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 1 mg Powder and solvent for 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 Injection consists of a powder and solvent for solution for injection. 1. Acetate Injection is and what it acetate. is used for TheWhat white,Terlipressin freeze-dried powder contains terlipressin 2. Before you use Terlipressin Acetate Injection Terlipressin Acetate Injection is used inisthe treatment of bleeding oesophageal varices. 3. How Terlipressin Acetate Injection administered Bleeding oesophageal 4. Possible side effectsvarices are enlarged blood vessels that form in the stomach or oesophagus as aTerlipressin complication of liverInjection disease. They may burst and bleed and this is a 5. How to store Acetate serious and life-threatening 6. Contents of the pack andcondition. other information When injected into the bloodstream, the active ingredient, terlipressin acetate is
broken down to release a substance called lysine vasopressin. This acts wallsFOR 1. WHAT TERLIPRESSIN ACETATE INJECTION IS AND WHAT ITon ISthe USED of the blood vessels, causing them to narrow and restrict the blood flow to the affected Terlipressin Injection consists of a powder and solvent for solution for injection. veins so thatAcetate bleeding is reduced. The white, freeze-dried powder contains terlipressin acetate. Terlipressin Injection is used in the ACETATE treatment ofINJECTION bleeding oesophageal varices. 2. BEFOREAcetate YOU USE TERLIPRESSIN
Bleeding oesophageal varices are enlarged blood vessels that form in the stomach or Terlipressin Acetate Injectionofshould not beThey used: oesophagus as a complication liver disease. may burst and bleed and this is a •serious if youand arelife-threatening pregnant condition.
- if you are allergic to terlipressin acetate or any of the other ingredients of When injected into the bloodstream, the 6. active ingredient, terlipressin acetate is Terlipressin Acetate listed in section broken down to release a substance called lysine vasopressin. This acts on the walls Please consult yourcausing doctor them before Acetate is to administered of the blood vessels, to Terlipressin narrow and restrict theInjection blood flow the affected to you: veins so that bleeding is reduced.
- if you have hypertension (high blood pressure)
- if you have a heart condition (such as an irregular heart beat) 2. BEFORE YOU USE TERLIPRESSIN ACETATE INJECTION
- if you have heart or lung disease e.g. coronary insufficiency (a condition in which the arteries ofAcetate the heartInjection become should hardened, or blocked leading to an insufficient Terlipressin notnarrow be used: supply to the heart muscle)
- ifblood you are pregnant haveallergic diabetes
- if you are to terlipressin acetate or any of the other ingredients of
- Terlipressin if you have atherosclerosis disease6.of the arteries in which fatty plaques develop Acetate listed in(asection on the inner linning of the arteries, preventing blood from flowing normally) Please Terlipressin Acetate Injection administered
- if youconsult have a your septicdoctor shock,before a serious condition that occurs when a is major infection to you: leads to low blood pressure and low blood flow. •• ifif you (high blood pressure) you have have hypertension diabetes
- if you have a heart condition (such as an irregular heart beat) If any of the above apply to you (or you are not sure) talk to your doctor or nurse before
- if you have heart or lung disease e.g. coronary insufficiency (a condition in which the you are given Terlipressin Acetate. arteries of the heart become hardened, narrow or blocked leading to an insufficient blood supply to the heart muscle) Taking with other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other
- if you have atherosclerosis (a disease of the arteries in which fatty plaques develop medicines, including medicines obtained without a prescription. on the inner linning of the arteries, preventing blood from flowing normally) •Please if youinform have ayour septic shock,immediately a serious condition that occurs a major infection doctor if you take any of when the following medicines: leads to can low blood pressure andbeating low blood flow.heart (arrhythmia) such as the Drugs that trigger irregular of the •following: if you have diabetes anti-arrhythmic drugstoknown Class (quinidine, If• any of the above apply you (orasyou areIAnot sure) talkprocainamide, to your doctordisopyramide) or nurse before Class Terlipressin III (amiodarone, sotalol, ibutilide, dofetilide) you and are given Acetate.
- erythromycin (an antibiotic)
- antihistamines used to treat allergies but also found in certain cough and Taking with other(mainly medicines coldtell remedies) Please your doctor or pharmacist if you are taking or have recently taken any other
- tricyclic including antidepressants used to treatwithout depression medicines, medicines obtained a prescription.
- medicines that may alter the level of salt or electrolytes in your blood, particularly Please inform yourtablets doctorused immediately if you take any ofand theheart following medicines: diuretics (water to treat high blood pressure failure). Drugs that can trigger irregular beating of the heart (arrhythmia) such as the 5009001915 following:
- anti-arrhythmic drugs known as Class IA (quinidine, procainamide, disopyramide) and Class III (amiodarone, sotalol, ibutilide, dofetilide)
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.
How to store it
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.
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.
07 Apr 2025
Title Leaflet GLYPRESSIN powd and solv for sol for inj vial 5x 1mg Ferring Item N° 5009001915 TPM Item N° N/A Proof N° 01 F-MS N° 3015 Barcode N° 5009001915 Colours P Pro Black.
Perigord N° 879560 Approving Country(ies) GB Dimensions 130×300 mm Perforation pre-cut
Frequently asked questions about Terlipressin Acetate 1 mg Powder and solvent for solution for injection
How do I take Terlipressin Acetate 1 mg Powder and solvent for solution for injection?
Terlipressin Acetate 1 mg Powder and solvent for solution for injection comes as injection containing 1mg. 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 1 mg Powder and solvent for solution for injection?
The active substance in Terlipressin Acetate 1 mg Powder and solvent for solution for injection is terlipressin acetate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Terlipressin Acetate 1 mg Powder and solvent for 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 1 mg Powder and solvent for 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 acetate or any of the excipients listed in section 6.1.
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.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- ACETAT DE TERLIPRESINA EVER PHARMA 0,2 mg/ml prescriptionTERLIPRESSINUM · injection / infusion
- GLYPRESSIN prescriptionTERLIPRESSINUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- GlypressinTerlipressini acetas · injection / infusion
- Terlipressini acetas EVER PharmaTerlipressini acetas · injection / infusion
- Terlipressin SUNTerlipressinum · injection / infusion
- Terlipressin acetate AltanTerlipressini acetas · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Terlipressin Acetate 1 mg Powder and solvent for solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
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.