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1. Octreotide 50 Micrograms/Ml Solution For Injection In Prefilled Syringe
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Cod. 01662/7

Material type/Tipo di materiale	Description/Descrizione	Country - Language/Paese - Lingua	Code / Codice
LEAFLET	OCTREOTIDE Solution	UK	PK20355

Min. Size:	N° colori	Colore 1			Colore 2	TACCHE LAETUS		Min. Size
199 x 590/37	1	BLACK				404		10

PELLICOLA DI PROPRIETA

VIETATA LA MANOMISSIONE - RENDERE DOPO LA STAMPA

NUOVO

TESTO

ITALFARMACO s.p.A.

14-03-14

PACKAGE LEAFLET: INFORMATION FOR THE USER

OCTREOTIDE 50 micrograms /ml,

Solution for injection in prefilled syringe

OCTREOTIDE 100 micrograms /ml,

Solution for injection in prefilled syringe

OCTREOTIDE 500 micrograms /ml,

Solution for injection in prefilled syringe

OCTREOTIDE

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.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    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:

1.    What Octreotide is and what it is used for.

2.    Before you are given Octreotide.

3.    How you will be given Octreotide.

4.    Possible side effects.

5.    How to store Octreotide.

6.    Further information.

1.    WHAT OCTREOTIDE AND WHAT IT IS USED FOR

Octreotide is a synthetic version of a hormone, called somatostatin, that occurs naturally in the body. 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 intestine (gut).

•    To reduce the levels of growth hormone and insulin-like growth factor number 1 (IGF-1) if you have acromegaly (a condition where you make too much growth hormone) and to improve symptoms that you may have due to over-production of these hormones.

•    To prevent further complications before having an operation on the pancreas.

2.    BEFORE YOU ARE GIVEN OCTREOTIDE You should not be given Octreotide:

•    If you are allergic to octreotide or any of the ingredients in OCTREOTIDE (see Section 6 ‘Further information’). Take special care with Octreotide:

•    because 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 thyroid problems

•    if you have liver disease

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

•    if you have a slower than normal heartbeat (bradycardia), tell your doctor

•    if you have a history of vitamin B12 deficiency, tell your doctor

•    if you are pregnant. If you do become pregnant, tell your doctor immediately.

•    if you are breast-feeding Taking other medicines

•    Please tell your doctor if you are taking 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, a condition where you make too much growth hormone, 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 about all the medicines you are taking.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. 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 use adequate contraception, if necessary, during treatment with octreotide. If you do become pregnant, tell your doctor immediately.

You should not breastfeed your infant whilst receiving treatment with Octreotide.

Important information about some ingredient of Octreotide

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

3.    HOW YOU WILL BE GIVEN OCTREOTIDE

-    A doctor or nurse will usually give you this medicine. You should check with your doctor or pharmacist if you are unsure of anything.

-    The medicine will be given to you either as a subcutaneous injection (underneath the skin) or as a slow intravenous injection (via a drip into the vein) or by continuous intravenous infusion

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

-    To reduce discomfort, Octreotide solution for injection should reach room temperature before it is given to you or inject by yourself.

-    Multiple subcutaneous injections at short intervals at the same administration site should be avoided.

-    The local effects, at the administration site, are generally mild and of short duration (pain, tumefaction and cutaneous eruption at the administration site)

Usual dosage:

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:

•    Gastrointestinal tumours

To treat the symptoms that occur with hormone producing gastrointestinal tumours: 50 micrograms each 24 hours or each 12 hours, depending on your response, the dose may be increased to 100 to 200 micrograms every 8 hours. The usual recommended maximum daily dosage is 600 micrograms.

•    Acromegaly (a condition where you make too much growth hormone):

If you have acromegaly: initial doses of 50 to 100 micrograms, every 8 hours. For most patients the dosage is 200 to 300 micrograms per day and the maximum daily dosage is 1500 micrograms.

•    Pancreatic Surgery:

Before having an operation on the pancreas: you will be given 100 micrograms every 8 hours for 7 days, starting on the day of the operation.

If you are given more OCTREOTIDE than you should

Tell your doctor or nurse immediately if you are concerned that you may have been given too much Octreotide.

If you miss an injection of Octreotide.

Tell your doctor or nurse if you think you have missed a dose of your medicine. They will give you the injection unless it is almost time for your next one.

You must NOT have a double dose or two injections at once.

4.    POSSIBLE SIDE EFFECTS

As other medicinal products, Octreotide can cause side effects, although not everybody gets them.

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

Rare side effects (occur in less than 1 in 1000 patients)

•    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 feel constipation and abdominal pain.

Very rare side effects (occur in less than 1 in 10000 patients)

•    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).

•    acute hepatitis with possible icterus (yellowish discolouration of skin and mucosae)

The above are very serious side effects. Tell your doctor immediately as you may need urgent medical attention.

Tell your doctor as soon as possible if you notice any of the following side effects:

Very common (occur in more than 1 in 10 patients)

•    diarrhoea

•    stomach pain

Cod. 01662/7

Material type/Tipo di materiale LEAFLET

Description/Descrizione OCTREOTIDE Solution

Country - Language/Paese - Lingua UK

Code / Codice PK20355

O =»graph packaging graflca design

Min. Size:	N° colori	Colore 1			Colore 2	TACCHE LAETUS		Min. Size
199 x 590/37	1	BLACK				404		10

PELLICOLA DI PROPRIETA

VIETATA LA MANOMISSIONE - RENDERE DOPO LA STAMPA

NUOVO

TESTO

14-03-14

•    nausea

•    constipation

•    flatulence - excessive gas in your stomach or bowels

•    headache

•    gallstones that could give gallbladder pain.

•    high blood sugar levels

•    pain where the injection has been given

Common side effects (occurs in less than 1 in 10 patients)

•    dyspepsia (upset stomach)

•    vomiting

•    abdominal distension

•    steatorrhea (fatty material in the faeces)

•    loose stools

•    discolouration of faeces

•    dizziness

•    thyroid dysfunction, with decreased level of thyroidal hormones

•    increased levated levels of hepatic enzymes named transaminases

•    severe loss of appetite (anorexia)

•    difficulty of breathing (dyspnoea)

•    cholecystitis (constant, severe pain in the right upper quadrant of the abdomen, with low grade fever, diarrhea, vomiting and nausea).

•    pruritus

•    rash

•    loss of hair

•    important reduction of your heart beating (bradycardia)

•    changes in blood sugar levels (both high or low levels may occur)

•    asthenia (weakness)

Uncommon side effects (occurs in less than 1 in 100 patients):

important increase of your heart beating (tachycardia)

•    dehydration (an excessive loss of body fluid, with thirst, decreased urine volume, abnormally dark urine, tiredness, irritability, headache, dry mouth, dizziness).

Post marketing reported adverse reaction:

•    irregular hearth beat (arrhythmia)

•    increased levels of hepatic enzymes named alkaline phosphatase and gamma glutamyl transferase

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

If you notice any side effects not listed in this leaflet, please tell your doctor (or pharmacist).

5.    HOW TO STORE OCTREOTIDE

•    Store in a refrigerator (2°C to 8°C).

•    Do not freeze. Store the pre-filled syringes in the blister in order to protect the product from light.

•    For day by day use the product may be stored below 30°C for up to 30 days.

•    After dilution in sodium chloride 0.9% solution when stored in glass bottles: chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately

•    Keep out of the reach and sight of children.

•    The injection should reach room temperature before it is given to you (See Section 3 How you will be given for further information).

•    Do not use Octreotide after the expiry date stated on the carton and label.

•    The injection should only be used if it is clear and free of particles.

•    Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

6.    FURTHER INFORMATION What Octreotide contains

The active substance is octreotide as octreotide acetate

Each prefilled syringe with 1 ml of solution for injection contains 50 micrograms of octreotide as octreotide acetate. Each prefilled syringe with 1 ml of solution for injection contains 100 micrograms of octreotide as octreotide acetate.

Each prefilled syringe with 1 ml of solution for injection contains 500 micrograms of octreotide as octreotide acetate.

The other ingredients are: (S)-Lactic acid, sodium chloride, sodium hydroxide and water for injection.

What Octreotide looks like and content of the pack.

The medicinal product is available as prefilled syringes containing 1 ml of a clear, colourless solution for injection.

Packs of 5, 6 or 30 prefilled syringes in thermoformed white, opaque PVC blister, sealed with an aluminium foil. Not all pack sizes may be marketed.

Marketing Authorisation Holder

CHEMI S.p.A.

Via Dei Lavoratori, 54 Cinisello B. (MI) 20092 Italy

Manufacturer

ITALFARMACO S.p.A.

Viale F. Testi, 330 - 20126 Milano.

Tel. + 39 02 64431

Fax. + 39 02644346

e-mail: info@italfarmaco.com

This medicinal product is authorized in the Member States of the EEA under the following names:

UK:

Octreotide 50 micrograms/ml, Solution for injection in prefilled syringe Octreotide 100 micrograms/ml, Solution for injection in prefilled syringe Octreotide 500 micrograms/ml, Solution for injection in prefilled syringe

IT:

Octreotide Chemi 50 microgrammi/ml, soluzione iniettabile in siringa preriempita Octreotide Chemi 100 microgrammi/ml, soluzione iniettabile in siringa preriempita Octreotide Chemi 500 microgrammi/ml, soluzione iniettabile in siringa preriempita

DE:

Octreotid-hameln 50 Mikrogramm/ml Injektionslosung Octreotid-hameln 100 Mikrogramm/ml Injektionslosung Octreotid-hameln 500 Mikrogramm/ml Injektionslosung

Date of preparation: January 2013

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

Octreotide solution for injection

This is an extract from the SmPC to help you with the administration of Octreotide For parenteral use only: Subcutaneously (SC) or Intravenously (IV)

Storage

Store in a refrigerator (2°C - 8°C). Do not freeze. Store the prefilled syringe in the blister in order to protect the product from light.

Storage conditions after dilution in sodium chloride 0.9% solution when stored in glass bottles.

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C From a microbiological point of view, the product should be used immediately.

Use

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.

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

Disposal

Any solution or item used (or that has been in contact) with Octreotide solution for injection must be discarded according to local recommendations for injections.

Administration

The recommended route of administration is subcutaneous, however, in instances where a rapid response is required, e.g. carcinoid crises, the initial recommended dose of Octreotide may be administered by the intravenous route, diluted and given as a bolus, whilst monitoring the cardiac rhythm through ECG.

Subcutaneous injection:

Octreotide is recommended to be given subcutaneously without reconstitution.

Intravenous infusion:

GEP tumours where a rapid response is required (IVbolus administration): Octreotide should be diluted with 0.9% Sodium Chloride w/v solution to a ratio of no more than 1:100.

CHEMI