Wednesday, October 5, 2016

Somatuline LA






Somatuline
LA 30 mg



solution for injection



lanreotide



Read all of this leaflet carefully before you start using this medicine.


  • 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.



In this leaflet:


  • 1. What Somatuline LA is and what it is used for

  • 2. Before you use Somatuline LA

  • 3. How to use Somatuline LA

  • 4. Possible side effects

  • 5. How to store Somatuline LA

  • 6. Further information




What Somatuline La Is And What It Is Used For


Somatuline LA is a long acting formulation of lanreotide.


Lanreotide is similar to a naturally occurring hormone, somatostatin. Lanreotide lowers the levels of hormones in the body that cause growth. It also lowers the level of some hormones produced in your stomach and intestines.



Somatuline LA is used to treat


  • acromegaly (a condition where too much growth hormone is produced).

  • symptoms caused by the abnormal growth of a type of nerve cell (neuroendocrine tumours). Neuroendocrine tumours cause the over production of certain other hormones.

  • abnormal growth of a type of cell in the pituitary gland (thyrothrophic tumours). This can cause you to have high thyroid hormone levels.




Before You Use Somatuline La


If you have been allergic to lanreotide or any other medicine similar to somatostatin in the past do not use Somatuline LA.



Do not use Somatuline LA if you are pregnant or breast feeding.

Consult your doctor or pharmacist if you are concerned.



Take Special Care with Somatuline LA


  • if you are diabetic. Your doctor may check your blood sugar levels and possibly alter your anti-diabetic treatment while you are receiving Somatuline LA.

  • if you ever had liver or kidney problems. Your doctor may check how your liver and kidney are working and may change how often you are given Somatuline LA.

Gall bladder problems can occur with this type of medicine. Your doctor may want to take a scan of your gall bladder when you start receiving Somatuline LA and every 6 months afterwards.


You may also get too much fat in your stools which your doctor may want to treat.


If any of the above applies to you, or if you have any side effect that is troublesome then you should speak to your doctor.




Using Other Medicines


If you are taking cyclosporin as well as Somatuline LA, your doctor may want to monitor the amount of cyclosporin in your blood.


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




Pregnancy and Breast Feeding


Do not take Somatuline LA if you are pregnant or breast feeding.




Use in Children


Somatuline LA is not recommended in Children.




Driving and Using Machines


Somatuline LA is unlikely to affect your ability to drive or use machines.





How To Use Somatuline La


Somatuline LA is given by injection into a muscle and will usually be injected into your buttock.



How many injections will you need?


You will normally be given one injection every 14 days. Your doctor may change the length of time between your injections. This will depend on your symptoms and how you respond to the medicine. Your doctor will also decide on how long you should be treated for.




If you are given more Somatuline LA than you should:


If you are given too much Somatuline LA you may experience additional or more severe side effects. (See Section 4. 'Possible Side Effects').




If you forget to have an injection of Somatuline LA


As soon as you realise that you have missed an injection, contact your doctor. They will give you advice about the timing of your next injection.



If you have any further questions on the use of this medicine, ask your doctor or pharmacist.




Somatuline LA Side Effects


Like all medicines, Somatuline LA can cause side effects although not everybody gets them.



The side effects that could occur with Somatuline LA are listed below:


  • moderate pain and redness at the injection site. This should not last long.

  • diarrhoea or soft stools, stomach ache, wind, lack of appetite, feeling sick and vomiting.

  • your blood sugar level may change.

  • gallbladder problems (e.g. gallstones) may occur with prolonged treatment (Also see section 2).

  • rarely, inflammation of the pancreas has occurred after the first dose of Somatuline LA.


If any of the side effects become serious or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.




How To Store Somatuline La


Keep out of the reach and sight of children.


Do not use after the expiry date which is printed on the label and box.


Store Somatuline LA between 2°C and 8°C in a refrigerator in its original package. Do not freeze.


Each syringe is packed individually.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further Information



What Somatuline LA contains


The active ingredient is lanreotide. The dose of lanreotide you will receive is 30mg. The other ingredients are Lactide-glycolide copolymer, Lactic-glycolic copolymer, Mannitol, Carmellose (Na) and Polysorbate 80.




What Somatuline LA looks like and contents of the pack


Somatuline LA is a powder. Just before it is injected your doctor or other healthcare professional will add a suspension vehicle to the powder. The solution will then look milky. The suspension vehicle contains mannitol in water for injection.


The pack will contain 1 vial of Somatuline LA. The pack will also include the suspension vehicle, needles and syringes for use with the Somatuline LA supplied.




Marketing Authorisation Holder and Manufacturer


Somatuline LA is manufactured by



Ipsen Pharma Biotech

83870 Signes

France


The Marketing Authorisation Holder is



Ipsen Ltd.

190 Bath Road

Slough

Berkshire

SL1 3XE

UK



For more information on Somatuline LA, please contact



Ipsen Ltd.

190 Bath Road

Slough

Berkshire

SL1 3XE

UK



This leaflet was last approved in October 2007.



Marketing Authorisation number


Somatuline LA PL number: 06958 / 0018


Suspension Vehicle PL number: 06958 / 0019








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