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HOSPITALS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Octreotide 50 micrograms/ml,

100 micrograms/ml and 500 micrograms/ml Solution for injection or Concentrate for solution for infusion

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.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

TEVA UK Ref: 231-30-61204-B LEA OCTREOTIDE A/S SOLN TEVAH <GOD    Version: 2    08 October 2014

1.    What Octreotide is and what it is used for

2.    Before Octreotide is used

3.    How to use Octreotide

4.    Possible side effects

5.    How to store Octreotide

6.    Further information

OWHAT OCTREOTIDE IS AND WHAT IT IS USED FOR

Octreotide is a synthetic form of a hormone called somatostatin which occurs naturally in the body. It helps stop the release of some hormones, including growth hormone, in the body.

Octreotide is used:

• To treat acromegaly

Acromegaly is a condition where the body produces too much growth hormone. The level of growth hormone controls the growth of tissues, organs and bones. Too much hormone means the size of bones and tissues, especially in the hands and feet, is larger than normal. The symptoms of acromegaly include headache, excessive perspiration, numb hands and feet, tiredness and joint pain. In most cases, the overproduction of growth hormone is caused by an enlargement in the pituitary gland (a pituitary adenoma).

Octreotide is used to treat people with acromegaly; • when other types of treatment for acromegaly (surgery or radiotherapy) are not suitable or have not worked;

• after radiotherapy, to cover the interim period until the radiotherapy becomes fully effective;

• before surgery on the pituitary gland

• To relieve stomach or bowel symptoms associated with certain tumours known as 'gastroenteropancreatic' tumours (rare tumours of the stomach, bowels or pancreas)

Overproduction of specific hormones and other related natural substances can be caused by some rare conditions of the stomach, bowels or pancreas. This 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 pancreatic surgery

Octreotide can be used in some patients when they have an operation on the pancreas. It may help reduce some of the problems which can occur in the abdomen after the operation, such as inflammation (swelling) and infection.

A BEFORE octreotide is used

You should NOT be given Octreotide

• if you are allergic (hypersensitive) to octreotide acetate or any of the other ingredients of Octreotide (see section 6)

• if you are breast-feeding.

Take special care with Octreotide

• if you are pregnant

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

• if you have any thyroid problems, or have had a disease which may have affected your thyroid • if you have any problems with your liver, or have you had a disease which may have affected your liver • if you have ever suffered from gallstones or other stomach problems

• if you have a history of Vitamin B12 deficiency. Yourdoctormay need to monitor yourvitamin B12 levels during therapy with octreotide.

Your doctor may want to give you a check up from time to time while you are being treated with Octreotide.

Growth hormone secreting pituitary tumours may sometimes expand and cause problems. Tell your doctor if you experience any problems with your eyes or sight.

Tell your doctor if your stomach or bowel problems get worse.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines, including medicines obtained withouta prescription.

•    Insulinorotherdrugsfordiabetes

•    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)

•    Medicines to control blood pressure (beta-blockers or calcium channel blockers) or agents to control fluid and electrolyte balance (diuretics)

•    Medicines metabolised by the liver for example carbamazepine (a drug used in psychiatric disorders, epilepsy, trigeminal neuralgia and neuropathy), digoxin (medicine forcertain heart problems) and warfarin (a drug used to thin the blood) and terfenadine (to relieve allergic symptoms).

Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained withouta prescription.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicines. You should not use Octreotide if you are pregnant unless you have been told by your doctor that it is absolutely necessary for you to do so. You should not breast-feed your infant whilst receiving treatment with octreotide, unless you have been told to do so.

Driving and using machines

Octreotide may make you feel dizzy. If this happens, do not drive or operate machinery. Remember that if you are unwell your ability to operate machinery may be affected.

Important information about some of the ingredients of Octreotide

Octreotide50 micrograms/ml, 100 micrograms/ml and 500 micrograms/ml Solution for injection or Concentrate for solution for infusion contains less than 1 mmol sodium perdose, i.e. essentially "sodium-free".

Other Special Warnings

•    Tell your doctor if your stomach or bowel symptoms get worse

•    Octreotide should only be used in pregnancy if clearly needed. Tell your doctor if you are pregnant or want to become pregnant

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

j3^ HOW TO USE OCTREOTIDE

Always use Octreotide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure of anything.

Your medicine must be injected subcutaneously i.e. into the tissue under the skin. Your doctor or nurse will show you how to do this. If you are unsure, go back and ask for advice. You must use a clean, sterile syringe and needle every time.

The upper arms, thighs and stomach are good areas for subcutaneous injection. Choose a different place each time so that you don't irritate a particular area. Keep changing the injection site. Don't inject into the same place too frequently.

To avoid side effects like stomach ache, wind, diarrhoea and constipation do not inject at mealtimes. Inject between meals or before going to bed.

In rare cases Octreotide will have to be injected intravenously (into a vein). If this is necessary the doctor or nurse will do it and monitor you closely. You must NOT injectOctreotide into yourveins yourself.

The usual 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:

For the treatment of acromegaly

•    The usual dose is 0.1 to 0.2 mg three times a day bysubcutaneous injection. Dependingon how you respond, your doctor will adjust the dose until they find the right dose.

To relieve symptoms caused by over-production of some hormones

•    Your doctor will usually start your treatment with 0.05 mg once or twice daily by subcutaneous injection. Dependingon howyou respond, your doctor may gradually increase the dose until they find your ideal dose.

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

Instructions for use, handling and disposal:

For single use only.

Octreotide is an injection and a concentrate for solution for infusion. This must be handled with 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.

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If the solution comes into contact with the skin: wash with water and soap. If the solution comes into contact with membranes, wash (irrigate) the affected area with water.

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

Storage:

Storage conditions:

Before opening: Store in a refrigerator 2-8⁰C, protected from light. Do not freeze.

After opening: The product must be used immediately

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TEVA UK Ref: 231-30-61204-B LEA OCTREOTIDE A/S SOLN TEVAH <GOD    Version: 2    08 October 2014

Uncommon:

•    Dehydration

•    Fast heart beat.

Frequency not known:

•    Anaphylaxis (a type of allergic reaction which causes difficulty in breathing or dizziness), allergy/hypersensitivity reactions

•    Itchy rash

•    Inflammation of the pancreas

•    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

•    Irregularheartbeat

•    Liverdysfunction.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

A HOW TO STORE OCTREOTIDE

Keep out ofthe reach and sight of children.

Do not use Octreotide after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

Storage conditions:

Before opening: Store in a refrigerator 2-8⁰C, protected from light. Do notfreeze.

After opening: The product must be used immediately and any unused drug-product must be discarded.

After dilution: The chemical and physical stability of Octreotide solution diluted in 9 mg/ml (0.9%) sodium chloride solution for infusion has been demonstrated for 24 hours when stored below 25⁰C. From a microbiological pointofview, the product should be used immediately, if not used immediately, storage times and conditions are the responsibility of the user, unless dilution has taken place in controlled and validated aseptic conditions.

Do not use unless the solution is clear and free from visible particles.

For single use only.

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.

16 FURTHER INFORMATION

What Octreotide contains

•    The active substance is octreotide (as the acetate). Each ml of solution for injection or concentrate for solution for infusion contains 50 micrograms,

100 micrograms and 500 micrograms ocreotide.

•    The other ingredients are glacial acetic acid, sodium acetate trihydrate (E262), mannitol (E421) and water for injections.

What Octreotide looks like and contents of the pack

Octreotide50 micrograms/ml, 100 micrograms/ml and 500 micrograms/ml Solution for injection or Concentrate for solution for infusion is a clear and colourless solution. The solution is supplied in colourless glass vials closed with serum rubber stoppers and sealed with aluminium flip-off caps fitted with plastic flip-off discs. The product is packed in cardboard boxes.

Octreotide50 micrograms/ml, 100 micrograms/ml and 500 micrograms/ml solution for injection or concentrate forsolution for infusion is available in pack sizes of1,3, 5, 6, 10, 20 and 30 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

Teva UK Limited, Eastbourne, BN22 9AG,

United Kingdom

Manufacturer

Teva Pharmaceutical Works Private Limited Company H-2100 Godollo Tancsics Mihaly ut 82 Hungary

This leaflet was last revised in October 2014.

PL 00289/1257 PL 00289/1264-5

3-29133300/B

61204-B

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