Patient Information Leaflet

Syntocinon 10 IU/mL injectable solution and for infusion

Oxytocin

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Syntocinon is and what it is used for

2. What you need to know before you start using Syntocinon

3. How to use Syntocinon

4. Possible side effects

5. Storage of Syntocinon

6. Contents of the pack and additional information

Syntocinon is presented in the form of injectable solution and for perfusion.

Syntocinon belongs to the group of medications known as oxytocics (medications that promote childbirth by stimulating uterine contractions). The action produced is identical to that produced by oxytocin, a natural hormone released by the pituitary glands.

Syntocinon is indicated in the following cases:

• Induction of term labor.
• Stimulation of contractility in cases of uterine inertia.
• Prevention and treatment of postpartum hemorrhage.

No use Syntocinon:

• If you are allergic to oxytocin or any of the other components of this medication (listed in section 6).

• If the fetus presents cephalopelvic disproportion, abnormal presentation.
• If there is a predisposition to amniotic fluid embolism (fetus dead in utero, premature placental abruption).
• If you have a history of cesarean section or any surgical procedure affecting the uterus, placenta previa, vasa previa, hypertonic contractions.
• If there is fetal distress and if delivery is not imminent.
• If you are being administered prostaglandins or other uterine stimulants concurrently and in any case, at least six hours should have passed since the administration of the latter.
• In the case of multiple births.

Warnings and precautions

Consult your doctor or nurse before starting to use Syntocinon.

The use of oxytocin for labor induction should be carried out strictly for medical reasons, not for convenience.

Syntocinon should not be used for prolonged periods in patients with resistant uterine inertia, severe pre-eclampsia, or severe cardiovascular disease.

Special caution should be exercised in the presence of limited cephalopelvic disproportion, secondary uterine inertia, mild or moderate pregnancy-induced hypertension, or heart disease, and in patients over 35 years or with a history of lower uterine segment cesarean section.

Cardiovascular disorders

To avoid significant changes in blood pressure and heart rate, Syntocinon should be used with caution in patients with pre-existing cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease, and/or ischemic heart disease, including coronary artery vasospasm). Inform your doctor if you have any of these conditions.

QT syndrome

Syntocinon should be administered with caution to patients with long QT syndrome or related symptoms

and to patients being treated with medications known to prolong the QT interval (see "Use of Syntocinon with other medications").

Fetal suffering and death

The administration of oxytocin at excessive doses causes uterine overstimulation, which may cause fetal suffering, asphyxia, and death, or may lead to uterine hypertonicity, tetanic contractions, or rupture.

Disseminated intravascular coagulation (DIC):

In rare cases, pharmacological induction of labor with uterotonic agents, including oxytocin, increases the risk of postpartum DIC. This risk is particularly increased in women with additional risk factors for DIC, such as being 35 years or older, complications during pregnancy and gestational period of more than 40 weeks.

Water intoxication

Due to the oxytocin's slight antidiuretic activity, its intravenous administration

for prolonged periods at high doses along with large volumes of fluid, such as treatment of inevitable or delayed abortion, or in the treatment of postpartum hemorrhage, may therefore cause water intoxication associated with hyponatremia. Special caution should be exercised in patients with severe renal insufficiency, due to the possible retention of water and accumulation of oxytocin.

Renal insufficiency

Special caution should be exercised in patients with severe renal insufficiency, due to the possible retention of water and accumulation of oxytocin.

Latex allergy

The active ingredient of Syntocinon may cause a severe allergic reaction (anaphylactic reaction) in patients allergic to latex. Inform your doctor if you are allergic to latex.

Children and adolescents

The safety and efficacy of Syntocinon in children and adolescents (under 18 years of age) have not been established. No data are available.

Use of Syntocinon with other medications:

Inform your doctor if you are using, have used recently, or may need to use

any other medication. Certain medications may interact with Syntocinon, in these cases, your doctor may change the dose or discontinue treatment with one of them. In particular:

• Inhaled anesthetics with strong uterine-relaxing power (such as halothane, chloroform, etc.), as they may reduce the effect of Syntocinon.
• Vasopressor agents (medications that produce constriction in the blood vessels), as Syntocinon may potentiate their effect and produce severe hypertension during the postpartum period.
• Prostaglandins or other uterine stimulants, as Syntocinon may potentiate their effect (see section 2).
• Medications that prolong the QT interval (which cause irregular heartbeats),as Syntocinon may potentiate this effect.
• Caudal anesthesia, when administered during or after caudal block, Syntocinon may potentiate the pressor effect of vasoconstrictor sympathomimetic agents.

Pregnancy, lactation, and fertility

The available data on a limited number of pregnancies indicate that oxytocin in pregnancy does not show adverse reactions, when administered in accordance with therapeutic indications.

Oxytocin may be excreted in small amounts in breast milk. However, it is unlikely to cause harm to the newborn, as oxytocin is rapidly inactivated in the newborn's digestive tract.

Driving and operating machinery

No data are available on the effects on the ability to drive and operate machinery

Syntocinon contains ethanol (alcohol) and sodium

This medication contains 0.6% ethanol (alcohol), which corresponds to 4.8 mg per ml, equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medication has no perceptible effect.

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

Oxytocin will be administered always in a hospital setting and under medical supervision.

Induction of labor or uterine contractility stimulation

For labor induction, oxytocin will always be administered intravenously.

The healthcare professional will control the infusion rate, and use an infusion pump or

similar equipment (see section “Instructions for correct use of Syntocinon”, at the end of this leaflet).

The initial infusion rate is usually set between 1-4 milliUI/minute (2-8 drops/minute). It can be gradually increased, at intervals of no less than 20 minutes, until a pattern of contractions similar to those of a normal labor is established, with a maximum recommended rate of 20 milliunits/minute (40 drops/minute).

In women with a term labor in which regular contractions have not been initiated after administering a quantity of oxytocin of 5 UI (equivalent to 500 ml of the solution prepared according to section “Instructions for correct use of Syntocinon”), it is recommended to interrupt labor induction and repeat the next day, starting again from a dose of 1-4 milliUI/minute.

The dose must be adjusted at all times to the individual response. For this, you will be closely monitored (fetal heart rate, blood pressure, etc.). In case of uterine hyperactivity or fetal distress, the infusion will be suspended immediately.

Prevention of postpartum hemorrhage

The usual dose is 5 UI via intravenous infusion (5 UI diluted in a physiological saline solution) or 5 to 10 UI via intramuscular injection after placental expulsion.

Treatment of postpartum hemorrhage

The usual dose is 5 UI via intravenous infusion (5 UI diluted in a physiological saline solution) or 5 to 10 UI via intramuscular injection, in severe cases, followed by another intravenous infusion of a solution containing 5-20 UI of oxytocin.

If you use more Syntocinon than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call

The Toxicological Information Service. Phone 915 620 420, indicating the medication and the amount used.

When signs or symptoms of overdose occur during continuous intravenous administration of Syntocinon, your doctor should immediately interrupt the infusion and administer oxygen to the mother.

In case of water intoxication, it is essential to restrict fluid intake, promote diuresis, correct electrolyte imbalance, and control seizures that may occur.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects have been reported. Side effects are classified under frequency titles, with the most frequent first, using the following convention: Very common (≥ 1/10); common (≥ 1/100, <1>based on available data).

The side effects derived from post-marketing experience with Syntocinon have been obtained through spontaneous case reports and cases described in the literature. As these side effects are reported voluntarily by an unknown population size, it is not possible to estimate their frequency reliably, and therefore they are classified as unknown.

Table 1: Side effects in the mother

Table 2: Side effects in the fetus/newborn

Reporting of side effects

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

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

• Store in the original container in the refrigerator (between 2 and 8 °C). Do not freeze.

• Store in the original container to protect it from light.

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

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Syntocinon

• The active principle is oxytocin. Each ml of solution contains 10 UI of oxytocin.
• The other components (excipients) are ethanol, sodium acetate trihydrate, chlorobutanol, sodium chloride, glacial acetic acid, and water for injection.

Appearance of the product and content of the container

Transparent glass ampoules containing 1 ml of a clear, sterile, and colorless solution.

Container containing 10 ampoules.

Holder of the marketing authorization

Alfasigma S.p.A.

Via Ragazzi del ’99, n.5

40133 Bolonia. ITALY

Responsible for Manufacturing:

Alfasigma, S.p.A.

Via Pontina Km 30.400

00071 Pomezia (Rome). ITALY

Local Representative:

Alfasigma España, S.L

Avenida Diagonal, 490 4th

08006 Barcelona, Spain

Date of the last review of this leaflet:February2021

This information is intended solely for healthcare professionals.

Instructions for correct use of Syntocinon

Prepare the oxytocin solution by dissolving one 10 UI ampoule aseptically in 1,000 ml of physiological saline solution or 5% glucose. Ensure, by gentle agitation or rotation of the bottle, that the mixture is homogeneous (the solution contains 10 milliUI/ml of oxytocin).

Instructions for correct opening of the ampoule

Breakable ampoule. The break line is located below the colored point. Place the

thumb above the colored point and break the ampoule by pressing backwards.

“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.es/”