Thursday, September 22, 2016

Synacthen Ampoules 250mcg





Synacthen Ampoules 250 micrograms



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 Ampoules is and what it is used for


  • 2. Check before you receive Synacthen Ampoules


  • 3. How Synacthen Ampoules is given to you


  • 4. Possible side effects


  • 5. How to store Synacthen Ampoules


  • 6. Further information





What Synacthen Ampoules is and what it is used for



Synacthen Ampoules 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 Ampoules is used as a test to find out if the pituitary and adrenal glands are working normally.





Check before you receive Synacthen Ampoules




You should not be given Synacthen Ampoules if:



  • you are allergic (hypersensitive) to adrenocorticotropic hormone (ACTH), tetracosactide acetate or any of the ingredients of Synacthen Ampoules (see Section 6 Further information)


  • you suffer from any allergies, including allergies to any medicines


  • you suffer from asthma


  • you are pregnant, trying to become pregnant, or breast-feeding.

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 Ampoules.





Taking other medicines



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





Pregnancy and breast-feeding



You should not receive Synacthen Ampoules 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 Ampoules, do not drive or operate machinery until these effects have worn off.





Important information about some of the ingredients of Synacthen Ampoules



Synacthen Ampoules is essentially ‘sodium-free’ - it contains less than 1 mmol sodium (9 mg) per 1mg.






How Synacthen Ampoules is given to you



Your treatment with Synacthen Ampoules 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 Ampoules.



You will be given one injection followed by a blood test. The liquid will be drawn up into a syringe and injected into a muscle by your doctor or nurse.



Adults including elderly patients will be given 250 micrograms (one ampoule).



Children will be given a lower dose based on their age and weight.




What to do if you think you have received more Synacthen Ampoules 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 Ampoules



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.





Possible side effects



Do not worry. Like all medicines, Synacthen Ampoules can cause side effects, although not everyone gets them.



Very rarely, Synacthen Ampoules can cause an allergic reaction with skin irritation and swelling, faintness, wheezing, flushing, feeling or being sick. For this reason, you should be monitored carefully for 30 minutes after the injection. Once you have had an allergic reaction like this, you should never be treated with Synacthen Ampoules or similar medicines again.



As Synacthen Ampoules is a single injection you are unlikely to experience any other side effects. However, if you have any side effects which you feel may have been caused by Synacthen Ampoules contact your doctor or pharmacist.





How to store Synacthen Ampoules



Synacthen Ampoules will be stored in the hospital pharmacy.



Keep out of the reach and sight of children.



Do not use Synacthen Ampoules 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 Ampoules?



The active ingredient in this medicine is tetracosactide acetate.



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





What Synacthen Ampoules looks like and contents of the pack



Synacthen Ampoules comes in packs of 5 ampoules.





Marketing Authorisation Holder and Manufacturer



The product licence holder is:




Alliance Pharmaceuticals Ltd

Avonbridge House

Chippenham

Wiltshire

SN15 2BB

UK



Synacthen Ampoules is manufactured by




Nycomed Austria GmbH

St-Peter-Strasse 25

A-4020 Linz

Austria




The information in this leaflet applies only to Synacthen Ampoules. 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 v2





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