- lanreotide acetate
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 34926/0004 .
PACKAGE LEAFLET: INFORMATION FOR THE USER
Somatuline LA 30 mg
Powder and solvent for prolonged release suspension for injection
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Somatuline LA 30 mg is and what it is used for
2. What you need to know before you use Somatuline LA 30 mg
3. How to use Somatuline LA 30 mg
4. Possible side effects
5. How to store Somatuline LA 30 mg
6. Contents of the pack and other information
1. WHAT SOMATULINE LA 30 MG IS AND WHAT IT IS USED FOR
Somatuline LA 30 mg is a long acting formulation of lanreotide.
Lanreotide – the active substance – belongs to the group of Antigrowth hormones. It is similar to the naturally occurring hormone called somatostatin.
Lanreotide lowers the levels of hormones in the body such as GH (Growth Hormone) and IGF-1 (Insulin-like Growth Factor-1) and inhibits the release of some gastro-intestinal hormones and intestinal secretions.
Somatuline LA 30 mg is indicated for
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SOMATULINE LA 30 MG
Do not use Somatuline LA 30 mg
Warnings and precautions
Talk to your doctor or pharmacist before using Somatuline LA 30 mg:
If any of the above applies to you, talk to your doctor or pharmacist before using Somatuline LA 30 mg.
Somatuline LA 30mg is not recommended in children.
Other medicines and Somatuline LA 30 mg
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Special care should be taken in case of co-administration with:
Dose adjustments of such concomitant medications may be considered by your doctor.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor immediately if you are pregnant, or if you think you might be pregnant, or if you are breast-feeding. If so, Somatuline LA 30 mg should be administered to you only if clearly needed.
Driving and using machines
Somatuline LA 30 mg is unlikely to affect your ability to drive or use machines, however possible side effects such as dizziness may occur with Somatuline LA 30 mg. If you are affected, be careful when driving or using machinery.
Important information about the sodium content of Somatuline LA 30 mg
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
3. HOW TO USE SOMATULINE LA 30 MG
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Somatuline LA 30 mg should be administered by healthcare professionals. Your doctor or nurse will prepare and give the injections.
The recommended dose
The recommended starting dose is 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 decide on how long you should be treated for.
Method of administration
Somatuline LA 30 mg is administrated intramuscularly into the buttock. The injection is performed by healthcare professionals only.
If you receive more Somatuline LA 30 mg than you should
If you are given too much Somatuline LA 30 mg, you may experience additional or more severe side effects (see section 4 “Possible Side Effects”). Please tell your doctor if you think it is the case.
If you forget to use Somatuline LA 30 mg
As soon as you realise that you have missed an injection, contact your healthcare professional, who will give you advice about the timing of your next injection. Do NOT administer yourself extra injections to make up for a forgotten injection.
In long-term treatment with Somatuline LA 30 mg one forgotten dosage will not dramatically affect the success of your therapy.
If you stop using Somatuline LA 30 mg
An interruption or early termination of the Somatuline LA 30 mg treatment can affect the success of the treatment. Please ask your doctor before you stop the treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist, or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice any of the following side effects:
The frequency of these side effects is common, it may affect up to 1 in 10 people.
Tell your doctor immediately if you notice that:
These might be the result of an allergic reaction.
The frequency of this side effect is not known; it cannot be estimated from the available data
Other Side Effects
The most commonly expected side effects are gastrointestinal disorders, gall bladder problems and injection site reactions. The side effects that could occur with Somatuline LA 30 mg are listed according to their frequencies below.
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Not known: frequency cannot be estimated from the available data:
Since lanreotide may alter your blood sugar levels, your doctor may want to monitor your blood sugar levels especially at the initiation of the treatment.
Similarly, as gall bladder problems can occur with this type of medicine, your doctor may want to monitor your gall bladder when you start receiving Somatuline LA 30 mg and from time to time afterwards.
Tell your doctor or pharmacist or nurse if you notice any of the side effects above.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist 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 at:www.mhra.gov.uk/yellowcard By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE SOMATULINE LA 30 MG
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C to 8°C) in the original package.
Do not use this medicine after the expiry date which is stated on the carton and labels after <EXP>. The expiry date refers to the last day of that month.
Somatuline LA 30 mg is for single use only. Your doctor or nurse will dissolve the powder into the solvent to obtain a suspension which should be used immediately after reconstitution. Any unused suspension should be discarded appropriately.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Somatuline LA 30 mg contains
The active substance is:
Lanreotide (30 mg)
The other ingredients are:
Lactide glycolide copolymer
Lactic glycolic copolymer
Water for injections.
What Somatuline LA 30 mg looks like and contents of the pack
Somatuline LA 30 mg is provided as powder and solvent for prolonged release suspension for injection.
The powder is practically white and the presence of air bubbles at the top is normal. It is supplied in a small glass vial (fitted with an elastomer stopper and crimped with an aluminium/plastic cap) together with an ampoule containing 2 mL of solvent and with a sterile set of injection made of 1 empty syringe and 2 needles.
The glass vial is slightly tinted.
After reconstitution the suspension has a milky aspect.
Pack size of 1 vial, 1 ampoule, 1 syringe and 2 needles.
Pack size of 2 vials, 2 ampoules, 2 syringes and 4 needles.
Pack size of 6 vials, 6 ampoules, 6 syringes and 12 needles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
This leaflet was last revised in September 2018.
190 Bath Road, Slough, Berkshire, SL1 3XE
+44 (0)1753 627 778
+44 (0)1753 627 777
+44 (0)1753 627 777
+44 (0)1753 627 627