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Terlipressin Acetate 1 mg Powder and solvent for solution for injection

Active Ingredient:
terlipressin acetate
Company:  
Ferring Pharmaceuticals Ltd See contact details
ATC code: 
H01BA04
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 15 Jul 2025
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 03194/0018.

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Terlipressin Acetate 1mg, powder and solvent for solution for injection

PACKAGE LEAFLET: INFORMATION FOR THE USER

Terlipressin Acetate 1mg

Powder and solvent for solution for injection

Read all of this leaflet carefully before you start using this medicine.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
  • The full name of your medicine is Terlipressin Acetate 1mg powder and solvent for solution for injection. In this leaflet from here onwards it is called Terlipressin Acetate.

In this leaflet:

1. What Terlipressin Acetate Injection is and what it is used for
2. Before you use Terlipressin Acetate Injection
3. How Terlipressin Acetate Injection is administered
4. Possible side effects
5. How to store Terlipressin Acetate Injection
6. Contents of the pack and other information

1. WHAT TERLIPRESSIN ACETATE INJECTION IS AND WHAT IT IS USED FOR

Terlipressin Acetate Injection consists of a powder and solvent for solution for injection. The white, freeze-dried powder contains terlipressin acetate.

Terlipressin Acetate Injection is used in the treatment of bleeding oesophageal varices. Bleeding oesophageal varices are enlarged blood vessels that form in the stomach or oesophagus as a complication of liver disease. They may burst and bleed and this is a serious and life-threatening condition.

When injected into the bloodstream, the active ingredient, terlipressin acetate is broken down to release a substance called lysine vasopressin. This acts on the walls of the blood vessels, causing them to narrow and restrict the blood flow to the affected veins so that bleeding is reduced.

2. BEFORE YOU USE TERLIPRESSIN ACETATE INJECTION
Terlipressin Acetate Injection should not be used:
  • if you are pregnant
  • if you are allergic to terlipressin acetate or any of the other ingredients of Terlipressin Acetate listed in section 6.

Please consult your doctor before Terlipressin Acetate Injection is administered to you:
  • if you have hypertension (high blood pressure)
  • if you have a heart condition (such as an irregular heart beat)
  • if you have heart or lung disease e.g. coronary insufficiency (a condition in which the arteries of the heart become hardened, narrow or blocked leading to an insufficient blood supply to the heart muscle)
  • if you have diabetes
  • if you have atherosclerosis (a disease of the arteries in which fatty plaques develop on the inner linning of the arteries, preventing blood from flowing normally)
  • if you have a septic shock, a serious condition that occurs when a major infection leads to low blood pressure and low blood flow.

If any of the above apply to you (or you are not sure) talk to your doctor or nurse before you are given Terlipressin Acetate.

Taking with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Please inform your doctor immediately if you take any of the following medicines:

Drugs that can trigger irregular beating of the heart (arrhythmia) such as the following:

  • anti-arrhythmic drugs known as Class IA (quinidine, procainamide, disopyramide) and Class III (amiodarone, sotalol, ibutilide, dofetilide)
  • erythromycin (an antibiotic)
  • antihistamines (mainly used to treat allergies but also found in certain cough and cold remedies)
  • tricyclic antidepressants used to treat depression
  • medicines that may alter the level of salt or electrolytes in your blood, particularly diuretics (water tablets used to treat high blood pressure and heart failure).

Pregnancy and breast-feeding

You must not be given Terlipressin Acetate if you are pregnant or breast-feeding. It is not known if Terlipressin Acetate passes into the mother’s milk.

Ask your doctor, nurse or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

3. HOW TERLIPRESSIN ACETATE INJECTION IS ADMINISTERED

The doctor will administer the appropriate dose by injection into a vein.

The usual dose of Terlipressin Acetate Injection in acute bleeding from oesophageal varices is 2mg followed by 1 or 2 mg every 4 to 6 hours until bleeding is controlled, up to a maximum of 48 hours. During treatment, your blood pressure, serum sodium and potassium and fluid balance will normally be monitored constantly.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Terlipressin Acetate can cause side effects, although not everybody gets them

Very commonly reported side effects (may affect more than 1 in 10 people):

  • Stomach pain

Commonly reported side effects (affect less than 1 in 10 people):

  • Muscle weakness and twitching (symptoms of hyponatraemia)
  • Headache
  • Chest pain
  • Raised blood pressure, very slow heart rate
  • Skin becoming white which usually goes away after a short time (transient blanching)
  • Cyanosis (bluish discolouration of the skin caused by lack of oxygen)
  • Fluid in the lungs
  • Shortness of breath
  • Cramps, diarrhoea, nausea or vomitting

Uncommon (may affect up to 1 in 100 people):

  • Heart failure, rare form of rapid heart beat (Torsade de pointes).
  • Skin damage
  • Irregular or rapid heartbeat, palpitations, chest pain, heart attack
  • Fluid in the lungs, severe breathing problems
  • Hot flush
  • Skin damage at the injection site
  • Frequent forceful bowel movements, blood in stools (symptoms of intestinal ischaemia)

Not known: frequency cannot be estimated from the available data

  • Uterine constriction (constriction of the womb)
  • Decreased uterine blood flow

Reporting of side effects

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE TERLIPRESSIN ACETATE INJECTION

Keep Terlipressin Acetate Injection out of the sight and reach of children.

Do not store above 25°C. Keep container in the outer carton.

Do not use after the expiry date marked on the packaging.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Your medicine is called Terlipressin Acetate 1mg powder and solvent for solution for injection.. Each carton contains:

  • one vial of freeze-dried powder containing 1mg of the active ingredient, terlipressin acetate, and mannitol. Hydrochloric acid is added to adjust the acidity.
  • one ampoule of liquid (solvent) containing a 5ml solution of sodium chloride in water for injection to dissolve the powder before injection. Hydrochloric acid is added to adjust the acidity to make it suitable for injection.

Marketing Authorisation Holder:
Ferring Pharmaceuticals Ltd.
Drayton Hall
Church Road
West Drayton
UB7 7PS
UK

Manufacturer
Ferring GmbH.
Wittland 11
D-24109 Kiel
Germany

Terlipressin Acetate 1mg powder and solvent for solution for injection - PL 03194/0018

This leaflet was last revised in Dec 2023.

5009001915

Ferring Pharmaceuticals Ltd
Company image
Address
Drayton Hall, Church Road, West Drayton, UB7 7PS, UK
Telephone
+44 (0)844 931 0050
Fax
+44 (0)844 931 0051
Medical Information e-mail
[email protected]
WWW
http://www.ferring.co.uk
Customer Care direct line
0800 111 4125