Terlipressin sun
Poland
Table of Contents
Package leaflet: Information for the user
Terlipressin SUN, 0.1 mg/mL, solution for injection
Terlipressinum
Please read all of this leaflet carefully before using this medicine because it contains
important information for the patient.
- Keep this leaflet, as you may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.
Leaflet contents:
- What Terlipressin SUN is and what it is used for
- What you need to know before using Terlipressin SUN
- How to use Terlipressin SUN
- Possible side effects
- How to store Terlipressin SUN
- Contents of the pack and other information
1. What Terlipressin SUN is and what it is used for
Terlipressin SUN is a synthetic pituitary hormone.
Terlipressin SUN is used in the treatment of bleeding from dilated veins in the upper gastrointestinal tract leading to the stomach (oesophageal variceal bleeding).
2. Important information before using Terlipressin SUN
When not to use Terlipressin SUN
- if the patient is allergic to terlipressin or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
This medicine will be prescribed to the patient if they have severe or life-threatening bleeding in the gastrointestinal tract (oesophagus). The medicine should be administered under continuous monitoring of the patient's heart and circulation.
If able, the patient should inform the doctor if any of the following conditions apply:
severe infection called septic shock;
bronchial asthma or other diseases affecting breathing;
acute coronary syndromes (ACS), which are symptoms related to poor blood flow to the heart muscle leading to heart attack, resulting in chest pain or angina;
untreated or poorly controlled high blood pressure, insufficient blood circulation in the heart vessels (e.g. angina), history of heart attack (myocardial infarction), narrowing of blood vessels (atherosclerosis);
irregular heartbeat (heart rhythm disorders);
poor blood circulation in the brain (e.g. stroke) or in the limbs (peripheral vascular disease);
impaired kidney function (kidney failure);
disturbances in blood electrolyte levels;
reduced fluid volume in the circulatory system or significant blood loss;
age over 70 years;
pregnancy.
Children and adolescents
Terlipressin SUN is not recommended for use in children and adolescents due to lack of experience in this age group.
Terlipressin SUN and other medicines
Tell your doctor or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor immediately if the patient is taking any of the following medicines:
- medicines affecting heart rhythm (e.g. so-called beta-blockers or propofol);
- medicines that may cause irregular heart rhythm (heart rhythm disorders), such as:
Class IA (quinidine, procainamide, disopyramide) and Class III (amiodarone, sotalol, ibutilide, dofetilide) antiarrhythmic drugs;
an antibiotic called erythromycin;
antihistamines (used mainly in allergy treatment, but also included in some cough suppressants and cold remedies);
tricyclic antidepressants used in the treatment of depression;
medicines that may cause disturbances in blood salt or electrolyte levels, particularly diuretics (water tablets used in the treatment of high blood pressure and heart failure).
Pregnancy and breastfeeding
Terlipressin SUN may be used only if the doctor considers it necessary.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
It is not known whether terlipressin passes into human milk, therefore any potential effect on the infant is unknown. Possible risks to the infant should be discussed with the doctor.
Driving and operating machinery
No studies have been conducted on the effects of this medicine on the ability to drive or operate machinery. However, if the patient feels unwell after receiving the injection, they should not drive or operate machinery.
Terlipressin SUN contains sodium
This medicine contains 15.7 mmol (or 361 mg) of sodium per dose. This should be taken into consideration for patients on a controlled sodium diet.
3. How to use Terlipressin SUN
This medicine must always be used exactly as directed by the physician. In case of doubt, consult
your doctor.
Dosage of Terlipressin SUN
Adults
Initially, 1 to 2 mg of terlipressin acetate (corresponding to 8.5 to 17 mL of solution for injection) administered as a slow intravenous injection. The dose depends on the patient's body weight.
After the initial injection, the dose may be reduced to 1 mg of terlipressin acetate (corresponding to 8.5 mL of solution) every 4 to 6 hours.
The maximum daily dose is 120 micrograms per kilogram of body weight.
Use in elderly patients
If the patient is over 70 years of age, they should speak with their doctor before using Terlipressin SUN.
Method of administration
Terlipressin SUN must be administered as a slow intravenous injection.
Duration of treatment
Use of this medicine is limited to 2–3 days, depending on the course of the disease.
Use of a higher than recommended dose of Terlipressin SUN
Do not exceed the recommended dose. If too high a dose is administered, a sudden increase in blood pressure may occur, particularly in patients who already have pre-existing hypertension. In such a case, the patient will be given another medicine called an alpha-blocker (e.g. clonidine) to regulate blood pressure.
Inform the doctor if dizziness, vertigo, or fainting sensations occur, as these may be symptoms of bradycardia. This can be treated by administering another medicine called atropine.
Missed dose of Terlipressin SUN
Terlipressin SUN will be administered in a hospital setting under strict medical supervision.
Stopping Terlipressin SUN
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects which require attention and actions to be taken
Severe side effects may occur very rarely during treatment with this medicine. Immediately consult a doctor, if possible, if any of the following symptoms occur in the patient. The doctor should advise discontinuation of terlipressin treatment.
Severe shortness of breath due to an asthma attack, severe breathing difficulties or respiratory arrest, severe chest pain (angina pectoris), severe and persistent heart rhythm disturbances, skin necrosis around the injection site, seizures (seizure attacks), renal failure.
Other possible side effects
Common (affects less than 1 in 10 people):
- headache
- very slow heart rate
- signs of inadequate blood circulation in the coronary vessels, visible on ECG
- high blood pressure
- low blood pressure
- inadequate blood circulation in the arms, legs and skin, skin pallor
- abdominal cramps
- diarrhoea
Uncommon side effects (may affect less than 1 in 100 people):
- too low sodium concentration in blood (hyponatremia), if not monitored
- skin necrosis in areas other than the injection site
- sudden increase in blood pressure
- too fast heart rate (palpitations)
- tissue swelling or presence of fluid in the lungs
- chest pain
- myocardial infarction
- excessive accumulation of fluid in the lungs
- heart rhythm disturbances of the type torsade de pointes
- insufficient blood supply to the intestines
- uterine contractions
- reduced blood flow in the uterus
- blue discoloration of the skin or lips
- hot flushes
- transient nausea
- transient vomiting
- inflammation of lymphatic vessels (visible as small red streaks under the skin extending from the affected area towards the armpit or groin, accompanied by fever, chills, headache and muscle pain)
Rare side effects (may affect less than 1 in 1,000 people):
- shortening of breath
Very rare (may affect less than 1 in 10,000 people):
- too high blood sugar concentration (hyperglycaemia)
- stroke
Frequency not known: cannot be estimated based on available data
- uterine contractions
- decreased blood supply to the uterus
Reporting of side effects
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps to provide more information on the safety of the medicine.
5. How to store Terlipressin SUN
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and the ampoule
following the abbreviation "EXP:". The expiry date refers to the last day of the stated month.
Store in a refrigerator at 2°C – 8°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the
environment.
6. Contents of the pack and other information
What Terlipressin SUN contains
- The active substance is terlipressin (as terlipressin acetate). Each ampoule contains 0.85 mg of terlipressin as 1 mg of terlipressin acetate in 8.5 mL of injection solution. Each mL contains 0.1 mg of terlipressin as 0.12 mg of terlipressin acetate.
- The other ingredients are: sodium acetate trihydrate, sodium chloride, glacial acetic acid (for pH adjustment), and water for injections.
What Terlipressin SUN looks like and contents of the pack
Terlipressin SUN is a clear, colourless solution for injection, free from visible particles.
The Terlipressin SUN pack contains 5 ampoules.
Marketing Authorisation Holder:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Manufacturer/Importer:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
S.C Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Romania
For further information and details on the names of the medicinal product in other Member States of the European Economic Area, please contact the representative of the Marketing Authorisation Holder.
The following information is intended for healthcare professionals only:
INFORMATION FOR HEALTHCARE PROFESSIONALS
Further information is available in the Summary of Product Characteristics.
Administration of Terlipressin SUN
Terlipressin is administered in emergency cases of acute bleeding from oesophageal varices until endoscopic therapy becomes available. Further use of terlipressin in the treatment of oesophageal varices is usually complementary to endoscopic haemostasis.
Adults
The recommended initial dose is 1 to 2 mg of terlipressin acetate (corresponding to 8.5 to 17 mL of solution), administered as a slow intravenous injection.
Depending on the patient's body weight, the dose may be adjusted as follows:
- body weight below 50 kg: 1 mg terlipressin acetate (8.5 mL)
- body weight from 50 kg to 70 kg: 1.5 mg terlipressin acetate (12.75 mL)
- body weight above 70 kg: 2 mg terlipressin acetate (17 mL)
After the initial injection, the dose of terlipressin acetate may be reduced to 1 mg every 4 to 6 hours.
The approximate maximum daily dose of Terlipressin SUN is 120 micrograms of terlipressin acetate per kilogram of body weight.
Treatment should be limited to 2–3 days, depending on the course of the disease.
1 to 2 mg of terlipressin acetate corresponds to 0.85 mg to 1.7 mg of terlipressin.
Elderly
Terlipressin should be used with caution in patients over 70 years of age.
Children and adolescents
The use of terlipressin in children and adolescents is not recommended due to insufficient data on safety and efficacy.
Renal impairment
Terlipressin should be used with caution in patients with chronic renal failure.
Hepatic impairment
Dose adjustment is not required in patients with hepatic impairment.
Pharmaceutical incompatibilities
The medicinal product must not be mixed with other medicinal products, as compatibility studies have not been conducted.