• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Synacthen Ampoules is and what it is used for
2. What you need to know before you are given Synacthen Ampoules
3. How to use Synacthen Ampoules
4. Possible side effects
5. How to store Synacthen Ampoules
6. Contents of the pack and other information

• you are allergic (hypersensitive) to adrenocorticotropic hormone (ACTH), tetracosactide acetate or any of the other ingredients of Synacthen Ampoules (listed in Section 6)
• you suffer from any allergies, including allergies to any medicines
• you suffer from asthma
• you suffer from any serious mood or mental health disorders
• 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
• it is for the treatment of primary adrenocortical insufficiency or adrenocongenital syndrome (where your adrenal glands are not working properly)

If any of the above applies to you, or if you are not sure, speak to your doctor or nurse before you are given Synacthen Ampoules.

Before you are given Synacthen Ampoules tell your doctor or nurse if:

• you suffer from high blood pressure
• you suffer from thromboembolism (blood vessel blocked by a blood clot)
• you suffer from myasthenia gravis (extreme muscle weakness)
• you suffer from osteoporosis (thinning of the bones)
• you suffer from an inflammation of the bowel (e.g. ulcerative colitis or diverticulitis)
• you have been recently vaccinated
• you have a severe liver disease (cirrhosis)
• you have a reduced immune system
• you are pregnant, think you might be pregnant or are breast feeding
• you have ocular herpes simplex (viral infection of the eye)
• you have kidney problems.

Tell your doctor or nurse if you are taking/using or have recently taken/used any of the following medicines as they may interfere with Synacthen Ampoules:

• medicines to control high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan)
• medicines to control diabetes such as insulin or metformin
• corticosteroids (medicines used to treat inflammatory conditions in your body such as asthma or arthritis)
• medicines to control convulsions (fits) such as valproate, phenytoin, clonazepam, nitrazepam, phenobarbital or primidone
• medicines to control conception (birth control).

It may be necessary to change the dose or in some cases to stop the medicine.

Please tell your doctor or nurse if you are taking or have recently taken/used any other medicines, including medicines obtained without a prescription.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine. Your doctor will discuss with you the potential risk of using Synacthen during pregnancy. Synacthen Ampoules should be given with caution to women who are breast-feeding.

If you feel dizzy or get blurred vision after you have been given Synacthen Ampoules, do not drive or operate machinery until these effects have worn off.

Synacthen Ampoules contains less than 1 mmol sodium (23mg) per 1mg, i.e. is essentially ‘sodium-free’.

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.

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.

• Anaphylactic shock or severe allergic reaction (symptoms may include redness or pain at the injection site, rash, itching, hives or flushing, dizziness, feeling or being sick, difficulty breathing, and swelling of the face, lips, tongue or other parts of the body, feeling very unwell). This tends to be more severe in people, who suffer from allergies (especially asthma). For these reasons, you should be monitored carefully for 30 minutes after the injection. If you have had an allergic reaction, you should never be treated with Synacthen Ampoules or similar medicines again.
• 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
• blood clot (symptoms may include pain, swelling, redness, warmth and tenderness in the area of the clot depending on location in the body)
• blood in your stools
• blood in your urine
• blood in your vomit.

If you experience any of these at any time, tell your doctor straight away or go immediately to the nearest hospital accident and emergency department.

• allergic reaction with skin irritation and swelling
• menstrual (period) problems
• swelling of the face (moon face)
• increased thirst
• mood changes or fits
• decreased or blurred vision
• high blood pressure
• heart problems which can cause shortness of breath or ankle swelling
• inflammation of the blood vessels (sometimes with a rash, arthritis or kidney failure)
• inflammation of the pancreas which causes severe stomach and back pain
• feeling or actually being sick
• general feeling of being unwell
• acne, other skin problems or unusual bruising
• muscle cramps or pain, muscle weakness
• pain in back, hips, arms, shoulders or legs
• itching
• poor healing of wounds
• 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
• thinning of the skin
• may affect the results of skin prick test reactions
• diabetes mellitus (increased sugar levels in your blood and urine)
• fluid retention
• sodium 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”
• 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.

Reporting of suspected adverse reactions

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme by connecting to the following website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

Synacthen Ampoules contains the active ingredient tetracosactide (as acetate) 250 micrograms per ampoule.

The other ingredients are acetic acid, sodium acetate, sodium chloride and water for injections.

Synacthen is a clear, colourless sterile liquid that comes in a 1ml (millilitre) clear glass ampoule. Synacthen Ampoules comes in packs of 1 ampoule and 5 ampoules. Not all pack sizes may be marketed.