Octreotide Sun 100 micrograms/ml solution for injection EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Octreotide SUN 100 micrograms/ml injection solution EFG

Octreotide

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What Octreotida SUN is and what it is used for

Octreotida SUN is a synthetic compound derived from somatostatin, a substance naturally present in the human body that inhibits the effects of certain hormones, such as growth hormone. The advantages of Octreotida SUN over somatostatin are that it is more potent and its effects last longer.

Octreotida SUN is used

• for acromegaly, a condition in which the body produces too much growth hormone. Normally, growth hormone regulates the growth of tissues, organs, and bones. Excess growth hormone leads to an increase in the size of bones and tissues, especially in the hands and feet. Octreotida SUN significantly reduces the symptoms of acromegaly, including headache, excessive sweating, numbness in the hands and feet, fatigue, and joint pain.
• to relieve symptoms associated with certain gastrointestinal tract tumors (e.g. carcinoid tumors, VIPomas, glucagonomas, gastrinomas, insulinomas). In these conditions, 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 causes various symptoms, such as flushing, diarrhea, low blood pressure, urticaria, and weight loss. Treatment with Octreotida SUN helps control these symptoms.
• to prevent complications following pancreatic gland surgery. Treatment with Octreotida SUN helps reduce the risk of post-surgical complications (e.g. abdominal abscess, inflammation of the pancreatic gland).
• to stop bleeding and to prevent recurrence of bleeding from ruptured gastroesophageal varices in patients with cirrhosis (a chronic liver disease). Treatment with Octreotida SUN helps control bleeding and reduces the need for blood transfusions.
• to treat pituitary tumors that produce too much thyroid-stimulating hormone (TSH). Excess thyroid-stimulating hormone (TSH) causes hyperthyroidism.

Octreotida SUN is used to treat patients 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 been effective;

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

2. What you need to know before using Octreotida SUN

Do not use Octreotida SUN

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

Warnings and precautions

Talk to your doctor before starting to use Octreotida SUN:

• If you currently have gallstones, have had them in the past, or experience any complications such as fever, chills, abdominal pain, or yellowing of the skin or eyes; inform your doctor, as long-term use of Octreotida SUN may lead to the formation of gallstones. Your doctor may wish to monitor your gallbladder periodically.
  • If you have a history of vitamin B12 deficiency. Your doctor may want to monitor your vitamin 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 monitoring

If you are receiving treatment with Octreotida SUN for a prolonged period, your doctor may periodically monitor your thyroid function.

Your doctor will monitor your liver function.

Your doctor may check the function of your pancreatic enzymes.

Children

There is limited experience with the use of Octreotida SUN in children.

Use of Octreotida SUN with other medicines

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

You can usually continue taking other medicines while being treated with Octreotida SUN. However, Octreotida SUN may affect certain medicines, such as cimetidine, cyclosporine, bromocriptine, quinidine, and terfenadine.

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 to receive treatment with lutetium (177Lu) oxodotreotide, a radiopharmaceutical, your doctor may interrupt and/or adjust treatment with octreotide.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Octreotida SUN should only be used during pregnancy if strictly necessary.

Women of childbearing potential should use an effective method of contraception during treatment.

You must not breastfeed during treatment with Octreotida SUN. It is unknown whether Octreotida SUN passes into breast milk.

Driving and use of machines

Octreotida SUN has no effect or only negligible effects on the ability to drive or operate machinery. However, some of the adverse effects you may experience during treatment with Octreotida SUN, such as headache and fatigue, may reduce your ability to drive or use machines safely.

Octreotida SUN contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per ml of solution and is therefore considered essentially "sodium-free".

3. How to use Octreotida SUN

Follow exactly the instructions given by your doctor for the administration of this medicine. If in doubt, consult your doctor or pharmacist again.

Depending on the condition being treated, Octreotida SUN is administered either by:

• subcutaneous injection (under the skin) or
• intravenous infusion (into the 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 Octreotida SUN under the skin. However, intravenous infusion must always be performed by a healthcare professional.

Subcutaneous injection

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

A new injection site should be selected each time to avoid irritating a specific area. Patients who will self-administer the injection must receive specific instructions from their doctor or nurse.

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

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

Before using a vial of Octreotida SUN, check for the presence of particles or any change in colour. Do not use it if you notice anything abnormal.

If you use more Octreotida SUN than you should

Symptoms of overdose may include:

• irregular heartbeat
• low blood pressure
• cardiac arrest
• reduced oxygen supply to the brain
• severe upper abdominal pain
• yellowing of the skin and eyes
• nausea
• loss of appetite
• diarrhoea
• weakness
• fatigue
• lack of energy
• weight loss
• abdominal swelling
• malaise
• high blood lactate levels
  • abnormal heart rhythm.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Octreotida SUN

Administer the dose as soon as you remember, and then continue with your usual dosing schedule. Forgetting a dose will not harm you, but your symptoms may temporarily reappear until you resume your regular treatment schedule.

Do not inject a double dose of Octreotida SUN to make up for a missed dose.

If you stop using Octreotida SUN

If you stop treatment with Octreotida SUN, your symptoms may return. Therefore, do not interrupt treatment with Octreotida SUN unless instructed by your doctor.

If you have any further questions about 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 may be serious. Immediately inform your doctor if you experience any of the following:

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

• gallstones causing sudden back pain
• too much sugar in the blood.

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

• decreased activity of the thyroid gland (hypothyroidism), causing 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 part of the abdomen, fever, nausea, yellowing of the skin and eyes (jaundice)
• too little sugar in the blood
• impaired glucose tolerance
• slow heartbeat.

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

• thirst, reduced urine output, dark-colored urine, dry red skin.
• fast heartbeat.

Other serious side effects

• hypersensitivity (allergic) reactions including skin hives
• a type of allergic reaction (anaphylaxis) which may cause difficulty swallowing or breathing, swelling and tingling, possibly with a drop in blood pressure leading to 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 being unwell, itching, lightly colored urine
• irregular heartbeat
• low platelet count in the blood; this may result in increased bleeding or bruising.

Immediately inform your doctor if you notice any of the above side effects.

Other side effects:

Inform your doctor, pharmacist, or nurse if you notice any of the side effects listed below. These effects 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 (gas)
• headache
• local pain at the injection site.

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

• stomach discomfort after eating (dyspepsia)
• vomiting
• feeling of fullness in the stomach
• fatty stools
• liquid stools
• change in stool color
• dizziness
• loss of appetite
• changes in liver function tests
• hair loss
• difficulty breathing
• weakness.

If you experience any type of side effect, consult your doctor, nurse, or pharmacist.

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

If you are administered Octreotida SUN by subcutaneous injection, you may help reduce the risk of gastrointestinal side effects by avoiding meals close to the time of injection. Therefore, it is recommended to administer Octreotida SUN between meals or at bedtime.

Reporting of side effects

If you experience any side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Octreotide SUN

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Keep in the original packaging to protect from light.

Unopened vials of Octreotide SUN may be stored below 25°C for up to 2 weeks, provided they remain in the original packaging.

The diluted solution has been shown to be physically and chemically stable for 8 hours at 25°C. From a microbiological standpoint, the product should be used immediately after dilution. If not used immediately, the duration and conditions of in-use storage are the responsibility of the user.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure how to dispose of medicines or their packaging, please consult your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Octreotide SUN 100 micrograms/ml solution for injection

• The active substance is octreotide.

Each 1 ml vial of injectable solution contains 100 micrograms of octreotide as octreotide acetate.

The other components are: sodium acetate trihydrate, glacial acetic acid, sodium chloride,
water for injections.

Appearance of the medicinal product and contents of the pack

This medicine is a clear, colourless injectable solution.

Each pack contains 5, 10 or 30 vials, or a multiple pack containing 30 vials (3 boxes of 10) of 1 ml.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55
08007 Barcelona
Spain
Tel: +34 93 342 78 90

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names

Denmark: Octreotide SUN 0.1 mg/1 ml solution for injection

Active substance: Octreotide

Pharmaceutical form: Solution for injection

Strength: 0.1 mg per 1 ml

Manufacturer: SUN

This medicinal product is authorized in Denmark.
For full details, refer to the Danish Summary of Product Characteristics, available from the Danish Medicines Agency.

Germany: Octreotide SUN 0.1 mg/1 ml Solution for Injection

Italy: Octreotide SUN 0.1 mg/1 ml solution for injection

Spain: Octreotide SUN 100 micrograms/ml injectable solution EFG

Sweden: Octreotide SUN 100 microgram/ml injection solution, solution

United Kingdom (Northern Ireland): Octreotide 100 micrograms/ml Solution for Injection

Date of the latest review of this summary: September 2022

Up-to-date detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

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This information is intended for healthcare professionals only:

Intravenous infusion (for healthcare professionals)

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in the section on special precautions for disposal and other handling.

Special precautions for storage

Vials:

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Keep vials in their outer packaging to protect them from light.

Unopened vials may be stored at 25°C for up to two weeks.

Special precautions for disposal and other handling

Vials:

Vials should be opened immediately before use, and any unused portion must be discarded.

To reduce local discomfort, allow the solution to reach room temperature before injection. Avoid repeated injections at short intervals in the same location.

Subcutaneous administration

Octreotida SUN must be administered subcutaneously without dilution.

Intravenous administration

For intravenous administration, octreotide must be diluted with normal saline at a ratio of not less than 1 volume of octreotide to 1 volume of saline and not more than 1 volume of octreotide to 9 volumes of saline. Since octreotide may affect glucose homeostasis, physiological saline solutions are preferred over dextrose-containing solutions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

Dosage of Octreotida SUN

The dose of Octreotida SUN depends on the condition being treated.

Acromegaly

Treatment is usually initiated at doses of 0.05 to 0.1 mg every 8 or 12 hours by subcutaneous injection. The dose may subsequently be adjusted according to its effects and symptom relief (such as fatigue, sweating, and headache). In most patients, the optimal daily dose will be 0.1 mg three times daily. The maximum dose of 1.5 mg/day must not be exceeded.

Gastrointestinal tract tumors

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

Complications following pancreatic surgery

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

Gastroesophageal variceal bleeding

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

Thyroid-stimulating hormone (TSH)-secreting pituitary adenomas

The usual effective dose is 100 micrograms three times daily by subcutaneous injection. The dose may be adjusted according to TSH and thyroid hormone response. At least 5 days are required to assess efficacy.