Somatuline
autogel
60/90/120 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 Autogel is and what it is used for
- 2. Before you use Somatuline Autogel
- 3. How to use Somatuline Autogel
- 4. Possible side effects
- 5. How to store Somatuline Autogel
- 6. Further information
What Somatuline Autogel Is And What It Is Used For
Somatuline Autogel 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 other hormones produced in your stomach and intestines.
Somatuline Autogel is used to treat acromegaly (a condition where too much growth hormone is produced). It is also used to treat symptoms caused by the abnormal growth of a type of nerve cell (tumour of the neuroendocrine system). Neuroendocrine tumours cause the over production of certain other hormones.
Before You Use Somatuline Autogel
If you have ever been allergic to lanreotide or any other medicine similar to somatostatin do not use Somatuline Autogel.
Consult your doctor or pharmacist if you are concerned.
Take Special Care with Somatuline Autogel
- If you are diabetic. Your doctor may check your blood sugar levels and possibly alter your anti-diabetic treatment while you are receiving Somatuline Autogel.
- If you have ever had liver, kidney, gall bladder or heart problems.
If any of the above applies to you then you should speak to your doctor.
Using Other Medicines
If you are taking cyclosporin as well as Somatuline Autogel, 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
If you are pregnant or breast feeding, ask your doctor or pharmacist for advice before taking any medicine.
Use in Children
Somatuline Autogel is not recommended in Children.
Driving and Using Machines
Somatuline Autogel is unlikely to affect your ability to drive or use machines.
How To Use Somatuline Autogel
Somatuline Autogel should be injected deep under your skin. It is for single use only.
How many injections will you need?
You will normally be given one injection every 28 days. Your doctor may change the dose of your injections (between 60 and 120 mg). For patients with Acromegaly, who are well controlled on their treatment the doctor may increase the length of time between injections of the 120mg Autogel to a maximum of 56 days. Any change in dose 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.
Where will you be injected?
If the injection is being given by a healthcare professional or someone else who has been trained the injection will
usually be given in the upper, outer external quadrant of the buttock (see Figure 6i in the Instructions for Administration section of this leaflet).
If you are injecting yourself, the injection should be given in the upper, outer thigh. (see Figure 6ii in the Instructions for Administration section of this leaflet).
The injection site should be alternated between right and left sides.
Instructions For Administration Of Somatuline Autogel
FOLLOW THESE INSTRUCTIONS CAREFULLY.
1. Remove Somatuline Autogel from the fridge 30 minutes prior to administration.
2. Wash hands and ensure there is a clear area for preparation.
3. Unless the product is being self-administered, surgical gloves should be worn.
4. Check the laminated pack is intact before opening and take out the pre-filled syringe.
5. Remove the plunger protection.
6. If the injection is being administered by a healthcare professional (HCP) or a trained relative/friend of the patient, the injection should be given in the upper, outer quadrant of the buttock (see figures marked i - Injection by HCP or trained person).
If the injection is being self-administered, the injection should be given in the upper, outer thigh (see figures marked ii - Self injection).
For subsequent injections, the injection site should be alternated between right and left sides.
7. Clean the injection site without rubbing the skin excessively.
8. Remove the needle cap.
9. Stretch the skin of the injection site and rapidly insert the needle to its full length, at right angles (90°) to the skin (deep subcutaneous injection).
10.Inject all the drug slowly, using a constant pressure on the plunger and without moving the needle.
11.Press a cotton wool ball against the skin around the needle. Remove the needle and press on the cotton wool for 5 seconds or until any bleeding has stopped. DO NOT rub or massage the injection site after administration.
12.After using, do not attempt to re-sheath the needle but carefully dispose of the used device in the special bin provided. DO NOT dispose of the device in your general household rubbish.
13.Keep the sharps bin and Somatuline Autogel out of reach and sight of children.
DO NOT USE AFTER THE EXPIRY DATE SHOWN ON THE LABELS AND BOX.
DO NOT USE IF THE LAMINATED PACK IS DAMAGED OR OPENED.
If you are given too much Somatuline Autogel:
If you are given too much Somatuline Autogel you may experience additional or more severe side effects. (See Section 4. ‘Possible Side Effects’).
If you forget to have an injection of Somatuline Autogel
As soon as you realise that you have missed an injection, contact your healthcare professional. They will give you advice about the timing of your next injection. Do NOT give yourself extra injections to make up for one that you have forgotten.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Somatuline Autogel can cause side effects although not everybody gets them.
Gall bladder problems can occur with this type of medicine. Your doctor may want to give you a gall bladder scan when you start receiving Somatuline Autogel and from time to time afterwards.
Other side effects that could occur with Somatuline Autogel are listed below:
Very common (occur in more than 1 in 10 patients treated) side effects are:
- diarrhoea
- stomach ache
- feeling sick
Common (occur in less than 1 in 10 patients treated) side effects are:
- constipation
- flatulence (wind)
- gallstones and gall bladder problems
- increased bilirubin
- loss of energy and tiredness
Uncommon (occur in less than 1 in 100 patients treated) side effects are:
- pain at the injection site
- skin nodules
- drowsiness
- hot flushes
- leg pain
- generally feeling unwell
- headache
- vomiting
- decreased libido
- itching
- sweating
In addition you may not be able to go to the toilet when you want to. It is also possible that your blood sugar may change.
Rare (occurring in less than 1 in 1000 patients treated) the following side effects have been observed with other
medicines containing lanreotide:
- heart problems
- inflammation of the pancreas (pancreatitis)
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 Autogel
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 Autogel 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 Autogel contains
The active constituent is lanreotide. The only other ingredient is water for injection.
What Somatuline Autogel looks like and contents of the pack
Somatuline Autogel is a viscous solution for injection. This solution is packaged in a pre-filled syringe, ready to be
injected.
Somatuline Autogel is available in three strengths of 60 mg, 90 mg and 120 mg lanreotide.
Marketing Authorisation Holder and Manufacturer
Somatuline Autogel is manufactured by
The Marketing Authorisation Holder is
For more information on Somatuline Autogel, please contact
This leaflet was last approved in June 2008.
5161.03
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