Glipressin

Package Leaflet: Information for the User

Glypressin, 1 mg, Solution for Injection

Terlipressin Acetate

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.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Table of Contents of the Leaflet:

• 1. What is Glypressin and what is it used for
• 2. Important information before using Glypressin
• 3. How to use Glypressin
• 4. Possible side effects
• 5. How to store Glypressin
• 6. Contents of the pack and other information

1. What is Glypressin and what is it used for

Glypressin solution for injection contains the active substance terlipressin acetate.

Glypressin is used to treat bleeding from oesophageal varices.

Oesophageal varices are enlarged blood vessels that develop in the oesophagus as a complication of liver disease. They can rupture and bleed, which is a life-threatening condition.
After injection into the bloodstream, the active substance terlipressin is broken down, releasing a substance called lysine-vasopressin. It acts on the walls of blood vessels, causing them to constrict and reduce blood flow to the varices, thereby reducing bleeding.

2. Important information before using Glypressin

When not to use Glypressin

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

Warnings and precautions

Caution should be exercised:

• if you have high blood pressure,
• if you have heart or lung disease,
• if you have diabetes,
• in children and the elderly, as experience in these age groups is limited,
• if you have septic shock; septic shock is a serious condition that occurs when a severe infection leads to low blood pressure and poor blood flow.

If you experience any of these conditions, discuss them with your doctor before starting treatment with Glypressin.

During treatment with Glypressin, your heart rate, blood pressure, and fluid balance should be constantly monitored.

Glypressin contains sodium

This medicine contains 30.7 mg of sodium (the main component of common salt) per ampoule. This corresponds to 1.5% of the maximum recommended daily intake of sodium in the diet for adults. If you are on a controlled sodium diet, tell your doctor.

Glypressin and other medicines

Tell your doctor about all medicines you are taking or have recently taken,

and about medicines you plan to take.
It is especially important to tell your doctor if you are taking any heart medicines, such as beta-adrenergic blockers, as their effect may be enhanced if used with Glypressin.
Tell your doctor immediately if you are taking any of the following medicines:

Medicines that may cause irregular heartbeat (arrhythmia) include:

• anti-arrhythmic medicines of class IA (quinidine, procainamide, disopyramide) and class III (amiodarone, sotalol, ibutilide, dofetilide)
• erythromycin (an antibiotic)
• antihistamines (used mainly to treat allergies, but may also be present in some cough and cold medicines)
• tricyclic antidepressants used to treat depression
• medicines that may alter the level of salts or electrolytes in the blood, especially diuretics (used to treat high blood pressure and heart failure).

Pregnancy and breastfeeding

Glypressin should not be used during pregnancy.
Glypressin should not be used during breastfeeding, as it is not known whether this medicine passes into breast milk.

Driving and using machines

This is not relevant, as Glypressin is a hospital-only medicine.

3. How to use Glypressin

Glypressin is a hospital-only medicine and should only be administered by qualified personnel.
Glypressin is injected into a vein (directly into the bloodstream).
The usual initial dose of Glypressin for acute bleeding from oesophageal varices is 2 mg. Subsequent doses, usually ranging from 1 mg to 2 mg, are given every 4 hours for a period of 24 hours, until bleeding is controlled. Treatment should not exceed 48 hours.
After the initial dose, subsequent doses may be adjusted based on the patient's body weight or if any side effects occur.

4. Possible side effects

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

Very common side effects (may affect more than 1 in 10 patients)

• abdominal pain.

Common: affects 1 to 10 users in 100

• low sodium levels in the blood
• headache
• chest pain
• bradycardia (very slow heart rate)
• rapid pulse
• vasoconstriction
• cyanosis (bluish discoloration of the skin due to lack of oxygen)
• fluid in the lungs
• shortness of breath
• reduced blood flow to the limbs
• pallor
• increased blood pressure
• diarrhoea
• nausea
• vomiting.

Uncommon: affects 1 to 10 users in 1,000

• irregular heartbeat
• heart attack (myocardial infarction)
• severe heart rhythm disorders of the type Torsade de pointes
• heart failure. Symptoms include: shortness of breath, feeling of tiredness, swelling of the ankles
• reduced blood flow to the intestines
• heat stroke
• acute respiratory failure and respiratory distress (difficulty breathing)
• skin necrosis (dead skin)
• necrosis (dead skin) at the injection site.
• Unknown: frequency cannot be estimated from the available data
• uterine contractions
• reduced blood flow to the uterus.

Reporting side effects

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

5. How to store Glypressin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the words "EXP:". The expiry date refers to the last day of the month stated.
Store in a refrigerator (2°C - 8°C). Store the ampoules in the outer packaging to protect from light.
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 Glypressin contains

• One ampoule with 8.5 ml of solution contains 1 mg of terlipressin acetate, which corresponds to 0.85 mg of terlipressin. 1 ml of solution contains 0.12 mg of the active substance - terlipressin acetate, which corresponds to 0.1 mg of terlipressin
• The other ingredients are: sodium chloride, acetic acid, sodium acetate trihydrate, water for injections

What Glypressin looks like and contents of the pack

This medicine is a clear, colourless solution for injection.
Pack sizes available:
5 ampoules of 8.5 ml solution each.

Marketing authorisation holder and manufacturer:

Marketing authorisation holder:

Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

Manufacturer:

Ferring-Léčiva a.s.
K Rybníku 475
252 42 Jesenice u Prahy
Czech Republic
Ferring GmbH
Wittland 11
D-24109 Kiel
Germany
For more detailed information on this medicine, contact the representative of the marketing authorisation holder.
Ferring Pharmaceuticals Poland Sp. z o.o.
Szamocka 8
01-748 Warsaw
Phone: +48 22 246 06 80
Date of last revision of the leaflet:May 2024