Somatostatin-eumedica

Leaflet attached to the packaging: patient information

Somatostatin-Eumedica, 3 mg, powder for solution for injection/infusion

Somatostatin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Somatostatin-Eumedica and what is it used for
• 2. Important information before using Somatostatin-Eumedica
• 3. How to use Somatostatin-Eumedica
• 4. Possible side effects
• 5. How to store Somatostatin-Eumedica
• 6. Contents of the pack and other information

1. What is Somatostatin-Eumedica and what is it used for

Somatostatin-Eumedica contains somatostatin. At therapeutic doses, somatostatin inhibits the function and peristalsis of the gastrointestinal tract, as well as its secretory function, and reduces blood flow in the splanchnic bed. Somatostatin-Eumedica is indicated for use in adult patients:

• for the treatment of acute gastrointestinal bleeding caused by gastric or duodenal ulcer, bleeding gastritis, or esophageal varices, suspected on the basis of clinical presentation or confirmed by endoscopy;
• for the treatment of intestinal and pancreatic fistulas;
• for the symptomatic treatment of excessive secretion by gastrointestinal endocrine tumors;
• for the prevention of complications after pancreatic surgery or after endoscopic retrograde cholangiopancreatography (ERCP).

2. Important information before using Somatostatin-Eumedica

Somatostatin-Eumedica is intended for use in a hospital setting.

When not to use Somatostatin-Eumedica

• if the patient is hypersensitive to the active substance, its analogs, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Somatostatin-Eumedica, discuss it with your doctor, pharmacist, or nurse. Somatostatin-Eumedica should be used with caution in the following situations:

• if the patient has severe renal impairment (creatinine clearance ≤ 30 ml/min), half of the recommended dose should be administered;
• if the patient is at risk of cardiovascular disease;
• if the patient has or has had arrhythmias in the past;
• the medicine administered as a direct intravenous injection should be given slowly over at least 1 minute, and the infusion should be given continuously;
• patients using Somatostatin-Eumedica should be under close medical supervision due to the possibility of hypoglycemia (decreased blood glucose levels) in the initial phase of infusion and increased blood glucose levels in the later phase. The doctor will decide on blood glucose monitoring at appropriate intervals;
• during the use of Somatostatin-Eumedica, a decrease in glomerular filtration rate, urine flow, and sodium levels in the blood may occur, so the doctor may recommend regular monitoring of kidney function and electrolyte levels in the blood.

Somatostatin-Eumedica inhibits the intestinal absorption of some nutrients and the secretion of other gastrointestinal hormones (including cholecystokinin, gastrin, and secretin). Abrupt discontinuation of the infusion may lead to a rebound effect (see "Discontinuation of Somatostatin-Eumedica").

Somatostatin-Eumedica and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Inform your doctor if you are taking:

• medicines that affect blood glucose regulation (medicines used in diabetes), as Somatostatin-Eumedica may alter the effect of these medicines;
• medicines that affect renin levels in the blood and blood pressure (medicines used in hypertension), as Somatostatin-Eumedica may alter the effect of these medicines;
• carbohydrates in any form (including glucose, fructose, or total parenteral nutrition). Concurrent administration of carbohydrates may cause glycemic disorders (blood glucose levels), so close monitoring of blood glucose levels is necessary. Insulin administration may be necessary.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. There is insufficient data on the use of Somatostatin-Eumedica in pregnancy and breastfeeding, so the medicine should not be used in pregnant or breastfeeding women.

Driving and using machines

This does not apply, as the medicine is administered in a hospital setting.

3. How to use Somatostatin-Eumedica

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Somatostatin-Eumedica is intended for use in a hospital setting. Your doctor will decide on the appropriate dosage and method of administration. The recommended dose is 3.5 μg/kg body weight/hour (or usually 6 mg/24 hours in a patient weighing 75 kg), administered as a continuous infusion of 250 μg/hour. The infusion should be administered for 12 hours to 24 hours (depending on the dose of 3 mg or 6 mg). After completion of treatment, the patient should remain under close observation.
Additional recommendations for the treatment of acute gastrointestinal bleeding
The infusion of Somatostatin-Eumedica should be started before endoscopy, as soon as possible after the first signs of bleeding, and continued for five days. The minimum duration of treatment is 48 hours. Immediately after starting the continuous infusion, the doctor will administer Somatostatin-Eumedica as a direct intravenous injection (bolus) of 3.5 μg/kg body weight. The doctor will decide on the next direct intravenous injection one minute before the endoscopic procedure. The direct intravenous injection should be administered slowly (at least over one minute). After the endoscopic procedure, the doctor will decide on the need for further administration of similar doses of the medicine in the form of direct intravenous injections if the patient experiences clinical symptoms of bleeding.
Additional recommendations for the treatment of fistulas or excessive secretion by endocrine tumors
Administration as a direct intravenous injection is not required. In most patients, fistula healing occurs within 7 to 14 days. After healing, it is recommended to administer half of the dose as an intravenous infusion for a further 48 hours to avoid a possible rebound effect.
Detailed dosage information intended for healthcare professionals is provided at the end of the leaflet.

Overdose of Somatostatin-Eumedica

In case of overdose, symptomatic treatment should be used. There is no specific antidote. In reported cases of somatostatin overdose, no other hazards were observed than adverse reactions associated with the recommended dose of the medicine. In case of somatostatin overdose, close monitoring of blood glucose levels, circulatory parameters, kidney function, and electrolyte levels in the blood is recommended. After discontinuation of the intravenous infusion of somatostatin administered at the recommended therapeutic dose, the half-life of somatostatin in the blood is approximately 2 minutes.

Missed dose of Somatostatin-Eumedica

Do not take a double dose to make up for a missed dose.

Discontinuation of Somatostatin-Eumedica

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse. Abrupt discontinuation of the infusion may lead to a rebound effect (recurrence of symptoms), particularly in patients with fistulas. The doctor will decide on the discontinuation of the medicine at the appropriate time.

4. Possible side effects

Like all medicines, Somatostatin-Eumedica can cause side effects, although not everybody gets them. The following side effects have been observed:

Heart disorders:

Atrioventricular block
Bradycardia (slow heart rate)
Arrhythmia (heart rhythm disorders)
Extrasystoles

Gastrointestinal disorders:

Abdominal pain
Diarrhea
Nausea
Vomiting

Metabolic and nutritional disorders:

Hyperglycemia (increased blood glucose levels)
Hypoglycemia (decreased blood glucose levels)

Vascular disorders:

Hypertension
Hypotension
Hot flashes
Abrupt discontinuation of the continuous infusion may lead to a rebound effect, particularly in patients with fistulas.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Somatostatin-Eumedica

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 and vial after "EXP". The expiry date refers to the last day of the month. Store in a temperature below 25°C. After reconstitution, store for no more than 24 hours in the refrigerator (2°C – 8°C). From a microbiological point of view, somatostatin solutions should be used immediately after preparation. If not used immediately, the in-use storage times and conditions are the responsibility of the user and should not exceed 24 hours at 2-8°C, unless the preparation has taken place in controlled and validated aseptic conditions.

• The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Somatostatin-Eumedica contains

The active substance of the medicine is somatostatin in the form of somatostatin acetate. One vial contains 3 mg of somatostatin. The other ingredients of the medicine are: powder in a vial containing, in addition to somatostatin, sodium hydroxide or concentrated hydrochloric acid.

What Somatostatin-Eumedica looks like and contents of the pack

The vial of Somatostatin-Eumedica contains a white, lyophilized powder. Somatostatin-Eumedica is available in a pack containing a vial with 3 mg of somatostatin powder.

Marketing authorization holder and manufacturer

Marketing authorization holder: EUMEDICA Pharmaceuticals GmbH, Basler Straße 126, 79540 Lörrach, Germany, tel: +49 (0) 7621 424 7562, e-mail: [email protected]. Manufacturer: EUMEDICA SA, Chemin de Nauwelette 1, 7170 Manage, Belgium. EUMEDICA Pharmaceuticals GmbH, Basler Straße 126, 79540 Lörrach, Germany.

Date of last revision of the leaflet:

Information intended for healthcare professionals only

Due to the short half-life in plasma (1-2 minutes), Somatostatin-Eumedica should be administered as a continuous intravenous infusion. The solution should be prepared immediately before administration, dissolving the powder in 1 ml of sodium chloride solution (0.9%). Adults: The recommended dose is 3.5 μg/kg body weight/hour (or usually 6 mg/24 hours in a patient weighing 75 kg), administered as a continuous infusion of 250 μg/hour. The infusion should be administered for 12 hours to 24 hours (depending on the dose of 3 mg or 6 mg). Elderly patients: In elderly patients with severe renal impairment, dose adjustment is recommended (see section: Patients with severe renal impairment). Children and adolescents: The product is not recommended for use in children and adolescents due to the lack of appropriate clinical trials determining its safety and efficacy in this patient population. Patients with severe renal impairment (creatinine clearance ≤ 30 ml/min): The dose should be reduced to 1.75 μg/kg body weight/hour for both continuous infusion and direct intravenous injection (bolus). Patients with liver function disorders: In patients with liver function disorders, dose adjustment is not required. After completion of treatment, the patient should remain under close observation.
Additional recommendations for the treatment of acute gastrointestinal bleeding
The infusion of Somatostatin-Eumedica should be started before endoscopy, as soon as possible after the first signs of bleeding, and continued for five days. The minimum duration of treatment is 48 hours. Immediately after starting the continuous infusion, Somatostatin-Eumedica should be administered as a direct intravenous injection (bolus) of 3.5 μg/kg body weight. The next direct intravenous injection should be administered one minute before the endoscopic procedure. The direct intravenous injection should be administered slowly (at least over one minute). After the endoscopic procedure, similar doses of the medicine should be administered in the form of direct intravenous injections if the patient experiences clinical symptoms of bleeding.
Additional recommendations for the treatment of fistulas or excessive secretion by endocrine tumors
Administration as a direct intravenous injection is not required. In most patients, fistula healing occurs within 7 to 14 days. After healing, it is recommended to administer half of the dose as an intravenous infusion for a further 48 hours to avoid a possible rebound effect.