Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Terlipressin Acetate 0.12 mg/ml solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Terlipressin acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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.
How to take it
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.
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.
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. 5009001914
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.
22 Apr 2025
Title Leaflet GLYPRESSIN sol for inj 1mg amp 5x 8.5ml Ferring Item N° 5009001914 TPM Item N° N/A Proof N° 02 F-MS N° 3003 Barcode N° 5009001914 Colours P Pro Black.
Perigord N° 879194 Approving Country(ies) GB Dimensions 180×585 mm Perforation pre-cut
Frequently asked questions about Terlipressin Acetate 0.12 mg/ml solution for injection
How do I take Terlipressin Acetate 0.12 mg/ml solution for injection?
Terlipressin Acetate 0.12 mg/ml solution for injection comes as injection containing 0.12mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Terlipressin Acetate 0.12 mg/ml solution for injection?
The active substance in Terlipressin Acetate 0.12 mg/ml solution for injection is terlipressin acetate.
Are there equivalent medicines to Terlipressin Acetate 0.12 mg/ml solution for injection?
Medicines with the same active substance, strength and form include: Terlipressin acetate 0.12 mg/ml solution for injection. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Terlipressin Acetate 0.12 mg/ml solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Terlipressin Acetate 0.12 mg/ml solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: terlipressin acetate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Glypressin is indicated in the treatment of bleeding oesophageal varices.
4.2. Posology and method of administration
Posology
In acute variceal bleeding:
Adults:
Initially an i.v. injection of 2 mg Glypressin is given every 4 hours. The treatment should be maintained until bleeding has been controlled for 24 hours, but up to a maximum of 48 hours. After the initial dose, the dose can be adjusted to 1 mg i.v. every 4 hours in patients with body weight < 50 kg or if adverse effects occur.
Paediatric population:
There is no relevant use of Glypressin in paediatric population.
Method of administration Intravenous injection use
4.3. Contraindications
Contraindicated in pregnancy.
Hypersensitivity to terlipressin or any other excipients of the product.
4.4. Special warnings and precautions for use
Monitoring during treatment During treatment regular monitoring of blood pressure, ECG or heart rate, oxygen saturation, serum levels of sodium and potassium, as well as fluid balance are required.
Particular care is required in the management of patients with cardiovascular or pulmonary disease since terlipressin may induce ischaemia and pulmonary vascular congestion.
Caution should also be exercised in treating patients with hypertension.
Injection site reaction
To avoid local necrosis at the injection site, the injection must be given i.v.
Septic shock
In patients with septic shock with a low cardiac output Glypressin should not be used.
Skin necrosis
During post-marketing experience with terlipressin several cases of cutaneous ischaemia and necrosis unrelated to the injection site have been reported (see section 4.8). Patients with diabetes mellitus and obesity seem to have a greater tendency to this reaction. Therefore, caution should be exercised when administering terlipressin in these patients.
Torsade de pointes
During clinical trials and post-marketing experience, several cases of QT interval prolongation and ventricular arrhythmias including “Torsade de pointes” have been reported (see section 4.8). In most cases, patients had predisposing factors such as basal prolongation of the QT interval, electrolyte abnormalities (hypokalemia, hypomagnesemia) or medications with concomitant effect on QT prolongation. Therefore, extreme caution should be exercised in the use of terlipressin in patients with a history of QT interval prolongation, electrolyte abnormalities, or concomitant medications that can prolong the QT interval (see section 4.5).
Children and the elderly: Particular caution should be exercised in the treatment of children and elderly patients, as experience is limited in these groups.
There is no data available regarding dosage recommendation in these special patient categories.
4.5. Interaction with other medicinal products and other forms of interaction
The hypotensive effect of non-selective beta-blockers on the portal vein is increased with terlipressin. Concomitant treatment with medicinal products with a known bradycardic effect (e.g. propofol, sufentanil) may lower the heart rate and cardiac output. These effects are due to reflexogenic inhibition of cardiac activity via the vagus nerve due to the elevated blood pressure.
Terlipressin can trigger “torsade de pointes” (see sections 4.4 and 4.8). Therefore, extreme caution should be exercised in the use of terlipressin in patients with concomitant medications that can prolong the QT interval, such as class IA and III antiarrhythmics, erythromycin, certain antihistamines and tricyclic antidepressants or medications that may cause hypokalaemia or hypomagnesemia (e.g. some diuretics).
4.6. Fertility, pregnancy and lactation
Pregnancy
Treatment with Glypressin during pregnancy is contraindicated (ref. 4.3 and 5.3).
Glypressin has been shown to cause uterine contractions and increased intrauterine pressure in early pregnancy and may decrease uterine blood flow. Glypressin may have harmful effects on pregnancy and foetus.
Spontaneous abortion and malformation have been shown in rabbits after treatment with Glypressin.
Breast-feeding
It is not known whether terlipressin is excreted in human breast milk. The excretion of terlipressin in milk has not been studied in animals. A risk to the suckling child cannot be excluded. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with terlipressin should be made taking into account the benefit of breast-feeding to the child and the benefit of terlipressin therapy to the woman.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
4.8. Undesirable effects
Summary of safety profile
The most frequently reported undesirable effects in clinical trials are abdominal pain, nausea, diarrhoea, pallor, vomiting, and bradycardia.
Table: Frequency of undesirable effects
SYSTEM ORGAN CLASS
Frequency
VERY COMMON
>1/10
COMMON
≥1/100 to <1/10
UNCOMMON
≥ 1/1,000 to < 1/100
FREQUENCY NOT KNOWN*
Metabolism and nutrition disorders
Hyponatraemia
Nervous system Disorders
Headache
Cardiac disorders
Chest pain
Bradycardia
Tachycardia
Atrial fibrillation
Myocardial infarction
Torsade de pointes
Cardiac failure
Ventrical extrasystoles**
Vascular disorders
Vasoconstriction
Peripheral ischaemia
Pallor
Hypertension
Cyanosis
Hot flush
Respiratory thoracic and mediastinal disorders
Pulmonary oedema
Dyspnoea
Respiratory failure
Respiratory distress
Gastrointestinal disorders
Abdominal Pain
Diarrhoea
Nausea
Vomiting
Intestinal ischaemia
Skin and subcutaneous tissue disorders
Skin necrosis (unrelated to the site of administration)**, ***
Pregnancy, puerperium and perinatal conditions
Uterine hypertonus
Reproductive system and breast disorders
Uterine ischemia
General disorders and administration site disorders
Injection site necrosis
* Frequencies of these adverse events cannot be estimated from the available data
** Adverse reactions identified from post-marketing sources are presented by frequency category based on a theoretically calculated frequency if not observed in clinical trials
*** See section 4.4 for further information
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
The recommended dose in the specific patient population should not be exceeded as the risk of severe circulatory adverse effects is dose-dependent.
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Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.