Patient Information Leaflet: Product Information

Octreotide GP-Pharm 1mg/5 ml (0.2 mg/ml) Injectable Solution and for Infusion EFG

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

6. Contents of the pack and additional information

Octreotide GP-Pharm contains octreotide. This medication is a synthetic compound derived from somatostatin, a substance that is normally found in the human body that inhibits the effects of some hormones such as growth hormone. The advantages of this medication compared to somatostatin are that it is more potent and its effects are longer-lasting.

Octreotide GP-Pharm is 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 means an increase in the size of bones and tissues, especially in the hands and feet. This medication significantly reduces the symptoms of acromegaly, which include headache, excessive sweating, numbness of the hands and feet, fatigue, and joint pain.
• to alleviate symptoms associated with somegastrointestinal tract tumors(e.g. carcinoid tumors, VIPomas, glucagonomas, gastrinomas, insulinomas, GRFomas). 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 natural hormonal balance of the body and produces various symptoms, such as hot flashes, diarrhea, low blood pressure, urticaria, and weight loss. The treatment with this medication helps to control these symptoms.
• to preventcomplications after pancreatic gland surgery. The treatment with this medication helps to reduce the possibility of complications after surgery (e.g. abdominal abscesses, pancreatitis inflammation).
• to stop bleeding and to protect against arepetition of bleeding due to rupture of esophageal varicesin patients suffering from cirrhosis (chronic liver disease). The treatment with this medication helps to 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.

This medication 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 completely effective.

Do not use Octreotide GP-Pharm:

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  3. How to use Octreotide GP-Pharm

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

  This medication is administered via:

  • 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 this medication 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 tempered 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 GP-Pharm, 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 GP-Pharm than you should:

  The symptoms of overdose are: irregular heartbeat, low blood pressure, cardiac arrest, decreased oxygen supply to the brain, intense pain in the upper stomach, yellow color on the skin and eyes, nausea, loss of appetite, diarrhea, weakness, fatigue, lack of energy, weight loss, swelling, and abdominal discomfort, high levels of lactic acid in the blood, and abnormal heart rhythm.

  If you think you have overdosed and are experiencing any of these symptoms, inform your doctor immediately. You can also call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount used.

  If you forgot to use Octreotida GP-Pharm

  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 to compensate for missed doses.

  If you interrupt treatment with Octreotida GP-Pharm

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

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

  4. Possible Adverse Effects

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

  Some side effects 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, which can cause sudden back pain.
  • High blood sugar.

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

  • 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.

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

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

  Other serious side effects

  • Allergic reactions (hypersensitivity) including skin hives.
  • A type of allergic reaction (anaphylaxis) that can cause difficulty swallowing or breathing, swelling, and possibly a drop 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 heart rate.
  • Low platelet count in the blood; this may mean an increase in 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. They are usually mild and tend to disappear as treatment progresses.

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

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

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

  • Discomfort in the stomach 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 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 massaging the injection site gently for a few seconds.

  If you are administered Octreotida GP-Pharm 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 GP-Pharm between meals or before going to bed.

  Reporting side effects

  If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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:https://www.notificaram.es. By reporting side effects, you can contribute toproviding more information about the safety of this medicine.

  5. Conservation of Octreotide GP-Pharm

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

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

  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.

  Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at your local SIGRE collection pointat your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

  6. Contents of the packaging and additional information

  Composition of Octreotida GP-Pharm:

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

  Holder of the authorization and responsible for the manufacture:

  GP-Pharm, S.A.

  Industrial Polygon Els Vinyets-Els Fogars, sector 2

  Comarcal Road C-244, km22,

  08777 – Sant Quintí de Mediona (Barcelona)

  Date of the last review of this leaflet:January 2025

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

  This information is intended solely for healthcare professionals:

  Conditions for storage after piercing the vial:

  The physical and chemical stability of the Octreotida GP-Pharm solution once the vial is pierced is 15 days in the refrigerator (between 2 and 8 °C). Do not freeze. From a microbiological point of view, the product must be used immediately. If not used immediately, the time and storage conditions in use are the responsibility of the user and are normally not greater than 24 hours at a temperature between 2°C and 8°C unless the handling has taken place in controlled and validated aseptic conditions.

  • Intravenous infusion (for healthcare professionals)

  To administer intravenously, dilute the medication before administration.

  Normally, 1 mL of the product should be dissolved in 100 mL of isotonic sodium chloride solution 0.9%. The solution should be administered through a perfusion pump. This should be repeated as necessary to achieve the duration of treatment prescribed.

  Storage conditions after dilution:

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

  To reduce local discomfort, the injectable solution should be allowed to reach room temperature before administration.

  Before using a vial of Octreotida GP-Pharm, check if the solution contains particles or if there is a change in color. Do not use it if you see anything abnormal.

  How much Octreotida GP-Pharm should be used

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

  • Acromegaly

  Normally, treatment is initiated at doses of 0.05 to 0.1mg every 8 or 12hours 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 0.1mg 3 times/day. The maximum dose should not exceed 1.5mg/day.

  • Gastrointestinal tract tumors

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

  • Complications after pancreatic surgery

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

  • Esophageal variceal hemorrhage

  The recommended dose is 25micrograms/hour for 5días by continuous intravenous infusion. Blood sugar level control is necessary during treatment.

  • Pituitary adenomas secreting TSH

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