SANDOSTATINA 10 mg Proszek I Rozpuszczalnik Do Sporządzania Zawiesiny Do Wstrzykiwań

Treść ulotki

1. Sandostatina ® 50 micrograms/1 mL, injectable solution/infusion, ® 100 micrograms/1 mL, injectable solution/infusion, ® 500 mg/1 mL, injectable solution/infusion
   1. What is Sandostatina and what is it used for
   2. What you need to know before you take Sandostatina
   3. How to take Sandostatina
   4. Possible side effects
   5. How to store Sandostatina
   6. Package contents and other information
2. Sandostatina LAR 10 mg powder and solvent for injectable suspension
   1. What is Sandostatina LAR and what is it used for
   2. What you need to know before you take Sandostatina LAR
   3. How to take Sandostatina LAR
   4. Possible side effects
   5. How to store Sandostatina LAR
   6. Content of the pack and other information

Sandostatina ® 50 micrograms/1 mL, injectable solution/infusion, ® 100 micrograms/1 mL, injectable solution/infusion, ® 500 mg/1 mL, injectable solution/infusion

octreotide

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Sandostatina is and what it is used for
• 2. What you need to know before you use Sandostatina
• 3. How to use Sandostatina
• 4. Possible side effects
• 5. How to store Sandostatina
• 6. Contents of the pack and other information

1. What is Sandostatina and what is it used for

Sandostatina is a synthetic compound analogue of somatostatin. Somatostatin is normally present
in the human body, where it inhibits the release of certain hormones such as growth hormone. The advantages of
Sandostatina compared to somatostatin are that it is more potent and its action has a longer duration.

Sandostatina is used

• in acromegaly, a condition in which the body produces an excessive amount of growth hormone. Normally, growth hormone controls the growth of tissues, organs and bones. When present in excessive quantities, it causes an increase in the size of bones and tissues, especially of the hands and feet. Sandostatina significantly reduces the symptoms of acromegaly, which include headache, excessive sweating, numbness of the hands and feet, fatigue and joint pain.
• to relieve symptoms associated with some gastrointestinal tract tumors(e.g. carcinoid tumors, VIPomas, glucagonomas, gastrinomas, insulinomas). In these conditions, there is an excessive production of some specific hormones and related substances in the stomach, intestine or pancreas. This excessive production alters the body's natural hormonal balance and causes a variety of symptoms, such as hot flashes, diarrhea, hypotension, skin rashes and weight loss. Treatment with Sandostatina helps to control these symptoms.
• to prevent complications following surgery on the pancreas.Treatment with Sandostatina helps to lower the probability of complications (e.g. abdominal abscess, inflammation of the pancreas) after surgery.
• to stop bleeding and to protect against re-bleeding from rupture of gastro-esophageal varicesin patients with cirrhosis (chronic liver disease). Treatment with Sandostatina helps to control bleeding and reduce the need for transfusions.
• to treat pituitary adenomas that produce an excessive amount of the hormone that stimulates the thyroid

(TSH). An excessive amount of thyroid-stimulating hormone (TSH) leads to hyperthyroidism.
Sandostatina is used to treat people with pituitary tumors that produce too much thyroid-stimulating
hormone (TSH):

• when other treatments (surgery or radiotherapy) are not indicated or have not been effective;
• after radiotherapy, to cover the period needed for radiotherapy to reach maximum effectiveness

2. What you need to know before you take Sandostatina

Do not take Sandostatina:

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

Warnings and precautions
Talk to your doctor before taking Sandostatina:

• if you know you have gallstones, or have had them in the past, or if complications such as fever, chills, abdominal pain or yellowing of the skin or eyes occur; report this to your doctor, as prolonged use of Sandostatina may lead to the formation of gallstones. Your doctor may ask you to have periodic checks of your gallbladder.
• if you know you have problems with blood sugar levels, too high (diabetes) or too low (hypoglycemia). When Sandostatina is used to treat bleeding from gastro-esophageal varices, blood sugar levels should be monitored.
• if you have previously had episodes of vitamin B12 deficiency, your doctor may ask you to check your vitamin B12 levels periodically.
• Octreotide can lower the heart rate and, at very high doses, can cause an irregular heartbeat. Your doctor may monitor your heart rate during treatment.

Tests and checks
If you receive treatment with Sandostatina for a long period, your doctor may ask you to check
periodically the thyroid function.
The doctor will check the liver function.

Children
Experience with the use of Sandostatina in children is limited.

Other medicines and Sandostatina
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In general, you can continue to take other medicines while being treated with Sandostatina. However, it
has been reported that Sandostatina can interact with some drugs, such as cimetidine, cyclosporine,
bromocriptine, quinidine and terfenadine.
If you are taking medicines to control blood pressure (such as beta-blockers or calcium
antagonists) or agents for controlling fluid and electrolyte balance, your doctor may decide to adjust
the dosage.
If you are diabetic, your doctor may decide to adjust the dose of insulin.
If you are about to receive lutetium (Lu) oxodotreotide, a radiopharmaceutical therapy, your doctor may interrupt
and/or modify the treatment with Sandostatina.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor for advice before taking this medicine.
Sandostatina can only be used during pregnancy if clearly necessary.
Women of childbearing potential must use adequate contraception during treatment.
Patients should not breastfeed during treatment with Sandostatina. It is not known whether Sandostatina is
excreted in breast milk.

Driving and using machines
Sandostatina does not alter or negligibly alters the ability to drive vehicles or use machines.
However, some undesirable effects such as
headache and fatigue may occur during treatment with Sandostatina, which may reduce the ability to drive and use machinery safely.

Sandostatina contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is practically ‘sodium-free’.

3. How to take Sandostatina

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
Depending on the condition to be treated, Sandostatina can be administered as:

• subcutaneous injection (under the skin) or
• intravenous infusion (into a vein).

If you are a patient with cirrhosis (chronic liver disease), your doctor may need to adjust the
maintenance dose.
Your doctor or nurse will explain how to inject Sandostatina under the skin, but the infusion into a vein must
always be performed by a healthcare professional.

• Subcutaneous injection

The most suitable sites for subcutaneous injection are arms, thighs and abdomen.
Choose a new site for each subcutaneous injection so as not to irritate a particular area. Patients who wish to proceed with the injection independently must receive precise instructions from their doctor
or nurse.
If you store the medicine in the refrigerator, it is recommended to bring it to room temperature before using it.
This reduces the risk of pain at the injection site. It can be brought to room temperature
by holding it in your hand, but it should not be heated.
Few people experience pain at the subcutaneous injection site. This pain usually lasts only a
short period of time. If this occurs, it can be relieved by gently massaging the injection site
for a few seconds afterwards.
Before using the vial of Sandostatina, check for particles or color changes. Do not use
if you notice anything unusual.

If you take more Sandostatina than you should
.
Symptoms of overdose are: irregular heartbeat, low blood pressure, cardiac arrest,
reduced oxygen supply to the brain, severe pain in the upper abdomen, yellowing of the skin and eyes,
nausea, loss of appetite, diarrhea, weakness, fatigue, lack of energy, weight loss, abdominal swelling,
discomfort, high levels of lactic acid in the blood and irregular heartbeat.
If you think you have symptoms of an overdose, tell your doctor immediately.

If you forget to take Sandostatina
Take a dose as soon as you remember and then continue therapy as usual. If you miss a dose you will not
have particular consequences but may have a temporary recurrence of symptoms until returning to
normal.
Do not inject a double dose of Sandostatina to make up for the missed dose.

If you stop taking Sandostatina
If you stop treatment with Sandostatina, the symptoms may return. Therefore, do not stop the
therapy with Sandostatina unless your doctor tells you to.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

Some side effects can be serious. Tell your doctor immediately if you experience any of the
following:
Very common(may affect more than 1 in 10 people):

• Gallstones which can cause sudden back pain.
• High blood sugar levels.

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

• Decreased thyroid activity (hypothyroidism) with changes in heart rate, appetite or weight, fatigue, feeling cold or swelling in the front of the neck.
• Changes in thyroid function tests.
• Inflammation of the gallbladder (cholecystitis); symptoms may include pain in the upper right side of the abdomen, fever, nausea, yellowing of the skin and eyes (jaundice).
• Low blood sugar.
• Impaired glucose tolerance.
• Slow heartbeat.

Uncommon(may affect up to 1 in 100 people):

• Thirst, decreased urination, dark urine, reddened and dry skin.
• Fast heartbeat.

Other serious side effects

• Hypersensitivity reactions (allergy), including skin rash.
• A type of allergic reaction (anaphylaxis) that can cause difficulty swallowing or breathing, swelling and tingling, possibly with a drop in blood pressure with dizziness or loss of consciousness.
• Inflammation of the pancreas (pancreatitis) symptoms may include sudden pain in the upper part of the abdomen, nausea, vomiting, diarrhea.
• Inflammation of the liver (hepatitis); symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, general feeling of illness, itching, urine that is slightly colored.
• Irregular heartbeat.
• Low platelet count in the blood; this may cause increased bleeding or bruising.

Tell your doctor immediately if you notice any of the above-described side effects.

Other side effects:
Tell your doctor, pharmacist or nurse if you notice any of the following side effects. These are usually mild and tend to disappear as treatment continues.
continues.

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

• Diarrhea.
• Abdominal pain.
• Nausea.
• Constipation.
• Flatulence.
• Headache.
• Local pain at the injection site.

Common(may affect up to 1 in 10 ):

• Stomach discomfort after meals (dyspepsia).
• Vomiting.
• Feeling of fullness in the stomach.
• Greasy stools.
• Soft stools.
• Pale stools.
• Dizziness.
• Loss of appetite.
• Changes in liver function tests.
• Hair loss.
• Shortness of breath.
• Weakness.

If you experience any of these side effects, tell your doctor, nurse or pharmacist.
Few people experience pain at the subcutaneous injection site. This pain usually lasts only a
short period of time. If this occurs, it can be relieved by gently massaging the injection
site for a few seconds.
If you are taking Sandostatina for subcutaneous injection, avoid the injection near meals, this may help
to reduce the risk of gastrointestinal side effects. It is therefore recommended to administer the injection
between meals or at bedtime.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system at the Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Sandostatina

Keep this medicine out of the sight and reach of children.
Store in the original package to protect the medicine from light.
Store in a refrigerator (2°C to 8°C). Do not freeze.
Vials must be stored at a temperature below 30°C for a maximum of 2 weeks.
Vials must be used immediately after opening.
The diluted solution must be used immediately after preparation.
Do not use this medicine after the expiry date which is stated on the label and the carton after
“EXP”. The expiry date refers to the last day of that month.
Do not use the medicine if you notice any colour changes or the presence of particles.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sandostatina contains

• The active ingredient is octreotide Sandostatina 50 micrograms/1 ml, injectable solution/infusion Sandostatina 100 micrograms/1 ml, injectable solution/infusion Sandostatina 500 micrograms/1 ml, injectable solution/infusion
• The other ingredients are: lactic acid, mannitol (E421), sodium bicarbonate, water for injections.

Description of the appearance of Sandostatina and package contents
Colourless glass vial featuring two rings of different colours containing a clear and
colourless solution.
Sandostatina 50 micrograms/1 ml: with a blue ring and another yellow ring
Sandostatina 100 micrograms/1 ml: with a blue ring and another green ring
Sandostatina 500 micrograms/1 ml: with a blue ring and another pink ring
Packs contain three, five, six, ten, twenty and fifty vials.
Multipacks of ten packs, each containing three vials.
Not all pack sizes may be marketed.

Marketing authorisation holder
Novartis Farma S.p.A.
Largo Umberto Boccioni, 1
21040 Origgio (VA)
Italy

Manufacturer
Novartis Farma SpA
L.go U. Boccioni, 1
21040 Origgio (VA)
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona,
Spain

This medicinal product is authorised in the Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) under the following denominations:
Other sources of information
Detailed information on this medicinal product is available on the website of the Italian Medicines Agency.
The following information is intended exclusively for doctors or healthcare professionals:

• Intravenous infusion (for healthcare professionals)

Visually inspect the medicine before administration to check for colour changes and the
presence of particles. Do not use if you see anything unusual. For intravenous infusion dilute the
product before administration. Sandostatina (octreotide acetate) is physically and chemically
stable for 24 hours in sterile saline solution or in sterile aqueous solutions of dextrose (glucose) 5%.
However, as Sandostatina may interfere with glucose balance, it is recommended to use saline solution rather than dextrose solution.
Diluted solutions are physically and chemically stable for at least 24 hours below 25°C. From a microbiological point of view, the diluted solution
should be used immediately. If not used immediately, the storage times and conditions are the responsibility of the user.
The contents of a 500 microgram vial should be dissolved in 60 mL of saline solution and the
resulting solution should be administered using an infusion pump. This procedure
should be repeated as often as necessary for the prescribed duration of treatment.

Amount of Sandostatina to be used
The dose of Sandostatina depends on the condition being treated.

• AcromegalyTreatment is normally started with 0.05 - 0.1 mg every 8 or 12 hours subcutaneously. This may subsequently be modified based on the effects and control of symptoms (such as fatigue, sweating and headache). In the majority of patients the optimal daily dose is 0.1 mg three times a day. It is recommended not to exceed the maximum dose of 1.5 mg per day.
• Gastrointestinal tract tumoursTreatment is normally started with a dose of 0.05 mg once or twice a day by subcutaneous injection. Based on the response and tolerability, the dosage may be gradually increased to 0.1 - 0.2 mg three times a day. In carcinoid tumours, therapy should be discontinued if no benefit is obtained after 1 week of treatment at the maximum tolerated dose.
• Complications following pancreatic surgeryThe normally used dosage is 0.1 mg three times a day subcutaneously for 1 week, starting at least 1 hour before surgery.
• Gastro-oesophageal variceal bleedingThe recommended dosage is 25 micrograms/hour by continuous intravenous infusion for 5 days. Blood sugar levels should be monitored during treatment.
• Treatment of TSH-secreting pituitary adenomasThe generally most effective dosage is 100 micrograms three times a day by subcutaneous injection. The dose may be adjusted based on TSH and thyroid hormone responses. At least 5 days of treatment will be needed to assess efficacy

Sandostatina LAR 10 mg powder and solvent for injectable suspension

Sandostatina LAR 20 mg powder and solvent for injectable suspension
Sandostatina LAR 30 mg powder and solvent for injectable suspension
octreotide

Read this leaflet carefully before you start to use this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

• 1. What Sandostatina LAR is and what it is used for
• 2. What you need to know before you use Sandostatina LAR
• 3. How to use Sandostatina LAR
• 4. Possible side effects
• 5. How to store Sandostatina LAR
• 6. Contents of the pack and other information

1. What is Sandostatina LAR and what is it used for

Sandostatina LAR is a synthetic compound analogue to somatostatin. Somatostatin is normally
present in the human body, where it inhibits the release of certain hormones such as growth hormone. The advantages
of Sandostatina LAR over somatostatin are that it is more potent and its action has a longer
duration.

Sandostatina LAR is used

• to treat acromegaly. Acromegaly is a condition in which the body produces an excessive amount of growth hormone. Normally, growth hormone controls the growth of tissues, organs and bones. When present in excessive amounts, it causes an increase in the size of bones and tissues, especially the hands and feet. Sandostatina LAR significantly reduces the symptoms of acromegaly, which include headache, excessive sweating, numbness of the hands and feet, fatigue and joint pain. In most cases, excessive production of growth hormone is caused by an enlargement of the pituitary gland (pituitary adenoma); treatment with Sandostatina LAR can reduce the size of the adenoma. Sandostatina LAR 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 transition period until the radiotherapy reaches maximum effectiveness.
• to relieve symptoms associated with the excessive production of certain specific hormones and other related substances in the stomach, intestine and pancreas. Excessive production of specific hormones and other related natural substances can be caused by some rare conditions of the stomach, intestine and pancreas. This situation alters the body's natural hormonal balance and causes a variety of symptoms, such as hot flashes, diarrhea, hypotension, skin rashes and weight loss. Treatment with Sandostatina LAR helps to control these symptoms.
• to treat neuroendocrine tumors located in the intestine (e.g. appendix, small intestine or colon). Neuroendocrine tumors are rare tumors that can be found in different parts of the body. Sandostatina LAR is also used to control the growth of these tumors when they are located in the intestine (e.g. appendix, small intestine or colon).
• to treat pituitary adenomas that produce an excessive amount of thyroid-stimulating hormone (TSH). An excessive amount of thyroid-stimulating hormone (TSH) leads to hyperthyroidism. Sandostatina LAR is used to treat people with pituitary tumors that produce too much thyroid-stimulating hormone (TSH):
• when other treatments (surgery or radiotherapy) are not indicated or have not been effective;
• after radiotherapy, to cover the time needed for the radiotherapy to reach maximum effectiveness.

2. What you need to know before you take Sandostatina LAR

Follow all of your doctor's instructions carefully. These may differ from those contained in
this leaflet.
Read the following instructions before using Sandostatina LAR.

Do not take Sandostatina LAR:

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

Warnings and precautions
Talk to your doctor before taking Sandostatina LAR:

• if you know you have gallstones, or have had them in the past, or if complications such as fever, chills, abdominal pain or yellowing of the skin or eyes occur; report this to your doctor, as prolonged use of Sandostatina LAR may lead to the formation of gallstones. Your doctor may ask you to have periodic checks of your gallbladder.
• if you know you have diabetes, as Sandostatina LAR may affect blood sugar levels. If you are diabetic, your blood sugar levels should be checked regularly.
• if you have previously had episodes of vitamin B12 deficiency, your doctor may ask you to check your vitamin B12 levels periodically.

Tests or checks
If you receive treatment with Sandostatina LAR for a long period, your doctor may ask you to check
thyroid function periodically.
The doctor will check liver function.

Children
Experience with the use of Sandostatina LAR in children is limited.

Other medicines and Sandostatina LAR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In general, you can continue to take other medicines while being treated with Sandostatina LAR.
However, it has been reported that Sandostatina LAR may interact with some drugs, such as cimetidine,
cyclosporine, bromocriptine, quinidine and terfenadine.
If you are taking medicines to control blood pressure (such as beta-blockers or calcium
channel blockers) or agents for controlling fluid and electrolyte balance, your doctor may decide to adjust
the dosage.
If you are diabetic, your doctor may decide to adjust your insulin dosage.
If you are about to receive lutetium (Lu) oxodotreotide, a radiopharmaceutical therapy, your doctor may interrupt
and/or modify treatment with Sandostatina LAR for a short period of time.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.
Sandostatina LAR may be used during pregnancy only if clearly necessary.
Women of childbearing potential should use adequate contraception during treatment.
Patients should not breastfeed during treatment with Sandostatina LAR.
It is not known whether Sandostatina LAR is excreted in breast milk.

Driving and using machines
Sandostatina LAR does not alter or alters negligibly the ability to drive vehicles or use
machinery. However, some side effects such as headache and fatigue may occur during treatment with
Sandostatina LAR which may reduce the ability to drive and operate machinery safely.

Sandostatina LAR contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is practically ‘sodium-free’.

3. How to take Sandostatina LAR

Sandostatina LAR must always be administered with a deep gluteal injection. The site for
repeated injections should be alternated between the left and right gluteus.

If you take more Sandostatina LAR than you should
No reactions have been reported that have caused a life-threatening situation after an overdose of Sandostatina
LAR.
The symptoms of overdose are: hot flashes, frequent urination, fatigue, depression, anxiety and lack
of concentration.
If you think you have symptoms of an overdose, inform your doctor immediately.

If you forget to take Sandostatina LAR
If you forget the injection, it is recommended to administer it as soon as you remember and then continue the therapy as usual. A delay of a few days in administration will not cause harm but may have a
temporary recurrence of symptoms until a return to normal.

If you stop taking Sandostatina LAR
If you stop treatment with Sandostatina LAR, the symptoms may reappear. Therefore, do not
interrupt the therapy with Sandostatina LAR unless your doctor tells you to.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

Some side effects may be serious. Tell your doctor immediately if you experience any of the
following:
Very common(may affect more than 1 in 10 people):

• Gallstones which may cause sudden back pain.
• High levels of sugar in the blood.

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

• Decreased thyroid activity (hypothyroidism) with changes in heart rate,

appetite or weight, fatigue, feeling cold or swelling in the front of the neck.

• Changes in thyroid function tests.
• Inflammation of the gallbladder (cholecystitis); symptoms may include pain in the upper right abdomen, fever, nausea, yellowing of the skin and eyes (jaundice).
• Low blood sugar.
• Impaired glucose tolerance.
• Slow heartbeat.

Uncommon(may affect up to 1 in 100 people ):

• Thirst, decreased urination, dark urine, flushed and dry skin.
• Fast heartbeat.

Other serious side effects

• Hypersensitivity reactions (allergy) including skin rash.
• A type of allergic reaction (anaphylaxis) that can cause difficulty swallowing or breathing, swelling and tingling, possibly with a drop in blood pressure with dizziness or loss of consciousness.
• Inflammation of the pancreas (pancreatitis) Symptoms may include sudden pain in the upper abdomen, nausea, vomiting, diarrhea.
• Inflammation of the liver (hepatitis); symptoms may include yellowing of the skin and eyes (jaundice), nausea, vomiting, loss of appetite, general feeling of illness, itching, urine becoming slightly colored.
• Irregular heartbeat.
• Low level of platelets in the blood; this may cause increased bleeding or bruising.

Tell your doctor immediately if you notice any of the side effects described above.

Other side effects:
Tell your doctor, pharmacist or nurse if you notice any of the following side effects. These are usually mild and tend to disappear as treatment continues.

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

• Diarrhea.
• Abdominal pain.
• Nausea.
• Constipation.
• Flatulence.
• Headache.
• Local pain at the injection site.

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

• Stomach discomfort after meals (dyspepsia).
• Vomiting.
• Feeling of fullness in the stomach.
• Greasy stools.
• Soft stools.
• Pale stools.
• Dizziness.
• Loss of appetite.
• Changes in liver function tests.
• Hair loss.
• Shortness of breath.
• Weakness.

If any of these side effects occur, tell your doctor, nurse or pharmacist.

Reporting of side effects
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 through the
national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse. By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Sandostatina LAR

Keep this medicine out of sight and reach of children.
Store in its original packaging to protect the medicine from light.
Store in a refrigerator (2°C-8°C). Do not freeze.
Sandostatina LAR must be stored at a temperature below 25°C on the day of
administration.
Do not store Sandostatina LAR after reconstitution (it must be used immediately).
Do not use this medicine after the expiry date which is stated on the label and the packaging after
“EXP”. The expiry date refers to the last day of that month.
Do not use the medicine if visible particles or a colour change are observed.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Sandostatina LAR contains
The active ingredient is octreotide
One vial contains 10 mg, 20 mg, 30 mg of octreotide (as octreotide acetate)
The other ingredients are:
in the powder (vial): poly(DL lactide-co-glycolide), mannitol (E421).
in the solvent (pre-filled syringe): sodium carboxymethylcellulose, mannitol (E421), poloxamer 188, water for
injections.

Description of the appearance of Sandostatina LAR and contents of the pack
One pack contains a 6 ml glass vial closed with a rubber stopper (bromobutyl rubber),
sealed with an aluminum crimp cap with a tear-off tab, containing the powder for injectable suspension
and a colorless glass syringe with 3 mL with a plunger with a front cap (chlorobutyl rubber) pre-filled
with 2mL of solvent, packaged in a sealed blister tray together with a vial adapter and
a safety injection needle.
Multiple packs of three single packs, each containing: a 6 mL glass vial
closed with a rubber stopper (bromobutyl rubber), sealed with an aluminum crimp cap with a tear-off
tab, containing the powder for injectable suspension and a colorless glass syringe with 3 mL with
plunger with a front cap (chlorobutyl rubber) pre-filled with 2mL of solvent, packaged in a
sealed blister tray together with a vial adapter and a safety injection needle.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Novartis Farma S.p.A.
Origgio (VA)

Manufacturer
Novartis Farma S.p.A
Torre Annunziata (NA)
Novartis Farma SpA
L.go U. Boccioni, 1
21040 Origgio (VA)
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
Other sources of information
Detailed information on this medicinal product is available on the website of the Italian Medicines Agency.
The following information is intended only for doctors or healthcare professionals:

Amount of Sandostatina LAR to be used

Acromegaly
It is recommended to initiate treatment with the administration of Sandostatina LAR 20 mg at intervals of
4 weeks for 3 months. Patients treated with Sandostatina by subcutaneous route may initiate treatment with Sandostatina LAR the day after the last dose of Sandostatina by subcutaneous route.
Subsequent dosage adjustments should be based on growth hormone (GH) and insulin-like growth factor-1/somatomedin C (IGF-1) blood levels and clinical symptoms.
In patients in whom, within the 3-month period, both clinical symptoms and biochemical parameters (GH; IGF-1) have not been adequately controlled (GH levels still above
2.5 micrograms/L), the dose may be increased to 30 mg every 4 weeks. If, after 3 months, GH, IGF-1,
and/or symptoms are still not adequately controlled at a dose of 30 mg, the dose may be
increased to 40 mg every 4 weeks.
In patients where GH levels remain consistently below 1 microgram/L, serum IGF I levels normalize and most signs/symptoms
reversible of acromegaly disappear, after 3 months of treatment with 20 mg, Sandostatina may be administered

LAR 10 mg every 4 weeks. However, especially in this group of patients where this low
dose of Sandostatina LAR is used, adequate monitoring of serum GH and
IGF-1 levels and clinical signs and symptoms is recommended.
In patients with a stable dose of Sandostatina LAR, GH and IGF I checks should be performed every
6 months.

Gastro-entero-pancreatic neuroendocrine tumors

• Treatment of patients with symptoms associated with functioning gastro-entero-pancreatic neuroendocrine tumorsIt is recommended to initiate treatment with the administration of Sandostatina LAR 20 mg at intervals of 4 weeks. Patients treated with Sandostatina by subcutaneous route should continue treatment with the dose previously found to be effective for 2 weeks after the first injection of Sandostatina LAR. In patients in whom both clinical symptoms and biochemical parameters are well controlled after 3 months of treatment, the dose may be reduced to Sandostatina LAR 10 mg every 4 weeks.

In patients in whom both clinical symptoms and biochemical parameters are only partially
controlled after 3 months of treatment, the dose may be increased to Sandostatina LAR 30 mg every
4 weeks.
On days when, during treatment with Sandostatina LAR, symptoms associated with gastro-entero-
pancreatic tumors worsen, additional administration of Sandostatina by subcutaneous route is recommended
at the dose used before the start of treatment with Sandostatina LAR. This may occur
especially in the first 2 months of treatment until therapeutic octreotide concentrations are reached.

• Treatment of patients with advanced midgut neuroendocrine tumors or withunknown primary tumor location where extra-intestinal sites have been ruled outThe recommended dose of Sandostatina LAR is 30 mg administered every 4 weeks. Treatment with Sandostatina LAR for tumor control should be continued even in the absence of tumor progression.

Treatment of TSH-secreting pituitary adenomas
Treatment with Sandostatina LAR should be initiated at a dose of 20 mg at intervals of 4 weeks for
3 months before considering a dose adjustment. The dose will then be adjusted based on the response
of TSH and thyroid hormone

Instructions for the preparation and intramuscular injection of Sandostatina LAR
FOR DEEP INTRAMUSCULAR INJECTION ONLY

Included in the injection kit:

• a. A vial containing Sandostatina LAR powder,
• b. A pre-filled syringe containing the vehicle solution for reconstitution,
• c. A vial adapter for reconstituting the medicine,
• d. A safety injection needle.

Follow the following instructions carefully to ensure correct reconstitution of Sandostatina LAR
before intramuscular deep injection.
There are 3 critical actions in the reconstitution of Sandostatina LAR. Failure to comply with these
may result in inappropriate leakage of the medicine.

• The injection kit must reach room temperature.Remove the injection kit from the refrigerator and leave the kit at room temperature for at least 30 minutes before reconstitution, but no more than 24 hours.
• After adding the diluent solution, make sure the powder is completely saturatedby leaving the vial for 5 minutes.
• After saturation, gently shake the vialin a horizontal direction for at least 30 seconds until a uniform suspension is formed. The Sandostatina LAR suspension must be prepared only immediatelybefore administration.

It is recommended that the administration of Sandostatina LAR is carried out only by trained healthcare personnel.

Step1

• Remove the Sandostatina LAR injection kit from the refrigerator.

WARNING: it is essential to start the process of
reconstitution only after the reconstitution kit
has reached room temperature. Leave the
kit at room temperature for at least
30 minutes before reconstitution, but no more than
24 hours.
Note: The injection kit can be refrigerated again
if necessary.

Step2

• Remove the plastic cap from the vial and clean the rubber stopper of the vial with a cotton ball soaked in alcohol.
• Remove the film from the packaging containing the vial adapter, but DO NOT remove the vial adapter from its packaging.
• Holding the vial adapter packaging, place the adapter on top of the vial and push it all the way down until it clicks into place, confirmed by an audible "click".

• Lift the outer packaging of the vial adapter with a vertical movement.

Step3

• Remove the cap from the pre-filled syringe with diluent solution and screw the syringe into the vial adapter.
• Gently push the syringe plunger all the way down to transfer all the diluent solution into the vial.

Step4

WARNING: it is essential to let the vial stand for
5minutesto allow the diluent to completely
saturate the powder.
Note: It is normal for the plunger to move as there may
be slight overpressure in the vial.

• At this point, prepare the patient for injection.

Step5

• After the saturation time, make sure the plunger is pushed all the way into the syringe. WARNING: Holding the plunger, shake the vial gentlyin a horizontal direction for at least30 secondsso that the powder is completely suspended (uniform milky suspension). Repeat gentle shaking for another30 seconds if the powder is not completely suspended.

Step6

• Invert the syringe and vial, slowly pull back the plunger and transfer the entire contents from the vial into the syringe.
• Unscrew the syringe from the vial adapter.

Step7

• Screw the safety injection needle onto the syringe
• If immediate administration is delayed, gently shake the syringe to ensure a uniform milky suspension.
• Prepare the injection site with a cotton ball soaked in alcohol
• Pull the protective cap off the needle.

• Gently tap the syringe to eliminate any visible bubbles and expel them from the syringe.
• Proceed immediatelyto step 8 for administration to the patient. Any delay may cause sedimentation.

Step8

• Sandostatina LAR must be administered only by deep intramuscular injection, NEVERintravenously.
• Insert the needle completely into the left or right gluteus at a 90° angle to the skin.
• Slowly pull back the plunger to check that no blood vessel has been crossed (reposition if a blood vessel has been crossed).
• Press the plunger with constant pressure until the syringe is empty. Remove the needle from the injection site and activate the safety protection (as indicated in Step 9).

Step9

• Activate the safety device above the needle using one of the two methods indicated:
• Press the hinged part of the safety device downwards onto a hard surface (figure A)
• Or push the hinged part forward with your finger (figure B).

• An audible "click" confirms correct activation.
• Dispose of the syringe immediately (in the appropriate container).