SOMATULINE LA 30 MG POWDER FOR SUSPENSION FOR INJECTION - patient leaflet, side effects, dosage

Somatuline LA 30 mg Powder and solvent for prolonged release suspension for injection

Lanreotide

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).

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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following information is intended for medical or healthcare professionals only:

INSTRUCTIONS FOR RECONSTITUTION

FRONT / RECTO

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

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 in the gallbladder. In this case, you may need to be monitored periodically. Your doctor may decide to stop treatment with lanreotide if complications arising from gallstones occur.
• 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.

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 it is essentially ‘sodium-free’.

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.

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

Method of administration

Somatuline LA 30 mg is administered intramuscularly into the buttock.

The injection is performed by healthcare professionals only.

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.

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 this is the case.

Lanreotide – the active substance i – 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.

Special care should be taken in case of co-administration wit­h:

• Ciclosporin (a drug reducing immune reaction taken 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, such as beta blockers).

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, as you may have with Somatuline LA 30 mg one forgotten dosage will not dramatically affect the success of your therapy.

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).

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, 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.

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.

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

DO NOT INVERT THE VIAL DO NOT USE THIS PRODUCT IF THE EXPIRY DATE ON THE BOX HAS BEEN PASSED

m

m

GENTLY shake the contents of the vial from side to side, 20 to 30 times until a milky homogeneous suspension is obtained.

Transfer the suspension vehicle into the Somatuline LA 30 mg vial by inserting the needle through the rubber stopper and slowly injecting the solution. DO NOT REMOVE THE SYRINGE.

Draw up the suspension vehicle (mannitol solution 2 ml) into the syringe with one of the pink needles.

DO NOT INVERT THE VIAL This is important to ensure that most of the suspension is drawn up into the syringe. Draw up as much of the suspension as possible. An extra amount is included to compensate for the small residue that will remain in the vial.

REMOVE THE NEEDLE, push the air from the syringe and then

attach the other pink needle. The injection should be given INTRAMUSCULARLY, ideally in the gluteal muscles. Inject the contents of the syringe IMMEDIATELY AND RAPIDLY.

Q £0459