Octreotide GP-Pharm 1 mg/5 ml (0.2 mg/ml) solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Octreotide GP-Pharm 1 mg/5 ml (0.2 mg/ml) solution for injection and infusion EFG

Read the entire leaflet carefully before you start using this medicine, because 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Octreotide GP-Pharm is and what it is used for

2. What you need to know before using Octreotide GP-Pharm

3. How to use Octreotide GP-Pharm

4. Possible adverse effects

5. How to store Octreotide GP-Pharm

6. Contents of the container and other information

1. What Octreotide GP-Pharm is and what it is used for

Octreotide GP-Pharm contains octreotide. This medicine is a synthetic compound derived from somatostatin, a substance normally present in the human body that inhibits the effects of certain hormones such as growth hormone. The advantages of this medicine over somatostatin are that it is more potent and its effects last longer.

Octreotide GP-Pharm is used

• for acromegaly, a disease in which the body produces too much growth hormone. Normally, growth hormone regulates 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. This medicine 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, GRFomas). 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 this medicine helps control these symptoms.
• to prevent complications following pancreatic gland surgery. Treatment with this medicine helps reduce the likelihood of complications after surgery (e.g., abdominal abscesses, inflammation of the pancreas).
• to stop bleeding and to protect against recurrence of bleeding from ruptured gastroesophageal varices in patients with cirrhosis (a chronic liver disease). Treatment with this medicine 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.

This medicine 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 radiotherapy becomes fully effective.

2. What you need to know before using Octreotida GP-Pharm

Do not use Octreotida GP-Pharm:

• 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 treatment with Octreotida GP-Pharm:

• If you currently have gallstones or have had them in the past, or if you 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 GP-Pharm may lead to the formation of gallstones. Your doctor may wish to monitor your gallbladder periodically.

• If you have problems with blood sugar levels, either too high (diabetes) or too low (hypoglycemia). When Octreotida GP-Pharm is used to treat bleeding from gastroesophageal varices, monitoring of blood glucose levels is mandatory.

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

Octreotide may reduce heart rate, and at very high doses may cause abnormal heart rhythms. Your doctor may monitor your heart rate during treatment.

Tests and monitoring

If you are receiving Octreotida GP-Pharm 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 GP-Pharm in children.

Use of Octreotida GP-Pharm with other medicines:

Tell 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 GP-Pharm. However, it has been reported that some medicines such as cimetidine, cyclosporine, bromocriptine, quinidine, and terfenadine may be affected by Octreotida GP-Pharm.

If you are taking a medicine to control blood pressure (e.g. a beta-blocker or a calcium channel antagonist) 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 adapt treatment with Octreotida GP-Pharm.

Pregnancy and breastfeeding

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

Octreotida GP-Pharm should only be used during pregnancy if strictly necessary.

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

Breastfeeding must be avoided during treatment with Octreotida GP-Pharm. It is unknown whether Octreotida GP-Pharm passes into breast milk.

Driving and using machines

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

3. How to use Octreotida GP-Pharm

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

Depending on the condition being treated, this medicine is administered 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 this medicine 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 chosen for each subcutaneous injection to avoid irritating a specific area. Patients who will self-administer the injection must receive specific instructions from their doctor or nurse.

If the medicine has been stored in the refrigerator, it is recommended to allow it to reach room temperature before use. This will reduce the risk of injection site pain. The vial may be warmed by holding it in the hand, but must not be heated.

A small number of patients experience pain at the subcutaneous injection site. This pain usually lasts only a short time. If this occurs, it may be relieved by gently massaging the injection site for a few seconds afterward.

Before using a vial of Octreotida GP-Pharm, 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 GP-Pharm than you should:

Symptoms of overdose 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 and discomfort, high blood lactate levels, and abnormal heart rhythm.

If you think you have taken an overdose and experience any of these symptoms, inform your doctor immediately. You may also call the Toxicology Information Service at telephone number 91.562.04.20, indicating the medicine and the amount used.

If you forget to use Octreotida GP-Pharm

Take the missed 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 return to your regular treatment schedule.

Do not inject a double dose to make up for a forgotten dose.

If you stop using Octreotida GP-Pharm

If you stop treatment with this medicine, your symptoms may return. Therefore, do not discontinue treatment 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 adverse effects

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

Some adverse reactions could be serious. Inform your doctor immediately 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 part 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 heart rate.

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

• Thirst, reduced urine output, dark-colored urine, dry red skin.
• Fast heart rate.

Other serious adverse reactions

• 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 heart rate.
• Low platelet count in the blood; this may lead to increased bleeding or bruising.

Inform your doctor immediately if you notice any of the above adverse reactions.

Other adverse effects:

Inform your doctor, pharmacist, or nurse if you notice any of the adverse effects listed below. 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 (gas).
• Headache.
• Local pain at the injection site.

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

• Stomach discomfort after eating (dyspepsia).
• Vomiting.
• Feeling of fullness in the stomach.
• Fatty stools.
• Watery stools.
• Change in stool color.
• Dizziness.
• Loss of appetite.
• Changes in liver function tests.
• Hair loss.
• Difficulty breathing.
• Weakness.

If you experience any kind of adverse effect, consult your doctor, nurse, or pharmacist.

A few patients experience pain at the subcutaneous injection site. 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 GP-Pharm by subcutaneous injection, you may help reduce the risk of gastrointestinal adverse effects by avoiding meals close to the time of injection. Therefore, it is recommended to administer Octreotida GP-Pharm between meals or at bedtime.

Reporting of adverse effects

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

5. Storage of Octreotide GP-Pharm

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

Store in a refrigerator (between 2ºC and 8ºC). Keep the vial in the outer packaging to protect it from light. For daily use, the medicine may be removed from the refrigerator and kept at room temperature for a few hours before administration, without affecting its therapeutic properties. Do not freeze.

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your usual pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Octreotida GP-Pharm:

• The active substance is octreotide. Each 5 mL vial contains 1 mg of octreotide in the form of octreotide acetate.
• The other components (excipients) are: glycine, water for injections, hydrochloric acid, phenol, and mannitol.

Marketing Authorization Holder and Manufacturer:

GP-Pharm, S.A.

Polígono Industrial Els Vinyets-Els Fogars, sector 2

Carretera comarcal C-244, km 22,

08777 – Sant Quintí de Mediona (Barcelona)

Date of the most recent review of this leaflet: January 2025

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

This information is intended for healthcare professionals only:

Storage conditions after vial puncture:

The physical and chemical stability of Octreotida GP-Pharm solution after vial puncture is 15 days when stored in the refrigerator (between 2 and 8 °C). Do not freeze. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage time and conditions during use are the responsibility of the user and should normally not exceed 24 hours at a temperature between 2°C and 8°C, unless handling has taken place under controlled and validated aseptic conditions.

• Intravenous infusion (for healthcare professionals)

For intravenous infusion, the medication must be diluted prior to administration.

Typically, 1 mL of product should be diluted in 100 mL of 0.9% isotonic sodium chloride solution. The solution should be administered using an infusion pump. This should be repeated as necessary to achieve the prescribed duration of treatment.

Storage conditions after dilution:

The physical and chemical stability of Octreotida GP-Pharm solution diluted in 0.9% sodium chloride injectable solution and stored in PVC bags is 48 hours when stored at temperatures below 25°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage time and conditions during use are the responsibility of the user and should normally not exceed 24 hours at a temperature between 2°C and 8°C, unless dilution has taken place under controlled and validated aseptic conditions.

To reduce local discomfort, allow the injectable solution to reach room temperature before administration.

Before using a vial of Octreotida GP-Pharm, inspect the solution for particles or discoloration. Do not use if any abnormalities are observed.

Dosage of Octreotida GP-Pharm

The dose of Octreotida GP-Pharm depends on the condition being treated.

• Acromegaly

Treatment is usually initiated at a dose of 0.05 to 0.1 mg every 8 or 12 hours by subcutaneous injection. The dose may then 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 should 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.

• TSH-secreting pituitary adenomas

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