Prospect: information for the patient

Somatostatina GP-Pharm 3 mg powder and solvent for solution for infusion EFG

Somatostatina

Read this prospect carefully before starting to use this medication, because 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 to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Somatostatina GP-Pharm and for what it is used

2.What you need to know before starting to use Somatostatina GP-Pharm

3.How to use Somatostatina GP-Pharm

4.Possible adverse effects

5.Storage of Somatostatina GP-Pharm

6.Contents of the package and additional information

Somatostatina is a fourteen amino acid polypeptide hormone primarily identified in the hypothalamus and the digestive tract. Somatostatina GP-Pharm is a synthesized 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 splenic blood flow.

Somatostatina GP-Pharm is indicated for:

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

No use Somatostatina GP-Pharm:

• If you are allergic (hypersensitive) to the active ingredient or analogues of somatostatina or to any of the other components of this medication (listed in section 6)
• If you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Somatostatina GP-Pharm:

• If you have severe renal insufficiency (creatinine clearance ≤ 30 ml/min), you will be administered half the recommended dose.
• The patient's glucose levels should be monitored regularly (every 4-6 hours) when Somatostatina GP-Pharm is administered, as somatostatina has inhibitory effects on the release of glucagon and insulin;
• Regular checks of renal function and plasma electrolytes should be performed, as the glomerular filtration rate, urine flow, and plasma sodium levels decrease during treatment with Somatostatina GP-Pharm;
• Somatostatina GP-Pharm inhibits the secretion of other gastrointestinal hormones. Stopping treatment may cause a rebound effect, especially in patients with fistulas; therefore, after the fistula has healed, half the dose should be administered intravenously over the next 48 hours to prevent a rebound effect;
• If you are insulin-dependent, frequent glucose level checks should be performed, as somatostatina has an inhibitory effect on insulin release.

Your doctor will evaluate the suitability of its use in the hospital. Additionally, you will be under strict medical observation at all times during treatment.

Other medications and Somatostatina GP-Pharm

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Somatostatina may interact with medications that affect 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 exacerbate glucose imbalances 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.

Somatostatina prolongs the hypnotic (sedative) effect of barbiturates (sedative and hypnotic medications) 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.

Use of Somatostatina GP-Pharm with food and beverages

Precaution is recommended when administering any form of sugar (see Somatostatina GP-Pharm interactions with other medications).

Pregnancy and lactation:

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

Somatostatina, due to its inhibitory action on growth hormone secretion, is contraindicated during pregnancy, childbirth, and lactation. If it is necessary to administer it to a breastfeeding mother, natural breastfeeding should be suspended.

Driving and operating machinery:

Not applicable.

Somatostatina GP-Pharm contains sodium

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

Follow exactly the instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

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

Somatostatina GP-Pharm must be reconstituted with physiological serum immediately before use, and the resulting solution added to the infusion fluid.

Patients should be closely monitored after treatment interruption.

Adults:

The recommended dose is 3.5 micrograms/kg/hour, or typically 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 elderly patients with severe renal insufficiency (see below, patients with renal insufficiency).

Children and adolescents:

No adequate clinical studies have established the safety and efficacy of Somatostatina GP-Pharm 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 liver insufficiency:

No dose adjustment is necessary in patients with liver 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 via slow intravenous injection over a period of approximately 3 minutes to prevent 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 do not require an initial loading dose. 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, while 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 ultimately require surgical closure. 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.

If you use more Somatostatina GP-Pharm than you should

No cases of somatostatin intoxication have been described.

If necessary, discontinue infusion and administer symptomatic treatment. No specific antidote is known.

In case of overdose or accidental ingestion, consult the Toxicological Information Service indicating the medication and the amount ingested. Tel. 915 620 420.

If you forgot to use Somatostatina GP-Pharm

Do not use a double dose to compensate for missed doses.

If you interrupt treatment with Somatostatina GP-Pharm

Brusque or inadequate discontinuation of infusion may cause a secretory rebound effect

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

Like all medications, this medication may produce adverse effects, although not all people will 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 frequency are: atrioventricular block, arrhythmia, ventricular extrasystole and vomiting.

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

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

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use. Website:www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store in the refrigerator between 2 and 8 °C.

Shelf life of reconstituted and diluted solutions:

After reconstitution with 1 ml of saline solution: Physical and chemical stability under use conditions has been demonstrated for 24 hours at temperatures not exceeding 25°C.

After dilution: Physical and chemical stability under use conditions has been demonstrated for 48 hours at temperatures not exceeding 25°C.

From a microbiological point of view, the product must be used immediately, unless the dilution and reconstitution methods exclude the risk of microbiological contamination. If not used immediately, the storage times under use conditions and the conditions prior to use will be the responsibility of the user.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Somatostatina GP-Pharm

The active principle is somatostatina. Each vial contains 3 mg of somatostatina (in the form of acetate hydrate). The other components arehydrochloric acid or sodium hydroxide (for pH adjustment).

Each ampoule of solvent contains 1 ml of sodium chloride 0.9% solution. In the ampoules of solvent, the other components are hydrochloric acid (for pH adjustment) and water for injection.

Appearance of the product and contents of the package

Somatostatina GP-Pharm is presented in the form of powder and solvent for solution for infusion. Each package contains a vial and an ampoule of solvent. The clinical package contains 25 vials and 25 ampoules of solvent.

Holder of the marketing authorization and responsible for manufacturing

GP-PHARM, S.A.

Pol.Ind. Els Vinyets-Els Fogars, 2.Ctra. C-244, Km 22

08777 Sant Quintí de Mediona – Barcelona

Spain

Date of the last version of this leaflet:07/2022

Other sources of information

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

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This information is intended solely for 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 in a slow and continuous manner. When a bolus endovenous dose of 0.25 mg is required prior to the infusion, it must be infused in a slow and continuous manner (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 the removal of the medication.

Brusque or inadequate interruption of the infusion may produce a rebound secretory effect.

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

Administration form

1. Administration in continuous infusion:

1. The lyophilized powder must be reconstituted with 1 ml of physiological serum immediately before use. No special handling instructions are required, other than those of any injectable form
2. This solution must be injected into the infusion bottle.
3. Adjust the infusion rateto the prescribed rate.

1. Administration of loading doses of250 micrograms

1. The 3 mg lyophilized powder must be reconstituted with 3 ml of physiological serum immediately before use (note that the ampoule of solvent containing the product only contains 1 ml of physiological serum). No special handling instructions are required, other than those of any injectable form.
2. Take 0.25 mL of the obtained solution, corresponding to 250 micrograms, and inject the patient through a slow intravenous injection in a time of about 3 minutes. If necessary, to facilitate the bolus injection during 3 minutes, the 0.25 mL can be diluted with physiological serum to an adequate volume (up to 5mL).

Incompatibilities

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