What is a Patient Information Leaflet and why is it useful?

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 can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 34926/0004 .

Somatuline LA

PACKAGE LEAFLET: INFORMATION FOR THE USER

Somatuline LA 30 mg

Powder and solvent for prolonged release suspension for injection

Lanreotide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

  • 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. WHAT YOU NEED TO KNOW BEFORE YOU USE SOMATULINE LA 30 MG

Do not use Somatuline LA 30 mg

  • If you are allergic (hypersensitive) to lanreotide, somatostatin and drugs from the same family (analogues of somatostatin) or any of the other ingredients of Somatuline LA 30 mg (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using 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 anti-diabetic 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 any of the above applies to you, talk to your doctor or pharmacist before using Somatuline LA 30 mg.

Children

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:

  • 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.

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:

  • Feeling more thirsty or tired than usual, and having a dry mouth – these may be signs that you have high blood sugar levels or are developing diabetes
  • Feeling hungry, shaky, sweating more than usual or feeling confused. These may be signs of low blood sugar levels.

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:

  • Your face becomes flushed or swollen or you develop spots or a rash
  • Your chest feels tight, you become short of breath or wheezy
  • You feel faint, possibly as a result of a drop in blood pressure.

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):

  • Diarrhoea, loose stools, abdominal pain
  • Gallstones and other gall bladder problems. You may have symptoms such as severe and sudden abdominal pain, high fever, jaundice (yellowing of the skin and whites of the eyes), chills, loss of appetite, itchy skin.

Common (may affect up to 1 in 10 people):

  • Weight loss
  • Lack of energy
  • Slow heart beat
  • Feeling very tired
  • Decrease in appetite
  • Feeling generally weak
  • Excess fat in the stools
  • Feeling dizzy, having a headache
  • Loss of hair or less development of body hair
  • Pain that affects muscles, ligaments, tendons and bones
  • Site reactions where the injection is given such as pain, hard skin or itching
  • Abnormal liver and pancreas test results and changes in blood sugar levels
  • Nausea, vomiting, constipation, wind, stomach bloating or discomfort, indigestion
  • Biliary dilatation (enlargement of the bile ducts between your liver and gall bladder and the intestine). You may have symptoms such as stomach pain, nausea, jaundice and fever

Uncommon (may affect up to 1 in 100 people):

  • Hot flushes
  • Difficulty sleeping
  • Faeces discoloured, a change in the colour of the stools
  • Changes to sodium and alkaline phosphatase levels, shown in blood tests

Not known: frequency cannot be estimated from the available data:

  • Sudden, severe pain in your lower stomach – this may be a sign of an inflamed pancreas (pancreatitis)
  • Abscess at the site of injection which may feel fluid-filled when pressed (redness, pain, warmth and swelling which may be associated with fever)
  • Inflammation of the gallbladder - you may have symptoms such as severe and sudden pain in the upper right or centre abdomen, the pain may spread to the shoulder or back, tenderness of the abdomen, nausea, vomiting and high fever

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:

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 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:

Ipsen Ltd
190 Bath Road
Slough
Berkshire
SL1 3XE
UK

Manufacturer:

Ipsen Pharma Biotech
Parc d’activités du plateau de Signes
Chemin départemental N°402
83870 Signes
France

This leaflet was last revised in September 2018.