Terlipressin Sun

Package Leaflet: Information for the User

Terlipressin SUN, 0.1 mg/mL, Solution for Injection

Terlipressinum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• 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, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Terlipressin SUN and what is it used for
• 2. Important information before using 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 is Terlipressin SUN and what is it used for

Terlipressin SUN is a synthetic pituitary hormone.
Terlipressin SUN is used to treat bleeding from enlarged veins in the part of the digestive tract leading to the stomach (bleeding from esophageal varices).

2. Important information before using Terlipressin SUN

When not to use Terlipressin SUN

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

Warnings and precautions

This medicine will be prescribed to you if you have severe or life-threatening bleeding in the digestive tract (esophagus). The medicine should be used under constant heart and blood circulation monitoring of the patient.
If you are able, you should inform your doctor if you have any of the following conditions:
­
severe infection called septic shock;
­
asthma or other diseases that affect breathing;
­
acute coronary syndrome (ACS), which are symptoms related to poor blood flow to the heart muscle leading to a heart attack, causing chest pain or angina pectoris);
­
uncontrolled high blood pressure, insufficient blood circulation in the heart vessels (e.g., angina pectoris), previous heart attack (myocardial infarction), narrowing of blood vessels (atherosclerosis);
­
irregular heart rhythm (arrhythmia);
­
poor blood circulation in the brain (e.g., stroke) or in the limbs (peripheral vascular disease);
­
kidney function disorders (renal failure);
­
electrolyte imbalance in the blood;
­
decreased fluid volume in the circulation or significant blood loss;
­
age over 70 years;
­
pregnancy.

Children and adolescents

Terlipressin SUN is not recommended for use in children and adolescents due to lack of experience in this age group.

Terlipressin SUN and other medicines

Tell your doctor or nurse about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Tell your doctor immediately if you are taking any of the following medicines:

• medicines that affect heart rhythm (e.g., beta blockers or propofol);
• medicines that may cause irregular heart rhythm (arrhythmia), such as: ­ antiarrhythmic drugs of class IA (quinidine, procainamide, disopyramide) and class III (amiodarone, sotalol, ibutilide, dofetilide); ­ the antibiotic erythromycin; ­ antihistamines (used mainly to treat allergies, but also as ingredients in some cough and cold medicines); ­ tricyclic antidepressants used to treat depression; ­ medicines that may cause electrolyte imbalance in the blood, mainly diuretics (water pills used to treat high blood pressure and heart failure).

Pregnancy and breastfeeding

Terlipressin SUN can only be used if your doctor considers it necessary.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before using this medicine.
It is not known whether Terlipressin SUN passes into breast milk, so the possible effect on the baby is not known. You should discuss the possible risk to the baby with your doctor.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines. However, if you feel unwell after injection, you should not drive or operate machinery.

Terlipressin SUN contains sodium

The medicine contains 15.7 mmol (or 361 mg) of sodium per dose. This should be taken into account for patients on a controlled sodium diet.

3. How to use Terlipressin SUN

This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor.

Dosage of Terlipressin SUN

Adults

Initially 1 to 2 mg of terlipressin (corresponding to 8.5 to 17 mL of solution for injection), administered as a slow intravenous injection. The dose depends on the patient's body weight.
After the initial injection, the dose may be reduced to 1 mg of terlipressin (corresponding to 8.5 mL of solution) every 4 to 6 hours.
The maximum daily dose is 120 micrograms per kilogram of body weight.

Use in elderly patients

If you are over 70 years old, you should talk to your doctor before using Terlipressin SUN.

Method of administration

Terlipressin SUN should be administered as a slow intravenous injection.

Duration of treatment

The use of this medicine is limited to 2-3 days, depending on the course of the disease.

Use of a higher than recommended dose of Terlipressin SUN

Do not exceed the recommended dose. If too high a dose is used, a sudden increase in blood pressure may occur, especially in patients with pre-existing hypertension. In such cases, the patient will receive another medicine, called an alpha-blocker (e.g., clonidine), to regulate blood pressure.
Tell your doctor if you experience dizziness, dizziness, or fainting, as these may be symptoms of slow heart rate. This can be treated with the administration of another medicine, called atropine.

Missing a dose of Terlipressin SUN

Terlipressin SUN will be administered in the hospital under close medical supervision.

Stopping the use of Terlipressin SUN

If you have any further questions about 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 to look out for and actions to be taken

During the use of the medicine, very rare but serious side effects may occur. You should immediately contact your doctor if you experience any of the following symptoms. Your doctor will advise you to stop using terlipressin.
Severe shortness of breath due to an asthma attack, severe breathing difficulties, or respiratory arrest, severe chest pain (angina pectoris), severe and persistent arrhythmia, skin necrosis at the injection site, seizures (epileptic seizures), kidney failure.

Other possible side effects

Common (occurring in less than 1 in 10 people):

• headache
• very slow heart rate
• symptoms of insufficient blood circulation in the heart vessels, visible on ECG
• high blood pressure
• low blood pressure
• insufficient blood circulation in the hands, feet, and skin, pale skin
• abdominal cramps
• diarrhea

Uncommon side effects (may occur less frequently than 1 in 100 people):

• low sodium levels in the blood (hyponatremia), if not monitored
• skin necrosis in areas other than the injection site
• sudden increase in blood pressure
• rapid heart rate (palpitations)
• swelling of tissues or fluid in the lungs
• chest pain
• heart attack
• excessive fluid accumulation in the lungs
• arrhythmia of the torsade de pointes type
• insufficient blood supply to the intestines
• uterine contractions
• decreased blood flow to the uterus
• blue discoloration of the skin or lips
• hot flashes
• transient nausea
• transient vomiting
• inflammation of the lymphatic vessels (visible as small red streaks under the skin running from the affected area to the armpit or groin, and fever, chills, headache, and muscle pain)

Rare side effects (may occur less frequently than 1 in 1000 people):

• shortness of breath

Very rare (may occur less frequently than 1 in 10,000 people):

• high blood sugar levels (hyperglycemia)
• stroke

Frequency not known: cannot be estimated from the available data

• uterine contractions
• decreased blood flow to the uterus

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: + 48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Terlipressin SUN

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and ampoule after the abbreviation "EXP:". The expiry date refers to the last day of the month.
Store in a refrigerator at a temperature of 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

What Terlipressin SUN contains

• The active substance of the medicine is terlipressin (in the form of terlipressin acetate). Each ampoule contains 0.85 mg of terlipressin in the form of 1 mg of terlipressin acetate, in 8.5 mL of solution for injection. Each mL contains 0.1 mg of terlipressin in the form of 0.12 mg of terlipressin acetate.
• The other ingredients are: sodium acetate trihydrate, sodium chloride, glacial acetic acid (to adjust pH), and water for injection.

What Terlipressin SUN looks like and contents of the pack

Terlipressin SUN is a clear, colorless solution for injection, without visible particles.
The pack of Terlipressin SUN contains 5 ampoules.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

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

Manufacturer/Importer:

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
S.C Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Romania

To obtain more detailed information and information on the names of the medicine in other European Economic Area member states, contact the marketing authorization holder.

Date of last revision of the leaflet:

The following information is intended for healthcare professionals only:

INFORMATION FOR HEALTHCARE PROFESSIONALS

More information can be found in the Summary of Product Characteristics.

Administration of Terlipressin SUN

Terlipressin is administered in emergency cases of acute bleeding from esophageal varices, until endoscopic therapy is available. Further use of terlipressin in the treatment of esophageal varices is usually complementary to endoscopic hemostasis.
Adults
The recommended initial dose is 1 to 2 mg of terlipressin (corresponding to 8.5 to 17 mL of solution), administered as a slow intravenous injection.
Depending on the patient's body weight, the dose can be adjusted as follows:

• body weight below 50 kg: 1 mg of terlipressin (8.5 mL)
• body weight from 50 kg to 70 kg: 1.5 mg of terlipressin (12.75 mL)
• body weight above 70 kg: 2 mg of terlipressin (17 mL)

After the initial injection, the dose of terlipressin can be reduced to 1 mg every 4 to 6 hours.
The approximate value of the maximum daily dose of Terlipressin SUN is 120 micrograms of terlipressin per kilogram of body weight.
Treatment should be limited to 2-3 days, depending on the course of the disease.
1 to 2 mg of terlipressin corresponds to 0.85 mg to 1.7 mg of terlipressin.
Elderly patients
Terlipressin should be used with caution in patients over 70 years old.
Children and adolescents
Terlipressin is not recommended for use in children and adolescents due to lack of sufficient data on safety and efficacy.
Renal impairment
Terlipressin should be used with caution in patients with chronic renal failure.
Hepatic impairment
No dose adjustment is required in patients with hepatic impairment.
Incompatibilities

Do not mix the medicinal product with other medicinal products, as compatibility studies have not been performed.