Patient Leaflet Updated 30-Jun-2021 | Atnahs Pharma UK Ltd
Synacthen Depot Ampoules 1 mg/ml
Synacthen® Depot Ampoules 1mg/ml
Tetracosactide acetate
What is in this leaflet
1. What Synacthen Depot is and what it is used for
2. What you need to know before you are given Synacthen Depot
3. How to use Synacthen Depot
4. Possible side effects
5. How to store Synacthen Depot
6. Contents of the pack and other information
Synacthen Depot belongs to a group of medicines called pituitary hormones and analogues.
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, rheumatoid arthritis and osteoarthrosis. 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.
Synacthen Depot must not be used for premature babies and neonates less than one month. This is due to the presence of benzyl alcohol, an ingredient that may cause toxic reactions and allergic reactions.
Before you are given Synacthen Depot, tell your doctor or nurse if:
If you suffer an injury or have surgery during Synacthen Depot treatment or within one year after the end of the treatment, the Synacthen Depot dose may have to be increased or the Synacthen Depot treatment restarted.
Tell your doctor or nurse if you are taking/using, have recently taken/used or might take/use any of the following medicines as they may interfere with Synacthen Depot:
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.
Since Synacthen Depot can cause salt and water retention, your doctor may advise a low-salt diet during treatment.
If you are pregnant or breast-feeding, 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 Depot during pregnancy. Synacthen Depot 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 Depot, do not drive or operate machinery until these effects have worn off.
This medicine contains 10 mg of benzyl alcohol in each ampoule of 1ml which is equivalent to 10 mg/ml.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children.
Do not give to newborn baby (up to 4 weeks old).
Do not use for more than a week in young children (less than 3 years old), unless advised by the doctor or pharmacist.
Ask your doctor or pharmacist for advise if you are pregnant or breast-feeding. This is because large amount of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Ask your doctor or pharmacist for advice if you have a liver of kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Synacthen Depot is essentially ‘sodium-free’ - it contains less than 1 mmol sodium (23 mg) per 1mg.
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. Your doctor will decide on a suitable dose of Synacthen Depot depending on your condition.
Adults
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
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.
The ampoules should be shaken before use. The liquid in the ampoule will be drawn up into a syringe and injected into a muscle by your doctor or nurse (never into a vein).
For 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 are beneficial.
For diagnostic tests use: You will be given a single injection of Synacthen Depot. You will have six blood samples taken, one before the injection and the others 30 minutes, 1, 2, 3, 4 and 5 hours after the injection. These blood samples will show whether your adrenal glands are functioning as well as they 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.
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.
Like all medicines, Synacthen Depot can cause side effects, although not everyone gets them.
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.
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 Depot will be stored in the hospital pharmacy.
Keep out of the sight and reach of children.
Do not use Synacthen Depot after the expiry date which is stated on the ampoule and the carton. The expiry date refers to the last day of that month after EXP.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer require. These measures will help protect the environment.
The active substance of Synacthen Depot is tetracosactide acetate 1 mg per ampoule.
The other ingredients are zinc chloride anhydrous pure, disodium phosphate dodecahydrate, benzyl alcohol (50 mg/5 ml), sodium chloride, sodium hydroxide and water for injections.
Synacthen Depot is a sterile, milky white suspension in a 1 mL (millilitre) clear glass ampoule. Synacthen Depot comes in packs of 1 ampoule and 10 ampoules. Not all pack sizes may be marketed.
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 nurse.
This leaflet was last revised in: May 2020
© Atnahs Pharma UK Ltd.
SYNACTHEN is a registered trademark of Novartis AG and is used under licence by Atnahs Pharma UK Ltd
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