SANDOSTATIN 50 micrograms/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

SANDOSTATIN 50 micrograms/ml solution for injection and infusion

octreotide

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. See section 4.

Contents of the pack

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

1. What Sandostatin is and what it is used for

Sandostatin is a synthetic compound derived from somatostatin, a substance that is normally found in the human body, which inhibits the effects of some hormones such as growth hormone. The advantages of Sandostatin over somatostatin are that it is more potent and its effects are longer-lasting.

Sandostatin is used

• for acromegaly, a disease in which the body produces too much growth hormone. Normally, growth hormone controls the growth of tissues, organs, and bones. An excess of growth hormone means an increase in the size of bones and tissues, especially in the hands and feet. Sandostatin 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 tumors(e.g., carcinoid tumors, VIPomas, glucagonomas, gastrinomas, insulinomas, GRFomas). In these diseases, there is an overproduction of specific hormones and other related substances by the stomach, intestine, or pancreas. This overproduction disrupts the body's natural hormonal balance and produces various symptoms, such as hot flashes, diarrhea, low blood pressure, hives, and weight loss. Treatment with Sandostatin helps control these symptoms.
• to prevent complications after pancreatic surgery. Treatment with Sandostatin helps reduce the likelihood of complications after surgery (e.g., abdominal abscesses, pancreatitis).
• to stop bleeding and protect against re-bleeding from gastroesophageal varicesin patients with cirrhosis (chronic liver disease). Treatment with Sandostatin helps control bleeding and reduce the need for transfusions.
• to treat pituitary tumors that produce too much thyroid-stimulating hormone (TSH). An excess of thyroid-stimulating hormone (TSH) causes hyperthyroidism.

Sandostatin is used to treat people with pituitary tumors 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 period until the radiotherapy is fully effective.

2. What you need to know before you use Sandostatin

Do not use Sandostatin:

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

Warnings and precautions

Consult your doctor before starting treatment with Sandostatin:

• if you currently have gallstones or have had them in the past, or if you have any complications such as fever, chills, abdominal pain, or yellowing of the skin or eyes; inform your doctor, as prolonged use of Sandostatin may cause gallstones to form. Your doctor may want to check your gallbladder periodically.

• if you have problems with blood sugar levels, either too high (diabetes) or too low (hypoglycemia). When Sandostatin is used to treat bleeding from gastroesophageal varices, it is mandatory to monitor blood sugar levels.

• if you have a history of vitamin B12 deficiency, your doctor may monitor your B12 levels periodically.

• octreotide may reduce heart rate and at very high doses may cause an abnormal heart rhythm. Your doctor may monitor your heart rate during treatment.

Tests and checks

If you receive treatment with Sandostatin for a prolonged period, your doctor may periodically check your thyroid function.

Your doctor will check your liver function.

Your doctor may check the functioning of your pancreatic enzymes.

Children

There is limited experience with the use of Sandostatin in children.

Other medicines and Sandostatin

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

Normally, you can continue taking other medicines while being treated with Sandostatin. However, it has been reported that some medicines such as cimetidine, cyclosporine, bromocriptine, quinidine, and terfenadine are affected by Sandostatin.

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

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Sandostatin should only be used during pregnancy if it is strictly necessary.

Women of childbearing age must use an effective contraceptive method during treatment.

Do not breastfeed during treatment with Sandostatin. It is not known whether Sandostatin passes into breast milk.

Driving and using machines

Sandostatin has no or negligible influence on the ability to drive and use machines. However, some of these side effects that you may experience during treatment with Sandostatin, such as headache and fatigue, may reduce your ability to drive and use machines safely.

Sandostatin contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ampoule; this is essentially "sodium-free".

3. How to use Sandostatin

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Depending on the disease being treated, Sandostatin is administered by:

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

If you have liver cirrhosis (chronic liver disease), your doctor may need to adjust your maintenance dose.

Your doctor or nurse will explain how to inject Sandostatin under the skin, but infusion into a vein must always be done by a healthcare professional.

• Subcutaneous injection

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

A new site should be chosen for each subcutaneous injection to avoid irritating a particular area. Patients who are going to administer the injection themselves should receive specific instructions from their doctor or nurse.

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

A few patients experience pain at the subcutaneous injection site. This pain usually only lasts for a short time. If this happens to you, you can alleviate it by gently massaging the injection site for a few seconds afterwards.

Before using a Sandostatin ampoule, check for the presence of particles or a change in color. Do not use it if you notice anything abnormal.

If you use more Sandostatin 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, abdominal discomfort, high levels of lactic acid in the blood, and abnormal heart rhythm.

If you think you have had an overdose and experience any of these symptoms, inform your doctor immediately.

In case of overdose or accidental ingestion, you can also contact the Toxicology Information Service, Tel. 91 5620420.

If you forget to use Sandostatin

Administer a dose as soon as you remember and then continue with your regular schedule. Forgetting a dose will not harm you, but your symptoms may temporarily return until you get back to your regular treatment schedule.

Do not inject a double dose to make up for missed individual doses.

If you stop treatment with Sandostatin

If you stop your treatment with Sandostatin, your symptoms may return. Therefore, do not stop treatment with Sandostatin unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor, nurse, or pharmacist.

4. Possible side effects

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

Some side effects could 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.

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

• Decreased activity of the thyroid gland (hypothyroidism) which can cause 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.
• Alteration of glucose tolerance
• Slow heart rate.

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

• Thirst, low urine output, dark urine, dry reddened skin.
• Fast heart rate.

Other serious side effects

• Allergic reactions (hypersensitivity) including skin rash.
• A type of allergic reaction (anaphylaxis) that can cause difficulty swallowing or breathing, swelling, and tingling, possibly with a decrease 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 discomfort, itching, slightly colored urine.
• Irregular heart rhythm.
• Low platelet count in the blood; this can increase the risk of bleeding or bruising.

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

Other side effects:

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

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

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

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

• Discomfort in the stomach after eating (dyspepsia).
• Vomiting.
• Feeling of having a full stomach.
• Fatty stools.
• Loose stools.
• Change in stool color.
• Dizziness.
• Loss of appetite.
• Changes in liver function tests.
• Hair loss.
• Difficulty breathing.
• Weakness.

If you experience any side effects, talk to your doctor, nurse, or pharmacist.

A few patients experience pain at the subcutaneous injection site. This pain usually only lasts for a short time. If this happens to you, you can alleviate it by gently massaging the injection site for a few seconds afterwards.

If you are given Sandostatin by subcutaneous injection, you can help reduce the risk of gastrointestinal side effects by avoiding meals near the time of injection. Therefore, it is recommended that you administer Sandostatin between meals or at bedtime.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Sandostatin

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

Store in the original packaging to protect from light.

Store in the refrigerator (between 2°C and 8°C). Do not freeze.

Ampoules can be stored below 30°C for two weeks. Ampoules should be used immediately after opening.

Diluted solutions should be used immediately after preparation.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Do not use this medicine if it contains visible particles or if you notice a change in color.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Sandostatin Contents

• The active ingredient is octreotide. 1 ml of solution contains 50 micrograms of octreotide.

• The other components are: lactic acid, mannitol (E421), sodium bicarbonate, water for injectable preparations.

Product Appearance and Container Contents

Colorless glass ampoule with two colored rings (one blue and one yellow) containing a clear and colorless solution.

Packs of three, five, six, ten, twenty, and fifty ampoules.

Multiple packs of 10 packs, each containing three ampoules.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Novartis Pharma GmbH

Jakov-Lind-Straße 5, Top 3.05 1020 Wien Austria

Novartis Pharma NV

Medialaan 40/Bus 1, 1800 Vilvoorde, (Belgium).

Novartis Healthcare A/S

Edvard Thomsens vej 14, DK-2300 Copenhagen S, (Denmark).

Novartis Finland Oy

Metsänneidonkuja 10, 02130 Espoo, (Finland)

Novartis Pharma SAS

8-10 rue Henri Sainte-Claire Deville, 92500 Rueil-Malmaison (France)

Novartis Pharma GmbH

Roonstrasse 25, 90429 Nürnberg, (Germany).

Novartis Pharma GmbH

Sophie-Germain-Strasse 10, 90443 Nürnberg (Germany).

Novartis Farma-Produtos Farmacéuticos, SA

Avenida Professor Doutor Cavaco Silva nº10E, Taguspark, 2740-255 Porto Salvo, (Portugal).

Novartis Farma S.p.A.

Via Provinciale Schito 131, 80058 Torre Annunziata, NA, (Italy).

Novartis Sverige AB

Torshamnsgatan 48, 164 40 Kista (Sweden)

Novartis (Hellas) S.A.

12th km National Road Athinon-Lamia 14451 Metamorphosis Attiki, (Greece).

Novartis Pharma B.V.

Haaksbergweg 16, 1101 BX Amsterdam (Netherlands).

Novartis Poland Sp. z o.o.

15 Marynarska Street, 02-674 Warsaw (Poland).

Novartis Hungária Kft.

Vasút u.13, 2040 Budaörs (Hungary).

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:12/2023

Other sources of information

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals:

• Intravenous infusion (for healthcare professionals)

Check visually for any change in color or visible particles before administration. Do not use if you notice anything abnormal. For intravenous infusion, dilute the medicinal product before administration.

Sandostatin (octreotide acetate) is physically and chemically stable for 24 hours in sterile physiological saline solution or sterile 5% glucose (dextrose) solutions in water. However, since Sandostatin may affect glucose homeostasis, it is recommended to use physiological saline solutions instead of dextrose.

The 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 time and conditions before use are the responsibility of the user.

The contents of a 500 microgram ampoule are normally dissolved in 60 ml of saline solution, and the resulting solution is administered via an infusion pump. This should be repeated as necessary until the prescribed treatment duration is reached.

How much Sandostatin to use

The dose of Sandostatin depends on the disease being treated.

• Acromegaly

Treatment is usually started at a dose of 0.05 to 0.1 mg every 8 or 12 hours by subcutaneous injection. It is then adjusted according to its effects and relief of symptoms (such as fatigue, sweating, and headache). In most patients, the optimal daily dose will be 0.1 mg 3 times/day. The maximum dose should not exceed 1.5 mg/day.

• Gastrointestinal tumors

Treatment is usually started at a dose of 0.05 mg once or twice a day by subcutaneous injection. Depending on the response and tolerability, the dose can be gradually increased to 0.1 mg to 0.2 mg 3 times/day. In carcinoid tumors, treatment should be discontinued if no improvement is observed after 1 week of treatment at the maximum tolerated dose.

• Complications after pancreatic surgery

The usual dose is 0.1 mg 3 times/day by subcutaneous injection for 1 week, starting at least 1 hour before surgery.

• Gastroesophageal variceal hemorrhage

The recommended dose is 25 micrograms/hour for 5 days by continuous intravenous infusion. Blood sugar levels should be monitored during treatment.

• Pituitary adenomas secreting TSH

The effective dose is usually 100 micrograms three times a day by subcutaneous injection. The dose can be adjusted according to the TSH and thyroid hormone response. At least 5 days are needed to assess efficacy.