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SOMATULINE LA 30MG POWDER FOR SUSPENSION FOR INJECTION

Active substance(s): LANREOTIDE ACETATE

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PACKAGE LEAFLET :
INFORMATION FOR THE USER

Somatuline LA 30mg
powder and solvent for prolonged release suspension for injection
Active substance : 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 onto 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 30mg is and what it is used for
2. Before you use Somatuline LA 30mg
3. How to use Somatuline LA 30mg
4. Possible side effects
5. How to store Somatuline LA 30mg
6. Further information
1. WHAT SOMATULINE LA 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
• the long-term treatment of acromegaly (a condition where too much growth
hormone is produced).
• the treatment of symptoms that occur with certain endocrine tumours of the
gastrointestinal tract.
• the treatment of primary thyrotropic adenomas (pituitary tumour associated
with hyperthyroidism),
2. BEFORE YOU USE SOMATULINE LA
Do not use Somatuline LA 30 mg
• if you are allergic (hypersensitive) to lanreotide or drugs from the same
family (analogues of somatostatin) or any of the other ingredients of
Somatuline LA 30 mg.

• Take special care with Somatuline LA 30 mg.
• if you are diabetic as lanreotide may affect your blood sugar levels. Your
doctor may check your blood sugar levels and possibly alter your antidiabetic treatment while you are receiving Somatuline LA 30 mg
• if you have gallstones, as lanreotide may lead to gallstone formation.
Therefore you may need to be monitored periodically.
• if you have any thyroid problems, as lanreotide may slightly decrease your
thyroid function.
• if you have cardiac disorders, as sinus bradycardia (slower heart beat)
may occur under lanreotide treatment. Special care should be taken when
initiating treatment with lanreotide in patients with bradycardia.
• if you have an endocrine tumour of the gastrointestinal tract, your doctor
should not prescribe you lanreotide before excluding the presence of an
obstructive intestinal tumour.
If any of the above applies to you, then you should speak to your doctor.
Taking or using other medicines
Some medicines have effects on the action of other medicines. Please tell
your doctor or pharmacist if you are taking, or have recently taken, any other
medicines, including medicines obtained without a prescription.
Special care should be taken in case of co-administration with
• ciclosporin (a drug reducing immune reaction e.g. after transplantation or
in case of autoimmune disease),
• bromocriptine (dopamine agonist used in the treatment of certain types of
tumours of the brain and Parkinson’s disease or to prevent lactation
following childbirth),
• bradycardia-inducing drugs (drugs slowing the heart beat, e.g. beta
blockers).
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.
Please tell your doctor immediately if you are pregnant, or if you think you
might be pregnant, or if you are breast-feeding. If so, lanreotide should be
administered to you only if clearly needed.

Use in children
Somatuline LA 30 mg is not recommended in children.
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.
3. HOW TO USE SOMATULINE LA
Somatuline LA 30 mg should be administered by healthcare professionals.
Your doctor or nurse will prepare and give the injections.

Validation BAT
Nom du client : IPSEN PHARMA
BIOTECH
Code produit : 0961.06
Désignation : Somatuline LA 30 mg UK
Notice à plat : 396 x 210 mm
Notice pliée : 49,50 x 210 mm
Mode de pliage : 3 plis, 8 volets
Grammage : 50 g/m2

The usual 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 lanreotide 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 product, ask your doctor or
pharmacist.

Couleur recto :
noir u P660 u P185 u

Couleur verso :
noir u P660 u

Edition n° : 05
Date : 01/10/10
Validation client :

Recto
Ce document a valeur de lecture de
textes, graphiques et agencement des
couleurs uniquement.
Les teintes présentées ne sont
qu’approximatives. Les couleurs du
tirage seront les références mentionnées
sur le BAT
Nous attirons votre attention, sur le fait
que votre signature sur les BAT engage
votre responsabilité en cas d’erreurs ou
d’omissions non signalées.
Soyez aimable de nous renvoyer ce document pourvu de vos remarques dans les
plus brefs délais afin de ne pas retarder la
livraison.

Very common (more than 1 patient in 10):
a. diarrhoea, loose stools, abdominal pain
b. gallstones and gall bladder problems
Common (1 to 10 patients in 100):
c. fatigue
d. injection site reactions
e. nausea, vomiting, constipation, flatulence, abdominal distension,
abdominal discomfort, dyspepsia (indigestion)
f. biliary dilatation (enlargement of the gall bladder)
g. sinus bradycardia (slower heart beat)
h. dizziness, headache
i. alopecia, hypotrichosis (loss of hair or reduced development of body hair)
j. hypoglycaemia (low blood sugar level)
k. abnormal laboratory values (ALAT, ASAT, blood bilirubin, blood glucose,
glycosylated haemoglobin)
l. decreased weight
Uncommon (1 to 10 patients in 1.000):
m. hot flushes
n. faeces discoloured
o. diabetes mellitus, hyperglycaemia (high blood sugar level)
p. asthenia (high blood sugar level)
q. insomnia (difficulty in sleeping)
r. abnormal laboratory values (blood alkaline phosphatase, blood sodium)
Occasional cases of inflammation of the pancreas (pancreatitis) have also been
reported.
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.

5. HOW TO STORE Somatuline LA 30 mg
Keep out of the reach and sight of children.
Store in a refrigerator (2°C to 8°C) in the original package.
Do not use after the expiry date which is stated on the carton and labels after
. The expiry date refers to the last day of that month.
Somatuline LA 30mg 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.
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.
6. FURTHER INFORMATION
What Somatuline LA 30 mg contains
The active substance is:
lanreotide (30 mg)

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
The Marketing Authorisation Holder is:
Ipsen Ltd, 190 Bath Road, Slough , Berkshire, SL1 3XE, UK
The Manufacturer is:
Ipsen Pharma Biotech
Parc d’activités du plateau de Signes
Chemin départemental N°402
83870 Signes
France

This leaflet was last approved in 07/2009.

The other ingredients are:
• Powder:
Lactide glycolide copolymer,
Lactic glycolic copolymer,
Mannitol,
Carmellose sodium,
Polysorbate 80.
• Solvent:
Mannitol,
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 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.

Verso Réf. : 0961.06

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.

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.

0961.06

4. POSSIBLE SIDE EFFECTS
Like all medicines, Somatuline LA 30 mg can cause side effects, although not
everybody gets them.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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