Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Somatuline Autogel.
Tell your doctor if you are breastfeeding.
Tell your doctor if you have diabetes or any heart problems.
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Things you should not do
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Do not stop using this medicine suddenly.
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Driving or using machines
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Be careful before you drive or use any machines or tools.
This medicine may cause dizziness in some people.
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Looking after your medicine
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Store Somatuline Autogel at 2°C - 8°C in a refrigerator in its original package. Do
not freeze.
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Do not use Somatuline Autogel if:
Check with your doctor if you:
Pregnancy and breastfeeding
How much to use
The recommended starting dose is 60 mg to 120 mg injected every 28 days.
The recommended dose is 120 mg every 28 days.
When to use Somatuline Autogel
How to use Somatuline Autogel
If you forget to use Somatuline Autogel
If you use too much Somatuline Autogel
(by calling 13 11 26), or
Call your doctor straight away if you:
Talk to your doctor or pharmacist if you:
Diabetes
Heart problems
Gallbladder problems
Driving or using machines
Looking after your medicine
Getting rid of any unwanted medicine
Serious side effects
Serious side effects
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What to do
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Signs of gallbladder stones (cholelithiasis) or complications:
severe and sudden abdominal pain, that may spread to the shoulder or back
tenderness of the abdomen
high fever, fever, chills
vomiting, feeling nauseous, loss of appetite
yellowing of the skin and eyes (jaundice), itchy skin
dark urine, clay-coloured stools
Slowing of the heart rate:
dizziness
fainting
shortness of breath
feeling confused
fatigue
Signs of low blood sugar levels:
feeling confused
feeling hungry
feeling shaky
sweating more than usual
Signs of high blood sugar levels or development of diabetes:
feeling more thirsty or tired than usual
dry mouth
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Less serious side effects
Less serious side effects
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What to do
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Metabolism related:
decrease in appetite
Nervous system related:
headache
lack of energy
Gastrointestinal related:
excess fat in the stools
bowel problems including diarrhoea or loose stools, abdominal pain, passing wind or
constipation
feeling sick, vomiting, heartburn, abdominal bloating or discomfort
Skin and hair related:
hair loss or no hair growth
Muscle and bone related:
pain that affects muscles, ligaments, tendons and bones
General and injection site related:
tiredness
feeling generally weak
moderate and short-lived pain at the injection site, sometimes with redness, swelling
(nodule), itching tenderness or abscess
weight loss
Blood test related:
changes in some liver or pancreas test results
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Reporting side effects
What Somatuline Autogel contains
Active ingredient
(main ingredient)
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Lanreotide acetate
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Other ingredients
(inactive ingredients)
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Sterile water
Acetic acid
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Potential allergens
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n/a
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What Somatuline Autogel looks like
Australian Sponsor of Somatuline Autogel
Level 5, 627 Chapel Street
South Yarra Victoria 3141
1. Ensure that the medication has been refrigerated in its original package.Remove Somatuline Autogel from the refrigerator 30 minutes prior to administration. Injection of cold medication may be painful. Keep laminated pouch sealed until just prior to injection.
2. Before opening the pouch, check that it is intact and that the medication has not expired. The expiration date is printed on the outer carton and the pouch.
3. Wash hands with soap and ensure there is a clean area for preparation.
4. Tear open the pouch along the dotted line and take out the pre-filled syringe. The content of the pre-filled syringe is semi-solid with a gel-like appearance, and a colour varying from white to pale yellow. The solution can also contain very small bubbles that can clear up during injection. These differences are normal and do not interfere with the quality of the product.
5. Select an injection site:
6. Clean the injection site without rubbing the skin excessively and let it dry.
7. Before injecting, remove the pre-filled syringe from its tray. Discard the tray.
8. Remove the needle cap by pulling it off and discard it.
9. Flatten injection area using the thumb and index finger of the hand not holding the pre-filled syringe to stretch the skin. Do not pinch the skin. Use a strong, straight dart-like motion to quickly insert the needle perpendicular to the skin (90° angle), all the way into the skin.It is very important that you insert the needle completely. You should not see any needle once it is fully inserted. Do not aspirate (do not draw back).
10. Release injection site that has been flattened by your hand. Push plunger with steady very firm pressure. The medication is thicker and harder to push than you might expect. Typically, 20 seconds are needed. Inject the full dose and give a final push to make sure you cannot depress it any further.
11. Without releasing the pressure on the plunger, withdraw the needle from the injection site.
12. Then release the pressure on the plunger. The needle will automatically retract into the needle guard where it will be locked permanently.
13. Apply gentle pressure to the injection site with a dry cotton ball or sterile gauze to prevent any bleeding. Do not rub or massage the injection site after administration.
14. Dispose of the used syringe in the syringe disposal container as instructed by your doctor or healthcare provider. Do not dispose of the device in your general household rubbish.Keep the disposal container and Somatuline Autogel out of reach and sight of children.