C). Keep ampoules in the outer carton to protect
from light. Any solution remaining after injection should be discarded.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the label and box.
The product should be used immediately after opening.
CONTENTS OF THE PACK AND OTHER INFORMATION
What Synacthen 250 micrograms/ml contains
The active substance is 250 micrograms of tetracosactide. Each ampoule contains tetracosactide
250 micrograms, as tetracosactide acetate.
The ampoules also contain glacial acetic acid, sodium acetate, sodium chloride and water for
What Synacthen 250 micrograms/ml looks like and contents of the pack
The product is a clear, colourless aqueous solution in a type 1 (Ph. Eur.) clear glass 1 ml ampoule.
The product is presented as a pack of 5 ampoules of 1 ml.
Marketing Authorisation Holder and Manufacturer
Via Pontina Km 30.400
00071- Pomezia (Rome)
Doppel Farmaceutici srl
Via Volturno, 48
20089 Rozzano (Milan)
Product licence/authorisation holder:
Alfasigma S.p.A. –
Via Ragazzi del ’99, n.5,
40133 Bologna (BO)
CD Pharma S.r.l.
Viale Cassiodoro, 16
Tel. +39 02-43980539
This leaflet was last revised 03/2019