Package leaflet: Information for the user

Octreotide 0.05 mg/1 ml solution for injection Octreotide 0.1 mg/1 ml solution for injection Octreotide 0.2 mg/ml solution for injection Octreotide 0.5 mg/1 ml solution for injection

Octreotide acetate

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, 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1.    What Octreotide is and what it is used for

2.    What you need to know before you use Octreotide

3.    How to use Octreotide

4.    Possible side effects

5.    How to store Octreotide

6.    Contents of the pack and other information

1. What Octreotide is and what it is used for

Octreotide is a synthetic version of a hormone that occurs naturally in the body, called somatostatin. Octreotide inhibits the release of growth hormone and some gut hormones and secretions.

Octreotide is used:

*    To treat the symptoms that occurs with hormone producing gastrointestinal tumours. These symptoms are associated with the over-production of some of the body’s natural substances which may result in an imbalance of your natural hormone levels. This imbalance may cause a variety of symptoms in the stomach, pancreas or intestines (gut).

*    To reduce the levels of growth hormone and insuiin-like growth factor number 1 (1GF-1) if you have acromegaly and to improve symptoms that you may have due to over-production of these hormones.

*    Prior to having an operation on the pancreas, to prevent further complications.

2. What you need to know before you use Octreotide

*    if you are breast-feeding

*    if you are younger than 18 years old Other medicines and octreotide:

Tell your doctor if you are using any of the following medicines;

*    ciclosporin (a drug used after a transplant)

*    cimetidine (a drug used to reduce stomach acid)

*    bromocriptine (a drug used in Parkinson’s disease or in acromegaly or to suppress breast milk)

*    terfenadine (to relieve allergic symptoms)

*    carbamazepine (a drug used in psychiatric disorders, epilepsy, trigeminal neuralgia and neuropathy)

*    digoxin (medicine for certain heart problems)

*    warfarin (a drug used to thin the blood)

Other medicines that are metabolised by the liver can also be affected, so tell your doctor or pharmacist if you are using any other medicines.

Pregnancy, breasf-feeding and fertility

There is no data regarding treatment with octreotide and its effects on fertility.

Women of child bearing potential must use an effective contraceptive method during treatment with octreotide.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Octreotide should not be used if you are pregnant or breast-feeding unless the benefits to the mother outweigh the risk to the baby.

3. How to use Octreotide

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

A doctor or nurse will usually give you this medicine.

The medicine will be given to your either as a subcutaneous injection (underneath the skin) or as a slow intravenous injection (via a drip into the vein).

The recommended dosages are given below; however your doctor will decide what dosage to give to you, as this depends on the nature of your treatment, your age and your medical condition:

*    To treat the symptoms that occur with hormone producing gastrointestinal tumours: 0.05 mg each 24 hours or each 12 hours, Depending on your response, the dose may be increased to 0.1-0.2 mg every 8 hours. The usual recommended maximum daily dosage is 0.6 mg.

*    If you have acromegaly: initial doses of 0.05-0.1 mg, every 8 hours. For most patients the dosage is 0.2-0.3 mg per day and the maximum daily dosage is 1.5 mg.

*    Prior to having an operation on the pancreas: 0.1 mg every 8 hours for 7 days, starting on the day of the operation.

Your injection should be given between meals or at bedtime in order to reduce stomach and intestinal (gut) side effects.

Do not use octreotide:

* If you are allergic to octreotide or any of the ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using octreotide.

Special care will be taken:

*    as octreotide may affect your blood sugar levels. You or your doctor should closely monitor your blood sugar levels.

*    if you have a tumour (growth) that produces insulin (insulinoma). You or your doctor should closely monitor your blood sugar levels.

*    if you have any thyroid problems

*    if you have gallstones (gallstones can occur sometimes without symptoms. This is the reason why your doctor may perform ultrasonic examinations before and after treatment with octreotide)

*    if you have liver disease

*    if you are pregnant or planning to become pregnant, if you do become pregnant, tell your doctor immediately.

To reduce discomfort, Octreotide solution for injection should reach room temperature before administration. Multiple subcutaneous injections at short intervals at the same administration site should be avoided.

If you use more octreotide than you should: this medicine is given to you by healthcare professionals, and so it is unlikely that you will receive any overdose. However, if you think you have had too much octreotide, teii your doctor or nurse immediately.

4. Possible side effects

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

them.

If any of the following happen, tell your doctor immediately:

*    severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing).

*    pancreatitis - this may give you sudden severe pains in your abdomen. It may occur in the first few hours or days of treatment.

*    intestinal obstruction - you may experience constipation and abdominal pains.

These are very serious side effects. You may need urgent medical attention. These side

The following information is intended for healthcare professionals only:

Octreotide solution for injection

This is an extract from the SmPC to help you with the administration of Octreotide Solution for injection.

For parenteral use only: Subcutaneously (SC) or Intravenously (IV)

Storage

Store in a refrigerator (2*C - 8°C). Do not freeze. Store the vial in the outer carton in order to protect the product from light.

Shelf-life after first opening: The product must be used immediately and any unused drug-product must be discarded

The multidose vials of Octreotide 0.2 mg/ml solution for injection for daily use may be stored for two weeks below 25°C.

The multidose vials can be stored for 2 weeks at room conditions for daily use, however to prevent contamination, it is recommended to puncture the cap of the vial no more than 10 times (Multidose vials only).

Chemical and physical stability of diluted solution has been demonstrated for 7 days below 25*C when stored in PVC bags or polypropylene syringes and diluted in sodium chloride 0.9% solution. From a microbiological point of view, the product should be used immediately, if not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8*C, unless dilution has taken place in controlled and validated aseptic conditions

Use

Octreotide is an injection, so it must be handled with particular caution. The dilution must be done under aseptic conditions, by trained staff and in a specific area. The contact of octreotide with skin and membranes should be avoided, if the injection comes into contact with skin: wash with water and soap. If it comes into contact with membranes, wash (irrigate) the affected area with water.

To reduce local discomfort, let the solution reach room temperature before injection. Avoid multiple injections at short intervals at the same site.

Prior to administration the solution should be inspected visually for changes of colour or presence of particles.

it is not recommended to mix or dilute the octreotide solutions for injection except with 0.9% Sodium Chloride solution.

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effects are rare (occur in less than 1 in 1000 patients but more than 1 in 10,000).

Tell your doctor as soon as possible if you notice any of the following side effects: Very common (occurs in more than 1 in 10 patients):

*    gallstones that could give gallbladder pain

*    increases in blood sugar levels (hypergiycaemia)

*    headache

*    stomach ache, diarrhoea, constipation, nausea (feeling sick) and wind (these may be less if you inject between meals or before going to bed)

*    pain where the injection is given

Common (occurs in less than 1 in 10 patients but more than 1 in 100):

*    changes in activity of the thyroid gland (hypothyroidism)

*    changes in blood sugar levels (low levels may occur - hypoglycaemia)

*    impaired glucose tolerance

*    anorexia

*    dizziness

*    slow heart beat

*    stomach discomfort after a meal

*    bloated stomach

*    loose stools

*    vomiting

*    fatty material in the faeces (steatorrhea)

*    discolouration of faeces

*    itching

*    rash

*    hair loss

*    shortness of breath

*    inflammation of the gallbladder

*    biliary sludge

*    yellow skin and eyes (jaundice)

*    gallstone

*    abnormal liver function test results

Uncommon (occurs in less than 1 in 100 patients but more than 1 in 1000):

*    fast heart beat

*    dehydration

*    liver problems

Rare (occurs in less than 1 in 1000 patients but more than 1 in 10,000):

*    pancreas inflammation (acute pancreatitis)

*    ileus-like conditions (your gut may not work properly)

*    severe epigastric pain (pain in upper part of stomach)

*    allergic skin reactions (hypersensitivity)

Very rare (occurs in less than 1 in 10,000 patients)

*    reversible liver inflammation (acute hepatitis)

*    slow development of yellow skin and eyes (hyperbiiirubinaemia in association with abnormal liver function test results

*    pain in your upper right side (biliary colic)

Your doctor will take blood tests to check for changes in liver and thyroid function, which a side effect of treatment with octreotide.

if you get any of the side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

5. How to store Octreotide

Keep the vial in the outer carton in order to protect the product from light.

Medicinal product as packaged for sale: Store in a refrigerator (2*C-8*C). Do not freeze.

Shelf-life after first opening: The product must be used immediately and any unused drug-product must be discarded.

The multidose vials of Octreotide 0.2 mg/ml solution for injection for daily use may be stored for two weeks below 25*C.

Octreotide, diluted in 0.9% sodium chloride would not normally be stored for longer than 24 hours in a refrigerator.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label. The injection should only be used if it is clear and free of particles.

Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment.

6. Contents of the pack and other information

What Octreotide Solution for Injection contains

*    The active substance is octreotide;

*    The other excipients are glacial acetic acid, sodium acetate trihydrate, sodium chloride and water for injections. The multi-dose vials additionally contain phenol (a preservative).

This medicinal product contains less than 1 mmol (23 mg) of sodium (i.e., essentially sodium free) per ml of solution.

What Octreotide Solution for Injection looks like and contents of the pack

Octreotide Solution for injection is available as vials containing a clear, colourless solution for injection.

Octreotide Solution for Injection is available in the following pack sizes:

Octreotide solution for injection 0.05 mg/1 ml (packs of 5, or 30 vials)

Octreotide solution for injection 0.1 mg/1 ml (packs of 5, or 30 vials)

Octreotide solution for injection 0.5 mg/1 ml (packs of 5, or 30 vials)

Octreotide solution for injection 0.2 mg/ mi (packs of 1 or 10 muitidose vials)

The vials may be overwrapped with a protective plastic to minimise the risk of spillage if the vials break; these vials are referred to as ONCO-TAiN™.

Marketing authorisation holder and manufacturer:

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

United Kingdom

This leaflet was last revised in 08/2012

C00P1406 /V-05 (373763