TERLIPRESINA SUN 1 mg INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Terlipresina SUN 1 mg solution for injection EFG

terlipresina acetate

Read all of this leaflet carefully before this medicine is administered to you 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 nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Terlipresina SUN and what is it used for

Terlipresina SUN is a synthetic pituitary hormone.

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

2. What you need to know before you are given Terlipresina SUN

You should not be given Terlipresina SUN

• if you are allergic to terlipresina or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

This medicine will be given to you if you have a severe or life-threatening bleeding in the esophagus. It must be used with continuous monitoring of your heart and blood circulation.

If possible, inform your doctor if you have any of the following conditions:

• if you have a severe infection known as septic shock
• if you have bronchial asthma or other respiratory diseases
• if you have acute coronary syndrome (whose symptoms are related to insufficient blood flow to the heart muscle that can lead to a heart attack and cause chest pain or angina pectoris)
• if you have uncontrolled high blood pressure, insufficient blood circulation in the heart vessels (e.g. angina), if you have had a heart attack (myocardial infarction) before or if you suffer from hardening of the arteries (arteriosclerosis)
• if you have irregular heartbeats (cardiac arrhythmias)
• if you have poor blood circulation to the brain (e.g. you have had a stroke) or to your limbs (peripheral vascular disease)
• if you have impaired kidney function (renal insufficiency)
• if you have alterations in the level of salt (electrolytes) in the blood
• if you have a decrease in the amount of fluid in 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.

Using Terlipresina SUN with other medicines

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

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

• medicines that affect heart rate (e.g. beta-blockers or propofol)
• medicines that can cause irregular heartbeats (arrhythmias) such as:
• Class IA antiarrhythmics (quinidine, procainamide, disopyramide) and Class III (amiodarone, sotalol, ibutilide, dofetilide)
• an antibiotic called erythromycin
• antihistamines (mainly used to treat allergies, but also present in some cough and cold remedies)
• medicines used to treat depression called tricyclic antidepressants
• medicines 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 essential for your treatment. If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor before this medicine is administered to you.

It is not known if Terlipresina SUN is present in breast milk. Therefore, it is not known if it can have an effect on the baby. Consult your doctor to know the potential risk for the breastfed baby.

Driving and using machines

No studies have been performed on the effects on the ability to drive and use machines. However, if you do not feel well after the injection, do not drive or use machines.

Terlipresina SUN contains sodium

Patients on low-sodium diets should note that this medicine contains 361 mg (15.7 mmol) of sodium per maximum single dose.

3. How to use Terlipresina SUN

This medicine will always be administered to you by your doctor. Ask your doctor for more information on its use.

How much Terlipresina SUN will you be given

Adults

Initially, 1-2 mg of terlipresina acetate (equivalent to 8.5-17 ml of solution) is administered by slow intravenous injection.

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 per day is approximately 120 micrograms/kg of body weight.

Elderly

If you are over 70 years old, consult 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 will you be given Terlipresina SUN

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

If you are given too much Terlipresina SUN

You should not use more Terlipresina SUN than the recommended dose. If you receive too much, you may experience a rapid increase in blood pressure, especially if you already have high blood pressure. If this happens, you need another medicine called an alpha-blocker (e.g. clonidine) to control blood pressure.

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

If you miss a dose of Terlipresina SUN

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

If you stop treatment with Terlipresina SUN

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important side effects or symptoms to which you should pay attention and measures to be taken if you experience them

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

Severe breathing difficulties due to an asthma attack, severe breathing difficulties or cessation of breathing, acute chest pain (angina), severe and persistent irregular heartbeats, local skin death (necrosis), convulsions, kidney failure.

Other possible side effects

Frequent (may affect up to 1 in 10 people)

• headache
• heart rate too slow
• signs of insufficient blood circulation in the heart 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

Uncommon (may affect up to 1 in 100 people)

• low sodium levels in the blood (hyponatremia) if fluid balance is not controlled
• skin death (necrosis) not related to the injection site

• rapid increase in blood pressure
• heart rate too fast (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
• bluish discoloration of the skin or lips
• hot flashes
• temporary nausea (discomfort)
• temporary vomiting
• inflammation of the lymph vessels (fine red lines under the skin that extend from the affected area to the armpit or groin and fever, chills, headache and muscle pain)

Rare (may affect up to 1 in 1,000 people)

• breathing difficulties

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

• high blood sugar levels (hyperglycemia)
• stroke

Not known (frequency cannot be estimated from the available data)

• uterine contractions
• decreased blood flow to the uterus.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Terlipresina SUN

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

Do not use this medicine after the expiry date which is stated on the carton and on the ampoule after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (2°C - 8°C).

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 Terlipresina SUN

• The active substance is terlipresina acetate. Each ampoule contains 1 mg of terlipresina acetate in 8.5 ml of solution for injection, equivalent to 0.85 mg of terlipresina. 1 ml of solution for injection contains 0.12 mg of terlipresina acetate, equivalent to 0.1 mg of terlipresina.
• The other ingredients are sodium acetate trihydrate, sodium chloride, glacial acetic acid (for pH adjustment) and water for injections.

Appearance and pack contents

Terlipresina SUN is a clear and colorless solution for injection without visible particles.

Terlipresina SUN is available in a box containing 5 ampoules.

Marketing authorisation holder

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Manufacturer

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 authorised in the Member States of the European Economic Area under 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 solution inyectable EFG

Sweden: Terlipressin SUN 1 mg injektionsvätska, lösning

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

Date of last revision of this leaflet:October 2017.

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

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This information is intended only for healthcare professionals:

INFORMATION FOR HEALTHCARE PROFESSIONALS

For more information, see also the Summary of Product Characteristics.

Administration of Terlipresina SUN

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

Adults

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

According to the patient's body weight, the dose may be adjusted as follows:

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

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

The approximate value for the maximum daily dose of Terlipresina SUN is 120 μg of terlipresina acetate per kg of body weight.

Treatment should be limited to 2-3 days depending on the course of the disease.

From 1 to 2 mg of terlipresina acetate is equivalent to 0.85 to 1.7 mg of terlipresina.

Elderly

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.

Hepatic insufficiency

No dose adjustment is necessary in patients with hepatic insufficiency.

Incompatibilities

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