Octreotide 50micrograms / ml solution for injection

• 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 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. This includes any possible side effects not listed in this leaflet. See section 4.

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

• in acromegaly, a condition where the body produces too much growth hormone. Normally, growth hormone controls growth of tissues, organs, and bones. Too much growth hormone leads to an increase in the size of bones and tissues, especially in the hands and feet. Octreotide markedly reduces the symptoms of acromegaly, which include headache, excessive perspiration, numbness of the hands and feet, tiredness, and joint pain.
• to relieve symptoms associated with some tumours of the gastrointestinal tract (e.g. carcinoid tumours, VIPomas, glucagonomas, gastrinomas, insulinomas). In these conditions, there is overproduction of some specific hormones and other related substances by the stomach, bowels, or pancreas. This overproduction upsets the natural hormonal balance of the body and results in a variety of symptoms, such as flushing, diarrhoea, low blood pressure, rash, and weight loss. Treatment with Octreotide helps to control these symptoms.
• to prevent complications following surgery of the pancreas gland. Treatment with Octreotide helps to lower the risk of complications (e.g. abscess in the abdomen, inflammation of the pancreas gland) after the surgery.
• to stop bleeding and to protect from re-bleeding from ruptured gastro-oesophageal varices in patients suffering from cirrhosis (chronic liver disease). Treatment with Octreotide helps to control bleeding and reduce transfusion requirements.
• to treat pituitary tumours that produce too much thyroid-stimulating hormone (TSH). Too much thyroid-stimulating hormone (TSH) leads to hyperthyroidism.
  Octreotide is used to treat people with pituitary tumours that produce too much thyroid-stimulating hormone (TSH):
• when other types of treatment (surgery or radiotherapy) are not suitable or have not worked;
• after radiotherapy, to cover the interim period until the radiotherapy becomes fully effective.

• if you are allergic to octreotide or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor before using Octreotide:

• if you know that you have gallstones now, or have had them in the past or experience any complications like fever, chills, abdominal pain, or yellowing of your skin or eyes; tell your doctor, as prolonged use of Octreotide may result in gallstone formation. Your doctor may wish to check your gallbladder periodically.
• if you have problems with your blood sugar levels, either too high (diabetes) or too low (hypoglycaemia). When Octreotide is used to treat bleeding from gastro-oesophageal varices; monitoring of blood sugar level is mandatory.
• if you have a history of vitamin B12 deprivation your doctor may wish to check your vitamin B12 level periodically.

Octreotide may lower your heart rate and at very high doses may cause abnormal heart rhythm. Your doctor may monitor your heart rate during treatment.

If you receive treatment with Octreotide over a long period of time, your doctor may wish to check your thyroid function periodically.

Your doctor will check your liver function.

Your doctor may wish to check your pancreatic enzyme function.

There is little experience with the use of Octreotide in children.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You can generally continue taking other medicines while on Octreotide. However, certain medicines, such as cimetidine, ciclosporin, bromocriptine, quinidine and terfenadine have been reported to be affected by Octreotide.

If you are taking a medicine to control your blood pressure (e.g. a beta blocker or a calcium channel blocker) or an agent to control your fluid and electrolyte balance, your doctor may need to adjust the dosage.

If you are diabetic, your doctor may need to adjust your insulin dosage.

If you are going to receive lutetium (177Lu) oxodotreotide, a radiopharmaceutical therapy, your doctor may stop and/or adapt octreotide treatment.

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 only be used during pregnancy if clearly needed.

Women of child-bearing age should use an effective contraceptive method during treatment.

Do not breast-feed while using Octreotide. It is not known whether Octreotide passes into breast milk.

Octreotide has no or negligible effects on the ability to drive and use machines. However, some of the side effects you may experience while using Octreotide, such as headache and tiredness, may reduce your ability to drive and use machines safely.

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

The upper arms, thighs, and abdomen are good areas for subcutaneous injection.

Choose a new site for each subcutaneous injection so that you do not irritate a particular area. Patients who will be injecting themselves must receive precise instructions from the doctor or nurse.

If you store the medicine in the refrigerator, it is recommended that you allow it to reach room temperature before using it. This will reduce the risk of pain at the site of injection. You can warm it up in your hand but do not heat it.

A few people experience pain at the site of the subcutaneous injection. This pain usually only lasts a short time. If this happens to you, you can relieve this by gently rubbing the site of injection for a few seconds afterwards.

Before using a Octreotide ampoule, check the solution for particles or a change of colour. Do not use it if you see anything unusual.

To prevent contamination the cap of the multidose vials should be punctured not more than 10 times.

The symptoms of overdose are:

• irregular heart beat
• low blood pressure
• cardiac arrest
• reduced supply of oxygen to the brain
• severe upper stomach pain
• yellow skin and eyes
• nausea
• loss of appetite
• diarrhoea
• weakness
• tiredness
• lack of energy
• weight loss
• abdominal swelling
• discomfort
• high level of lactic acid in the blood
• abnormal heart rhythm.

If you think that an overdose has happened and you experience such symptoms, tell your doctor straight away.

Administer one dose as soon as you remember, and then continue as usual. It will not do any harm if you miss a dose, but you could get some temporary re-appearance of symptoms until you get back on schedule.

Do not inject a double dose of Octreotide to make up for forgotten individual doses.

If you interrupt your treatment with Octreotide your symptoms may come back. Therefore, do not stop using Octreotide unless your doctor tells you to.

• hypersensitivity (allergic) reactions including skin rash
• a type of an allergic reaction (anaphylaxis) which causes difficulty in swallowing or breathing, swelling and tingling, possibly with a drop in blood pressure with dizziness or loss of consciousness
• an inflammation of the pancreas gland (pancreatitis); symptoms may include sudden pain in the upper abdomen, nausea, vomiting, diarrhoea
• liver inflammation (hepatitis); symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, generally feeling unwell, itching, light-coloured urine
• irregular heart beat
• low level of platelet count in blood; this could result in increased bleeding or bruising.

Tell your doctor straight away if you notice any of the side effects above.

Tell your doctor, pharmacist or nurse if you notice any of the side effects listed below. They are usually mild and tend to disappear as treatment progresses.

Very common (may affect more than 1 in 10 people):

• diarrhoea
• abdominal pain
• nausea
• constipation
• flatulence (wind)
• headache
• local pain at the injection site.

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

• stomach discomfort after meal (dyspepsia)
• vomiting
• feeling of fullness in the stomach
• fatty stools
• loose stools
• discolouration of faeces
• dizziness
• loss of appetite
• change in liver function tests
• hair loss
• shortness of breath
• weakness.

If you get any side effects, please tell your doctor, nurse or pharmacist.

A few people experience pain at the site of the subcutaneous injection. This pain usually only lasts a short time. If this happens to you, you can relieve this by gently rubbing the site of injection for a few seconds afterwards.

If you are administering Octreotide by subcutaneous injection, it may help to reduce the risk of gastrointestinal side effects if you avoid eating meals around the time of injection. It is therefore recommended that you inject Octreotide between meals or when you go to bed.

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.

The active substance is octreotide, as octreotide acetate.

One ampoule of 1 ml solution for injection contains octreotide acetate equivalent to 0.05 milligrams, 0.1 milligrams, 0.5 milligrams octreotide.

One multidose vial of 5 ml solution for injection contains octreotide acetate equivalent to 1 milligram octreotide. 1 ml of solution contains 0.2 milligrams octreotide

The other ingredients are: sodium acetate trihydrate, acetic acid, glacial, sodium chloride, water for injection, phenol (for the multidose vial only).

This medicinal product is presented as a clear colourless solution for injection.

Pack size of 5, 10 or 30 ampoules of 1 ml solution

Pack size of 1, 10 or 30 multidose vials of 5 ml solution.

Not all pack sizes may be marketed.

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Octreotid SUN 0,05, 0,1, 0,5 mg/1ml, 1 mg/5ml injektionsvæske, opløsning

Germany: Octreotid SUN 0,05, 0,1, 0,5 mg/1ml, 1 mg/5ml Injektionslösung

Italy: Octreotide SUN 0,05, 0,1, 0,5 mg/1ml, 1 mg/5 ml soluzione iniettabile

Spain: Octreotida SUN 100 microgramos/ml solución inyectable EFG

Sweden: Oktreotid SUN 50, 100, 200, 500 mikrogram/ml injektionsvätska, lösning

United Kingdom (Northern Ireland): Octreotide 50, 100, 200, 500 micrograms/ml Solution for Injection