Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Terlipressin SUN 1 mg injection solution EFG

terlipressin acetate

Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Terlipresina SUN is a synthetic pituitary hormone.

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

2. What you need to know before Terlipresina SUN is administered to you

Do not administer Terlipresina SUN

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

Warnings and precautions

This medicine will be administered 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 serious infection known as septic shock
• if you suffer from bronchial asthma or other diseases affecting your breathing
• if you have acute coronary syndrome (symptoms related to insufficient blood flow to the heart muscle, which may lead to myocardial infarction and cause chest pain or angina)
• if you have uncontrolled high blood pressure, insufficient blood circulation in the heart vessels (e.g., angina), if you have previously had a heart attack (myocardial infarction), or if you have hardening of the arteries (arteriosclerosis)
• if you have irregular heartbeats (cardiac arrhythmias)
• if you have poor blood circulation to the brain (e.g., history of stroke) or to your limbs (peripheral vascular disease)
• if you have impaired kidney function (renal failure)
• if you have disturbances in blood salt levels (electrolytes)
• if you have reduced blood volume or have already lost a large amount of blood
• if you are over 70 years old
• if you are pregnant.

Children and adolescents

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

Use of Terlipresina SUN with other medicines

Tell your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

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

• medicines affecting heart rate (e.g., beta-blockers or propofol)
• medicines that may cause irregular heartbeats (arrhythmias), such as:
• Class IA antiarrhythmics (quinidine, procainamide, disopyramide) and Class III antiarrhythmics (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 may alter blood salt or electrolyte levels, especially diuretics (used to treat high blood pressure and heart failure).

Pregnancy and breastfeeding

Terlipresina SUN should only be used during pregnancy if essential for your treatment. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medicine.

It is unknown whether Terlipresina SUN is present in breast milk. Therefore, it is unknown whether it may have an effect on the infant. Consult your doctor to understand the potential risk to the breastfed infant.

Driving and use of machines

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

Terlipresina SUN contains sodium

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

3. How to use Terlipressin SUN

This medicine will always be administered to you by your doctor. Consult your doctor for further information about its use.

How much Terlipressin SUN you should be given

Adults

Initially, 1–2 mg of terlipressin acetate (equivalent to 8.5–17 ml of injectable solution) is administered by injection into a vein. Your dose depends on your body weight.

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

The maximum daily dose you may receive is approximately 120 micrograms/kg of body weight.

Elderly patients

If you are over 70 years of age, consult your doctor before being administered Terlipressin SUN.

How Terlipressin SUN is administered

Terlipressin SUN must be administered slowly by intravenous injection.

How often Terlipressin SUN should be administered

Treatment should be limited to 2–3 days, depending on the progression of the disease.

If you are given more Terlipressin SUN than you should

Do not use more Terlipressin 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 medicine called an alpha-blocker (for example, clonidine) to control blood pressure.

If you experience fainting, dizziness, or feeling faint, consult your doctor, as these could be symptoms of a slow heart rate. This can be treated with a medicine called atropine.

If you forget to use Terlipressin SUN

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

If you stop treatment with Terlipressin SUN

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Important adverse effects or symptoms you should pay attention to, and actions to take if you experience them

In very rare cases, there is a possibility of serious adverse effects occurring when terlipressin is administered. If you experience any of the following adverse effects, inform your doctor immediately, if possible. Your doctor must stop administering terlipressin to you.

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

Other possible adverse effects

Frequent (may affect up to 1 in 10 people)

• headache
• slow heart rate
• signs of inadequate blood flow in the heart vessels on electrocardiogram
• high blood pressure
• low blood pressure
• poor blood circulation in arms, legs, and skin, paleness of 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 monitored
• tissue necrosis not related to the injection site
• rapid increase in blood pressure
• fast heart rate (palpitations)
• pulmonary edema
• chest pain
• heart attack
• excess fluid in the lungs
• heart failure (Torsade de Pointes)
• inadequate blood flow to the intestines
• uterine contractions
• reduced blood flow to the uterus
• bluish discoloration of the skin or lips
• hot flushes
• temporary nausea (feeling unwell)
• temporary vomiting
• inflammation of the lymphatic vessels (fine red lines under the skin spreading from the affected area to the armpit or groin, accompanied by fever, chills, headache, and muscle pain)

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

• difficulty breathing

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

• high blood sugar levels (hyperglycemia)
• stroke

Not known (frequency cannot be estimated from available data)

• uterine contractions
• decreased blood flow to the uterus

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Terlipressin SUN

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

Do not use this medicine after the expiry date stated on the packaging and on the ampoule after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Terlipresin SUN

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

Appearance of the product and contents of the pack

Terlipresin SUN is a clear, colourless injectable solution free from visible particles.

Terlipresin SUN is supplied in a carton containing 5 vials.

Marketing Authorisation Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The Netherlands

Manufacturer

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

The 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 medicinal product 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

The 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 most recent review of this summary: October 2017.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

INFORMATION FOR HEALTHCARE PROFESSIONALS

For further information, please also refer to the Summary of Product Characteristics.

Administration of Terlipresin SUN

Terlipressin administration is indicated for emergency management of acute oesophageal variceal bleeding until endoscopic treatment can be performed. Subsequently, terlipressin administration for the treatment of oesophageal varices is usually used as an adjuvant therapy to endoscopic haemostasis.

Adults

The recommended initial dose is 1–2 mg of terlipressin 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 below 50 kg: 1 mg of terlipressin acetate (8.5 ml)
• weight between 50 kg and 70 kg: 1.5 mg of terlipressin acetate (12.75 ml)
• weight above 70 kg: 2 mg of terlipressin acetate (17 ml).

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

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

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

1 to 2 mg of terlipressin acetate is equivalent to 0.85 to 1.7 mg of terlipressin.

Elderly patients

Terlipresin SUN should be used with caution in patients over 70 years of age.

Children and adolescents

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

Renal impairment

Terlipresin SUN should be used with caution in patients with chronic renal impairment.

Hepatic impairment

Dose adjustment is not necessary in patients with hepatic impairment.

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.