Prospect: information for the patient

Somatostatina NORMON 6 mg Powder and solvent for solution for infusion EFG

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 doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they present the same symptoms of disease as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect.

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

2. What you need to know before starting to use Somatostatina NORMON

3. How to use Somatostatina NORMON

4. Possible adverse effects

5. Storage of Somatostatina NORMON

6. Contents of the package and additional information

Somatostatin is a fourteen-amino acid polypeptide hormone primarily identified in the hypothalamus and the digestive tract. Somatostatina NORMON is a synthetically identical somatostatin to the natural one.

Somatostatin inhibits the secretion of numerous hormones such as growth hormone, adrenocorticotropic hormone (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 splenic blood flow.

Somatostatina NORMON is indicated for:

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

• No use Somatostatina NORMON

• If you are allergic (hypersensitive) to the active ingredient or analogues of somatostatina or to any of the other components of this medication (including those listed in section 6).
• If you are pregnant, or during the lactation period.

• Warnings and precautions

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

• If you have severe renal insufficiency (creatinine clearance ≤ 30 ml/min), you will be administered half the recommended dose;
• Glucose levels of the patient should be monitored regularly (every 4-6 hours), when Somatostatina NORMON is administered, since somatostatina exerts inhibitory effects on the release of glucagon and insulin;
• Regular checks of renal function and plasma electrolytes should be performed, due to the fact that during treatment with Somatostatina NORMON, glomerular filtration percentage, urine flow, and plasma sodium levels decrease;
• Somatostatina NORMON inhibits the secretion of other gastrointestinal hormones. Discontinuation of treatment may cause a rebound effect, especially in patients with fistula; therefore, after the fistula is cured, half the dose should be administered in an infusion over the next 48 hours to prevent a rebound effect;
• If you are insulin-dependent, frequent glucose level checks should be performed, due to the fact that somatostatina exerts an inhibitory effect on insulin release.

• Interaction of Somatostatina NORMON with other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Somatostatina may interact with medications that influence plasma glucose regulation, plasma renin levels, and blood pressure.

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

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

Prolongs the hypnotic (sedative) effect of barbiturates (medications with sedative and hypnotic properties) and potentiates the action of penteprazol (a medication that reduces stomach acid secretion), so somatostatina should not be administered with these medications, but rather the ongoing treatments should be suspended.

• Somatostatina NORMON with food and beverages:

Precaution is recommended in the case of administration of any form of sugar (see Interaction of Somatostatina NORMON with other medications).

• Pregnancy and lactation:

Consult your doctor or pharmacist before using any medication.

Somatostatina, due to its inhibitory action on growth hormone secretion, is contraindicated during pregnancy, childbirth, and lactation. In the case of a lactating mother, natural lactation should be suspended.

• Driving and operating machinery:

Not applicable.

• Somatostatina NORMON contains sodium:

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

Follow exactly the administration instructions for Somatostatina NORMON indicated by your doctor. Consult your doctor if you have any doubts.

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

Somatostatina NORMON should be reconstituted with physiological serum immediately before its use, and the resulting solution should be added to the perfusion fluid.

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 at 12 hours or 24 hours (for 3 mg and 6 mg respectively).

Geriatric patients:

Dose adjustment is recommended in geriatric patients with severe renal insufficiency (see below, patients with renal insufficiency).

Children and adolescents:

No adequate clinical studies have been conducted to establish the safety and efficacy of Somatostatina NORMON in children and adolescents. Therefore, its use is not recommended in this patient population.

Patients with severe renal insufficiency:

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 insufficiency:

No dose adjustment is necessary in patients with hepatic insufficiency alone.

In the treatment of gastrointestinal bleeding and esophageal variceal rupture, immediately after starting the continuous infusion, a loading dose of 250 micrograms will be administered through a slow intravenous injection, over a period of about 3 minutes, to avoid the onset of nausea and heat sensation. DURING THE ADMINISTRATION OF THE LOADING DOSE, BLOOD PRESSURE SHOULD BE CLOSELY MONITORED. For this indication, the minimum duration of treatment is 48 hours and the maximum duration is 120 hours (5 days). Pancreatic fistulas require longer treatment and an initial loading dose is not necessary. Closure of the fistulas 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, although somatostatin reduces fistula flow and may facilitate skin care of the stoma, it does not increase the number of fistula closures and therefore does not reduce the proportion of patients who eventually require surgical closure of the same. Furthermore, it does not replace standard treatment measures. In order to avoid possible rebound effects after healing, half the dose (1.75 micrograms/kg/hour) should be infused for the next 48 hours.

Closely monitor patients after treatment interruption.

Somatostatin treatment should be administered preferably in the intensive care unit.

• If you use more Somatostatina NORMON than you should

No cases of somatostatin intoxication have been described.

In case of interruption of the infusion and administration of symptomatic treatment. No specific antidote is 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 medication and the amount ingested.

• If you forgot to use Somatostatina NORMON

Do not receive a double dose to compensate for the missed doses.

• If you interrupt treatment with Somatostatina NORMON

Brusque or inadequate discontinuation of perfusion may cause a secretory rebound effect.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, Somatostatina NORMON may have adverse effects, although not all people may experience them.

The frequent adverse effects (may affect between 1 and 10 of every 100 patients) are: abdominal pain, nausea, hyperglycemia (increase in blood glucose) and hot flashes.

The infrequent adverse effects (may affect between 1 and 10 of every 1,000 patients) are: diarrhea, decrease in blood glucose (hypoglycemia), decrease in heart rate (bradycardia), decrease in blood pressure (hypotension) and increase in blood pressure (hypertension).

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

At the beginning of the infusion, hypoglycemia may occur, followed, possibly after 2 to 3 hours, by an increase in blood glucose due to alterations in the balance of insulin counter-regulatory hormones and glucagon. Therefore, it is necessary to monitor blood glucose levels at regular intervals and avoid the simultaneous administration of any type of sugar (including glucose solutions). Insulin administration may be necessary.

Brusque interruption of the perfusion may lead to a rebound effect, especially in patients with fistulas being treated.

During repeated treatments, it is not possible to rule out the risk of hypersensitivity (allergy) to somatostatina.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

Do not store at a temperature above 25°C.

Keep out of the reach and sight of children.

Shelf Life of Reconstituted Solutions

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

Expiration Date:Do not use Somatostatina NORMON after the expiration date appearing on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

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

Composition of Somatostatina NORMON:

The active principle is somatostatina. Each vial contains 6 mg of somatostatina (in the form of acetate hydrate). The other components are: manitol.

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

Appearance of the product and contents of the package:

Somatostatina NORMON 6 mg is presented in the form of powder and solvent for solution for infusion. Each package contains a vial and an ampoule of solvent.

Holder of the marketing authorization and responsible manufacturer:

LABORATORIOS NORMON, S.A.

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

This information is intended solely for doctors or healthcare professionals:

The treatment will be administered preferably in the intensive care unit.

Patients undergoing treatment with somatostatina must be kept under strict medical observation. The infusion must be administered slowly and continuously. When a bolus endovenous injection of 0.25 mg is required before the infusion, it must be infused slowly and continuously (duration greater than 3 minutes).

Somatostatina exerts a blocking action on the release of glucagon and insulin. Due to this action, blood glucose levels must be controlled at regular intervals of 4-6 hours during treatment; in addition, special attention must be paid to insulin-dependent patients.

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

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

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

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

To achieve the loading dose from the 6 mg dose, the 6 mg lyophilized powder must be reconstituted with 6 ml of physiological serum immediately before use (the ampoule of solvent contained in this package is 1 ml and not the 6 ml required 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 the patient via slow intravenous injection over a period of 3 minutes (see section 4.2). If necessary, to facilitate the bolus injection over 3 minutes, the 0.25 ml can be diluted with physiological serum to an appropriate volume (up to 5 ml).

To reconstitute the 6 mg dose, the lyophilized powder must be reconstituted with 1 ml of physiological serum immediately before use and add the obtained solution to the infusion liquid.

Somatostatina is unstable at alkaline pH, so its dissolution in solutions with a pH greater than 7.5 should be avoided.

OTHER PRESENTATIONS:

Somatostatina NORMON 3 mg Powder and solvent for solution for infusion EFG

Last review date of this leaflet: July 2022.

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