1 mg solution
for injection
terlipressin acetate
What Terlipressin SUN is and what it is used for
Terlipressin SUN is a synthetic pituitary hormone.
Terlipressin SUN is used to treat bleeding from veins in the esophagus, leading down to the stomach (bleeding oesophageal varices ).
The terlipressin contained in Terlipressin SUN may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have further questions, and always follow their instructions.
What you need to know before using Terlipressin SUN
Do not use Terlipressin SUN
- if you are allergic to terlipressin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
This medicine is given to you if you have serious or life-threatening bleeding in the gullet (esophagus).
It is given under continuous monitoring of your heart and blood circulation.
If you can, tell the doctor if you suffer from any of the following conditions:
- if you suffer from a severe infection called septic shock
- if you suffer from bronchial asthma or other conditions that affect your breathing
- if you suffer from acute coronary syndrome (i.e. symptoms caused by poor blood flow to the heart muscle leading to a heart attack. This results in chest pain, or angina pectoris .)
- if you suffer from uncontrolled high blood pressure, insufficient blood circulation in the vessels of the heart (e.g. angina), have previously had a heart attack (myocardial infarction), or if you have atherosclerosis ( arteriosclerosis )
- if you suffer from irregular heartbeats ( cardiac arrhythmias )
- if you have poor blood flow to the brain (e.g. if you have had a stroke ) or to the extremities ( peripheral vascular disease)
- if you suffer from reduced kidney function ( renal insufficiency )
- if you suffer from an imbalance in the levels of salts ( electrolytes ) in the blood
- if you suffer from dehydration or have already lost a large amount of blood
- if you are older than 70 years
- if you are pregnant.
Children and young people
Terlipressin SUN is not recommended for use in children and adolescents due to insufficient experience.
Other medicines and Terlipressin SUN
Tell the doctor or nurse if you are using, have recently used, or might be using other medicines.
Inform the doctor immediately if you are using any of the following medicines:
- medicines that affect the heart rate (eg beta blockers or protocol)
- medicines that can trigger irregular heartbeats ( arrhythmia ) such as e.g. following:
- antiarrhythmics called class IA ( quinidine, procainamide , disopyramide ) and class III ( amiodarone, sotalol, ibutilide, dofetilide)
- an antibiotic called erythromycin
- antihistamines (mainly used to treat allergies but also found in some cough and cold medicines)
- medicines used to treat depression called tricyclic antidepressants
- medicines that can change the level of salts or electrolytes in the blood, especially diuretics (used to treat high blood pressure and heart failure ).
Pregnancy and breastfeeding
Terlipressin SUN should only be used during pregnancy if the treatment is vital for you. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before being given this medicine.
It is not known whether Terlipressin SUN is present in breast milk. Therefore, possible effects on your child are not known. You should discuss the potential risk to your child with a doctor.
Driving ability and use of machinery
No studies have been carried out regarding the effects on the ability to drive vehicles and use machines. Therefore, you should not drive or operate machinery if you feel unwell after receiving an injection.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Terlipressin SUN contains sodium
This medicinal product contains 15.7 mmol (or 361 mg) of sodium per dose. This should be taken into account by patients prescribed a low-salt diet.
How to use Terlipressin SUN
This medicine is always administered by a doctor. Ask the doctor for further information regarding its use.
How much Terlipressin SUN is given
Adults
Initially, 1-2 mg of terlipressin acetate (equivalent to 8.5-17 ml solution for injection ) is given via injection into the vein. Your dose depends on your body weight. After the initial injection, the dose can be reduced to 1 mg of terlipressin acetate (equivalent to 8.5 ml of solution) every 4 to 6 hours.
The maximum dose you can receive each day is approximately 120 micrograms/kg body weight.
Older
If you are older than 70 years, you should talk to your doctor before you are given Terlipressin SUN.
How Terlipressin SUN is given
Terlipressin SUN should be injected slowly and intravenously.
How often you will be given Terlipressin SUN
Use is limited to 2-3 days depending on the course of your condition.
If you have used too much Terlipressin SUN
You must not use more than the recommended dose of Terlipressin SUN. If you get too much, your blood pressure can rise quickly, especially if you already suffer from high blood pressure. If this happens, you need another medicine called an alpha blocker (eg clonidine ) to control blood pressure, etc.
Tell the doctor if you feel dizzy or faint as this may be a sign of a low heart rate. This can be treated with a medicine called atropine.
If you forget to use Terlipressin SUN
You will be given Terlipressin SUN in the hospital under the doctor’s supervision.
If you stop using Terlipressin SUN
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important side effects or signs you should be aware of and measures to be taken if you are affected
Serious side effects are possible in very rare cases when you are given terlipressin. If you are affected by any of the following side effects, tell the doctor immediately if you can. The doctor should not give you more terlipressin.
Pronounced shortness of breath due to an asthma attack, great difficulty in breathing or cessation of breathing, pronounced pain in the chest (angina), pronounced and persistent irregular heartbeat, local dead skin ( necrosis ), convulsions (seizures), kidney failure.
Other possible side effects are
Common (may affect up to 1 in 10 people)
- headache
- too low heart rate
- signs of insufficient blood circulation in the heart vessels according to the ECG
- high blood pressure
- low blood pressure
- insufficient blood circulation in arms, legs, and skin, pale skin
- abdominal cramps
- diarrhea
Uncommon (may affect up to 1 in 100 people)
– too little sodium in the blood ( hyponatremia ) if not controlled
– dead skin ( necrosis ) in areas other than the injection site
– rapid increase in blood pressure et
– too high heart rate ( palpitations )
– swelling of tissue in the body or fluid in the lungs
– chest pains
– heart attack
– too much fluid in the lungs
– heart failure ( Torsade de pointes )
– insufficient blood flow to the intestines
– cramps in the uterus
– reduced blood flow to the uterus
– bluish discoloration of the skin or lips
– ramparts
– temporary nausea
– occasional vomiting
– inflammation of the lymph vessels (thin red streaks under the skin extending from the affected area to the armpit or groin with fever, chills, headache, and muscle pain).
Rare (may affect up to 1 in 1,000 people)
- shortness of breath
Very rare (may affect up to 1 in 10,000 people)
- too much sugar in the blood ( hyperglycemia )
- stroke
Unknown (cannot be calculated from available data)
– cramps in the uterus
– reduced blood flow to the uterus.
How to store Terlipressin SUN
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and ampoule one after Ex.date. The expiration date is the last day of the specified month.
Store in a refrigerator at 2°C–8°C.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is terlipressin in the form of acetate. Each ampoule contains 1 mg of terlipressin acetate in an 8.5 ml solution for injection, corresponding to 0.85 mg of terlipressin. This corresponds to 0.12 mg of terlipressin acetate per ml, corresponding to 0.1 terlipressin per ml.
- Other ingredients are sodium acetate trihydrate, sodium chloride, acetic acid (for pH adjustment), and water for injection.
Appearance and package sizes of the medicine
Terlipressin SUN is a clear, colorless solution for injection without visible particles.
Terlipressin SUN is packaged in a carton with 5 ampoules.
Sun Pharmaceutical Industries Europe BV
87 Polaris Avenue
2132 JH Hoofddorp
Netherlands
Manufacturer
Sun Pharmaceutical Industries Europe BV
87 Polaris Avenue
2132 JH Hoofddorp
Netherlands
SC Terapia SA
124 Fabricii Street
400632, Cluj-Napoca
Cluj Country
Romania
| This medicine is approved in the European Economic Area under the names: | |
| Denmark: | Terlipressin Acetate SUN |
| Germany: | Terlipressin SUN 0.1 mg/ml Injection solution |
| Finland: | Terlipressiini SUN 0.1 mg/ml injection test, liuos |
| France: | Terlipressin SUN 0.12 mg/ml, solution injectable |
| Italy: | Terlipressina SUN 0.1 mg/ml soluzione iniettabile |
| Netherlands: | Terlipressine SUN 0.1 mg/ml, oplossing voor injectionie |
| Norway: | Terlipressin SUN 1 mg injection, solution |
| Spain: | Terlipresina SUN 1 mg solución injectable EFG |
| Sweden: | Terlipressin SUN 1 mg solution for injection |
| UK: | Terlipressin acetate SUN 0.12 mg/ml solution for injection |