Terlipressin Acetate 0.2 mg/ml, solution for injection – patient leaflet, side effects, dosage

1. WHAT TERLIPRESSIN IS AND WHAT IT IS USED FOR

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

What Terlipressin is used for

Terlipressin 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 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

You must not be given Terlipressin if you:

• are allergic (hypersensitive) to terlipressin acetate or any of the other ingredients of Terlipressin, (listed in Section 6).
• are pregnant.

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

Warnings and precautions

Please check with your doctor before Terlipressin 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).

• 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.

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 can affect the way some other medicines work. Also some other medicines can affect the way Terlipressin 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 if you are pregnant or breast-feeding. It is not known if Terlipressin 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.

Terlipressin contains sodium

This medicine contains 18 mg of sodium (main component of cooking table salt) in each 5 ml vial/ ampoule, 31 mg of sodium in each 8.5 ml vial/ ampoule and 36 mg of sodium in each 10 ml vial/ ampoule. These are equivalent to 0.9%, 1.6% and 1.8% respectively of the recommended maximum daily dietary intake of sodium for an adult.

3. HOW YOU WILL BE GIVEN TERLIPRESSIN

Terlipressin is used in hospitals and will be given to you by a doctor or nurse.

Terlipressin 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.

Package leaflet: Information for the user Terlipressin Acetate 0.12 mg/ml solution for injection Terlipressin Acetate 0.2 mg/ml solution for injection terlipressin acetate

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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 (affects less than 1 in 10 people):

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

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pack.

Do not store above 25ºC. Store in the original packaging to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Terlipressin contains

• The active substance is Terlipressin acetate.
• The other ingredients are sodium acetate trihydrate, acetic acid, glacial, sodium chloride and water for injection

What Terlipressin looks like and contents of the pack

Terlipressin is a clear colourless solution.

Terlipressin Acetate 0.12 mg/ml, solution for injection

It is available in glass ampoules of 8.5 ml in pack sizes of 1 or 5 ampoules.

It is available in glass vials of 8.5 ml in pack sizes of 1 or 5 vials.

Terlipressin Acetate 0.2 mg/ml, solution for injection

It is available in glass ampoules of 5 ml or 10 ml in pack sizes of 1 or 5 ampoules.

It is available in glass vials of 5 ml or 10 ml in pack sizes of 1 or 5 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Farmak Pharmaceuticals UK Ltd

First Floor, 47 Queen Street, Hull, HU1 1UU, United Kingdom

This leaflet was last revised in January 2026.