Prospect: information for the user

Octreotide SUN 100 micrograms/mL injectable solution EFG

octreotide

Read this prospect carefully before starting to use this medication, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only to you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Octreotide SUN and how it is used

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

3.How to use Octreotide SUN

4.Possible adverse effects

5.Storage of Octreotide SUN

6.Contents of the package and additional information

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

SUN Octreotideis used

-foracromegaly, 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 leads to an increase in the size of bones and tissues, especially in the hands and feet. SUN Octreotide significantly reduces the symptoms of acromegaly, which include headache, excessive sweating, numbness in the hands and feet, fatigue, and joint pain.

-to alleviate symptoms associated with somegastrointestinal tract tumors(e.g. carcinoid tumors, VIPomas, glucagonomas, gastrinomas, insulinomas). In these diseases, there is an overproduction of certain specific hormones and other related substances by the stomach, intestine, or pancreas. This overproduction alters the body's natural hormonal balance and produces various symptoms, such as hot flashes, diarrhea, low blood pressure, urticaria, and weight loss. Treatment with SUN Octreotide helps control these symptoms.

-to preventcomplications after pancreatic gland surgery. SUN Octreotide treatment helps reduce the likelihood of complications after surgery (e.g. abdominal abscess, pancreatitis inflammation).

-to stop bleeding and to protect against arepetition of bleeding due to rupture of gastroesophageal varicesin patients with cirrhosis (chronic liver disease). SUN Octreotide treatment 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.

SUN Octreotide is used to treat people with pituitary tumors that produce too much thyroid-stimulating hormone (TSH):

-when other types of treatment (surgery or radiation therapy) are not suitable or have not worked;

-after radiation therapy, to cover the period until the radiation therapy is

fully effective.

No use Octreotida SUN

-If you are allergic to octreotide or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to use Octreotida SUN:

-If you know you currently have gallstones, or have had them in the past or have any complications such as fever, chills, abdominal pain, or yellow discoloration of the skin or eyes; inform your doctor, as prolonged use of Octreotida SUN may cause the formation of 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 Octreotida SUN is used to treat bleeding due to esophageal varices, blood sugar level control is mandatory.

-If you have a history of vitamin B12deficiency. Your doctor may want to monitor your vitamin B12levels 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.

Analysis and controls

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

Your doctor will monitor your liver function.

Your doctor may check the functioning of your pancreatic enzymes.

Children

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

Use of Octreotida SUN with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

You can usually continue taking other medications while undergoing treatment with Octreotida SUN. However, Octreotida SUN may affect some medications, such as cimetidine, cyclosporine, bromocriptine, quinidine, and terfenadine.

If you are taking a medication 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 or adapt the octreotide treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

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

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

Driving and operating machinery

Octreotida SUN has no effects or these are insignificant 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 and operate machinery safely.

Octreotida SUN contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per ml of solution, making it essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Depending on the disease for which you are being treated, Octreotida SUN is administered through:

-subcutaneous injection (under the skin) or

-intravenous infusion (in the vein).

If you have cirrhosis of the liver (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, but 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 location should be chosen for each subcutaneous injection to avoid irritating a specific area. Patients who will administer the injection themselves should receive specific instructions from their doctor or nurse.

If you store the medication 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. It can be warmed in the hand, but not heated.

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

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

If you use more Octreotida 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 stomach

-yellow discoloration of the skin and eyes

-nausea

-loss of appetite

-diarrhea

-weakness

-fatigue

-lack of energy

-weight loss

-abdominal distension

-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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Octreotida SUN

Administer a dose as soon as you remember and then continue with the usual schedule. Missing a dose will not cause any harm, but symptoms may temporarily reappear until you return to the usual treatment schedule.

Do not inject a double dose of Octreotida SUN to compensate for missed individual doses.

If you interrupt treatment with Octreotida SUN

If you interrupt your treatment with Octreotida SUN, your symptoms may reappear. Therefore, do not interrupt treatment with Octreotida SUN unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor, nurse, or pharmacist.

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

Someside effects could be severe. Inform 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 rhythm, 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)

-very 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, red skin.

-fast heart rate.

Other severe side effects

-hypersensitivity reactions (allergic) including skin urticaria

-a type of allergic reaction (anaphylaxis) that may cause difficulty swallowing or breathing, swelling, and tingling, possibly with a decrease in blood pressure and 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, slightly colored urine

-irregular heart rate.

-low platelet count in the blood; this may increase the risk of bleeding or bruising.

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

Other side effects:

Inform your doctor, pharmacist, or nurse if you notice any of the following side effects. These side effects 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

-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

-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 type of side effect, consult your doctor, nurse, or pharmacist.

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

If you are administered Octreotida SUN via 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 Octreotida SUN between meals or before going to bed.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Store in the original packaging to protect it from light.

Octreotide SUN vials that have not been opened can be stored below 25°C for a maximum of 2 weeks and in the original packaging.

The physical and chemical stability of the diluted solution has been demonstrated for 8 hours at 25°C. From a microbiological standpoint, the product should be used immediately after dilution. If not used immediately, the storage conditions in use will be the responsibility of the user.

Medications should not be disposed of through the drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment

Compositionof Octreotide SUN100 micrograms/ml injectable solution

-The active ingredient is octreotide.

Each ampoule of 1 ml of injectable solution contains 100 micrograms of octreotide in the form of octreotide acetate.

The other components are: sodium trihydrate acetate, glacial acetic acid, sodium chloride,

water for injectable preparations.

Aspectof the productand contents of the packaging

This medicine is a transparent and colorless injectable solution.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Sun Pharma Laboratories, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Phone:+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) with the following names

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

Germany:Octreotide SUN 0.1mg/1ml Injection solution

Italy:Octreotide SUN 0.1mg/1ml injectable solution

Spain:Octreotide SUN 100 micrograms/ml injectable solution EFG

Sweden:Oktreotide SUN 100 micrograms/ml injection solution, solution

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

Last review date of this leaflet: September 2022

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended only for healthcare professionals:

Intravenous perfusion (for healthcare professionals)

Incompatibilities

This medicine should not be mixed with other medicines except those mentioned in the special precautions for disposal and other manipulations section

Special precautions for storage

Ampoules:

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

Ampoules:

Ampoules should be opened immediately before use and any unused residue should be discarded.

To reduce local discomfort, allow the solution to reach room temperature before injection. Avoid multiple injections in the same area over short periods of time.

Subcutaneous administration

Octreotide SUN should be administered subcutaneously without dilution.

Intravenous administration

For intravenous administration, octreotide should be diluted with normal saline solution in a ratio of not less than 1 vol: 1 vol and not more than 1 vol: 9 vol. Due to the fact that octreotide can affect glucose homeostasis, it is preferable to use physiological saline solutions rather than dextrose solutions

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

How much Octreotide SUN should be used

The dose ofOctreotide SUNdepends on the disease being treated.

Acromegaly

Normally, treatment is started at doses of 0.05 to 0.1 mg every 8 or 12 hours by subcutaneous injection. Subsequently, it is adjusted according to its effects and the 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 daily dose should not exceed 1.5 mg.

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.

Variceal hemorrhage

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

Pituitary adenomas secreting thyroid-stimulating hormone (TSH)

The usual effective dose is 100 micrograms 3 times a day by subcutaneous injection. The dose can be adjusted according to the TSH response and thyroid hormone levels. At least 5 days are needed to evaluate efficacy.