SOMATOSTATIN NORMON 6 mg POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Somatostatin NORMON 6 mg Powder and Solvent for Solution for Infusion EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What Somatostatin NORMON is and what it is used for
2. What you need to know before you use Somatostatin NORMON
3. How to use Somatostatin NORMON
4. Possible side effects
5. Storage of Somatostatin NORMON
6. Contents of the pack and further information

1. What Somatostatin NORMON is and what it is used for

Somatostatin is a polypeptide hormone consisting of 14 amino acids, mainly identified in the hypothalamus and the digestive tract. Somatostatin NORMON is a synthetic somatostatin identical to the natural one.

Somatostatin inhibits the secretion of numerous hormones such as somatotropin, corticotropin (ACTH), gastrin, insulin, and glucagon, as well as gastric and pancreatic secretions, both endocrine and exocrine. It also reduces the motility of the digestive tract and splanchnic blood flow.

Somatostatin NORMON is indicated for:

• Treatment of digestive hemorrhages due to rupture of esophageal varices. It should be applied in all cases in conjunction with other measures (sclerotherapy, surgery), which it complements but does not replace.
• Adjuvant in the treatment of pancreatic fistulas secreting at least 500 ml per day.

2. What you need to know before you use Somatostatin NORMON

• Do not use Somatostatin NORMON

• If you are allergic (hypersensitive) to the active substance or analogs of somatostatin or to any of the other components of this medicine (listed in section 6).
• If you are pregnant or breastfeeding.

• Warnings and precautions

Consult your doctor or pharmacist before starting to use Somatostatin NORMON:

• the patient's blood glucose levels should be monitored at regular intervals (every 4-6 hours) when Somatostatin NORMON is administered, as somatostatin has inhibitory effects on the release of glucagon and insulin;
• regular checks of renal function and plasma electrolytes should be performed, as treatment with Somatostatin NORMON decreases the percentage of glomerular filtration, urine flow, and plasma sodium levels;
• Somatostatin NORMON inhibits the secretion of other gastrointestinal hormones. Discontinuation of treatment may cause a rebound effect, especially in patients with fistulas; therefore, after healing, half the dose should be administered by infusion over the next 48 hours to prevent a rebound effect;

• Interaction of Somatostatin NORMON with other medicines:

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Somatostatin may interact with drugs that influence the regulation of plasma glucose, plasma renin levels, and blood pressure.

The simultaneous administration of any form of sugar (including glucose, fructose, or total parenteral nutrition) may favor glycemic alterations and requires close monitoring of blood sugar. In some cases, insulin administration may be necessary.

Some cases of synergy (addition of effects) with cimetidine (a drug used to treat ulcers) have been described.

It prolongs the hypnotic effect (sedative) of barbiturics (drugs with sedative and hypnotic properties) and potentiates the action of penteprazol (a drug that reduces stomach acid secretion), so somatostatin should not be administered with these drugs, but rather the ongoing treatments should be suspended.

• Somatostatin NORMON with food and beverages:

Caution is recommended in the case of administration of any form of sugar (see Interaction of Somatostatin NORMON with other medicines).

• Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

Somatostatin, due to its inhibitory action on the secretion of growth hormone, is contraindicated in pregnancy, during childbirth, and breastfeeding. In the case of administration to a breastfeeding mother, breastfeeding should be suspended.

• Driving and using machines:

This is not applicable.

• Somatostatin NORMON contains sodium:

This medicine contains less than 23 mg of sodium (1 mmol) per dose; i.e., it is essentially "sodium-free".

3. How to use Somatostatin NORMON

Follow exactly the administration instructions of Somatostatin NORMON indicated by your doctor. Consult your doctor if you have doubts.

Given its short half-life, 1 to 2 minutes, Somatostatin NORMON should be administered through a continuous and uniform intravenous infusion to maintain plasma levels.

Somatostatin NORMON should be reconstituted with physiological serum immediately before use and the resulting solution added to the infusion liquid.

Adults:

The recommended dose is 3.5 micrograms/kg/hour, or normally 6 mg/24 hours for a 75 kg patient, administered as a continuous infusion of 250 micrograms/hour. The rate should be adjusted to 12 hours or 24 hours (for 3 mg and 6 mg, respectively).

Elderly patients:

Dose adjustment is recommended in elderly patients with severe renal impairment (see Patients with renal impairment below).

Children and adolescents:

Adequate clinical studies have not been conducted to establish the safety and efficacy of Somatostatin NORMON in children and adolescents. Therefore, its use is not recommended in this patient population.

Patients with severe renal impairment:

The dose should be reduced to 1.75 micrograms/kg/hour in a continuous infusion and 1.75 micrograms/kg for a loading dose.

Patients with hepatic impairment:

No dose adjustment is necessary in patients with hepatic impairment only.

In the treatment of gastrointestinal hemorrhages and esophageal variceal rupture, immediately after starting the continuous infusion, a loading dose of 250 micrograms should be administered through slow intravenous injection over a period of about 3 minutes to avoid the appearance of nausea and sensation of heat. DURING THE ADMINISTRATION OF THE LOADING DOSE, BLOOD PRESSURE SHOULD BE CLOSELY MONITORED. For this indication, the minimum treatment duration is 48 hours and the maximum duration is 120 hours (5 days). Pancreatic fistulas require more prolonged treatment, and no initial loading dose is necessary. Fistula closure is usually achieved in most patients between 7 and 14 days of treatment, although shorter or longer periods are possible. It should be noted that while somatostatin reduces fistula output and may facilitate skin care around the stoma, it does not increase the number of fistula closures and therefore does not reduce the proportion of patients who ultimately require surgical closure. It also does not replace usual treatment measures. To avoid possible rebound effects after healing, half the dose (1.75 micrograms/kg/hour) should be infused over the next 48 hours.

Patients should be closely monitored after treatment discontinuation.

Treatment with somatostatin is preferably administered in an intensive care unit.

• If you use more Somatostatin NORMON than you should

No cases of somatostatin overdose have been reported.

If necessary, interrupt the infusion and administer symptomatic treatment. There is no specific antidote known.

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

• If you forget to use Somatostatin NORMON

Do not take a double dose to make up for forgotten doses.

• If you stop using Somatostatin NORMON

Sudden or inadequate discontinuation of the infusion may cause a secretory rebound effect.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Somatostatin NORMON can cause side effects, although not everybody gets them.

Frequent side effects (may affect up to 1 in 10 people) are: abdominal pain, nausea, hyperglycemia (elevated blood glucose), and flushing.

Uncommon side effects (may affect up to 1 in 100 people) are: diarrhea, decreased blood glucose (hypoglycemia), decreased heart rate (bradycardia), decreased blood pressure (hypotension), and increased blood pressure (hypertension).

Side effects for which there are no data to determine frequency are: atrioventricular block, arrhythmia, ventricular extrasystole, vomiting.

At the start of the infusion, hypoglycemia may occur, followed possibly after 2 to 3 hours by an elevation of glycemia due to alterations in the balance of counter-regulatory hormones insulin and glucagon. Therefore, blood glucose levels should be monitored at regular intervals, and the simultaneous administration of any form of sugar (including glucose solutions) should be avoided. Insulin administration may be necessary.

Sudden discontinuation of the infusion may lead to a rebound effect, especially in the treatment of patients with fistulas.

During repeated treatments, the risk of hypersensitization (allergy) to somatostatin cannot be excluded.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storage of Somatostatin NORMON

Do not store above 25°C.

Keep out of the reach and sight of children.

Validity period of the reconstituted solutions

Once the solution is reconstituted, it should be protected from light and stored at a temperature not exceeding 25°C for no more than 24 hours.

Expiry date:Do not use Somatostatin NORMON after the expiry date stated on the packaging after the abbreviation EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Somatostatin NORMON:

The active substance is somatostatin. Each vial contains 6 mg of somatostatin (as hydrated acetate). The other components are: mannitol.

Each ampoule of solvent contains 1 ml of 0.9% sodium chloride solution.

Appearance of the product and pack contents:

Somatostatin NORMON 6 mg is presented as a powder and solvent for solution for infusion. Each pack contains a vial and an ampoule of solvent.

Marketing authorization holder and manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This information is intended only for healthcare professionals:

Treatment should preferably be administered in an intensive care unit.

Patients under treatment with somatostatin should be kept under strict medical observation. The infusion should be administered slowly and continuously. When a 0.25 mg intravenous bolus is required before the infusion, it should be infused slowly and continuously (over more than 3 minutes).

Somatostatin has a blocking action on the release of glucagon and insulin. Due to this action, blood glucose levels should be monitored at regular intervals of 4-6 hours during treatment; special attention should also be paid to insulin-dependent patients.

It is recommended not to administer the drug with carbohydrates that require insulin for their metabolism and infusion solutions containing glucose or fructose, to avoid glycemic alterations. In cases deemed appropriate, additional insulin doses may be administered.

Somatostatin produces the inhibition of intestinal absorption of certain nutrients. Therefore, parenteral nutrition should be administered concomitantly in prolonged treatment with somatostatin.

In all cases, the patient should be monitored after treatment withdrawal.

During the 15 minutes following intravenous administration of the medicine, the patient should remain in a supine position.

To achieve the loading dose from the 6 mg dose, the 6 mg lyophilized powder should be reconstituted with 6 ml of physiological serum immediately before use (the ampoule of solvent in this pack contains 1 ml, not the 6 ml necessary for the reconstitution of the loading dose). No special handling instructions are required, other than those for any injectable form.

Take 0.25 ml of the obtained solution, corresponding to 250 micrograms, and inject it into the patient through slow intravenous injection over a period of about 3 minutes (see section 4.2). If necessary, to facilitate bolus injection over 3 minutes, the 0.25 ml can be diluted with physiological serum up to an adequate volume (up to 5 ml).

For the reconstitution of the 6 mg dose, the lyophilized powder should be reconstituted with 1 ml of physiological serum immediately before use, and the resulting solution added to the infusion liquid.

Somatostatin is unstable at alkaline pH; therefore, its dissolution in solutions with a pH above 7.5 should be avoided.

OTHER PRESENTATIONS:

Somatostatin NORMON 3 mg Powder and Solvent for Solution for Infusion EFG

Date of last revision of this leaflet: July 2022.

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