Terlipressin Sun

PACKAGE LEAFLET

Package leaflet: information for the user

Terlipressin SUN 0.1 mg/ml injection solution

Equivalent medicine
Please read this leaflet carefully before taking 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 experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet

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

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

Terlipressina SUN is a synthetic pituitary hormone.
Terlipressina SUN is used to treat bleeding caused by dilated veins in the esophagus, the tube that carries food to the stomach (bleeding esophageal varices).

2. What you must know before being given Terlipressina SUN

Terlipressina SUN must not be administered

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

Warnings and precautions
You will be given this medicine in case of severe or life-threatening bleeding from the oesophagus. It is used under continuous monitoring of the heart and blood circulation. If you are able to, please inform your doctor if you suffer from any of the following conditions:

• if you have a severe infection known as septic shock
• if you suffer from bronchial asthma or other conditions affecting your breathing
• if you suffer from acute coronary syndrome (symptoms related to inadequate blood supply to the heart muscle, leading to heart attack; this may cause chest pain or angina pectoris)
• if you have high and uncontrolled blood pressure, inadequate 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 suffer from irregular heartbeat (cardiac arrhythmias)
• if you have poor blood circulation in the brain (e.g., you have had a stroke) or in the limbs (peripheral vascular disease)
• if you have impaired kidney function (renal failure)
• if you suffer from disturbances in blood salt (electrolyte) levels
• if you have reduced fluid supply to the circulation or have previously lost large amounts of blood
• if you are over 70 years of age
• if you are pregnant.

Attention for athletes: The active substance contained in this preparation is included in the list of prohibited substances for doping.
Children and adolescents
The use of Terlipressina SUN is not recommended in children and adolescents due to insufficient experience in this patient group.
Other medicines and Terlipressina SUN
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Inform your doctor immediately if you are taking the following medicines:

• medicines affecting heart rate (e.g., beta-blockers or propofol)
• medicines that may cause irregular heartbeat (arrhythmia), such as:
• class IA (quinidine, procainamide, disopyramide) and class III (amiodarone, sotalol, ibutilide, dofetilide) antiarrhythmics
• an antibiotic called erythromycin
• antihistamines (mainly used for treating allergies, but also contained in some cough and cold remedies)
• medicines used to treat depression, known as tricyclic antidepressants
• medicines that may alter salt or electrolyte levels in the blood, especially diuretics (used to treat high blood pressure and heart failure).

Pregnancy and breastfeeding
Terlipressina SUN should only be used during pregnancy if it is vital to treat your condition. If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before this medicine is administered.
It is not known whether Terlipressina SUN is present in breast milk. Therefore, possible effects on the infant are unknown. You should discuss the potential risk to your baby with your doctor.
Driving and using machines
No studies have been conducted on the ability to drive or operate machinery. However, if you do not feel well after the injection, do not drive or operate machinery.
Terlipressina SUN contains sodium
This medicine contains 15.7 mmol (i.e., 361 mg) of sodium per dose. This should be taken into consideration in patients on a controlled sodium intake diet.

3. How to use Terlipressin SUN

This medicine will always be administered to you by a doctor. If you would like further
information on the use of this medicine, please consult your doctor.
Dose of Terlipressin SUN
Adults
The initial dose is 1–2 mg of terlipressin acetate (equivalent to 8.5–17 ml of injectable solution),
administered by intravenous injection. The 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 is approximately 120 micrograms/kg of body weight.
Elderly
If you are over 70 years old, consult your doctor before receiving Terlipressin SUN.
Method of administration of Terlipressin SUN
Terlipressin SUN must be administered by slow intravenous injection.
Frequency of administration of Terlipressin SUN
Use is limited to 2–3 days, depending on the progression of your condition.
If you are given more Terlipressin SUN than you should
You must not receive a dose of Terlipressin SUN higher than that recommended. If you receive an
excessive dose, you may experience a rapid increase in blood pressure, especially if you already suffer
from this condition. In such a case, you will need to be given another medicine called an alpha-blocker
(e.g., clonidine) to control your blood pressure.
If you experience mental confusion, dizziness, or fainting, consult your doctor: these may be signs of
bradycardia (slow heart rate). This condition can be treated with a medicine called atropine.
If you forget to take Terlipressin SUN
You will receive Terlipressin SUN in a hospital setting under the supervision of your doctor.
If you stop treatment with Terlipressin SUN
If you have any doubts about the use of this medicine, consult 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 signs you should pay attention to, and actions to take
Very rarely, serious side effects may occur after administration of terlipressin.
If you experience any of the following side effects, contact your doctor immediately if you are able to do so. Your doctor will stop the administration of terlipressin.
Severe shortness of breath due to an asthma attack, severe breathing difficulty or cessation of breathing, severe chest pain (angina), severe and persistent irregular heartbeat, local death of skin cells (necrosis), seizures, kidney failure.

Other possible side effects
Common (may affect up to 1 in 10 people)

• headache
• heart rate too low
• signs of inadequate blood circulation in the heart vessels shown by electrocardiogram
• high blood pressure
• low blood pressure
• inadequate blood circulation in the arms, legs, and skin, pale skin
• abdominal cramps
• diarrhoea

Uncommon (may affect up to 1 in 100 people)

• too low levels of sodium in the blood (hyponatraemia) without monitoring
• death of skin cells (necrosis) not related to the injection site
• rapid increase in blood pressure
• heart rate too fast (palpitations)
• swelling of tissues or presence of fluid in the lungs
• chest pain
• heart attack
• excess fluid in the lungs
• heart failure (torsades de pointes)
• inadequate blood supply to the intestine
• 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 (thin red streaks under the skin extending 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)

• shortness of breath

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

• too high levels of sugar in the blood (hyperglycaemia)
• stroke

Not known (cannot be estimated from the available data)

• uterine contractions
• reduction in blood supply to the uterus

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 carton and vial after
Exp. The expiry date refers to the last day of that month.
Store in a refrigerator at 2-8°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Terlipressina SUN contains

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

Description of the appearance of Terlipressina SUN and package contents
Terlipressina SUN is a clear, colourless injectable solution free from visible particles.
Terlipressina SUN is packaged in a carton containing 5 vials.

Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Legal representative in Italy:
Ranbaxy Italia S.p.A. - Viale Giulio Richard, 1 - 20143 Milano

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

S.C. Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Denmark: Terlipressinacetat 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

The following information is intended exclusively for physicians or healthcare professionals:
INFORMATION FOR HEALTHCARE PROFESSIONALS
For further information, see the Summary of Product Characteristics.
Administration of Terlipressina SUN
Terlipressin is administered for emergency treatment of acute bleeding oesophageal varices, pending endoscopic therapy. Subsequently, terlipressin is administered for the treatment of oesophageal varices, typically as adjunctive 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 intravenous injection over a period of time.
Depending on the patient's body weight, the dose may be adjusted as follows:

• Body weight below 50 kg: 1 mg of terlipressin acetate (8.5 ml)
• Body weight between 50 kg and 70 kg: 1.5 mg of terlipressin acetate (12.75 ml)
• Body 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 maximum daily dose of Terlipressina SUN is approximately 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.

Elderly
Terlipressin should be used with caution in patients over 70 years of age.

Children and adolescents
The use of Terlipressina is not recommended in children and adolescents due to insufficient experience regarding safety and efficacy in this patient group.

Renal impairment
Terlipressin should be used with caution in patients with chronic renal impairment.

Hepatic impairment
No dose adjustment is required in patients with hepatic impairment.

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