Label: information for the user

Terlipresina SUN 1 mg injectable solution EFG

terlipresina acetate

Read this label carefully before this medicine is administered to you, as it contains important information for you.

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

Terlipresina SUN is a synthetic pituitary hormone.

Terlipresina SUN is used for the treatment of bleeding from dilated veins in the tube that leads to the stomach (bleeding esophageal varices).

Do not administer Terlipresina SUN

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

Warnings and precautions

This medication will be administered to you if you have a severe or life-threatening esophageal hemorrhage. It must be used with continuous monitoring of your heart and blood circulation.

Inform your doctor as soon as possible if you have any of the following conditions:

• if you have a known severe infection called septic shock
• if you suffer from asthma or other respiratory diseases
• if you have acute coronary syndrome (whose symptoms are related to insufficient blood flow to the heart muscle that may lead to a heart attack and cause chest pain or angina)
• if you have uncontrolled high blood pressure, insufficient blood circulation in the heart vessels (for example, angina), if you have previously had a heart attack (myocardial infarction) or if you have atherosclerosis
• if you have irregular heartbeats (cardiac arrhythmias)
• if you have poor blood circulation to the brain (for example, you have had a stroke) or to your extremities (peripheral vascular disease)
• if you have altered kidney function (renal insufficiency)
• if you have electrolyte imbalances in the blood
• if you have a decrease in the amount of fluid in the circulation or have already lost a large amount of blood
• if you are over 70 years old
• if you are pregnant.

Children and adolescents

Terlipresina SUN is not recommended for use in children and adolescents due to insufficient experience.

Use of Terlipresina SUN with other medications

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

Inform your doctor immediately if you are using any of the following medications:

• medications that affect heart rate (for example, beta-blockers or propofol)
• medications that can cause irregular heartbeats (arrhythmias) such as the following:
• Class IA antiarrhythmics (quinidine, procainamide, disopyramide) and Class III antiarrhythmics (amiodarone, sotalol, ibutilide, dofetilide)
• an antibiotic called erythromycin
• antihistamines (used primarily to treat allergies, but also present in some cold and cough remedies)
• tricyclic antidepressants used to treat depression
• medications that can alter the level of salt or electrolytes in the blood, especially diuretics (used to treat high blood pressure and heart failure).

Pregnancy and breastfeeding

Terlipresina SUN should only be used during pregnancy if it is vital for your treatment. If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before you are administered this medication.

The presence of Terlipresina SUN in breast milk is unknown. Therefore, the potential effect on the infant is also unknown. Consult your doctor to know the potential risk for the infant.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery. However, if you do not feel well after the administration of the injection, do not drive or operate machinery.

Terlipresina SUN contains sodium

Patients with low-sodium diets should be aware that this medication contains 361 mg (15.7 mmol) of sodium per maximum single dose.

This medication will be administered to you by your doctor at all times. Consult with your doctor for additional information on its use.

What amount of Terlipresina SUN should be administered

Adults

Initially, 1-2 mg of terlipresina acetate (equivalent to 8.5-17 ml of injectable solution) will be administered by injection into a vein. Your dose will depend on your body weight.

After the initial injection, the dose may be reduced to 1 mg of terlipresina acetate (equivalent to 8.5 ml of solution) every 4-6 hours.

The maximum dose you can receive each day is approximately 120 micrograms/kg of body weight.

Senior citizens

If you are over 70 years old, consult with your doctor before Terlipresina SUN is administered to you.

How Terlipresina SUN is administered

Terlipresina SUN must be injected slowly by intravenous route.

How often Terlipresina SUN should be administered

Use should be limited to 2 – 3 days, depending on the development of the disease.

If more Terlipresina SUN is administered than recommended

You should not use more Terlipresina SUN than the recommended dose. If you receive an excessive amount, you may experience a rapid increase in blood pressure, especially if you already have hypertension. If this occurs, you will need another medication called an alpha-blocker (for example, clonidine) to control your blood pressure.

If you experience dizziness, fainting, or a sensation of fainting, consult your doctor as these may be symptoms of low heart rate. This can be treated with a medication called atropine.

If you forget to use Terlipresina SUN

Terlipresina SUN will be administered to you in the hospital, under the supervision of your doctor.

If you interrupt treatment with Terlipresina SUN

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

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

Important side effects or symptoms to be aware of and measures to take if you experience them

In very rare cases, there is a possibility of severe side effects when you are administered terlipressin. If you experience any of the following side effects, inform your doctor immediately if possible. Your doctor should stop administering terlipressin to you.

Severe difficulty breathing due to an asthma attack, severe difficulty breathing or cessation of breathing, acute chest pain (angina), severe and persistent irregular heartbeats, localised dead skin (necrosis), convulsions, renal insufficiency.

Other possible side effects

Frequent (may affect up to 1 in 10 people)

• Headache
• Too slow heart rate
• Signs of insufficient blood circulation in the heart's blood vessels on the electrocardiogram
• High blood pressure
• Low blood pressure
• Insufficient blood circulation in arms, legs and skin, paleness in the face
• Abdominal cramps
• Diarrhea

Rare (may affect up to 1 in 100 people)

• Low sodium levels in the blood (hypontremia) if fluid balance is not controlled, non-related skin necrosis at the injection site

• Rapid increase in blood pressure
• Too fast heart rate (palpitations)
• Pulmonary edema
• Chest pain
• Heart attack
• Excess fluid in the lungs
• Heart failure (Torsade de Pointes)
• Insufficient blood flow to the intestines
• Uterine contraction
• Decreased blood flow to the uterus
• Blue discoloration of the skin or lips
• Seizures
• Temporary nausea (discomfort)
• Temporary vomiting
• Lymphatic vessel inflammation (fine red lines under the skin extending from the affected area to the armpit or groin and fever, chills, headache and muscle pain)

Rare (may affect up to 1 in 1000 people)

• Difficulty breathing

Very rare (may affect up to 1 in 10,000 people)

• High blood sugar levels (hyperglycemia)
• Stroke

Unknown (frequency cannot be estimated from available data)

• Uterine contractions
• Decreased blood flow to the uterus.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side 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: https://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.

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

Store in refrigerator between 2°C and 8°C.

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

Composition of Terlipresina SUN

• The active ingredient is terlipresin acetate. Each ampoule contains 1 mg of terlipresin acetate in 8.5 ml of injectable solution, equivalent to 0.85 mg of terlipresin. 1 ml of injectable solution contains 0.12 mg of terlipresin acetate, equivalent to 0.1 mg of terlipresin.
• The other components are sodium acetate trihydrate, sodium chloride, glacial acetic acid (to adjust the pH), and water for injectable preparations.

Aspect of the product and content of the package

Terlipresina SUN is a transparent and colorless injectable solution without visible particles.

Terlipresina SUN is presented in a box containing 5 ampoules.

Holder of the marketing authorization

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Responsible for manufacturing

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Terapia S.A.

124 Fabricii Street

400632 Cluj Napoca

Romania

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007-Barcelona

Spain

Tel.: + 34 93 342 78 90

This medicine is authorized in the member states of the European Economic Area with the following names:

Denmark: Terlipressinaceat SUN

Germany: Terlipressin SUN 0.1 mg/ml Injektionslösung

Finland: Terlipressiini SUN 0.1 mg/ml injektioneste, liuos

France: Terlipressine SUN 0.12 mg/ml, solution injectable

Italy: Terlipressina SUN 0.1 mg/ml soluzione iniettabile

Netherlands: Terlipressine SUN 0.1 mg/ml, oplossing voor injectie

Norway: Terlipressin SUN 1 mg injeksjonsvæske, oppløsning

Spain: Terlipresina SUN 1 mg solución inyectable EFG

Sweden: Terlipressin SUN 1 mg injektionsvätska, lösning

United Kingdom: Terlipressin acetate 0.12 mg/ml solution for injection.

Date of the last review of this leaflet:October 2017.

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

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This information is intended solely for healthcare professionals:

INFORMATION FOR HEALTHCARE PROFESSIONALS

For more information, please also refer to the Technical Dossier.

Administration of Terlipresina SUN

The administration of terlipresin is intended for emergency care of acute variceal hemorrhage until endoscopic treatment can be performed. Subsequently, the administration of terlipresin for the treatment of esophageal varices is usually an adjuvant therapy to endoscopic hemostasis.

Adults

The recommended initial dose is 1-2 mg of terlipresin acetate#(equivalent to 8.5-17 ml of solution) administered by slow intravenous injection.

The dose may be adjusted according to the patient's body weight as follows:

• body weight less than 50 kg: 1 mg of terlipresin acetate (8.5 ml)
• body weight between 50 kg and 70 kg: 1.5 mg of terlipresin acetate (12.75 ml)
• body weight greater than 70 kg: 2 mg of terlipresin acetate (17 ml).

After the initial injection, the dose may be reduced to 1 mg of terlipresin acetate every 4-6 hours.

The approximate maximum daily dose of Terlipresina SUN is 120 μg of terlipresin acetate per kg of body weight.

The treatment should be limited to 2-3 days according to the course of the disease.

# 1 to 2 mg of terlipresin acetate is equivalent to 0.85 to 1.7 mg of terlipresin.

Older adults

Terlipresina SUN should be used with caution in patients over 70 years old.

Children and adolescents

Terlipresina SUN is not recommended for use in children and adolescents due to insufficient experience on safety and efficacy.

Renal insufficiency

Terlipresina SUN should be used with caution in patients with chronic renal insufficiency.

Liver insufficiency

No dose adjustment is necessary in patients with liver insufficiency.

Incompatibilities

In the absence of compatibility studies, this medicine should not be mixed with other medications.