OCTREOTIDE SUN 100 micrograms/ml Injectable Solution

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

Octreotide SUN 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 Octreotide SUN compared to somatostatin are that it is more potent and its effects are longer-lasting.

Octreotide SUNis 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. Octreotide SUN 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 tumors of the gastrointestinal tract (e.g., carcinoid tumors, VIPomas, glucagonomas, gastrinomas, insulinomas). 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 Octreotide SUN helps control these symptoms.
• to prevent complications after pancreatic surgery. Treatment with Octreotide SUN helps reduce the likelihood of complications after surgery (e.g., abscess in the abdomen, inflammation of the pancreas).
• to stop bleeding and protect against repeated bleeding from gastroesophageal varices in patients with cirrhosis (chronic liver disease). Treatment with Octreotide SUN 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.

Octreotide SUN 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

completely effective.

2. What you need to know before you use Octreotide SUN

Do not use Octreotide SUN

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

Warnings and precautions

Consult your doctor before starting treatment with Octreotide SUN:

• if you currently have gallstones, or have had them in the past, or have any complications such as fever, chills, abdominal pain, or yellowing of the skin or eyes; inform your doctor, as prolonged use of Octreotide SUN may cause gallstones. Your doctor may want to monitor your gallbladder periodically.
• if you have problems with blood sugar levels, either too high (diabetes) or too low (hypoglycemia). When Octreotide SUN is used to treat bleeding due to gastroesophageal varices, it is mandatory to monitor blood sugar levels.

• 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 checks

If you receive treatment with Octreotide SUN for a prolonged period, your doctor may periodically monitor your thyroid function.

Your doctor will monitor your liver function.

Your doctor may check your pancreatic enzyme function.

Children

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

Using Octreotide SUN with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Normally, you can continue taking other medicines while being treated with Octreotide SUN. However, Octreotide SUN may affect some 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 going to receive treatment with lutetium (177Lu) oxodotreotide, a radiopharmaceutical, your doctor may interrupt and/or adapt the 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.

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

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

You should not breastfeed during treatment with Octreotide SUN. It is not known whether Octreotide SUN passes into breast milk.

Driving and using machines

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

Octreotide SUN contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per ml of solution, so it is essentially "sodium-free".

3. How to use Octreotide SUN

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

Depending on the disease being treated, Octreotide SUN is administered by:

• subcutaneous injection (under the skin) or
• intravenous infusion (in 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 Octreotide SUN under the skin, but intravenous infusion should always be performed 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.

Some 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 an ampoule of Octreotide SUN, you should check for the presence of particles or a change in color. Do not use it if you detect anything abnormal.

If you use more Octreotide SUN than you should

The 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 level of lactic acid in the blood
• abnormal heart rhythm.

If you think you have overdosed and are experiencing any of these symptoms, inform your doctor immediately.

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

If you forget to use Octreotide SUN

Administer a dose as soon as you remember and then continue with your usual schedule. It will not harm you if you forget a dose, but your symptoms may temporarily recur until you return to your usual treatment schedule.

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

If you stop using Octreotide SUN

If you stop your treatment with Octreotide SUN, your symptoms may recur. Therefore, do not stop treatment with Octreotide SUN unless your doctor tells you to.

If you have any further questions 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.

Someside 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 that cause sudden back pain
• high blood sugar.

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

• decreased activity of the thyroid gland (hypothyroidism) that causes 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
• altered 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, lightly colored urine
• irregular heartbeat.
• low platelet count in the blood; this may 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 after eating (dyspepsia)
• vomiting
• feeling of fullness
• greasy 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 side effects, talk to your doctor, pharmacist, or nurse.

Some 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 administered Octreotide SUN 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 Octreotide SUN 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 them directly through the Spanish Pharmacovigilance System for Human Use 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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

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

Store in the original package to protect from light.

Unopened Octreotide SUN ampoules can be stored below 25°C for a maximum of 2 weeks and in the original package.

Physical and chemical stability of the diluted solution has been demonstrated for 8 hours at 25°C. From a microbiological point of view, the product should be used immediately after dilution. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you are in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. 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 ampoule of solution for injection contains 100 micrograms of octreotide in the form of octreotide acetate.

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

Appearance and packaging of the product

This medicine is a clear and colorless solution for injection.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

You can obtain further information about this medicine by contacting the local representative of the marketing authorization holder:

Sun Pharma Laboratories, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Tel: +34 93 342 78 90

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names

Denmark: Octreotid SUN 0,1 mg/1ml injektionsvæske, opløsning

Germany: Octreotid SUN 0,1mg/1ml Injektionslösung

Italy: Octreotide SUN 0,1mg/1ml soluzione iniettabile

Spain: Octreotida SUN 100 microgramos/ml solución inyectable EFG

Sweden: Oktreotid SUN 100 mikrogram/ml injektionsvätska, lösning

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

Date of the last review of this prospectus: September 2022

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

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This information is intended solely for healthcare professionals:

Intravenous infusion (for healthcare professionals)

Incompatibilities

This medication should not be mixed with others except those mentioned in the special precautions for elimination and other handling section

Special storage precautions

Ampoules:

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

Unopened ampoules can be stored at 25°C for two weeks.

Special precautions for disposal and other handling

Ampoules:

The ampoules should be opened immediately before use, and any unused remainder should be discarded.

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

Subcutaneous administration

Octreotide SUN should be administered subcutaneously without dilution.

Intravenous administration

For intravenous administration, octreotide should be diluted with normal saline at a ratio of not less than 1 vol: 1 vol and not more than 1 vol: 9 vol. Since octreotide can affect glucose homeostasis, the use of physiological saline solutions is preferred over dextrose solutions

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of packaging and medicines that are no longer needed. This will help protect the environment.

How much Octreotide SUN should be used

The dose of Octreotide SUN depends on the disease being treated.

Acromegaly

Normally, treatment is started at a dose of 0.05 to 0.1 mg every 8 or 12 hours by subcutaneous injection. Subsequently, it is changed 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 3 times/day. The maximum dose of 1.5 mg/day should not be exceeded.

Gastrointestinal tract tumors

Treatment is usually started with a dose of 0.05 mg 1 or 2 times 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 bleeding

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 thyroid-stimulating hormone (TSH)

The effective dose is usually 100 micrograms 3 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.