SOMATOSTATIN ACCORD 0.25 mg POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Somatostatina Accord 0.25 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. See section 4.

Contents of the pack

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

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

Somatostatina is a polypeptide hormone consisting of fourteen amino acids, mainly identified in the hypothalamus and the digestive tract. Somatostatina Accord is a synthetic somatostatina identical to the natural one.

Somatostatina 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.

Somatostatina Accord 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 Somatostatina Accord

Do not use Somatostatina Accord

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use somatostatina:

• if you have severe renal impairment (creatinine clearance ≤ 30 ml/min), you will be given half the recommended dose;
• the patient's blood glucose levels should be monitored at regular intervals (every 4-6 hours) when somatostatina is administered, as it has inhibitory effects on the release of glucagon and insulin;
• regular checks of renal function and plasma electrolytes should be performed, as somatostatina treatment decreases glomerular filtration rate, urine flow, and plasma sodium levels;
• somatostatina inhibits the secretion of other gastrointestinal hormones. Stopping treatment may cause a rebound effect, especially in patients with fistulas; therefore, after healing, half the dose should be administered in an infusion over the next 48 hours to prevent a rebound effect;
• if you are insulin-dependent, blood glucose levels should be monitored frequently, as somatostatina has an inhibitory effect on insulin release.

In any case, your doctor will assess the convenience of its use in the hospital.

Additionally, during treatment, you will be under strict medical observation at all times.

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Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Somatostatina may interact with drugs 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) 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 barbiturates (drugs with sedative and hypnotic properties) and potentiates the action of pentetrazol (a drug that reduces acid secretion in the stomach), so somatostatina should not be administered with these drugs, but rather, ongoing treatments should be suspended.

Using Somatostatina Accord with food and drinks

Caution is recommended in the case of administration of any form of sugar (see Other medicines and Somatostatina Accord).

Pregnancy and Breastfeeding:

Consult your doctor or pharmacist before using any medicine.

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

Somatostatina, due to its inhibitory action on growth hormone, is contraindicated in pregnancy, during childbirth, and lactation. In the case that it needs to be administered to a breastfeeding mother, breastfeeding should be suspended.

Driving and using machines

Not applicable.

S

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

3. How to use Somatostatina Accord

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

Given its short half-life, 1 to 2 minutes, somatostatina must be administered through continuous and uniform intravenous infusion to maintain plasma levels.

Somatostatina should be reconstituted with physiological serum immediately before use and the resulting solution added to the infusion fluid.

Patients should be closely monitored after stopping treatment.

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 below, patients with renal impairment).

Children and adolescents:

The safety and efficacy of somatostatina in children and adolescents have not been established. 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 due to rupture of esophageal varices, immediately before starting the continuous infusion, a loading dose of 250 micrograms will be administered through slow intravenous injection over 3 minutes to avoid nausea and sensation of heat. During the administration of the loading dose, blood pressure should be closely monitored. For this indication, the minimum duration is 48 hours and the maximum duration is 120 hours (5 days).

Pancreatic fistulas require more prolonged treatment and do not require the administration of an initial loading dose. 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 taken into account that, while somatostatina reduces fistula output 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 ultimately require surgical closure of the fistula. Likewise, it does not replace the usual treatment measures. In order to avoid possible rebound effects after healing, half the dose (1.75 micrograms/kg/hour) should be infused over the next 48 hours.

If you use more Somatostatina Accord than you should

No cases of somatostatina 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 the Toxicology Information Service indicating the medicine and the amount ingested. Phone: 91 562 04 20.

If you forget to use Somatostatina Accord

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

If you stop using Somatostatina Accord

Abrupt or inadequate interruption 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, Somatostatina Accord can cause side effects, although not everybody gets them.

Common side effects (affecting 1 to 10 in every 100 patients) are: abdominal pain, nausea, hyperglycemia (elevated blood glucose), and flushing.

Uncommon side effects (affecting 1 to 10 in every 1,000 patients) 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, and vomiting.

At the start of the infusion, hypoglycemia may occur, followed possibly after 2 to 3 hours by an elevation of blood glucose 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.

Abrupt interruption of the infusion may cause a rebound effect, especially in the treatment of patients with fistulas.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System. Website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Somatostatina Accord

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

Do not store above 25°C.

Once the solution is reconstituted, it should be stored at a temperature not exceeding 25°C, kept in its original packaging, and protected from light.

The reconstituted solution should be used within 24 hours of preparation.

Do not use Somatostatina Accord after the expiry date stated on the packaging after EXP:

The expiry date is the last day of the month indicated.

Medicines 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

Composition of Somatostatina Accord

The active substance is Somatostatina. Each vial contains 0.25 mg of somatostatina (as hydrated acetate).

Each vial of solvent contains 2 ml of 0.9% sodium chloride solution.

Appearance of the product and pack contents

Somatostatina Accord 0.25 mg powder and solvent for solution for infusion is available in a single unit pack with 1 vial of lyophilized powder and 1 vial of solvent. The clinical pack contains 25 vials of lyophilized powder and 25 vials of solvent.

Marketing Authorisation Holder:

Accord Healthcare, S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona

Manufacturer:

COMBINO PHARM, S.L.

C/ Fructuós Gelabert, 6-8

08970 Sant Joan Despí

Barcelona

Date of last revision of this leaflet:February 2025

This information is intended only for healthcare professionals:

Treatment should be administered preferably in the intensive care unit.

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

Somatostatina 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.

Somatostatina causes 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 withdrawal of the medicine.

Abrupt or inadequate interruption of the infusion may cause a secretory rebound effect.

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

Form of administration

• Administration of a 250 mcg loading dose:

1. The lyophilized powder should be reconstituted with 1 ml of physiological serum immediately before use. No special handling instructions are required, other than those for any injectable form.
2. Inject slowly into the patient over 3 minutes.

Incompatibilities

Somatostatina is unstable at alkaline pH, so it should be avoided to dissolve it in solutions with a pH above 7.5.