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Terlipressin Acetate 0.12 mg/ml 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 03194/0101.

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Terlipressin Acetate 0.12 mg/ml solution for injection

PACKAGE LEAFLET: INFORMATION FOR THE USER

Terlipressin Acetate 0.12 mg/ml solution for injection

Read all of this leaflet carefully before you are given this medicine.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If any of the side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.
  • The full name of your medicine is Terlipressin Acetate 0.12 mg/ml solution for injection. In this leaflet from here onwards it is called Terlipressin Acetate.

In this leaflet:

1. What Terlipressin Acetate is and what it is used for
2. Before you are given Terlipressin Acetate
3. How you will be given Terlipressin Acetate
4. Possible side effects
5. How Terlipressin Acetate is stored
6. Contents of the pack and other information

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

Terlipressin Acetate is a ready‑to‑use solution for injection containing the active substance, Terlipressin acetate.

What Terlipressin Acetate is used for

Terlipressin Acetate is used to treat `bleeding oesophageal varices’.

  • ‘Oesophageal varices’ are veins in your food pipe (oesophagus) that are enlarged because they have an increased blood flow. This is caused by liver problems.
  • The increased blood flow can cause them to burst and bleed.

This is a serious and life-threatening problem.

How Terlipressin Acetate works

When the medicine is injected into your bloodstream:

  • The active ingredient (terlipressin acetate) is broken down to release a substance called “lysine vasopressin”.
  • This substance acts on the walls of your blood vessels, causing them to narrow and decrease the blood flow to your affected veins.
  • This helps to stop or slow the bleeding.

2. BEFORE YOU ARE GIVEN TERLIPRESSIN ACETATE
You must not be given Terlipressin Acetate if you:
  • are allergic (hypersensitive) to terlipressin acetate or any of the other ingredients listed in section 6.
  • are pregnant

You must not be given Terlipressin Acetate if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given Terlipressin Acetate.

Warnings and Precautions

Please check with your doctor before Terlipressin Acetate is given to you if you:

  • have high blood pressure (hypertension)
  • have a heart problem such as an irregular heart beat.
  • have heart or lung disease such as where your heart’s arteries have become hardened, narrow or blocked. This means that your heart’s muscle is not getting enough blood supply (coronary insufficiency).
  • if you have diabetes.
  • have a circulation problem (atherosclerosis). This is where fatty plaques have developed on the inner lining of your arteries and are stopping your blood from flowing normally.
  • have septic shock. Septic shock is 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.

Using other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. Terlipressin Acetate can affect the way some other medicines work. Also some other medicines can affect the way Terlipressin Acetate works.

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 YOU WILL BE GIVEN TERLIPRESSIN ACETATE

Terlipressin Acetate is used in hospitals and will be given to you by a doctor or nurse. Terlipressin Acetate will be given to you as an injection into a vein.

  • The usual starting dose is 2 milligrams (mg).
  • Your doctor may then give you 1 to 2 mg every 4 to 6 hours until the bleeding has been controlled.
  • Your treatment could last up to a maximum of 48 hours.

During treatment, your blood pressure, serum sodium and potassium and fluid balance will be monitored closely.

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 treated):

  • 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 vomiting

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

  • Heart failure, rare form of rapid heartbeat (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 TERLIPRESSIN ACETATE IS STORED

Keep out of the sight and reach of children. Do not use Terlipressin Acetate after the expiry date which is stated on the pack. The expiry date refers to the last day of that month. Store in a refrigerator at 2-8ºC.

Keep the ampoules in the outer carton in order to protect from light.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Terlipressin Acetate contains
  • The active substance is terlipressin acetate. Each ampoule contains 1 mg of terlipressin acetate in 8.5 ml solution for injection. This is equivalent to 0.12 mg terlipressin acetate per ml.
  • The other ingredients are sodium chloride, acetic acid, sodium acetate and water for injection.

What Terlipressin Acetate looks like and contents of the pack

Terlipressin Acetate is a clear, colourless solution for injection. It is available in one pack size of 5 ampoules with 8.5 ml of solution in each ampoule.

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

Manufacturer
Ferring-Léciva a.s.
K Rybniku 475
252 42 Jesenice near Prague
Czech Republic

Ferring GmbH
Wittland 11
D-24109 Kiel
Germany

Terlipressin Acetate 0.12 mg/ml Solution for injection – PL 03194/0101

This leaflet was last revised in December 2023.

5009001914

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